SCP20: Kenyan intervention on Patents and Health

20TH Session of the Standing Committee on the Law of Patents

Statement by Kenya

Agenda Item No. 8: Patents and Health, 28th January 2014

Thank you Mr. Chairman for giving Kenya the floor.

Kenya supports the statement made by Algeria on behalf of the African Group and the proposal put forward by the Group and the DAG.

Patents and public health is a subject which is of immense importance not only to the African Group but to also to several other members of this Organization. In view of this several members have been keen to avail themselves the flexibility of derogating from the substantive provisions of several bilateral, pluralateral and multilateral arrangements in order to take necessary measures to protect human, animal or plant health.

Mr Chairman, before I present Kenya’s specifics, may I take this opportunity to introduce the approach taken by the East African Community (EAC), to which Kenya is a Partner State together with other four WIPO members, as relates to patents and health. EAC has adopted a regional policy related to this matter: the EAC Regional Intellectual Property Policy on the Utilisation of Public Health-Related WTO-TRIPS Flexibilities and the Approximation of National Intellectual Property Legislation (EAC-TRIPS). The overall objective of this Policy is to guide the EAC Partner States on how their national intellectual property legislation should be adjusted in order to enable them to fully utilise the Public Health-related WTO-TRIPS Flexibilities. It provides a comprehensive ‘road map’ of how the latter can facilitate op¬timisation of the populations’ access to health and other health-related products. It further identifies the lowest common denominator of intellectual property legislation that can be approximated across all the EAC Partner States.

Mr Chairman, in this Policy, EAC Partner States reaffirm their commitment to availing themselves, in line with their respective public policies and priorities, of the public health related flexibilities contained in the TRIPS Agreement and its related instruments in order to help them address public health problems afflicting their populations. Further Mr Chairman, the EAC Partners States undertake to reject any attempts, both at national, regional or international level, which may hinder their full utilisation of the TRIPS flexibilities.

In addition, the Common Market for Eastern and Southern Africa (COMESA), again of which Kenya is a member amongst other several WIPO members, has developed, or endeavours to improve or develop, policies on intellectual property rights and public health. Public health is a priority and thus safeguarding of the Public-Health-related TRIPS flexibilities is essential.
Further Mr Chairman, the African Union (AU) is quite keen in this specific subject matter.
Mr Chairman therefore, Kenya hopes that the work of the SCP will be supportive of these EAC, COMESA and AU efforts.

Having said that Mr Chairman, I may now turn to issues specific to Kenya.

Kenya appreciates the role of patents in facilitating solutions to public health problems. However, it holds that patent rights as private rights should be supportive of public health interests including those relating to public health. This position has been consistently pronounced in various forums held before, during, and after Doha including those under WIPO, WTO and WHO. In this respect Kenya recalls, among others,

1. The 1947 General Agreement on Trade and Tariffs (GATTS), and especially its general exceptions under Article 20;

2. The WTO Doha Declaration on the TRIPS Agreement and Public Health of 2001, and its paragraph six-related Decision of 2003 and Protocol of 2005;

3. The WIPO Development Agenda of 2007, and especially Recommendation 17 thereof; and

4. The 2008 WHO Global Strategy and Plan of action on Public Health Innovation and Intellectual Property.

Mr Chairman Kenya recalls that prior to the conclusion of the above-said arrangements, and especially 2-4, several studies were undertaken to guide in their discussions/negotiations. Such studies were sanctioned by the greater majority of the stakeholders of this SCP process. In this respect, Kenya would like to name, as an illustration, just a few of the reports of these studies:

1. The 2002 report of the UK Commission on Intellectual Property Rights entitled “Integrating Intellectual Property Rights and Development Policy”;

2. The 2002 WTO & WHO joint report on WTO Agreements and Public Health;

3. The 2003 report of the WHO Commission on Intellectual Property, Innovation and Public Health (CIPIH); and

4. The 2012 WIPO, WTO & WHO joint report on Promoting Access to Medical
Technologies and Innovation: Intersections between public health, intellectual property and trade.

Mr Chairman these studies were extensive and some of them are recent. Their findings were, and some still are, factual. Their recommendations were very useful for the respective processes they were to inform, as well as other related subsequent processes. Therefore, it is Kenya’s belief that the said findings and recommendations can enrich the SCP process in respect of this subject matter: patents and health.

Perhaps, it may be useful for the WIPO Secretariat to facilitate ease access of such reports for the ease reference by the SCP stakeholders. Probably by compiling them and posting them in easily accessed website. Where necessary, the secretariat may also summarise the reports as regards the findings and recommendations, despite most of them having executive summaries. In this way, the reports can enrich the SCP process.

Mr Chairman,

Kenya now wishes to share a bit of its experience in its use of the public health related TRIPS flexibilities. In its national legislation, Kenya has provisions in most of the flexibilities. So far the legislation and the application thereof, has been helpful in addressing public health problems in Kenya including facilitating access to affordable medicines. For example, in 2001, upon coming into force of the Kenyan patent law, significant reduction of prices of medicines was witnessed. This may be attributed to the flexibilities incorporated in the law. These comprise exceptions as well as limitations to patent rights such as international exhaustion, research exemption, compulsory licensing including governmental use, Bolar provision (marketing approval); patentability exclusions; as well as prohibition of anti-competitive practices.

Mr Chairman, in 2000s, a Kenyan pharmaceutical manufacturer, Cosmos Ltd wanted to manufacture HIV-AIDS related pharmaceutical products: Lamivudine (patented in Kenya by GSK), Zidovudine and Stavudine (that had no Patent in Kenya); and Nevirapine (patented in Kenya Boerhinger Ingleheim). It therefore sought a Voluntary Licence (VL) in respect of the patented products. However, Cosmos “Cosmos waited for over 1 year with two reminders. The letters were acknowledged without a substantive response. Cosmos applied for CL and within 2 or 3 weeks received visitation by both companies. Boerhinger stated they did not know Cosmos existed and came to confirm by taking photos. There was no CL because both hurriedly accorded Cosmos with VL. The Minister for Trade & Industry officiated a function at GSK for VL.

The treatment regime was changed to triple combination after application for WHO prequalification by the Government following WHO new guidelines that removed Stavudine from formulation and replaced it with Zidovudine. This distorted completely Cosmos plans to launch the product. Despite Government purchase of ARVs from Cosmos and use by patients, the same GOK could not use donor funds to purchase. (products from Cosmos). This may be seen as a challenge in the use of CL flexibility. The same GOK purchased other products from Cosmos eg for TB; Antibiotics etc.

Mr Chairman, despite some flexibilities working for Kenya, there exists some challenges. This is why Kenya is in support of the study to unearth some of them and even propose solutions.

Mr Chairman, in view of the above-said the signal is clear from Kenya: that the patent system should be supportive of public health policies of Kenya – a position which Kenya seeks to retain in any discussions or negotiations relating to patents and health including those under the SCP.

Thank you Mr Chairman.