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MANAGING THE CHALLENGES OF WTO PARTICIPATION: CASE STUDY 19

Patents, Parallel Importation and Compulsory Licensing of HIV/AIDS Drugs: The Experience of Kenya

Ben Sihanya*

 Disclaimer:
Opinions expressed in the case studies and any errors or omissions therein are the responsibility of their authors and not of the editors of this volume or of the institutions with which they are affiliated. The authors of the case studies wish to disassociate the institutions with which they are associated from opinions expressed in the case studies and from any errors or omission therein.

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ON THIS PAGE: 
> I. The problem in context: patent issues in access to AIDS drugs in Kenya
> II. The local and external players and their roles
> III. Challenges faced and the outcome
> Beyond the patent debate
> Other non-IP strategies that can facilitate access to AIDS drugs in Kenya 
> IV. Lessons for others: the players’ views
 

I. The problem in context: patent issues in access to AIDS drugs in Kenya    back to top

Patents, the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Kenya’s Industrial Property Act, 2001 have been singled out as the main scapegoats in the problem of accessing AIDS drugs in Kenya. This has prevented the pursuit of a more realistic national health policy and strategy to address the problem. Remarkably, AIDS-related deaths are also associated with limited care and support. AIDS is generally undermining Kenya’s survival, development, productivity and competitiveness.

The daily number of deaths in Kenya from AIDS has reached about 300, and Dr Patrick A. Orege, the Director of the National AIDS Control Council (NACC), reports that there are 1.5 million people living with HIV/AIDS (PLWHA) in Kenya.(1) Another report, by Noel Wandera, puts the PLWHA figure at 1.2 million.(2) The reporting and computation of AIDS-related deaths is controversial; there are indications that as compared with other African countries, and even in absolute terms, infection rates in Kenya may actually be declining.(3)

Remarkably, a publication issued in August 2004 by the African Civil Society Governance and AIDS Initiative (GAIN), ‘HIV/AIDS, Democracy and Governance in Africa’, states that recent statistics published by UNAIDS on HIV prevalence show that ‘previous estimates appear to have been too high’.(4)

The document goes on,

There have recently been suggestions that even the lower figure for HIV numbers in Africa is too high, and that the real figure may be as much as 25% lower. Downward revisions in estimated prevalence rates arise chiefly because of the revision of assumptions about the representativeness of data sources used for estimating national prevalence rates. For example, HIV rates in small towns are typically higher than in villages, but data from antenatal clinics in small towns have often been used as the basis for assessing rates in rural areas, which leads to overestimation. As population-based methods for measuring HIV prevalence are becoming more common, prevalence estimates are usually reduced. However, there are serious methodological difficulties with population surveys, in particular because of the relatively large number of individuals who refuse to provide a sample. Until assessment methodologies are improved, there will remain a high level of uncertainty about prevalence estimates.(5)

GAIN concludes that ‘it is important to listen carefully to the statisticians, who always insist that it is impossible to know the exact number of people living with HIV and AIDS, and that the best use for surveillance statistics is to identify trends over time rather than “correct” prevalence levels’.(6)

AIDS drugs are expensive: this is partly because of royalties that must be paid to patent holders under the TRIPS Agreement and Kenya’s Industrial Property Act, 2001,(7) but also because of limited research and development (R and D) on diseases affecting Kenyans. Non-governmental organizations (NGOs) such as Médecins Sans Frontières (MSF), Action Aid and other health campaigners have argued that more than 50% of Kenyans live on US$1 a day and cannot afford the expensive antiretroviral (ARV) drugs or to maintain optimal nutrition levels associated with effective drug use. Following calls by experts throughout the 1990s, the Industrial Property Act has finally been amended to allow for the parallel importation of generics from India, Brazil and other countries.(8)

There have also been controversies regarding compulsory licensing. First, many stakeholders argue that Kenyan firms do not have the capacity to manufacture or distribute such drugs. Second, NGO activists and others argue that the pharmaceutical industry in Kenya is largely oligopolistic and firms have not been keen to process drugs under a compulsory licence. Third, accessing AIDS drugs has revealed more serious health policy problems: even non-patented drugs have not been easily accessible, or they have expired in the central storage facilities, or they have been pilfered through rent-seeking Ministry of Health bureaucrats.

II. The local and external players and their roles    back to top

The Kenyan government’s position on patents has been that intellectual property rights should be exercised for the mutual benefit of rights holders and consumers. According to Mboi E. Misati, a senior patent examiner at the Kenya Industrial Property Institute (KIPI), ‘the TRIPS Agreement should ensure a balance of the rights and the duties of the rights holders vis-à-vis the poor’.(9) Kenya has also argued that the TRIPS Agreement should reflect the socio-economic development of Kenya and other developing countries; that the TRIPS Council should work closely with all stakeholders in order to ensure that the TRIPS Agreement is not in conflict with the public interest, including public health. Kenya’s main areas of concern include access to medicines to address public health and nutrition, and its position has been to encourage patent protection but to relax the law to facilitate research and development.(10) The relaxation should be exercised so that it does not infringe the rights of the patent holder.(11)

The key negotiators have also played a key role in advancing these concerns. Kenya, South Africa, Malawi and Lesotho started a campaign within the WTO to relax patent protection on drugs. Activists and other players observe that this campaign was successful because they worked closely with other governments. NGOs claim credit for helping developing countries frame policies on the initiatives while also lobbying policy-makers in the European Union (EU) and the United States, where major pharmaceutical companies were based. For instance, activists advised the South African government on its Medicines Act. In February 1999, US campaign members proposed adding provisions to African trade legislation to cut off funding to agencies that pressed African countries to adopt intellectual property laws exceeding the requirement of the TRIPS Agreement.(12)

Developing country negotiators were also reportedly well briefed and qualified. NGOs worked closely with the southern African states as they advocated a new essential medicine strategy as a means to counter US and EU trade pressure on patent issues. Dr Olive Shisana, the key negotiator for the African countries, was reportedly tough and well informed.(13) Generic manufacturers also made a difference; pharmaceutical companies in developing countries have also played a critical role in the process. For instance, India’s Cipla offered generic substitutes for HIV drugs which would cost US$350 a year for the treatment. This is a small fraction of the price charged by Western firms holding patents on the drugs.

Pressure from developing countries placed the issue of public health on the agenda of the Doha Ministerial Conference. Article 1 of the Doha Declaration recognizes the gravity of health problems afflicting developing countries, including AIDS, malaria and tuberculosis. Article 6 empowered the Council to find an expeditious solution by the end of 2002.(14)

There were many formal and informal sessions to execute this mandate.(15) Various problems were recognized in the TRIPS Agreement as identified by the African Group of which Kenya has been a leader.

1. The first impediment was that Article 31(f) of the TRIPS Agreement restricts the use of compulsory licensing to authorising ‘predominantly for the supply of the domestic market of the member authorising such use’. This means that a country making use of a compulsory licence must manufacture the product locally for the domestic market. Thus, the country must have sufficient local manufacturing capacity. This is not the case in most of the developing countries. There are three main problems: (i) Kenya and many other developing countries argue that they are too poor to set up factories and they lack sufficient local manufacturing capacity; (ii) the domestic market is too small to attract sufficient investment in the pharmaceutical sector; and (iii) if the domestic market cannot be expanded, economies of scale cannot be achieved.
    
2. The series of meetings to execute the mandate of the Declaration comprised representatives of developing and developed countries. Kenya, together with forty-one members of the African Group that it chaired, demanded a broader approach in designing the solution and an interpretation of the effective use of compulsory licensing so as to facilitate strategies to supply the current needs of members.
    
3. Kenya argued for Article 31(f) of the TRIPS Agreement to be either deleted or amended; it also argued for subsequent interpretations to ensure sufficiency in manufacturing capacity for Kenya to make use of compulsory licensing. The EU supported the amendment conditionally to ensure non-diversion and transparency. No decision had been reached as the deadline under the Declaration of the end of 2002 drew near. The first decision was made on 24 November 2002, but the African Group argued that it was unsatisfactory and unworkable. It considered this was ‘a step back from Doha because it created further restrictions on the current flexibilities in the TRIPS Agreement’.(16)
    
4. The decisions on the implementation of paragraph 6 of the Doha Declaration(17) of 30 October 2003 clarified some of the issues. Article 2 of the Decision would waive the obligations of an exporting country under Article 31(f) of the Agreement with respect to the granting of a compulsory licence.
    
5. According to some, this waiver should be revised to be an actual amendment rather than an interim measure which can be repudiated at any time. There should be a permanent change to the provision to provide for certainty, since pharmaceutical companies need some certainty before they can invest in the industry.(18)
    
6. Some members have proposed that Article 30 of the TRIPS Agreement be interpreted broadly to give WTO members the right to allow production without the consent of the patent holder to address public health needs in another country.(19)
    
7. The first comprehensive decision was given in the Perez Motta text.(20) It was unsatisfactory to Kenya and other developing countries as it did not tackle most of the problems. In the course of rejecting it, the chairman of the African Group(21) expressed disappointment and frustration, saying that the Decision was neither a practical solution nor was it workable. He described it as a step back from Doha.

In a speech read by the African representative,(22) the African Group stated:

The African Group is disappointed and frustrated by the progress made so far. The group feels if the discussions continue on the same line as they have been conducted to date, then it is unlikely that the desired solution will be forthcoming, and particularly one meant to address the public health problems afflicting Africa. Members may wish to seriously reflect on the reasons why the African group raised the issue in the TRIPS Council prior to the Doha conference and their subsequent expectations after the issue in the Doha [Declaration] as stated in the various communications of the TRIPS Council. This probably gives them a better understanding of the nature of the solution Africa expects.

Lobbying efforts finally began to yield some advances. By the conclusion of the Cancún Ministerial Conference in September 2003, members had agreed to relax the provisions of the TRIPS Agreement. For instance, they agreed that a patented technology required for the production of medicines and allied kits should be accessible to deserving WTO members on favourable terms. The final text of an acceptable decision was adopted on 31 August 2003.

Additionally, the Kenyan government, including the Ministry of Health and the Ministry of Trade and Industry, as well as the Kenya Industrial Property Office (KIPO), played a major role in the discussions on public health and patents. KIPO prioritized and advised on the reform of patent law and policy, and sought and secured the enactment of the Industrial Property Act’s provisions on compulsory licensing, parallel importation and government use, as well as the transformation of KIPO into the Kenya Industrial Property Institute (KIPI).

Businesses which played a part in the process included pharmaceutical companies, pharmacies, importers and exporters.(23) The most visible player in the campaign was Cosmos Industries, which lobbied the government to allow compulsory licensing.

Many local and international civil society associations and research outfits also participated. These included the Consumer Information Network (CIN),(24) MSF,(25) Health Action International (HAI), Kenya Aids Watch Institute (KAWI), Christian Children’s Fund (CCF),(26) Oxfam, EcoNews Africa and Innovative Lawyering.(27)

A statement posted by MSF on their website captures the developments and the perspectives of the players. We cite it in extenso:

Kenya Coalition on Access to Essential Medicines today warned that the Kenyan government needs to carefully examine the extent of the reductions and the impact that this could have on more long-term access to life-saving medicines. The government should be guided by the fact that a generic manufacturer (CIPLA of India) has offered to provide US quality approved antiretrovirals at US$800-1000 per person per year. If the big pharmaceutical companies give an 85% reduction on the current global price of US$15, 000 per patient per year, as announced publicly in May, then the price would be US$2,250. This means that twice as many patients would be able to be treated in Kenya by using medicines supplied by the Indian manufacturer than with the big pharmaceutical company offer which is being negotiated.
 

In order to have the right to import these affordable medicines, Kenya would need to issue compulsory licences to override patents, which is their right within international trade law (TRIPS within WTO). According to the law, inexpensive generic drugs can be legally manufactured locally or imported (cf. stipulations on ‘governmental use’ and ‘compulsory licensing’ provided by the Kenyan Industrial Property Act, 1989). Negotiations on price cuts should never substitute these rights or hamper the implementation of these provisions. The Kenyan Coalition points out that the price cuts coincide with upcoming discussions about a new Industrial Property Bill, 2000. This Bill should create opportunities to improve access to cheaper drugs by softening the conditions for compulsory licensing and by introducing parallel imports, all of which are legal under international WTO TRIPS law. Price negotiations should not compromise any proposed amendments to the Bill, 2000, which are in favour of access to drugs….
 

Therefore, the Kenya Coalition on Access to Essential Medicines encourages the Kenyan government and UNAIDS to recognize that although there could be short-term benefits from the deal, these could be outweighed by negative consequences in the long run, unless serious efforts are made to stimulate generic production of antiretroviral drugs by local manufacturers and/or to import inexpensive drugs. The introduction of generic drugs will increase competition and will lead, according to general market rules, to considerable price reductions.(28)

III. Challenges faced and the outcome    back to top

Many players focused on legal provisions: patents. They lobbied the government and the National Assembly to facilitate legislative reform. They also convened fora to condemn the WTO, TRIPS, and pharmaceutical transnational corporations (TNCs). The process of coming up with a comprehensive Industrial Property Act on the issues was also characterized by intense lobbying. In a press conference in 2001 the Coalition for Access to Essential Medicines warned the government of the possibility of powerful pharmaceutical companies using ‘not too transparent’ ways to woo MPs to vote against a Bill aimed at facilitating access to cheaper medicines.(29)

Dr Chris Ouma, Action Aid’s national co-ordinator, HIV/AIDS Programme Kenya, argued that

MPs should think about the plight of their people. They now have the power to alleviate their suffering … But we know [the MPs] are also under pressure from pharmaceutical companies ready to use subtle but not-very transparent ways of pushing their case … We cannot be sure the MPs we have talked to will vote for the Bill. Things have been happening that leave us worried.(30)

As indicated, domesticating the TRIPS Agreement was a major first step in complying with the WTO Agreement. President Daniel arap Moi on 27 July 2001 assented to the Industrial Property Act replacing the Industrial Property Act, 1989.(31) Thus Kenya revised the Industrial Property Act, partly to be WTO/TRIPS-compliant, and also took the opportunity to address one of the most critical issues in the post-TRIPS dispensation: access to HIV/AIDS drugs. S. 58(2) of the 2001 Act limits a patentee’s rights:

The rights under the patent shall not extend to acts in respect of articles which have been put on the market in Kenya or in any other country or imported into Kenya by the owner of the patent or with his express consent.

The words in italics were added through an amendment a month after the Act was passed.(32) There was extensive lobbying against this provision by NGOs that believed that it did not sufficiently limit the rights of a patent holder. According to the Kenya Coalition on Access to Essential Medicines, a lobby group bringing together several local and international NGOs in Nairobi,(33) the contentious amendment is especially troubling because it was introduced just a month after the 2001 Industrial Property Act was enacted.(34)

We are shocked that the amendment to an Act, which we were involved in, was drafted and passed without the consultation of any of the stakeholders in the civil society … it seems some of the important gains that the IPA [brought about] have now been taken away.(35)

In December 2001 Kenya’s Assistant Minister for Trade and Industry, Albert Ekirapa, explained to an enraged National Assembly that his ministry had not given a commencement date because the Attorney General’s office had not drafted subsidiary regulation to govern its implementation six months after it had been passed. The same office, however, took less than a month to draft the amendment. Partly because of this controversy, the amendment was withdrawn(36) and the Act was reinstated to its original condition. The Industrial Property Act also provides for government use under s. 80.

The first applicant for a licence was Cosmos Industries. It sought to be allowed to produce a drug, the product of Glaxo SmithKline and Boehringer Ingelheim of Germany. On realizing that the government was about to issue a licence, Boehringer offered a voluntary licence, slowing down the negotiations on the licence. According to Dr William Mwatu, the company’s East Africa Medical and Regulatory Director,

Cosmos would be able to manufacture zidovudine and larnivudine, as well as a combination of the two, for sale in Burundi, Kenya, Rwanda, Tanzania and Uganda … this action we believe will go a long way to help increase access to [the life-prolonging drugs], and also have another health-care company play a significant role in addressing the HIV/AIDS crisis in Kenya.(37)

While signing the agreement in Nairobi, the chairman and managing director, Prakash Patel, said, ‘The door of access to essential medicines for the people of Kenya and East Africa will now be open.’(38) Cosmos will be Africa’s second manufacturer of generic ARV drugs, after the South African company Aspen Pharmacare, which announced a similar move in early 2004. Cosmos Industries received its licence from Glaxo SmithKline in 2004.

The Minister of Trade and Industry, Dr Mukhisa Kituyi, made a quotable speech at the presentation ceremony:

Nevertheless it is a road to success. When I was informed that there was a company that had filed an application for government’s use of antiretroviral patents as provided under the Industrial Property Act, 2001, I was really delighted. Kenya is a signatory to major international treaties on intellectual property like the convention establishing the World Intellectual Property Organization [WIPO] and the [TRIPS] Agreement. We therefore have an obligation to protect and respect the rights of all patent holders.(39)

The Minister also cited the constitutional protection of property in the context of access to HIV/AIDS drugs:

Our Constitution also provides for the sanctity of property and the government indeed respects the Constitution, being the supreme law of the land. Similarly, the government has a duty to provide for easy access to antiretroviral drugs to its citizens who are living with HIV/AIDS, more so when the AIDS pandemic was declared a national disaster.(40)

Dr Kituyi then addressed the immediate stakeholders in the licence transaction:

I am therefore very grateful to the two parties, Glaxo SmithKline and Cosmos, who negotiated and agreed on acceptable terms for a voluntary licence. It is my hope that many other pharmaceutical companies in Kenya will follow this noble example to enable the people living with HIV/AIDS to easily access antiretroviral drugs. Once again, Kenya has taken the lead in this region and I am glad to note that the territory referred to in the voluntary licence includes Kenya, Uganda, Tanzania, Burundi and Rwanda.(41)

The Minister was optimistic about the impact of the licensing arrangement, and about KIPI’s role in the administration of intellectual property:

It is my hope that this function will mark the beginning of a truly healthy competition in the manufacture of not only antiretroviral drugs but all other health drugs in the country for the benefit of all. This will certainly have the ripple effect of creating the much needed wealth in Kenya. Finally let me also take this opportunity to thank KIPI for the role it has played in the negotiations between the two parties here and the eventual registration of the voluntary licence as one of the Institute’s mandate under the Industrial Property Act, 2001. My ministry is keen to see all its departments carry out their mandates as provided for under the respective legislations.(42)

Another problem identified in Kenya is that the influx of generics may lead to an influx of counterfeit drugs. KIPI has devised some rules for identifying a counterfeit, which it defines as a pharmaceutical product availed to the market or presented to it and intentionally tailored to derive and ride on the reputation or goodwill of another good through labelling or marking. ‘The counterfeits are not necessarily substandard goods. But they infringe the patent. Goods are counterfeits when a person other than the owner of the patent makes them without the patentee’s licence.’(43)

Significantly, there is widespread ignorance in Kenya on the importance of intellectual property rights. Local manufacturing companies are generally afraid to invest in compulsory licensing or parallel importation for fear generally of taking on the pharmaceutical giants.(44) They do not actually realize that they have the legal backing to do so. Even trained lawyers do not actually commit enough time on the complex and wide area of intellectual property.

Beyond the patent debate    back to top

The debate on patents has not resolved the problem of access to AIDS drugs. Critics observe that most of the government’s resources on AIDS are spent on emoluments, workshops and spurious awareness campaigns.(45) They cite, for example, the KSh 13 million spent on the International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA),(46) when the 2003 conference was held at Nairobi’s Kenyatta International Conference Centre (KICC), on 21-26 September 2003.

Numbering just about a hundred, activists under the aegis of the Pan-African AIDS Treatment Access Movement (PATAM) spoke, kicked, railed and acted up against many ‘enemies’ of access to treatment for HIV/AIDS in Africa: Big Pharma, the unfeeling, profit-focused multinational corporations, and African leaders who have refused to provide treatment for their peoples. ‘You talk, we die,’ yelled the activists, as they mounted a blockage of the VIP and heads of governments lounge at the Kenyatta International Conference Centre, venue of the 13th International Conference on AIDS and STIs in Africa (ICASA).(47)

At the conference one speech after another was read by participants expressing their disappointment in the way the WTO and the government were working toward achieving access to drugs. One person living with AIDS, Nomfundo Dubula,(48) on behalf of people living with HIV, said during the closing ceremony of the ICASA conference:

I want to say that as communities and people living with HIV we are angry. Our people are dying unnecessarily. African leaders, the ball is in your hands. You have to decide whether you want to lead a continent without people. So, stop playing hide and seek whilst people are dying. The World Health Organization has declared antiretroviral therapy a state of global emergency and our leaders are still in a state of denial. The Doha and the UNGASS declarations have opened the way to decide about the future of Africa, so, when is your action? The Doha declaration on health is hope, and it must be implemented. Two years ago, the Abuja declaration promised 15% of the budget on health but up to now that has not happened. How many people must die? Please, move from talks to real action. I also want to address the WHO. WHO has promised to give technical assistance in the procurement of drugs. Now we need your assistance in our countries to ensure that cheaper generic drugs reach every country, with or without manufacturing capacity.
 

You also have a key role in ensuring resources for poor countries. The 3 by 5 initiative should also ensure that all treatment programmes include treatment literacy efforts. On our side, we commit ourselves in educating our people and ensuring adherence. We need real leadership in the implementation of effective strategies to reach the 3 by 5 target. We will assist you in this effort if you show commitment and independence in prioritizing people’s health over any other interest. I want to refer to the drug companies, whose bags are full with profits. Stop squeezing poor Africans which only represent 1.3% of your global market. Don’t delay access by giving exclusive licenses that are only transferring the monopoly to local companies blocking competition. Your diagnostics are still too expensive and inaccessible. Provide low prices and allow our governments to bring us life-saving essential drugs and the essential monitoring systems.(49)

Government procurement of drugs, which is not constrained by the WTO, the TRIPS Agreement or the Industrial Property Act, 2001, is largely inefficient. It further illustrates the policy defects highlighted in the foregoing appeal.

There is limited support for research and development, a matter that has arisen with regard to about five announcements of alleged breakthroughs in AIDS drug development. These ‘patent races’ or ‘wars’ include Kemron, Dr ‘Stone’s’ ‘Ozone therapy’, collaboration between the Universities of Nairobi and Oxford, and the work of Professor Arthur Obel.

Obel developed Pearl Omega, which was challenged by the medical profession and the Kenya AIDS Society (KAS) for, inter alia, not conforming to standards under Kenya’s health law and policy regarding clinical testing, efficacy, approval and registration of new drugs.(50)

KAS went to court(51) and claimed that its members (patients) would be harmed, and that Obel’s representation that he had found a cure could be counter-productive, as there might be recklessness based on false hope. Justice Gideon Mbito upheld Obel’s right to process and distribute the drug, thus making important pronouncements on the policy of AIDS research: Obel had taken great personal risks in researching a dangerous disease. Such researchers need incentives. The Court of Appeal(52) upheld the decision (also on a technicality), partly because patients’ suffering was alleged but not proved.

Issues regarding incentives and intellectual property have invariably arisen in the five major AIDS drugs announcements. In Kemron there were two major contests of ownership and control. The first pitted the Kenya Medical Research Institute (KEMRI) (or scientific researchers) against traditional healers and herbalists, who claimed a share because they had allegedly contributed biological materials (herbs) and their traditional knowledge.(53)

What of the efficient use of external and internal resources? Donor funds are being sought and received to battle against the scourge. According to a communication from Dr Patrick Orege, the Director of the National AIDS Control Council (NACC), in the media on 1 July 2004,(54)

Kenya’s war on HIV/Aids has received a major boost after the World Bank on 30 June released KSh 300 million to fight the disease. The Director said his organization would pay out the bulk of the money — KSh 248 million — to community-based groups while AIDS control units in various ministries would get the rest. The KSh 300 million is part of the KSh 1.7 billion which the Bank had earlier withheld until it got an audit report for the past financial year.

The World Bank is the leading donor to the AIDS Council, and is providing about KSh 4 billion ($50 million) over a five-year period. The loan programme, under the Kenya National HIV/AIDS Strategic Plan, was signed in 2001 and expires in 2005. The fact is that even if patents are an obstacle to getting drugs, at least there are funds to pay royalties and accountability should be encouraged.(55) Kenya should learn from past failures.

Other non-IP strategies that can facilitate access to AIDS drugs in Kenya    back to top

1. Therapeutic value pricing. This has been adopted mostly in Australia. The buyer or the state Pharmaceutical Benefit Scheme determines the drug price based on therapeutic value. When a new drug becomes available, they examine it and if it is an improvement on the original, they may allow it to be sold at, say, 10% more.
    
2. Pooled procurement. For small economies, whereby several countries combine to purchase drugs together, this procedure may be of immense value. In the Caribbean it has halved the prices of drugs. Kenya can try using this through the regional trade arrangements established under the East African Community (EAC) and the Common Market for Eastern and Southern Africa (COMESA).
    
3. Negotiated procurement. This is where large organizations such as WHO buy drugs in large quantities. In doing so they get huge discounts from the pharmaceutical companies. WHO and WTO member states can derive enormous advantages from this. Concerted international procurement efforts on vaccines and contraceptives have reduced the prices of some drugs. For example, the price of the oral polio vaccine which is sold to developing countries at 33.3 times lower than to the US government. Likewise, the oral contraceptive prices are 130-240 times lower in poor countries than in the United States. The same could be negotiated for antiretrovirals.
    
4. Planned donations. WHO and other organizations have done well in establishing guidelines for drug donations. For example, Kenya in 2002 received 1 million doses of Nevirapine, an ARV that helps prevent mother-to-child transmission of the HIV/AIDS virus.(56) This will go a long way in saving the lives of millions of Kenyans.
    
5. Government commitment. The commitment shown by the Brazilian and Indian governments in the campaign for access to drugs is overwhelming. If the Kenya government were to exhibit such commitment the question of access to drugs would be significantly improved.

The former South African President, Nelson Mandela, has persuasively argued that an effective strategy for combating the AIDS problem requires the engaged commitment of national leaders to provide not only for prevention but also for anyone who needs drugs ‘wherever they may be in the world and regardless of whether they can afford to pay or not’.(57)
 

Kenya has shown some commitment by setting up an anti-Aids campaign dubbed TOTAL WAR ON HIV/AIDS; President Kibaki chairs the committee.(58) In January 2004, Charity Ngilu, the Minister of Health, met with various NGOs and interest groups to get their support, which she did, on the fight at grass-roots level.
 

The government has also committed itself to fighting AIDS through the AIDS Bill,(59) s. 19 of which commits the government to ensuring that everyone who needs to gets access to AIDS drugs.(60) Remarkably, in 2004 the price of ARVs in public hospitals became as low as KSh 500 a month, down from KSh 6000 a month only a year previously and available in private hospitals only. The government’s policy on prevention through condoms and family life education has been weak. It imported condoms in an effort to reduce the rate of infections, against a backdrop of protests by a section of the Catholic Church who for a long time argued that condoms and family life education would encourage promiscuity.
 

According to one Catholic activist,
 

Condoms are also promoted in Kenya as barriers against STDs [sexually transmitted diseases]. This is despite the countless STDs condoms cannot prevent. These include HPV, which causes genital warts and cancer of the cervix. This is a deadly cancer, very common in Kenya, especially among poor, malnourished, and disadvantaged women. Screening for this cancer is not practical because the health sector has been moribund for a long time. Other STDs condoms cannot prevent include clamydia, which causes sterility, Hepatitis B and C which cause pain and liver cancer, Herpes genitalis, chancroid, and syphilis. Most of these diseases are incurable: the consequences on those treatable are permanent. Condom users are not aware of these facts; those who distribute them dishonestly withhold this information. Since condoms prevent neither HIV nor STDs, those who promote them do so to make blood money as they sacrifice helpless uninformed Kenyans. How do you make informed decisions and informed choice without information? When leaders pass the message that it is all right to be immoral as long as you use a condom, promiscuity increases and AIDS spreads. Asking Kenyans to use condoms is tantamount to sentencing them to death. But even if condoms were 100% protective, their use would still be illicit and below the dignity of the human person created in the image of God.(61)

6. Differential or dynamic pricing. Pharmaceutical companies could charge less for developing countries than in developed countries. This is consistent with the TRIPS Agreement and is backed by, among others, WHO, the EU, MSF and some corporations. The main problems now include preventing the drugs from ‘leaking’ back to the developed countries, and convincing the citizens of developed countries to be taxed more for the benefit of the poor.(62)

IV. Lessons for others: the players’ views    back to top

As already mentioned, some of the players have indicated that the problem of access to AIDS drugs is more complex, and does not only implicate patents or the WTO. Other problems include inefficient resource allocations, poverty and distribution problems, as well as government policy on public health and patents.

Significantly, the WTO agreed that the TRIPS rules be implemented by 2006. India and other countries which have been providing Kenya with drugs may stop doing so.

In August 2004 WHO delisted some of the generic drugs used for AIDS treatment, arguing that the test to determine their efficacy was conducted in dubious laboratories.(63) This is seen as a backward step, since some Kenyans depend on a particular drug, Rabanoxyl, an Indian product, which is a combination drug consisting of several individual drugs. The individual drugs, which are patented, cost a lot more when used individually. There are new drugs which experts insist are more effective, but the newer the drug the more expensive and the harder for poor Kenyans to obtain.

Activists opposed to the patenting of AIDS drugs have been criticized a lot. At the thirteenth ICASA conference, they characteristically joined in the protest.(64) The Kenyan government, which the activists have cursed, in 2003 published an AIDS Bill with non-discrimination clauses.(65) In addition, in the 2003 budget the government set aside KSh 3 million to fight the AIDS problem. There is sustained pressure by some activists who are unappreciative of the effort being made and are offensive. Can their strategies be effective? Is the ‘one shoe fits all’ confrontational approach taken by many activists, most of whom belong to local donor-funded NGOs or are in their 30s and living in the rich Nordic countries, really working to improve access? The same question can be posited to the outdated blanket condemnation of pharmaceutical companies and TNCs generally.(66)

Kenya should learn to invest in research and development, and national health law and policy as well as patent law, all of which have affected AIDS research and development.

The effort to combat HIV/AIDS must not be handled in the traditional manner of tying foreign aid to politics. Kenya must act with a sense of urgency and purpose and approach the battle against HIV/AIDS with the same resolve and commitment that the world is using to fight terrorism. Towards this goal Kenya requires leadership and local and international co-operation. Shifting goalposts and blaming non-critical factors such as patents, the Industrial Property Act, 2001, TRIPS and the WTO is not terribly helpful. Efficient policy, legal, institutional and administrative reforms of public health, research and development and patent law are all important.

NOTES:
1.- See Patrick Orege, ‘The Need for Antiretrovirals’, Sunday Standard (Nairobi), 29 Aug. 2004, p. 20. back to text
2.- See Noel Wandera, ‘New Health Plan to Benefit Aids Patients’, East African Standard (Nairobi), national news section, 27 Aug. 2004, p. 4. back to text
3.- See Daily Nation article, 27 Aug. 2004. back to text
4.- See generally Kenya AIDS Watch Initiative (KAWI) website at http://www.kenyaaidinstitute. org (last visited 22 Oct. 2004). back to text
5.- Ibid. back to text
6.- Ibid. back to text
7.- Aspects of the TRIPS and patent problem in access to AIDS drugs in Kenya have been captured in three of my studies: Ben Sihanya, ‘Constructing Copyright and Creativity in Kenya: Cultural Politics and the Political Economy of Transnational Intellectual Property’, JSD (doctoral) dissertation, Stanford Law School, 2003 (forthcoming book, 2005); Ben Sihanya, ‘TRIPS and Access to Drugs, Food and the Relevant Technologies in Kenya: Reforming Intellectual Property and Trade Laws for Sustainable Development’, research report for EcoNews Africa (Nairobi), on addressing the impact on Kenya of the intellectual property regime under the TRIPS Agreement — preparations for the Cancún WTO meeting, 2003; Ben Sihanya, ‘Patent Wars Raging over Aids Cure’, Daily Nation, Opinion: Pandemic, 17 Dec. 2003, at p. 9. Cf. Arthur Okwemba, ‘Kenya Now Producing Aids Drugs: But Subtle Pressure Is Already Being Put On Government to Stop Licensing’, Daily Nation, Horizon, Science/Technology/The World of Ideas, 1 April, 2004, pp. 23-4; Correspondent, ‘Move by Pharmaceuticals Could Limit US Funding’, ibid., p. 23. back to text
8.- It is significant, if ironic, that the Act had been promulgated in 1989 partly to protect Kenyan scientists and the Kenya Medical Research Institute (KEMRI) over the claim that they had invented a drug for AIDS, Kemron. back to text
9.- See Arts. 28, 30, 31, 32 of the TRIPs Agreement and Part VII (ss. 53-59) of Kenya’s IPA 2001 (on the rights of the patent holder). See Mboi Misati, Senior Patent Examiner, Kenya Industrial Property Institute (KIPI), ‘The TRIPS Agreement and Access to Essential Medicines in Kenya’, paper presented at a seminar on ‘The Role of Intellectual Property Rights in Health Research and Development’, organized by the Kenya Medical Research Institute (KEMRI), 24-25 Feb. 2004. back to text
10.- Relaxation of the patent regime would involve repealing some of the rules on using a patent without the owner’s consent. This includes declining to produce the article in reasonable quantities, which implicates Art. 31(f) of the TRIPs Agreement. And Kenya championed the amendment of this article. See Misati, ‘TRIPS Agreement’. back to text
11.- Ibid. back to text
12.- See Angene Wilson, ‘Good News about AIDS-Case Countries: Lesotho, Kenya, Malawi and South Africa’, available at www.rpcr.org (accessed on 24 Aug. 2004). back to text
13.- Ibid. back to text
14.- For the search for a solution, see below. back to text
15.- The discussions encompassed product coverage, beneficially importing member, eligible supplying member, transfer of technology, meaning of domestic market, legal mechanisms, transition period, exclusive marketing rights and non violation complaints. back to text
16.- Nelson Ndirangu, Kenya’s trade attaché in Geneva, on behalf of the African Group. back to text
17.- The Decision was adopted by the General Council in the light of a statement read out by the chairman of the African Group; it can be found in Job (03)/177 of the WTO. This statement was reproduced in the minutes of the General Council to be issued as WT/GC/M/82. See the footnotes to the Decision. back to text
18.- Interview with Evans Mboi Misati, chief patent examiner at KIPI, Nairobi, 17 Aug. 2004. back to text
19.- Art. 30 of TRIPS provides for ‘limited exceptions to the exclusive rights conferred by the patent provided that such exceptions do not unreasonably conflict with the normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking into account the legitimate interests of the third parties’. back to text
20.- The text was named after the then chairman of the Council, Eduardo Perez Motta. back to text
21.- Nelson Ndirangu, Kenya’s trade attaché in Geneva. back to text
22.- Ndirangu, on behalf of the African Group. back to text
23.- Pharmaceutical companies such as Cosmos and Cipla lobbied the government extensively to allow for parallel importation and compulsory licensing. back to text
24.- EcoNews Africa participated in lobbying through research, media campaigns, and general lobbying and raising public awareness, including through articles. It commissioned a study by the author: ‘TRIPS and Access to Drugs, Food and the Relevant Technologies in Kenya: Reforming Intellectual Property and Trade Laws for Sustainable Development’, research report for EcoNews Africa Nairobi, on addressing the impact on Kenya and the intellectual property regime under the TRIPS Agreement, March 2003. This report drew from earlier work with MSF and KIPI, among others, leading to IPA 2001. Oduor Ong’wen and Karin Gregow of EcoNews were key players in the research, advocacy and lobbying process. See also Oduor Ong’wen, ‘Intellectual Property Rights Promote Piracy’, East African Standard, 14 July 2004. back to text
25.- MSF and HAI participated by organizing a conference on 15-16 June 2000 in Nairobi on ‘Improving Access to Essential Medicines in East Africa: Patents and Prices in the Global Economy’. For conference documents see www.accessmedicine. msf.org. The conference was also supported by the Rockfeller Foundation. See http://www.harweb.org/mtgs/nairobi (last accessed 16 March 2003). Innovative Lawyering played a role in addressing the legal issues, especially intellectual property. back to text
26.- The Christian Children’s Fund (CCF) has been responding to this global call to action with innovative programmes based on a seven-point strategy focusing on home-based care; psychosocial support for orphans and other vulnerable children; HIV/AIDS prevention; nutrition and child health; educational assistance and vocational training; promotion of positive living for people with HIV/AIDS; and sustainable livelihoods through income-generating activities. See generally www.christianchildrenfund.org (last accessed 24 Aug. 2004). back to text
27.- Innovative Lawyering participated through the author, its chief strategist; I worked with MSF and other agencies in advocating progressive reforms to IPA, 1989, and by working with EcoNews Africa in producing the research report cited in n. 7 above. back to text
28.- Available at www.msf.org (last accessed 24 Aug. 2004). There is an explicit and implicit assumption that normal market conditions and principles (or the market mechanism of demand and supply) operate efficiently in Kenya, especially as far as HIV/AIDS drugs are concerned. back to text
29.- See Ken Opala, ‘Don’t Quit Anti-Aids Drugs War, MPs told’, Daily Nation, (Nairobi), 11 May 2001. back to text
30.- Ibid. back to text
31.- Act No. 3 of 2001, Kenya Gazette Supplement, 60 (2001).The Act came into effect via a notice issued on 28 March 2002 which indicated that the commencement date would be announced by notice. The commencement date was 1 May 2002. back to text
32.- Kenya Gazette, 49 (2002). back to text
33.- The members are Action Aid, the Association of People Living with AIDS in Kenya (TAPWAK); Health Action International (HAI Africa); Network for People Living with HIV/AIDS (NEPHAK); Women Fighting AIDS in Kenya (WOFAK); Society for Women and AIDS in Kenya (SWAK); Nyumbani; Federation of Women Lawyers of Kenya (FIDA); CARE International; Médecins Sans Frontières (MSF); DACASA; Pharmaciens Sans Frontières (PSF); Kenya Medical Association (KMA); Consumer Information Network (CIN); and Campaigners for AIDS-Free Society. back to text
34.- The main issue in this contention was the speed with which the amendment was drafted. See Dagi Kimani, ‘New Law Blocks Import of AIDS Generics in Kenya’, East African, 1 July 2002. back to text
35.- Lisa Kimbo, the Co-ordinator of the Kenya Coalition on Access to Essential Medicines, on 1 July 2003. back to text
36.- Kenya Gazette, 23 Aug. 2003. back to text
37.- See Konchora Gurancha and Mutahi Rukanga, ‘Aids Drug Prices To Drop’, East African Standard, 23 Sept. 2004, p. 40; see also Jeff Otieno, ‘Patients Set To Benefit from Cheap Aids Drugs’, Daily Nation, 23 Sept. 2004, p. 4; UN Office for the Co-ordination of Humanitarian Affairs, ‘Kenya To Produce ARVs in Weeks’, at www.irinnews.org. back to text
38.- Ibid. back to text
39.- This speech is reported in full on the Ministry of Trade and Industry’s website (http://www.tradeandindustry.go.ke). It is analysed briefly by Jeff Otieno on the website. back to text
40.- Ibid. back to text
41.- Ibid. back to text
42.- Ibid. back to text
43.- KIPI, ‘Detailed Analysis in Response to Shako and Co. Advocates — Differentiating Between Counterfeits and legally Imported Pharmaceutical Products’ (2004). back to text
44.- As per Misati, ‘TRIPS Agreement’. back to text
45.- For instance, Dr Margaret Gachara, the former director of the government’s AIDS body, the National AIDS Control Council (NACC), was on 30 Aug. 2004 convicted and sentenced to one year in jail for fraudulently earning about KSh 27 million (or KSh 2 million per month) in emoluments and for abuse of office, when NACC spent much less on some crucial programmes. See Daily Nation, 26 Aug. 2004; Jillo Kadida and Mark Agutu, ‘Gachara Is Jailed for One Year: Former Aids Control Boss Is Found Guilty of Fraud and Abuse of Office’, Daily Nation, Tuesday, 31 Aug. 2004, p. 48. Critics also observe that in 2004 the Ministry of Health organized a two-day women’s conference at Kasarani in Nairobi on AIDS, at which about KSh 30 million were spent. This was opened by President Mwai Kibaki and allegedly organised by an NGO fronted by the Health Minister’s daughter. See East African Standard and Daily Nation, 23 Feb. 2004 and after, including nation reporter and KNA, ‘Abrupt End to Aids meeting’, Daily Nation, 23 Feb. 2004. back to text
46.- The ICASA Conference is a forum held under the auspices of UNAIDS where every two years African scientists, social leaders, political leaders and communities come together to share experiences and updates on the responses to the HIV/AIDS pandemic. back to text
47.- See http://www.equinetafrica.org/newsletter/ (accessed 24 Aug. 2004). See generally the speeches at the conference at www.listkabisa.org equinet-newsletter: [Equinet-news], equinet newsletter October 2003: ‘Stop Playing Hide and Seek Whilst People Are Dying’. back to text
48.- He is from the Treatment Action Campaign in South Africa and represents the Pan African Treatment Access Movement. back to text
49.- See equinet newsletter, ‘Stop Playing’. The ‘3 by 5’ is the global target of providing 3 million people living with HIV/AIDS in developing and middle-income countries with life-prolonging antiretroviral treatment (ART) by the end of 2005 (source: WHO website, accessed in April 2005). back to text
50.- Kenyan medical practitioners also expressed concern, because Obel did not disclose the ingredients or side effects. The other HIV/AIDS drugs announcements are discussed in this report and in Sihanya, ‘Patent Wars Raging over Aids Cure’. back to text
51.- Kenya AIDS Society v. Professor Arthur Obel, HCCC No 1079. back to text
52.- Civil Appeal No. 188 of 1997. back to text
53.- See Sihanya, ‘Patent Wars Raging over Aids Cure’. back to text
54.- Mike Mwaniki, ‘HIV Aids War Gets Shs 300m Boost’, Daily Nation, 1 July 2004. back to text
55.- Kenya in 2002 had failed to qualify for AIDS aid funding under the World AIDS Fund to tackle AIDS, tuberculosis and malaria. The reasons cited included lack of accountability in Kenya’s proposal. Other countries that received a boost included South Africa, Zambia and Zimbabwe. Sources within Kenya’s NGO sector said that among the things that were working against the country getting any support for HIV-related programmes from such organizations as the Global Fund is the fact that the country’s AIDS programme falls under the Office of the President, and not the Ministry of Health. See Dagi Kimani, ‘Aids Funds: Ministry of Health Fails Test’, East African, 29 April 2002. back to text
56.- In Kenya mother-to-child transmission is a major cause of AIDS. Researcher Anna Coutsoudis startled her colleagues at the thirteenth International AIDS Conference in Durban, South Africa, with the following information: in a study of 551 mother-and-child pairs, first published in the prestigious peer-reviewed journal The Lancet (7 Aug. 1999), her group found that mothers who breastfed their babies for at least three months had no more chance of transmitting HIV to their children than mothers who never breastfed at all. Even more surprising, children who received a mixed diet of formula and breast milk had the highest HIV rates over a period of six months. Coutsoudis followed these children for more than fifteen months, and the results remained the same. See Anna Coutsoudis et al., ‘Method of Feeding and Transmission of HIV-1 from Mothers to Children by Fifteen Months of Age: Prospective Cohort Study from Durban, South Africa’, AIDS 15 (2001): 379-7. See www.virusmyth.net, accessed on 24 Aug. 2004. back to text
57.- Nelson Mandela, ‘Care, Support and Destigmatisation’, preliminary address to the XIV International AIDS Conference, Barcelona, Spain, 7-12 July 2002. back to text
58.- The president appears in TV and newspaper advertisements, and posters, holding hands with ordinary citizens and saying, ‘Let’s Strangle [or eliminate] AIDS’ in Kiswahili, the Kenyan lingua franca, ‘Pamoja Tuangamize Ukimwi’. AIDS was (belatedly) declared a national disaster by President Moi on 25 Nov. 1999. back to text
59.- Kenya Gazette Supplement, 76, 23 Sept. 2003. back to text
60.- This is still a pipedream. See Orege, ‘The Need for Anti-retrovirals’, and Wandera, ‘New Health Plan’ (in which the government promises that under its proposed controversial National Social Health Insurance Scheme (NSHIF), 181, 000 people living with AIDS (out of about 1.5 million) will be put on ARVs). back to text
61.- See Stephen Karanja, ‘Kenya: A Land of Graves’, Catholic Medical Quarterly, November 2002, at www.catholicdoctors.org. back to text
62.- See Mike Moore, ‘Give the Poor Drugs and Charge the Rich’, East African, Business Opinion, 12 March 2001. back to text
63.- Dagi Kimani, ‘Key AIDS Drugs Dropped from WHO List’, East African, 9-13 Aug. 2004. back to text
64.- ‘The cause of the disagreement was that just 4, 000 of the estimated 250, 000 people who are in need of ARVs have access to them on a regular basis, while in the whole of Africa just 1% of the 4 million who need the drugs receive them, despite the fact they are only generic versions.’ See Dagi Kimani, ‘Activists of the World, Chill Out, We Have Heard You’, East African, 6 Oct. 2003. back to text
65.- For examples, see the Bill cited above. back to text
66.- Kimani, ‘Activists of the World’. back to text
 

* Lecturer in Intellectual Property, Constitutionalism and Communications Law, University of Nairobi Law School. The author holds a Ph.D. in intellectual property from Stanford University. I am grateful to Dr Patrick Low and an anonymous WTO reviewer for insights, and to Daisy Ajima, a graduating student at the University of Nairobi Law School, for the excellent research assistance she provided.