[Ip-health] European Commission supports indefinite exemption for LDCs from WTO IP rules for pharmaceuticals

Thiru Balasubramaniam thiru at keionline.org
Fri Sep 11 08:28:35 PDT 2015


European Commission supports indefinite exemption for LDCs from WTO IP
rules for pharmaceuticals

http://keionline.org/node/2319

In a closely watched announcement, the European Commission issued a press
release <http://europa.eu/rapid/press-release_IP-15-5620_en.htm> on
Thursday, 10 September 2015 supporting the indefinite exemption for least
developing country Members of the World Trade Organization (WTO) from TRIPS
obligations on pharmaceutical products. These TRIPS obligations include
pharmaceutical patents, pharmaceutical test data protection, exclusive
marketing rights and the mailbox provisions.

The LDC Group, in their February 2015 submission to the WTO TRIPS Council,
requested the following:

11. Article 66.1 provides that the Council for TRIPS "shall, upon duly
motivated request by a least developed country Member, accord extensions of
this period."

12. Least developed country Members of the WTO hereby submit a duly
motivated request for an extension of the transitional period (that ends on
1 January 2016) for as long as the WTO Member remains a least developed
country.

13. Least developed country Members also request that the TRIPS Council
recommend to the General Council a waiver for LDCs from obligations under
Articles 70.8 and 70.9 of TRIPS for as long as the WTO Member remains a
least developed country.

At the June 2015 TRIPS Council, Uganda, presenting on behalf of the LDC
Group provided a stark reminder <http://keionline.org/node/2245> of the
gravity of the situation facing least-developed countries (according to the
World Bank, in 2014, the average per capita income of persons living in
LDCs was just $928):

It would be unconscionable for WTO Members to grant LDCs – the most
vulnerable segment of countries – a time limited transition period,
requiring them to repeatedly seek extensions. A time limited transition
period creates an uncertain environment for the producers of affordable
medicines, procurement agencies, donors as well as LDC governments that
rely on the specific pharmaceutical transition period to produce and import
affordable medicines. This in turn jeopardizes the health situation of the
people and communities within LDCs, with especially adverse consequences
for the scaling up of HIV/AIDS treatment. LDCs cannot deal with increasing
communicable and non-communicable disease burden without the assurance of
continuous availability of generic medicines as long as they remain LDCs.

In closing Chair, Considering that our health needs persist, and in many
ways are growing because of the continued threat of infectious, neglected,
and non-communicable diseases and other new emerging diseases. As evidenced
by our continuing LDC status, we still face unrelenting development and
capacity challenges. To address these pressing public health needs, to
secure the ability to progressively realize the right to health, and to
ensure our continuing right of access to more affordable medicines of
assured quality; we the Least Developed Countries call upon you and the
Council to grant the extension of the transitional period under Article
66.1 of the TRIPS Agreement for Least Developed Countries with respect to
Pharmaceutical Products, and for waivers from the obligation of Articles
70.8 and 70.9 for as long as the member is an LDC.

In July 2015, European Trade Commissioner, Cecilia Malmström, foreshadowed
the EU position by noting,

By the way, we don't have to wait until the communication is published to
take action to support the world's least developed countries. They have
requested an exemption from the WTO's intellectual property rules on access
to medicines, for as long as they remain LDCs. Provided I have the backing
of the College of Commissioners, the Council and this Parliament, I want to
respond positively to that request.

The 10 September 2015 press release
<http://eeas.europa.eu/delegations/wto/press_corner/all_news/news/2015/20151109_eu_medicines_access_en.htm>
provided
more clarity on the European Commission's position which appears to respond
to public health and humanitarian challenges faced by LDCs in accessing
medicines.

Specifically, the Commission noted,

The Commission today agreed to support the least developed countries'
(LDCs) call for easier access to cheaper medicines by means of an
indefinite exemption from World Trade Organization (WTO) intellectual
property rules for pharmaceuticals. This exemption allows generic medicines
to be imported, and produced locally, regardless of patents, for example
when licenses are not available. It means producers of generics and
international programmes can supply drugs like HIV treatment in affected
countries without fear of patent infringement suits....The poorest
countries of the world need effective access to medicines. Although patents
stimulate innovation in developed and emerging economies, intellectual
property rules should be a non-issue when the world's poorest are in need
of treatment. This exemption will give the least developed countries the
necessary legal certainty to procure or to produce generic medicines...The
WTO granted a time-limited exemption before to these countries, but the
Commission believes that extending it indefinitely would give legal
certainty for long-term supply as well as enhance local production of
much-needed medicines.

Now that the European Commission backs the indefinite exemption (until
graduation from LDC status), attention now turns to the position of the
United States of America. As President Obama enters the twilight of his
administration, what enduring legacy will he leave least-developed
countries? The moral choice is clear: the United States should promptly
announce its unequivocal support for the LDC exemption.
------------------------------

The full text of the Commission press release is reproduced below.

European Commission supports better access to medicines in poorest countries

Brussels, 10 September 2015

The Commission agreed to support the least developed countries' call for
easier access to cheaper medicines by means of an indefinite exemption from
World Trade Organization (WTO) intellectual property rules for
pharmaceuticals.

The Commission today agreed to support the least developed countries'
(LDCs) call for easier access to cheaper medicines by means of an
indefinite exemption from World Trade Organization (WTO) intellectual
property rules for pharmaceuticals. This exemption allows generic medicines
to be imported, and produced locally, regardless of patents, for example
when licenses are not available. It means producers of generics and
international programmes can supply drugs like HIV treatment in affected
countries without fear of patent infringement suits.

*Commissioner Malmström said: "The poorest countries of the world need
effective access to medicines. Although patents stimulate innovation in
developed and emerging economies, intellectual property rules should be a
non-issue when the world's poorest are in need of treatment. This exemption
will give the least developed countries the necessary legal certainty to
procure or to produce generic medicines. I am confident that the Council
will support this approach, and that the EU will take the lead in the WTO
in this field."*

The WTO granted a time-limited exemption before to these countries, but the
Commission believes that extending it indefinitely would give legal
certainty for long-term supply as well as enhance local production of
much-needed medicines.

The Council must now decide on the Commission's proposal. This will
determine the position to be taken by the Commission on behalf of the
European Union in the WTO special Council on intellectual property – the
TRIPS Council. That body will take a decision on the request from LDCs for
an indefinite exemption at its 15-16 October 2015 session.

This step complements the Commission funded development programmes for
supply of essential medicines in developing countries and reinforces the
coherence of the EU approach on development policy.



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