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.
> Case
Studies main page
> Introduction
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
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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.
- 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.
- 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.
- 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)
- 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.
- 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)
- 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)
- 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
- 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.
- 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).
- 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.
- 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.
- 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)
- 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
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* 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.
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