[Ip-health] Bridges Weekly: WHO Members Divided Over Plan For Promoting Pharmaceutical Innovation

[Thiru Balasubramaniam]

http://www.ictsd.org/weekly/07-04-25/story3.htm


Volume 11 =09Number 14 =0925 April 2007

WHO MEMBERS DIVIDED OVER PLAN FOR PROMOTING PHARMACEUTICAL INNOVATION

The World Health Organization (WHO) last week made public member
governments' written comments on the development of a global strategy
and plan of action for research and development on diseases that
disproportionately affect poor countries. Differences persist, even
though countries are scheduled to wrap up their discussions in the
autumn.

To date, nineteen countries and regional groups have submitted their
views on the initial draft texts drawn up in December 2006 by the
Intergovernmental Working Group (IGWG) on Public Health, Innovation and
Intellectual Property (see BRIDGES Weekly, 13 December 2006).

Created by WHO members in 2006, the new working group is mandated to
draw up a medium-term framework to support sustainable, needs-driven,
essential medical research and development (R&D), in accordance with
the findings of the global health body's Commission on Intellectual
Property Rights, Innovation, and Public Health (CIPIH). Some see the
group's deliberations as an opportunity to explore alternatives to drug
patents as a means of encouraging innovation and the development of new
and affordable drugs.
The working draft of the IGWG's plan of action has attracted a wide
range of recommendations on topics including the strengthening of
innovative capacity, transfer of technology, management of intellectual
property, and financing mechanisms.

The sharpest division between governments relates to the WHO's role in
dealing with international intellectual property rules, particularly
the WTO Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS). Especially controversial was whether the action plan
should deal with promoting the use of legal flexibilities in the TRIPS
Agreement which make it easier to bring generic drugs to market and are
widely considered to be crucial to the affordability of medicines.

Brazil suggested that many IP-related matters deserve increased
attention, such as the full implementation of TRIPS flexibilities,
ensuring the immediate entry of generic medicines into markets
following patent expiry, and improving the patent approval process. It
suggested "mapping out the various flexibilities provided for in
international agreements that might be relevant to ensure access to
medicines."

Malaysia called for a "re-evaluation of the current (IP) system with
emphasis on ensuring that public health needs are not adversely
affected by strong intellectual property rights."

At the same time, several developed countries argued that the TRIPS
Agreement and IP rules in bilateral trade agreements fell "outside the
mandate of the WHO." The US indicated that the IGWG should not consider
several specific issues present in the current draft action plan,
including topics such as legal flexibilities in the TRIPS, bilateral
trade agreements, compulsory licensing, and provisions encouraging
generic entry upon patent expiry. It said that they were more
appropriate to the scope and mandate of the WTO and the World
Intellectual Property Organization (WIPO).

Australia said that it "cannot accept any binding proposal that
bilateral agreements not contain 'TRIPS-plus' provisions," which entail
IP obligations beyond those required by the TRIPS Agreement. Further,
it endorsed a proposal for cooperation with WIPO, the WTO, and other
international bodies "taking into account their mandates."

Other controversial issues included alternative financing mechanisms
for promoting pharmaceutical innovation. One such proposal seeks a
global treaty that would have governments fund medical R&D and then
make the findings public, allowing drugs thus produced to be
manufactured and sold cheaply since there would be no research costs to
offset. Another mechanism envisions the collective management of
intellectual property rights through patent pools. A third model would
be based on 'prize funds', and would give innovators monetary awards
tied to improvements in healthcare outcomes.

Bangladesh proposed that the IGWG consider the prize fund model, noting
that its separation of incentives for innovation from drug prices would
ensure low prices for medical inventions. The country also backed calls
for giving the proposed R&D treaty formal consideration. In contrast,
the US submission stated that it does not support any new funding
mechanisms. Japan recommended use of existing mechanisms to promote R&D
efficiently.

A submission from Iran suggested that innovative new health related
products should be shared between developed and developing countries,
in order to counteract the "brain drain" caused by developing country
scientists who emigrate and contribute to the development of innovation
in industrialised countries. A paper from the US, on the other hand,
held that developing countries should "strengthen their own human
resources," and address the migration of health professionals in a
manner that respects the freedom of individuals to emigrate and build a
better life for themselves and their families.

One underlying theme in the submissions was the need for more
information and best practices about innovation promotion. The EU wants
more background information on the elements of the action plan, and
raised questions about impediments at the national and international
level to investment in R&D, as well as options for improving policy
coherence. Thailand called for the compilation of "good practice and
lessons on the implementation of TRIPS flexibilities," noting that
experience sharing would be very useful for cross-fertilization among
developing countries. The US suggested that the WHO collaborate with
WIPO to compile and disseminate best practices to improve
health-related innovation.

Ellen 't Hoen of M=E9decins Sans Fronti=E8res told Bridges that the IGWG
process had thus far focused on procedures, and lacked discussion on
substance. Now, member states were debating concrete proposals.

Spring Gombe and Thiru Balasubramaniam of Knowledge Ecology
International praised countries including Bangladesh, Bolivia, Iran,
Norway, India, Thailand, and East Timor for showing "great leadership
in recognising the need for examining new methods of stimulating
research and development, pledging their support for the prize system
as a method for rewarding R&D in lieu of high drug prices." They also
expressed hope that the African countries, which had played a leading
role at the inception of the IGWG process, would make new submissions
in light of the issue's importance to them.

The Secretariat will incorporate countries' comments on the current
draft text into a revised version by July. The IGWG is scheduled to
meet for its final session in November 2007. In principle, the final
plan of action should be ready for adoption at the May 2008 session of
the World Health Assembly, the WHO's top decision-making body.
Bangladesh and Bolivia have expressed concern that there is simply not
enough time for the IGWG to complete its work by then, and called for a
one-year extension to 2009 (see BRIDGES Weekly, 7 March 2007).

Documents relating to the IGWG, including the country submissions are
available at: http://www.who.int/phi/en/

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