[Ip-health] Bridges Weekly: European Parliament Delays Vote on Trips Agreement, Pending New Support for Affordable Drugs

[Thiru Balasubramaniam]

http://www.ictsd.org/weekly/07-07-18/story3.htm

EUROPEAN PARLIAMENT DELAYS VOTE ON TRIPS AMENDMENT, PENDING NEW SUPPORT
FOR AFFORDABLE DRUGS

The European Parliament has delayed the ratification of an amendment to
WTO intellectual property rules aimed at easing poor countries' access
to patented drugs, demanding that EU member states first take concrete
steps to help developing nations manufacture and import medicines at
affordable rates.

The parliament's international trade committee announced on 17 July
that promises of monetary and political support from the EU's 27 member
governments remained insufficient.

Five days earlier, European Parliament members from across the
political spectrum passed a resolution identifying the complementary
policies they deemed necessary to ensure that ratifying the amendment
would promote access to medicines in poor countries. They also demanded
that the EU stop seeking WTO-plus intellectual property protections for
pharmaceuticals in bilateral and regional trade negotiations with
developing countries.

However, EU member states' inadequate response to these objectives made
it impossible to approve the amendment, the trade committee said. With
the committee's decision pushed back to10 September, the issue will not
come up for a parliament-wide vote later that month or in October.
Under EU procedures, the European Parliament must assent to the
potential amendment before each of the member states can ratify it.

WTO Members agreed on the formal changes to the Agreement on
Trade-related Aspects of Intellectual Property Rights (TRIPS) in
December 2005. For the amendment to enter into force on schedule,
two-thirds of WTO Members - some 100 countries - need to ratify the
changes by 1 December. Thus far, however, only seven have done so (see
BRIDGES Weekly, 27 June 2007).

The amendment makes permanent a 2003 waiver from TRIPS rules setting
out the conditions for Members to legally issue compulsory licences for
the production and export of cheap generic copies of patented drugs to
poor countries.

Echoing civil society critics of the proposed amendment such as
M=E9decins sans Fronti=E8res (MSF), several members of European Parliament
(MEPs) have complained the waiver on which it is based is so complex
that it has never once been used to export medicine.

The resolution MEPs adopted on 12 July stressed that the TRIPS
amendment "represents just part of the solution to the problem of
access to medicines and public health." In it, they urged the Council
of EU member governments to "support the idea... that other measures to
improve healthcare and infrastructure are equally indispensable."

The entry into force of the TRIPS Agreement in 1994 had hampered
developing countries' ability to produce and afford generic drugs, the
resolution suggested, and the amendment's mechanism was difficult, if
not impossible to use effectively.

Arguing that "EU policy should aim at maximizing the availability of
pharmaceutical products at affordable prices in the developing world,"
the parliament called on the European Commission and member states to
commit funding for transfer of pharmaceutical-related technology to
poor countries. It also asked them to boost financial support for the
development of drugs to treat diseases that disproportionately affect
developing countries, and to play a more active role in the World
Health Organisation's intergovernmental working group (IGWG) that is
seeking to develop alternatives to patents to spur pharmaceutical
innovation (see BRIDGES Weekly, 23 May 2007).

Financial assistance aside, the resolution also called for the European
Commission and member states to provide political support for
governments that seek to "provide essential medicines at affordable
prices under their domestic public health programmes" by using
flexibilities in TRIPS rules permitting the suspension of patents in
exchange for a royalty payment.

Such support is not always forthcoming in practice. Alexandra Heumber,
a spokesperson for MSF in Brussels, said that compulsory licences for
HIV/AIDS medicines recently issued by Brazil and Thailand provided
Brussels with an opportunity to reaffirm its support for the use of the
flexibilities highlighted in the 2001 Doha Declaration on TRIPS and
Public Health. Instead, however, the European Commission questioned
their decisions, even though they were well in line with WTO rules (see
BRIDGES Weekly, 31 July 2007).

MSF believes that compulsory licensing and the ensuing generic
competition could help make expensive second-line HIV/AIDS treatment
more widely affordable in developing countries such as Thailand.
Heumber noted that after Thailand suspended the patent on HIV/AIDS drug
efavirenz, enough of the medicine was imported in a single day in
January to allow 20,000 additional patients to be treated.

Several of the parliament's demands echoed recommendations made by
Frederick Abbott, a professor of international law at Florida State
University, and Jerome Reichman, a law professor at Duke University, in
a report on the TRIPS amendment commissioned by the EU. In that paper,
they warned that making the amendment functional for access to medicine
would require vigilant and deliberate government action, including a
"combination of political will, good lawyering, financial support for
appropriate implementation efforts and collective action." They wrote
that the effectiveness of the amendment could be enhanced through
regional cooperation on procurement and compulsory licensing, as well
as the creation of funding mechanisms other than patent rights to
encourage the development of new drugs.

In a recent interview with Bridges, Abbott suggested that attempts to
re-negotiate the TRIPS amendment would likely end in a stalemate, and
potentially risked producing even more restrictive provisions.

Targeting EU policy vis-=E0-vis bilateral free trade agreements, the
parliament asked member states to explicitly mandate the Commission not
to "negotiate pharmaceutical-related TRIPS-plus provisions affecting
public health and access to medicines, in the framework of the
negotiation of the Economic Partnership Agreements with the ACP
[African, Caribbean, and Pacific] countries and other future bilateral
and regional agreements with developing countries."

This prompted EU Enlargement Commissioner Olli Rehn to insist that the
EU was "committed" to not including provisions affecting access to
medicine in either the EPAs or other trade agreements. Intellectual
Property Watch reports that Rehn, speaking in the place of Trade
Commissioner Peter Mandelson, said that the fact that the waiver had
not been used was not very significant, since it had strengthened the
hand of developing countries in price negotiations with pharmaceutical
companies. However, the study by Abbott and Reichmann said that on the
basis of draft agreement texts in the EPA negotiations, the European
Commission had been pushing for intellectual property provisions that
risked impairing the availability of generic drugs.

MSF's Heumber welcomed the "strong coalition" of support from all
political groups for the resolution, describing it as proof that the
parliament was aware that many policies would need to be pursued to
safeguard access to medicine for patients in the developing world. She
reiterated that all governments that signed on to the Doha Declaration
on TRIPS and Public Health should support developing nations' efforts
to use compulsory licences in order to support public health
programmes.

ICTSD reporting; "Parliament Delays WTO IP Health Deal Till EU Boosts
Bilateral Drug Access," INTELLECTUAL PROPERTY WATCH, 12 July 2007; "EU
pledges easier drug access for poor nations," REUTERS, 11 July 2007.

---------------------------------
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