We would like to express our warmest appreciation for all those who helped to make this resource book possible.  

Above all, we wish to thank the book's authors.  As BU law students, Brandeis/SIDS MA students and ICLAD interns, the authors learned to use institutional legislative theory and methodology (ILTAM) to guide their search for relevant evidence and to organize the facts logically in research reports to justify their proposed bills' detailed provisions as likely to help improve all East Africans' health care.  The authors worked as a team to gather evidence, debate the relevant issues, and write their chapters.¹   They shared the hope that their work might facilitate the efforts of East Africans – more knowledgeable about East African realities – to assess and draft effectively implemented laws to alter or eliminate institutions that perpetuated East Africans' relatively short life expectancy.  In the process, they aimed to demonstrate the potentials – as well as the limits – of using law to facilitate democratic social change.

We wish to congratulate the staff of the International Consortium for Law and Development (see www.ICLAD-law.org) – especially Lorna Seitz, now ICLAD's Executive Director, and Laura Lucas, ICLAD's Director of Research – for setting up the summer programs which, through a learning-by-doing process, equipped ICLAD interns with the theoretical and practical tools to conduct relevant research and draft research reports and bills.   We also appreciate the comments and suggestions ICLAD's board members have made for improvement of the resource book and arrangements for the proposed workshop.

We are thankful the support of Dean Maureen O'Rourke and then Associate Dean, Gerald Leonard, of the Boston University School of Law (BUSL) for this project, and the establishment of future links with the African Parliamentary Knowledge Network (APKN).   In this connection, we particularly welcome the proposal by Prof. Sean Kealy – now head of BUSL's legislative program – to invite African law-makers to submit requests to BU's legislative drafting clinic to assign students to draft bills, justified by research reports, to help resolve a specific social problem in their countries.

We especially want to express our appreciation to Elizabeth Bakibinga-GaswagaBakibinga-Gaswaga (Principal Legislative Counsel, Parliament of Uganda and member the Executive Council, Commonwealth Association of Legislative Counsel) for taking the initiative in arranging the proposed EAC workshop on Health Legislation for which this book’s chapters will serve as a resource; Flavio Zeni (Chief Technical Adviser of Africa i-Parliaments Action Plan, United Nations Department of Economic and Social Affairs (UNDESA) in Nairobi, Kenya) for agreeing to co-sponsor, circulating the draft resource book, and helping to promote the on-going ‘learning-by-doing’ process hopefully sparked by this book and the workshop; the Hon. Speaker, Abdirahin Haithar Abdi, of the East African Legislative Assembly, for arranging for EALA support of the proposed workshop.

We also wish to thank Brian Quinn for providing the technical expertise for preparing the resource book's chapters, diagrams, maps, and tables, facilitating their exchange via the Internet with colleagues in the United States, East Africa, and throughout the world and making the final preparations for circulating the completed volume to all the participants in the EAC workshop and interested colleagues around the world.

And last, but by no means least, we want to express our real gratitude to Sue Morrison, our suite’s secretary.   She has always been helpful in the various projects on which we have worked.   In this case, however, she voluntarily undertook to copy edit this entire manuscript.  Once again, we are deeply in her debt.

ABOUT THE AUTHORS –

Robert B. Seidman and Ann Seidman, co-founders of ICLAD (www.ICLAD-law.org), work as Professors in the Boston University School of Law.  They taught for 12 years in African universities (Ghana, Nigeria, Tanzania, Zambia, Zimbabwe, and South Africa), and served as consultants for UNDP, USAID, DANIDA, and OECD for national workshops to strengthen legislative drafting capacity and law-making institutions in China, Bhutan, Indonesia, Vietnam, Laos, Guyana, Estonia, and several other countries.   The Seidmans co-authored  Legislative Drafting for Democratic Social Change: A Manual for Drafters (Kluwer, 2001; now available through ICLAD which has been published in 10+ languages, including Arabic, Chinese, Bahasa Indonesia) as well as other materials for use in country-based 'learning-by-doing' processes (see www.ICLAD-law.org) 
 
Abel Mote recently graduated Brandeis University after completing his master's degree in sustainable international development. Prior to this, Mote worked as a consultant with various NGOs in Kenya, Somalia and Somaliland. He has developed and implemented projects on human rights, and established legal resource centers for marginalized communities.  He has also researched and designed projects on education, culture and poverty reduction in East Africa.

Ali Ross

Carolyn Musyimi currently serves as president and co-founder of Children of Africa initiative; she also works with ICLAD to ensure formulation of laws that will enable East Africa to manufacture pharmaceuticals locally. She completed her Master's degree in International Sustainable Development at Brandeis University in May 2008. Prior to this she worked with World Vision Kenya and did a comprehensive research on HIV/AIDS at Kibera and Dandora in Nairobi, Kenya with the Baptist AIDS Response agency.  Musyimi completed her undergraduate work at Daystar University in Kenya with a double major in Communication and Community Development.
 
Joyce Richard holds a Master's degree in Public Health Nursing from Boston University, and a law degree, JD, from Northeastern University School of Law.  Richard's experience in nursing includes work as a nurse practitioner in an inner-city health center in Boston.  Richard's other interests include issues of access to health care and environmental problems which affect public health.  Following graduation from law school, she worked as an environmental consultant to major institutional investors, as well as the general practice of law. 

LaKeisha M. Applegate is currently working on a law degree from Boston University.  Applegate received a Bachelor's of Arts with Honors from Brown University in Anthropology in 2002.  Prior to law school, Ms. Applegate worked for four years as a Research Assistant at Columbia University for a neurologist.  Ms. Applegate received her Master's in Public Health from Columbia University in 2006.  While at Boston University School of Law, Ms. Applegate has focused her studies on health law and worked as the research assistant for Ann and Robert Seidman beginning in May 2008.  During the summer of 2009, Ms. Applegate will work as a Summer Associate at Reed Smith LLP.  Ms. Applegate will serve as an editor for the Africa Parliaments Clinics in 2009-2010.

Mia Levi, after graduating college, worked as an intern for ICLAD with a special focus on health issues.   She served as an organizer for the ICLAD Google Group that prepared the EAC resource book.  Prior to attending Fordham Law School for her JD, she will be working for a year in an attorney general's office.

Michael Javid focused his legal studies in Boston College School of Law on private and public international law, and served as an ICLAD intern in 2007.  He graduated law school in 2009.  Prior to law school, Javid worked as a strategy consultant in financial services. Michael completed his undergraduate work at Cornell University with a degree in Economics. 

Michael Kempster has a medical degree and worked as a surgeon for many years before acquiring his JD from Suffolk University's School of Law.   He participated as an editor and student instructor in the Boston University School of Law legislative drafting clinic, and has been working with the ICLAD on issues of law related to health.

Nisha Patel graduated from the Boston University School of Law with a JD in 2009.  While at BUSL, she focused her studies on corporate law and the law of developing nations.  She served as the Development Article Editor on the Review of Banking and Financial Law.  During the Fall 2008 semester, Ms. Patel studied abroad at Tsinghua University in Beijing, China. While at Tsinghua University, she studied Chinese Law including: Chinese Corporation Law; Chinese Investment Law; Chinese Constitutional Law; and Chinese Administration Law.  Patel received a Bachelors of Science in both Accountancy and Finance from the University of Illinois in 2003.  Before law school, she worked for three years as an Internal Audit Consultant.   She is currently an associate in the Corporate Department at Locke, Lord, Bissell & Liddell LLP in Chicago. 
Ruha Devanesan received her Bachelor's of Arts in Journalism and Political Science from Rutgers University in 2006.  While at Boston University School of Law, she has focused her studies on International Law and Legislative Drafting, working with ICLAD for two of her three years at BU.  She is also concurrently pursuing a Master's Degree in International Relations from the Boston University International Relations Department.  Upon graduation, Devanesan hopes to work in Legislative Drafting for Developing Countries or in International Development work, focusing on development in post-conflict nations and in South Asia.

The Editors

The majority of the people living in  the East African Community (EAC) – citizens of Burundi, Kenya, Tanzania, Rwanda and Uganda – experience difficulties in accessing affordable, efficacious medicines that could improve their life expectancy.  EAC countries have some of the world's lowest life expectancies.  This resource book explores some of the possibilities, as well as the limits, of designing legislation to help overcome their difficulties' historically shaped, institutional causes.

To underscore the reasons for undertaking this task, this chapter briefly summarizes the available evidence as to the leading indicators that illustrate the pervasive, if uneven, nature and scope of the five EAC member states' health problems.  It then reviews the colonial and post-colonial histories that contributed to shaping those states' health institutions.  Finally, it outlines the book's remaining chapters.  Using institutional legislative theory and methodology as a guide, each chapter offers examples of the possibilities and limits of designing and drafting evidence-based legislation to create new regional and state health institutions to help meet the Community's inhabitants' health needs.
 
A. Some indicators of the nature and scope of the East African region's health problems

Health and healthcare expenses may play a role in many families' economic life.  The World Health Organization estimates that "out-of-pocket payments for health care put patients in many countries in hardships, sometimes causing them financial catastrophes."² This section discusses health status indicators for the East African Community (EAC) nations of Burundi, Kenya, Tanzania, Rwanda, and Uganda and compares these indicators to developing and developed countries.  Although numerous indicators exist to assess a nation's healthcare system and the health of the general population, this section focuses on life expectancy, three communicable diseases, and child specific health status indicators.  Indicators such as the availability of healthcare workers, healthcare system funding and the availability of vital medications also provide useful tools in assessing the health of a country.  This chapter cannot address all of these indicators.   

1. Terminology

In order to understand each indicator, one must first understand the terminology used and the collection of data points.  Data for this chapter were collected from the World Health Organization (WHO), the International Monetary Fund (IMF), and the United Nations (UN)   WHO estimates a population's life expectancy as a measure to reflect the overall mortality level of the population and as a method to summarize the mortality pattern that prevails across all age groups.³  WHO calculates life expectancies from vital registration, census data, and surveys.⁴  An estimate for HIV prevalence includes all persons aged 15 years or older per 100,000 people in the population.⁵  WHO defines HIV prevalence as the percentage of people 15-49 who are HIV positive.  HIV prevalence data comes from antenatal clinic attendees and population based surveys.⁶ WHO calculates incidence of TB per 100,000 people in a population.  Estimating the incidence (cases arising in a given time period) of TB gives a suggestion of the burden of TB in a population.  Additionally, estimating TB incidence provides a glimpse of the size of the task faced by a national TB control program. "Incidence can change as the result of changes in transmission (the rate at which people become infected with the bacterium that causes TB), or changes in the rate at which people infected with this bacterium develop TB disease (e.g. as a result of changes in nutritional status or of HIV infection) "  TB incidence is estimated using case notification and death registration systems. 

2. Discussion

This section compares overall health of the population in the EAC nations along with those of developed and other developing nations.  All data comes from the WHO, the IMF, and the UN estimates. 

The authors chose these health indicators due to the indicator's ability to portray the overall health of a nation while also providing a marker that can compare nations' health easily.  Many societal forces contribute to life expectancy, including war, adequate nutrition and the healthcare delivery system.  "HIV and AIDS has become a major public health problem in many countries and monitoring the course of the epidemic and impact of interventions is crucial."⁷  Reducing HIV/AIDS prevalence is important to the Millennium Development Goals (MDG) and the United Nations General Assembly Special Session on HIV and AIDS (UNGAS); both organizations have set goals of reducing HIV prevalence.⁸ Malaria and TB, when left uncontrolled, can cause a great deal of unnecessary morbidity and mortality in a population.  A nation's medical infrastructure, the amount of accidents, and the impact on present or past wars, especially with regard to remaining land mines greatly impact child mortality.  Child mortality also decreases a nation's life expectancy.  Child mortality levels also speak to a country's future potential.  High child mortality rates reduce the number of adults able to become productive members of a nation, contributing to the work force, passing on cultural norms and contributing to the government's tax system.  
      
3. Health Status Indicators

a. Life expectancy

The social and economic health of the country plays an important role in the nation's life expectancy.  Adults pass cultural traditions on to the younger members of society and provide guidance. 

EAC nations' average life expectancy rate in 2003 was 46.2 years.  Kenya and Burundi represented the highest, 50 year, and lowest, 42 years, life expectancy rates respectively.  Of the 51 African nations counted in the WHO statistics, the average life expectancy rate, 50.7 years, was higher than that of the average for the five member states of the EAC.  The lowest life expectancy rate in all of Africa, Swaziland with 35 years, was lower than the lowest EAC life expectancy rate.  However, the highest life expectancy rate in all of Africa was 73 years with five nations in Africa having life expectancy rates of 70 years or more.  Twelve nations in South America reported 2003 life expectancy rates.  The average was 70.6 years.

In contrast, the average life expectancy for all of Asia, regardless of economic development, was nearly 21 years higher, 67 years, than the life expectancy for EAC member states.  Four out of the five or eighty percent of EAC nations had a life expectancy rate of less than 50 years.  Of the 41 Asian nations reporting life expectancies, only one, Afghanistan, had a life expectancy rate of less than 50 years.  Nineteen, nearly half, of Asian nations had a life expectancy rate of 70 years or more; two nations had life expectancy rates of 80 years or more.  The average life expectancy for the 40 European nations with estimates was 74.8 years.  Six European nations had life expectancies of at least 80 years.  Of those European nations counted, only six did not have a life expectancy of at least 70 years in 2003.  Developed nations had the highest life expectancies.  These life expectancy rates nearly doubled those of EAC nations.  Australia, Canada, France, Iceland, Israel, Italy, Japan, Spain, Sweden, and Switzerland all had life expectancy rates of 80 years or more.  

b.  Communicable Diseases

Transitional and developing countries frequently experience many communicable diseases that have been eradicated in developed nations.  Treating and preventing the spread of communicable diseases requires accurate reporting.⁹ Accurate reporting will allow health system administrators and governmental officials to develop treatment programs and public health legislation as well as to purchase the optimal amount of medications to combat the spread treatable diseases.¹⁰
    
WHO estimated HIV prevalence in EAC nations at 6.2 per 100,000 people in 2003.  Tanzania had the highest HIV prevalence among EAC nations with an estimate of 9 per 100,000 people.  Uganda had the lowest HIV prevalence, 4 per 100,000.  EAC member states have HIV prevalence rates similar to selected neighbors.  Democratic Republic of Congo and Ethiopia both have estimates of 4 HIV infections per 100,000.   Malawi, 14; Mozambique, 12; and Zambia 17 per 100,000 all have an HIV prevalence rate higher than the highest EAC nation.  The WHO website did not have an HIV prevalence for Somalia.  The United States had an HIV prevalence for the same time period far lower than all EAC nations, 1 per 100,000.  WHO estimated that Australia, New Zealand, Canada and several European nations had an HIV
prevalence less than 1 per 100,000.  Guyana and Suriname were the only South American nations reporting an HIV prevalence greater than one in 2003.  The highest estimates in Asia were in Cambodia and Thailand, 3 and 2 per 100,000 respectively. 

c.  Tuberculosis

Tuberculosis (TB) is another contagious disease.  TB, like the common cold, spreads through the air.¹¹ Only those sick with TB can spread the disease when coughing, talking, sneezing or spitting. "Left untreated, each person with active TB disease will infect on average between 10 and 15 people every year. But people infected with TB bacilli will not necessarily become sick with the disease."¹² The WHO estimates that one person in the world every second becomes newly infected with TB, one-third of the world's population currently has a TB infection, and that 5-10% of those with TB, but not HIV, become infections at some time during their life.¹³        

According to WHO estimates, the largest number of new TB cases in 2005 occurred in the WHO South-East Asia Region, which accounted for 34% of incident cases globally.¹⁴ However, the estimated incidence rate in sub-Saharan Africa is nearly twice that of the South-East Asia Region.  WHO data estimated that 1.6 million deaths resulted from TB in 2005.  The Africa Region had the highest number of TB deaths and the highest mortality per capita of the WHO regions.¹⁵ The TB epidemic in Africa grew rapidly during the 1990s, but this growth has been slowing each year, and incidence rates now appear to have stabilized or begun to fall.¹⁶
 
In 2003, Africa had the highest incidence of TB.  During this same time, the EAC nations had a TB incidence higher than the continental incidence.  The EAC represented 13%, or 907 cases, of all of Africa's reported TB cases in 2003.  Kenya and Burundi represented the highest and lowest, 262 cases per population 100,000 and 148 cases per population 100,000, respectively.  The middle three nations reported similar incident rates with an average of 166 cases per population 100,000.  The EAC had an incidence of 181.4 cases per 100,000.  The incidence of Europe, 17.2, including its transitional countries, US and Canada, 2, Australia, 4, and South America, 39.5, equal approximately one-third of all the new TB cases in EAC nations.      

d.  Malaria

The WHO has defined malaria as both a preventable and treatable disease.  However, according to WHO estimates more than one million people die of malaria every year, mostly infants, young children and pregnant women, and most of them in Africa.¹⁷  Parasites cause malaria.  The disease spreads among all age groups and between both genders.¹⁸  Untreated malaria can result in serious illness or death.  Transmission of the disease depends on such factors as, rainfall, proximity of mosquito breeding sites and mosquito species in the area.  "Some regions have a fairly constant number of cases throughout the year – these are 'malaria endemic'. In other areas there are 'malaria seasons' usually coinciding with the rainy season."¹⁹  According to the WHO, epidemics usually occur in areas where people have little contact with the parasite and in locations of complex emergencies or natural disasters.  Approximately, 40% of people, mostly those in the world's poorest countries, are at risk of malaria. Annually, more than 500 million people become severely ill with malaria. "Most cases and deaths are in sub-Saharan Africa. However, Asia, Latin America, the Middle East and parts of Europe are also affected."²⁰

The most recent data for malaria statistics differed between the EAC nations.  The most recent data for Burundi and Kenya came from 2002, while the most recent data for the remaining three nations came from 2003.  Comparing most-recent data, Uganda and Tanzania had the highest prevalence of malaria among the EAC nations.  

 

4.  Child Indicators

WHO has limited data for child underweight for all continents.  Data for EAC nations comes from differing years. The WHO website had no data for child underweight for Australia, Canada, United States, and most of Africa, Asia, Europe, and South America.  This may indicate unavailable or unreliable data.

Of the available data, Burundi reported the highest levels of child underweight measures.  Kenya reported the lowest rate of child underweight.  The average reported child underweight was 28.2 per 100,000 children.  The average EAC child mortality rate was 164.2 per 100,000 children.  Burundi reported the highest rate with 190 per 100,000 while Kenya reported the lowest rate, 123 per 100,000

B. Colonial and post-colonial histories' shaped EAC member states' existing health institutions – or their absence

In the centuries before they won political independence, all five EAC member states experienced various forms of colonial rule that dominated and shaped the health institutions – the hospitals and health providers – doctors and trained nurses who, for the most part, work in the major urban centers; the government agencies and pharmacies that import and distribute limited supplies of modern, high priced medicines, few of which reach remote rural areas; and the higher educational institutions, primarily located in the major urban centers, that provide training for managers, scientists, and medical personnel responsible for administering their national health systems.

Four distinctly different – and sometimes conflicting – colonial powers administered the emerging social, political and economic institutions (including the health systems) that shaped the lives of those living in the five nation-states that have joined the East African Community. Upon attaining independence, however, each nation inherited political-economic institutions that perpetuated the external dependence, poverty and vulnerability characteristic of the lives of the four fifths of the world's population that, today, receive only about 20 percent of the world's gross output.²¹   

More than a century ago, during the 'scramble for Africa' in the 1880s, both the British and Germans expanded their political, economic, and social influence in East Africa.²²  In 1910, the European Convention of Brussels fixed the borders of Uganda as a British sphere of influence; the Congo, as a Belgian colony; and Tanganyika and Ruanda-Urundi as German East Africa.  During World War I, Belgian forces advanced from the Congo into 'German East Africa.'   After Germany lost the war, the League of Nations, in 1923, mandated Belgium to govern Ruanda-Urundi along with the Congo; and Great Britain to rule Tanganyika and other German colonies.   

Kenya emerged as the trade and financial center of British-ruled East Africa. 
The British constructed a rail line to bring machinery, equipment, and consumer luxuries from the Mombasa port up through Nairobi to the region's fertile plateau to the British settler-farmers.  In turn, the settlers employed hundreds of thousands of low-paid African laborers to grow and ship agricultural produce back by rail to Mombasa and across the ocean to industrializing Europe.  The British built the railroad beyond Kenya's borders into Uganda to collect sacks of coffee and tea grown by African peasants for British companies to ship to European – especially British – consumers.  

After Germany’s defeat in World War I, the British took over and ruled then-Tanganyika  (now Tanzania) as part of its regional empire.²³  They used the German-built railroads to ship Tanganyikan tea, coffee and cotton, cultivated by European settler-farms and African peasants, to European markets.   In the 1920s, the British sought to cement its regional colonial rule by uniting Kenya, Uganda, and Tanganyika into the East African Common Market – the forerunner of the East African Community established in the late 20th Century after Independence and the downfall of the Ugandan dictator, Idi Amin.the EAC collapsed in 1977 partly because of Idi Amin who was still in power then. He was overthrown on 11 April 1979

Immediately after World War II Ruanda-Urundi had become a United Nations (UN) "trust territory" administered by Belgium.^[6]   The roots of Tutsi-Hutu conflict lie in the pre-colonial history of the Kingdom of Rwanda that spread from modern-day Rwanda into parts of modern-day Congo around Lake Kivu.  A highly organized society, that Kingdom had its own religion and creation myths.  Its citizens, the Banyarwanda – known even then for their military discipline – fended off attacks from outsiders and mounted raids into the lands west of Lake Kivu.  The three ethnic groups who populated the area – Hutus, Tutsis and Twas – lived in a semi-feudal relationship, paying tribute to the king and nobles who granted them various favors and protection.  Tutsi, who lost their cattle due to epidemics like Rinderpest, sometimes might be considered Hutu; Hutu, who obtained cattle, might climb the ladder of social strata to become viewed as Tutsis.   The Belgian colonialists, however, adopted measures that blocked this apparent social mobility.  They depended on the Tutsi aristocracy to collect taxes, expand the Tutsi labor system, and perpetuate Tutsi dominance in local administration.  In so doing, they helped to lay the basis for deep-rooted ethnic, even genocidal, conflicts.²⁴

In short, in East Africa as throughout most of the developing world, colonial political and economic institutions introduced and perpetuated lop-sided, externally dependent patterns of resource development that have condemn most East Africans, especially those living in remote rural areas, to poverty.  As elsewhere in the developing world, East African member states' health institutions  mirror their economies' distorted pattern of resource allocation: Hospitals, health training centers and universities, even the availability of imported medicines essential for limiting the ravages of HIV/AIDS, tuberculosis, and malaria – as well as the many other less widely known tropical diseases – remain primarily located in the higher-income urban areas that emerged over decades as centers of externally oriented production and trade.   The millions of impoverished East Africans still living in remote rural areas have little or no access, either to affordable essential medicines or to qualified health care providers to help them use those medicines safely and effectively.  This history shapes the health-related social problems to resolve which the authors of the chapters in this resource book sought to draft detailed legislation provisions.  The authors have accompanied their bills by research reports containing the relevant evidence, logically organized, to demonstrate that their bills' detailed provisions will likely prove effectively implemented, and help to resolve the health problems they target.

C. Designing laws to restructure EAC health institutions and help resolve EAC's persisting health problems

Using institutional theory, methodology, and techniques, the authors of this resource book's subsequent chapters have conducted research to provide logically organized relevant facts as the basis for designing a legislative program. In doing so, they have sought to illustrate the possibilities and limits of using evidence-based law²⁵ to transform the inherited health institutions that still negatively impact the impoverished majority of the regional inhabitant's length and quality of life. 

In Chapter 2, the Seidmans outline the institutional legislative theory, methodology, and techniques that guided the authors of the following chapters in designing and drafting their bills' detailed provisions, justified by carefully organized evidence.  That theory's roots lie in (1) legal realism's recognition that a law-in-action (a person's actual behavior) typically differs from a law-in-the-books; (2) the reality (underscored by Hans Kelson) that an effective law must prescribe appropriate new conforming behaviors, not only for the targeted set of social actors, but also for the responsible implementing agency's officials; (3) Sociology of Law's emphasis that the causes of a set of  social actors' problematic behaviors in the face of existing law lie the non-legal objective and subjective circumstances in which those actors live and work, as well as in the wording of the law itself; and (4) John Dewey's problem-solving methodology which offers a guide to legislative drafters engaged in gathering of relevant evidence required to design an evidence-based bill's detailed provisions to change problematic behaviors. Grounded on the experiences of legislative drafting teams in almost 40 countries worldwide,²⁶ institutional legislative theory's four-step, problem-solving methodology equips drafters to gather and organize the facts logically to justify the claim that their bill's detailed provisions likely will prove effectively implemented and ameliorate the social problem addressed.

In Chapter 3, Michael Kempster's draft research report aims to justify a bill to set up the proposed EAC Commission on Health as called for by the 2007 East African Community Summit meeting.²⁷ Following the four steps of institutional theory's problem-solving methodology, Kempster first briefly reviews the difficulties posed for the historically shaped East African Legislative Assembly and the member states' legislatures which confront the task of ensuring the drafting and enactment of the many detailed bills required to resolve the region's manifold health problems on the regional and member state levels. He specifies as problematic the law-making behaviors that contribute to those difficulties: In the face of the regionally distorted allocation of health resources, the law-makers of the separate member states as yet have no coordinated way of gathering the relevant evidence and coordinating the legislative drafting process to produce legislation logically likely, especially in remote rural areas, to:

• improve the process of importing (and eventually manufacturing) and distributing affordable essential medicines; and
• ensuring the creation, training and optimal allocation of the region’s health and resources to improve the health of all the Community’s inhabitants.

As required by problem-solving's second step, Kempster gathered the available evidence as to all the possible causes of each set of the relevant social actors' problematic behaviors (identified by the sociological term, 'role occupants.'²⁸)   In so doing, he provided the facts on the basis of which he logically designed and drafted the bill's detailed provisions for establishing an EAC Health Commission.

As called for by problem-solving's fourth step, Kempster incorporated in the bill a separate provision that specified the criteria and procedures for the essential process of monitoring and evaluating, after its enactment, the law's implementation and social impact.  In today's complex and always-changing world, even assuming the validity of the initial fact-gathering's results and efforts logically to design a law's detailed provisions, new problems will inevitably emerge.  In that sense, law-making inevitably constitutes an ongoing process.

The underlying premise, of course, remains:   Anyone – particularly the participants in a possible EAC workshop – who can provide better, more detailed, relevant information as to the nature and causes of problematic behaviors likely negatively to affect the East African Health Commission's potential for improving EAC health provisions, should do so.   Indeed, hopefully, this resource book will stimulate health professionals and legal experts to revise Kempster's report and bill to create a Health Commission logically more likely to prove effective in conducting research and drafting the kinds of bills required to implement a regional legislative health program.

Kempster's report and bill raise several questions which, in light of their deeper knowledge of East Africa's health problems, a workshop team might consider:

1. Who should appoint commission members, using what criteria and procedures, to ensure appropriate coordination and development of the relationships between EAC member states' and regional health care institutions?
2. Does the existing bill provide adequate criteria likely to ensure transparent, accountable and participatory decision-making procedures for ensuring the proposed Commission – essentially a new law-making institution for conducting research and drafting effective regional health legislation to help mobilize regional human, financial and physical resources – to overcome the EAC health care problems?  
3. Can the workshop team identify and answer other key questions?

In Chapter 4, Ruha Devanesan presents a draft research report to justify the details of a draft bill to establish an EAC regional government system for registering and licensing essential medicines for distribution throughout the region.  Following problem-solving's four steps, she first describes the nature and scope of the social problem that persists because the five EAC member  state governments have separate and quite different governmental systems for registering medicines sold in their countries.  This problem not only involves a duplication and possible wastage of personnel and financial resources, as well as aggravating delays that aggravate essential medicines' shortages.   It also discourages both domestic and international pharmaceutical firms – separately or as partners – from investing in much-needed manufacture and sale of essential medicines, at affordable prices, throughout the already substantial, and potentially expanding, East African market.²⁹  

Devanesan provides what limited evidence she could find to describe the relevant role occupants' problematic behaviors:  The member states' registration authorities who, without cooperating to share resources, find it difficult to finance and administer adequate registration services for their own countries; and their countries' relevant implementing agencies which, to date, have failed to find ways to cooperate to establish an effective regional registration and licensing system.

Devanesan formulates explanatory hypotheses suggested by the limited available evidence as to the objective and subjective causes of the responsible country-based role occupants' failure, despite seemingly significant potential benefits, to cooperate in setting up a regional registration system.  After considering several logically possible alternative legislative solutions, she proposes a bill to empower a joint regional registration agency to bring together experts from the five countries to conduct research and, building on the potential contributions of each, establish the joint Registration Authority.  

Devanesan's proposal poses two major sets of questions which the participants in the relevant team in an EAC workshop should consider:

1. The first set relates to need for more evidence to justify (and perhaps revise) Devanesan's choice of relevant role occupants:
   
   1. In the Drug Registration Authority [DRA] in each of the five EAC member states, does further evidence exist as to who  does what – including a responsible monitoring and supervisory agency – that seems 'problematic' and hinders effective coordination?
   2. Should the research report examine evidence relating to any other sets of role occupants' problematic behaviors and, if so, which ones?   [Note:  By definition, the existing problematic 'repetitive behavior patterns' comprise the 'institutions'³⁰ that a bill's detailed provisions presumably aim to change.]
2. A second set of questions, requiring more evidence, relates to the draft bill's detailed provisions:
   
   
   1. What relationship will exist between the proposed Regional Agency for establishing a regional system for registering medicines and the Regional Health Commission?
   2. Do the draft bill's detailed provisions adequately prescribe the criteria and procedures which will govern the relationships between existing national Drug Registration Authorities and the proposed Community Registration Authority?
   3. How will the law setting up the proposed Regional Registration Authority relate to the member states' existing national laws?  [Note:  This comprises a key theoretical and practical problem confronting all 53 African nation states:  How to restructure inherited institutions, initially shaped during decades of colonial rule, to facilitate regional—and perhaps, ultimately, continental cooperation?]

   Chapter 5 incorporates elements of three detailed draft research reports on the problems posed by the existing systems of distributing essential, effective medicines in Uganda, Rwanda, and Tanzania.  The author/drafters of these reports – Nisha Patel, Alison Ross, and Mia Levi, respectively – gathered and organized the relevant available evidence in separate research reports for each country according to institutional theory's four step problem-solving methodology.  They first summarized the relevant available evidence as to how the particular country's historically shaped health institutions – the patterns of behaviors of the relevant social actors – seem to contribute to the persistent inequitable distribution of medicines.³¹  Using institutional legislative theory as a guide, they structured the evidence according to its four-step problem-solving methodology.

   First, they described the nature and scope of the country's difficulties in attempting to distribute affordable, efficient medicines to all its inhabitants.  Since law can only help to solve social problems by changing the behaviors (the institutions) that comprise them, the authors then summarized the available facts as to the two sets of social actors in the nation's distribution chain whose problematic behaviors seemed to contribute to the problems: (1) The pharmacy and local health center personnel (the primary role occupants)  These appeared unable, especially in the rural areas, to avoid delivery delays and shortages, and sometimes sold expired (out-dated) medicines; and (2) the government implementing agencies responsible for appointing and overseeing the managers and employees of the national and provincial institutions, responsible for handling the import, storage and distribution of medicines, as well as the local drug stores and health centers which sell them to the final consumers – the patients.  In all three countries, the evidence indicated that both sets of role occupants experienced similar difficulties in trying to improve the quality and quantity of medicines available, especially in the rural areas.
   
   Secondly, since a law can only help to change problematic behaviors by eliminating their causes, the three authors formulated explanatory hypotheses to guide them in gathering the limited evidence available as to the objective and subjective causes of the responsible local, provincial and national authorities' problematic behaviors.³² Despite the relevant social actors' differing job titles in each country, not only their specific roles but also the causes of their problematic behaviors appeared quite similar:  The wording of each country's relevant Rule (the 'cage' of existing laws, whether enacted by the legislature, or in the form of regulations formulated and implemented by the responsible implementing agency) seemed vague, granting the role occupants discretion to decide to obey, or simply ignore the Rule.  In many cases, the role occupants' employment gave them the Opportunity to follow the rule, but they had neither the skills nor resources (the Capacity) to obey it.  
   
   In all three countries, limited numbers of sufficiently trained personnel, poor storage and maintenance facilities, inadequate record keeping, and delayed communications between national, provincial and local staff – all combined to aggravate their difficulties in overcoming the obstacles that chronically delayed deliveries and perpetuated outages and expiry of essential drugs.
   Not infrequently, the responsible implementing agency officials apparently failed to Communicate the Rules to the primary role occupants:  the drug store or health managers and center employees.  In all three countries, evidence suggests that some agency officials – not only poorly paid local employees, but even high-level administrators – found it in their Interest to profit by corruptly 'misallocating' high-value medicines.
    
   Throughout the national distribution chains, the relevant role occupants' Process for deciding what to do too often appeared non-transparent, non-accountable, and non-participatory.  Little evidence suggested that central decision-makers made significant efforts to justify their decisions to the broader community – especially to the 'poor and vulnerable'³³ majority – or even to take seriously that community's complaints about their decisions' impact on patients' access to essential medicines.  This may have reflected an historically shaped Ideology, that those with power 'know best' how to use it – and at all levels, those who made decisions concerning high-priced medicines apparently did have significant power in allocating them primarily to those who could afford to pay for  them.
   
   For problem-solving's third step – the logical formulation of a bill's detailed provisions to help reduce delays and loss of essential medicines – each author proposed very similar legislative measures.  Only two of the authors, however, found enough evidence to make even rough estimates of the extent to which the socio-economic benefits of enacting and implementing their proposed draft bills might – or might not – outweigh the socio-economic costs.  As seemed probable at all three steps, engaging people who live and work in each country appeared essential for making more realistic cost-benefit estimates.
   
   As required by problem-solving's fourth step, all three authors' research reports proposed that their bills incorporate a monitoring and evaluation mechanism to determine, after their enactment into law, whether the detailed provisions proved effectively implemented to ensure more equitable distribution of affordable, essential drugs to the impoverished majority of East Africans, especially in remote rural areas. 
   
   In short, in all three countries, the authors' reports revealed similar evidence as to similar difficulties, contributed to by similar sets of role occupants' behaviors which seemed caused by similar legal and non-legal constraints and resources.   To save space, therefore, the editors decided it made sense for this resource book to include only one of the research report – that of Uganda – in the text, with a brief appendix to summarize the differences found in the other two countries.  [If anyone who would like to read and compare all three reports, the editors will happily supply electronic versions of those for Rwanda and Tanzania.]
   
   Questions raised (and hopefully answered) by the relevant workshop team members during the proposed EAC workshop:

   1. What does the evidence, contained in the authors' research reports, suggest as to the significance of the nature and causes of the similarities and differences the role occupants' problematic 'behaviors' that plague EAC member state's existing distribution system?   
   2. After reviewing the available evidence, both in Chapter 5 and introduced by the workshop participants, what possibilities exist that a regional EAC agency, established by an EAC law, might facilitate the individual member states' efforts to ensure more equitable distribution of affordable, efficient drugs? For example:
      
      1. Could the five member countries increase their bargaining power to obtain those medicines in bulk form at a lower price by setting up a regional importing authority?
      2. Could all 5 nation states, working together, reduce the costs and improve the distribution of drugs from a regionally –administered, authority located at a coastal port, with good railroad connections to the interior land-locked member states?
      3. Would establishing a regional training center for all five countries' distribution personnel ensure better training at less cost per trainee than separate national training programs can provide?
      4. Might it prove possible to obtain additional savings of financial and human resources through cooperative regional efforts
   3. For enacting and implementing laws to improve the medicine distribution chains of Burundi, Rwanda, Uganda, Kenya, and Tanzania,  who will decide, by what criteria and procedures, on the appropriate relationships between the laws of the nation states and the EAC/EALA? 
   4. In Chapter 6, Abel Mote and Joyce Richards, based on their own field research, explore two alternative models for designing national and/or regional legislation to strengthen the role of rural health providers working in the very different circumstances prevailing in Kenya and Rwanda.  Mote examines in detail the nature and causes of difficulties experienced by rural health providers in seeking to provide health services by working with mobile units in remote rural regions of Kenya.   Richards describes the efforts of Partners in Health to train rural health providers to improve rural health services in one of Rwanda's poorest provinces.
        
      Questions raised for the workshop discussions (and hopefully answered) by the relevant workshop team members:    
      
      1. What evidence exists as to the difficulties rural health service providers experience in trying to help rural dwellers gain access to, and successfully use, essential, affordable medicines and health services?
      2. To what extent, and how, might a regional EAC program help to equip rural health service providers to assist rural EAC inhabitants to gain greater access to and use affordable, efficient medicines to improve the quality of their lives and life expectancy?
      3. What other kinds of regional EAC health institutions might the EAC Legislative Assembly establish to help strengthen specific aspects of member states' rural health services?
      4. What other questions might the workshop team consider?

      In Chapter 7, Arthur Rugango describes his research designed to assess a new agricultural extension agency's efforts to assist small farmers to increase their production and sale of food crops.  This project comprised an important counterpart of the Partners in Health program to improve rural dwellers' nutrition as an essential foundation for an effective health program. 

      Questions for workshop team members to consider (and perhaps answer) during their discussions:   

      1. Why should a legislative program to improve EAC regional and member state health care in the region's rural areas include a bill to improve small farmers' agricultural productivity?
      2. What, if any, additional questions might Rugango have asked to make a more useful assessment of the existing agricultural extension agents' efforts?
      3. What further research might help to lay a basis for drafting national and/or East African Legislative Assembly (EALA) legislation to strengthen agricultural extension efforts to help small farmers in remote areas increase their production and sale of essential food crops?

      In Chapter 8, Carolyn Musyimi describes the potential, as well as the obstacles, for manufacturing essential medicines within the enlarged regional market. Focusing her analysis on Kenya's pharmaceutical industry, she describes its limited manufacturing capacity. The few pharmaceutical manufacturing that currently exist in Kenya remain clustered around the nation's major urban center, Nairobi.  Owned by transnational pharmaceutical or generic companies, sometimes in partnership with Kenyan entrepreneurs, these firms mainly import the essential medical ingredients, and combine and package them for sale at high prices that few Kenyans can afford.   
      
      In considering possible alternative legislative solutions, Musyimi observes that in the not-too-distant past, pharmaceutical manufacturing in both Cuba and India exhibited similar characteristics: shortages of skilled labor, capital, weak domestic financial institutions, insufficient foreign direct investment, weak legal and regulatory systems, and minimal research capacity.   Over time they trained personnel, acquired equipment, and eventually begun to manufacture pharmaceuticals locally.  This initiative, she suggests, led to several benefits, including cost cutting, creation of new jobs, and the production of essential medicines for local and international markets at affordable prices.  
      
      Musyimi concludes her analysis with a proposal for a bill to train more qualified medical professionals and scientists in Kenyan universities as an essential first step in strengthening national and regional pharmaceuticals production.
      
      Questions for workshop team members to consider (and perhaps answer) during their discussions:    

      1. Does the available evidence support Musyimi's analysis of the existing constraints that limit the growth of pharmaceutical manufacturing in the EAC region, and the importance of training and retaining health professionals and scientists in the region to spur the manufacture of affordable pharmaceuticals?
      2. Does the available evidence suggest that increased cooperation in the import and distribution of affordable medicines within the larger regional market might foster greater investment by joint national-international firms in EAC regional pharmaceuticals manufacture?
      3. What further evidence, gathered by whom, might contribute to designing legislation likely to facilitate increased manufacture of essential medicines in EAC member states?  

      In Chapter 9, Michael Javid describes some problems posed – according to some of the relevant literature – for countries seeking greater access to essential affordable medications by international institutions. These include transnational pharmaceutical companies which, to control global markets, seek to enforce patent rights; international donor agencies that, in helping developing countries access medicines, impose their own, sometimes counter-productive rules; developed countries' trade representatives that pressure developing country governments and the World Trade Organization (WTO) on behalf of 'their' transnationals.  For the most part, these remain outside of the purview of national, and perhaps even regional, legislation.  Nevertheless, Javid suggests, regional law-makers should work together to design detailed bills as part of a regional legislative program to improve their peoples' access to affordable, efficient medications.
      
      Questions for workshop team members to consider (and perhaps answer) during their discussions: 

      1. What evidence exists relating to the problems Javid suggests may affect member states' efforts to deal with transnational pharmaceuticals in purchasing essential medicines? How and to what extent might the EALA develop legislation to alleviate those problems?    
      2. What evidence exists as to problems EAC member states experience in dealing with international donor agencies providing assistance in obtaining affordable essential medicines?  How and to what extent might the EALA develop legislation to alleviate those problems?

      In Chapter 10, the editors summarize and draw conclusions about the potential for using facts and logic to design an effective EAC legislative program for health.  Again, they emphasize that participants in the proposed workshop should raise questions as to the possibilities of designing and drafting legislative programs to transform the historically shaped institutions that obstruct good governance and development in the context of today's increasingly interrelated and rapidly changing global realties.

Ann Seidman and Robert B. Seidman

INTRODUCTION

The Africa Parliamentary Knowledge Network (APKN) underscores the importance of drafting 'evidence-based legislation.'  Some hold that constitutes an impossible task.³⁴   This chapter not only explains why drafting evidence-based legislation proves possible, it offers a theory and methodology to guide drafters in drafting effectively implemented laws grounded on the relevant available evidence.

This resource book comprises a case study of the possibilities of using law to help improve the health care delivery systems of the East African Community's five member states.   Its chapters illustrate the potential use of theory,³⁵ methodology and techniques to gather evidence for designing legislation, and revising it in light of available evidence.   The book aims to enable the proposed workshop's participants to engage in assessing, and as necessary, in light of their own more in depth East African experience, redrafting the bills and reports.   By assessing these drafts and in the process deepening their understanding of these tools (and their limits) as guides, hopefully the workshop participants will contribute to creating a legislative program likely to help to lessen and ultimately overcome East Africa's health crisis.³⁶
   
As part of its underlying theme, this book centers attention on two interrelated skills a drafter requires to design transformatory legislation:  

1. A legislative theory and methodology to guide the process of conceptualizing whose and what behaviors³⁷comprise a targeted social problem; and those behaviors' causes.³⁸  In order to
2. induce new behaviors likely, in the country-specific circumstances, to help resolve the problem, a bill's detailed provisions must alter or eliminate those causes.³⁹
3. The social science skills necessary to gather relevant evidence.  That evidence purports to demonstrate that the hypothesized nature and causes of the problematic behaviors do in fact prove consistent with the evidence of the country-specific circumstances in which those behaviors arise.   That evidence constitutes the factual basis that a research report must provide to justify the bill's detailed provisions.    

(Note that this Chapter and indeed this entire sourcebook concern the instrumental use of law to transform problematic institutions. They do not concern drafting 'symbolic' law – i.e., law whose proponents desire only to see the law enacted – and never mind its behavioral consequences.) 

This Chapter begins by describing the social problem this Chapter addresses. Part I(A) first describes the surface appearance of the problem confronting a drafter in a developing or transitional country, and which evidence-based legislation aims to address: The loss of the Fatal Race, between populist governors, pledged to transform the received institutions, and those institutions' resistance to change.  Which would change the other? Part I(B) explains why legislative drafters have a central responsibility for the loss of that race, and the consequent failure of Development. Part I(C) describes the drafter's professional obligation to predict the behavioral consequences of proposed legislation – a professional duty towards which drafters seem notably derelict. 

That weak ability to carry out their professional responsibility accurately to predict the consequences of their proposed bills, and the consequent inability to draft bills that work constitutes the narrow social problem this chapter discusses. (In this chapter, legislation works if it both induces its prescribed behaviors, and those behaviors help to reduce the targeted social problem.) 

This chapter's Part II then explains why drafters so frequently fail to adequately fulfill their professional obligation to draft legislation that works.  Part III, the bulk of the Chapter, describes Institutional Legislative Theory and Methodology (ILTAM) which aims to guide drafters in producing evidence-based legislation.  Part IV, the Conclusion, demonstrates how the possibility of discovering post hoc that a newly implanted law will work opens, ex ante, the possibility of using evidence as a basis for estimating the probability that a proposed law probably will work. 

PART I
WHY THE WIDESPREAD FAILURE OF LIBERATION'S GOLDEN PROMISE?

A.The difficulty addressed: The too-frequent loss of the Fatal Race

In developing and transitional countries everywhere, liberation leaders invariably promise to exercise state power on behalf of their citizens. The first president of Ghana, the first newly independent sub-Saharan nation, Kwame Nkrumah, proclaimed what in effect became a mantra for populist parties everywhere: "Seek ye first political independence and all else will follow."⁴⁰ Too often, the world around, people lament, "we have good laws, but they remain unimplemented." 
 
New, populist governors did win state power.  Then began a Fatal Race. Would the new governors transform the received, colonialist, frequently racist institutions?  Or would those institutions co-opt the new, populist governors?

Almost everywhere, the institutions won.  Among the new, populist, anti-colonial rulers, few effectively used law – the primary instrument for the exercise of state power – to resolve their countries' social problems. In some, newly elected populist governors transferred their attention to lining their own pockets.  In others, powerful interests ousted those who persisted in trying to change dysfunctional systems.  Almost everywhere, new governments failed to fulfill promises of peace, a better quality of life, and effective, people-oriented governance.  Four-fifths of the world's populations still suffer poverty, vulnerability and poor governance. 

Why the gap between the new governors' promises, and the reality? To answer that question, we preliminarily explain why this resource book focuses on the role of the drafter.

B. The legislative drafters' role

Few academics study, far less seek, to strengthen the legislative drafter's capacity to design legislation to transform the institutions that perpetuate poverty and poor governance.  In most countries, the 'drafter' plays two roles.  Conventionally, the drafter puts pen to paper (or, now-a-days more realistically, struggles with a computer) to write out a bill's words. (Call that the 'scrivener' role.)   Most people see that as the drafter's primary, indeed her sole task.
 
The drafter in practice plays an equally, perhaps even more important second role that receives almost no recognition. (Many flatly deny it.) The instructions the drafter receives from the policy-maker rarely include the details required to make the bill work.  To draft a bill, a drafter must do more than merely write out the bill's wording.  Since the policy-maker's instructions typically omit the bill's substantive details as to who must do what to implement the proposed law, in order to draft its words the drafter has no choice but to design those substantive details. Call that the 'bill-designer' role.) That role circumstances thrust, willy-nilly, on the drafter.

The bill-designer role compels the drafter to go far beyond that of scrivener, assuming a position vis-à-vis the policy-maker resembling that of the architect vis-à-vis the client.  Consider:

A family decides on a new 'policy' to obtain a new house.  At that point, if asked to describe what they mean by the policy, the family members answer only in general terms:  "Well, you know, a house, a place to live."  They consult an architect.  They discuss budget, required rooms, styles of architecture, and much more.  In time, the architect produces detailed plans and specification – i.e., detailed instructions to the builder.   Now, asked what they mean by their family 'policy', the family points to the plans and specifications.  Who 'designed' the family's policy, the family – or the architect?  Or both together?

In the same way, in the bill-designer role, a drafter inevitably must specify the detailed instructions to both sets of law's addressees (i.e., the primary actors and implementing agencies). So to do ineluctably contributes to policy-making.  In drafting legislation that works, the bill-designer role proves important – with respect to development-related legislation, all-important.  This resource book aims to illustrate the use of theory to guide drafters in their role as bill-designers of evidence-based legislation to improve the East African health care delivery system.

Too often, those who drafted development-related legislation designed laws that failed to work. That violated the essence of the drafter's professional responsibility and the corresponding professional ethical obligation.

C. The drafter's professional responsibility: to predict behavior in response to proposed legislation

Throughout society, where one person employs another in circumstances in which the client has no choice but to rely on the good faith and competence of the other, a 'fiduciary' duty arises.  As a patient, I must rely on my physician's advice and discretion.  The physician therefore has a fiduciary obligation to give me competent advice in good faith.   So also with lawyers:  A client relies on the advice and discretion of a lawyer; in turn, the lawyer has a corresponding fiduciary duty to give competent advice to that client.

And so also a client who instructs a drafter to draft legislation addressing a specific social problem (or, alternatively phrased, to achieve a specific 'generalized' end):  The client instructs the drafter:  "Draft legislation to assure that every household has a readily available supply of clean, potable water," or alternatively, by a substantively similar instruction,  "Draft legislation to address the social problem that many homes do not have a readily available supply of clean, potable water."  The drafter fulfils the duty of competence by drafting a bill that works.  Whoever else works on the bill, the drafter has the final cut and, ex necessitate, must assume responsibility for the bill's provisions.  That implies that the drafter honestly believes (a) that those provisions will induce the behaviors prescribed; and (b) that those behaviors will reduce the social problem addressed – that is, that, after enactment and implementation, the new legislation will work.  By submitting the draft bill to the client, the drafter impliedly predicts those two outcomes.

D. Summary 

A draft bill implies that the drafter predicts that people will conform their behaviors to the new legislation's dictates.  The failure to use law to implement development promises, culminating in the widespread loss of the Fatal Race, testifies to the drafters' failure to make good on their predictions: The drafter too often drafts bills that do not work.  That constitutes the social problem ILTAM seeks to help resolve.  Part II explains the drafters' behaviors that contribute to that failure.

PART II
WHY DO DRAFTERS FAIL TO ACCURATELY TO PREDICT THE BEHAVIORS 'CAUSED' BY THEIR LAWS?

As a core task in development conditions, a drafter/bill-designer should use law instrumentally to transform existing, dysfunctional institutions.  Arising from the fiduciary obligation competently to serve the drafter's client/policy-maker, a drafter has a professional, ethical responsibility to draft bills that, when enacted and implemented, work   The loss of the Fatal Race testifies to the drafters' repeated failures to live up to that ethical imperative. This Part's Section A describes some academics' explanations that the instrumental use of law to attain development goals never had any possibility of working.  Sections B and C suggest alternative hypotheses to explain their failures.

A. Does instrumentalism prove inherently incapable of producing legislation that works?

As its basic thrust, ILTAM aims to guide drafters in designing laws as government's primary tool for facilitating social change.   Many, perhaps most legal academics, strongly object to that project. Putting to one side instrumentalism in adjudication, here we focus only objections raised to instrumentalism in legislation.⁴¹

1. The naysayers considered 
   Arguments abound denying the possibility or the desirability of instrumentalism in legislating.⁴²  Vermeule defines the instrumentalism of interest here as 'designed law,' that is, "legal rules that are produced by the deliberate or willful engineering of some official or set of officials."⁴³  Tamanaha declares that 'designed law' frankly, openly, and in blatant disregard to much academic opinion, uses legislation "as a means to an end."⁴⁴  
   
   Many scholars deny that government either can or should use law for instrumental purposes.⁴⁵  Some place their reliance on an ideal 'free market' economy.⁴⁶ A number of sociologists use alternate routes to reach the same conclusion.⁴⁷  For different reasons, other academics, too, condemn the very idea of using legislation instrumentally.⁴⁸
   
   Some, citing the Nazi or the Soviet experience, object that the use of law for purely instrumental reasons may foster emergence of an authoritarian state.⁴⁹  Yet, while one polity may use the law to carry out a new Holocaust, another may use it for benign purposes – for example, to establish a minimum wage or social security, or to protect children against exploitation.
   
   Others maintain that the law remains 'unimportant.'   For some, only the 'policy' that a law purports to serve merits our interest. (Who cares if someone drives an automobile while drunk?  Whether an accident ensues constitutes the issue of importance, not whether before driving home a driver had a tot too many.⁵⁰)  Reaching the same result by a different route, many writers view law as always playing 'catch-up' with society:  Society changes, and law changes to express its new social relationships.⁵¹ Law emerges from society's very matrix.  The epiphenomenon of a society cannot shape the very society that generates it.  All these authors end by denigrating law's utility as an instrument of deliberate social change.⁵²
   
   Their reasoning varies.  Everywhere, however much the naysayers crowd the legal commentariat, they err.
2. The nay-sayers refuted
   Against the nay-sayers, a growing cluster of jurisprudential and sociological theorists have marshaled arguments to support the instrumental use of legislation.  The American legal realists patently believed firmly that legislation has its social consequences.  So did the sociologists of law. A sociologist, Roger Cotterell, sums up the case:
   
   "As long as law is seen as an aspect of society – a certain side of social life as a whole – there can be no possibility of it 'standing apart' in some way and 'acting upon' society.
   
   "But when law is seen as no more than an instrument of state power, as it has almost invariably been seen in contemporary Western societies, it is thought of as independent of other aspects of social regulation.  It is no longer considered to derive its effectiveness from its congruence with popular mores but from the concentration of political power which the state represents....To legislators and ordinary citizens alike law appears increasingly as a purely technical regulation, much of it lacking any clear moral content.....
   
   "As technical regulation, however, it appears to be available for any regulatory purpose.  Its freeing from whatever community roots it may have possessed is paralleled by its liberation as a mechanism of purposeful government.  Modern law is thus the instrument of the modern state."⁵³
   
   In so holding, the realists aligned jurisprudential theory with the evidence. Available evidence clearly demonstrates that the naysayers err.  In some cases, the law clearly causes changed behaviors. But for the law, nobody would pay taxes.  But for the law, an election becomes impossible. At least in these cases, law does induce conforming behaviors.  As Karl Popper argued, one instance falsifying a proposition overcomes a thousand in favor.⁵⁴  Law can work instrumentally.
   
   Moreover, the claim that the drafter ought not to use law instrumentally also falls. But for the law, we would still have chattel slavery.  But for the law and the Department of Weights and Measures created by it, motorists would have no assurance that what they pump into their cars – and paid for – truly amounted to 11.6 gallons of 80 octane gasoline.   Without a well-designed Food and Drug Administration law, experience demonstrates the dangers confronting consumers who eat foods or use pharmaceuticals produced under unsupervised circumstances.  The list goes on and on…..
   
   Anti-instrumentalism destroys the very raison d'etre for legislation.  The American legal realist school of jurisprudence taught unapologetically that society ought to use legislation to achieve appropriate social objectives, that is, instrumentally.  As earlier adumbrated, the Realist school taught that law prescribes behaviors.⁵⁵  Why bother to write a law unless one does so to instate desired, new behaviors?  Why instate new behaviors save for dissatisfaction with the existing ones?  In the teachings of American legal realists, as in the sociology of law, ILTAM finds strong support for its central thesis: That legislation constitutes government's tool for inducing desired behaviors. Not only can law-makers use law instrumentally, but they should so use it as government's primary instrument for resolving social problems like the difficulties East Africans confront in trying to access affordable medicines and adequate health care. 
   
   Most of the egregious misuses of instrumental law constitute instances of what Van Aekan dubs 'naïve' instrumentalism, i.e., the use of law to bring about social change that impliedly or explicitly assumes (a) that the law-giver is autonomous and free to act as he (supreme lawgivers rarely follow the female persuasion!) chooses; that the addressee of the new law will receive it as the law-maker intended, without interference; and that the addressee of the law will unfailingly obey its mandate to the letter.⁵⁶  These assumptions all err. Nevertheless, the 'naïve instrumentalists' adhere to them. Why did drafters so frequently so behave?

B. Why do drafters fail to design transformatory legislation that works?

Drafters may fail in their bill-designer roles for a variety of reasons.  Most new governors mistakenly assume that lawyers have the necessary skills. (After all, they spent years in law schools.  They must have learned how to draft laws!)   That assumption ignores the reality:  Almost everywhere, law schools teach lawyers how to take their clients by the hand through the forest of existing laws to enable them to emerge safely – and profitably – on the other side. Almost never do law schools train future lawyers to design new laws likely to transform the historically shaped institutions that perpetuate the status quo. Most drafters learn their 'bill-designer' role 'on the job', from other drafters equally without formal training in the art.

If one does travel to the legal academy for advice about drafting, one finds a remarkably dry well.  Idealizing the lawyer's interaction with a judge, most academic lawyers see their task one of making rational arguments to rational decision-makers.⁵⁷  Legislation, most lawyers believe, take their substantive design in the rough and tumble of the legislature.  Many lawyers adopt the common belief that, in legislatures, not rational argument but power reigns.  Academic lawyers tend to leave the study of the problems of making legislation to the discipline of political science, a discipline that they assume studies power and its uses.  If a law school exceptionally offers a course in 'Legislative Drafting,' all but invariably it concerns only the scrivener's techniques.

Other factors conspire to ensure that few drafters design a bill's details competently.  A deep-seated tradition teaches drafters that they should not interfere with a bill's substantive content.  Most remain convinced that their job consists only of translating the clients 'policy' into 'legal' language.⁵⁸
 
Lacking trained capacity to design a bill competently, and in most cases socialized into believing that drafters ought not to concern themselves with a bill's substance, drafters nevertheless all but invariably finds themselves thrust into the bill-designer's role. The Minister instructs a drafter to draft a bill to reach a generalized end:  "Our policy is to ensure that every child attends not less than eight years of primary school," or that "every home will have potable running water available" (usually coupled with the injunction "to have the bill on my desk by Monday.") Willy nilly, circumstances compel the drafter to design the bill's substantive detailed provisions.

What can the drafter do in such case? Innocent of legislative theory, most drafters adopt either of four 'fall-back' strategies:  (1) To copy a law from another country that purports to deal with a similar problem – ignoring the differences in country circumstances that produce the behaviors that contribute to the problem;⁵⁹ (2) to invite conflicting interest groups to bargain out the details of the proposed bill;⁶⁰ (3) to 'criminalize' and impose heavy punishments on those who behave in problematic ways; or (4) to draft in general terms that do little more than repeat the generalities of most policy statements ("Let there be no more corruption"). 

Only serendipitously do these fall-back strategies produce legislation that works. None of them require the drafter to examine in detail the evidence as to the circumstances in which the new law will function.  Yet without the necessary evidence, the drafter has no basis for predicting the behaviors the new law will induce.  Unable to make a prediction grounded on logically organized facts, the drafter has no basis for designing a bill's detailed provisions.

Each of the four fall-back strategies suffers additional weaknesses. Copying law frequently leads to ludicrous results. For example, for export to their colonies (including those in sub-Saharan Africa), colonial drafters in London codified the common law of crimes as it applied in the United Kingdom.  They included provisions from the Black Acts of 1735.  These aimed at reducing poaching in the King's Forests. The poachers frequently put charcoal on their faces to avoid gleaming in the moonlight.  The codes promulgated in Britain's African colonies therefore copied a provision from the Black Act that made it a capital offense to be found wandering about at night with intent to commit a felony – with a black face.

Inviting interest groups to bargain out their differences, without regard to local circumstances, inevitably may reflect, not necessarily a just outcome, but only a convenient one.  Too often, the 'convenient' outcome caters to the interests of power and wealth.

Criminalization constitutes seldom effectively changes the behaviors that contribute to social problems, at least when the outlawed behavior does not fall into one of the traditional categories of 'true' crime.⁶¹   Among those who study the effectiveness of criminal measures, many, perhaps most, have abandoned deterrence, i.e., the use of fear of penal sanction as an effective motivation to avoid criminal penalties.  Drafters, however, continue to criminalize unwanted behaviors.  For too many, criminalization becomes the instrument of choice.   

Finally, drafters frequently draft in broad, vague terms.  Inherently, these seem unlikely to induce transformatory behaviors.  Existing actors tend to have a mind set supportive of the way they do things now – frequently with precisely the behaviors that laws looking to transformation must change.  If a vaguely drafted law grants the relevant actors discretion to decide whether and how to 'behave' – frequently in ways that conform to their own mindsets, and too often in their own interest – leading, not to change, but  yet again to another loss in the Fatal Race.

Ignoring the drafters' bill-designer role, a strong belief remains that drafters ought not to influence a bill's substantive provisions, and entropic drafting methods: All combine persuade drafters to deny that they actually design bills.  More:  Most apparently strongly believe either they ought not or cannot successfully use law instrumentally to change institutions. 

C. Summary

The instrumental use of law does not state an impossible dream.  For it to function as law-makers dream, however, the drafter in her bill-designer role must follow a methodology that makes possible the prediction of the consequences of the bill.  ILTAM offers such a theory and methodology.

PART III
THE FOUNDATIONS OF INSTITUTIONAL LEGISLATIVE THEORY, METHODOLOGY (AND TECHNIQUES)

Institutionalist legislative theory and methodology (ILTAM) guided the authors represented in this book in gathering evidence on which to ground proposed legislation likely to help overcome the obstacles that hinder the East African member states' health care delivery systems.  Scholarship does not arise, as legend claims did Athene from the brain of Zeus, fully armed for the wars.  No more did ILTLAM spring up in vacuo.
 
The foundations that undergird institutionalist theory and methodology include legal realism's focus on the differences between the 'law-in-the-books' and law-in-action; Sociology of Law's emphasis on behaviors in the face of existing law; Kelson's insights into law-making and implementing institutions; and John Dewey's pragmatic problem-solving methodology.⁶²

A. Legal realism

Long ago, legal realists observed that the law-in-the-books seldom correspond with the law-in-action.  In the real world, social actors rarely behave completely in conformity with existing law's prescriptions. That raised the question: Why? Legal realists and sociologists alike suggest the answer lies in the circumstances in which social actors decide how to behave. That offers a critical starting point for developing a theory to guide legislative drafting:  Why, in the face of existing law, do social actors behave as they do?  Because a drafter must predict what behaviors new legislation will likely induce, institutionalist legislative drafting theory adopts this as the critical question a drafter must ask.  

B. Kelson's observation that to 'work' a law must address two sets of actors

The Austrian jurisprudent, Hans Kelson, introduced the notion that existing law almost always aims at two sets of actors.⁶³  The law targets one set, whose problematic behaviors constitute a specified social problem, whose behaviors the new law's prescriptions aim to change.  The law also targets a second set of actors, whom the law assigns to implement those prescriptions.  

C. Sociology of law

To develop predictions of behavior in response to the prescriptions, the drafter/bill-designer must discover the explanations (or 'causes') of the behaviors in the face of a rule of the law – the core problematic for both drafters and the sociology of law. Karl Barth remarked that the simplest model of society consists of people making choices⁶⁴ within the constraints and resources of their circumstances – their 'arenas of choice.'  Institutional legislative theory builds on that observation.

ILTAM incorporates Barth's insights and Kelson's analysis into a model of the relationship between the two sets of social actors whose behaviors a law prescribes (see Diagram 2.1 below).  The diagram denotes the two sets of actors, 'primary' and 'secondary' role occupants, because each plays a specific 'role'.⁶⁵

Diagram 2.1

Institutionalist legislative theory offers seven categories that, broadly conceived, purport to include all the possible interrelated causes of a role occupant's problematic behaviors.   Remembered by the mnemonic ROCCIPI,⁶⁶ these categories constitute a check list of categories of possible explanations (or 'causes') of relevant behaviors. 

The ROCCIPI categories serve two purposes:  developing explanations for behaviors in the face of existing law, and predicting those behaviors in the face of proposed law.  Attending to each of these categories in turn, for identified problematic behaviors, the drafter seeks plausible explanatory hypotheses arguably subsumed by the ROCCIPI category under consideration.  In so doing, these categories of the ROCCIPI agenda assist the drafter to direct a drafter/bill-designer to consider all the relevant objective and subjective causal factors that may explain the behaviors addressed.  That becomes the basis for formulating explanatory hypotheses for a set of role occupant's problematic behaviors.  Those 'educated guesses' guide drafters in gathering relevant evidence to demonstrate that their explanations prove consistent with the available facts.   Once the evidence seems, in that sense, to warrant their hypotheses, the drafters can design and draft logically possible legislative solutions, and predict the likelihood they will alter or eliminate the causes identified.  

If their explanatory hypotheses do not prove consistent with the available evidence, however, the drafters must revise them so that they do so prove.   Of necessity, the drafters must also revise their proposed legislative solution to ensure that, logically, it will likely 'work' to alter or eliminate the actual causes of existing problematic behaviors and induce new ones likely to help solve the targeted problem.

Conversely, in designing a bill, the drafter must predict how the new provisions will affect behavior.  For that prediction, a 'reverse ROCCIPI' proves useful. Here, the drafter proposes a tentative prescription, and then searches the ROCCIPI categories to discover plausible explanatory hypotheses to predict behaviors in the face of the new rule

D. John Dewey's pragmatic problem-solving methodology

Philosopher and educator John Dewey's problem-solving methodology constitutes the fourth scholarly source for institutionalist legislative drafting theory and methodology.   Dewey's approach qualitatively differs from what some call 'ends-means' methodologies.⁶⁷   These tend to emphasize that managers and policy-makers should ground the 'end' they seek to achieve – their 'vision' – on their values.  Adopting the positivists' 'fact-value dichotomy', they reject the possibility of using facts to assess whether a proposed solution seems likely to achieve their envisioned ends. ⁶⁸  

Adapted for law-making, these policy-makers simply specify the 'end' or 'goal' of a law they would like to see drafted, and leave it to the drafters to design the 'means' – that is, the law's detailed provisions to prescribe who shall, may, or may not do what to achieve that stated end.  The ends-means approach seems to underpin the commonly adopted drafting practice⁶⁹ of encouraging bargaining among interest groups; copying laws from elsewhere; or criminalizing unwanted behaviors.

In contrast, as an educator, Dewey emphasized the importance of engaging people in a learning-by-doing process of gathering and analyzing the available relevant evidence as to the nature and causes of the problem of concern.  Using explanations warranted by those facts, they should seek to design a solution that logically seems likely to alter or eliminate the targeted problem's causes. 

Institutionalist theory adapts Dewey's learning-by-doing process to the law-drafting process.  It employs a four-step, problem-solving methodology to guide drafters in designing laws likely to alter or eliminate the causes of specified problematic behaviors – by definition,⁷⁰ the institutions – that contribute to social problems like those that comprise East Africa's health crisis:

Step 1: Gather the available evidence as to the nature and scope of the specified social problem, and whose and what behaviors contribute to it.⁷¹  Specifically organize the evidence to describe the problematic behaviors of the relevant social actors' (both the primary role occupants and the relevant implementing agencies – sometimes called the 'secondary role occupants'. Those behaviors comprise the 'institutions' which, to help solve the social problem, the proposed law's detailed provisions must change.)

Step 2: Using the ROCCIPI agenda,⁷² formulate hypotheses as to the causes of each set of role occupants' problematic behaviors.  Using those hypotheses as guides, drafters should capture the relevant evidence needed to prove each one consistent with the available evidence.

Step 3: Design detailed provisions of the bill logically likely to alter or eliminate the causes of both the primary and secondary (implementing) role occupants' problematic behaviors in order to induce them to behave more appropriately.  Be sure to consider all the logically possible alternative legislative provisions, and chose those most likely to prove effectively implemented to help resolve the social problem in the most cost-effective way.  (In this step, the drafters must also provide the facts to demonstrate that detailed legislative solution's social and economic benefits will likely outweigh its social and economic costs.)
   
Step 4: Incorporate in the proposed law a monitoring and feedback mechanism to identify and resolve whatever new problems may emerge. This step proves essential, for two reasons.  First, the drafters may not have successfully gathered the evidence at earlier steps to justify their claim that the law constitutes 'evidence-based legislation' (at best, that task proves difficult)   Second, and perhaps more important, today's increasingly rapidly changing global realities inevitably give rise to new social problems. That reality underscores the necessity of institutionalizing and strengthening national capacities to redraft old laws and design new ones to make it more likely that relevant actors will behave in new ways likely to ameliorate newly emerging social problems.  Step 4 underscores the necessity for governments to institutionalize ongoing processes for training new cadres to work together in gathering and organizing the available facts in new research reports as quality controls to justify new rules.

1. Using legislative drafting techniques
   This resource book seeks to provide theoretical tools and facts to empower participants in a possible future East African legislative drafting workshop to design laws that address East Africa's existing health crisis.  For that, the participants need to learn how to employ legislative drafting techniques likely to ensure that a bill's detailed provisions prescribe the relevant role occupants' appropriate new behaviors clearly, unambiguously and precisely. The guidelines, prepared by Toby Dorsey for the African Parliamentary Knowledge Network (see www.APKN.org), aim to facilitate assessment of existing draft bills and, where appropriate, guide the process of drafting new ones. In addition, the 'B-Stream' manual, prepared for ICLAD's distance learning program (see www.ICLAD-law.org), and the Drafter's Manual offer a series of rules for drafting a bill's provisions.  These rules aim to ensure that the words of a bill inform role occupants, precisely, unambiguously, accessibly and in usable form, how they shall, may, or may not behave.
   
   This section briefly reviews two essential aspects of legislative drafting techniques:  (a) the importance of ensuring that a bill fits into a complete legislative scheme; and (b) using appropriate drafting techniques to make likely the effective implementation of the prescribed behaviors to resolve the targeted social problem.
2. Using RIC-D-FRETT to ensure a bill fits into an adequate legislative scheme
   A drafter must ensure that a proposed new law fits into a complete legislative scheme. Take, for example, the proposed law to establish an EAC Joint Registration Authority to register and license medicines and drugs for all EAC countries (see Chapter 4 below)   To accomplish that law's objectives will require more than the proposed law's detailed prescriptions – commands, permissions, prohibitions – to the role occupants (R) and the implementing agency (IA) the research report specifies.
   
   In two ways, institutionalist legislative theory's RIC-D-FRETT checklist may help design a bill.  First, it offers the drafter a guide in the process of going from a research report's descriptive sentences to a bill's prescriptive sentences – the commands, permissions and prohibitions that usually constitute some 95% of a bill's provisions.⁷³  In that sense, the RIC-D-FRETT checklist offers the drafter a guide for translating a report's descriptions into the bill's prescriptions
   
   Second, the RIC-D-FRETT checklist guides the drafter in making sure that the bill includes the provisions necessary to complete the legislative scheme required for the bill's effective implementation. The Joint Registration Authority bill, for example, prescribes the primary actors' and the Joint Registration Authority's appropriate behaviors.  Other actors – not explicitly mentioned in the new law, but essential to the proposed law's effective implementation – may include officials in institutions to help settle disputes likely to arise under the new law; make funds available for the Joint Registration Authority; formulate and implement detailed subordinate legislation (or regulations); and the like.  The drafter must turn her attention to each of these categories (see Box 2-1) to ensure that the proposed bill fits into a complete legislative scheme.
   
   BOX 2:1
   TRANSLATING A RESEARCH REPORT'S 'SOLUTION' INTO A BILL:
   THE RIC-D-FRETT CHECKLIST AS A GUIDE FOR DESIGNING A LEGISLATIVE SCHEME
   
   Using the RIC-D-FRETT checklist, the drafting team must ensure that a complete legislative scheme, involving additional institutions established under already-existing laws, will provide the essential supports the proposed legislation requires effectively to transform the problematic institutions involved. These may include:⁷⁴
   
   • *R:The primary role occupants whose behaviors the bill ultimately aims to change;
   • *I:The structure and procedures of the implementing agenc(ies) whose officials' behaviors the bill must change to facilitate and ensure that the primary role occupants behave as the bill prescribes;
   • *C:Conformity-inducing measures used by relevant implementing agencies.
   • *D:Dispute settlement mechanisms – a tribunal, an arbitration panel to resolve disagreements between agency officials, firms engaged in importing medicines, and customers; 
   • *F:Funds to finance the registration agency's ongoing work;
   • *R:The registration agency's power, using specified criteria and procedures; to formulate and implement rules in the form of subordinate legislation or administrative regulations;
   • *E:An ongoing evaluation process as required by the fourth step of legislative theory's problem-solving' methodology;
   • *T:Transitional measures to protect interests established under pre-existing laws;
   • *T:Technical provisions, e.g., specifying date when new law goes into effect.
3. Using legislative drafting techniques likely to ensure the bill's effective implementation
   A bill's form – the techniques, the very words, a drafter uses to draft it – inevitably affects the bill's substantive provisions.  The author-drafters, who drafted the bills in this resource book, aimed to use appropriate legislative drafting techniques to ensure that the form of the bill's detailed prescriptions unambiguously specify who shall, may, or may not do what to ensure effective implementation of the bill's provisions.  By the same token, those who read those bills (and accompanying research reports) should critically assess, not only the facts and logic that underpin the reports' substantive claims, but also the techniques the authors used to design and draft the bill.   Only if the bill prescribes clearly and unambiguously the behaviors it commands, permits or prohibits can a workshop participant – or any other reader, for that matter – predict what that role occupant will or will not do in the face of the bill.

PART IV
WHAT MEANS 'EVIDENCE-BASED LEGISLATION?

In the real world, none of the assumptions of naïve instrumentalism hold. No wonder that a law drafted using it as a drafting guide only serendipitously works.

To work, instrumentalism has to take the world as it actually exists.  A social problem consists of actors behaving in problematic, repetitive patterns – that is, their behaviors constitute problematic institutions.  ILTAM holds that people behave as they do because the constraints and resources of their surroundings – including what goes on in their heads – induced or compelled them so to act. 

Those constraints and resources of in an actor's surround in large part result from the behaviors of other actors within that surround.  Barth's model of behavior, sketched above, implies that to explain problematic behaviors, the instrumentalist law-maker must investigate and understand all these multifarious, interacting behaviors that constitute the throbbing, dynamic, interesting world.  Those patterns of behavior do not function in vacuo.  The drafter must discover in detail the constraints and resources in the surround that presently influence the actors of concern to produce the social problem addressed. 

Only then can the drafter consider available governmental resources that the new law can add to the mix.  Those resources considered in the light of existing constraints and resources in the arena within which the new law will function constitute what Roscoe Pound long ago famously labeled "the limits of law."⁷⁵  The sophisticated instrumentalist drafter discovers that the more one learns about how and why people behave as they do, the more the drafter learns about the competence of government measures, the smaller becomes the scope for meaningful governmental intervention.  In the bill-designer mode, the drafter needs not the heady, seemingly unbounded ambitions of the naive instrumentalist, but the cool calculation of the knowledgeable social engineer. Cool-headed social engineers may not attempt the sweeping law-induced changes so often attempted but failed by naïve instrumentalists.  Guided by ILTAM, that cool-headed social engineer/bill-designer may not aim so far but she does aim far more accurately.  She gets more done.

After instituting a new law and implementing it – that is, ex post – the drafter/designer can test whether the drafter in fact produced a 'good' law.  If that law induces its prescribed behaviors and if those behaviors ameliorate the perceived social problem – that is, if the new law works – the drafter/designer can justly assert that the law did prove itself.  (It rarely proves itself so simply. Even if overall the bill's designer believes that she would re-enact much the same law, invariably on second chance the drafter/designer discovers ways to improve the earlier version.)  At least in the sense of the suitability of the bill to achieve its instrumental objectives, evidence can demonstrate that the bill did or did not work. (The fact/value dichotomy true believers err.)

Before the enactment of the new law, and therefore before its implementation – that is, ex ante – the drafter can develop evidence on which to ground a prediction of the behaviors that the new law will likely induce, and their consequences for the social problem at issue.  Following ILTAM, the drafter has a measurable probability of actually predicting the behavioral consequences of proposed legislation.

Predictions, however, always have a probabilistic element.⁷⁶ The more the drafter bases her predictions on evidence, however, the more probable those predictions will approximate reality. 

ILTAM teaches that in all but trivial instances, a drafter should accompany a bill with a justification for the bill's substantive provisions.⁷⁷   Whether people obey legislation depends in some part on its legitimacy, that is, whether its addressees perceive it as a measure that the addressee ought to obey. 

To achieve legitimacy, the bill must meet the requirements of rationality.  That requires above all else that its proponents demonstrate that they ground its provisions on evidence.   Because the proponents must justify the proposed bill ex ante, they must, on the basis of evidence, predict the behaviors it will probably induce. The research report should describe the evidence upon which the drafter bases the prediction that the new legislation, once enacted, will work. That evidence the drafter discovers by using the ROCCIPI categories as a guide to formulating specific hypotheses explaining problematic behaviors, and then using the hypotheses thus generated as guides to finding relevant evidence. The drafter/bill-designer can then devise measures to address those causes of problematic behaviors. 

The more accurate, the more detailed the evidence on which the bill rests and that the research report recites, the higher the probability that the bill's measures will lead to changed behavior – that is, than the new law will work.  Thus does the quality of the research report define the quality of the bill it purports to justify.    

The more evidence about the causes of the problematic behaviors at issue, and the better the quality of that evidence, the higher the probability that the new law's measures will address those causes, and therefore the higher the probability that the bill will work. That is what we mean when we speak of evidence-based legislation.  ILTAM aims at facilitating the production of legislation thus grounded.

CONCLUSION

This chapter offered a brief explanation of the theory, methodology, and techniques required to produce evidence-based legislation, and a definition of 'evidence-based legislation.'  It first pointed out the important dual role of drafters in designing a bill's detailed provisions.  Too often, they design a bill that specifies the policy-makers' envisaged goal, but which, after enactment into law, remains unimplemented – at most a symbol of the policy makers' 'values.'  Very few lawyers ever have opportunity to draft transformatory laws of the kind required to alter or eliminate institutional obstacles like those that perpetuate East Africa's crisis in its health care delivery system.  To ensure that proposed, purportedly transformatory laws will work requires that they merit the title 'evidence-based.'

To draft evidence-based bills, a drafter requires two quite different capacities:  one, to conceptualize the detailed provisions of a bill likely to help resolve the social problem specified; the other to gather and organize the available evidence to demonstrate that the bill's provisions will likely induce their prescribed behaviors, and that those behaviors will likely ameliorate the targeted social problem.  For that, the drafter needs adequate training in legislative theory, methodology and techniques.

Each chapter of this draft resource book raises questions about how a drafter might design the detailed provisions of particular bills as part of a legislative program to improve East Africans' access to essential, affordable  medical care.  In doing so, it aims to offer insights into the potential of using theoretical and practical legislative drafting tools for designing and implementing evidence-based legislation to improve the quality of life for all East Africans.

This chapter has only briefly described the roots and some of the debates about the institutionalist legislative theory and methodology employed by the authors of the remaining chapters of this book.  Hopefully, in reading and discussing the book's remaining chapters, however, the workshop participants will explore and assess the available legislative theory and methodology, as well as techniques, as possible aids for designing appropriate regional health legislation.   

As a resource, this book aims to illustrate the problems and possibilities of using available evidence to design new laws' detailed provisions as possible elements of a legislative program for improving regional health care as called for by the East African Community Summit of June, 2007.  It is a preliminary step towards an evidence-based East African law of health care delivery.

[Note:  If the EAC workshop takes place, the workshop organizers will make every effort to revise the details of each chapter in this resource book to include the evidence and arguments introduced by the workshop participants.]

Michael Kempster

(Editors' note:  As emphasized in this resource book's first chapter – and as remains true of all the other chapters – Kempster's report and bill comprise drafts.  Those drafts identify issues which the relevant EAC workshop team members will undoubtedly wish to consider – and perhaps revise – in light of their more intimate knowledge of East African realities.   The chapter raises question which include:

1. Who should appoint commission members, using what criteria and procedures, to ensure appropriate coordination and development of the relationships between EAC member states' and regional health care institutions?
2. Does the existing bill provide adequate criteria likely to ensure transparent, accountable and participatory decision-making procedures for enabling the proposed Commission – essentially a new law-making institution for conducting research and drafting effective regional health legislation to help mobilize regional human, financial and physical resources – to overcome the EAC health care problems?  
3. Hopefully, the workshop team will identify and answer any other questions they consider important.]

On 27 December, 2007, Kenya's presidency hung in the balance in a disputed election between the incumbent, Mwai Kibaki, of Kikuyu ethnicity, and a challenger, Raila Odinga, of Luo ethnicity.⁷⁸  Accusations of gross irregularity in Kibaki's declared victory quickly led to serious and widespread civil unrest.  By 8 February, more than a thousand people had died.⁷⁹  Interethnic strife forced at least 600,000 people throughout the country from their homes.⁸⁰  'Horrible' living conditions, diet, water and sanitation prevailed amongst the refugees.⁸¹

Of these people, roughly 90,000 had HIV;⁸² they entered a zone characterized by the sort of civil strife in which sexual and other sorts of violence are, alas, prevalent, and likely to spread the disease.  Roughly 5,600 had tuberculosis⁸³ and lived in often close quarters ideal for transmission of the disease.  Between 200,000 and 400,000 had malaria;⁸⁴ mosquitoes bit these people at least thrice daily, and went on to bite inhabitants, infected or not, of other regions. 

Much Ugandan commerce passes through the affected region on its way to Mombasa, Kenya's major port.  Civil unrest disrupted Mombasa's commerce as well, diverting significant volumes of trade to Dar Es Salaam, Tanzania, which typically handles half Mombasa's trade volume.⁸⁵ HIV spreads readily along trucking routes (China,⁸⁶ India⁸⁷ and Africa⁸⁸); trade diversion to Dar Es Salaam  exposed citizens of Tanzania to infectious agents from Kenya, which they had not encountered before, and against which they had never developed immunity.

Prior to the 2007 EAC Health Summit Meeting, the East African Legislative Assembly (EALA) and Secretariat, as presently constituted, had neither identified or prioritized health issues, conducted or utilized research on health issues, or responded to health issues  with legislative solutions at the community level. Instead, duplicating efforts without taking advantage of economies of scale, the separate member states efforts to resolve their health problems did not effectively address community-wide health needs.  The First East African Health and Scientific Conference of 2007 recognized this unmet need.  It explicitly called for the establishment of community-wide institutions and a community legislative health agenda.⁸⁹ Since that time, two more regional health conferences have taken place.⁹⁰  Member states' Ministries of Health, apparently have only begun to work together to coordinate their health programs on a community-wide basis.

This research report aims to provide evidence to justify the proposed East African Health Commission Act. That Act's detailed provisions will establish an East African Community Health Commission to conduct or sponsor research, set priorities, and propose legislation addressing specified health issues both to the EALA and, as seems appropriate, to the legislatures of the EAC member states.

A. The larger context   

The founding document of the EAC, the EAC Treaty of 1999, specifically alludes to the manifest economic, political and health concerns which the member nations of the East African Community share in common. The EAC leaders realized that, in today's rapidly evolving technological era, they must work more effectively together to identify and coordinate their human, physical, and financial resources to resolve the health problems that shortened their citizens' life expectancy. 

The epidemiology of infectious disease does not respect political borders.  The brief introductory paragraph's description of a single event and its potential consequences demonstrates that the causative agents of infectious diseases confined to rural areas or urban areas may abruptly and unpredictably mix and spread.  Such agents, introduced in a single country, or a region within a country, do not respect national boundaries.  Local or even national, rather than region-wide solutions to the problems of infectious disease, will likely fail.  In some cases, only a regional solution may suffice.  Yet the EAC member states' Health Ministries have not yet successfully worked together to coordinate their efforts on a regional level.  Moreover, while the member states' Ministries of Health have identified health issues, they have not done so on a more than national level.  A community-level institution, capable of conducting research to identify health problems, and proposing legislative solutions, could mobilize their community resources to address new constellations of health problems, whether arising from a sudden mass movement of refugees, or from unanticipated epidemics.  Absent such an institution, the EAC can neither identify nor deal in a timely fashion with health problems likely to lead to human suffering and economic losses – disasters that EAC health institutions, working together, might prevent or mitigate.

[Editors' Note: In Kempster's original Research Report, the remainder of this Introductory Part I incorporates additional relevant information, here provided in the first Chapter of this Resource Book.]

B. Methodology

This report uses institutionalist legislative theory's four-step, problem-solving methodology to structure the available evidence in the form of a research report to justify a proposed law to establish an EAC Health Commission.⁹¹
 
Step 1 (in this report's Part I) briefly describes the EAC member states' uncoordinated health programs as they superficially appear. It identifies the officials of the five member states' various health-related institutions as the primary role occupants, and their Ministries of Health as the main implementing agencies.  By definition,⁹² these social actors' historically shaped behaviors comprise the institutions that tend to perpetuate the uncoordinated national health policies and practices.  The proposed Health Commission bill focuses on using law to change both sets of role occupants' behaviors.  That change will maximize the use of the region's human, physical and financial resources to improve regional health care.
 
Step 2 (in this report's Part II) uses legislative theory's ROCCIPI categories⁹³ to formulate hypotheses as to the causes of the problematic behaviors of the responsible health officials as individuals, and the Ministries of Health as implementing agencies.  Those explanatory hypotheses serve to guide the search for the available relevant evidence to demonstrate that the hypotheses prove consistent with the facts.   (If, any one hypothesis does not so prove, the theory calls for revising that hypothesis until it does.)  

Once warranted  by  the evidence, these  explanatory  hypotheses lay the basis for Step 3 (in the report's Part III):  The design of the proposed bill's detailed provisions makes it likely that the proposed EAC Health Commission will facilitate drafting interrelated regional and member states' legislation. That legislation in turn will coordinate and improve affordable, effective health care for all East Africans.

Step 4 (included in the report's Part IV) specifies the bill's provisions for a transparent, accountable monitoring and evaluation mechanism.  Those provisions must empower and induce relevant stakeholders – especially the region's poor and vulnerable – to provide evidence as to whether the law, once enacted, will likely prove effectively implemented, and, once implemented, likely to advance East African public interest.

This Part briefly describes the narrow problem which the bill, described in this report, aims to help resolve.  That problem constitutes the way East African health care delivery to institutions, shaped by the region's colonial rulers, still primarily allocate the region's available health resources to serve the needs of its well-to-do populations, predominantly located in urban commercial centers.  Law can only help to resolve social problems by changing the behaviors that comprise them. This research report therefore identifies⁹⁴ and provides evidence as to the problematic behaviors of the relevant role occupants.⁹⁵  These mainly comprise the member states' health officials, and the Ministries of Health that supervise their efforts to implement existing law.  

A. The Social Problem:  The inadequacy of East Africa's inherited health institutions to resolve the region's health problems

The surface appearance of the problem constitutes the myriad unsolved, even undefined, health problems left unaddressed at the community level.  Existing institutions permit health issues transcending national boundaries⁹⁶  to remain unidentified or imprecisely defined.  The Introduction to Part I demonstrates the danger that an event that, originally seemingly isolated in a single nation, may have region-wide epidemiological consequences. 

As another example, consider the difficulties East Africans experience in accessing affordable, effective medicines. Routine, well-established drug regimens exist to treat, prevent, or cure three of the major infectious diseases in East Africa – HIV, tuberculosis and malaria.  The enormous economic, social and political burden these diseases impose on the EAC and, for that matter, on all African countries, in any strategy for development make their control a central consideration.  The EAC, with a population of about 125 million, and a GDP of around US$104 billion, forms a large and potentially lucrative market for pharmaceutical manufacture and sales.  Foreign firms, however, manufacture the bulk of EAC medications abroad.
In the event, EAC member states pay high global pharmaceutical prices at great expense, reducing the availability of affordable, effective medicines, and aggravating the net flow of capital out of the area.  Further, the capital investment, economic growth and employment opportunities that would attend a robust domestic capacity to manufacture medicines in the region remain, not a reality, but a vision.

Existing national laws authorize the member states' Ministries of Health to act only within their national borders.  The EAC Treaty of 1999 explicitly recognized the desirability of community-wide cooperation on health issues in general, and issues surrounding pharmaceutical quality control, registration, licensing, research and development of pharmaceuticals in particular.⁹⁷ It called upon the member states to cooperate, and 'undertake to act' on a variety of issues, offering no further specific mechanism or guidance.   To date, the East African Community, both at the community and member state levels, however, still encounters difficulties in drafting and implementing regional legislation to improve health care delivery.

B. History of the East African Community's Health Institutions

The inadequacy of EAC health care delivery institutions arises from inherent weaknesses attendant on the East African Community's history, and the structure of its institutions under its founding treaty.

Building on the British precedent of establishing a common market area in the colonial era,⁹⁸ Kenya, Uganda and Tanzania first founded the East African Community (EAC) in 1968.  An attempt to establish a common post-colonial currency failed when Tanzania nationalized its banks in 1966.  Idi Amin's ascension to power in Uganda in 1971, and the ensuing regional and civil war, broke up the common structures of the then-extant EAC, which ended in 1977.⁹⁹  In 1999, Kenya, Uganda and Tanzania reconstituted the EAC by treaty.  Rwanda and Burundi joined as member states in 2007.

The East African Community Treaty of 1999 established the East African Legislative Assembly, inaugurated in 2001.¹⁰⁰ The national legislatures of its member states elect the EALA's members, with the addition of one minister from each member state and the secretary general and Counsel to the community.¹⁰¹  The treaty clearly aimed to constitute the EALA as a representative body not just of the member states' governments, but of their peoples:

The National Assembly of each Partner State shall elect, not from among its members, nine members of the Assembly, who shall represent as much as it is feasible, the various political parties represented in the National Assembly, shades of opinion, gender and other special interest groups in that Partner State, in accordance with such procedure as the National Assembly of each Partner State may determine.¹⁰²

However, not a body of the EAC, but 'the institution of the Partner State that determines questions of the election of members of the National Assembly responsible for the election in question'¹⁰³ has authority over all questions as to membership.  The EALA cannot pass a bill unless it is approved not only by the EALA, but also by the presidents of the Partner States.¹⁰⁴

The founding EAC treaty thus severely circumscribes the EALA's power, and freedom of action.  The EALA depends entirely on legislators who act as creatures of their respective national assemblies, and its actions remain hostage to unilateral veto by a president of but one of the member states.  It does not seem surprising, therefore, that critics have described the EALA as a 'paper tiger'.¹⁰⁵  A Ugandan commenter contributed this jaundiced view of the EALA:

Commentators often charge the EAC with 'elitism', working at a distance remote from the common person.  Kenya's relatively larger economy,¹⁰⁷ whose primacy in the region dates to colonialist times and imperatives,¹⁰⁸ often forms the context of such charges.

The EAC treaty, however, explicitly grants the EALA the power to establish 'any committee or committees for such purposes as it deems necessary,'¹⁰⁹ and affirms the right of persons to attend and take part in the Assembly at the invitation of the Speaker.¹¹⁰   In 2007, the EAC called the 1st East African Health and Scientific Conference in Uganda.¹¹¹  The EAC plans to reconvene the conference annually.¹¹²  The agenda items included a draft protocol for the establishment of the East African Health Professions Authority, and the East African Food and Drugs Authority, as community-wide organizations.  The goals of the conference included movement towards community-wide integration in health, as has started to accomplish in trade:

Ambassador Juma Mwapachu, the EAC Secretary-General, addressed the building of community-wide institutions:

The EAC posted on its website the position of principal EAC health officer, vacant for quite some time.¹¹⁵ The job description placed it within the Secretariat of the EAC, reporting to 'the Director Productive and Social Sector.'¹¹⁶  The description mentioned neither the 'East African Health Research Council' of Mwapachu's remarks, nor the 'East Africa Health Professions Authority' of the Conference program, nor the Sector Committee on Health.  The EAC Web site mentioned the attempt to recruit a Health Coordinator as early as 2004.¹¹⁷ A search of the Web for information about the 'Productive and Social Sector' of the EAC, or its Director, yielded nothing save for the reference just cited, and for a 'social sector' in very general terms, rather than, as the job posting implied, a specific governmental entity.  The EAC Web page mentions a 'Health Sectoral Committee' and a 'Sectoral Council' of Ministers of Health, but offers no information on them.¹¹⁸  A Web search yields no further information.¹¹⁹

Chapter Five of the EAC treaty creates a Council, made up of the 'Ministers responsible for regional cooperation of each Partner State and such other Ministers of the Partner States as each Partner State may determine.'¹²⁰  The treaty gives the Council the power to make policy,¹²¹ monitor and review implementation of Community programs,¹²² initiate and submit bills to the EALA¹²³ and regulations, directives and the like.¹²⁴

The EAC treaty assigns implementation, and the monitoring of implementation, to a Co-ordination Committee made up of the Partner States' permanent secretaries for regional cooperation.¹²⁵ The Co-ordination Committee has the mandate to receive and consider reports of the Sectoral Committees, and to coordinate their activities.¹²⁶

Under the treaty, the Council, on recommendation of the Co-ordination Committee, creates Sectoral Committees, presumably including the Health Sectoral Committee referred to above.  Their mandate includes:

Summarizing the above, under the EAC Treaty, the Council proposes legislation to the EALA, as well as regulations and directives, presumably on recommendation of the Sectoral Committees, acting through the Co-ordination Committee. The treaty variously assigns responsibility for implementing, monitoring, and evaluating legislation to the Council, the Coordinating Committee, and the Sectoral Committees. 

Explicitly recognizing a need for a community-level response to health problems, the EAC convened the 2007 Health and Scientific Conference and called for the establishment of community-wide organizations to address the issues. The establishment of a Health Legislation Commission, as proposed in this report, would mirror positions held publicly from the Secretary General of the EAC on down, and facilitate the specification of goals and institutions to deal with the health issues delineated in the Conference.  As envisioned in this research report, the Health Commission would share functions that the EAC treaty assigns, though not exclusively,¹²⁸ to existing bodies.  As outlined below in this report's suggested bill, the Commission's design would require it – more effectively than have existing bodies – to conduct research, obtain data, define problems relating to health, and propose legislation to change the behaviors causing these problems.

By its own admission, the health needs of the EAC remain unmet.  Apparently, the responsible EAC institutions have not succeeded in identifying regional health issues, designing and implementing appropriate health laws, and monitoring and evaluating their social impact.  The EAC member states' Ministries of Health, by law required to view their missions nationally rather than on a community-wide basis, cannot fulfill this need.  Using legislative theory's ROCCIPI categories,¹²⁹ this Part suggests several explanatory hypotheses as to why each of these social actors seems unable to carry out their responsibilities. It also indicates the kinds of evidence required to warrant those explanations.  Once warranted, the workshop participants will have opportunity to assess whether the proposed bill's detailed provisions logically seem likely to alter or eliminate the causes of the problematic behaviors, as identified by those hypotheses, thus to induce new drafting behaviors – i.e., new drafting institutions. Those new drafting behaviors aim to produce a legislative program that will effectively change dysfunctional inherited institutions and provide improved health care for all East Africans.

A.Responsible Officials

1. The EALA

Rule:  Essentially, the EALA remained limited by structural constraints on their membership and access to funding.¹³⁰   All heads of member states must assent before the EALA can enact a bill related to any issue, thus granting every member state president¹³¹ power to veto any EALA law, including any related to health.¹³²   Article 118 of the EAC Treaty discusses health issues solely in the context of possible actions which member states might take in concert.   The article does not mention, or prescribe actions, which the EALA, or indeed any community institution, might take related to health.¹³³

Opportunity:The EALA may establish committees for any purpose deemed necessary.¹³⁴

Capacity: The EALA itself has no capacity to research health issues. No easily available evidence indicates appointment of an EALA committee responsible for taking action on health issues, or any ongoing interaction between the EALA and the Sector Committee on Health. 
Communication:  No easily available data indicates that either EALA or an EALA committee communicates regularly with relevant member state officials about health problems.

Interest:  With the exception of two ex officio members, member state national assemblies elect their EALA legislators. EALA legislators thus elected may feel beholden to their countries' legislators and their interests, rather than considering the needs either of the community as a whole, or other Member States.¹³⁵

Process: EALA legislators do not actively solicit information, and have no specific responsibility for health matters.¹³⁶  The 2007 EAC Health and Scientific Conference called for legislation addressing health problems.¹³⁷ The EAC treaty, however, requires only that the EALA communicate with the National Assemblies of the Partner States,¹³⁸  heads of government and the secretariat.  No statutory or constitutional provision exists requiring that the EALA communicate with other stakeholders or the citizenry of the EAC, save through publication of enacted legislation in 'the Gazette.'¹³⁹ No mechanism exists through which citizens can petition, or even be heard, though the EAC Treaty specifically allows for the possibility.

Ideology:  The EALA as a whole seems to find trade issues more compelling than health issues.

2. The EAC Secretariat

No easily available evidence seems to explain the EAC Secretariat's apparent inactivity relating to health issues.

3. The EAC Health Sectoral Committee, Coordinating Committee and Council

No evidence about these bodies, other than the enabling clauses in the EAC treaty and the occasional references cited, seems easily available.  Absent firmer evidence on which to ground recommendations, any solution -- including the one proposed by this report -- must remain tentative.

4. The Member States' Ministries of Health

Rule:  The member state Health Ministries operate under charters issued under their separate existing national legislation.  These tend to restrict their efforts to consider formulation and implementation of consideration of possible regional health laws.

Opportunity: The Ministries seem limited by national considerations, apparently still significantly influenced by the concerns of the urban, wealthy, vocal population.  These apparently tend to crowd out the concerns of the poor majority, especially those living in rural areas.

Capacity:  The member state Ministries have limited research capacity, and little means of coordinating and exploring the regional implications of their findings, far less for designing potentially effective regional health legislation. Even on the national level their research resources appear limited. Regional logistical support – roads, infrastructure, electricity, Internet computers – all remain in short supply.

Communication:  To date, the EAC leaders have supported few channels – other than the recently established annual regional health conferences – to encourage member state Health Ministries' efforts to design and implement improved regional health legislation. 

Interest:  The Ministries' interests in health-related priorities primarily seem to reflect those of their member state governments.  And, alas, as too often happens the world around, the needs of the urban, wealthy, vocal populations tend to crowd out those of the impoverished majority of the region's inhabitants, whether they inhabit urban or rural areas.

Process:  As yet, little evidence seems available as to a community-level process of ongoing inter-EAC Health Ministries' cooperation to facilitate the conduct of research, drafting and implementation of effective regional health-related legislation.¹⁴⁰

 (WE WOULD MUCH APPRECIATE RECEIVING RELEVANT DOCUMENTS AS TO THE PROGRESS MADE ON THESE ISSUES AT THE THREE REGIONAL CONFERENCES OF EAC HEALTH MINISTRIES, ESPECIALLY THE MOST RECENT CONFERENCE IN KIGALI.) 

Ideology:  EAC member state health ministries, responsible for dealing with their parent governments' health problems, do not appear predisposed to see them in a larger, community-wide context.  That tends to make discovery of regional solutions for some of them more difficult, if not impossible.

5. The Ministries of Trade and Industry

Again, paralleling the Ministries of Health discussion above, potential economies of scale in providing training, scientific research, and manufacture of medical equipment and effective, affordable medicines underscore the importance of exploring community-wide solutions.  Nevertheless, the prevailing ideology seems focused on advancing national rather than community interests (as illustrated by the neglect of possibilities of expanding pharmaceutical manufacturing for a larger regional market, providing more integrated production processes in regional plants, more and better paying jobs for regional inhabitants, etc.).¹⁴¹

6. The Universities

Rule:  Member states' governments fund the universities and subsidize tuitions.   No member state rules seem to require those universities to work together to develop training materials and courses to equip regional medical professionals with the skills and attitudes required to manage rural health facilities as well as to fulfill essential rural health needs.  Few if any member state governments have introduced incentives or imposed restrictions to discourage medical and engineering graduates, on leaving school, from leaving for greener pastures in urban centers or even abandoning the African continent altogether.  

Opportunity:  The region's medical faculties regularly encounter the full spectrum of health problems.  University faculty members and staff do know about modern, up-to-date scientific advances likely to expand the limits on what works, what does not.  Nevertheless, their countries face continued difficulties in maximizing the region's inhabitants' benefits from those advances unless the EAC universities' faculties and staffs cooperate to improve their countries' scientific and professional human capacity to make better use of their region's physical and financial resources.

Capacity:The East African governments do not fund their medical faculties lavishly, nor do graduates who remain in their countries earn lavish salaries.  Even if no university graduates emigrated in search of better remuneration in seemingly safer environments, the number of well-trained physicians, nurses, pharmaceutical technicians, and other health professionals would likely remain insufficient.  

Communication:Member state governments make insufficient efforts to inform potential medical professionals about the critically important potential value of conducting research and training to ensure greater use of their countries' human, physical and financial resources to improve their countries' poor majorities' health services, and ultimately their regional capacity to manufacture medicines to improve their inhabitants' health and life expectancy.

Interest:The universities' health faculties would like to maintain and, if possible, increase their funding, and increase the size of the student body.  Higher salary and better working conditions, however, predispose too many medical professional members to consider emigration, instead of working to improve health conditions in their own countries.

Process:University decision-making processes do not sufficiently focus on whether and how to equip faculty and students – not only in medical and scientific professions, but also those in social science and law programs – to conduct research on the use of evidence-based law to resolve health problems.

Ideology:University faculty appear not to have devoted sufficient attention to engaging and persuading students of the importance – rather than seeking high paying jobs serving the urban, powerful and wealthy few – of creating new institutions to improve all East Africans' health care and life expectancy – especially the largely voiceless poor majority.

7. Non-governmental Organizations (NGOs)

Rule:  Many NGOs have internal rules, which restrict their donations, and retain control over the resources and gifts they do donate.¹⁴² Member states' laws may limit their efforts to coordinate programs to improve training, foster better use of equipment, and, in general, Community health professionals' contribution to improving health services available throughout the region.¹⁴³

Opportunity:  Large amounts of monetary and substantive aid enter Africa on a steady basis.  Some of it goes to waste, due to poor logistics, poor prioritization of needs, or corruption.  NGOs, too, might benefit from economies of scale if they could work with EAC-level organizations to improve their allocation of resources.

Capacity:  Highly visible groups like the Bill and Melinda Gates and the Clinton foundations, the United Nations groups like UNESCO, and others have made financial resources available, but apparently without sufficiently engaging local health professionals in finding ways to use them to improve member states' – far less regional – use of their own resources.

Communication:  Member state governments make insufficient effort to facilitate efforts of civil society and NGO personnel to work together to improve their use of NGOs' personnel and financial resources.

Interest:  As their stated raison d'être, most NGOs aim to help people through wise, even participatory, deployment of resources. Their officials' personal interests, however, sometimes may override that declared objective.

Process: NGO personnel do not always operate with transparency, accountability or participation.   To the extent that their organization's rules do not require them to make their decisions in public, grounded on evidence obtained from the relevant stakeholders – especially the poor and vulnerable – their actions may undermine their proclaimed efforts to empower EAC member states inhabitants to achieve improved, sustainable health care.

Ideology:  NGOs' ideologies relating to health seem to vary widely, with varying degrees of insistence as to its primacy.

In sum, a review of the ROCCIPI agenda, as to the possible causes for relevant social actors' problematic behaviors, suggests a variety of explanatory hypotheses – educated guesses.   Some of these hypotheses have proven consistent with the available relevant facts.   Far more evidence seems required, however, to warrant the suggested explanations.   Members of the proposed workshop may offer some of the essential necessary additional facts.   Nevertheless, the difficulty of finding the necessary facts underscores the necessity of setting up an EAC Commission empowered to conduct the essential research as to the probable causes of the seemingly problematic behaviors of all the primary role occupants and implementing agencies listed.  On the basis of that evidence, the Commission drafters, presumably well-trained, will find it possible to draft a number of bills – a legislative program – to empower the EALA, together with the member states, to change the problematic behaviors of the many social actors discussed in this report's Part III.

To formulate and implement an appropriate legislative solution, Part IV incorporates two essential problem-solving steps – Step 3 which defines the proposed solution, and Step 4 which calls for monitoring the new law's implementation and social impact.   In this case, Step 3 involves designing the proposed bill to establish a Regional Health Commission, and Step 4 calls for incorporation in the bill of a provision for monitoring and evaluating.
 
Part IV first reviews the alternative legislative solutions, observing that, based on the available evidence, the proposed bill to establish an EAC Health Commission to conduct research and draft bills in the context of a legislative program seems most likely to improve regional health care.  It demonstrates that, logically, the bill's detailed provisions will likely prove cost-effective in overcoming the causes of the problematic behaviors at issue.  Finally, as required by problem-solving's Step 4, this Part describes the bill's provisions to establish a transparent, accountable and participatory monitoring and evaluation system to permit, after enactment, ongoing assessment and – if necessary, revision – of the Health Commission Law.

A. Possible alternative legislative solutions

Without creating another administrative agency, the EALA might set up an ad hoc Committee to conduct the necessary research and draft the needed health legislation. That might happen if, say, a member of the EALA, possibly of long service and well-regarded expertise, developed an interest bordering on a preoccupation in health issues, as occasionally happens in the American Congress.¹⁴⁴

Unfortunately, reliance on exceptional individuals, while fortuitous in the event, seems an unreliable route to institutional change.  The EALA, or a member or group of members of the EALA, as presently structured, seem unlikely to have the capacity to obtain data, conduct research, and analyze the findings so as to produce a bill grounded in facts and logic, or to monitor and evaluate a bill's implementation on an ongoing basis.¹⁴⁵

Alternatively, the EAC member states' Ministries of Health could take on the task of conducting research and drafting regional legislation.  The bill here proposed would not, of course, preclude that kind of action.  Indeed the proposed Commission should encourage the health ministries to initiate needed legislation.  Past experience, however, suggests that the national health ministries, concerned with their own countries' health problems, lack both the interest and capacity to pursue community level solutions.¹⁴⁶

As the EAC treaty seems to permit, the EAC Sectoral Committee on Health could take on many of the functions of the envisioned Commission.  (Need more research on structure, membership and history of action/inaction by the Sectoral Committee to determine why it has not done so; the 2007 Summit call for a Health Commission,¹⁴⁷ however, seems, a priori, to suggest that conclusion.)

As another alternative, the proposed Regional Health Commission might issue subordinate legislation, or administrative regulations, rather than propose legislation.  The regulations could take effect on issuance, as do rules promulgated by the Occupation, Safety and Health Agency (OSHA) in the United States.  Regulations alone, however, could not – as could a legislative commission – introduce legislation to change existing institutional structures, or create new institutions.  As well, a legislative commission could, should the facts and logic emerging from research suggest it, propose legislation of the intransitive sort, creating a subordinate department charged with making regulations.

The Sector Committee on Health could itself take on the role envisioned for a Commission in this report, or form a body to do so.  Given, however, the current inadequate response of the Sector Committee, as acknowledged by the EAC itself in calling for new institutions in 2007, such an allocation of responsibility would probably not result in a more productive, transparent body.     

The situation could continue as it presently exists.  As all acknowledge the necessity for action on the unsolved health problems of both the EAC and its member states, on local and regional levels, the status quo seems an unacceptable alternative.

B. The Proposed Regional Health Commission

This report supports the establishment of an EAC Health Commission with the power to conduct research and draft health legislation to maximize the potential use of member state and regional human, physical and financial resources to improve regional health care for all East Africans.

Under the proposed bill, the Commission draws its members from the Community's member states through a transparent process of appointment. The Commission serves primarily to represent, not competing interest groups, but rather the insights of knowledgeable professionals in the health care delivery systems. (Two advocacy NGOs representing the rural poor constitute an exception to that proposition.)  The Commissioners therefore consist of public health professionals with experience in-country.  A wide range of authorities and organizations nominate those members: The Ministers of Health and of Justice of the EAC Partner States, the Deans of their medical faculties, EAC nurses', pharmacists' and other professional organizations, and organizations that advocate for the rural poor.  Involvement by academics as well as government functionaries will broaden and deepen the Commission's agenda, further involve academics in policy, facilitate research and analysis, and make the Commission more independent of other entities.   The National Legislatures will retain confirmation power, maintaining their stake in the Commission without thereby limiting Commissioners' independence or freedom of action.  (See Schedule A to the draft bill.) 
Under the proposed bill, each year the Commission will hold two regular meetings.  They invite participation from every level of society and every stakeholder throughout the community, not only at those meetings (see draft bill, Article 9).  The Commissioners seek information from as broad a range of sources as possible, and, using this input, identify and prioritize health care problems (Draft Bill, Chapter Four).  The act requires public and regularly convened meetings;; that all who wish to speak may do so, that all stakeholders receive notice of the meetings and given time to attend, submit and respond; that the Commission's deliberations, in and out of the meetings, are made public (Draft Bill, passim).  The widest possible representation on the Commission, and the widest possible collection of data, will help the Commission prioritize, respond to urgent and long-ignored needs, and monitor and evaluate its prior actions and their implementation, with a view towards improving them.

The Commission will establish drafting teams to gather the available evidence, or to carry out original research, as the basis in facts, logically organized, for recommending legislative solutions – i.e., bills.   
 
The proposed Act requires that the drafting teams accompany their bills by research reports to provide the evidence, logically organized, to justify the bills' detailed provisions (Articles 13 and 14).  The Commission must make these reports available to the public, thus to enable interested parties to provide inputs to the design of legislative solutions based, not on power politics or trade-offs, but on the available facts and logic.  Publication of the reports will contribute to making the law-making process transparent, accountable, and participatory – an essential quality control:  The reports will  inform any who read them of the factual and logical bases that undergird the proposed legislation; any interested person can assess whether the proposed solution seems logically derived from relevant facts which correspond to reality.

Once the EALA or a member state enacts a bill proposed by the Commission, the accompanying research report will facilitate public participation in monitoring and evaluating whether it proves effectively implemented to help achieve the desired social impact.

The establishment of a Health Legislation Commission, as proposed in this report, would reflect the position, held publicly from the Secretary General of the EAC down, that the health problems of the EAC require a community-wide response. It will facilitate the definition, prioritization, and achievement of goals for improvement in health, and the institutions dealing with health issues, delineated in the 2007 Conference.  Note that the EAC treaty includes language specifically enabling the member states to act on health issues, including pharmaceutical issues.¹⁴⁸

The Commission will share functions that the EAC Treaty assigns, though not exclusively, to existing bodies.  The commission's design empowers it to prioritize problems in the health care delivery system,  conduct research, obtain data, define problems relating to health, and propose legislation – backed by facts and logic elucidated and recorded in a research report accompanying proposed legislation – to change the behaviors causing these problems, in a more effective manner than do existing bodies.

The Commission, under the proposed Act's detailed rules requiring published data and analysis, more than do existing law-making institutions, likely will act positively and with a view to fill the need for improved regional health care.  By virtue of its scheduled meetings (Chapter Three), carefully prescribed bill-designing methodology and detailed research reports (Articles 13 and 14), under the proposed bill the Commission has the capacity and opportunity to prepare legislative proposals more likely to ensure effective regional health care delivery systems.  Its well-defined processes facilitate the prioritizing of problems, the capturing of relevant evidence, and its use of problem solving methodologies in proposing, justifying and evaluating solutions – all critical to its mission.  The meetings specified in the Act will improve data collection, expand outreach to people not always represented or heard, and promote citizen and institutional involvement in health problem solving.

The proposed Act requires the Commission to communicate with stakeholders, citizens and others in timely fashion, and to solicit and accept communications from them.  Transparency, accountability and the greatest possible public participation can only contribute to achieving optimal use of available human and financial resources in providing adequate EAC health care delivery systems.

The Commission's underlying ideology – the improvement of health in the East African Community through action on a community-wide basis – can only prove congenial to stakeholders, and provide an incentive to cooperate with its agenda rather than dismiss or marginalize it. 
 
The bill's mechanism for periodic information gathering also includes monitoring and evaluation of the effect of enacted legislation. Ongoing improvement in legislation, by a continuously operating entity, makes significant results possible even with incremental steps, or with initial moves requiring later correction.

This report documents a need for action on health issues at the level of the East African Community, and not just at the level of its member states.  The East African Community has itself called for the establishment of institutions to provide this action.

The report documents institutional deficiencies at the level of the East African Legislative Assembly, and national Ministries of Health, as presently constituted, which limit those bodies' ability to respond to the need.

The suggested legislation would establish a Health Legislation Commission which, by design, would meet the identified need:

1. It will represent the member states and their health ministries;
2. It will be required to gather data throughout the EAC;
3. It will function in an open and public manner;
4. It will propose solutions to both the EALA and member states' legislatures and Ministries of Health for their consideration;
5. It will involve institutions such as universities and current health care givers;
6. It will propose legislation based on research findings reflecting realities on the ground;
7. It will monitor the effects of legislation if passed, evaluating its efficacy, and if necessary recommend changes, again after conducting research and obtaining wide input from all stakeholders and citizens.

A ROUGH DRAFT OF THE PROPOSED BILL:
 
[Editors' Note:  In view of the difficulties in obtaining the relevant essential evidence essential for establishing an effective EAC Commission, as noted above, this comprises at best a very rough draft of the kinds of detailed legislative provisions likely to prove necessary.   If the proposed EAC workshop takes place, the EAC legislative drafters, health professionals and others who participate will have an opportunity to provide the essential additional information (as indicated above)  On that basis, they can revise the draft research report, and the rough draft of the bill here outlined.]

1.Short title

This  Act may be cited as "The East African Legislative Health Commission Act."

2.Objectives

(1)  In this Act –

'bill' means draft legislation, draft subordinate legislation or a draft regulation; it does not include a rule for the internal administration or governance of the Commission.

'Commission' means the East Africa Community Health Research and Drafting Commission as established by this Act.

'to design a bill' includes devising the detailed substance of a bill's provisions.

'to draft a bill' means to write out the words of a proposed bill.

'EAC' means the East African Community.

'EALA' means the East African Legislative Assembly

'Partner State' means a partner state of the EAC.

(2)This Act has the following objectives:

1. to identify health problems in EAC and its Partner States.
2. to conduct research concerning these problems and the behaviors that constitute them, as the necessary grounding of evidence-based legislation likely to ameliorate them;
3. to prioritize bills for designing and drafting;
4. following that prioritization, to design and to draft bills addressing those identified and prioritized social problems;
5. to propose  evidence-based bills for further study and enactment or adoption and promulgation by EALA or by the relevant subordinate bodies of EAC;
6. so far as feasible, to utilize legislation, subordinate legislation and regulations to ameliorate health care delivery problems in the EAC in ways that maximize benefits and minimize costs;
7. towards that objective to utilize the collective economic, political and social power of EAC;
8. so far as feasible, within EAC, to ensure that EAC inhabitants wherever or however situated have equal access to health care delivery systems
9. in drafting a bill, to ensure the maximum feasible inputs to the drafting process from civil society advocates for the poor and disinherited, for ethnic minorities, for women, for children, and for others usually excluded from the corridors of power;
10. to provide the highest feasible level of training for EAC health care professionals  
11. in drafting a bill, to the maximum feasible extent, to ground the bill on facts and logic;
12. in its efforts to achieve the objectives of this Act, to base its actions and its recommendations on sound science;
13. to the maximum feasible extent, to foster the conditions in which the EAC Member Countries can develop a pharmaceutical industry to supply pharmaceuticals and other medical supplies to the EAC market.

3.Establishment of the Commission

This Act establishes the Commission as a constituent part of the Secretariat of the EAC.

4.Composition of the Commission; appointment of members

The Commission shall have the membership, with the qualifications, and enjoying the tenure, pursuant to Schedule A to this Act.

5.Foundational and subsequent meetings; appointment of Director General of the Commission

1. The Commission shall hold its foundational meeting and appoint its Director-General pursuant to Schedule A to this Act
2. At subsequent meetings of the Commission –

1. The Director-General shall serve as Chair, and have a casting vote.
2. If the post of Director-General becomes vacant, in conformity to the provisions of Schedule A, Article 5 (concerning the Acting Chair in the absence of a Director-General, and appointment of a new Director General) the Commission shall appoint a new Director General.

6.Quorum

Absent a provision to the contrary, at a meeting of the Commission, by a simple majority vote a quorum of not fewer than half the members may conduct business of the Commission.

7.Regular Meetings

1. The Commission shall meet twice a year on the call of the Chair.
2. A reasonable time before the scheduled date of a regular meeting, and in any event not later than two calendar weeks before a regular meeting, the Chair shall circulate an agenda for the meeting, together with supporting documents.
3. By written notice received by the Chair not less than three calendar weeks before a regular or special meeting, a member may require the Director-General to include in the agenda an item, and to circulate to members of the Commission necessary supporting documents, as the member may request.
4. The Chair shall conduct either a regular or a special meeting called pursuant to Article 8 in accordance with Roberts' Rules of Order.
5. The Director-General shall ensure that a member of the public may attend a regular or a special meeting of the Commission

8.Special meetings

1. The Commission shall meet in special meeting at the call of the Chair, or at the call of three members of the Council.
2. The Chair, or the parties who pursuant to sub-Article (1) call a special meeting, as the case may be, shall give not less than two weeks' written notice of the time and place of the meeting.
3. The Chair or the parties who pursuant to sub-Article (1) call a special meeting, as the case may be, shall accompany the call for the meeting, or in any event not less than one week before the special meeting, shall circulate an agenda for the meeting, together with supporting documents.
4. By written notice received by the Chair not less than three calendar weeks before a regular or special meeting, a member may require the Chair to include in the agenda an item, and to circulate to members of the Commission necessary supporting documents, as the member may request.

9.Publicizing matters of concern in EAC health care delivery systems

1. In this Act, 'to publicize' means informing the public by all feasible means.
2. When required by this Act to publicize a matter of concern, as a minimum, the Director-General shall –
   
   • inform institutions of the media such as newspapers, radio and television stations, and magazines, and relevant University departments, faculties or other university institutions within the EAC concerning the matter of concern;
   • post the matter on a web site easily accessible to a person with access to a computer and the Internet; and
   • conform with sub-Article 15(3) (concerning sending information to persons who have registered with the Commission); and,
   • if in the Director-General's or the Commission's opinion the circumstances so warrant, organize one or more public meetings on the matter of concern, in locations and at a time convenient for most stakeholders in the matter.
3. Publicizing the solicitation as widely as feasible, the Director-General shall solicit identifications of problems arising in health care delivery systems within the East African Community or within a particular Partner State.
4. The Director-General shall keep a record of reports of such problems whether they arise within the jurisdiction of the East African Community or within a particular Partner State, or whether a member of the public, a concerned non-governmental organization, an official of EAC or of a Partner State, or a member of the Commission report the problem to the Director-General.
5. The Director-General shall make a preliminary investigation of a problem in the health care delivery system within East Africa called to the attention of the Director-General's office, and describe that problem in not more than five hundred words.
6. The Director-General shall circulate that description of the problem among members of the Commission and others who the Director-General believes should learn about it.

10.Prioritizing health care delivery problems for legislative attention

1. Semi-annually, the Director-General shall compile a list of health care delivery problems within the East African Community, accompanied with a description of the problem as prepared by the Director-General pursuant to sub-Article 9(5)
2. Semi-annually, the Director-General shall make a preliminary prioritization of the health care delivery problems mentioned in the list compiled pursuant to sub-Article (1)
3. Semi-annually, prior to a regular meeting of the Commission, the Director-General shall forward to each member of the Commission the list of projects mentioned in sub-Article (1) and the preliminary prioritization mentioned in sub-paragraph (2)
4. Taking into account –
   
   • the relative medical urgency of the several health care delivery problems in the list provided pursuant to sub-paragraph (3);
   • the relative social urgency of those problems;
   • the resources available for completing the research necessary to produce a meaningful draft bill addressing each of those problems;
   • the drafting resources available;
   • the likely available legislative time before the Council or the EALA for consideration of the proposed legislation; and
   • the preliminary prioritization made pursuant to sub-Article (2),
   • the Commission shall compile a schedule indicating the priority for drafting bills addressing the problems mentioned in the list made pursuant to sub-Article (1).
5. The Commission shall accompany the schedule mentioned in sub-Article (4) with a memorandum justifying the prioritizations in that schedule.
6. In compiling the schedule mentioned in sub-article (4), the Commission shall indicate which, if any, of the proposed bills mentioned in that schedule addresses a matter of insufficient importance and simplicity to warrant excusing the drafter from the obligation imposed by Article 14 (requiring the drafter to accompany the bill with a research report formulated pursuant to Article 14).

11. Emergency health care delivery system problems

1. If two Ministers among the Ministers of Health or Ministers for EAC Council Affairs of the Partner States, or the Director-General, believe that a medical emergency requires immediate legislative or regulatory intervention in the health care delivery system of either the Community or of a Partner State, any two of those Ministers from two different Partner States may require the Director to convene, or the Director on the Director's own motion may convene, as soon as feasible, in a venue that the Director may select, an emergency meeting of the Commission.
2. Pending that meeting, the Director-General, and at that meeting, the Commission, may take whatever action within the Commission's powers seems appropriate to address the medical-legislative emergency mentioned in sub-paragraph (1) 

12.Drafting a bill for EAC

1. So far as feasible conforming to the prioritization determined pursuant to Article 10, and as the Director-General may require, a staff drafter shall design and draft a bill appropriate for ameliorating a social problem identified in the prioritization schedule mentioned in Article 10 (concerning the prioritizing of health care delivery problems for legislative attention)
2. Except as required by action taken pursuant to Article 10 (concerning emergency health care delivery system problems), the Director-General shall assign a drafter to design and draft a bill in the order of prioritization set forth in the list compiled pursuant to Article 9 (concerning the prioritizing of health care delivery problems for legislative attention)

13.  Designing a bill: criteria

1. In designing a bill, the drafter shall take into account only the objectives of this Act as set forth in Article 2 (stating the objectives of this Act).
2. In designing a bill, the drafter shall follow a problem-solving decision-making methodology, as prescribed in Article 14 (concerning research and the Research Report) with respect to the design of a Research Report.

14.    Research and the Research Report

1. A drafter assigned, pursuant to Article 12 (1) (requiring a drafter on the instructions of the Director-General to draft a designated bill) to draft a bill, shall undertake detailed research on the several aspects of the assigned bill, following the methodology prescribed by sub-Article (3). 
2. Except with respect of bills with low importance and low complexity as mentioned in sub-Article 10(5), the drafter shall accompany a bill with a Research Report, which demonstrates that the bill's detailed provision rest on facts, logically organized.
3. In designing a bill as mentioned in sub-Article (1), and, pursuant to sub-Article (2), in writing the Research Report, the drafter shall –
   
   • first, examine in detail the behaviors that constitute the social problem that the designated bill will address;
   • second, identify in detail the relevant constraints and resources that influence those problematic behaviors;
   • third, design a bill whose provisions address the factors, identified pursuant to sub-paragraph (ii), which likely influence the problematic behaviors at which the bill aims, and demonstrate that the prescriptions of the bill will likely provide the most economical available legislative solution for the social problem addressed; and
   • fourth, include in the bill provisions for monitoring and evaluating the law after its enactment and implementation.
4. The drafter shall write the Research Report mentioned in sub-Article (1)—
   
   • a.in a form that explicitly tracks the decision-making methodology prescribed  in sub-Article (3);
   • b.including evidence to support a claim that the addressees of the several prescriptions in the bill will conform their behaviors to those prescriptions;
   • c.in a manner that the drafter believes will win support of the draft bill by a  rationally skeptical voter. 
5. In the Research Report, the drafter shall make every effort accurately to predict the behaviors that the bill will induce in the relevant actors.

15.    Participation in a drafting project

1. When pursuant to Article 12 (concerning drafting bills for consideration by EAC) the Director-General assigns a health care delivery problem to a drafter, absent a prescription to the contrary, the Commission shall publicize that it has undertaken drafting a bill to address that problem.
2. A person desirous of receiving notice of progress in drafting the bill may submit his or her name and address to the Director-General, together with a specification of the bill of interest to that person.
3. Thereafter, whenever pursuant to sub-paragraph 9(2)(b) this Act requires the Director-General to publicize a draft of that proposed bill, in addition to other publicizing efforts, the Commission shall notify by ordinary mail or by e-mail a person who pursuant to sub-paragraph (2) has submitted a name and address to the Commission.
4. Until the closing date for comment mentioned in paragraph 15(2)(b),  person may at any time submit to the Director-General a suggestion for inclusion in, or exclusion from, a proposed bill.

16.    Publicizing the draft bill; comment.

1. Upon completion to the satisfaction of the Director-General of a preliminary draft bill that purports to ameliorate the designated health care delivery problem, together with the Research Report mentioned in Article 13, the Director-General shall publicize that preliminary draft bill and its accompanying research report in conformity to sub-Article 9(2) (prescribing steps required to publicize a matter).
2. In publicizing, pursuant to sub-Article (1), a preliminary draft bill and its accompanying Research Report, the Director-General shall include – 
   
   • a.the text of that preliminary draft, or advice where a stakeholder or other interested person may obtain a copy of that preliminary draft bill, and its accompanying research report, if any; and
   • b.an invitation to stakeholders and other interested persons to comment on that preliminary draft bill, together with a time limit for submission of comments.      

17. Promulgation of the bill

1. After the expiration of the time limit prescribed by sub-paragraph 16(2)(b), the responsible drafter shall revise the bill in light of the comments received.
2. In the bill revised pursuant to sub-Article (1), the Director-General shall either –
   
   • include the substance of a comment made after publicizing the preliminary draft bill pursuant to sub-Article 16(1)  and before the expiration of the time limit mentioned in sub-Article 16(2)(b), or
   • explain why the Director-General rejected such a comment.

18.Commission approval of a bill

1. Upon completing the revision of the bill pursuant to Article 17(1), the Director-General shall circulate to each member of the Commission the following:
   
   • a copy of the preliminary draft bill, as publicized pursuant to sub-Article 16(1);
   • the research report that pursuant to Article 14(2)(requiring that a Research Report accompany a preliminary draft bill) accompanied the preliminary draft bill;
   • the bill as revised pursuant to sub-Article 17(1), and
   • the statement of reasons, if any, made pursuant to sub-paragraph 17(2)(b)
2. If within thirty calendar days after circulating the bill pursuant to sub-Article 1, a member of the Commission does not request that the Director-General schedule the bill for further Commission discussion and vote, the Director-General shall forward the bill and its accompanying research report and other materials to the Secretary-General of EAC for appropriate EALA or EAC action.
3. If within thirty calendar days after sending the bill pursuant to sub-Article 1 a member of the Commission does request that the Commission schedule the bill for further Commission discussion and vote, the Director-General shall place the bill on the agenda for the next Commission meeting, and shall so notify the members of the Commission.
4. At the meeting mentioned in sub-Article (3), the Commission shall approve some or all of the revised bill, the research report, and the reasons for rejecting a comment, or reject some or all of these, or require changes in any of these.

19.    Miscellaneous powers and duties of the Commission

1. The Commission shall:
   
   • make, keep, store, preserve and make available to an interested party:
   • records of Commission proceedings; and
   • research reports generated or used  by the Commission;
   • publicize the times and locations of all Commission hearing
   • open all its meetings to the public
   • keep account of the funds of the Commission, and keep those funds in a secure account;
   • record the Commission's expenses;
   • annually, make public an annual account of the Commission's income, expenses, cash reserves and transactions;
   • make public rules, procedures and regulations made pursuant to Article 8.
2. Within budgetary limitations, the Commission may employ staff to help it carry out its functions.
3. The Commission shall train drafting staff in designing and justifying draft legislation in terms of facts and logic, and in conforming to the requirements of Article 14..
4. The Commission shall collect, store and preserve information concerning –
   
   • the specific types of public health programs implemented in the Partner States; 
   • the criteria Partner States explicitly employ in designing their public health programs., and in choosing between alternative possible designs for those programs;
   • the criteria Partner States employ in selecting persons in charge of implementing their public health programs;  
   • procedures for terminating a public health official's tenure;
   • the resources Partner States allocate for public health programs;
   • the cost of implementing and sustaining Partner States' public health programs;
   • the monitoring, evaluation and feedback mechanisms Partner States employ with respect to their public health programs, and their effectiveness;   
   • how frequently Partner States review their public health programs;
   • the major challenges facing the several public health programs of the Partner States; and
   • the data collection and storage system of the Partner States' public health systems, and their accessibility to the public.

20.    Dispute Settlement

1. A party aggrieved by an action purportedly taken in terms of this Act may petition the Secretary General of EAC for relief.
2. The Director General shall appoint a senior EAC civil servant as Master to hear the matter and to recommend an appropriate remedy, if any.
3. The Master shall expeditiously hear the parties in person and through counsel, record the proceedings and the evidence, write an opinion with recommendations for action, and submit the record and the Master's opinion in the matter to the Director-General.
4. The Director shall decide the matter in writing, stating reasons, on the record made before the Master.
5. A party aggrieved by the Director-General's decision may appeal on the record made before the Master to the EAC Court.

21. Funding

1. As part of the EAC Secretariat, in estimates for the Secretrariat, the Director-General shall include funding for the Commission.

22.    Making rules for governance of the Commission

1. Except for sub-Article 18(2) (concerning forwarding a bill to the Secretary-General of EAC) following the procedures for designing, drafting and promulgating a bill in terms of  Chapter Five, the Director-General may make a Rule for the better governance of the Commission, or to enlarge its capacity to accomplish the objectives of this Act.
2. If within thirty calendar days after circulating the Rule pursuant to the procedures prescribed in sub-Article 18(1), a member of the Commission does not request that the Director-General schedule the Rule for further Commission discussion and vote, the Director-General shall forthwith promulgate the Rule as a Rule for the governance of the Commission.
3. If within thirty calendar days after circulating the Rule pursuant to procedures prescribed in sub-Article 17(1) a member of the Commission does request that the Commission schedule the Rule for further Commission discussion and vote, the Director-General shall place the Rule on the agenda for the next Commission meeting, and shall so notify the members of the Commission.
4. At the meeting mentioned in sub-Article (3), the Commission shall approve some or all of the revised Rule, the research report, and the reasons for rejecting a comment, or reject some or all of these, or require changes in any of these.
5. After final approval by the Commission of the proposed Rule, the Director-General shall forthwith promulgate the Rule as a Rule for the governance of the Commission.

23.    Evaluation and Monitoring

1. At the regular meeting of the Commission that falls closest to the beginning of a new calendar year, the Commission shall elect three persons to serve as that year's Evaluation Committee.
2. The Evaluation Committee shall forthwith prepare a Report describing, commenting upon and evaluating the Commission's work during the relevant calendar year.
3. The Director-General shall assign one or more regular Commission staff to aid the Commission in its tasks.
4. Within sixty days after appointment pursuant to sub-Article (1), the Evaluation Committee shall forward its Report to the Director-General.
5. Immediately upon receipt of the Report pursuant to sub-Article (4), the Director-General shall send a copy to Commission members, to members of Commission staff, to the media, and to all persons who pursuant to Article 15 have registered with the Commission,
6. Not more than seven calendar days after the date specified pursuant to sub-paragraph (5)(a), the Director-General shall send a copy of the Report and of comments received pursuant to that sub-paragraph to the Secretary-General of EAC.
   
   • The Director shall accompany the Report sent pursuant to this sub-Article (5) with the address of the Evaluation Committee, and a statement that the Committee will accept a comment on the Report until a specified time and date, thirty calendar days next following the receipt of the Report, pursuant to sub-Article (4), by the Secretary-General.
7. The Secretary-General of EAC shall forthwith circulate the Report and accompanying comments, if any, to the members of EALA, to the Ministers of Health of the several EAC Partner States, and to the Presidents of the Partner States.

22.    Definitions

1. In this Act –
   'bill' has the meaning assigned to it in sub-Article 2(1)
   
   'Commission' has the meaning assigned to it in sub-Article 2(1)
   
   'to design a bill' has the meaning assigned to it in sub-Article 2(1) includes devising the detailed substance of a bill's provisions.
   
   'to draft a bill' has the meaning assigned to it in sub-Article 2(1) means to write out the words of a proposed bill.
   
   'EAC' has the meaning assigned to it in sub-Article 2(1) means the East African Community.
   
   'EALA' has the meaning assigned to it in sub-Article 2(1) means the East African Legislative Assembly
   
   'Partner State' has the meaning assigned to it in sub-Article 2(1) means a partner state of the EAC.
   
   'to publicize' has the meaning assigned to it in sub-Article 9(1)

Ruha Deveneson

[Editors' note:  As a member of Boston University School of Law's Legislative Policy and Drafting Clinic, Ruha Devanesan drafted the following research report to accompany the following proposed bill to establish a joint system for registering pharmaceuticals for distribution throughout the five  East African Community member states.]

SUMMARY

The lack of access to essential medicines remains worse in East Africa than in many other developing regions of the world.  Because of delays in treatment, diseases such as AIDS/HIV, Tuberculosis and Malaria run rampant in Kenya, Tanzania, Uganda, Rwanda and Burundi.  Other curable diseases such as respiratory diseases, diarrhea and malnutrition, also claim many lives.  Ineffective national pharmaceutical registration processes, i.e. the processes to license legally imported pharmaceuticals for marketing within a country, exacerbate the shortage of medicines for treating these diseases.  This report and bill address three aspects of problematic registration practices: undue delays in the registration of vital medicines by national drug regulatory authorities; the registration of more expensive patented drugs over cheaper generics; and the registration of low-quality drugs because of inadequate pre-registration quality testing and GMP requirements.¹⁴⁹ 

National drug regulatory authorities act the way they do mainly because of resource constraints, inadequate guidelines or training for effective registration, and corruption.  Local manufacturers lack the capacity to conduct thorough clinical trials (for the future production of medicines domestically) and fall below international GMP standards. Foreign manufacturers do not have an incentive to register cheaper generics in individual EAC member states because each country's market remains too small to provide an incentive to initiate local manufacture or even to sell innovator drugs at lower than world prices.

As a partial solution, this report proposes a joint registration system for the entire EAC region. By making the entire EAC regional market available under one registration requirement instead of five, joint registration will create a larger market, more likely to attract imports of cheaper generics as well as innovator drugs.   Creating a joint system will also pool the resources of the five EAC countries to avoid overlaps in registration processes and quality assurance.  Finally, a uniform registration system entailing higher standards of GMP and quality assurance will help to screen substandard medicines out of regional markets.

In Kenya, Tanzania, Uganda, Rwanda and Burundi (collectively the East African Community, or "EAC"), every day thousands of people die of preventable or at least treatable diseases, for example, AIDS/HIV, malaria and tuberculosis.  In Kenya alone, every day seven hundred people die from AIDS-related disease.  A shortage of essential anti-retroviral medicines (ARVs) contributes to these deaths.¹⁵⁰ In 2002, only 6,000 of an estimated 2 million Kenyans living with HIV received ARVs.  The rest either could not afford to purchase them at the high price of US$75 per month, or, because of supply shortages, could not buy them at local pharmacies.¹⁵¹  Similarly, in 2007, only 41 percent of Ugandans who needed ARVs received them.¹⁵²  The World Health Organization estimates that of the million deaths caused annually by malaria, if the drugs taken to combat the disease had proven genuine, patient access to those drugs would have saved 200,000 lives.
 
WHO estimates that up to 50 per cent of drugs sold in Asia and Africa appear fake.¹⁵³  While in most countries, the law forbids the sale of fake (or counterfeit) drugs illegal, legally produced and circulated substandard medicines continue to circulate.  Directly or indirectly, an adequate system of pharmaceutical registration could have prevented many, perhaps most of these deaths.      

A. Ineffective national registration systems contribute to the shortage of essential medicines in the EAC

This report addresses the problems of sub-standard registration practices by the EAC's national regulatory bodies leading to shortages in affordable, quality medicines in the five EAC countries.  As a solution to this problem, this Report recommends a bill to establish a joint registration system for all five EAC countries.   That will enable the drug regulatory authorities in each country to pool their current resources and staff to create a uniform regional registration system that prioritizes the provision of good quality, affordable medicines to East Africans within the Community. 

1. Importation and local production of unsafe or expensive medicines, and the shortage in essential medicines, remain part of the larger problem of ineffective Drug Regulation in the EAC

The broader picture into which this report on registration fits is that of a general lack of access to essential medicines in the East African Community.  Several factors contribute to this lack of access.  First, no individual EAC country has the capacity to produce essential effective medicines.  The EAC countries must therefore import most of them from abroad.   The member states, however, often lack financial capacity to pay for medicines to treat their entire populations for the range of sicknesses that plague: HIV, Malaria, and TB, three diseases which kill thousands of East Africans every year – and a devil's cauldron of others.  A 2004 report on Uganda demonstrated that perinatal and maternal conditions caused 20.4 percent of the total death burden, malaria caused 15.4 percent, acute lower respiratory tract infections 10.5 percent, AIDS 9.1 percent, and diarrhea 8.4 percent.  Other diseases mentioned included TB, malnutrition, intestinal worms and anemia.¹⁵⁴ According to the same report, "although the disease burden and mortality from preventable or curable illness is highest in Africa, pervasive poverty means that the continent's share of the global pharmaceutical market is only slightly more than 1 percent."¹⁵⁵ 

The five EAC countries' national DRAs do properly address diseases such as HIV, Malaria and TB.  In Kenya, for example, a 2005 random survey by the National Quality Control Laboratories (NQCL) and the Pharmacy and Poisons Board reported that almost 30 percent of the drugs in the Kenyan market proved counterfeit.   Some "were no more than just chalk or water marketed as legitimate pharmaceutical products."¹⁵⁶ The Kenyan Association of Pharmaceutical Industry estimates that counterfeit pharmaceutical products account for approximately $130 million annually in sales in the country.¹⁵⁷
Because of the delayed discovery of the ineffectiveness of imported first-line anti-malarial drugs', originally admitted by the Government regulatory authorities, the Kenyan Ministry of Health finally prohibited them.  Health policy and planning scholars observe the continued use of an outdated drug "may encourage parasite resistance and undermine the effectiveness" of the new drugs distributed to fight Malaria in Kenya.¹⁵⁸

By failing to filter out substandard medicines from domestic markets, as well as failing to provide a reliable legitimate channel through which consumers may obtain affordable quality medicines, ineffective systems of regulation, or no regulation at all, exacerbate the problem of access to quality medicines.  Thorough analysis of drug quality before licensing, vigilant checks at Ports of Entry ("PoE") for quality of drugs entering the country, and follow-up monitoring of the same drugs once they reach the market:  These functions that must take place to ensure that drug quality remains unadulterated.  Without thorough regulation, the other factors affecting access to essential medicines – increasing donor aid, importing innovator drugs¹⁵⁹ and generics,¹⁶⁰ locally producing essential medicines, and improving distribution systems for these drugs – cannot work effectively.
   
The prohibitively high prices of high-quality medicines contributes to the inadequate access to medicines in the EAC.  Populations consisting largely of persons living either on meager incomes or below the poverty line¹⁶¹ cannot afford high-priced medicines – no matter how good the quality.  Both patent laws and domestic taxes contribute to these high prices.  Most EAC consumers have very limited incomes and must pay out-of-pocket for their medicines (e.g. in Burundi). Because allopathic or traditional medicines cost less, those consumers have small choice but to turn to those alternatives. "The World Health Organization [WHO] has reported that between 60 and 70 percent of Africans approach traditional healers as their first line of healthcare" and "people are starting with traditional healers and then moving back and forth" between treatments. ¹⁶² In Kenya, the figures for rural consumption of traditional medicines soar higher, with dire consequences: "an estimated 70% to 80% of Kenyans, mostly rural, predominantly depend on traditional rather than formal medicine for their primary health care and have little or no access to secondary or tertiary care."¹⁶³ In recognition of these problems, the five EAC countries, at their (DATE?) EAC Ministerial Conference, laid out several objectives on healthcare in general and on registration in particular.¹⁶⁴

Before it can improve access to quality medicines, the EAC must address many aspects of regulation.  This report addresses the narrow issue of how registration policies and processes contribute to the entry into, and use of, low-quality drugs in the pharmaceutical markets of the five EAC countries.   It proposes a narrow solution to this problem.  Other research reports submitted by ICLAD to the EAC on improving access to medicines address other essential aspects of reform – improving procurement processes, coordinating efforts to deal with donor aid agencies and pharmaceutical companies better, and streamlining distribution processes within the national health systems.
   
By focusing on registration, this report addresses quality assurance of medicines before they enter the EAC market (see diagram below), as well as these countries' licensing processes.  Effective registration reform requires thorough quality control procedures, and systematic post-marketing testing to ensure that, further down the pipeline of procurement and registration, dealers or others do not adulterate or tamper with medicines.  These processes entail different enforcement mechanisms, and therefore other bills must address these aspects of procurement and distribution.

Continual entry of low-quality drugs into these countries, due to ineffective registration practices, exacerbates the broad harm.  First, low-quality drugs cannot properly treat these diseases and might even produce adverse drug reactions in patients.  Second, treatment of these diseases with low-quality drugs could interfere with the effects of quality drugs, administered later.   Third, effective registered drugs sometimes prove too expensive, in part because registration authorities do not prioritize attracting generic manufacturers.  Fourth, sometimes, bureaucratic behaviors or corruption may drag out the essential registration process for months or even years past the average registration period, endangering the medicines' potential effectiveness.

2. The Problem-Solving Approach

This report follows the four steps of institutionalist legislative theory's problem-solving methodology.¹⁶⁵  As a first step, this paper describes the social problem that the bill aims to help resolve (in this paper, that of ineffective registration by national regulatory authorities in the East African Community) In its Section II, this Report identifies the different actors, or role occupants that contribute to that problem, and describes their behaviors that constitute the social problem at issue.  Section III explains the problematic behaviors identified in Section II.  It examines the governing law and the range of objective and subjective causes of those behaviors.  Section IV then proposes a solution aimed at altering or eliminating the causes of those behaviors as identified in Section III.  It puts forward several alternative registration methods and structures to those currently in use.  In part via a cost/benefit analysis, Section IV justifies the Report's preferred solution, a solution that effectively changes the identified problematic behaviors and fosters effective registration practice. 

This Step I of the problem-solving methodology describes the specific social problems created by the existing ineffective drug registration systems.   This step focuses attention on the problems the 'solution' (the final bill) must address and the problematic behaviors the bill must seek to transform. 

Substandard medicines frequently cause serious harm to consumers, and increase resistance of diseases to otherwise effective medicines.  In Tanzania, for example, 11 percent of medicine samples collected from public facilities, and 13 percent of those from private pharmacies failed quality testing. 

Poor-quality drugs, including counterfeits, are thought to be widely available, especially in the private sector. In the first five months of 2001, 30 percent of the samples tested by the National Quality Control Laboratory failed, with a quarter of those being counterfeit drugs. It is estimated that half of the drugs on the market are unknown to the local drug authority.¹⁶⁶

In four ways, the failure of drug regulation contributes to the severe medical issues in the EAC.  First, adverse drug reactions (ADRs), caused by the administration of inappropriate medicines, cause several thousands of deaths per year.  They constitute the 4th to 6th largest cause of morbidity in the United States.  In Least Developed Countries such those in the EAC, ADRs likely cause even more deaths, but adverse drug reactions in the EAC remains extremely under-reported.¹⁶⁷  A Burundian Guideline asserted that, "[t]his problem may be aggravated by a lack, in Burundi, of legislation, quality control and proper drug regulations, including ADR reporting," combined with "a large number of substandard and counterfeit products circulating in our markets, a lack of independent information and the irrational use of drugs."¹⁶⁸

Resistance constitutes the second major problem associated with substandard medicines in the EAC.  Resistance of plasmodium falciparum (the Malaria parasite) to chloroquine, the cheapest and most available drug to fight malaria, has spread throughout endemic areas, including East Africa.¹⁶⁹  Administration of the wrong quantities of a medicine can breed resistant parasites, and therefore sub-normal or supra-normal quantities of an active ingredient can foster resistance to otherwise effective medicines.¹⁷⁰  In Uganda in 2001, one study found 39 percent of chloroquine tablets surveyed of inferior quality, 11 percent of tablets having sub-normal quantities of the active ingredient and 28 percent having supra-normal quantities of the active ingredient.  Similarly, of the chloroquine injections tested, 51 percent of samples failed the quality test, containing either too much or too little of the active ingredient.  Even these figures appear as an improvement on the 55 percent of tablets and 62 percent of injections reported in a 1998 as sub-quality.  (The study attributes this slight improvement to the establishment of Uganda's National Drug Quality Control Laboratory (NDQCL), which carries out randomized quality-control tests on all registered drugs within the country.)  Nevertheless, the study concludes that these figures remain "unacceptably high."¹⁷¹

Third, the price of medicines significantly limits East Africans' access to essential medicines.¹⁷²  At an East African "Improving Access" conference in 2000, a pharmacist, Kirsten Myhr, presented information on the retail prices of 15 essential medicines in Kenya, Tanzania and Uganda, as compared with prices in Norway.  The antibiotic ciprofloxacin cost twice as much in Uganda as Norway, and the anti-malarial mefloquine was also twice as expensive in Tanzania as in Norway.  Although mefloquine has a limited market in Norway, in Tanzania, , given its malaria epidemic, that market stretches widely.  Myhr concluded, "the entire region is suffering from reverse equity... the poor are paying more than the rich."¹⁷³  This difference in price increases exponentially when considering the differences in income in the two countries and the differences in out-of-pocket payments in each country.  In most Western countries, insurance and government assistance minimize out-of-pocket expenses. In developing countries, patients pay for 80 percent of drugs out of pocket. "(T)he average Tanzanian would have to work 215 days to purchase a basket of 13 essential medicines, while a Canadian would only have to work 8."¹⁷⁴ 

The same report pointed out the difference in prices persists not only between rich and poor countries, but between countries with and without patents on particular medicines.  In Thailand, for example, patients enjoy ready availability of several generic versions of the AIDS-related meningitis treatment, fluconazole.  Competition between them has driven the price of the drug down to US$0.30 per 200mg capsule.  In Kenya, the same drug costs US$18.00, because fluconazole enjoys patent protection.¹⁷⁵  In other words, patent protection renders the drug sixty times more expensive in Kenya than Thailand.

Current East African registration practice perpetuates a fourth harm: The delayed registration of certain essential medicines.  In 2002, of 87 ARVs awaiting registration by Kenya's regulatory authority, the Pharmacy and Poisons' Board (PPB), that Board had registered only three.¹⁷⁶  The rest have been waiting far longer than the estimated 3-month average approval period, and some have even awaited approval since as long ago as 1999.¹⁷⁷ 

Such delays in registration contribute to general shortages of essential medicines in East Africa.  In 2002 in Rwanda, for example, 37 percent of hospitals reported 'stock-outs' of essential medicines.  This number included 50 percent of the district pharmacies, 35 percent of district hospitals, and 38 percent of health centers experiencing drug shortages.¹⁷⁸  In Uganda, the figures appear significantly better.  Even there the median percentages of key medicines available there remained only 75 percent in public health facilities and 55% in district warehouses.  The median stock-out duration in Uganda averaged about 3 months in public health facilities, and 6 months in district warehouses.  These durations seem "unacceptably" long.¹⁷⁹  The Tanzanian situation appears only slightly better, with 65-70 percent of key drugs available through the government procurement department, the Medical Stores Department (MSD).   When the MSD cannot supply medicines, however, buyers turn to local private wholesalers and distributors, who "often sell products at less favorable prices and of dubious quality."¹⁸⁰

In Kenya, in public health facilities and regional warehouses, a basket of essential medicines had a median stock-out of about one month.  Of these, half the public health facilities had stock-out durations that lasted longer than a month, and 13 percent greater than 3 months.  In addition, 20 percent of regional facilities experienced stock-outs of essential medicines for more than 3 months.¹⁸¹ In early March 2004, most public and private hospitals ran out of Efavirenz (brand name Stocrin), a medicine produced by Merck and used in ARV treatment. This approved disastrous for HIV/AIDS patients who must follow treatment constantly: "Shortages, which in turn affect adherence to treatment, can lead to serious potential consequences ranging from development of resistance to first line treatments to, ultimately, death of HIV/AIDS patients."¹⁸²

A.  Note on social costs and benefit

The current system of registration benefits patent-holding manufacturers of medicines in several ways, while the consumers of these medicines pay not only with an unfairly large amount their meager earnings¹⁸³ but worse, with their health and their lives.  An unfocussed registration system, operating without guidance from a public health-focused national policy, allows non-essential medicines to enter the market, while excluding essential ones.  Manufacturers benefit from a weak registration system because they may avoid proving the quality of their medicines and their manufacturing processes.   Counterfeiters also may take advantage of a weak registration system (coupled with a weak regulatory system)    Operating in a semi-open fashion, they may adulterate genuine pharmaceuticals or manufacture their own fake versions, either within the country or abroad, and then distribute them with near impunity.¹⁸⁴ On the other hand, when the registration and regulatory system remain weak, patients become the losers.  They either have no access to medicines because of shortages, or, because of their expense, they cannot buy available medicines.  Instead, these patients too often have no alternative but to turn to substandard medicines.  The governments of the EAC countries, which often buy medicines from innovator or generic producers at great cost to their limited national resources, only to discover that – improperly tested before registration – they prove ineffective.

In sum, the East African countries' currently inadequate registration systems lead to the importation of substandard or over-priced medicines, and delays in the registration of essential qualified medicines – all serious obstacles to EAC access to essential, effective medicines.  Whose and what behaviors produce these lamentable outcomes?

A.   Introduction

This section identifies as role occupants the officials who administer the drug regulatory systems of each of the five EAC countries, and the pharmaceutical manufacturers who seek to obtain licenses to sell their pharmaceuticals in those countries' markets.  This Report explores these actors' problematic behaviors – behaviors that the proposed bill aims to change.   In Part III, the Report analyzes and provides evidence as to the causes of each set of problematic behavior.  In Part IV, it suggests logically possible legislative solutions (the detailed provisions of a bill) likely to change those behaviors. 

1. The Drug Regulatory Authorities (DRA's)

Although the five EAC countries' drug registration systems in some respects vary in competency, in many other respects they remain similar.   Common threads of problematic behaviors characterize the five EAC five drug regulatory authorities.  Before they enter national markets, they subject pharmaceuticals (1) to poor quality testing, (2) if at all, to loose GMP testing, and (3) to registration procedures uncoordinated with national drug policies.  Finally, (4) they neither prioritize nor fast-track for regulatory approval cheaper generic versions of essential drugs.

As the regulator of Kenya's Pharmacy market, the Pharmacy and Poisons Board (PPB) has a demanding mandate – to police the largest pharmaceutical production market in the Common Market for Eastern and Southern Africa (COMESA) region. The PPB's drug registration and quality assurance processes remain slow (they take an average of 6 months to register a drug) and inflexible (given a sudden outbreak of a disease, for example, the PPB fails to speed up the registration process to increase the supply of drugs to fight it) ¹⁸⁵

The functions of Kenya's National Quality Control Laboratory appear limited.  Of the samples collected in 2003 for regulatory purposes, it tested less than 20 percent (see Table 3).¹⁸⁶

A disconnect between national treatment policies and the PPB's registration processes has had disastrous consequences for disease treatment.  In the 1990s, for example, the PPB registered sulfamethoxypyridazine products for human use in treating malaria, even though the national antimalarial policy declared this drug unsuitable for human use, and restricted to veterinary use only.¹⁸⁸ As late as 1998, one could find in the Kenyan market at least seven products containing this ingredient.¹⁸⁹

The PPB supposedly inspects and licenses pharmaceutical manufacturers and retail outlets.  Because the law does not provide the PPB with guidelines for inspection, however, the Board has fallen behind on enforcing compliance with the national medicines legislation.  Despite Pharmacy and Poisons Act requirements, the PPB apparently failed properly to inspect pharmaceutical plants for good manufacturing practices.¹⁹⁰

As one of PPB's major problems, it takes an inordinate time to register medicines.¹⁹¹  Formally, PPB sets no time limit on applications.  For a five-year license, it charges a fee of $1,000 per product.¹⁹²   For a foreign importer, the process usually takes around 6-9 months, but in some cases may take several years.  These delays discourage patent-holding manufactures from applying for licenses. They also diminish the utility of TRIPS flexibilities such as compulsory licenses and the Bolar exception.  (The Bolar exception allows generics manufacturers to register and prepare to market a drugs before the patent expires, so that once the patent expires, they can market their versions immediately.  A slow registration process renders that exception redundant because, even after the patent expires, a generic's sales may still have to wait for completion of its registration.¹⁹³)

Of the five EAC countries' DRAs, Tanzania's Food and Drug Authority ('TFDA') appears the most operational and efficient.  Created in 2003 as an executive agency under the Tanzanian Ministry of Health, TFDA replaced the Pharmacy Board, also formerly operated under the Ministry of Health.  TFDA has responsibility for controlling quality and safety in food, drugs, cosmetics and medical devices.  It has created very comprehensive guidelines for manufacturers on the registration of medicines, both patented and generic, and even has a separate set of guidelines for the registration of traditional medicines.  (In contrast, the Kenyan PPB, for example, has no mandate to regulate or register these.)  

Information on possible problems encountered in the TFDA's registration practices remains limited.   Available evidence, however, suggests that it has tackled several problems experienced by the earlier Tanzanian Pharmacy Board.  One of the first countries to adopt an essential drugs list, TFDA prioritizes the procurement and delivery of essential medicines.  Until 1999, when new management took over the Pharmacy Board, the Pharmaceutical and Poisons Act requirement to register all pharmaceuticals suffered weak enforcement.  That year, the new Pharmacy Board instituted a registration unit staffed by seven pharmacists with extensive experience in pharmacy but little experience in registration issues.   By 2001, TFDA had registered some 60 percent of the drugs on the National Essential Drugs List (NEDLIT)    Although in that year, out of 4,800 products submitted for registration, the TFDA had registered only 1,408 human drugs and 64 veterinary drugs (i.e., a third of those submitted),  by 2000 it had registered 123 percent more human drugs than in 1999.¹⁹⁴

The TFDA still, apparently, currently applies national GMP standards that remain below international standards.¹⁹⁵  As a result, it remains uncertain whether any of the pharmaceutical manufacturers within Tanzania maintain manufacturing practices that ensure that the quality of medicines they produce conform with international standards.  Requiring lower GMP standards of manufacturers may set attainable goals for small pharmaceutical producers.  Donor agencies and other purchasers in other EAC member states, however, tend to require different (and in most cases, higher) GMP standards.  The lower GMP standards set by Tanzania limits Tanzania manufacturers to selling only in the Tanzanian market.  Similarly, the TDFA does not do Quality Assurance testing of local Tanzania-produced medicines.  Instead, the companies themselves conduct that testing.¹⁹⁶  While this reduces TFDA's regulatory burden, it also means that TFDA does not play the essential role as a watchdog over the manufacturers' practices.

Uganda's National Drugs Authority ('UNDA') also seems well-established, with a clearly defined process for registering manufacturers' drugs.  Before registering the product, and to maintain its license, every three years after that, the NDA must inspect a site that manufactures a final pharmaceutical product.¹⁹⁷  

The Ugandan Ministry of Health's ARV Taskforce Logistics Subcommittee estimates that the drug registration process takes between 3-6 months.  Delays in documentation and communication may increase the average registration time to 6 months for generics and to a year for new medicines.  As part of the national health policy, however, the NDA prioritizes and fast-tracks ARVs.  As a result, registration of ARVs in Uganda takes an average of only 1-3 months, although each new strength of a drug requires a separate license.¹⁹⁸

According to the Logistics Subcommittee, every time it receives a new drug application, Ugandan law requires UNDA to inspect the manufacturing factory for GMP for each different product category.  For example, unless the manufacturer already has registered one or more ARVs for the Ugandan market, "if a generic manufacturer in India has antibiotics registered for the Ugandan market, but has applied to register an ARV, NDA must re-inspect that manufacturing site for the category of ARVs."¹⁹⁹ 

The UNDA's thorough testing mandate strains the Ugandan quality control labs (the NDQCL)   Their seven staff members operate the laboratories' three quality-testing machines seven days a week.  The Logistics Subcommittee warns that without a fourth machine, increases in imports will further strain the system.  Quality testing then may become a bottleneck in the supply chain.²⁰⁰

The UNDA provides free tests for the first three batches of a drug that enters Uganda. To avoid the payment of testing fees, many importers therefore limit their shipments to three batches.  Because some firms interrupt shipments when they must pay registration fees, this contributes to Uganda's shortage of essential medicines.²⁰¹

In Rwanda, the Law on Pharmaceutical Art mandates the establishment of a national commission responsible for drug registration (Article 42) pursuant to a Presidential Order (Article 43) and requires manufacturers to comply with WHO GMP standards (Article 36).   As of 2006, however, the Presidential Order specifying the details necessary to establish the drug registration authority apparently still awaited for Cabinet approval.²⁰² Given the lack of a national registration authority with the equipment, labs and qualified technicians to conduct the necessary quality tests, the Rwandan Ministry of Health allowed into the country only medicines registered elsewhere (e.g., US Federal Drug Administration-approved) or that had WHO certifications.²⁰³  This system, also called reliance registration, or vicarious registration, ²⁰⁴ ensures that the quality of medicines approved by the Ministry of Health, but inevitably limited the Rwandans' access only to medicines that meet the FDA's very high standards – mainly expensive patented medicines from the West – or those prequalified by WHO.²⁰⁵ The WHO pre-qualification system, while effective, only covers medicines treating HIV/AIDS, malaria, tuberculosis reproductive health.  As a result, Rwandans suffering from other diseases, such as respiratory diseases, and diarrhoeal diseases, seemed less likely to have access to affordable treatments.

A decade of civil war left the government of Burundi struggling to rebuild its infrastructure.  In 2004, the health system, like other social services, only barely functioned.²⁰⁶ In 2002, the government introduced a cost-recovery policy, which required patients to pay 100 percent of all medical expenses related to their treatment, and 115 percent for medicines (i.e., patients pay 15 percent more than the medicine's cost the government).   Theoretically, this covered local additional healthcare expenses, including payments for those patients who could not afford to pay.  In practice, however, although they could not afford to pay, the government did not register most Burundians as destitute.  Not certifiably destitute, they had to cover the costs of their treatment.²⁰⁷  In 2004, 81.5 percent of patients consulted said they had to go into debt or sell portions of their harvest, livestock or land to pay for treatment.²⁰⁸  When they cannot pay, health centers in Burundi may confiscate patients' identity papers or belongings.  According to MSF, until someone pays the fees (including the price of medicines), some health centers detain patients -- without giving them care.  In such cases, NGOs and other civil organizations have tried to reimburse the health centers for these debts and thereby obtain the patients' release. ²⁰⁹  The health care situation in Burundi remains dire.  In those circumstances, government authorities appear not to view registration of medicines as a high priority. Burundi therefore does not currently have a drug registration authority.  According to one report published in 2007, the Ministry of Public Health has just started delivering ARV therapy in hospitals and NGOs deliver medicines through HIV/AIDS centers,²¹⁰ but it is unclear whether the Burundian government carries out registration in a manner like that of Rwanda's Ministry of Health, or whether medicines are imported without regard to licensing.

Adequate registration of medicines requires that their quality be ensured before procurement.  Apparently, however, none of the EAC member states' national drug quality control laboratories operates under the optimal conditions necessary to monitor the quality of drugs registered in their national markets.  None of the EAC's national DRAs requires manufacturers to meet international GMP standards.  This suggests the danger that registered (and therefore presumably regulated) medicines may prove only slightly safer and more effective than un-registered medicines. In addition, the national registry authorities apparently do not adequately coordinate drug registration with national procurement policies and essential drugs lists – coordination required to ensure prioritization of most needed medicines in entering the country.   Some DRAs' bureaucratic decision-making, for example,  apparently has required applications for registration of generic medicines to wait in line until after the registration of more expensive patented versions of the same drugs.  This has tended to discourage generics manufacturers from seeking to enter their national markets.

The manufacturers of pharmaceuticals registered in EAC countries vary greatly in size, type, quality of production and country of origin. With respect to the social problems posed by high drug prices, lower quality of drugs, and time delays, this report specifies three groups of manufacturers and their relevant behaviors. (1) Large international pharmaceutical companies, like Merck and Pfizer (often called 'Big Pharma'), export patented drugs for sale in East African countries at higher prices.  There. Big Pharma may invest in last stage assembly and packaging processes.  (2) Foreign generics producers, based in countries like India and Brazil, export their lower-priced medicines for sale.  These, too, may invest in last stage manufacturing in EAC country markets.   (3) At least initially, domestically owned EAC-country-based manufacturers may partner with foreign manufacturers to produce generic versions of lower cost medicines.  They sometimes conduct the final stages of assembling and packaging active ingredients for in-country sale, and if possible, in EAC-wide markets. This section of this Report analyzes the extent to which different factors reflecting their specific circumstances influence the behaviors of these firms' decision-makers.

Manufacturers of patented medicines in developed countries such as the United States (e.g. Pfizer, Merck, Johnson & Johnson and Novartis), Switzerland (Roche) UK (GlaxoSmithKline) and France (Aventis),²¹¹ supply countries such as the EAC's members with great quantities of essential medicines.  By patenting their medicines' formulae, these companies – 'Big Pharma' – gain exclusive rights to manufacture and sell them in markets.  Absent competition, they can – and do – set prices so high that few citizens in these countries can afford them.  In practice, these companies sell their medicines directly only to private distributors accessed by the narrow wealthy elites.   Some make special arrangements to sell to international donor agencies and non-government organizations, sometimes at lower prices.   In various ways, they earn sufficient profits to make it worthwhile to register their drugs in the EAC member countries.²¹²

Professor Kevin Outterson, an expert on intellectual property rights and patented pharmaceuticals, points out that, during the period of exclusivity that patents and other restrictive marketing arrangements grant these manufacturers, those pharmaceuticals "may be priced at more than 30 times the marginal cost of production."²¹³  For example, GlaxoSmithKline produces a three-drug combination ARV treatment called Trizivir, which costs $1,602  (for what unit?  A year?)  in Africa.  One of India's largest generics producers, Cipla, however, sells its generic version Triomune in Malawi for just $304 a year.²¹⁴  In countries where Glaxo's Trizivir's patent is protected, however, Cipla would not be able to sell Triomune, and the citizens of those countries would be deprived of an equivalent treatment at under one-fifth the price.

Big Pharma uses another mechanism to maintain their monopoly over the supply of essential medicines: data-exclusivity periods during the registration process.   For five years, when registering their own products with a country, the data-exclusivity period bars a generic producer from relying on data submitted by the original drug's manufacturer.  That bar holds even if the generics manufacturer can prove its generic version chemically and biologically identical to the original drug.²¹⁵  For those sometimes crucial five years, data exclusivity therefore functions like a patent.  It effectively prevents the marketing of cheaper 'copies' of specified drugs in a certain market – even when the patent for that drug has expired.  An essential medicines advocate writes:

Big Pharma aggravate the difficulties that thwart most low-income East Africans from accessing essential medicines by insisting on patent protection and, at the registration stage, on data exclusivity.  Thus does Big Pharma strengthen their monopoly of the medicines markets, making possible high and largely unaffordable prices.

b.    Foreign Exporters of Generic Drugs

Exports of generic drugs from foreign countries such as India, Brazil and Thailand, have drastically reduced the prices of essential drugs, increasing thousands of East Africans access to life-saving medicines.²¹⁷

Generic exporters do, however, face severe barriers, some of which (patents and data exclusivity periods) this Part earlier discussed.  In addition to patent laws in receiving countries, pressures related to TRIPS and from Big Pharma have forced exporting countries to impose patent laws within their borders.  Frequently that has effectively prevented the local manufacture of generics.²¹⁸

As another problem, some countries – like Rwanda and Burundi – rely on external monitoring by WHO,²¹⁹ or an internationally respected DRA like the US Food and Drug Administration (FDA)   If neither has approved a generic producer's drugs, that producer may not export them to those countries. 
Counterfeit production of medicines in generic producers' home countries also may bar their registration in the EAC countries.  India's generics industry confronts this problem in a particularly stark way.  The managing director of an Indian generics producer, explains:
 

According to the article quoting Thacker, the WHO estimates that 10 percent of the global pharmaceutical market, or $21 billion, consists of counterfeit drugs, and 35 percent of this counterfeit production originates in India.  This, according to the article, results in "loss of brand equity, loss of reputation, and mistrust of customers, health officials and regulatory authorities."²²¹

Foreign generics exporters could do a great deal to bring down prices in the EAC and thereby increase access to essential medicines in a big way.  The resistance they face from patent-holding manufacturers, and the lack of regulatory control within their own markets, however, apparently has sometimes either compromised their medicines' quality, or created doubts in EAC importing countries.  That they too may have to comply with TRIPS patent laws has also restricted the ability of foreign generics manufacturers to produce new generics based on patented drugs, therefore further restricting their contribution to EAC's supply of essential medicines.

c.    Local Producers in the EAC

The main obstacle posed by local producers to EAC inhabitants' access to affordable, efficient medicines lies in their dependence on assembling ingredients produced and imported from elsewhere.  They do little research as the essential basis for creating new chemical entities or generics for domestic use.   Even the pharmaceuticals they do produce remain little more than a fraction of the drugs their communities need, requiring the import of medicines to satisfy the bulk of the demand.

In 2005, Kenya reportedly had the largest pharmaceutical production capacity in the Common Market for Eastern and Southern Africa (COMESA) region, with 34 of the region's 50 recognized manufacturers.²²² Some companies comprised subsidiaries of multinational pharmaceutical companies, performing the final stages of production like drug repackaging or constituting raw materials into dosage form.²²³  Others produced generic pharmaceuticals – an industry that, if allowed to grow, could drastically reduce the regional cost of medicines.  In general, however, the local produced generic manufacturers do not conduct clinical trials on their drugs; they argue that they do not manufacture new medicines, but merely copy known ones.  The companies do supposedly conduct bioavailability and stability trials in-house, but since the Kenyan Pharmacy and Poisons Board does not regulate or authenticate in-house trials, it is difficult to determine the extent to which they follow industry quality standards,²²⁴ To bring these manufacturers up to international GMP standards and quality production, not only generics but possibly new drugs, proves a demanding task.   Not required by the Kenyan government to meet international quality standards, many fall behind.
As another problem, Kenya still imports most essential medicines its inhabitants use.   Local manufacturers cannot step up to cover shortages, forcing patients to go without until more international supplies arrive.  This heavy reliance on imported medicines, especially patented medicines, proves troublesome, especially since large pharmaceutical manufacturers may withhold supplies unless Kenyan importers meet their patents or price demands.²²⁵

Kenyan manufacturers also conduct very limited research and development.  What R&D they do is restricted to innovation in manufacturing processes of current medicines, rather than in innovating new pharmaceutical products. ²²⁶
Uganda imports over 90 percent of its pharmaceuticals, producing only 10 percent locally.²²⁷ In 1999, the Ugandan government imported medicines valued at $73,776,000, more than ten times the value of domestic production, $7,440,632.²²⁸  Only five local firms produced pharmaceuticals on a large scale, while five remained small-scale manufacturers.²²⁹  Again, reliance on foreign exports may lead to shortages which the local Ugandan pharmaceutical industry could not produce enough to cover.  Ugandan President Yoweri Museveni announced the opening of an ARV and (?) anti-malaria factory in Uganda in early 2008, but it remained unclear whether the factory would take off (see Explanations section).²³⁰Media reports of  20 February 2009 reflected that the first batch of ARVs was produced.

The Tanzanian pharmaceutical manufacturing sector remained small; in 2007, only eight companies share the domestic market, mostly producing penicillin, injectibles and infusions.  Only one currently produced ARVs (Tanzania Pharmaceutical Industries, or TPI), while another, Shelys, might follow suit.²³¹  Local producers enjoy preferential treatment by the Tanzanian government, receiving a 15 percent preference for their tenders (?), and they did not use donor money purchase inputs (?) Because they abide by Tanzanian, not international GMP standards local producers do not have access to the donor market (i.e. the medicine purchased by NGOs and foreign countries as aid).²³² Tanzanian manufacturers generally do not produce essential medicines, and have largely kept to producing less vital medical supplies such as penicillin.

The situation in Rwanda appears similar.  After the 1994 genocide, the Rwandan government created a new national health policy, which prioritized resolution of the following five problems:

1. the shortage of drugs,
2. the inadequate distribution,
3. the high costs,
4. the problem of quality and
5. the scarcity of appropriate (?) regulations.

To meet shortages and high drug costs, the government established LABOPHAR (Rwanda Pharmaceutical Laboratory) to manufacture essential drugs locally as one of its functions.  LABOPHAR does not, however, produce ARVs or other essential medicines, but supplies 100 percent of the local market for sterile solutions for perfusion.²³³  Reliance on foreign imports, accompanied by increased costs and risks of delays, therefore affect Rwanda as well.  Burundi, as far as is known, does not possess pharmaceutical manufacturing capacity.

Manufacturers do play a part in the delays in registration process to the extent that they either have not conducted the right trials, or have not submitted complete information on their trials in time.  Bibiana Njue, Head of Drug Registration at Kenya's Pharmacy and Poisons Board, for example, told one news source that while the average registration time in Kenya is about 3 months, "The companies do not respond to our queries on time. There is no way that we can register them without all of the information required."²³⁴

In short, manufacturers, depending on whether they constitute foreign or local, or patent-holders or generic producers, may contribute in several ways to EAC member states' lack of access to essential medicines.  Foreign patent-holding manufacturers use patents and data exclusivity to block cheaper generics from entering the market, and charge high prices for their drugs in developing countries.  Foreign generics manufacturers meet resistance in marketing their generics in the EAC because of patent laws and data exclusivity rules, and meet resistance in their home countries because of domestic patent laws. Local manufacturers stick almost exclusively to generics manufacturing or to assembly of foreign-patented drugs and do not meet international GMP standards required to export to neighboring markets or to sell to donor organizations within their countries. 

A.    Introduction

Given the problematic behaviors of the DRAs and manufacturers described above, the next step in the problem-solving logic requires asking, why do these actors behave as they do.  To answer that question, this report uses institutionalist legislative theory's seven categories of possible explanations of problematic behaviors in the face of a rule: the rules themselves; the opportunities the actors have to continue engaging in their current behavior; each actor's capacity to behave more appropriately; the extent to which the relevant authorities have communicated the rules to actors; the actors' interests in continuing their current problematic behaviors; the implementing agencies' (here, the DRAs') decision-making processes hinder their effectiveness; and finally, the actors' ideology that might contribute to their current behaviors.  This part provides explanatory hypotheses as to the probable causes of the relevant sets of actors' problematic behaviors, and the evidence to demonstrate that those hypotheses prove consistent with the available facts.   That lays a basis for problem-solving's third step: The design of the detailed provisions of a legislative solution, grounded on facts,  which logically seems likely to alter or eliminate the causes of existing problematic behaviors, and induce new ones more likely to ensure effective registration of affordable essential medicines for all East Africans.

Drug Regulatory Authorities – Why do the National Drug Regulatory Authorities fail to fulfill their missions of filtering out substandard medicines and providing quality medicines to their populations in a prompt manner?

National Drug Regulatory Authorities in the EAC, like manufacturers, run the gamut in terms of size, availability of resources, and the markets they must regulate.  This Part discusses the causes of these authorities' problematic behaviors collectively because the available evidence suggests that significantly similar country (and regional) circumstances shape their registration behaviors.
The pharmaceutical registration laws in each of the five EAC countries (except possibly Burundi) on their face appear comprehensive, yet in none of these countries, do registration practices rise to the levels the laws seem to require.   Current laws therefore overreach, given current resources (this is especially the case in Rwanda) or do not address key issues in the registration situation (e.g., Kenya's laws do not call for fast-tracking in registration to meet the needs for essential medicines during outbreaks).    In other words, the rules do not ensure effective implementation.

Kenya's Pharmacy and Poisons Act (established in 1957 and most recently amended in 2002), for example, establishes the Pharmacy and Poisons Board (the PPB) and mandates it to oversee the drug registration process and licensing of pharmaceutical manufacturers within Kenya.   On the one hand, however, the law requires GMP inspection, but does not provide details necessary to ensure implementation.   On the other hand, Rule (1) of the Pharmacy and Poisons (Registration of Drugs) Rules makes it mandatory for the PPB to conduct an investigation into the pharmaceutical, pharmacological and other aspects of a drug, including local re-conduct of clinical trials.²³⁵ This rule's seeming inflexibility makes it difficult for the PPB to fast-track essential medicines such as ARVs even where might want, for example, during the informal declaration of HIV/AIDS as a national disaster.   Because the rule appears so inflexible that it becomes impractical to follow it, the Board apparently ignores it.  A DFID report on Kenya's willingness to use TRIPS flexibilities points out: "The rules prescribed with regard to drug registration are so inflexible that in emergency health situations in Kenya, essential medicines available abroad may not quickly be used [and] [b]esides, it is not known when these rules were last put into practice." (footnote??)

In Rwanda's case, two laws supposedly govern the pharmaceutical sector: "L'Art de Guérir," gazetted in 1998 to establish a legal framework for medical, dental, and pharmaceutical care; and "L'Art Pharmaceutique," which came into force in 1999 and governs the pharmaceutical sector in particular. ²³⁶  No formal procedures exist for a periodic review of the Essential Drugs List (EDL), created in 1997 and updated in 2002; and it remains unclear whether and how the relevant authorities use it in implementing national procurement policies.²³⁷ Apparently, these laws remain unimplemented, because no ministerial instructions provide detailed procedures for creating rules and regulations particular to Rwanda's pharmaceutical context.  L'Art Pharmaceutique calls for the creation of a National Committee for Drug Registration, but does not provide for its establishment, leaving Rwanda apparent without any drug registration body (footnote??)   A USAID report sums the situation up by saying:
 

Each of the five EAC countries, in short, have laws mandating effective registration of medicines, but few have promulgated thorough, yet flexible, rules and regulations to help the DRAs implement those laws.

The decision-making process by which DRA officials register medicines may explain why in some instances they delay registration, or why they do not prioritize cheaper drugs of equivalent quality over more expensive ones in registration.   In Kenya, for example, "bureaucratic delays" hold up registration of drugs for up to a year and a half, even though the PPB claims registration takes an average of 3 months. (footnote??)  According to Christa Cepuch, a pharmacist with Medecins Sans Frontieres, because Kenya's PPB officials did not consider the nation's updated drugs policy before registering drugs, they registered drugs no longer considered safe as treatments for malaria.   Kenya has an Essential Drugs List that sets the criteria for drug selection as quality, safety, efficacy and cost.   The PPB last updated the National Medicine Policy document over a decade ago, however, and does not address traditional medicines at all.  Nor, because the Policy remains outdated, has it adequately fast tracked registration of medicines necessary to address current public health priorities, like the HIV/AIDS and malaria epidemics.²³⁹  

This again is a problem with the process of registration in that country, because while Instead of coordinating the registration process with the latest national drug policies and essential drugs lists, the relevant officials seem to make their decisions side by side with little consideration of their decisions' potential interrelated implications. 

As another problematic feature, involving several agencies in regulating drugs may lead to overlapping of their activities and duties, creating a situation where no one body implements policy, because each expects the other to do the job.  For that reason, Tanzania's Ministry of Health decided to establish a Food and Drugs Authority, a single regulatory body responsible solely for "controlling the quality, safety and effectiveness of food, drugs (including herbal drugs), cosmetics and medical devices."²⁴⁰  Previously, "uncoordinated enforcement of the respective legislation," that is, the Food and Drug Ordinance cap 93 of 1946 and then the Pharmaceutical and Poisons Act of 1978, "overlapping of activities among state organs," and "increased volume of food, drugs, cosmetics and medical devices in the market," coupled with an "[i]nadequacy of skilled staff and lack of working tools," allowed illegal foods and drugs outlets to "mushroom" and counterfeit and substandard products to flood the market.²⁴¹

As in other developing nations, a gap may appear between the law's detailed provisions and EAC member state agency officials interpretation and implementation in practice.   That gap may reflect the agency officials' lack of resources required to implement the legislation, as well as their inability to implement rules that appear too complex.  Kenya's registration law, for example, allows the Pharmacy and Poisons Board to employ compulsory licensing and parallel importing tools to encourage domestic manufacture or the import of generic versions of innovator drugs, at a fraction of the cost of the innovator versions.²⁴²  Nevertheless, as of the latest available report, the PPB had not utilized those tools.  Given the significant differences in price between patented and generic versions of the same drug, Kenyan NGOs and civil action groups found this fact troubling.   Christa Cepuch, a pharmacist with Medecins Sans Frontieres, declared, "There is no legal barrier to stopping the government from importing cheaper ARVs that are of a good quality. It is time that we used our strong Intellectual Property Act for this purpose."²⁴³

Kenya has failed to implement its TRIPS flexibilities, probably because of the complexity of the process of obtaining a compulsory license.²⁴⁴ Also, Western countries and Non-Governmental Organizations with a strong pro-intellectual property rights bias strongly influence governmental policy-making.  They discourage deviations from IP-compliance.²⁴⁵ Government has broad discretion in exercising its options under the law.  (With respect of the supply of medicines, that scope of discretion likely constitutes the law's principal weakness.)

In terms of producer adherence to GMP standards, the law requires the Kenyan PPB to inspect manufacturers and retail outlets.  It contains, however, no adequate national guidelines on inspection.  In consequences, PPB inspectors do not effectively enforce compliance with the laws laid down.²⁴⁶ Without implementing rules and regulations, laws such as Kenya's on GMP inspection or Rwanda's on pharmaceutical registration become meaningless.  To make adequate GMP inspections likely, the relevant DRA must prescribe regulations to guide the inspectors.

Inadequate resources appear to be the largest obstacle to effective registration and GMP inspection in the EAC member countries.  Without adequate funding, the five respective DRAs cannot buy updated quality testing equipment, properly train existing staff, hire additional staff, or hire and train more GMP inspectors.
   
The National Drug Authority of Uganda, for example, receives 20 percent of its funding from the government budget, 20 percent from registration fees, and the rest from foreign aid (60 percent)   The UNDA charges 0.5 percent of the value of an imported product as a fee for inspection and testing.  It provides free testing for the first three batches, however, and charges for testing additional batches.  To avoid paying testing fees, some manufacturers send only three batches of their drugs.  Because it tests for free and does not get any future compensation for other batches, UNDA suffers.²⁴⁷ When foreign aid diminishes, UNDA also suffers.²⁴⁸ Irregularity in funding necessarily leads to fluctuations in the review and registration of drugs (either it takes more time to approve drugs, or drugs win a license without adequate testing.)  UNDA's chairperson admits that lack of funds has hampered UNDA operations.  For example, in the past four years, the government had not given funds to UNDA: "We depend entirely on drug fees and WHO."²⁴⁹ 

Of the EAC countries, Rwanda and Burundi suffer most from lack of resources.  As a consequence, to this day neither government has instated a registration body.  In these two countries, government procurement of medicines falls far below donor procurement.  In Rwanda and Burundi, for imported drugs these donors usually require either FDA approval or WHO pre-qualification.  (For example, the PEPFAR program requires FDA approval for all its drugs.)²⁵⁰  As mentioned above, for those who are not being treated by international NGOs, this can have adverse effects on the price and availability of medicines.
   
That an actor need not carry out functions at a specified level creates an opportunity for the actor to function below optimal levels.  Kenya's and Tanzania's DRAs carry out minimal GMP inspections, for example, because, under the current laws, they are not required to do more: "the Tanzanian DRA applies national GMP standards, which do not comply with international standards.  In addition to that, the Quality Assurance Departments of producing companies conduct their own internal audits."²⁵¹  The TFDA claims it takes an active role in assisting local manufacturers with improving the quality of their essential drugs production. As of 2005, however, TFDA considers that manufacturers that meet TFDA standards meet only "minimum standards."  Perceived weaknesses in the current system have led TFDA to insist on higher GMP standards, on par with those used by the WHO prequalification system. ²⁵² 

The Kenyan PPB also inspects and licenses pharmaceutical manufacturers and retail outlets.  It has fallen behind on enforcing compliance with the national medicines legislation.  As in Uganda, Tanzanian law does not provide TPPB with guidelines for inspection.  As a result, although required by the Pharmacy and Poisons Act, TPPB does not properly inspect manufacturers' plants for good manufacturing practices. ²⁵³

Corruption frequently arises when the rules and laws give officials excessive discretion.  In Uganda, officials may have too much discretion, and the registration process may not have transparency and accountability mechanisms.  Thus, corruption ensues.  In 2004, for example, a whistleblower accused two Ministers in the Ministry of Health of taking bribes from counterfeiters and, as a quid pro quo, of registering counterfeit or substandard medicines.  The whistleblower testified in a criminal case against them.  After the Ministers posted bail, UNDA reinstated them – and terminated the whistleblower's job, later advertising the job with specifications for qualifications lower than his.²⁵⁴  When law endows an official with excessive discretion, or enables the officials to avoid accountability, opportunity yawns for the official to use public position for private gain.

Given their extreme lack of resources, the DRAs of the five EAC countries sometimes find it in their interest to put registration on hold (e.g. Burundi) or to scale down registration processes when resources wane (e.g. Uganda)   Others turn to reliance registration in order to ensure the quality of medicines entering their markets without having to test for this quality themselves.  In Rwanda, for example, the Directorate of Pharmacy (DOP) is responsible for setting national drug policies, drug registration, and regulation of pharmaceutical facilities and technicians.  According to USAID in 2003, budgetary and human resources shortages have led DOP to cut several of these functions, including "drug registration, quality assurance, regulation of the pharmaceutical profession, and practices and provision of drug information."²⁵⁵ 

DRAs also may divert resources away from registration towards what they deem more pressing regulatory functions, such as policing their national markets for counterfeits.  Without a constant source of income, instability threatens the registration process. When registration fluctuates in efficiency, so do the problems associated with ineffective registration – delays, poorer quality drugs entering the market, and an inefficient selection process for cheaper quality medicines.

Manufacturers – Why do local and foreign manufacturers supply sub-standard or over-priced medicines to the EAC?

For several reasons, during the registration process local and foreign manufacturers of both generic and patented drugs behave problematically. In order to design an effective legislative solution for the social problem this Report and bill address, this Report explores the reasons for (that is, the causes of) those behaviors.

The pharmaceutical laws of all the EAC member countries (except perhaps Burundi) require a manufacturer to register with the respective country's DRA each drug that the manufacturer proposes to market.  To do so, the manufacturer usually must to submit a dossier for the drug.  In that dossier, the manufacturer submits proof of the safety, quality and efficacy of their drug and its components. In addition, where a country has particular GMP standards, the relevant national DRA inspects the manufacturer's production facilities for GMP compliance.²⁵⁶  In Kenya, Tanzania and Rwanda (and most probably Uganda to a certain degree), however, while the laws on the books require those actions by manufacturers, the DRAs in these countries do not enforce those laws to the letter.  By bribing DRA officials, manufacturers can therefore register their medicines²⁵⁷ without meeting national GMP standards.²⁵⁸  Other reasons may also prevent full enforcement. L'Art Pharmaceutique, Rwanda's drug registration law, remains unenforced.²⁵⁹  No Rwandan registration authority exists.

Kenya possesses the largest number of local manufacturers.  The problems that beset them seem not dissimilar to those that affect other manufacturers in the region.  Over the past decade, Kenya has seen very low economic growth.  Over half its population lives below the poverty line.  Its resources available for manufacturing range correspondingly low.  The generic manufacturing industry's R&D investment per capita stood at less than 1 cent in 2004 and patents per 1,000 people fell below 0.0001.  Most of Kenya's very limited R&D focuses on innovation in manufacturing processes and not in pharmaceutical products themselves.²⁶⁰ 

In addition, Kenya's generic medicine manufacturers lack local primary, secondary and tertiary ingredients for production.  Local manufacturers must therefore import ingredients from India, China and other developing countries, thereby rendering their cost of production higher than in other generic-producing countries.  Other factors further increase the cost of production:  Generally poor infrastructure, antiquated communications systems and high electricity costs (the cost of industrial electricity in Kenya soars to four times that in South Africa and Egypt, and almost twice as high as in Uganda).²⁶¹ 

The inadequacy of the pharmaceutical market constitutes a third major factor affecting local pharmaceutical manufacturers.  Domestic markets alone cannot sustain pharmaceutical manufacturers.  Kenyan manufacturers therefore seek to supply both Kenyan and non-Kenyan markets.  None of the Kenyan manufacturers, however, enjoy WHO pre-qualification.  That lacuna limits the scope of their market to Kenyan government procurement and perhaps purchases from other countries that do not themselves have high quality standards.²⁶² Depending on the type of trial, size of the trial group, and the area of study, clinical trials in Kenya cost a minimum of US$70,000.   This cost reaches far beyond the means of most of Kenya's pharmaceutical manufacturers.  Unless necessary, they avoid conducting trials.²⁶³  This further limits the scope of local manufacturers in terms of the kinds of medicines they can produce and market in the region.

The size of the domestic and regional markets also limits Tanzanian manufacturers.  Because they do not comply with international GMP standards and because international donors supply drugs that require WHO pre-qualification, Tanzanian manufactures also suffer from limited access to those markets.  According to one report on the viability of pharmaceutical production in Tanzania, the Tanzanian market is not large enough for manufacturers to achieve economies of scale, and their prices are therefore not competitive with generics producers from abroad.  Only because of a 15 percent preference they receive from the Tanzanian government can these manufacturers sell their drugs.²⁶⁴  A vicious cycle of limited resources and less marketable medicines thus trap local manufacturers. The higher costs of local production and the fact that local manufacturers do not comply with GMP standards render their products less marketable.  That in turn prevents them from making enough profits in order to upgrade their manufacturing processes.

In Kenya, the Pharmacy and Poisons Board does not authenticate or regulate local manufacturers' in-house trials or pre-formulation studies.  While companies conduct in-house experiments, the quality of these studies remains unknown.  Because the law does not require them to do so, these companies do not willingly share the findings. ²⁶⁵

TFDA does not require Tanzania's manufacturers to comply with international GMP standards, but only requires them to comply with Tanzanian standards.  Those fall below international requirements.  In 2000, the TFDA's predecessor regulatory body (the Pharmacy Board) performed GMP inspections at each of 10 registered local manufacturing plants.  Because they failed the inspection, TFDA had to order three of these plants to close down.  The Board decided, as a solution, to assist manufacturers in upgrading their level of compliance.  It decided to do so by letting each company set its own timetable to meet Tanzanian GMP standards and by merely monitoring their progress.²⁶⁶By allowing manufacturers to set their own pace in compliance, the Tanzanian regulatory authority, in a sense, gave them further opportunity not to comply.
 Similarly, in Rwanda, two small manufacturers locally produce 7 percent of drugs sold.  Neither of these manufacturers have GMP certification.  In a country with at best weak national quality control, this 7 percent of the national supply likely proves of substandard quality.²⁶⁷

Because their domestic governments do not require them to abide by high standards, and in a practical sense, they have an interest in avoiding, if they can, costly GMP and clinical study procedures, these manufacturers fall below international GMP standards.  In Kenya, as mentioned above, clinical trials can cost about $70,000 per trial.  In South Africa, those trials cost only about $50,000; in India, about $30,000.  Their domestic DRA does not require clinical trials, and local Kenyan companies therefore avoid them altogether.²⁶⁸  By avoiding clinical trials and complying only with domestic GMP standards, however, these local manufacturers bar themselves from the enormous markets of donor procurement within their region.  They also bar themselves from the export market in other countries within the region, and perhaps beyond.

Manufacturers also have a significant role in registration delays.  They often have little incentive to provide DRAs with the information needed to evaluate their drug promptly.  Local manufacturers find it difficult to conduct their own clinical or other tests and therefore must rely extensively on the registration data of foreign patent-holders, who for their part try their best to keep their registration data secret. 
Markets in EAC member states generate relatively little demand, and their DRAs have a reputation for taking time with registration.

An ideology that prioritizes profits over public policy justifies the high prices charged by foreign patent-holding manufacturers.  While Big Pharma recognizes the public health emergencies that their drugs can alleviate, they put profits first.  They attempt to alleviate public health crises only within the framework of this for-profit model.  Hence the answer of Jean Pierre Garnier, the head of GlaxoSmithKline in the UK, to the access to medicines problem:  "order from GSK in bulk, perhaps for the whole of sub-Saharan Africa, and the price will drop and, secondly, persuade the rich countries to support the Global Fund so that poor countries will have the money to buy GSK's drugs. It's win-win for Glaxo." ²⁶⁹

In the meanwhile, however, if a country's demand is smaller, Glaxo argues that it must sell drugs at higher prices to cover the costs of its own research and development for this drug and other future drugs.  In justifying their patent protections, Big Pharma argue that they deserve to profit from their own inventions. Garnier, like the heads of other drug companies, sees generic manufacturers as "pirates," a threat to the future existence of Big Pharma: "there is an economic war going on. This is a great opportunity for the Indian and Brazilian generic companies to conquer the world. If they could just get rid of our patents then the whole developing world would open up to them."²⁷⁰

The fact that generics producers outside and within the EAC focus on manufacturing smaller quantities of generics, solutions and injectibles rather than on doing R&D on new drugs for neglected diseases also ties into the prioritization of profits over the public interest.  In their case, if they do turn to new medicines research and production, these producers may go under.  These relatively small, local manufacturers cannot benefit from the economies of scale larger foreign exporters enjoy.  The Guardian Newspaper explains the difference in economies of scale between large brand name producers and smaller generics: "Cipla [an Indian generics manufacturer] only has the capacity to produce small quantities of the drugs .... With the very low manufacturing overheads in India, they offer cheap prices for thousands of tablets that would have to soar if they needed to produce millions. The overheads for producing Combivir in GSK's Kent factory, on the other hand, go down as the bulk goes up."²⁷¹  Their focus on generics production may therefore not rest so much on ideological reasons as in a cost-benefit analysis.

To recapitulate:  DRAs fail to coordinate national health policies and essential drug lists and fail to fast-track essential medicines because they have no mandate to do so.  Because they lack the resources to undertake these measures, they also fail to assure thorough quality testing and GMP inspections.  Finally, delays in registration also results from low DRA resources, especially, lack of competent staff and equipment to conduct testing and inspections. 

Manufacturers contribute to ineffective registration processes by prioritizing profits over the public good (this is often the case with foreign patent-holding manufacturers) and thereby charging unaffordably high prices for their drugs, or failing to meet international GMP and quality standards so that they can scale up production by catering to donors in the EAC (this is the case for foreign and local generic manufacturers)

A.    Introduction

The East African Community, a regional organization, consists of five partner states (Kenya, Tanzania, Uganda, Rwanda and Burundi).   These share similar health and access to medicines problems.  The Heads of State who signed the Treaty for the Establishment of the East African Community in 1999 proposed to "focus on a collective response to health problems." ²⁷²  The current national registration systems hamper this collective response of the EAC to its health problems.  As we have seen, it exacerbates the shortage, high prices, and the questionable quality of essential medicines that enter the five EAC countries. 

In proposing a partial solution to the current problems with national registration systems in the EAC, we must therefore address the reasons behind problematic behaviors by both national DRAs and manufacturers.  This section first proposes several alternative solutions and evaluates them in terms of their effectiveness in tackling the problematic behaviors described in this report.  Next, this section selects the most effective solution, and proposes a bill to implement that solution, a justification for its provisions, an analysis of its costs and benefits, and recommendations for monitoring and evaluating the effectiveness of the bill.


B. Alternative Solutions: Ways to improve the current national registration systems of the EAC
   
1. Selecting the quality standards to apply in the quality assurance stage²⁷³

The quality standards that registration agencies adopt must balance the need for effective medicines of the highest quality with the need for essential medicines now.  Creating a registration system that espouses the highest drug quality standards (e.g., adopting the U.S. Food and Drug Authority's quality standards), can easily create bureaucratic delays, or impose excessive demands on research-based and generic drugs, delay distribution, and increase systemic costs.²⁷⁴  Creating a system that allows medicines in with the least possible delay, however, could mean a compromise in quality testing.  Consumers (donors and patients) need assurance that, whether innovator drugs or generic, imported or locally produced, different brands of the same drug have the same effect.²⁷⁵  Without this uniformity of efficacy, at least in registered medicines, donors will continue their current practices of purchasing only WHO pre-qualified or FDA-approved medicines.  Patients will continue to purchase the cheapest remedies first, working their way up the price ladder as each remedy proves ineffective in treating their symptoms.

To improve the quality of medicines entering the EAC countries, the five national DRAs might implement quality standards currently used globally.  Those five DRAs might adopt the WHO's GMP standards.  Adopting such a uniform standard would enable producers who meet this standard to sell their medicines to donors domestically and to win GlobalFund tenders.  It would also enable them to sell their medicines outside their domestic markets and within the region.  That solution, however, does not address the other two problems associated with current registration practices – delays in registration and higher-priced medicines.

More: only a minority of medicine manufacturing facilities in the world currently produce medicines to GMP standards.  According to the UN Millenium Project Task Force on HIV/AIDS, Malaria, TB and Access to Essential Medicines ("the Taskforce"), "Achieving GMP is often an incremental process that, given the economic and logistical constraints inherent in many developing countries, will take longer for some manufacturers to fully implement than others."  The Taskforce therefore recommends applying GMP standards and evaluating companies that do not meet these standards on a case-to-case basis, based on the nature of the medicine concerned: "[N]o flexibility can be allowed for medicines with a narrow therapeutic margin, but some flexibility may be tolerated for medicines with a broad safety margin."²⁷⁶

2.  National fast-tracking for essential medicines

Some EAC members (e.g., Uganda) have established a national fast-tracking mechanism to prioritize and quickly approve medicines for high-impact diseases.  WHO prequalification might provide a gauge to measure which medicines to prioritize for AIDS, malaria and TB. ²⁷⁷  By fast-tracking essential medicines to treaty priority diseases (determined by the national health policy of each country), a country DRA can bring urgently needed medicines to the front of the registration queue.  Without further quality testing or GMP inspection by the national regulatory authority, the local DRA could approve a WHO pre-qualified medicine.

This solution addresses the registration delay and medicine shortage issue discussed in this report, but fails to address price and quality issues.  In fact, by fast-tracking medicines to treat certain diseases, national DRAs could exacerbate the problem of low-quality medicines entering their countries.  Fast-tracking medicines too often means less-stringent testing of that medicine.

3.  Local production of generic essential medicines

Another nationally based alternative would encourage the establishment of local manufacturing of generic medicines under voluntary license agreements²⁷⁸ from the patent-holding companies for essential medicines.  These local manufacturers could supply the local market through a preferential government subsidy.  If one or two of the EAC countries could produce medicines locally, e.g. Kenya and Tanzania, a regional market created by a regional pharmaceutical free-trade system could support such production with sufficient demand to justify the costs. Per contra, production of drugs within a developing country solely for domestic use might fail because the producer cannot take advantage of economies of scale.  Expanding the market for their increased production might create enough demand to bring down costs of production.²⁷⁹ 
Bioequivalency tests and compliance with GMP standards seem critical to ensuring quality products from these manufacturers.  Nevertheless, the registration system could foster the growth of the industry by fast-tracking registration of these medicines,
     
Requiring current and future generic manufacturers within these countries to comply with GMP standards and to ensure bioequivalency of their drugs with the originator drugs could lead to the inclusion of these drugs on the WHO's prequalification list.  Inclusion would open up regional markets to their products and this could foster a regional system of production and distribution of high-quality and low-cost essential medicines.²⁸⁰
   
Voluntary licensing of patented drugs by the EAC community could encourage national or regional production.  Subject to compensation for the patent holder, and relatively amicable terms between patent holder and licensing countries, voluntary licensing promotes technology transfer.  Local production could also drive down the cost of imported patented pharmaceuticals through increased competition. 

This solution would require a sea-change in manufacturing practices within the EAC.  Generics producers currently limit themselves to "simple, high-profit formulations."  For them to produce more and cheaper medicine for the EAC market, their products would have to meet bioequivalency requirements and WHO GMP standards, and become WHO prequalified.  According to the Taskforce, "[p]roducers wishing to ensure quality standards can avail themselves of WHO technical assistance to meet GMP and prequalification requirements.  They can also pursue cooperative agreements with larger manufacturers that can provide technology transfer and staff training."²⁸¹Taken in the context of generic production, WHO prequalification would not only assure GMP and quality pharmaceutical products, but would also give local producers, "as of January 2005, access to programmes and markets governed by procurement rules imposed by international donors such as the Global Fund and the World Bank."²⁸²

Requiring local manufacturers to ratchet up their manufacturing practices and drug quality to meet international standards such as those, set out by the WHO could improve the quality and price problems within the EAC in the end.  In the short term, however, solely focusing on local manufacturers may actually mean an increase in costs of medicines compared to generics from other countries, because local manufacturers currently incur higher costs of production than, for example, Indian or Chinese manufacturers.²⁸³

4. Compulsory licensing and parallel importation

Among other hurdles, intellectual property protection blocks importing and producing cheap versions of expensive originator drugs.  Patents prevent generic manufacturers from copying patented drugs – and patents run for 20 years after production the drug.  During those 20 years, pharmaceutical companies try to recover from the drug's sale their research and development costs for this and for other, failed drugs.  To do that, they frequently charge many times their actual cost of production.  This inflated price frequently has devastating effects in developing countries like those in the EAC.  Consequently, costs of treatment for HIV/AIDS exceed the income of many citizens.  Governments cannot fully subsidize the costs. 

The 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) created a global comprehensive patenting system that required a WTO member to comply.  The treaty extended to the Less Developed Countries and Least Developed Countries extra time to comply.  (For Least Developing Countries, the Doha Declaration extended until 2016 the timeframe for compliance (Paragraph 7, Doha Declaration).  Until then, those countries need not offer patent protection for pharmaceuticals.²⁸⁴

As one solution, as Less Developed and Least Developed Countries, EAC countries could make full use of the leeway given by TRIPPS.  That treaty provides several tools to facilitate their importation of cheaper generics.  First, by permitting technical preparation for registration of the same medicine from an alternative source (i.e. a generic version) before the patent expires, after it does expire, the Bolar Clause allows fast introduction of a generic. 

As a second possible solution within the boundaries erected by TRIPPS, Article 31(f) details the procedures of compulsory licensing and government use authorization. By a compulsory license, government authorizes a producer to replicate a patented drug without the permission of the patent holder. A Government Use Authorization licenses the government to do the same – i.e., produce a patented drug without the permission of the patent holder.  Under Article 31(f), the government must compensate the patent holder for its use, but has discretion as to how much compensation to pay.  Before using a patented drug in this manner, Article 31(f) requires a government to seek permission from the patent holder for use of the patent [i.e. seek a voluntary license].  If the government acts in "a national emergency or other circumstances of extreme urgency or in cases of noncommercial use" (WTO 1994), government may escape even that requirement.  The government has discretion in determining what constitutes a national emergency.  'Noncommercial use' includes public sector use.  Purchase by EAC governments of generic medicines for treatment of critical diseases would count as 'noncommercial use.' 

Finally, as we have seen, ordinarily in certain conditions, a country can manufacture generics for sale within that country – that is, a generic manufacturer can exploit only the manufacturer's home-country market.  Under TRIPPS's Paragraph 6, if both an importing country and an exporting country issue compulsory licenses for a particular generic, the generic may be imported into the country lacking production capacity.  That exception ensures that countries without production capacity can use compulsory licensing to import medicines from generic producers abroad.   This exception becomes especially important to countries such as Rwanda, which lack capacity to manufacture generic versions of essential medicines. 

This process, however, proves cumbersome.  Because of the many bureaucratic hoops through which both the importing and exporting countries must jump, EAC countries will probably not use it freely.²⁸⁵  (In its current attempt to purchase anti-retroviral drugs from a Canadian pharmaceutical company, Rwanda became the first country to exercise its Paragraph 6 right.²⁸⁶

5. Paying for pharmaceutical registration

DRAs could charge higher registration fees and use that money to retain quality staff, fund the DRA, and stimulate introduction of generics and perhaps even new chemical entities.  Currently, the registration fees charged by most developing countries' DRAs have no relation to cost of registration.²⁸⁷  Basing the fee on cost of registration could increase the funding available to the DRA, which might translate into more resources – for example, better-trained staff and more testing equipment.  Given the small size of individual EAC national markets compared to other potential markets in the world, charging higher drug registration fees, however, may discourage foreign generics producers (and perhaps even foreign patent-holding producers) from marketing their drugs in the country.

C.  Description of the Proposed Bill: Joint Registration in the EAC

The proposed bill creates a Joint Registration Authority ('JRA').  The bill details the composition of JRA, how it will make its decisions, and what issues the Commission will consider before instating a joint registration and license procedure for medicines and drugs for EAC.
 
JRA will consist of two individuals from each EAC member country and one Chairperson.  Within one month after enactment of this proposed bill and ratification, the Minister of Health for the five EAC member countries will meet at the call of, and at a time and place set by the Minister of Health of Burundi.  At that meeting, the Ministers of Health will cast lots to determine which of them will chair JRA for the first year of its existence.  Thereafter, the Ministers of Health of the five countries will serve as Chair of JRA in turn, following the alphabetical order of the five member states.  Each chair will serve as chair for one year.

A member state will appoint two members of JRA, the first of whom will in the first instance serve two years and the second of whom will serve four years.  Thereafter, a member of JRA will serve four years (thus ensuring that at least half of JRA members will have at least two years' experience on JRA).  (That ensures that JRA, consisting of two members from each EAC member state plus the Chairperson, will not tie on a vote, and that member states have equal representation on JRA.)  Should JRA need to decide a contentious matter by vote, it does so by majority vote, with the Chair having a casting vote. These appointees must have credentials based on the appointee's education, experience and expertise in the field of pharmaceutical regulation or registration.

The bill also requires the JRA to meet not less than annually at a time and place that JRA will, set by rule, and more often at the call of the Chair.  The Chair sets the agenda for a meeting of JRA, and will include in the agenda a matter requested by any two members of JRA.  The proposed bill also includes details about the tenure and terms of service of JRA members.

The bill also includes a statement of the powers and duties of JRA.  These include not only general 'housekeeping' duties (for example, the power to hire and fire staff),  but also its substantive duties, especially, its duty to set standards for the licensing of a new chemical entity ('NCE') for sale within EAC and the manufacturers and the processes that produce them.  

The bill also requires JRA to make regulations for its governance and decision-making.  It sets forth criteria and procedures for licensing that JRA will use, subject to JRA's adopting alternate criteria and procedures.  These criteria consist of the following:

1. Where the NCE has received approval from an NCE licensing board of recognized international standing, for example, the Food and Drug Administration of the United States; or,
2. Where JRA decides that the Regional Quality Control Laboratory will determines the safety, efficacy and quality of the drug by a chemical and manufacturing data review;
3. Whether the availability of the NCE will prove in the public health interest; and
4. Whether the drug proves safe, efficacious and of acceptable quality; and
5. Whether –

• the manufacturing facility of the drug complies with Good Manufacturing Practice (GMP) standards of the EAC, where GMP standards are those established by the WHO, or
• the manufacturer is on WHO's list of prequalified suppliers, in which case JRA will approve the manufacturer or the individual products listed using a fast-track mechanism.

The bill also requires JRA to license locally manufactured NCEs and traditional medicines. Until JRA promulgates specific regulations on NCEs manufactured by local manufacturers, or concerning licensing traditional medicines, JRA shall adhere to the criteria for NCEs set forth above.

The bill as well prescribes procedures for JRA decision-making.  It requires that after developing a proposed regulation, whether for its own governance or for the licensing of an NCE or approval of a GMP, JRA must publish the proposed regulation in a newspaper of general circulation in each of the EAC member countries, inviting comment, and setting a reasonable time limit for those comments.  After expiry of the time limit, JRA will finalize the proposed regulation, and publish it.  JRA will either include in the final version of the regulation a suggestion made in a comment, or, in an accompanying document, describe a comment that it rejected, and explain why JRA rejected it.
   
The public may attend a meeting of JRA. A member of the public may also access freely correspondence of JRA, internal memoranda and other JRA materials.  
   
The bill also contains provisions for funding JRA and its operations; resolving disputes that inevitably will arise; and making the transition from the present to the joint licensing systems.  JRA will receive funding as part of EAC's central government budget.  Disputes concerning congested licensing decisions and the like will in the first instance fall before an official of JRA detailed to hear the case and decide it.  From that decision, an intra-agency appeal lies to the senior EAC civil servant in JRA, and thence to the Head of EAC civil service.  Until JRA develops regulations to the contrary, licenses granted by an EAC member country's DRA will apply with respect to sales in that country, but not elsewhere in EAC.
   
The proposed bill also creates the East African Licensing Scientific Board ('EALSB')   Experience everywhere teaches that wrong-headed administrators and politicians can pressure the licensing body to ignore sound science in favor of ideology-determined (and sometimes corrupt) licensing decisions. 

To undercut political or ideological influence in the licensing decision, and especially, pressures to ignore sound science, this Act creates EALSB as an independent advisory body.  For scientists working in EALSB, career decisions – promotions, work assignments, remuneration – will depend not on irrelevant or corrupt factors, but on scientific merit.   EALSB will serve as JRA's scientific advisor.    It consists of three qualified scientists, appointed by the General Secretary of EAC.  These scientists, with the staff they will employ, do necessary testing of NCEs, drugs, medicines, and foods. It will make recommendations to JRA about licensing these.   Unless JRA explains in detail why it does not do so – and makes public those reasons – JRA must follow EALSB's recommendations on licensing decisions.
 
D.   Justification

The national NCE licensing systems in EAC countries suffer three endemic problems: registration delays, lack of prioritization for essential medicines and registration of lower quality medicines.   A fair and equitable system to ameliorate these problems requires the creation of a joint registration system to govern registration for the entire East African Community. 

The World Health Organization suggests several reasons why a regional approach to pharmaceutical registration will benefit countries in Africa: "Regional and sub-regional approaches and global initiatives are considered for:

• Pooling resources, to deal with capacity challenges,
• Reducing duplication of effort, redirect resources
• Standardizing requirements...
• Legal mechanisms to jointly negotiate
• Promotion of good governance"²⁸⁸

These benefits of joint registration specifically address the main problematic behaviors brought up in Sections II to IV of this report.  One of the main constraints on the current Drug Regulatory Authorities of each of the five EAC countries, for example, consists of a crippling lack of resources – especially so for Rwanda and Burundi.   As we have seen above, these two countries have little to no resources to dedicate to pharmaceutical registration. They have all but given up on the process of registration.  Pooling the resources of the five countries will help especially those countries currently struggling to perform pre-registration product evaluation.  One authority – JRA – will use the resources that previously tried to support the operations of five country DRAs.  JRA will have sums available for research equal to the funds that all five had previously individually to conduct similar research. 
   
The reduced duplication in efforts and overlap in processes makes this pooling of resources especially effective.  Previously, for example, each country's DRA would have had to evaluate one pharmaceutical product individually in each of the five countries for safety, efficacy and quality.²⁸⁹ Each DRA would be conducting similar tests on this pharmaceutical in its own labs, and would presumably come to the same conclusion (resource constraints and quality of testing aside).   Under a joint system, of each pharmaceutical product, JRA will make only one assessment – not five. 

Standardizing the requirements of registration will address the problem of arbitrary decision-making within the current drug regulatory authorities.  Creating consensus in quality standards will also enable manufacturers more easily to comply with standards, as they confront one, not five different set of criteria for their drugs.  Standardized quality and GMP requirements throughout the EAC will also facilitate trade within and between EAC countries in essential pharmaceuticals.  Currently, "[n]ot being coordinated on the regional level, national regulation authorities hamper East African trade flows significantly. Each time medicine passes a border, the registration process has to start from the beginning, trade flows are delayed and intraregional trade becomes less beneficial." ²⁹⁰
   
A joint registration system will give the EAC countries a legal framework within which to negotiate with each other on registration policies, as well as to negotiate with manufacturers and distributors on prices of drugs.  Under the 2003 Doha Declaration,²⁹¹ a customs union a majority of whose members rate as LDCs can obtain one compulsory license for use in the entire union.  A majority of EAC members do so rate (Tanzania, Uganda, Rwanda and Burundi). Once one EAC partner state obtains a compulsory license for a NCE, the manufacturer can export the generic drug from that country to another EAC member country.  (That exportation must, of course, accord with the importing country's patent laws.)²⁹²  If EAC decides that importing a generic version of a patented drug furthers the public health interest, the Joint Registration system allows EAC member countries to obtain compulsory licenses for that drug. 

It also means that the EAC as a bloc has greater negotiating powers with Big Pharma.  Compared to each of the member states, EAC has increased ability to negotiate down prices of patented drugs.  It has all the power that goes with bulk purchasing of a drug.  That power finds support in the potential that, if negotiations fail, EAC or one of its members might invoke the compulsory licensing provisions of Doha.

Finally, creating a joint system will promote good governance. The proposed bill establishes a more transparent decision-making body, accountable for its actions to each EAC country and to other stakeholders in the registration process.  By creating a Joint Registration System with built-in accountability and transparency mechanisms (e.g. the requirement that each registration decision is justified in a written report made publicly available at a central office), some of the problematic practices currently taking place within national DRAs may be overcome.

1. Costs and Benefits of a Regional Registration Body

What potential drawbacks does a joint EAC registration system have?  What benefits? A joint registration system creates the possibility of conflicts between the five parties of the EAC on decisions of policy, process, and resource allocation.²⁹³  Already, for example, tensions between EAC member states have risen in relation to pharmaceuticals trade.  In August 2005, negotiations between the then three members of the EAC (Kenya, Tanzania and Uganda) appeared dominated by Kenya.  After four years of EAC negotiations, the three partner states had agreed to follow the Tanzania Common External Tariff (CET) model (a ten percent tax) for finished pharmaceutical products for retail use (with  an exception for ARVs, anti-malarials, anti-TB and government medicine procurement, for which there was an agreement not to tax on entry).   Upon implementing the CET agreement (January 1, 2005), however, it appeared that as implemented the new protocol taxed at entry percent all pharmaceuticals, including ARVs, anti-malarials and anti-TB medicines.  

The multinational pharmaceutical companies based in Kenya launched a heavy attack on the CET as implemented.  They lobbied the Kenyan government to remove all tariffs on pharmaceuticals. The Kenyan government then unilaterally suspended the tariff on pharmaceuticals, thus returning to the pre-CET rate of zero percent.  Kenya's unilateral action went against the redress mechanism ordained by EAC protocol.  That protocol stated that only the Council of Ministers – not an individual state – could suspend the EAC-agreed tariff.²⁹⁴ This incident strengthened a general fear amongst smaller EAC states that the larger member states will not hear their voices – or will simply ignore them.  That suspicion could undermine the successful establishment of a Joint Registration System. ²⁹⁵

The creation of a Joint Registration System obviously involves the expenditure of time and money.  Either EAC or the individual country must relocate national registration staff and equipment to a central location, and re-train staff effectively to run the new registration system.  Start-up costs aside, the running costs of a Joint Registration System should prove far less than the combined costs of running five separate registration systems in five countries.

2. Monitoring and Evaluation

In its early years at least, monitoring and evaluation of the new joint registration system seems indispensable. To that end, the proposed bill provides an independent inspectorate to monitor performance of the regional system at all levels.  It will report at least annually.  The inspectorate will consist of senior/ well-respected individuals from the health sectors of each EAC country to ensure representation of different national interests and ensure non-bias.  Each country's Minister of Health will appoint one inspector, who must have a higher degree in public health or a medical qualification, and some experience in drug regulation and/or registration.  Their reports of success of certain processes should ensure that JRA will maintain those processes.  When the inspectors criticize other practices, the inspectors should accompany their remarks with recommendations for consideration by JRA.  JRA can then model new regulations or practices these recommendations.

The bill laid out above inevitably calls for broad rule-making powers in JRA.  As the registration practices of the joint EAC community improve, JRA can improve GMP and quality standards.  Quality improvement will come – gradually.  More effective implementation requires that JRA build resources and train staff. GMP and quality standards will of course begin at the level permitted and existing staff and equipment levels.  The Inspectorate and JRA must, however, develop a timeline over which JRA will review those standards and, as resources and staff capacity increase, raise them. The monitoring commission's recommendations will help gauge the appropriate times and levels at which to raise standards.

A joint registration system that combines most of the alternative solutions mentioned in the beginning of this section clearly seems the most effective organization ad process to tackle the problematic behaviors this report has addressed.  It engages the most severe set of problems that DRAs and manufacturers face – the resource constraints of a small developing country with a high disease burden.  To address those constraints, this bill will bring together into a structured relationship the joint resources of the EAC countries. This doing, the bill accords with EAC's plans to harmonize activities across many levels of government and society.  EAC came into being in response to the felt imperative that, working shoulder to shoulder, the EAC countries can conquer many of the obstacles that, when faced by an individual country, seem insurmountable.  In no sector does the strength of all working together seem far greater than the sum of the individual strengths of the EAC member states than it does with respect to perhaps the most essential of governmental duties: Improving for its citizens the delivery of health care.

Current national registration processes, including national DRAs and drug manufacturers alike, constitutes a powerful explanation for EAC citizens' poor access to essential medicines.  This report and bill attempt to address three aspects of ineffective registration practices: unnecessary delays in the registration of vital medicines by national drug regulatory authorities; the effective exclusion from registration of cheaper generics in favor of more expensive patented drugs; and the registration of low-quality drugs because of inadequate pre-registration quality testing and low-level GMP requirements.
   
This research report demonstrates that national drug regulatory authorities act the way they do mainly because of resource constraints, and inadequate guidelines and training, and corruption.  Foreign patent-holding manufacturers tend to prioritize profits over public health.  To retain a monopoly in a particular drug, and thus control over the price, by means both fair and foul, the manufacturer pushes for patent protection and data exclusivity,   Local manufacturers lack the capacity to conduct thorough clinical trials, necessary to advance new medicines and their future domestic production.  Too often, they fall below international GMP standards.  Foreign generics producers lack incentives to export to the EAC under current systems.  Delays in registration and complicated bureaucratic hoops make the small market of each individual country not worth the trouble of registration.

As a solution, this report and bill propose a joint registration system for the EAC.  Because this bill makes available to drug manufacturers and importers all five EAC national markets, the bill's unified registration system will attract imports of cheaper generics as well as innovator drugs.  Creating a joint system will also pool the resources of the five EAC countries, thus avoiding overlaps in registration and quality assurance processes.  Finally, a uniform registration system entailing higher standards of GMP and quality assurance will tend to screen out at the registration level substandard medicines.

A.Composition

1. The Commission shall consist of two individuals from each EAC member country and one Chairperson. 
2. A Minister of Health from one EAC member country shall be the Chairperson, and the Chairperson shall have a term of one year, after which the Minister of Health of a different EAC member state shall take over the Chair of the Commission. 
3. Each other Commissioner shall be appointed to the Commission by the individual EAC members states' Ministries of Health, and shall be chosen from civil society (i.e. they may not be government officials) based on the appointee's expertise in the field of pharmaceutical regulation or registration.
4. A Commissioner may be removed from the Commission by the Commissioner's own state's Ministry of Health if the Commissioner is found to have gravely breached the duties and responsibilities tasked to him or her.

B.Purpose and Function

1. Mission – The mission of the Joint Registration Commission is to establish a Joint Registration Authority for the EAC, in partnership with the EAC's legislative body, through detailed laws. The creation of the JRA shall take place in conformity with the recommendations laid out by study groups, this research report, public input, and the Commission's own expertise.  The purpose of establishing a Joint Registration Authority is to improve access of East Africans in the EAC to quality medicines at affordable prices without delay.
2. Jurisdiction – The Commission shall have jurisdiction over the creation of detailed recommendations to the EAC's legislative body on the laws governing the establishment of the EAC's Joint Registration Authority.
3. Recommendations – The Commission's recommendations and decisions shall be binding on the legislative body – all recommendations made by the Commission to the legislative body shall be implemented as law unless the legislative body is able to show that the Commission's decisions are not in the public interest of the EAC.
4. Decision-making procedures
   
   • The Commission shall consider, in formulating its recommendations:
   • the findings of the study/working groups,
   • public comments on the findings of the study/working groups, which shall be published on the EAC's website and made available for public comment within a week of the Commission receiving such study/working group findings
   • the expertise of members of the Commission themselves, who may submit their individual recommendations in written form for publication on the EAC's website
   • Should the Commission need to settle an issue, the Commission shall vote on the issue and the majority shall win.  If the Commission's vote is tied due to the absence of one member, the Chairperson shall cast the deciding vote. 

C.Decision

1. The Commission shall issue a written decision or report detailing its recommendations to the legislative body.  The Commission shall also publish the report on the EAC website for public comment, and shall leave one month from the date of issuance to the date of submission to the legislative body during which public comments received shall be incorporated into the Commission's recommendations, or the Commission shall append to the report reasons for not including those public comments it has rejected.

D.Monitoring and evaluation

1. Appeals from decisions – A person may appeal from the Commission's recommendations by submitting an objection to the Commission.  The Commission shall either reconsider its recommendations and incorporate the objection's reasoning into its recommendations, or respond to the objection in written form, explaining why it has chosen not to incorporate the objection's reasoning into its recommendations.
2. The Commission shall report to the EAC Ministry of Health, upon the establishment of the EAC Ministry of Health.  Until that time, the Commission shall report to the Sectoral Council of Ministers Responsible for EAC Affairs.²⁹⁶

Recommendations

A. Recommendation to the Joint Registration Commission on the establishment of study and working groups to evaluate the current situation in the EAC:

1. The Joint Registration Commission shall create study groups – one for each EAC member country
   
   • These groups shall evaluate and create reports on the current registration system in terms of:
   • Current GMP standards and their implementation by GMP inspectors
   • Standard of clinical trials by local manufacturers
   • Standard and occurrence of quality testing of imported and locally produced drugs by the current DRA before these drugs enter the market
   • Compliance of the current DRA with the National Drug Policy in selection of which drugs to approve, which to fast-track, etc.
2. In six months, once these working groups have completed their research and created their reports, they shall become working groups
   
   • The country study groups shall come together to form one working group
   • The working groups shall draw up comprehensive programs of action, based on their findings, and the guidelines presented in this research report
   • Once the Programs of Action have been approved by the Joint Registration Commission of the EAC, and endorsed by the EAC Health Commission, the EAC Joint Registration Commission shall draw up a Program of Action based on the recommendations of the Working Groups for unifying registration, its own expertise and on recommendations from the public, and shall decide on the modalities and mechanisms for implementation, coordination, monitoring & evaluation and, to the extent possible, provide short-term and long-term financial provisions for the transition.

B. Recommendation to the Joint Registration Commission on the necessary functions of the Joint Registration Authority:

1. Registration of imported New Chemical Entities (NCE's): The Joint Registration Commission shall mandate the Authority to consider in its evaluation of NCEs the following:
   
   • Whether the availability of the NCE is in the public health interest and
   • Whether the drug is safe, efficacious and of acceptable quality, where the Regional Quality Control Laboratory determines the safety, efficacy and quality of the drug by a chemical and manufacturing data review, and
   • Whether the manufacturing facility of the drug complies with Good Manufacturing Practice (GMP) standards of the EAC, where GMP standards are those established by the WHO
   • Whether the manufacturer is on WHO's list of prequalified suppliers, in which case the Authority shall approve the manufacturer or the individual products listed using a fast-track mechanism
2. Registration of imported generics: The Joint Registration Commission shall mandate the Authority to consider in its evaluation of imported generics the following:
   
   • Whether the availability of the NCE is in the public health interest and
   • Whether the drug is safe, efficacious and of acceptable quality, where the Regional Quality Control Laboratory determines the safety, efficacy and quality of the drug by chemical equivalence testing if manufacturing and chemical data of innovator drug available, or by chemical equivalence and bioequivalence and clinical trials if the manufacturing data of the innovator drug not available
   • Whether the manufacturing facility of the drug complies with Good Manufacturing Practice (GMP) standards of the EAC, where GMP standards are those established by the WHO
   • Whether the manufacturer is on WHO's list of prequalified suppliers, in which case the Authority shall approve the manufacturer or the individual products listed using a fast-track mechanism
3. Registration of locally/regionally manufactured generics: The Joint Registration Commission shall mandate the Authority to consider in its evaluation of locally manufactured generics the following:
   
   • Whether the availability of the NCE is in the public health interest and
   • Whether the drug is safe, efficacious and of acceptable quality, where the Regional Quality Control Laboratory determines the safety, efficacy and quality of the drug by rigorous testing for chemical and bioequivalence to the innovator drug
   • Whether the manufacturing facility of the drug complies with Good Manufacturing Practice (GMP) standards of the EAC, where GMP standards are those established by the WHO
   • Whether the manufacturer is on WHO's list of prequalified suppliers, in which case the Authority shall approve the manufacturer or the individual products listed using a fast-track mechanism
4. .Registration of locally/regionally manufactured NCEs: The Joint Registration Commission shall mandate the Authority to consider in its evaluation of locally manufactured NCEs the following:
   
   • Whether the availability of the NCE is in the public health interest and
   • Whether the drug is safe, efficacious and of acceptable quality, where the Regional Quality Control Laboratory determines the safety, efficacy and quality of the drug by a chemical and manufacturing data review, and
   • Whether the manufacturing facility of the drug complies with Good Manufacturing Practice (GMP) standards of the EAC, where GMP standards are those established by the WHO
   • Where these stan­dards have not yet been attained, the Authority may decide, on a case by case basis, whether a particular product or supplier offering lesser standards can, as a temporary measure, be regarded as acceptable.  Such a decision shall be made with reference to the therapeutic margin a particular medicine has, and shall be justified in a written report to ensure transparency in decision-making
   • Whether the manufacturer is on WHO's list of prequalified suppliers, in which case the Authority shall approve the manufacturer or the individual products listed using a fast-track mechanism
5. Registering locally/regionally manufactured traditional medicines: The Joint Registration Commission shall mandate the Authority to consider in its evaluation of locally manufactured traditional medicines the following:
   
   • Whether the availability of the drug is in the public health interest and
   • Whether the drug is safe, where the Regional Quality Control Laboratory determines the safety of the drug by a chemical and manufacturing data review and
   • Whether the manufacturing facility of the drug complies with Good Manufacturing Practice (GMP) standards of the EAC, where GMP standards are those established by the WHO

C.Recommendation to the Joint Registration Commission on the financing of the Joint Registration Authority:

1. The Joint Registration Commission of the EAC shall meet with the Finance Ministers of each of the EAC member countries to determine how much funding each shall give to the Joint Registration Authority (JRA)  
2. Each country's contribution shall be measured proportionately to its national income, as measured by Gross Domestic Product.
3. In addition to country financing, the JRA shall obtain financing from drug registration fees, which the Joint Registration Commission shall set, balancing the JRA's need for funding against the interest in attracting foreign manufacturers with lower registration fees
4. A third possible source of funding is donor aid from foreign nations.  The Commission shall establish guidelines for receiving such aid, and shall ensure that such aid does not become the major or sole source of funding for the JRA (i.e. increases in donor aid shall not result in a cutting back of state-sponsored or registration fee-sponsored finance)

Nisha Patel, Alison Ross, and Mia Levi

This chapter differs from the others in this book.   Focusing on Uganda, Rwanda and Tanzanian experience, it abstracts and combines the relevant parts of research reports drafted by the authors to begin the process of conceptualizing legislation to help improve the distribution of essential medicines to all EAC inhabitants, especially those in remote rural areas.  All three authors underscore the importance of engaging knowledgeable country nationals in gathering additional facts to warrant – and, as necessary, to revise – their draft reports' initial hypotheses as to the nature and causes of the  problematic behaviors – the institutions – which proposed legislation must change to enable all the region's inhabitants to access efficient, affordable medicines.

This chapter does not repeat the three drafters' description of the larger, historically shaped EAC context, essentially summarized in Chapter One, above.  That constitutes larger context within which East Africans experience difficulties in obtaining affordable, effective medicines,   Instead, this chapter focuses on the three authors' analysis of the evidence relating to problem-solving's Step I, describing the country-specific role occupants' behaviors that contribute to those problems; Step II,  explaining the causes of each set of those role occupants' problematic behaviors; and, Step III, the range of logically possible, legislative solutions for eliminating those difficulties.  As required by problem-solving's Step IV, all three authors recommend that the proposed law incorporate a transparent, accountable and participatory monitoring and evaluation processes.  Those processes must ensure that those affected by the law can assess – and suggest improvements – in its implementation and its contribution to improving all East Africans' access to affordable medicines.

In reality, the social problems posed by difficulties in accessing effective drugs in the three countries do not appear to differ greatly.   Nevertheless, partially reflecting the countries' differing histories, the specific role occupants whose behaviors contribute to those problems (ie the 'institutions' responsible for distributing the medicines) do seem to differ significantly.    The EAC workshop participants should assess the evidence on which the authors ground their descriptions and explanations in light of their own deeper knowledge of their countries' unique realities.   In doing so, they should consider whether the apparent differences seem to require each member EAC state to enact national legislation to achieve a more equitable distribution of medicines to all their country's inhabitants; and or whether regional legislation might facilitate more effective, coordinated use of regional resources to improve the distribution of medicines throughout the region.

To facilitate the workshop participants' efforts to make that assessment, this chapter presents an abridged version of the three authors' research reports' Parts II, III, and IV – ie their four step analyses of the relevant problematic behaviors that still perpetuate the difficulties so many EAC residents still experience in accessing medicines essential to extend their life expectancy.

[ Provide a Map of Uganda, identifying the capitol and medicinal distribution networks: districts, hospitals, health centers, and pharmacies, and a box with a glossary of all the alphabet 'soup' (titles) of the health agencies described below) ]

A number of role occupants contribute to the problem of inadequate distribution of essential medicines in East Africa, as exemplified in the Ugandan case.²⁹⁷  The National Medical Stores (NMS) Management – including the Board of Directors, the General Manager, and the Staff – play a significant role.   Local health center personnel, responsible for drug procurement, stock management, and overall logistics of ensuring an adequate supply of drugs, and third party donor programs also contribute.   To ensure more equitable access to essential medicines for all Ugandans, the proposed bill's detailed provisions must change these primary role occupants' problematic behaviors.   Before designing or revising laws to change these behaviors, however, Ugandan law-makers together with Ugandan medical personnel will want to examine in greater depth the available evidence as to the role of the NMS, health center personnel, and third party donor programs which, currently, have primary responsibility of ensuring essential medicines reach all Ugandans.

Insert diagram of relationship between these institutions here.  The editors and authors have not yet found this information.

In the early 1990s, the Ugandan government decentralized its health care.  The Ministry of Health retained responsibility for policy formulation, standard setting, and resource mobilization.  Local governments (districts and delegated health sub-districts) assumed responsibility for implementing the policies, mobilizing additional resources at the local level, and planning and managing district health services.²⁹⁸ The Ministry of Health determines the country's National Health policies, which provide equitable delivery of health services, accessibility to health services, and improved health financing and development.²⁹⁹  The National Drug Authority (NDA) enforces the National Drug Policy (NDP) and sets the policy and principles under which the government can import drugs into Uganda, ensuring the availability, accessibility, and affordability of essential medicines of appropriate quality, safety and efficacy.³⁰⁰
 
In 1995/96 the Ministry of Health initiated a ten year National Health Policy (NHP) (launched in 1999/2000) and a five year Health Sector Strategic Plan (HSSP) (launched in 2000/2001).  These policies aimed to provide a package of services known as the Uganda Minimum Health care Package (UMHCP) designed to overcome, as cost-effectively as possible, the major causes of high mortality diseases.³⁰¹ The UMHCP focuses on control of diseases like malaria, HIV/AIDS, and TB along with childhood illness, sexual and reproductive rights, and school health.³⁰² Additionally, the MoH proposed a sustainable National Health Financing Strategy geared towards equitable national health,³⁰³  and a Health Care delivery system, with core functions at the central and district levels, to improve the alignment of structures and responsibilities.³⁰⁴ More recently, the MoH formulated a five-year National Pharmaceutical Sector Strategic Plan 2002/3 -2006/7 to facilitate ongoing health care reform, including access to essential medicines.³⁰⁵  

Under Uganda's decentralized system, each of 56 districts has established a health care administrative structure consisting of five levels: health centers (HC I-IV, at village, parish, sub-county, county) and the district/general hospital.³⁰⁶  Additionally, eleven HC VIs act as referral hospitals at the district level, and two HC VIIs serve as national referral hospitals.³⁰⁷  NHP established health sub-districts as the operational zone in a district to take services closer to the population.³⁰⁸  The Ministry of Health reports that Uganda has 104 hospitals (57 government, 44 NGO, 3 private); 250 health centers (179 government, 68 NGO, and 2 private); 2 palliative care (1 government, 1 NGO); and 1,382 other (989 government, 352 NGO, and 41 private).³⁰⁹  Health center personnel dispense medicines from 2,939 public sector health facilities to 215 private pharmacies, and 2600 drug shops.³¹⁰ The Ministry of Health concentrates the delivery of UMHCP in HCs I-IV where the majority of the people live.³¹¹

Diagram the five levels ??

Private and missionary hospitals get their medicines from the Joint Medical Stores (JMS), while government and public hospitals obtain their drugs through the National Medical Stores (NMS), a government agency.³¹²   Under the National Medical Stores Statute, the NMS should ensure the continuous distribution of essential medicines to the population of Uganda, including the country's most remote regions.³¹³ The NMS specifically has responsibility for procuring, storing, and distributing essential medicines to the public sector.³¹⁴ 

The Ministry of Health set up the NMS as a corporation, with a Board of Directors, appointed by the Minister of Health, as its governing body.³¹⁵ The Board formulates and reviews the policy of the NMS regarding its procurement, storage, and distribution of medicines.³¹⁶The Board determines the NMS' organizational structure and staffing, and approves an Operations Manual for the NMS' internal operation.³¹⁷ The Minister of Health also appoints the General Manager, who oversees day-to-day NMS operations.³¹⁸

NMS manages a complex, unique, and highly integrated distribution network throughout the country.  NMS stores, distributes, and supplies goods in accordance with the NDP and NDA standards.³¹⁹ NMS stores and distributes imported drugs, including those donated by third parties.³²⁰ NMS runs its processes with Microsoft Navision 3.70, a tool that allows a business to streamline its internal processes, particularly in the areas of financial management, supply chain management, and customer relationship management.³²¹  The System used by NMS supports and facilitates its product distribution network, business processes and financial management, storage management and inventory control operations.³²²  

Under the decentralized system, district personnel use either a credit line, or directly purchase drugs for distribution.³²³ Under the credit line system, the Ministry of Health allocates funds to each health center's account with the NMS, and the NMS delivers drugs based on the health centers' requisition orders.³²⁴  NMS distributes these drugs to the districts from which HSDs collect and deliver them to local health centers.³²⁵ Under the direct purchases system, health centers must use at least 50% of public health care funds to purchase drugs.³²⁶ The districts must buy drugs from the NMS; only if the NMS issues a non-availability certificate³²⁷ may they purchase from another supplier.  The authority that purchases the drug must distribute it (i.e. if an HSD buys the drug, it must distribute it).   In a centralized book-keeping system, the districts distribute drugs to HSDs, which later distribute them to individual health centers.³²⁸  In a decentralized book keeping system, HSDs distribute the drugs.³²⁹  In the NMS "pull system" of drug procurement, a logical accounting system links all health facilities' credit lines.³³⁰  Districts and HSDs must place orders within specified ordering schedules, and receive orders within two months of the ordering date.³³¹  Delivery occurs every 8 weeks to each district and every 4 weeks for HIV treatment centers.³³²  In the pull system, each health facility estimates and places orders for its required quantities of medicines.³³³ NMS employs several distribution systems for: monthly supplies; quarterly schedule supplies; emergency supplies; flexible demand-based supplies; and door to door customer delivery.³³⁴  Government facilities most commonly use facility-managed vehicles (48%) or public transportation (48%) to transport drugs.³³⁵  Health center personnel perform inventory management at health centers and place orders for drugs.

Legislation to improve the implementation of this complex distribution system will have to alter or eliminate the causes of existing problematic behaviors of those who, at each level, manage it.  These include the managers and employees of the National Medical Stores; Health Center personnel at the District, HSD, and village level; and third-party donor personnel.

A.  National Medical Stores (Management and Employees)

Inadequate guidelines and supervision by the NMS managers, and NMS staff members' negligence and errors apparently contribute to life saving medicines' expiration on the shelves before reaching patients.³³⁶  In 2006, the Office of the Auditor General reported that 42,555 packs of anti-retrovirals (ARVs), valued at about $468,000, had expired at NMS.³³⁷  In 2007, the Parliamentary Social Services Committee discovered that, at NMS, Shs 1.2 billion (approximately $685,000) worth of already-expired ARVs and malaria drugs, and Shs1.65 billion (approximately $942,000) worth of other drugs about to expire.³³⁸ 

NMS staff members' non-compliance with specified drug-delivery procedures and schedules leads to late delivery of drugs to health centers, depriving patients of drugs they need immediately.³³⁹  As a result, some districts order from other sources without waiting for a certificate of non-availability from NMS.³⁴⁰  The higher the level of facility, the less time it takes to receive supplies: the majority of hospitals and HC IV level reported receiving supplies within one to two months, whereas the majority of HC III and HC II facilities reported that it took two to three months or more.³⁴¹  NMS delivers directly to most hospitals, and 73 percent of HC IV facilities stated that "they collect their supplies from the district, which allows for more control over timing."³⁴²  Only "25 percent of HC III and HC II facilities collect their own supplies; 50 percent rely on the HSD to deliver, and another 20 percent rely on the district to deliver their supplies."³⁴³ 

Lack of communication between the NMS staff, district, and HSD personnel concerning delivery dates aggravates local facilities' difficulties.   Not knowing the actual arrival date, district and HSD personnel cannot reserve vehicles in advance or plan for distribution to remote health centers.³⁴⁴The HSD often does not know that the District received an order, and sometimes discovers it only by chance.³⁴⁵ District level storekeepers and auditors may not know when to inspect and accept a delivery, causing more delays while the NMS District level staff waits for them to arrive.³⁴⁶ 

B.  Health Center Personnel (District, HSD, and village level)
 
Health center personnel's failure to keep adequate records as to drugs procured constitutes another seriously problematic behavior.   The 2006 Value for Money audit found that 19 out of 81 health centers did not have proper drug records.³⁴⁷  A 2002 survey indicated that 45% of facilities used stock cards³⁴⁸  for at least one of the contraceptives studied; 75% used stock cards for at least one of the essential drugs for treating OIs, malaria, and STIs; and 28% used stock cards for at least one of the TB medications studied.³⁴⁹  A comparison of the overall average percent discrepancy between the stock card and the physical count for all facilities surveyed revealed that a median discrepancy existed of 84% for contraceptives, 40% percent for OI/malaria/STI drugs, and 92% for TB drugs.³⁵⁰

A 2006 survey found improvements in the use of stock cards in some areas, finding that 80% of stock cards for selected essential drugs were up to date, however, in other areas, like HIV tests, only 50% of stock cards were up to date.³⁵¹ The lack of accurate data on levels of drugs makes health centers vulnerable to drug leakages and misappropriation by staff, especially when combined with very little segregation of duties.  Low levels of actual use of stock cards indicate that stock managers do not properly monitor their stock levels.  Not maintaining store records leads to delays in identification of drug stock outages and expired drugs.  In turn, this behavior tends to cause inadequate procurement and drug shortages that disrupt health service delivery.  A 2006 Value for Money audit showed that out of 81 health centers visited, 31 (38.3%) lacked essential drugs and sundries required by the medical personnel of the health centers in carrying out their duties.  Extrapolated, this indicates that 10,583 health centers nation-wide lack essential drugs.³⁵² Regular reporting of this information proves critical for making logistical decisions at each level of the supply chain.  The lack of these reports suggests that the Ministry of Health does not effectively draft, communicate, and enforce its guidelines regarding keeping accurate drug records at the health centers.

Health center inventory management personnel apparently neither maintain proper storage facilities nor comply with MOH and NDA handling procedures for proper storage to protect medicines from harmful conditions.  Inadequate storage at one out of three facilities storing medicines reportedly affected the medicines' quality.³⁵³  A 2002 survey found that about "half of government facilities were not maintaining their storage space" in clean conditions, with "all trash removed, sturdy shelves in place, and boxes organized."³⁵⁴ Similarly, approximately "half of the government facilities did not have sufficient space for the existing commodities."³⁵⁵  The 2006 Value for Money Audit found that 7 health centers out of 81 visited had improper drug stores, suggesting that, nationally, approximately 2,388 health centers might lack proper drug storage facilities.³⁵⁶ Some health centers had dusty and unventilated storage areas.   Other centers had no separate storage areas; their personnel stored medicines in the same areas from which they dispensed them to patients.³⁵⁷  Apparently, health center personnel did not separate expired from unexpired drugs.³⁵⁸ These inadequate storage conditions apparently contributed to deterioration of essential drugs' quality, destruction, and theft. 

C.  Third-Party Donor Programs

Third-Party Donor Programs, including Global fund, AIDS Control Programme, Clinton Foundation, and Malaria Control Programme, donate large amounts of medicines to Uganda.   No national or international authority, however, has responsibility for ensuring that third party donor programs efficiently store and adequately distribute their own donated drugs.   Although NMS did not engage in planning or procuring third party drugs supplies, it accepted all consignments, even on very short notice.³⁵⁹  Out of the 13,000 square meter-storage space at NMS, NMS drugs occupy only 2000 meters – i.e., 15 percent.³⁶⁰   The fact that NMS utilized over 80 percent of its available space to store donor drugs increased the number and value of medicines likely expire in NMS stores.  The NMS statute did not give NMS authority to distribute third party drugs, donated or otherwise.  Unless third party donors specify to whom and where the NMS should deliver their medicines, the NMS cannot send them out, even to national health centers.   The General Manager of NMS Apollo, Newton Mwesigye, indicated that third party programs procured big volumes of short-lived drugs (including some the NMS already has), and then stored them for long periods  with the NMS.³⁶¹Apparently as a result, some donated drugs, especially essential medicines with a short shelf life, expired.³⁶² The NMS often informed donors that their drugs would soon expire, but too often the donors failed to respond in time to save the drugs.³⁶³  The increased number and volume of redundant stock at NMS, such as condoms, homepaks for malaria, and ARV oral dosage syrups, also led to high inventory holding costs and inaccurate procurement planning by NMS.  These problematic behaviors apparently contributed to the failure of significant amounts of donated life-saving medicines to reach people who desperately needed them.³⁶⁴  

MINI-CONCLUSION

Evidence that large numbers of people – lacking access to life saving drugs -- simply die from preventable diseases, underscored the inadequacy of Uganda's distribution chain for delivering essential medicines, the three most significant role occupants who contributed to this problem included: the NMS Staff and Management, health center personnel, and third party donor agencies. The NMS managers' and staff members' poor organization of procurement, storage and delivery of drugs contributed to stock outages at health centers, especially those in remote rural areas.  Health center personnel contributed by keeping inaccurate records of drug received and storing them in inappropriate facilities, aggravating stock outages and expiration of drugs before they reach patients who need them.   Finally, third party donor programs, while providing many essential drugs to Uganda, did not pay enough attention to their storage and distribution, so Ugandans too often receive them too late or not at all.

In the next Part, III, this report offers explanatory hypotheses, along with the limited evidence available, as to these three sets of role occupants' problematic behaviors' causes.  Ugandan experts, whose work experience makes them more familiar with Uganda realities, undoubtedly have access to more up-to-date relevant information.   That should enable them to revise and deepen the initial explanatory hypotheses provided here.

       
Alteration of the problematic behaviors of the NMS management and Staff, the health center personnel, and third party donor programs may require several specific bills.  To ensure those bills' design and drafting, this report proposes that the Ugandan Parliament enact a law to establish a Ugandan branch of the proposed EAC Health Commission.   The Ugandan branch should further analyze and design appropriate legislative solutions to transform the problematic behaviors of the NMS, local health centers, and third party programs for obtaining, storing and distributing affordable essential drugs.  While conducting research for evidence-based solutions to the problems of distributing medicines in Uganda, the proposed Ugandan Health Commission branch should simultaneously provide information for use in designing regional legislation to improve the distribution of medicines to those in need – especially the poor and vulnerable -- throughout the East African region.

This Part IV first reviews several logically possible alternative solutions for overcoming the difficulties of ensuring timely and efficient distribution of medicines; describes how its proposed solution, the establishment of a Ugandan branch of the proposed regional Agency on Health, will work; shows that the social and economic benefits of implementing it will likely outweigh the social and economic costs; and, finally, suggests a monitoring and evaluation mechanism to enable those whom the law affects – especially the poor and vulnerable – to participate in assessing its implementation and social impact.

A.    Alternative Potential Proposals

To determine the most appropriate legislative solution for the inadequate distribution of medicines, drafters should consider the range of logically possible alternatives.  As one alternative, they might decide not to draft a bill, leaving in tact the current state of affairs.  While this solution might save the cost of making changes now, in the long run it would likely aggravate the social costs, not only to many individual Ugandans, but to the nation as a whole, likely to result from the loss of essential medicines.  By apparently ignoring its responsibility for fulfilling the people's basic needs – in this case, access to essential life-saving medicines – the government itself may lose legitimacy.
   
As a second alternative, UA drafters might incorporate detailed provisions to alter the existing problematic behaviors of the NMS, health center personnel, and third party donors in an overarching new law. While separate national rules ultimately will probably prove necessary to deal with specific national problems in drugs distribution, however, experience suggests that any attempt to incorporate them into one huge bill will not likely help to improve the drug distribution chain.   For a law to prove effective, its detailed provisions should focus narrowly on changing one or two sets of behaviors that contribute to the targeted social problem.  An effort to draft a large bill, with multiple sections aimed at changing several sets of role occupants' behaviors will require a great deal of disparate kinds of evidence; and probably prove difficult – if not impossible – to design, enact, and implement. 

As a third alternative, Ugandan drafting teams could create an independent Ugandan Agency tasked with gathering evidence required to compile adequate research reports to justify the detailed provisions of separate laws (parliamentary acts, agency regulations, perhaps even municipal ordinances), designed to change the problematic behaviors of the NMS (managers and Staff), the health center personnel, and third party donor agency staff.  While an independent Agency might facilitate somewhat better use of Uganda's medical resources, it might lose the potential benefits of cooperation with its neighboring EAC countries made possible by participating in the proposed EAC Health Commission.   In key areas – like training of health and logistics workers, and taking advantage of economies of scale in the use of regional personnel and medical resources to improve all East Africans' access to efficient, effective medicines – Ugandans might reap greater benefits from cooperating closely with the proposed regional Health Agency.  Uganda and its neighbors might benefit significantly from cooperating to import, and eventually – given its significant regional market – to manufacture medicines, as well as improving communications technologies essential for efficient distribution and storage in remote rural areas.

This review of alternative possible solutions suggests that, as the best solution, Ugandan drafters might draft a bill's detailed provisions to create a Ugandan Agency (UA) as a branch of the proposed EAC Health Commission.   The UA could set up sub-committees tasked with researching and creating detailed regulations to change the problematic behaviors of each relevant set of actors: The NMS, health center personnel, and donor agencies' representatives.

B. Designing the details of a Ugandan Health Agency as a branch of the EAC Health Commission proposed by the EAC Summit in 2007

To establish a Ugandan Agency as a branch of the proposed EAC Health Commission, the proposed bill must detail the Agency (UA)'s structure, authority, and proposed objectives.  As the Ugandan legislature' policy-making body, the bill must grant the Agency specified powers, and impose rules that, as far as possible, insulate it from politics.  The bill must specify criteria and procedures by which the Agency conducts research and drafts proposed regulations which prove participatory, transparent, and accountable. The Agency must present each draft regulation, justified by a research report structured by legislative theory's problem-solving methodology.  The Agency should submit each regulation to the Ugandan Legislature for review.  The Agency should accompany each regulation with a research report, published through the media and available to stake holders and concerned non-government organizations.  That report should provide evidence to demonstrate that the proposed regulation will likely prove effectively implemented and help to resolve the targeted social problem.   Unless the Legislature, within a month, by majority vote, decides otherwise, the Agency will proceed to put the regulation into effect.  

The Agency governing board and drafting team members must represent interests of all those whom the proposed regulation will likely affect.  Taking into consideration nominees from other governmental agencies (including the NDA and NMS) and concerned civil society organizations, the Minister of Health will appoint a health professional, preferably from the MoH, as the Agency Director.  Subject to approval by the Ugandan Legislature, the Director will appoint members of the Agency's governing board, representing different interest groups, for a term of ___ years.  The Director will publish the reasons for each individual member's appointment   The Agency Board members will include at least one person each from the NDA and NMS since they comprise integral components of Uganda's distribution chain for medicines.  They will include:

• Representatives from both the NMS management and staff who have access to  information essential for drafting regulations that affect the storage and recording of medicines at national, district, and local health facilities.  
• Representatives from civil society groups which work on health issues on a  community level who will help to ensure that the distribution chain serves all Ugandans' interests, especially poor in rural areas. 
• Health professionals from Ugandan health institutions and universities who may coordinate, and, as necessary initiate new efforts, to conduct research and gather the relevant evidence required to justify specific UA draft regulations.
  [The next section of this report suggests the kinds of further research needed to design detailed regulations likely to help resolve problematic behaviors described in this report's first three parts.]  
• Representatives from the health districts, sub-districts, and health center levels  I-IV because many of the regulations the UA must draft will directly affect their procedures and current practices. 
• Representatives of third party donor programs, like the Global Fund and USAID who may provide useful suggestions relating to sources of funds and other developing countries' experiences with distributing medicines.⁴⁰³  

Agency board members will meet regularly to ensure efficient and appropriate implementation of the Agency's responsibilities.  Initially, the Agency board may have to meet once a week. Once the members have established its presence and decision-making procedures, however, they may meet less frequently.  The Agency will appoint drafting teams, composed of members with expertise in legislative drafting and knowledge of the problematic behaviors that hinder effective distribution of available medicines to all Ugandans.  Each team that drafts a regulation will accompany it by a research report that provides the facts, logically organized, to demonstrate the likelihood that the regulation's detailed provisions will prove effectively implemented and help to achieve the desired social impact.  The law establishing the Agency will require its board to appoint a subcommittee with responsibility for monitoring, evaluating, and publishing an annual written report for the legislature and civil society, describing how each drafting team completed its task of drafting regulations accompanied by well-designed research reports.

All decisions and actions of the Agency must prove transparent and accountable.  The Agency will make all decisions by a majority vote.   Only in specified instances, for specified reasons, may the director overrule their decisions.  The requirement of majority approval helps to ensure that no single member may exercise more power than any other.   More than that:  The proposed Agency establishment law's requirement that a research report justify each regulation's detailed provisions will serve as a quality control to ensure that each teams' members ground their decisions on reason informed by experience: the available evidence, logically organized. 

All members of the Agency will review all draft research reports and regulations before submitting them to the Ugandan Legislature.  In the interest of transparency, on request, the Agency will hold town hall meetings and open forums in easily accessible locations to discuss with all interested parties proposed regulations and associated research reports, as well as other Agency activities.  The Agency will publish annual reports that detail work done each year, including UA members appointed, decisions made, research performed, regulations drafted,  funds allocated, and the conclusions of UA monitoring and evaluation procedures.  The Minister of Health will appoint an independent auditor to review the UA's annual reports to ensure the use of appropriate criteria and procedures in making all decisions as specified in the law establishing the UA itself.

The UA Director will coordinate the UA's cooperation with the EAC Agency regarding the implications of research, drafting and implementing regulations specific to Uganda for possible formulation of regional level legislative projects. Training of NMS Staff and management, health center (all levels) personnel regarding logistics management, record keeping, storage procedures, and delivery schedules and timetables seem potentially important areas for UA-EAC Agency cooperation.     

In sum, the detailed provisions of the UA bill will focus on making sure that the Ugandan Agency functions efficiently, in a transparent, accountable, and participatory manner to draft regulations, justified by adequate research reports, to improve the distribution of essential medications to all Ugandan