[Ip-health] SCP20: Kenyan intervention on Patents and Health

Thiru Balasubramaniam thiru at keionline.org
Tue Jan 28 08:44:36 PST 2014


http://keionline.org/node/1921

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 exist 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.



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