Acknowledgements

Chapter 2: Using Theory As A Guide... Chapter 2: Using Theory As A Guide To Design And Draft Evidence-Based Transformatory Legislation

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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.

Acknowledgements

Chapter 2: Using Theory As A Guide... Chapter 2: Using Theory As A Guide To Design And Draft Evidence-Based Transformatory Legislation