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

Thiru Balasubramaniam thiru at keionline.org
Fri Nov 11 02:25:22 PST 2016


http://keionline.org/node/2666

9 November 2016 - WTO TRIPS Council - EU's intervention on the Report of
the UN High-Level Panel on Access to Medicines


Submitted by thiru on 11. November 2016 - 12:19

On Wednesday, 9 November 2016, the European Union 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 Medicines.


--

"UNITED NATIONS SECRETARY-GENERAL’S HIGH LEVEL PANEL REPORT ON ACCESS TO
MEDICINES

The European Commission takes note of the contribution provided by the
Report of the United Nations Secretary-General's High-Level Panel on Access
to Medicines.

The work conducted by the Panel started from an assumption that there was a
"policy incoherence between the justifiable rights of inventors,
international human rights law, trade rules and public health". As the
European Commission already indicated in its written contribution to the
Panel, it does not share this assumption.

The Commission shares the Report's acknowledgement that there are many
reasons "why people do not get the healthcare they need, ranging from:
under-resourced health systems, a lack of sufficiently qualified and
skilled healthcare workers, inequalities between and within countries,
exclusion, stigma, discrimination and exclusive marketing rights". Another
important problem are the global medicines shortages and stock-outs.

This is why in its written contribution to the Panel, the Commission
encouraged it to adopt a holistic approach to the problem of access to
medicines that could result in a valuable contribution to the wider debate.

However, due to its limited mandate, the High-Level Panel has focused its
proposals exclusively on addressing an alleged conflict between a research
and development model that (partially) relies on intellectual property
rights and the possibility of providing affordable medicines. In doing so,
it has missed an opportunity to advance more balanced, comprehensive and
workable solutions to the problem of access to health. The Commission would
also highlight that no conclusions could be reached with the support by all
Members of the Panel, as demonstrated by the dissenting opinions attached
to this report.

The European Union is committed to increasing access to affordable
medicines and to find solutions to the world's pressing public health
challenges and inequities. In line with the 2010 Communication and Council
Conclusions on 'the EU role in Global Health', the EU pursues a
rights-based approach to health. Strengthening all areas of a health
system, including the availability of qualified health workers, the
provision of affordable medicines and the adequate financing of the sector,
is central to moving towards universal health coverage with quality health
services accessible and affordable for all. The quality and integrity of
the pharmaceutical distribution chain is also essential to improving public
health.

The challenge is to strike the right balance between the need to promote
and finance the research of new and better medicines for all, ensuring that
medicines are accessible and affordable to those in need, while
guaranteeing the sustainability of health systems. We believe that these
goals are not contradictory and must be pursued jointly.

The current innovation model, including the role of trade related to IP,
has delivered consistent progress in global public health, leading to key
new and improved treatments as well as much extended life expectancy, both
in developed and least developed countries. This model already integrates a
variety of tools such as incentives for innovation based on intellectual
property, on public and private financing and awards or on public research.
Such variety is necessary to address situations, where there is a
functioning market and those where there could be market failures.

The Report underplays the fact that the development of new drugs requires
significant investment and long-term research, coupled with clinical trials
and regulatory approval procedures. The exclusive right conferred by a
patent is an important incentive for innovator pharmaceutical companies to
make the necessary investments into that research and development. Without
incentivizing the innovator pharmaceutical companies to invest in research,
the sustainable development goal of ensuring healthy lives and promoting
well-being for all, including achieving universal health coverage, would be
severely undermined.

Several of the issues covered in the report's recommendations are addressed
in EU legislation, EU & Commission policies and actions, including at
multilateral level. To name a few examples: the Commission is a major
funder of research and innovation for poverty-related and neglected
diseases and for new antibiotics. At the WHO, the EU supports the
implementation of the WHO global strategy and plan of action on public
health, innovation and intellectual property, including the development of
the Global Observatory on Health Research and Development. In the area of
trade, the EU ensures that its free trade agreements are consistent with
the Doha Declaration and it has supported the extension of the drug patent
exemption for least-developed countries. As part of its health policy, the
EU adopted new legislation to ensure that all clinical trials to be
conducted in the EU will be registered in a publicly accessible EU database
(Regulation EU No 536/2014).

However, several other recommendations are not in line with the EU rules
and practices and thus cannot be supported. This is, in particular the case
for the proposals to revise the paragraph 6 decision or the TRIPS Agreement
on these matters, to create additional structures at UN level on the issue
of health technology innovation and access.

Any future activities at the UN level in this area should be conducted on
the basis of a much broader understanding of the complex issues involved.

The Commission would like to underscore that according to paragraph 9 of
the terms of reference establishing the Panel, it is for the UN Secretary
General to provide the lead on appropriate next steps following the release
of the final report."



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