[Ip-health] 9 November 2016 - WTO TRIPS Council - India's intervention on the Report of the UN High-Level Panel on Access to Medicines

Thiru Balasubramaniam thiru at keionline.org
Thu Nov 10 01:33:36 PST 2016


Submitted by thiru <http://keionline.org/user/6> on 10. November 2016 -

On Wednesday, 9 November 2016, India delivered the following statement at
the World Trade Organization's (WTO) TRIPS Council's discussions of the
United Nations Secretary-General's High Level Panel Report on Access to

Agenda item 13: the United Nations Secretary-General’s High Level Panel
Report on Access to Medicines

Statement by India.

Thank you Chairman.

At the outset, I would like to thank delegations of Brazil, China and South
Africa who are also co-sponsors of this agenda item.

Mr. Chairman, in November of 2015, the United Nations Secretary-General,
Mr. Ban Ki-moon, convened a High-Level Panel (HLP) on Access to Medicines
with an objective “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.” The High-Level Panel was co-chaired by
Ms.Ruth Dreifuss, former President of Switzerland and Mr.Festus Gontebanye
Mogae, former President of Botswana. The High-Level Panel was comprised of
15 eminent individuals with an understanding of a broad range of legal,
commercial, trade, public health and human rights issues central to
promoting innovation and access to technologies. Their work was supported
by a 25-member Expert Advisory Group constituted from academia, the private
sector, civil society and relevant United Nations and international
organizations, such as the World Trade Organization (WTO).

The HLP deliberations were informed by and benefitted from a broad
consultative process, which included a generous response to a public call
for contributions that netted 182 submissions, many of which were of high
quality. Hearings and Global Dialogues were held in London and Johannesburg
in March 2016 to examine the proposals and incorporate the views and inputs
from concerned parties and affected communities. On 14 September 2016, the
United Nations Secretary-General’s High-Level Panel on Access to Medicines
released its Final Report. The HLP, inter alia, made recommendations on
Intellectual Property laws and access to health technologies, especially on
(i) TRIPS flexibilities and TRIPS-plus provisions and (ii) Publicly-funded

Mr. Chairman, before going into the specific recommendations of the HLP,
I’ll brief state about the flexibilities in the TRIPS Agreement. The TRIPS
Agreement established minimum standards of protection that each government
has to give to the Intellectual Property of fellow WTO members. The TRIPS
Agreement tried to strike an appropriate balance between the interests of
rights holders and users. Article 7 of the TRIPS Agreement entitled
“Objectives” recognizes that the protection of intellectual property should
contribute to the promotion of technological innovation and to the transfer
and dissemination of technology, to the mutual advantage of users and
producers of technological knowledge and in a manner conducive to social
and economic welfare and to a balance of rights and obligations. The search
for a balance between the need to protect IPRs to provide incentives for
R&D on the one hand and, on the other hand, to address concerns about the
potential impact of such protection on the health sector – in particular
its effect on prices – has been an important consideration in the WTO’s

The TRIPS Agreement also recognizes that the principles of IP protection
are based on underlying public policy objectives. Article 8 of TRIPS
Agreement entitled “Principles” states that WTO Members may, in formulating
or amending their laws and regulations, adopt measures necessary to protect
public health and nutrition, and to promote the public interest in sectors
of vital importance to their socio-economic and technological development,
provided that such measures are consistent with the provisions of this
Agreement. Article 8 (2) further states that appropriate measures may be
needed to prevent the abuse of IPRs by right holders, or to resort to
practices which unreasonably restrain trade or adversely affect the
international transfer of technology.

Mr. Chairman, in furtherance of the objectives and Principles of TRIPS
enshrined in Articles 7 & 8, a number of safeguards or flexibilities have
become an integral part of the TRIPS framework. These flexibilities can be
used to pursue public health objectives. However, to implement these
flexibilities, action is needed at the domestic level by incorporating them
into national IP regime keeping in mind each country’s individual needs and
policy objectives. Key TRIPS flexibilities include transition periods for
LDCs (extended by the WTO last year until 01 January 2033), differing IP
exhaustion regimes ( international exhaustion allows parallel importation
of patented products from other countries where they are the cheapest ),
refining the criteria for grant of a patent ( patentability criteria),
pre-grant and post-grant opposition procedures, as well as exceptions and
limitations to patent rights once granted, including regulatory review
exception (“Bolar” exception) to facilitate market entry of generics,
compulsory licences, including through para 6 mechanism and government use.
For pharmaceutical patents, these flexibilities have been clarified and
enhanced by the 2001 Doha Declaration on TRIPS and Public Health that WTO
members have the flexibility to interpret and implement the TRIPS
provisions in a manner supportive of their right to protect public health.

Mr. Chairman, although the TRIPS Agreement provides substantial degree of
flexibility to WTO members, the full utilization of these flexibilities is
in the hands of relevant member States. However, many developing countries
are constrained by limited technical capacity to make full utilization of
the TRIPS flexibilities and therefore they need appropriate technical
assistance from relevant multilateral organizations in order to fully
utilize the TRIPS flexibilities from the perspective of specific sectors of
their economies such as agriculture, manufacturing, public health,
environment, etc. Moreover, even where some developing countries have used
the flexibilities available to them under the TRIPS Agreement to address
public interest objectives through measures which are fully consistent with
the TRIPS Agreement, these attempts have been challenged legally as well as
politically. A slew of regional trade agreements containing TRIPS plus
standards of IP protection and enforcement have the potential to
significantly undermine the effective and full use of the TRIPS
flexibilities. Investor- State disputes under regional or bilateral
investment protection agreements are also emerging as a major challenge to
the use of TRIPS flexibilities in the public interest.

Against this background, the recommendations of the HLP, especially on (i)
TRIPS flexibilities and TRIPS-plus provisions and (ii) Publicly-funded
research are very important with regard to access to health technologies.

4.2. TRIPS flexibilities and TRIPS-plus provisions

World Trade Organization (WTO) Members should commit themselves, at the
highest political levels, to respect the letter and spirit of the Doha
Declaration on TRIPS and Public Health, refraining from any action that
will limit their implementation and use in order to promote access to
health technologies. More specifically:

(a) WTO Members should make full use of the policy space available in
Article 27 of the TRIPS Agreement by adopting and applying rigorous
definitions of invention and patentability that curtail the evergreening to
ensure that patents are awarded when genuine innovation has occurred.
(i) The United Nations Conference on Trade and Development (UNCTAD), the
United Nations Development Programme (UNDP), the World Health Organization
(WHO), the World Intellectual Property Organization (WIPO) and the World
Trade Organization (WTO) should cooperate with one another and with other
relevant bodies with the requisite expertise to support governments to
apply public health-sensitive patentability criteria.
(ii) These multilateral organizations should strengthen the capacity of
patent examiners at both national and regional levels to apply rigorous
public health-sensitive standards of patentability taking into account
public health needs.

(b) Governments should adopt and implement legislation that facilitates the
issuance of compulsory licenses. Such legislation must be designed to
effectuate quick, fair, predictable and implementable compulsory licenses
for legitimate public health needs, and particularly with regards to
essential medicines. The use of compulsory licensing must be based on the
provisions found in the Doha Declaration and the grounds for the issuance
of compulsory licenses left to the discretion of governments.

(c) WTO Members should revise the paragraph 6 decision in order to find a
solution that enables a swift and expedient export of pharmaceutical
products produced under compulsory license. WTO Members should, as
necessary, adopt a waiver and permanent revision of the TRIPS Agreement to
enable this reform.

(d) Governments and the private sector must refrain from explicit or
implicit threats, tactics or strategies that undermine the right of WTO
Members to use TRIPS flexibilities. Instances of undue political and
commercial pressure should be formally reported to the WTO Secretariat
during the Trade Policy Reviews of Members. WTO Members must register
complaints against undue political and economic pressure, and take punitive
measures against offending Members.

(e) Governments engaged in bilateral and regional trade and investment
treaties should ensure that these agreements do not include provisions that
interfere with their obligations to fulfill the right to health. As a first
step, they must undertake public health impact assessments. These impact
assessments should verify that the increased trade and economic benefits
are not endangering or impeding the human rights and public health
obligations of the nation and its people before entering into commitments.
Such assessments should inform negotiations, be conducted transparently and
made publicly available.

4.3. Publicly-funded research

(a) Public funders of research must require that knowledge generated from
such research be made freely and widely available through publication in
peer-reviewed literature and seek broad, online public access to such

(b) Universities and research institutions that receive public funding must
prioritize public health objectives over financial returns in their
patenting and licensing practices. Such practices may include publication,
non-exclusive licensing, donations of intellectual property and
participation in public sector patent pools, among others. Sufficient
incentives must be in place in these practices to make it attractive for
developers to underwrite the cost of bringing a product to market at
affordable prices that ensure broad availability.

(c) Universities and research institutions that receive public funding
should adopt policies and approaches that catalyse innovation and create
flexible models of collaboration that advance biomedical research and
generate knowledge for the benefit of the public.”

To conclude Mr, Chairman, we encourage Members to share their views on the
recommendations of the HLP at this session of the TRIPS Council. Further,
at the subsequent sessions of the TRIPS Council, we encourage Members to
share their experiences in using the TRIPS flexibilities to address public
policy priorities, in particular, related to public health.

Thank you.

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