[Ip-health] SCP24: African Group submits revised proposal for a WIPO work program on Patents and Health

Thiru Balasubramaniam thiru at keionline.org
Wed Jun 29 09:53:45 PDT 2016


Submitted by thiru <http://keionline.org/user/6> on 29. June 2016 - 18:19

On Wednesday morning, 29 June 2016, Nigeria, on behalf of the African
Group, presented a revised proposal (SCP/24/4) for a WIPO work program on
Patents and Health in the Standing Committee on the Law of Patents (SCP).
The African Group proposal is a welcome breath of fresh air in the patent
committee; the proposal aims to make WIPO more responsive to recent
developments including: 1) "Challenges to public health .... including
pandemics such as the Ebola virus that gravely affected Africa in 2014-15,"
2) "the Zika virus in the Americas and the Caribbean, for which there
currently is no cure," 3) "the serious threat of Anti-Microbial Resistance
(AMR)," 3)" the need for new ways to finance and incentivize Research and
Development (R&D)," 4) the 2015 revision to the WHO Model List of Essential
Medicines which included expensive, patented medicines to treat cancer, HIV
and tuberculosis, 5) the establishment of the United Nations High-Level
Panel on Access to Medicines, 6) the WTO extension of the transition period
under Article 66.1 of the TRIPS Agreement for LDC Members for Certain
Obligations with Respect to Pharmaceutical Products (6 November 2015) and
7) the adoption of the Sustainable Development Goals (SDGs).

The text of the proposal follows:

PATENTS (SCP), 27 – 30 JUNE 2016.


At the 15th session of the SCP the African Group proposed that the
Committee should undertake a work program on the topic of “patents and
health”. At the 16th session of the SCP in 2011 the African Group and
Development Agenda Group submitted a proposal aimed at enhancing the
capacity of developing and least developed countries (LDCs) to adapt their
patent regimes and make full use of flexibilities in the international
patent system to address public policy priorities related to public health.
The African Group is of the view that a fundamental public policy priority
related to the promotion and protection of public health is the affordable
access to health care and medicines internationally. The African Group
submits this document as an update of the 2011 joint proposal contained in
document SCP/16/7 and SCP/16/7.Corr.


2. There has been significant international focus on the role of patents in
public health, specifically a persistent lack of access to health
technologies (medicines, diagnostics, medical devices, vaccines, etc.),
which includes lack of access to medicines in developing and
least-developed countries. Challenges to public health continue to emerge,
including pandemics such as the Ebola virus that gravely affected Africa in
2014-15, and more recently (since May 2015) the Zika virus in the Americas
and the Caribbean, for which there currently is no cure; the serious threat
of Anti-Microbial Resistance (AMR); and the need for new ways to finance
and incentivize Research and Development (R&D) and innovation to address
global health challenges, particularly neglected diseases or diseases
prevalent in developing countries and LDCs. Many reports and global
initiatives have directed serious attention to these and other issues.

3. It is instructive that in May 2015, the WHO published a revised Model
List of Essential Medicines that included new ground-breaking treatments
for inter alia, Hepatitis C, a variety of Cancers and Tuberculosis, many of
which are patented, very expensive and hardly affordable for patients
worldwide. This signaled a new approach since medicines on the WHO Model
List were hitherto those that could be made widely available at low cost.

4. In November of 2015, the United Nations Secretary-General, Mr. Ban
Ki-moon, convened a High-Level Panel (HLP) on Access to Medicines. The
proposed objective of the HLP is “to review and assess proposals and
recommend solutions for remedying the policy incoherence between the
justifiable rights of inventors, international human rights law, trade
rules and public health in the context of health technologies.” Thus, the
need to prioritize public health interests in pharmaceutical and health
policies is paramount, particularly in the context of the Sustainable
Development Goals (SDGs).

5. Also in November 2015, the WTO TRIPS Council extended to 2033, the
transition period for LDCs in respect of pharmaceutical products,
recognizing that implementation of patent protection for pharmaceutical
products in LDCs (most of which are in Africa) will be detrimental to their
public health challenges of securing access to affordable medicines. At
this juncture, the African Group recalls the range of flexibilities
contained in the TRIPS Agreement concerning IPRs and Public Health; the
2001 Doha Declaration on the TRIPS Agreement and Public Health; the 2008
WHO Global Strategy and Plan of Action (GSPOA) on Public Health which
underscored that IPRs should not prejudice protection of public health; and
reiterates the important moral principle that international commitments
(including bilateral and regional) should not hinder use of the
flexibilities and safeguards provided in the international patent system.

6. Anti-Microbial Resistance (AMR) has become one of the foremost global
health concerns, resulting in several engagements to develop relevant,
coherent international public health policy and actionable steps to
mitigate the challenge. The WHO Consultative Expert Working Group on
Research and Development: Financing and Coordination (CEWG) continues to
work towards filling gaps in the health R&D needs of developing countries
and LDCs, including neglected diseases or diseases that disproportionately
affect such regions, and for which R&D gaps remain unaddressed due to
market failures.

7. The WHO CEWG Report reiterated the need for further investment in health
R&D, which should be needs-driven, evidence-based, guided by the core
principles of affordability, effectiveness, efficiency, and equity; and
considered a shared responsibility. The WHO also recently adopted a Global
Action Plan on Anti-Microbial Resistance (GAP) and assisted to launch the
Global Antibiotic Research and Development (GARD) Partnership with the
Drugs for Neglected Diseases Initiative (DNDi), which aims to develop new
antibiotic treatments addressing AMR and to promote their responsible use
while ensuring equitable access to low and middle-income countries.

8. Furthermore, the post 2015 SDGs adopted by the United Nations places
emphasis on the achievement of universal health coverage, including access
to affordable essential medicines for all as one of the targets to be
achieved under SDG Goal 3. The SDG specifically states that countries
should support R&D of vaccines and medicines for the communicable and
non-communicable diseases that primarily affect developing countries and
LDCs, provide access to affordable essential medicines and vaccines, in
accordance with the Doha Declaration on the TRIPS Agreement and Public
Health, and, in particular, provide access to medicines for all.

9. Given the ever increasing global focus on R&D, innovation and public
health, including the role of the patent system as a tool for spurring
innovation in health technologies, it is important for the SCP to be a
significant facilitator in the critical work of analyzing the
patent-related challenges and questions at the intersection of public
health, access to medicines and patent rights. The Committee should draw up
a work program that assists countries in adapting their patent and health
regimes to ensure affordable access to medicines. In this regard, the
African Group presents the following work program.

*Work Program*

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

11. 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 LDCs, in relevant areas, and
building upon work undertaken in the first two elements of the work program.

*Element I – Studies*

12. Commission a study by leading independent experts to examine the
challenges faced by developing countries and LDCs in incentivizing
innovation in healthcare technologies where patents have proved to be an
insufficient motivator. This study should include:

(a) An examination of regulatory and other incentives that could spur
innovation without promoting overuse of antibiotics, including non-patent
incentives to drive drug committees to invest in AMR research. This
includes consideration of a ‘pay or play’ levy on the pharmaceutical sector
which would require companies to either pay the levy or invest in R&D that
is deemed useful for AMR.

(b) An assessment on possible adjustments to the patent system to encourage
innovation in healthcare technologies related to reducing AMR, including
improved diagnostics to better pinpoint infection and antibiotic treatment
in humans, and modifying plant patents to incentivize reduced antibiotic
use in agriculture. Such an exercise could include an assessment of the
de-linkage principle related to research funding and drug price.

(c) Study on the relationship between patent systems and challenges related
to the availability of medicines in developing and least developed
countries, including fostering of the requisite technology transfer to
facilitate access to affordable generic and patented medicines in
developing countries and LDCs.

13. Commission a study to examine the challenges and opportunities faced by
developing countries and LDCs in using licenses for healthcare
technologies. This study should 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.

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

(c) An analysis of the interface of competition law and patent rights in
the context of pharmaceuticals in different countries, including a
compilation of statutory and case law on anti-competition grounds for
compulsory license on pharmaceuticals. Experience from countries where the
intersection of competition law and patent law has been used to facilitate
access to medicines should be documented.

(d) A study and evaluation of the law and practice of WIPO Member States
with regard to voluntary licenses.

(e) The feasibility of a globally accessible license database for
compulsory and voluntary licenses.

*Element II – Information Exchange*

14. Appoint a balanced Working Group or Task Force to study and synthesize
the reports and recommendations from the HLP and commitments in the WHO
GAP, in relation to the patent system; and to consider how the SCP can
contribute to advancing the innovation and health related SDGs.

15. At a half-day Information Exchange session during SCP 26, invite the UN
Special Rapporteur on the Right to Health to present the report to the
Human Rights Council on Intellectual Property Rights and Access to
Medicines. Also invite WHO to present WHO CEWG and GAP reports, and the
Co-Chairs of the UN HLP to share their views on the HLP’s objectives and

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

17. Periodic information exchange on the margins of the SCP, involving
leading experts, on identified development-oriented issues related to
patents and health.

18. WIPO development of an international patent register, in consultation
with Member States and the support of WHO, for essential medicines to
facilitate determination of the patent status of a medicine
internationally, including those for communicable and non-communicable
diseases. Currently, there is no efficient or accurate way to determine the
patent status of medicines, including those on the WHO Model List of
Essential Medicines. This lack of transparency in the patent status of
essential medicines (and other medicines) negatively affects efforts of
governments and procurement agencies to negotiate terms and conditions of
access to medicines.

19. Development of an international license registry for licensed medicines
to facilitate access to a medicine internationally.

*Element III – Technical Assistance*

20. Flowing from the outcome 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.
These programs should provide a clear synergy between the studies and
information exchange and include:

A series of workshops on negotiating and drafting license agreements for
generic manufacturers, taking due cognizance of flexibilities in the
international patent system.

A development-oriented guide for the issuance of compulsory licenses on
medical patents, based on successful case studies.

Periodic workshops to facilitate more rigorous interpretation and
application of patentability criteria by patent examiners with regards to
patent applications covering health technologies in developing countries
and LDCs.

Development of a technical assistance module that explicitly demonstrates
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. This module 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

*Development Agenda (DA) Recommendation Links*

21. The proposed work program has links to DA recommendations 1, 7, 9, 14,
31, 32 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 anticompetitive practices, by providing technical
cooperation to developing countries, especially LDCs, at their request, in
order to better understand the interface between IPRs and competition

(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 Agreement.

(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 information.

(32) To have within WIPO opportunity for exchange of national and regional
experiences and information on the links between IPRs and competition

(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 programs.

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