Meeting on
Access to Essential Drugs in Kenya
31 August 1999, Nairobi Kenya
Organised by Dr. Christopher Ouma and Dr. Eva Ombaka
Sponsored by Health Action International-Africa and Medécins sans Frontières
Report prepared by Beryl Leach, Health Action International-Africa
30 September 1999
Table of Contents
The meeting in Nairobi on access to essential drugs was organised to follow up on an international meeting on access to essential drugs and compulsory licensing, held at the end of March in Geneva. Dr. Eva Ombaka and Dr. Christopher Ouma attended that meeting, which was organised by Health Action International (HAI), Médecins sans Frontières (MSF), and Consumer Project on Technology (CPT). They returned to Kenya committed to exploring access and trade issues in the Kenya context and to organising follow up activities at the national level that could raise awareness and help improve access to essential and affordable medicines.
They organised a small working group that produced A Concept Paper on Lack of Access to Essential Drugs and Action Areas for Concerned NGOs. This paper was the basis for generating interest in a larger organising meeting.
On 31 August, 23 healthcare providers, ministry officials and representatives from nongovernmental organisations (NGOs) and church-related groups came together to discuss key issues and problems affecting access to essential medicines and to plan activities to address them. All of the participants were interested in learning more about the issues, sharing information about what is being done and identifying practical next steps. As Liesbeth Aelbrecht (MSF) summarised, Access to medicines is an issue that affects everyone and which everyone can understand.
2. Improving Access: Needs and Possible Options for African Countries
Dr. Eva Ombaka (Pharmaceutical Programme of the Word Council of Churches/Community Initiative Support Services) pointed out the need to look at the emergence of new diseases in Africa, as well as the growing problem of existing ones, such as TB and malaria. The main problems are increasing resistance to current drug treatments and a lack of sufficient research underway to develop new drugs. Any new drugs that do eventually come to market will be patent protected. These patents will guarantee monopoly high prices for those drugs for 20 years.
TB and malaria kill millions in Africa every year. Nearly 28 million women, men and children are infected with HIV in Africa. Hundreds of thousands of them develop AIDS and die each year. HIV/AIDS and its related illnesses are creating health crises more and more African countries.
To respond to these public health emergencies, governments should be able to issue compulsory licenses to allow the local production (which is usually much less expensive) of these patented drugs. But first, each country must have enabling legislation. However, even countries that have laws that comply with World Trade Organisation (WTO) rules have been subject to intense pressure.
In Thailand, the US government threatened to slash US commitments to the Thai government if they insisted on allowing compulsory licensing. In the end, the Thai government backed down. The United States continues to pressure the South African government to repeal legislation that would give it the power to grant compulsory licenses and parallel import drugs that are needed to treat its health emergencies. Behind these political, bilateral pressures are pharmaceutical industry pressure groups.
But access is not just an issue of trade agreements or patent laws. Access is also determined by poverty, the state of healthcare systems, local market structures and other such local conditions.
It is also important to remember that the problem concerns access to all essential medicines that are needed to treat major health problems in Africa. While HIV/AIDS and the high cost of antiretroviral treatments are a clear example, the problem extends to a whole range of illnesses, for example, TB, malaria, sleeping sickness and river blindness.
3. MSF Access to Essential Drugs Project
Dr. Christopher Ouma (MSF-Belgium) gave an overview of the current MSF project on access to essential drugs. This is an international campaign that will be carried out in the next three years. The project has three main objectives: (1) stimulate research and development (R&D) for tropical and other neglected diseases; (2) overcome barriers to improving access to treatment of target diseases; and (3) humanise the WTO and the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement.
Dr. Ouma provided an overview of the economy and burden of disease: highest income industrialised countries (the United States, European Union and Japan) have the lowest rate of communicable diseases (6 percent); lowest income countries have highest rate (54 percent). Infant mortality rates in industrialised countries are seven per 1,000 for children under five years of age. Mortality for children under five years of age is 178 per 1,000 in Sub-Saharan Africa.
The leading cause of death globally is pneumonia, but HIV/AIDS is the leading cause from a single pathogen (pneumonia has multiple pathogens). HIV has infected an estimated 33.4 million persons world-wide, 83 percent of which live in Africa. Rates are declining world-wide, except in Africa and parts of Asia.
In order of efficacy, the following are the best uses of limited resources to prevent disease:
1. Prevention through education,
2. Vaccines,
3. Good nutrition and hygiene, and
4. Curative care: access to basic health care; access to affordable drugs.
Drug Development
It takes a long time to bring a drug to market, and it is expensive. Quality assurance, distribution and the approval and registration process all affect access. In the United States, much drug discovery is done by the government and then private companies are licensed to do clinical trials, patent and market the drug. Thirty percent of drugs developed in the United States were discovered and developed by the government or their discovery and development depended on government financing. In such cases, pharmaceutical companies are lying when they then claim the need to charge high prices to recover high R&D costs.
Tropical diseases, those which primarily affect Africans, are not a priority for R&D because Africans cannot afford to pay the prices the companies want to charge. In 1995, of 95,417 therapy-relevant publications, only 182 concerned tropical diseases. Between 1975 and 1997, only 3 percent of new drugs were for the treatment of tropical diseases. Global pharmaceutical sales (projected for 2002) will be $406 billion. Of this, North America will account for 41 percent of sales; Europe 25; Japan 11; Latin America 7;Asia 7; Central and Eastern Europe and the former Soviet Union 3; and Africa only 1 percent.
Pricing
Drug prices are set according to market conditions and ability to pay; they are not based on costs. Once an existing drug is found to be effective in treating an important illness, e.g., HIV, or HIV-related conditions, the price goes up. One example is Fluconozole. Prices also fluctuate widely in different countries and regions. Sometimes, manufacturers will withdraw drugs from the market because they are not profitable enough, for example, the treatment for sleeping sickness.
Cryptococcal meningitis and TB are two leading killers at Mbagathi Hospital in Nairobi. In Thailand, cryptococcal meningitis affects 15 to 20 percent of the population. The two drugs available to treat it must be taken for life. Fluconozole treatment is $2,500 per year in Thailand and $5,362 per year in Kenya. The generic version produced in Thailand is $320 per year.
In Kenya, the cost of treating multi-drug resistant TB treatment is $12,000.
Kenya does not have an effective program for HIV-positive pregnant mothers, even if AZT short courses were available.
Antiretroviral treatment is approximately $10,000/yr and requires a stable health care delivery system and counselling
4. Factors that Affect Access in Kenya
Beatrice Kereka (MSF Logistics Centre, Nairobi) summarised the key factors that affect access to medicines in Kenya:
5. Perspectives from People Living with HIV/AIDS
Simeon Opiyo is a counsellor at the DACASA counselling centre, a community-based AIDS support centre located in Dandora. He got involved in the HIV/AIDS issue because his wife of 8 months died from AIDS. He is HIV positive.
Opiyo, who has been counselling since 1991, believes that Africans need to learn to talk about sex. At the community centre, they train people to talk about sex and then go out and talk to groups in the communities. There is still a stigma about AIDS groups, so they stress community aspects. It is important to have strategies when talking about and living with HIV/AIDS. It is also important to see HIV-positive people as human beings and as members of the community. They are not seen as or called victims.
According to Opiyo, it is very difficult for HIV-positive people to live positively if they do not have a family. He is now married to a woman who is HIV-positive, and they have two children. One child is HIV positive; they have not told her about her condition.
The high cost of being HIV-positive is part of Opiyo's daily life. People with HIV should eat well, which is expensive. HIV positive people get more opportunistic infections. He has had pneumonia more than 15 times. His illness in March cost more than 42,000 Ksh ($560). He had to sell his fridge and three cows to meet the bill. A month later, he was ill again and the bill was 41,000 Ksh ($546). He had to sell his VCR and TV. He is currently being treated for his second bout of TB.
A great need exists for HIV-positive people to have access to affordable drugs and technology. For example, one test for viral load is 8,000 Ksh ($107). Dr. Ouma noted that costs in the United States are covered by insurance or company donations. Donations help maintain prices. It is the US pricing that is basis for Kenya pricing.
Oyipo encourages people to accept their situation and live. HIV can be managed. He noted that malaria can kill faster. He also counsels people to remember that they are the government, and that it is up to them to push for what they need.
6. Gender Perspectives on Access to Essential Medicines
Milly Odongo is an attorney at the International Federation of Women Lawyers (FIDA). In Kenya, they are known as the Kenya Federation of Women Lawyers. FIDA works on women’s and children’s rights issues.
Following on from Opiyo’s presentation about living with HIV, Odongo pointed out that the situation for HIV-positive women is always worse than for HIV-positive men. Women are always poorer. Kenyan girls are less educated. Women earn less money. Therefore, they are worse off economically, even less able to pay for drugs than men.
Women are victims of myth that a cure for HIV is to have sex with a virgin. This is causing a rise in HIV transmission rates in young girls. Rape rates are rising, and this is another transmission problem area. Most women cannot afford the post-rape treatment protocol.
Discussion
Peter Okaalet (MAP International) pointed out that everyone was talking about poverty. He noted the need to develop a mission statement before deciding strategies. It is important to remember that the issue is about people. Before talking about training, education and technologies, it is necessary to identify activists who have vision and who are working morning, noon and night on issues. When these people then rise in positions, they will start to make a difference in policy making. The Bible says that without a vision, people perish. Therefore to combat poverty, it is necessary to find visionary personnel then to develop policies and take action. The problem is not making policy. The problem is in translating it into action.
Liesbeth Aelbrecht (MSF) countered Okaalet’s point in stating that the issue was not poverty. It was injustice: the unequal distribution of resources and exclusion at a major scale.
Lillian Gitau (HAI Africa) was concerned about inaccessibility and especially the treatment of opportunistic infections. She was worried about availability of drugs for sexually transmitted infections (STIs) and antiretroviral drugs. Most available drugs are not relevant (through the former ODA now World Bank program). Augmentin is widely available.
She wondered if Simeon had the necessary information to get the appropriate drugs? What was the channel of communication for these drugs? How can people find out about them? MEDS, a church-related drug supplier in Nairobi, has problems distributing those drugs because of policies developed governing distribution.
Dr. Ouma told of a time when he went to a pharmacy supply store at a hospital and found plenty of drugs. Supply managers do not communicate to pharmacists, who then do not communicate with doctors.
Dr. N.A. Kimathi (Kenya National Drug Policy and Implementation Programme) observed that Kenya needs to set priorities correctly at the national level. The national AIDS and sexually transmitted infections programs compile drug requirements for STI drugs and forward them to the Ministry of Health for procurement. Drugs are prepared in kits. However, problems exist in the provision of drugs, and hospital personnel need training. Program people are supposed to check to see what drugs are being distributed. If drugs are not moving quickly, they are supposed to be sent back and redistributed. Pharmacy and therapeutics committees are supposed to exist and be the forum for communicating about drug supply and distribution. It is a management problem within health facilities. He advocates setting up pharmacy and therapeutics committees wherever they do not exist.
7. Kenya National Drug Policy and Implementation Programme (KNPIP)
Dr. Kimathi provided an overview of Kenyan drug policies and current activities related to the implementation of the national drug policy and essential drug list.
The Kenya National Drug Policy (NDP) was issued in 1994. It has 14 main components. Its main purpose is to ensure the constant availability of safe, affordable drugs.
The KNPIP is currently engaged in 10 major activities to implement the NDP:
The KNPIP is assisting the ministry in revising the essential drugs list (EDL). They work with all healthcare providers in the country. They have distributed the National Clinical Guidelines to them for review and comment. The biggest problem with the guidelines is in areas of rapid change in treatment protocols, such as HIV, TB and malaria. They distribute information from World Health Organisation (WHO).
He noted that the costs or TB and HIV drugs are not included in factoring the costs of drugs on the EDL, as they are factored separately. The Kenya EDL costs, excluding HIV, TB and malaria, are approximately $1-2 per person. The Kenya EDL was included as an appendix in the clinical guidelines in 1994.
Discussion
H. Dave (Philips Pharmaceuticals) noted that the Pharmacy and Poisons Board requires the manufacture date in addition to expiry date. However, the certificate shows the manufacturing date. The manufacture date requirement is very costly to meet and it discourages generics production.
Sam Ochieng (Consumer Information Network) wondered how well the Kenya NDP has worked since implementation. The Drug Information Centre exists in the Pharmacy and Poisons Board, but he did not know its status or whether or not it was open to the public.
Based on this presentation and discussion, some issues were identified: the need to change the manufacture date requirement; the need for consumer involvement in the government’s review of drug laws; consumer involvement in the development of the consumer awareness program at the ministry; need to clarify the role and accessibility of the Drug Information Centre; and the need to find ways to monitor implementation of the NDP.
Milly Odongo provided a short overview of the laws and regulations concerning pharmaceuticals. She began by noting that basic health is an explicit fundamental right in the constitution.
Pharmaceuticals are governed by multiple laws. Kenya has a public health act, which outlines what the government can do to address public health problems. The Pharmacy Act confers the right to declare an epidemic. The Pharmacy and Poisons Board Act establishes the board. It also handles promotion etc. of any type of drug. Breaking board rules is illegal.
The Industrial Properties Act of 1989 is being updated to take TRIPS into account. The existing one has a long section on patents. A patent can be registered for 6 years. The patent term is currently 7 years. This will have to be changed to meet the TRIPS requirement of 20 years. Compulsory licensing is permitted in current law, however, it appears to be triggered by the failure to work a patent (i.e., if patent not worked for 3 years after initial approval, the government can allow compulsory licensing). But, TRIPS does not require local working of the patent. Companies will be able to register the drug and import it.
Analysis of national laws are important. Notably, the mere signing of a treaty or convention does not bring it into force. It must be promulgated in national law. Therefore, joining the WTO requires Kenya to change existing laws or enact new laws to make sure that trade laws are compliant with WTO rules.
Gichinga Ndirangu (ActionAid Kenya) pointed out that the parliamentary committee members reviewing the Industrial Property Bill were not even aware of the issues. A priority need is to educate them about patents and the impacts of TRIPS.
Odongo pointed out that not many Kenyan lawyers are working on pharmaceutical patents.
Ochieng pointed out that United Nations guidelines on consumer protection contain a lot on drugs.
9. Commercial Perspectives: Kenya Generics Industry
Drugs are manufactured in Kenya. Therefore, compulsory licensing might be a useful strategy. However, H. Dave pointed out that local manufacturing may not mean that capacity exists to produce complicated drugs. In fact, such capacity is limited in Kenya.
The generics industry has a problem because duties are paid on raw materials, but no duties are charged on finished products.
According to T.S. Ramu (Lord’s Healthcare Ltd.), the 20-year patent life is too long. R&D costs are normally recovered in 2 to 3 years. He added that there is patent protection for all molecules.
Dr. Mike Momanyi, also from Lord’s, explained that, while consumers are given the choice between branded or generic drugs at the pharmacy, generics are shunned because of innovator promotion claims that branded drugs work better than generics.
The current registration system is very complicated and takes a long time. It is set up so that even slight changes, e.g., change in pill dose, is treated as new drug.
Dr. Kimathi of KNPIP noted two problems that limit generics use: (1) consumers want value for their doctor’s fees, and they see that value as getting a prescription, which should be "worth" something; and (2) some doctors write the brand name, which means there can be no substitution.
Kenya does not have any restrictions on generics registration prior to the end of a patent. Companies are also allowed to produce and stockpile generic forms of drugs in anticipation of the end of a patent.
10. ActionAid Campaign on the WTO and TRIPS
Gichinga Ndirangu (ActionAid Kenya) explained the extensive work ActionAid is undertaking concerning the WTO and the TRIPS agreement. ActionAid is interested in drugs because of its work on biodiversity, for example, 90 percent of biodiversity is in the global South and 50 percent of drugs are being developed from plants. Their main focus is the impact of TRIPS on farming communities.
According to Ndirangu, it is good to look at whole political context. The WTO will address patents at the next ministerial. TRIPS is another form of neo-colonialism. Even the United Nations Development Program has called for a review of TRIPS and has pointed out that trade agreements and trade liberalisation have had a negative impact on access to essential medicines. The amount of money being spent on cancer research is 250 percent more than on malaria research. It is clear that research is driven by profit, not public interest.
The ActionAid campaign is going on in 13 countries. In Kenya, they have been informing the public about TRIPS and trying to scale up discussions at the national level. They have tried to identify priority concerns:
Ndirangu identified three national issues:
ActionAid is involved in a range of activities to increase awareness about trade issues:
11. Discussion on Globalisation and the WTO
According to a colleague of Tom Maliti, journalist with Executive magazine, "Globalisation is the globalisation of unfettered capitalism."
Seventy percent of WTO members are from developing countries. However, they have very little actual power for three reasons:
The WTO is now the most powerful multilateral organisation because it has the legal mandate to impose sanctions on member countries for non-compliance with WTO rules. The consensus framework of the WTO is also a significant and ominous shift away from the UN system of countries enjoying equal voting rights.
According to Ndirangu, "International advocacy is the sum total of national advocacy." NGOs must take on the WTO and ensure that it is reformed to serve Southern needs. One possible change would be to revise TRIPS to rescind patents on products. Another is to insist on a complete review of implementation before any new negotiations are opened. Finally, Southern members must receive the training and resources necessary to be able to negotiate trade agreements competently and be on equal footing with wealthier WTO members.
UN agencies are limited in the impact they can have on the WTO. For example, the WHO is kept weak and marginalised in part because the United States refuses to pay its dues.
Poorer countries, such as most African countries, do not have the expertise, staffing or resources to participate effectively in international trade negotiations and forums. For example, at the Marrakesh meeting in 1994 that created the WTO, the US delegation had its usual team of expert trade negotiators and an entourage of 200 business men; Japan had its expert government delegation and 300 businessmen. Kenya sent three trade representatives. When the head of the delegation returned home, he asked the Kenyan attorney general to explain to him what he had just signed.
At the end of this discussion on the WTO, Dr. Momanyi spoke up and said, "It makes us feel so helpless. I hope that we can come up with something that makes me feel better."
The problems affecting access to essential medicines must be seen in the context that produces it: poverty and injustice. In Africa, that reality is further complicated by the crushing external debt owed by many countries. Every month, in Kenya and other countries operating in accordance with agreements with the International Monetary Fund (IMF) and World Bank, governments must make payments on this debt first: before financing, health, education, roadworks or any other public need. In Kenya, 30 percent of revenues service its external debt.
Meeting participants identified key issues that affect access to essential medicines in Kenya. They are outlined below, in no particular order of priority:
Cost of drugs (pricing). This is unambiguously a leading problem. Global surveys of retail pricing have consistently shown that "the poor pay more." Pharmaceutical companies set prices according to what the market will bear. Prices in African countries are often far higher than in developed countries, which have fully developed, competitive markets. Prices are also higher in Kenya than in countries where the same drugs are available without patent protection.
The exorbitant costs of antiretroviral cocktails for the treatment of HIV/AIDS have brought this long-known problem into stark relief. Effective HIV/AIDS drug treatments that are available in developed countries and that are paid for by insurance companies or donations programmes, are far beyond the reach of most Africans.
Lack of consumer awareness. Consumers are not aware of the issues and facts surrounding access to essential medicines. They do not know enough about essential drugs concepts or about generics. Consumers are duped by industry promotion of their products. This promotion is often misleading and incomplete. Sales representatives for patented drugs spend a lot of time convincing doctors and consumers that generics drugs are somehow inferior to their more expensive branded drugs--a lie that exploits people’s fears.
The Kenya Drug Information Centre has important information, but it did not appear to be very accessible. As a government office, the policy concerning public access is not clear.
Capacity/power to lobby—NGOs. NGOs need to increase their capacity to lobby effectively on access issues.
Capacity/power of African WTO delegations to understand and participate in the work of the WTO. As the WTO approaches its fifth anniversary, which will the time for a built-in review of certain agreements, more and more African and other developing countries are voicing their concerns about the impacts of the trade agreements they signed in 1994. The Kenyan delegation did not adequately understand the convention and agreements that established the WTO in 1995. As the WTO prepares to consider the built-in agenda, and more ominously, a new round of negotiations (the "Millennium Round"), African countries rightfully fear that they will not be in a position to negotiate responsibly in their country’s best interests.
Poverty and social injustice. Lack of access to essential medicines stems from these linked causes.
Problems concerning drug selection.
Drug supply system. Drug management of available supply is not adequate. Many persons involved in drug supply had stories concerning the lack of training and lack of communication between drug store managers and pharmacists and pharmacists and doctors. Access is reduced when poor management results in drugs not being on hand when needed and drugs expiring before they can be used.
Problems translating policies into practice. Policies are useless unless the means and political will exist to ensure they are implemented effectively. Kenya has a national drug policy, but lack of money and of trained staff and poor co-ordination and management of the healthcare system have hindered implementation. Translation into practice requires that consumers, prescribers and dispensers be involved. It is also important to monitor policy implementation and make sure that information and lessons learned are fed back into the implementation process.
Lack of political will. If politicians and legislators lack the will to safeguard the public’s health, it leaves ministries and others, however well meaning, without much of a foundation for tackling problems successfully. Notably, Kenya has legislation that would allow a minister to declare a national health emergency—by simple decree. Declaring HIV/AIDS a national health emergency would allow the government more options in how it might try and provide medicines more affordably. For example, invoking a health emergency would provide the legal rationale for authorising the issuance of compulsory licensing to for the local production (which should be less expensive) of key medicines used to battle HIV/AIDS.
Drug registration. Current drug registration requirements are unduly cumbersome, especially to local manufacturers. It could be streamlined without compromising drug quality standards. Simpler registration might encourage more local production,
Partnerships among stakeholders. Clearly, access to essential medicines is a problem that does not exist in a vacuum. The causes of lack of access involve many key stakeholders that need to learn about each other and to build partnerships to address these linked causes and eliminate them.
Discriminatory duties. In Kenya, local generics manufacturers must pay duty on the importation of raw materials used to formulate medicines. Importation of finished drug products is not taxed. This duty system introduces a bias toward the importation of higher priced drugs at the expense of locally manufactured drugs.
Intellectual property rights. No one disputes the need to grant basic intellectual property right (IPR) protection to innovators of new medicines. No one disputes their need to recoup legitimate R&D costs. But, in the case of drugs, the protections granted under TRIPS (e.g., 20-year protection and patents on products and processes), means that the price of essential drugs will rise and consumers will be forced to pay monopolistic prices for extremely long periods of time.
Educating/sensitising legislators. The recent committee readings of the Industrial Property Bill in Parliament pointed up the need to educate parliamentarians about the impacts of WTO agreements on Kenya’s people. There is also a need to educate them about possible ways to minimise their negative impacts.
Need for increased R&D of drugs to treat tropical diseases. The overall lack of new drugs for diseases that affect primarily Africans is a real and pressing problem. Increasing R&D for these diseases is one of the major objectives of the MSF international campaign to increase access to essential medicines. Kenyans should make their legislators and government representatives to multilateral organisations more aware of this problem. Nationally, more pressure could be brought on transnational pharmaceutical companies doing business in Kenya to do more R&D on these drugs. Internationally, more pressure is needed to make sure multilateral agencies are addressing this problem more effectively.
After summarising key issues and problems in providing access to essential medicines in Kenya, participants concentrated on identifying possible ways that government and NGOs can work to increase their availability. The following are proposed actions that group members have agreed to undertake. Responsible individuals and/or organisations are identified for each activity.