[Ip-health] Bridges: WHO Members Adopt Resolution On Pharmaceutical Innovation

[Judit Rius Sanjuan]

BRIDGES Weekly Trade News Digest - Vol. 11, Number 18 23 May 2007

WHO MEMBERS ADOPT RESOLUTION ON PHARMACEUTICAL INNOVATION

Intellectual property issues were prominent at the World Health
Organization's annual summit in Geneva from 14-23 May. After extensive
negotiations, member states adopted a last-minute resolution based on a
Brazilian proposal calling for the global health body to take on an
expanded role in encouraging health research and access.

The resolution on "Public Health, Innovation and Intellectual Property"
was adopted at the closing plenary of the 60th World Health Assembly,
which is the supreme decision-making body of the WHO's 193 member
states. However, the US made a statement to disassociate itself from the
decision.

The resolution largely refers to the role of the WHO secretariat in
supporting the work of a working group charged with developing a
framework for supporting sustainable, needs-driven, essential medical
research and development (R&D). Brazil said its proposal was designed to
give better "stewardship" to the Intergovernmental Working Group on
Public Health, Innovation, and Intellectual Property (IGWG) process,
which some see as an opportunity to explore alternatives to drug patents
as a means of encouraging innovation and the development of new and
affordable drugs for diseases that disproportionately affect developing
countries. The IGWG was set up last year to negotiate a global strategy
on essential health research based on the recommendations of the WHO
Commission on Intellectual Property, Innovation, and Public Health
(CIPIH) (see BRIDGES Weekly, 31 May 2006,
http://www.ictsd.org/weekly/06-05-31/story4.htm).

Chilean delegate Maximiliano Santa Cruz said the resolution will
"provide new impetus to push the process forward." It was valuable to
reiterate prior commitments, and "to have the secretariat on board," he
said.

Notably, the resolution requests the WHO secretariat to help develop
proposals on "a range of incentive mechanisms for addressing the linkage
between paying for the cost of R&D and the prices of medicines,
vaccines, diagnostic kits, and other health care products." Sources
report that Brazil and others had originally put forward language
referring to the explicit separation of R&D costs from drug prices,
which was supported by Canada, Chile, and Norway, But objections from
the US, Japan, and the EU eventually led to this compromise, suggested
by Switzerland. Chile's Santa Cruz said it was a "good resolution"
because initial negotiating positions had been "worlds apart."

In addition, the resolution requests the WHO secretariat to provide
"technical and policy support to countries that intend to make use of
the flexibilities contained in the [WTO] Agreement on Trade-Related
Aspects of Intellectual Property Rights [TRIPS] and other international
agreements." In theory, this would see the WHO taking a greater role in
the interpretation of TRIPS flexibilities, such as compulsory licenses
to temporarily override drug patents, to promote health.

The resolution also asks for further WHO support for "regional
consultative meetings in order to set regional priorities that will
inform the work of the IGWG." At a technical briefing on the IGWG at the
Assembly on 17 May, concerns were raised about the level of
participation of African and Latin American countries in these
consultations, which IGWG Chair Peter Oldham of Canada described as
"absolutely critical". IGWG Vice-Chair Ahmed Ogwell, head of
international health relations at the Kenyan health ministry, said "the
process is not running well in our part of the world," and appealed for
support for consultations in Africa.

At the briefing, WHO Director-General Margaret Chan said she had been
struck by the complexities involved in the IGWG but that she was
increasingly aware of the importance of intellectual property rights to
member states. Sources said her comments were greeted by delegates
following doubts about the WHO secretariat's commitment to the IGWG
process.

Assistant Director-General Howard Zucker also clarified that the IGWG
could be extended beyond its current timeframe, which calls for the
group to prepare a strategy and plan of action in time for next year's
World Health Assembly in May 2008 following a final meeting this
November. "We take our cues from member states on these items," he said,
in response to members' concern that divergence among their submissions
made agreement unrealistic by then (see BRIDGES Weekly, 25 April 2007,
http://www.ictsd.org/weekly/07-04-25/story3.htm).

At the summit's closing session, Chan added, "I am fully committed to
[the IGWG] process and have noted your desire to move forward faster ...
We must make a tremendous effort. We know our incentive: the prevention
of large numbers of needless deaths and suffering."

Resolutions on Malaria, Avian Flu and Children's Medicines

The World Health Assembly also dealt with the relationship between
intellectual property and public health in resolutions negotiated on
avian flu, malaria, and medicines for children.

A last-minute resolution was agreed on the 'Sharing of Influenza viruses
and access to vaccines and other benefits', proposed by Indonesia for a
"transparent, fair and equitable sharing of benefits" from vaccines
developed from virus samples. The country's Health Minister, Siti
Fadillah Supari, explained its decision to suspend sample-sharing of the
H5N1 bird flu virus with the WHO last December, saying that the
government had been concerned that the WHO had passed some samples on
without consent, which could have in turn resulted in intellectual
property rights that denied developing countries "equitable access" to
future vaccines.

A draft resolution on malaria was agreed after small group consultations
mainly between Kenya and the US. Each had submitted a proposal in
January, differing primarily in terms of their references to TRIPS
flexibilities. Kenya and other developing countries wanted to urge
members to provide for full use of flexibilities in their legislation
"to increase access to anti-malarial medicines, diagnostics and
preventive technologies." In contrast, the US, along with Switzerland
and Japan among others, did not want TRIPS flexibilities to be mentioned
in connection with access to the products. The compromise, reached on 21
May, inserted a definition of "pharmaceutical products" into an
explanatory footnote that referenced the 2001 WTO Doha Declaration on
TRIPS and Public Health. A similar footnote had been part of the
compromise on the Brazil IGWG resolution as well, sources said.

Brazil and Thailand were active in inserting language on TRIPS
flexibilities, the IGWG and access to essential medicines in a
resolution on "Better Medicines for Children".

On a related note, a source told Bridges that Brazil and Thailand's
recent decisions to issue compulsory licences for patented AIDS drugs
were not discussed in any detail during the World Health Assembly,
contrary to some expectations (see BRIDGES Weekly, 9 May 2007,
http://www.ictsd.org/weekly/07-05-09/story4.htm). Meanwhile, Thai
Minister of Public Health Mongkol Na Songkhla announced that Brazil and
Thailand would sign a "cooperation agreement" on health development,
including research into flu vaccines, in August.

ICTSD reporting; "Indonesia Lifts Bird Flu Sample Ban", FINANCIAL TIMES,
15 May 2007; "WHO Head Expresses Commitment to Strengthen IP Working
Group", INTELLECTUAL PROPERTY WATCH, 20 May 2007; "Thailand, Brazil to
Sign Health Cooperation Agreement," THAI NEW AGENCY, 20 May 2007; "WHO
Members Reach Preliminary Agreement on Malaria", IP-Watch, 21 May 2007;
"World Health Assembly Closes," WORLD HEALTH ORGANIZATION, 23 May 2007.



--
Judit Rius Sanjuan
Attorney
judit.rius@keionline.org

Knowledge Ecology International (KEI)
www.keionline.org / www.cptech.org
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