[Ip-health] WIPO SCP25 - European Union response to UN HLP

Thiru Balasubramaniam thiru at keionline.org
Wed Dec 14 09:18:17 PST 2016

On 14 December 2016, the European Union provided the following view in
response to WIPO discussions (at the Standing Committee on the Law of
Patents) on the Report of the United Nations Secretary General's High-Level
Panel on Access to Medicines.



WIPO Standing Committee on Law of Patents 25th session - Patents and Health

Geneva, 14/12/2016
Statements on behalf of the EU

World Intellectual Property Organization
Standing Committee on Law of Patents - 25th session
Patents and Health
14 December 2016
EU Opening Statement

Madam Chair,

The European Union and its Member States take note of the contribution
provided by the Report of the United Nations Secretary-General's High-Level
Panel on Access to Medicines, and of the subsequent message of the
Secretary-General, which encourages all stakeholder to chart a way forward
in appropriate fora to ensure access to medicines and health technologies
for all who need them, wherever they are.

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 European Union and its Member States share 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

This is why in its written contribution to the Panel, the European
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 European Union
and its Member States 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 and its Member States are 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 through 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 and its Member States
support 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, the recommendations in relation to INN and
standard international common names for biological products, and the
proposal 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.

Thank you.

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