[Ip-health] Bridges Weekly: EUROPEAN PARLIAMENT ENDORSES TRIPS AMENDMENT

[Thiru Balasubramaniam]

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[ Picked text/plain from multipart/alternative ]
<SNIP>

It added that "the European Union is not asking, and does not foresee
asking, to negotiate pharmaceutical-related provisions (sometimes
referred to as TRIPS + provisions), affecting public health and access
to medicines," either in its ongoing economic partnership agreement
(EPA) negotiations with the African, Caribbean, and Pacific countries,
or in future accords with "poor developing countries and LDCs."

A pledge not to oppose developing country governments that use WTO
flexibilities in order to produce or import generics for public health
purposes had been one of MEPs' key demands. Earlier this year, the
European Commission had publicly questioned the appropriateness of
compulsory licences issued by Thailand for two HIV/AIDS drugs and one
heart disease treatment, even though the WTO-legality of Bangkok's
decision was hardly contested.

However, the Council's specification of "poor" developing countries
could conceivably exclude nations such as Thailand and China, which the
World Bank classifies as 'lower-middle-income economies,' or Brazil and
South Africa, which are 'upper-middle-income economies'.

<SNIP>

MSF's Heumber also suggested that the back and forth over the TRIPS
amendment marked "really the first time that the European Parliament
took such a strong position, negotiating with the Council and the
Commission" to push pro-public health policies. She said that it had
forced the EU to engage in a broader debate on access to medicine.

However, Heumber noted that the EU had made similar statements in the
past, and that the proof of its sincerity would lie in the
health-related policies it pursues henceforth. She said that one
potential test of Brussels' latest promises would be for it to provide
"strong political support" to the World Health Organization's
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG).

This WHO committee is in the process of developing a new plan aimed at
galvanising innovation that targets health problems that predominantly
affect poor countries. Health activists say that these problems are
poorly served by the patent-based innovation model, since research and
development costs cannot practicably be recouped from high drug prices.
Some see the IGWG's deliberations as an opportunity to consider
alternatives to the patent system, for example prize funds, as a means
of encouraging and rewarding pharmaceutical innovation. Heumber
observed that de-linking research and development costs from drug
prices for diseases that disproportionately affect developing countries
would obviate at least some of the potential for tension over
compulsory licences and patent rights.


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BRIDGES Weekly Trade News Digest - Vol. 11, Number 36 24 October 2007

EUROPEAN PARLIAMENT ENDORSES TRIPS AMENDMENT

The European Parliament on 24 October endorsed an amendment to WTO
intellectual property rules aimed at easing poor countries' access to
essential medicines, after the EU's 27 member governments promised to
help developing nations manufacture and import affordable drugs.

Legislators from across the political spectrum had thrice postponed
voting on the amendment, pending additional pledges of monetary and
political support for developing country public health programmes from
EU member states and the European Commission (see BRIDGES Weekly, 18
July 2007, http://www.ictsd.org/weekly/07-07-18/story3.htm).

Council statement enables passage

MEPs' assent was finally secured when the Portuguese presidency of the
EU Council, which represents all member governments, read out a
statement in a plenary session of parliament committing to several of
their demands. The parliament had earlier received similar guarantees
from the Commission, officials said.

Alexandra Heumber, a Brussels-based access to medicines campaigner for
M=E9decins Sans Fronti=E8res (MSF), said she was pleased with the outcome,
though cautioned that the Council's statement "needs to be put into
practice."

Following months of wrangling, the parliamentary vote clears the way
for EU member states to ratify the amendment to the WTO Agreement on
Trade-related Aspects of Intellectual Property Rights (TRIPS) agreed by
the global trade body in December 2005.

The TRIPS amendment would make permanent a procedure established in
2003, which spells out the conditions under which it is legal for WTO
Members to issue compulsory licences for the production and export of
cheap generic copies of patented medicines to poor countries unable to
manufacture them.

Council reaffirms TRIPS flexibilites

The Portuguese presidency's statement declared that EU members "support
the use of the so-called flexibilities built into the TRIPS Agreement"
-- and reaffirmed in the 2001 Doha Declaration on TRIPS and Public
Health -- for poor countries "to be able to provide essential medicines
at affordable prices under their domestic public health programmes."

It added that "the European Union is not asking, and does not foresee
asking, to negotiate pharmaceutical-related provisions (sometimes
referred to as TRIPS + provisions), affecting public health and access
to medicines," either in its ongoing economic partnership agreement
(EPA) negotiations with the African, Caribbean, and Pacific countries,
or in future accords with "poor developing countries and LDCs."

A pledge not to oppose developing country governments that use WTO
flexibilities in order to produce or import generics for public health
purposes had been one of MEPs' key demands. Earlier this year, the
European Commission had publicly questioned the appropriateness of
compulsory licences issued by Thailand for two HIV/AIDS drugs and one
heart disease treatment, even though the WTO-legality of Bangkok's
decision was hardly contested.

However, the Council's specification of "poor" developing countries
could conceivably exclude nations such as Thailand and China, which the
World Bank classifies as 'lower-middle-income economies,' or Brazil and
South Africa, which are 'upper-middle-income economies'.

Notably, the Portuguese presidency's statement recognised that the
TRIPS amendment "represents just a part of the solution to the problem
of access to medicines and public health." "We look favourably upon
initiatives encouraging the transfer of technology, research, capacity
strengthening, regional supply systems and help with registration, in
order to facilitate and increase the production of pharmaceutical
products by the developing countries themselves," it added, also
alluding to budgetary support. MEPs had argued that such complementary
measures would have to accompany the amendment if it were to promote
public health.

While the European Parliament's international trade committee had
initially hoped for a joint declaration with the Council emphasising
the EU's commitment to the use of TRIPS flexibilities, it settled for
the Portuguese presidency's statement, which may ultimately be
submitted in writing. MEPs voted heavily in favour of the amendment,
although some Communists and Greens abstained because they wanted a
more formal declaration.

The successful extraction of additional promises from member states was
seen as a step forward for the parliament, which has often played
second fiddle to the Council and the Commission in setting the
direction of EU policy.

Erika Mann, trade spokesperson for the Socialist Group, described the
compromise as "an historic victory and an extraordinary advance for the
European Parliament." "For the first time, the [parliament] has managed
to secure tangible results from the Council of ministers in an area
regarded by the member states as their exclusive reserve," she added.

MSF pleased, but cautious

MSF's Heumber also suggested that the back and forth over the TRIPS
amendment marked "really the first time that the European Parliament
took such a strong position, negotiating with the Council and the
Commission" to push pro-public health policies. She said that it had
forced the EU to engage in a broader debate on access to medicine.

However, Heumber noted that the EU had made similar statements in the
past, and that the proof of its sincerity would lie in the
health-related policies it pursues henceforth. She said that one
potential test of Brussels' latest promises would be for it to provide
"strong political support" to the World Health Organization's
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG).

This WHO committee is in the process of developing a new plan aimed at
galvanising innovation that targets health problems that predominantly
affect poor countries. Health activists say that these problems are
poorly served by the patent-based innovation model, since research and
development costs cannot practicably be recouped from high drug prices.
Some see the IGWG's deliberations as an opportunity to consider
alternatives to the patent system, for example prize funds, as a means
of encouraging and rewarding pharmaceutical innovation. Heumber
observed that de-linking research and development costs from drug
prices for diseases that disproportionately affect developing countries
would obviate at least some of the potential for tension over
compulsory licences and patent rights.

TRIPS Council extends amendment deadline

In a related development in Geneva, WTO Members on 23 October agreed to
push back the deadline for ratifying the TRIPS amendment by two years,
to the end of 2009. As per the original agreement in 2005, the
amendment needs to be ratified by two-thirds of the WTO Membership -
some 100-odd countries - in order to enter into force on schedule this
December. Thus far, however, only 11 Members have done so. If all of
the EU's member states ratify, the total would rise to 38.

Rwanda and Canada are currently in the process of trying to use WTO
procedures identical to those in the potential TRIPS amendment in order
to allow a Canadian company to export generic copies of a patented
HIV/AIDS drug to the African country (see BRIDGES Weekly, 10 October
2007, http://www.ictsd.org/weekly/07-10-10/story4.htm).

ICTSD reporting.

---------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org
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