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Carolyn Musyimi

Carolyn Musyimi drafted the research report that comprises the substance of this chapter as part of her second year MA project in Brandeis University's Sustainable International Development Program. Focused on using law to facilitate Kenyan and East African manufacture of effective, essential, and affordable medicines, she sought to justify an evidence-based bill to strengthen the role of East African scientists and health professionals in grappling with that task.  Hopefully, a team at the proposed EAC workshop will provide additional evidence, not only to justify a bill along the lines Musyimi suggests, but to lay a basis for considering several bills – a legislative program – to foster the development of an East African pharmaceuticals industry.

A.  Statement of the Narrow Problem and Proposed Solution

Although many Kenyan professionals receive formal university-level education in medicine and related science at government expense, a significant proportion practices the profession outside of Kenya. Others choose career paths that do not, by research or otherwise, contribute to developing Kenya's pharmaceutical manufacturing industry. 

The legislative solution proposed here comprises a bill to require the Kenyan Ministries of Trade and Industry, Health and Education to formulate and implement a plan to strengthen Kenyans' contribution to the development of regional capacity to manufacture effective, efficient and affordable pharmaceuticals.  That plan will aim to ensure that professionals, educated and trained at the government's expense in sciences related to pharmaceuticals' manufacture and use, remain in Kenya to practice their professions and participate in research likely to help strengthen East African capacity to manufacture of affordable medicines for use throughout the region.  Simultaneously, the draft report calls for legislation to provide incentives to encourage expatriate Kenyan professionals and multi-nationals to contribute to technology transfer and development of a regional pharmaceutical manufacturing industry.

B.  Methodology and Brief Summary of the Argument

Following problem-solving's four step methodology, this research report's Part II first describes the surface appearance of the narrow problem that results from the failure of university graduates to contribute to expanding the East Africa's pharmaceuticals manufacturing industry, and suggests whose and what behaviors contribute to that problem: The Ministries of (1) Health, (2) Trade and Industry, and (3) Education.  

The second step, in Part III, reviews the evidence as to the probable objective and subjective causes of these ministries' failure to ensure that Kenyan scientists and medical professionals participate in strengthening Kenya's industrial capacity to manufacture pharmaceuticals.   That lays a basis in facts, logically organized, for the third step, in Part IV:  The design of the bill's detailed provisions to ensure these ministries contribute more effectively to encouraging Kenyan graduates to remain in the region and contribute the essential skills required to strengthen the region's capacity to manufacture essential effective medicines.  

In sum, the proposed bill seeks to solve the problem of lack of affordable pharmaceuticals in Kenya (and East Africa) by minimizing the existing brain drain, and ensuring that qualified university graduates contribute to research relating to the possibility of increasing local production and processing of raw materials required to manufacture essential  medicines in the region.

        
This section describes the harm caused by the behaviors of the three distinct actors:  the Medicine and Pharmaceutical Manufacturing companies, the Ministries of Health, Trade and Industry.   It first describes the problem limited and costly pharmaceuticals manufacture in Kenya that contributes to most Kenyans' and other East Africans' lack of access to affordable essential medicines. The section then introduces the actors' behaviors, which contribute to the social problem -- that is, the institutions that the proposed bill must change to eliminate it.
 
A.  The surface appearance of the problem: The failure to develop an integrated, efficient pharmaceutical industry in East Africa

Despite the fact that the combined population of the five East African
Community member states totals roughly a hundred million people, none has yet developed the capacity to manufacture the effective, efficient medicines essential adequately to improve the regional inhabitants' health (Chapter I provides the evidence that undergirds this assertion).

1.  The nature of pharmaceutical industry

The manufacture of pharmaceutical drugs requires two steps:  (1) the production of Active Pharmaceutical Ingredients (APIs), which requires chemical synthesis skills commonly referred as reverse engineering,⁵³⁹ and (2) the final formulation, involving mixing APIs and other non-active ingredients into pills, tablets or other forms of administration.⁵⁴⁰
 
Industrialized countries' patent laws have significantly shaped the global pharmaceutical manufacturing industry and the difficulties developing countries experience in building their own manufacturing capacity.   Transnational pharmaceutical companies insist that patent protection of the intellectual property rights proves essential to protect and promote innovation and production of their products.⁵⁴¹ Supported by their home governments, they defend the agreement on Trade Related Aspects of Intellectual Property Rights (hereafter, the TRIPS agreement), and the high profits patent holders reap as necessary sources of capital for the extensive research and development (R&D) they have undertaken to develop and bring new drugs to market.⁵⁴²

2.  The impact of the international patent system

The granting of uniform pharmaceutical patents in less developed and developing country-members of the World Trade Organization (WTO), in accordance with the TRIPS agreement, affect the inhabitants' access to essential medicines in a several ways by:

1. Restricting country-nationals' efforts to engage in the reverse engineering required to produce active pharmaceutical ingredients (APIs);
2. Limiting local manufacture and requiring the import of higher priced pharmaceuticals; and
3. Hindering poor countries' ability to acquire new 'upstream' technologies only available in developed countries subject to patent constraints.⁵⁴³

The transitional arrangement under the TRIPS agreement specifically mandated that all WTO developing country-members enact national laws compliant with TRIPS by 2005.⁵⁴⁴  After that, several countries which adopted TRIPS compliant patent regimes – including India – could no longer produce and export generic copies of brand name products patented elsewhere.⁵⁴⁵

The Doha declaration on TRIPS and public health granted least developed countries (including Kenya) an extension until 2016 to implement the pharmaceutical patent provisions of the TRIPS agreement.⁵⁴⁶  

Least developed countries without manufacturing capabilities, however, cannot exploit this legal concession. Developing countries, which bear the highest disease burden, remain unable to manufacture medicines locally in sufficient quantity and variety to meet their needs.   The higher cost of imported medicines limits peoples' access to them, and has serious consequences.⁵⁴⁷  
   
Manufacturing of pharmaceuticals, and especially the raw materials used to manufacture them, remains limited to a few countries.  This report proposes a bill to strengthen Kenya's capacity to manufacture medicines and raw materials locally.

3.  Kenya's pharmaceutical manufacturing industry

In 2001 the Kenyan parliament passed the Kenya Industrial Property Bill,⁵⁴⁸ allowing the importation and production of more affordable medicines for HIV/AIDs and other diseases. The Bill includes most of the WHO recommended safeguards which include parallel importing and compulsory licenses. By 2006, however 60% of the population was still unable to access and afford pharmaceuticals.⁵⁴⁹  Kenya remains heavily dependent on importing of medicines rather than local manufacturing. Currently Kenya imports 95% of manufacturing ingredients for essential medicines from other countries.⁵⁵⁰

The pharmaceutical sector consists of about 30 licensed plants, including local manufacturing companies and large multi national corporations (MNC), subsidiaries of joint ventures. Most are located within Nairobi and its environs.  A wider distribution of plants could facilitate the transportation and distribution of medicines to rural communities at a lower cost. They could also provide employment opportunities without forcing prospective workers to migrate to already overburdened cities. The chart below shows the location of some of Kenya's manufacturing plants.

The first eleven companies listed in Table 7-1, below, comprise affiliates of multinationals, subject to their overseas managers' decisions relating to what pharmaceuticals to produce, how much to produce, where to produce them – all the issues that determine their social impact in East Africa.

Table7-1:  Major pharmaceutical manufacturing plants and their location in Kenya

Source: Kenya Fact book (2001, 4)

These generic manufacturers, multinationals and local pharmaceutical firms all contribute in one way or the other to lack of affordable medicines. Generic manufacturers have shown insufficient regard for the industry-GMP.⁵⁵¹   Kenya has not addressed the danger of local production without adequate safeguards, as elsewhere, even major generic manufacturing countries like India and China.   Thousands of unregulated laboratories have churned out counterfeit and substandard medicines.⁵⁵² With little or no regulatory control, some firms produce and widely distribute sub standard goods.⁵⁵³

Relying on other countries for pharmaceuticals and pharmaceutical production ingredients remains very costly, contributing to the lack of affordable pharmaceuticals in Kenya. This report addresses the specific social problem created by its inadequate pharmaceutical manufacturing capacity.  It justifies a bill to change the problematic behaviors of the specific actors which may help to strengthen Kenya's capacity to manufacture essential affordable pharmaceuticals in Kenya.

Kenya largely imports medicinal and pharmaceutical products and ingredients for manufacturing them from Great Britain, India, Germany, France, the USA, China and Switzerland.⁵⁵⁴   Importers must meet standards such as those imposed by the National Policy and the Kenya Bureau of Standards (KBS) for quality checks and registration; they must pass regulatory quality control tests and pay tariffs and taxes.⁵⁵⁵ Kenyan laws require pharmaceutical manufacturers to register each drug, in order to ensure safety, quality and efficacy of drug components.⁵⁵⁶ 

Kenyan authorities inspect manufacturers' production facilities to ensure Good Manufacturing Practice (GMP) compliance.  Consumers bear a significant share of the costs of compliance.  High cost of effective pharmaceuticals contributes to the widespread (perhaps 80% of the population) reliance on traditional medicine for primary health care,⁵⁵⁷ and the high mortality rates from diseases that standard medical approaches could cure or control.

Kenya currently constitutes the second largest producer of pharmaceutical products in Eastern and Southern Africa (COMESA), supplying about 50% of the regional common market.⁵⁵⁸   Kenyan pharmaceutical firms have registered approximately 9000 pharmaceutical products for sale in Kenya.⁵⁵⁹ Given high production costs, however, the Kenyan pharmaceutical sector makes little profit.⁵⁶⁰   Kenyan firms produce few of the raw materials required for producing pharmaceuticals; they import 95% of the raw materials they use.⁵⁶¹  Domestic sources provide only about 5% of the total industrial requirements, mainly maize starch, refined sugar, glucose syrup, rectified spirit ethanol, sodium chloride, packaging materials.⁵⁶² These inexpensive ingredients contribute little to final product cost reduction.

Currently Kenya has sixty manufacturing plants, all of which work separately, failing to take advantage of the potential economies of scale they might achieve by working together.⁵⁶³  Kenya, like other African countries remains largely dependent on India and China for imports of affordable generics and raw materials.⁵⁶⁴  That both of those countries had to comply with patent laws by 2005 became a serious threat to continued import of affordable, essential medicines in Africa⁵⁶⁵ – an important reason for focusing on local pharmaceutical manufacturing.  Nevertheless, many Active Pharmaceutical Ingredients (APIs) required for manufacture of generics remain unavailable.⁵⁶⁶

4.  Whose and what behaviors contribute to Kenya's failure to develop its pharmaceutical manufacturing capacity

Understanding the origin of the sets of problematic behaviors – the institutions – that comprise a social problem constitutes a critical first step in designing a law to help resolve it. When understood, the underlying causes of behaviors can suggest solutions that logically seem likely to alter or eliminate them and induce new, more appropriate behaviors.⁵⁶⁷  This section analyzes the actions of the actors who primarily contribute to the persistent lack of affordable pharmaceuticals in Kenya.
This report suggests that the three relevant sets of actors whose behaviors contribute to the persistent lack of affordable pharmaceuticals in Kenya comprise the Ministry of Health, the Ministry of Education, and the Ministry of Trade and Industry.  This section reviews the way these three sets of actors' problematic behaviors hinder development of Kenya's and the region's essential pharmaceutical industry.

a.  The Kenyan Ministry of Health

The Ministry of Health has responsibility for arranging for the import and distribution of effective, efficient and affordable medicines.⁵⁶⁸  Kenya's reliance on foreign sources makes it difficult to deliver pharmaceuticals in a timely and efficient manner to the entire population, especially rural Kenya.   Procedures for the procurement, storage and distribution of medical supplies in Kenya contain loopholes, which facilitate corrupt practices.⁵⁶⁹ The Ministry of Health and Kenya Medical Supplies Agency (KEMSA) could significantly improve the quality of their service by taking measures to retain students and pharmaceutical personnel to ensure a more effective delivery system.

The Ministry of Health remains partly responsible for the students that study pharmacy, chemistry and medicine in public universities.  The Ministry of Health, together with the Ministry of Education, works to provide sponsorship for these students.   After they graduate, however, the Ministry provides few incentives or dis-incentives to ensure they stay in the country.  

The government sponsors most students in these institutions.   The Ministry of Health has not adequately considered how universities, and especially the medical schools and the pharmacy schools, might engage those students as part of their studies in conducting research as to how Kenyans might produce more raw materials for the manufacture of pharmaceutical.⁵⁷⁰  

At the same time, the Ministry provides neither incentives to encourage physicians, pharmacists and other trained personnel to remain in the country, nor disincentives to deter them from leaving.

Kenya does not yet have an adequate supply of trained pharmacists.  By 2007 Kenya had a total of 283 pharmacists which is way below the required number for sustainability in the pharmaceutical manufacturing industry. Sources of funds for health financing include donors (16.3%), the government of Kenya (GOK) (29.6%), house holds (51.1%), and NGOS (0.6%).⁵⁷¹  Of the total, 40% of this amount goes to training medical personnel.⁵⁷²

The Ministry of Health should put these scarce funds to productive use to make essential pharmaceuticals accessible in a timely, efficacious and affordable fashion across the country. The number of companies engaged in manufacturing and distribution of pharmaceutical products in Kenya continues to expand, driven by the government's efforts to promote local and foreign investment in the sector.⁵⁷³

b. The Kenyan Ministry of Education

An insufficient supply of skilled labor remains a constant in Kenya's manufacturing sector.⁵⁷⁴ The pharmaceutical manufacturing industry, in particular, relies heavily on the availability and quality of skilled university-graduate health professionals.  Unfortunately, Kenya's Ministry of Education has taken insufficient steps to ensure adequate investment of this kind of 'human capital' essential for the production and distribution of affordable pharmaceuticals to meet the needs of the inhabitants of Kenya alone, far less the entire East Africa region.

Kenya's health sector education falls into three fields:   medical education, nutrition and biochemistry, and pharmacy education.⁵⁷⁵  The public education sector includes fourteen governmental medical colleges, two institutes for health and technology; four postgraduate institutes, three specialized institutes and five medical assistant training colleges.⁵⁷⁶  The faculties of Nairobi University, Moi University, JKAUT, Maseno University, as well as private institutions like Baraton University, have all established departments of pharmacology.⁵⁷⁷

In addition, a number of institutions sponsored by the Ministry of Health conduct research in specific areas, such as cancer (National Institute of Cancer Research and Hospital) and cardiovascular disease.⁵⁷⁸ Yet these public sector institutions involved in teaching and delivery of health services seldom collaborate with Kenyan pharmaceutical firms. Almost no universities or public research institutes engage in new product development.   Yet almost all pharmaceutical firms (95.5%) engage in developing their production capacity.⁵⁷⁹  Fewer firms -- of 31% -- participate in process development.⁵⁸⁰   Involvement of university and college staff and students in this research could make a real contribution to that work, and, in the process, learn about how to make it more effective.  Kenya has an advantage because its existing educational institutions' staff already teach many essential skills, and could do more if the Education Ministry could provide essential equipment and more staff.

Unfortunately, however, university education and research in APIs remain grossly under-funded. The Kenyan government spends only US$1.75 million for public sector research, shared amongst universities, NGOs and all other public sector institutions in the entire country.⁵⁸¹   Universities' curricula, laboratory facilities and research budgets remain poorly equipped⁵⁸²  for producing graduates with the chemistry based-skills required for reverse engineer in the pharmaceutical sector.  Lack of adequate funding constitutes a significant cause of the disarticulation the skewed patterns of collaboration between public sector research and pharmaceutical product development. 

No country, of whatever its size and stage of economic development, can ever achieve entirely self sufficient pharmaceutical production.⁵⁸³  Yet, even if Kenya never achieves100% self sufficiency in pharmaceutical and API manufacturing, any movement in that direction will lower the costs of manufacturing and ultimately the price of medicines to all East Africans.  Some developing countries, such as India, China and Brazil, have become net exporters of medicines, while still requiring imports of finished products, intermediates or APIs.⁵⁸⁴  Nevertheless, the Ministry of Education should increase its investment in human capital significantly to strengthen the pharmaceutical manufacturing industry, not only in Kenya, but also throughout the EAC region.  At the same time, the Ministry of Education should implement measures to retain the human and financial resources generated by strengthening Kenya's pharmaceuticals manufacturing sector as an essential foundation for improving the nation's and region's health care system.

(1)  The Ministry of Trade and Industry  

The functions of the Ministry of Trade and Industry (MoTI) include trade development policy, industrial development policy, export promotion via KIRDI (Kenya Industrial Research and Development Institutes), patents policy, and the Kenya Industrial Training Institute.

The ministry does not work with the Ministries of Education or Health to ensure the conduct of sufficient research to support and improve the pharmaceutical industries' current technology to meet the reality of changing disease patterns and their impact the Kenyan population. In addition, the Ministry does not provide incentives, such as technology award schemes, to reward firms' efforts to improve their capacity to improve their output of medicinal products requiring high technology.  As a result, few local manufacturing companies have come into being. Few multinationals Corporations invest in Kenya or elsewhere in the region because, to invest on a larger scale, they require qualified labor, adequate technology, electricity and water at reasonable prices.  These often remain unavailable because the Ministry of Trade and Industry has not worked with other ministries to provide them.   Furthermore, to take advantages of economies of scale, they require access to the entire East African market.⁵⁸⁵

The Ministry of Trade and Industry sponsors some schools, like the Kenya Industrial Property Institute, that provide essential technological training for Kenyan students.   More efforts, however, seem necessary.   Providing adequate funds for research and development of new products, processes and technologies would, in turn, improve linkages between research institutions and industry, and spur competitive technology development and transfer to domestic manufacturers.⁵⁸⁶

Despite a African Union (AU) request,⁵⁸⁷ the Ministry of Trade and Industry's has not worked with Kenyan-based pharmaceutical firms to produce a plan to facilitate increased domestic pharmaceuticals manufacture.  The Ministry's failure to impose a 10% tariff on imported medicines, as recommended by the AU⁵⁸⁸early in 2008 reflects this failure. 

B. Summary and Conclusion

The section above has provided some evidence as to the nature and scope of the problem of the limits on increasing pharmaceutical manufacturing in Kenya and the EAC region.  In particular, it focused on the problematic behaviors of the Ministries of Health, Education, and Trade and Industry contributed to that problem. The next part will explain the causes of those problematic behaviors. Identifying those causes will lay a basis for designing a bill's detailed provisions logically likely to alter or eliminate them, and fostering new behaviors likely to prove effective if implemented and facilitate increased Kenyan and possibly regional manufacturing of medicines.

This Part explores the evidence as to the causes of the problematic behaviors of the three sets of actors – the Ministries of Health, Education, and Trade and Industry –  as a basis for designing and drafting the bill's proposed solution.   As a guide, to ensure consideration of all the possible causes of each set of actors' problematic behaviors, the second problem-solving step recommends using institutionalist legislative theory's ROCCIPI agenda.⁵⁸⁹

A. Why the Ministry of Health has not taken the lead in implementing measures to ensure a sufficient supply of adequately trained professionals to conduct research and provide leadership in building Kenya's pharmaceutical manufacturing capacity:

Rule:   Kenya's health sector policy states that the Ministry of Health will assist Kenyan-based manufacturing firms to produce low-cost essential pharmaceuticals.⁵⁹⁰  The policy, though, does not specify the details of who will do what to make technology, labor, raw materials and other essentials available to meet this goal.

Opportunity and Capacity: The available evidence indicates that Kenya's capacity to produce essential medicine remains limited due to lack of resources, knowledge, expertise and, especially, the 'brain drain' as qualified professionals educated at government expense, leave Kenya to work in developed countries. The manufacturing plants in Kenya only have equipment to manufacture medicines on a small scale.⁵⁹¹  Lack of up-to-date equipment in universities and learning institutions graduates have limited opportunity to acquire the skills required to operate and, if necessary, repair the advanced machines imported from other countries. As a result, plant managers must rely on foreign experts to repair machines that breakdown.

The Ministry of Health offered little leadership in altering the unfavorable working conditions like low wages, insecurity (robbery, road accidents due to poor roads),⁵⁹² and other socio-economic factors,  that caused graduates to migrate to other countries to practice their professions, leaving local manufacturing firms facing severe shortage of labor.  Students interviewed by the Daily Nation, Kenya's leading newspaper, indicated that they decided to migrate after two years of post-graduation joblessness. They claimed they would have preferred to remain and serve in the country.⁵⁹³

Interest :  The Ministry of Health officials may not focus on long-term problems and solutions because of Kenya's overwhelming disease burden.  Their interests may differ from those of the public.   A few have behaved corruptly, making scarce medicines available to the wealthy few without regard to needs of the majority poor.⁵⁹⁴

Process : The MoH remains excluded from important decisions affecting Kenya's Pharmaceutical Industry.   For example, the multinational corporation Glaxo Smith Kline PLC (GSK) agreed to license COSMO Ltd., a Kenyan manufacturing company, to produce generic versions of two of its life prolonging AIDS drugs Zidovudine and Larnivudine, as well as a combination of the two, for sale in Burundi, Kenya, Rwanda, Tanzania and Uganda.⁵⁹⁵ In this decision, Kenya authorities including the MoH apparently complied with Glaxo Smith Klein's with minimal public participation.⁵⁹⁶  Nor did Glaxo Smith Klein solicit public opinion on this initiative.⁵⁹⁷   That process seemed to compromise accountability, overlook the participation of the community and omit creative ideas, which might have led to more sustainability in future as opposed to the ministries personal interest.

On the other hand, the international pharmaceutical companies end up selling the medicines at high prices due to cost of APIs, taxation and transport costs. The manufacturers in Kenya rely on China and India for APIs. As mentioned earlier, Kenya's solution is in manufacturing APIs locally.

The Ministry of Health, through the Pharmacy and Poison Board, administers the profession of pharmacy, and also the manufacture and trade of pharmaceuticals.⁵⁹⁸This administrative process has led to marginalization of NGOs, manufacturers and pharmaceutical professionals. This is partially due to the fact the MoH headquarters sets policies, coordinates the activities of NGOs manages, monitors and evaluates policy formulation and implementation. Because of the centralized and non-inclusive nature of the decision making process at the MoH, many NGOs professionals and others involved in pharmaceutical production are not included in policy formulation.

Ideology:  Publicly, the MoH espouses an ideology of improving all Kenyans' access to affordable, essential medicines.  Its officials' behaviors suggest the possibility that other factors influence their decisions.

B.  Ministry of Trade and Industry

The Ministry of Trade and Industry (MoTI) holds responsibility for supervising the development of the manufacturing sector, including the pharmaceutical industry. Although this remains true in theory, MoTI has great difficulties controlling the activities of Private Firms. For example, the multinational pharmaceutical company Roche agreed to transfer technology to Kenya. It also agreed to provide expertise for factories in Bangladesh, Tanzania and Zimbabwe.  Roche provided these companies' free technical expertise to local companies for the manufacture of generic HIV medicine, based upon the processes to produce Saquinavir,⁵⁹⁹ an antiviral medication.
Viruses remain among the most common and widespread causes of infectious diseases. They cause such illnesses as AIDS, influenza, herpes simplex type. ⁶⁰⁰

Along with the technical expertise, ROCHE brought some sample machinery, which Kenyan manufacturers required. As noble as their efforts appear to be, some authors question whether in fact ROCHE intended this initiative to benefit Kenya, or to sell expertise and market machinery in Kenya and these other countries.  As a more sustainable approach, Kenya might benefit more if its universities' industrial engineering departments taught the necessary expertise and graduating students then helped to utilize and maintain the required equipment in the Kenya's manufacturing plants.⁶⁰¹

Using ROCCIPI categories, the available evidence suggests the following explanatory hypotheses for the MoTI officials' seeming problematic behaviors in failing to support measures to develop and strengthen Kenya's increasingly self-reliant pharmaceuticals industry. 

Rule: The WTO TRIPs council's implementing decision requires implementation of Article 66.2 of the TRIPS agreement (promoting technology transfer), and reporting. The TRIPS council agreement only requires the developed countries to report and hear discussions as well as  receive comments, but does not require technology transfers, or even  suggest who and when should transfer technology. ⁶⁰²

The agreement does not require foreign pharmaceutical manufacturers to  facilitate technology transfer. Instead, they have promoted their own    professionals and equipment at very exploitative costs to convince local  companies that, rather than manufacture locally, Kenyans should purchase finished products from them and concentrate on the tertiary stage, which involves assembling final products. In this way, the developed countries   control the market.

Opportunity: Because there no enforcement mechanism, neither Kenya's MoTI nor  Its equivalent other countries, have to report to anyone.  The companies simply transfer the technology, but not the skills to use or develop it to serve Kenyan requirements.

Communication: MoTI has made little effort to ensure communication between manufacturers and the Kenya industrial Research and Development Institute (KIRDI), or to establish an institutional mechanism to nurture and promote collaborative research.⁶⁰³

Capacity: The Ministry of Trade and Industry in Kenya can provide assistance, training and technology through existing institutions (but more evidence should reveal the extent to which it has done so – and whether it has sufficient expertise in the area of pharmaceutical manufacture).

Interest: As foreign corporations' main motivation, they seek to maximize profit:  They would rather sell technology and expertise than transfer it to other countries to which they sell their final products.  More evidence could help determine whether MoTI officials' have an interest, as well as the necessary resources, to oversee and regulate domestic and international   firms.

C.  Global pharmaceuticals manufacturing firms

Foreign multinationals, foreign generic drug manufacturers and the local    industry all serve the Kenyan and East African markets. As a result of transportation, manufacturing costs and taxes the cost of the final products end up being very high.⁶⁰⁴ Kenya can manufacture pharmaceuticals locally for sale at lower prices.  Current regulations require only that foreign manufacturers register their premises and products with the Kenyan manufacturing Board.⁶⁰⁵

The Board requires that companies label their products in English and Swahili, and contain a batch number, the date of manufacture, the expiry date and the address of the manufacturing facility.⁶⁰⁶ Costs of quality control remain a necessity no matter who manufactures the medicines where.   Establishment of an EAC regional registration system, however, will likely reduce that cost.⁶⁰⁷

Generic manufacturers, largely located in China and India, seem insufficiently and ineffectively regulated to ensure adequate quality control, and sometimes distribute substandard products.⁶⁰⁸

1. Generic Producers (India, China)

Rule:   Required by patent law to comply with restriction on the production of ARV (need evidence re Kenyan government's patent law rules).

Opportunity: Many developing countries depend on Indian generics to support their    treatment scale-up. Treatment advocates warn of a looming ARV⁶⁰⁹ access crisis that could sabotage efforts to control the epidemic if countries like Kenya and other developing nations do not take it upon themselves to foster local manufacturing.

Communication: MoH and MoTI seem to transfer little relevant information to generic producers as to what standards Kenyan rules require generic producers to follow, resulting in the sale of some substandard pharmaceutical products in the Kenyan market.  Nor do they seem to inform the generic producers of the importance of actively engaging in technology transfer to Kenya if they seek to gain access to the Kenyan market.⁶¹⁰

Capacity:  In Asia, the number of people on ARV has grown more than 50% in the last 6 years.⁶¹¹  This rapid scale up will almost inevitably contribute to growing drug resistance and the need for second ARV therapy.   By establishing their own manufacturing capacity, Kenyans could produce more current ARV for the local and possibly the regional market.

Interest:  Generic manufacturers may have an interest in supplying medicines to Kenya, rather than transferring technology and capacity to Kenyan manufacturers.
 
Ideology:  Generic manufacturers tend to prioritize profits over public policy ideologically.

2. Global pharmaceutical companies

Rule: The EAC Treaty gives member state ministries the authority to regulate health issues, consider and pass legislation and work together "towards the prevention and control of communicable and non-communicable diseases and to control pandemics and epidemics."⁶¹²  The Treaty seeks to encourage technology transfer, allowing multinationals to manufacture locally.

Opportunity:  Kenya has a lot of untapped labor, which could work in multinational-owned manufacturing plants, especially if multinationals assisted Kenyan institutions to offer appropriate training.
 
Capacity:  Kenya has limited infrastructure, especially in areas outside of Nairobi, to meet the needs of multinational firms that seek to manufacture medicines in the country.  As a result, multinationals still find it a challenge to invest in the Kenya due to lack of sufficient supplies of water, electricity and trained personnel. In this respect, Kenya has not done enough to implement the EAC Treaty provisions.⁶¹³
  
Communication:  [Author's note: Need more evidence about the nature of communication between government agencies and the multinational pharmaceutical which have invested in Kenya.]

Interests: The multinationals claim to have an interest in increasing productivity and life expectancy of the Kenyan populace; they have set up a plan, and seem to be interested in the sustainability and economic development of the EAC.⁶¹⁴

Ideology:  Historically, EAC member states perceive themselves as competing for multi-national pharmaceutical manufactures investment, and that, despite the new EAC structures, that ideology persists.

3.   Local Manufacturers

Rule: Kenyan law requires local pharmaceuticals manufacturers to carry out many functions and meet many standards, which the manufactures currently do not meet.⁶¹⁵

1. Most of manufactures cite cost.  So perhaps current laws overreach, given resources.
2. The Ministry of Health has not ensured an environment to attract multinationals to invest locally, either alone or in partnership with domestic investors.
3. Current laws do not address key manufacturing issues, resulting in a rift between legislation as drafted and implemented.  For example, Kenya's Trips concessions do provide sufficient guidance to facilitate implementation.

Opportunity & Capacity:  Now, Kenya lacks the qualified human resources, not only to implement any changes required to conform with the law, but also simply to provide labor to work in the manufacturing plants, let alone repair imported machinery. 
  
Neither government nor the firms provide incentives needed to attract either university graduates with expertise in the pharmaceuticals professions to remain and work in Kenya, or those in diaspora to return home.   

Communication:  Neither MoH, MoTI, or the universities communicate with manufacturers or university students and faculty about the potential for engaging in research to improve either technical conditions or social relations in the manufacturing plants.  For example, they might – but apparently do not communicate about research relating to the possibility of increasing pharmaceuticals' potential role in strengthening resistance to malaria.

Ideology:  Local firm managers apparently fail to seek improved manufacture of effective, high quality,  medicines because they remain persuaded consumers cannot afford them.

The analysis of the causes of the problematic behaviors lays a basis in facts for designing the detailed provisions of a bill to help change them.

INTRODUCTION

To address the Kenyan social problem of the lack of affordable pharmaceuticals, the Kenya parliament must enact a law for implementation by  the Ministries of Education,  Trade and Industry and  Health, to ensure  that Kenyan health training institutions, especially those in Kenyan universities, incorporate into their curricula courses and research projects relating to the manufacture of pharmaceuticals: chemistry, industrial engineering, and others necessary for improving pharmaceutical manufacturing industry.
 
These courses should emphasize the potentially strong link between academic training and industrial research.  If Kenyan educational and industrial experts systematically designed and taught courses that engaged students in relevant research projects, their collective efforts combined with those of domestically based manufacturing firms could effectively expand pharmaceutical production in Kenya to meet the needs of all Kenyans – indeed all EAC inhabitants – for affordable, efficient medicines.⁶¹⁶   Beyond that, the Kenyan government should provide incentives to ensure that the graduates of the nation's pharmaceutical training institutions remain in the country after graduation to contribute to ongoing research and manufacture to strengthen the nation's and the region's pharmaceutical manufacturing capacity. This report recommends that students sponsored by the government will not receive graduation certificates until they have worked for two years in the pharmaceutical manufacturing industry for two years or a specified time period assigned upon issuance of government grants.

This research report's proposed bill addresses only one aspect of the difficulties confronted by Kenyans and all East Africans of accessing affordable, effective pharmaceuticals.  The bill's detailed provisions must help to alter or eliminate the causes of the existing sets of problematic behaviors as an essential step for improving EAC inhabitants' access to affordable, effective medicines required to increase their life expectancy.

The recommended bill aims at eliminating the causes of the problematic behaviors of the sets of actors identified in the first two steps of legislative theory's problem-solving methodology.  For this purpose, the bill proposes criteria and procedures to ensure the Ministries of Health and Trade and Industry and the Pharmaceutical Manufacturers effectively implement its detailed provisions.

The bill incorporates a feedback system, which includes monitoring the implementation of the Ministries' joint strategy to assess whether their joint strategy positively transforms each set of actors' behaviors to achieve the desired social impact. This Part IIIsection contains two parts. The first part includes the alternative solutions looking at the case of India and Cuba, which shares some challenges and similarities with Kenya. The section also looks at both countries manufacturing capacity and compares it to Kenya's situation. The second part details the recommended solution and justification supporting the viability of the recommended solution.

A. Alternative Solutions

The alternative solutions here suggested arise from evidence of other countries' experiences from which Kenya and other East African countries may learn from -- even though they may not copy them because their circumstances differ from those in East Africa.   This report explores the consequences of some manufacturing strategies adopted in two quite different countries, India and Cuba, both of which initially faced challenges similar to those in the EAC.   These two countries successfully increased the manufacture of pharmaceuticals at prices affordable to all their inhabitants. Despite those countries' diverse setting Kenya may still learn from aspects of their strategies, and, in turn, minimize her dependency on more industrialized countries for pharmaceuticals and APIs.
    
Although Cuba, India and Kenya remain located on different continents, they share some similarities: Initially, Cuba and India both suffered shortages of skilled labor and capital, weak domestic financial institutions, insufficient foreign direct investment, minimal legal and regulatory systems, and inadequate development of pharmaceutical research capacity.   For a long time, these factors left both dependent on so-called 'developed' countries for supply of essential medicines.   Over time, however, they started to train personnel, acquire equipment and eventually begun to manufacture pharmaceuticals locally.  They began to reap some benefits in the form of job creation, lower costs, and available medicines for their own international use and for export at affordable prices.

1.  India

India's domestic pharmaceutical industry consists of large, foreign-owned multi- national corporations and domestic manufacturers. The foreign-controlled companies typically import most of their bulk drug ingredients, and formulate products for sale in the domestic market.⁶¹⁷  India's large domestic companies, created when several small companies came together to acquire up-to-date equipment, APIs and labor while cutting costs. The larger domestic firms make the largest contribution to India's pharmaceutical manufacturing Industry.⁶¹⁸ India's TRIPs-compliant patent regime, that came into force in 2005, contains clauses that protect local generic firms.  At the same time, it caters to access to medicines in the international market.   Certain Indian firms have already invested in reverse engineering and they continue manufacturing subject to the payment of a reasonable royalty to the patent holder firm. The law does not define reasonable royalty and this will likely cause some litigation.⁶¹⁹  Nevertheless, India continues to manufacture pharmaceuticals.  

Learning from India's experience, Kenya might start its own local pharmaceutical manufacturing industry.  As the main challenge, Kenya must establish structures to provide a framework within which these local pharmaceutical companies can operate.   In India, the Ministries of Health, Education, and Trade and Industry played – and continue to play – an instrumental role the manufacture of pharmaceuticals. The Ministry of Health encouraged a lot of research to expand India's capacity to produce APIs locally. The Ministry of Education focused on equipping local universities with current technology and equipment, and invited professionals from developing countries to teach industrial engineering and also to work with the manufacturing plants to buy current equipment and machinery. India also encouraged small manufacturing plants to join larger ones and cut on costs so as to afford the machinery, ingredients, labor, electricity and water. By following India's example, Kenyans will not have to incur the cost of re-inventing the wheel. They might simply replicate the structures that India has established and use that as a framework of establishing and effective pharmaceutical industry.

2. Case Study:  Cuba

Pre-revolutionary Cuba, like most developing countries, used to import most medicines from abroad, principally from the United States. At the time of the 1959 revolution, Cuba had no domestic pharmaceutical industry.⁶²⁰  In 1972, the Cuban government established Medicuba, a state enterprise charged with importing and exporting pharmaceutical products and medical equipment.⁶²¹   By 1986, Cuba imported only 18% of finished medicine used in the country, still the current rate.⁶²²   By 1987, Cuba imported $34.6 million worth of chemicals largely from market economies and exported approximately $70 million worth of pharmaceutical products, largely to Latin America.⁶²³   Cuba invested the difference in local manufacturing of raw materials.  By 1993, Cuban-based firms manufactured an estimated one thousand one hundred and fifty biologic and diagnostic products, non-prescription drugs, generic products and raw materials.⁶²⁴

The Cuban government backs pharmaceutical production capacity. By the mid-1990s, the pharmaceutical industry's exports earned Cuba some 100 million dollars a year, in addition to producing covering the domestic demand for medicines.  Today, it produces fully 80% of the finished pharmaceutical products used in Cuba.⁶²⁵ In addition, Cuba has been innovative in developing medicines that compete on the international market.   For example, all Cuban children receive, free of charge, a vaccine invented in Cuba to combat meningitis B.   Cuba also sells the vaccine to Argentina, Brazil, Mexico and elsewhere.⁶²⁶ 

Cuba has also ensured sustainable and reasonably priced electricity and water supplies and modern IT, telecommunication and reliable distribution networks. India on the other hand has ensured low taxation to attract external investors. Cuba and India have both concentrated on production of APIs to overcome the challenge of economies of scale.

Cuba remains a relatively small country, with a population of roughly  12 million people⁶²⁷ – barely more than 10 percent of East Africa's, and less than a third of Kenya's⁶²⁸ population. Nevertheless, today, Cuba not only manufactures assured-quality pharmaceuticals for most of its own inhabitants needs, but also exports them to much bigger Latin American countries.

a.    Six key things Kenyans, seeking to manufacture pharmaceuticals, can learn from Cuba's experience:

1. With adequate government support a small developing country can develop the manufacture of pharmaceuticals
2. Government ministries should focus on building 'human capital' – i.e., provide education for its citizens to a level where they can undertake the R & D required to manufacture pharmaceuticals.
3. Government ministries should train pharmaceutical professionals to utilize and develop the modern telecommunication technologies to ensure adequate communications between health care personnel, health care facilities, and pharmaceutical manufacturers.
4. To take advantage of economies of scale, small country-based pharmaceuticals manufacturing firms should work with their governments to make mutually beneficial export-import arrangements with neighboring countries.
5. Government utilities companies should ensure reliable reasonably priced electricity, labor and water supplies.
6. The relevant government agencies should ensure domestic pharmaceutical companies can obtain a sufficient supply of APIs, preferably from national/regional suppliers.

b.    Additional lessons Kenya can learn from Cuba's and India's experience

1. Although both Cuba and India have successfully developed pharmaceuticals manufacturing capacity, their initial steps encountered several challenges.  These included labor issues, lack of feed stocks, lack of trained personnel, the lack of up-to-date equipment and machinery. Kenyans and their neighbors can learn from how Cuba and India dealt with these challenges.   First, they sent their own students to developed countries to acquire education on chemistry, biology, pharmacy and technology. They also invited some professionals from these countries to teach and conduct research in their local universities on the industries requirements for modern technology and manufacturing. They created a conducive environment for the students to return to their home-country after their studies by ensuring they would get adequately paid, skilled jobs.
2. The governments of both India and Cuba have invested a lot of money in research (R&D). Local research to facilitate the local manufacture of APIs enabled India to become the main exporter of APIs' in the Asia and Africa.  Cuba too now relies primarily on its own producers for APIs. This self-reliance minimizes production delays, and cut the costs of final products.
   
   Since 1970, both countries' domestic firms have increased in number and in the new millennium, most have developed sufficient in-house R & D capacity to develop new drug molecules as well as produce bulk drugs.  Indeed, as mentioned earlier, some large Indian companies have become multinationals.⁶²⁹
   
   EAC will need to conduct more research as to how these two countries resolved their problems. Clearly, Kenya and EAC may learn from, but cannot copy, India and Cuba's experiences.

c.    Kenya and its neighbors can boost their local pharmaceutical manufacturing capacity by:

1. Developing more confidence in negotiating for technology transfer and capacity-building to participate directly in R&D.⁶³⁰
2. The success of the Indian Pharmaceutical sector has come mainly from Indian corporations. Governments may encourage smaller firms to work together by
   
   • Providing incentives, for example, by reducing tax
   • rates for merging manufacturing companies; and
   • Sending students abroad to learn in courses relevant to pharmaceutical manufacturing, like technology, chemistry, biology and pharmacology.
3. Creating an environment conducive to persuading professionals to return home, and to retain professionally trained graduates in the country.
4. Funding research proves a key prerequisite.
5. Lastly, Kenya and its neighbors have many educational institutions to which their governments can provide funding, up-to-date equipment, and other incentives to encourage them to engage students and faculty in ongoing research to ensure their manufacturing firms produce up-to-date, affordable medicines.

B.    Recommended Legislative Solution: a possible draft bill, as part of a larger legislative program

1.    Raw materials

Kenya and its neighbors should work together to develop the capacity to manufacture raw materials locally. Currently only Kenya manufactures only 5% of the raw materials its firms require, and must import the rest at a very high expense.⁶³¹ This report directs the Ministry of Health to work with the public university students especially in the pharmacy and medical school to conduct research as to how Kenya can manufacture its own raw materials for pharmaceuticals.  

The recommended bill directs the Ministry of Health to ensure that medical and pharmacy students remain in Kenya to ensure the government and all Kenyans realize a return on their investment in their education.
     
2.    Explanation of chart 8-1

As implementing agency, the Ministry of Health will choose a Committee, consisting of professionals practicing in fields like industrial engineering, chemistry, pharmacology, biology and medicine, as well as others still in school studying in those fields.  The committee must produce a strategy for dealing with the challenges described above, focusing in particular on reducing the existing 'brain drain'.

Student representation on the committee will undertake to discover why students do not participate in research and also why they want to leave Kenya upon graduation to practice in other countries, what incentives might motivate them to serve their country.  

The Committee will produce a budget to finance research in Kenya's universities and training institutions to facilitate Kenyan production of equipment necessary for manufacturing effective medicines.

The committee must provide a time frame that specifies who will do what, when and how to ensure the implementation of its proposed strategy.

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Chart 1 (Musyimi to provide this)

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The law that this report proposes will, if implemented, help to provide the 'human capital' essential to boost the production of ingredients in Kenya from the current 5% to at least about 70% in the next two decades.⁶³²  The bill encourages research, performed by institutions such as the universities, KEMRI and AMREF, on production of pharmaceuticals and APIs.  

The bill's detailed provisions will help to strengthen Kenya's human capacity to overcome other obstacles to pharmaceuticals manufacture in Kenya, including sustainable financing, compliance with GMP, GDP, GCP and GLC standards, sound regulatory systems, availability of appropriate human resources, reliable sources of electricity and water, technical feasibility and a viable market size.⁶³³  The drafters of the bill's detailed provisions must make every effort to reduce the danger of corruption.⁶³⁴ 

Many other social problems emerge which EAC and its member states will have to tackle by drafting legislation. For example, pricing policies linked to market size will also have an impact on the pace and expansion of pharmaceuticals in Kenya and the other EAC member states.  Another bill might lower member states' taxation rates to attract external investors. Yet another could focus on increasing production of APIs.   The list of legislation goes on – and on!

Self-evidently, as the 2007 EAC Summit concluded, no one bill can resolve the many institutional difficulties characteristic of a complex problem like that posed by Kenya's, and the EAC region's difficulties in providing affordable, effective pharmaceuticals for all East Africans.   For that reason, the Summit called for the establishment of an EAC Commission to draft a series of bills – essentially a legislative health program.⁶³⁵

3.  Cost and Benefits of this proposed bill

The benefits of implementing the recommended legislative solution outweigh the costs. Initially the cost might seem relatively high and input minimal since purchase of equipment, research and training personnel will take sometime. However, in the long term the benefits will outweigh the cost in that the trained personnel will serve the country for a long time and train others too. The machinery and equipment will provided for training purposes will function for a long time. The findings of the research should cut the nation's social costs by ensuring treatment of a particular disease with the correct dose and medicine.

To implement the recommended solution the Ministry of Health has to allocate funds for the training of personnel, research, raw materials and equipment required for manufacturing. The Ministry of Health can either allocate funds from the MoH general budget or request special funding from foreign donor agencies or the WHO. The MoH will incur expenses at the initial stages of the process. These expenses, however, prove trivial when compared to the money Kenyans spend on the import of raw materials, expertise, equipment and technologies required to transform raw materials to medicines – costs that make effective medicines too expensive for impoverished Kenyans, especially out in remote rural areas, to think of buying.⁶³⁶

4.  Monitoring and Evaluation

The bill here recommended, first, would help to ensure availability of current data indicating the results of effects of how importing pharmaceuticals has been ineffective in the country and the high costs of that process.  Some of the professionals trained, as required by the law after its enactment, should conduct ongoing research to assess the annual change in those costs because of the bill's proposed strategy.  The MoH Committee will provide a comparison of the relevant data collected annually, and submit a report to the relevant Kenyan legislative committee, as well as publish it in the media.  This will enable concerned citizens, non-government organizations, and patients affected the current high costs medicines to participate in monitoring and evaluating the implementation of the bill and its social impact.

The manufacturing plants, patients, Universities and professionals in the field will gather additional information and ideas through questionnaires. The rural communities through focus groups will have an opportunity to assess the impact of the bill's implementation.   The MoH Committee will initially specify additional criteria and procedures for the ongoing annual assessment, subject to revision in the course of the monitoring/evaluation process.   Those participating in the evaluation should take seriously the likely necessity to revise the law to ensure more effective implementation and the desired social consequences for all Kenyans, especially the poorest and most vulnerable.
 

Once Kenyans achieve the capability to manufacture pharmaceutical ingredients, then they will have the capacity to produce medicines and other pharmaceuticals locally and in the region with the ultimate goal of reducing their costs. Whatever Kenya does to improve its citizens' access to medicines and health services, it should do so in cooperation with other member states because ultimately regional manufacturing will be a more sustainable approach.

THE DRAFT BILL:⁶³⁷

Be it enacted by the Kenyan parliament and by the authority of the same as follows:

SECTION 1:

Definitions:

1. a) The minister means the Minister of Health
2. b) The committee means the committee on the manufacturing of pharmaceuticals
3. c)  The commissioner means the chairperson of the committee
4. d) Plan of action -the committee will come up with a plan of action.

SECTION 2:

Purpose:

This Bill ensures empowering of the manufacturing of pharmaceuticals in Kenya by production of raw materials, curbing brain drain by providing incentives like a good start off salary, housing or other benefits like health insurance to new graduates. The bill also considers disincentives like ensuring degree certificates are awarded two or more years after school completion for the students trained at government's expense in the pharmaceutical related fields. This will enable them to serve in the local manufacturing industry. The other is providing technology that will make research possible and the funding to facilitate the process.

SECTION 3:

1. RESEARCH ON PRODUCTION OF RAW MATERIALS: THE MINISTRY OF HEALTH ADVISORY COMMITTEE

3a) The Minister of Health shall appoint a Committee composed of faculty members chosen from the nation's Universities, other relevant educational institutions and a representative from the Ministry of Health, the Ministry of Trade and Industry and the Ministry of Education together with experts working in pharmaceutical-related professions to formulate a strategy to resolve the obstacles to developing Kenya's capacity to conduct research, reduce the current 'brain drain' of trained medical and scientific personnel, and produce essential raw materials and the technology required to manufacture affordable medicines in Kenya and East Africa.

3b) The Kenyan Minister of Health shall supervise this committee.

11. QUALIFICATIONS OF COMMITTEE MEMBERS

a) The Minister shall appoint members of the committee as follows:

• 2 student representatives, 2 professional representatives, a commissioner who will be appointed by the Minister of Health to run the committee a representative from the manufacturing firms
• The committee members shall be chosen from the schools and the pharmaceutical manufacturing plants.
• More than 10 years of experience in the field of pharmaceutical manufacturing will be required, however, the students will not require any experience.
• The professionals must hold a masters degree or higher in pharmaceutical related fields.

III.  PROCESS OF APPOINTMENT

a)  The Minister of Health shall:

• Solicit names of nominees from directors of pharmaceutical manufacturing firms and the deans of selected Universities and Institutions.
• Require students' inputs to come up with sustainable solutions of curbing brain drain and incentives to encourage more students to engage in research and development to strengthen Kenya's pharmaceutical manufacturing industry.
• Appoint practicing professionals for 3 years and pay them in accordance to their time and skills input.
• Terminate committee members for causes such as  missing meetings for more than five times a year and a lack on interest which will be measured by whether they complete assigned duties or not. This will be done after two verbal warnings have been issued  and one written warning 

IV. DUTIES AND RESPONSIBILITIES.

The committee shall:

1. Review the manufacturing system in Kenya.
2. Collect data from the residential treatment facilities indicating:
   
   • The number of Kenyans able to afford medicines and other pharmaceuticals prescribed by health practitioners.
   • The average period of waiting for medicines in rural Kenya.
   • Number of medics that practice in other countries and factors that they site cause them to migrate.
   • Mortalities caused by lack of medicines.
   • Machinery and equipment in manufacturing plants.
   • Number of trained personnel on the use of imported equipment and machinery.
   • Can they be locally repaired or does Kenya have to rely on expatriates' for repairs.
   • Does the school system have in its curriculum courses that will lead to sustainability of these manufacturing plants?
   • The total average costs spend on manufacturing of pharmaceuticals locally as compared to importing.
3. Collect data from the manufacturing companies, institutions and see the impact of importing raw materials, lack of personnel, and brain drain on the cost of pharmaceuticals and then look at the impact on the economy.
4. Devise the guideline plan after gathering this Information, the committee members shall vote all issues, with each committee member holding a single vote.

V.  Implementing the planned strategy guide lines

1. The Minister of Health shall review the guideline plan
2. The ministry shall have the discretion of implementing the recommended guideline plan as is or make suggestions to the committee, which the ministry deems would improve the guide line plan.
3. The institutions shall consider the suggestions as provided in the subsection
4. The Ministry of Health shall ensure that the guideline plan is implemented in all manufacturing plants, institutions.

VI. Enforcing compliance

1. To ensure that University students do not leave Kenya to practice in other countries, that manufacturing plants maintain high standards, and that Kenyan firms manufacture enough supply of pharmaceuticals, the Ministry of Health will work with the poison control board and KEMSA which is the pharmaceutical purchasing body of Kenya to:
   
   • Names of enrolled pharmaceutical students at the public  universities
   • Their graduation dates
   • Their  post graduation plan ( what research they intend to contact upon graduation and for how long and how much it will cost)
   • Records of sponsored research and whether they have been used in manufacturing plant.
   • There degree certificates will be kept by the MoH and handed after completion of the assigned period of service.
   • The students will also be assured of keeping the jobs they have been doing for the two years and a salary increment as an incentive for compliance.
2. Visit manufacturing plants unannounced.
3. Have full access to records pertaining to:
4. Seek explanation for
   
   • Research that has not been implemented by manufacturing plants
   • Students who have been sponsored by the government and have gone to other countries to practice and
   • Manufacturing plants that are falling short of guideline plan principles
5. Gather all other facts to ascertain whether there has been adherence to the guideline plan.
6. Report violations of the guideline plan to the Ministry of Health.

V11.  Sanctions for non- compliance

1. Institutions that are not participating in the research to manufacture raw materials as mandated by the plan of action shall loose their license to manufacture pharmaceuticals and support from the government. They shall also be highly taxed.
2. As they join schools' students' shall be required to sign documents before they get funding that:
   
   • They will participate in research that will assist Kenya to manufacture  raw materials for two years a
   • That their degree certificates will not be awarded to them until this period is over
   • That upon completion they will provide their services to ensure, that Kenya manufactures pharmaceuticals locally.
   • That if they travel to other countries to practice  they will be required to pay off the money that the government invested in training them otherwise a record will be kept so that when they return their licenses  will not be valid until they fulfill their obligation.

VIII.   Appeal process

1. Reconsideration
   
   • Manufacturing plants that are not adhering to the plan of action or graduates who are not compliant with the requirements which led to their being sponsored shall be required by the government through the Ministry of Health to submit within ten days a written request for reconsideration.
   • The commissioner shall notify the director(s) of the manufacturing plant  or student(s) right to appeal the decision by the Ministry of Health
2. Final Appeal
3. The committee shall discuss the written request for reconsideration by the sanctioned manufacturing plant or institution or student during the final appeal
4. The Ministry of Health will vote a decision to the appeal with the majority vote indicating the final decision of the appeal process.

IX.   Evaluating the Implemented Guideline plan

1. The Ministry of Health will require the institutions to collect data on how many students graduate with required skills for manufacturing pharmaceuticals locally.
2. The ministries shall then evaluate the results of the data in comparison with the initial committees' data
3. The ministry shall require the committee to make the changes within thirty days to the guideline plan, addressing the detected negative results from the evaluation data.
4. The ministry shall implement the changes in accordance with the agreements that the committee members come up with.
5. The ministry shall perform the evaluation procedures spelled in the subsection after every six months for the previous six months.

COPY OF THE AMENDED LAW:
KENYA GENERAL LAWS

Local manufacturing of pharmaceuticals in Kenya

The department shall ensure that manufacturing plants, universities and institutions participate in ensuring production of raw materials in Kenya. It shall also ensure that brain drain is curbed by providing incentives and disincentives. Funding towards research related to pharmaceutical manufacturing will be solicited and availed to the relevant personnel.
Each part shall be incorporated to ensure that strengthening of the manufacturing of pharmaceuticals in Kenya and access of medicine to both the poor and the rich the rural and urban communities is achieved. This shall initiative shall benefit the entire nation and neighboring nations that import pharmaceuticals from Kenya.

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