[Ip-health] WIPO SCP16: Joint proposal of the African Group and the Development Agenda Group on a work program on Patents and Health

Jamie Love james.love at keionline.org
Wed May 18 03:42:08 PDT 2011


WIPO SCP16: Joint proposal of the African Group and the Development
Agenda Group on a work program on Patents and Health

By Thiru Balasubramaniam

Created 18 May 2011

On May 18, 2011, during a WIPO meeting of the Standing Committee on
the Law of Patents (SCP), the topic of Patents and Health is being
discussed. The agenda item was requested by the Africa Group. When the
SCP turned to Patents and Health, South Africa made a lengthly and
substantive intervention on behalf of the Africa Group and the
Development Agenda Group. Albert Tramsposch, the USPTO official
chairing the SCP, referred to the proposal as "comprehensive and well
thought out." The reaction by public health NGOs was very positive.
The text of the proposal follows:


SCP 16, 16-20 MAY 2011


1.	At the 15th session of the Standing Committee on the Law of Patents
(SCP) the African Group proposed that the Committee should undertake a
work program on the topic “patents and health.” The African Group and
the Development Agenda Group are of the view that the patent system
should be consistent with fundamental public policy priorities, and in
particular the promotion and protection of public health.


2.	The issue of patents and its impact on public health has been the
subject of discussion in many fora. In 2003, the 56th World Health
Assembly of the World Health Organization (WHO) had urged Member
States “to reaffirm that public health interests are paramount in both
pharmaceutical and health policies,” and “to consider, whenever
necessary, adapting national legislation in order to use to the full
the flexibilities contained in the Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS).” Furthermore, the 2001 Doha
Ministerial Declaration on the TRIPS Agreement and Public Health
affirmed, inter alia, that the TRIPS Agreement does not and should not
prevent Members from taking measures to protect public health.

3.	The WHO Global Strategy and Plan of Action (GSPOA) on Public
Health, Innovation and Intellectual Property adopted in 2008 states
that while international IP agreements contain flexibilities that
could facilitate increased access to pharmaceutical products by
developing countries, they may face obstacles in the use of
flexibilities. Thus, there is a need to address this problem and
remove obstacles faced by developing countries in making full use of
the public health related flexibilities. The GSPOA also states that
IPRs should not prevent Member States from taking measures to protect
public health, and that international negotiations on issues relating
to IPRs and health should be coherent in their approaches to the
promotion of public health.

4.	In order to protect public health, the flexibilities and safeguards
contained and allowed by the TRIPS Agreement would need to be
incorporated in the national legislation. There is equally the need to
ensure that international commitments, including regional and
bilateral arrangements, do not restrict these flexibilities and
safeguards. Moreover, these safeguards and flexibilities have to be
workable in practice, particularly with respect to ensuring access to

5.	In this context, it will be pertinent for the Committee to discuss
the issue of patents and health and draw up a work program that
assists countries in adapting their patent regimes and make full use
of the patent flexibilities. In this regard, the African Group and the
Development Agenda Group are presenting the following work program.


6.	The proposed work program seeks to enhance the capacities of Member
States, and particularly developing countries and least developed
countries (LDCs), to adapt their patent regimes to make full use of
the flexibilities available in the international patent system to
promote public policy priorities related to public health. This work
program is composed of three interlinked elements that are to be
pursued simultaneously.

7.	These three elements are respectively: i) the elaboration of
studies to be commissioned by the WIPO Secretariat, following
consultations with the Member States at the SCP, from renowned
independent experts; ii) information exchange among Member States and
from leading experts in the field; and iii) the provision of technical
assistance to Member States, and particularly developing countries and
least developed countries (LDCs), in relevant areas, and building upon
work undertaken in the first two elements of the work program.


8.	Commission a framework study by leading independent experts to
examine the challenges and constraints faced by developing countries
and least developed countries (LDCs) in making full use of the public
health related patent flexibilities both in the pre-grant and in the
post-grant stage. This study should also include:

a.	A component on the law and practices with regard to compulsory and
government use licenses in WIPO Member States. Such a study will also
provide as detailed information as possible, as to Member States that
have issued or that have attempted to issue compulsory and government
use licenses, the details of the license issued, the challenges faced
as well as the impact on public health. This should also include the
provision of empirical data on the royalty rates set in each case.

b.	An examination on the extent to which countries use exhaustion of
rights to allow parallel trade in medicine.

c.	An assessment of the benefits of mandatory disclosure of
International Non-Proprietary Names (INNs) in the abstract or title of
patent applications. This would enable an easier identification of the
generic name of the medical product subject of the patent application.

d.	Conduct a cost-benefit analysis of the admissibility of Markush
claims (broad patent claims that may apply to a broad range of
compounds). It could be worthwhile to analyze whether such claims
based merely on theoretical inference can be considered to satisfy the
criteria for patentability.


9.	Invite the UN Special Rapporteur on the Right to Health, Mr. Anand
Grover, to the seventeenth session of the SCP, to present his report
to the Human Rights Council on Intellectual Property Rights and Access
to Medicines.

10.	Organize during SCP 17 and 18, experience sharing sessions on
countries’ use of patent flexibilities for promoting public health
objectives. The specific health related flexibilities to be discussed
in those sessions should be determined in consultation with Member

11.	Organize a technical workshop on state practice involving the
compulsory licensing of medical technologies, including the
application of TRIPS Articles 30, 31 and 44.

12.	Develop a database on the patent status in WIPO Member States of
relevant diagnostic tools and medicines for at least 10
non-communicable and communicable diseases. Such information will also
include information on the availability of generic versions of the
tools and medicines. The list of 10 non-communicable diseases and
communicable diseases will be identified in consultation with Member
States with the support of the WHO. The database will be useful in
identifying the patent status of medicines for both communicable and
non-communicable diseases and how access to these medicines can be
better ensured by making full use of the available flexibilities. It
should be noted that this request is not new, where in 2003 the WHO
had requested the WIPO Secretariat to provide information about the
patent status of essential medicines.


13.	Flowing from the outcomes of the studies and information exchange
as contained in elements I and II above, the WIPO Secretariat, in
consultation with Member States, should develop targeted technical
assistance programs.

14.	Develop a technical assistance module that explicitly demonstrate
the difference between compulsory licenses that are granted under the
procedures of Part II of the TRIPS Agreement, concerning patent
rights, and those granted under Part III of the Agreement, concerning
the remedies for infringement of those rights. These technical
assistance programs would explain both approaches, and focus on the
flexibilities afforded to both systems, noting that under the
structure of the TRIPS Agreement, Article 44 compulsory licenses are
not subject to the restrictions that exist for Article 30 and 31 of
the Agreement. These targeted technical assistance programs would
proceed from the study identified in paragraph 8 above.


The proposed work program has links to Development Agenda
recommendations 1, 7, 9, 14, 31 and 40.

1. WIPO technical assistance shall be, inter alia,
development-oriented, demand-driven and transparent, taking into
account the priorities and the special needs of developing countries,
especially LDCs, as well as the different levels of development of
Member States and activities should include time frames for
completion. In this regard, design, delivery mechanisms and evaluation
processes of technical assistance programs should be country specific.

7. Promote measures that will help countries deal with intellectual
property-related anti-competitive practices, by providing technical
cooperation to developing countries, especially LDCs, at their
request, in order to better understand the interface between IPRs and
competition policies.

9. Request WIPO to create, in coordination with Member States, a
database to match specific intellectual property -related development
needs with available resources, thereby expanding the scope of its
technical assistance programs, aimed at bridging the digital divide.

14. Within the framework of the agreement between WIPO and the WTO,
WIPO shall make available advice to developing countries and LDCs, on
the implementation and operation of the rights and obligations and the
understanding and use of flexibilities contained in the TRIPS

31. To undertake initiatives agreed by Member States, which contribute
to transfer of technology to developing countries, such as requesting
WIPO to facilitate better access to publicly available patent

40. To request WIPO to intensify its cooperation on IP related issues
with United Nations agencies, according to Member States’ orientation,
in particular UNCTAD, UNEP, WHO, UNIDO, UNESCO and other relevant
international organizations, especially the WTO in order to strengthen
the coordination for maximum efficiency in undertaking development

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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