E-DRUG: Innovative R&D Reform Agenda adopted at WHO
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Essential Action's Global Access to Medicines Bulletin
Issue No. 5, June 19, 2008
Innovative R&D Reform Agenda adopted at WHO
Having determined that the current corporate sector system of medical
R&D has largely failed to meet the needs of people in developing
countries, two years ago the member states of the World Health
Organization (WHO) launched an effort to come up with an ambitious
reform agenda. To achieve this goal, they created the WHO
Intergovernmental Working Group on Public Health, Innovation and
Intellectual Property (IGWG) and mandated it with developing a global
strategy and plan of action aimed at bridging the R&D gap in developing
countries within two years. [1]
On May 24 in Geneva, WHO member countries took an important step forward
in advancing this innovation reform agenda, adopting a Global Strategy
on Public Health, Innovation and Intellectual Property at the
organization's annual meeting. The strategy commits WHO and countries to
explore some common-sense measures aimed at spurring the development of
medicines and other products that will meet priority health needs of
people in developing countries, and making those products available on
an affordable basis. [2]
The global strategy was finalized during a difficult final round of
negotiations that took place in tandem with the annual World Health
Assembly, where the document was adopted. The strategy is innovative in
its own right, for the first time putting into practice the idea that
there can be "innovation plus access," instead of treating them as
contradictory objectives that must be counterbalanced to each other.
A number of country delegations hailed the adoption of the R&D strategy.
"This is the most important and significant multilateral document in the
area of public health and intellectual property since the adoption of
the Doha Declaration on TRIPS and Public Health in 2001," a key
Brazilian negotiator told several reporters upon the adoption of the
resolution at the assembly. "It deals with many issues to some extent
not dealt with in the Doha Declaration." [3]
The Doha Declaration reaffirmed that countries retain substantial
flexibilities when applying the patent rules in the World Trade
Organization Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS), and that TRIPS should be interpreted in a fashion that
supports the obligation to protect public health and promote access to
medicines. [4]
The final IGWG strategy text also reaffirms the TRIPS flexibilities, and
recommends that countries consider the health impact of trade
agreements. It also suggests that developing countries should prevent
and penalize anti-competitive practices regarding pharmaceutical patents
that undermine access to medicines.
Public health, consumer and other civil society groups expressed support
for the final strategy. "Six and a half years after the Doha Declaration
... the WHO has taken a big step forward to change the way we think about
innovation and access to medicines," said James Love, director of the
consumer group Knowledge Ecology International (KEI). "In a lengthy and
substantive document, the World Health Assembly has reached consensus on
a plethora of difficult and important topics, sometimes with impressive
detail and clarity, on topics that were considered controversial only a
short time ago." [5]
The IGWG strategy document [6] includes agreement on the following issues:
* To explore R&D incentive mechanisms like prizes that do not rely on
patent monopolies and the prospect of charging high drug prices as a
reward to innovators.
* To encourage future discussions of an R&D Treaty, which would involve
agreement that all countries should have to contribute to global R&D, or
at least participate in the R&D system, but that there should be
differential obligations based on countries' relative wealth.
* Expanded support for patent pools and other means to manage patents
collectively.
* The importance of creating a global patent database for
pharmaceuticals so that governments, procurement agencies, generic
manufacturers and the public can identify which drugs are claimed to be
covered by patents in different countries.
* The principle that the WHO has a crucial role to play regarding
health-related implications of patent and related rules, and in
particular in proactively providing technical assistance to developing
countries.
Observers were particularly pleased with the enhancement of the WHO's
role in patent and related issues.
"What is encouraging is that governments have clearly called for the WHO
to play a strategic and central role in intellectual property," said Dr.
Tido von Schoen-Angerer, Director of MSF's Access to Essential Medicines
Campaign. "Countries have pledged to give health interests the
pre-eminence they deserve when considering how to manage IP." [7]
At the same time, the nature of the WHO's role on patent and related
issues was a serious source of controversy at the talks. This
contributed to the failure to finalize the plan of action, the document
which guides stakeholders in operationalizing the global strategy. Many
developed country delegations such as the United States, the EU and
Japan objected to the WHO being the lead stakeholder on several elements
of the plan, seeking to limit the WHO's involvement in several key
issues. This echoes the stated position of developed country
pharmaceutical and biotechnology companies. [8]
Additional talks aimed at finalizing the plan of action will be held in
the coming year.
Provisions related to data exclusivity, test data, patentability
criteria and anti-counterfeiting were cut from the strategy document
after differences could not be overcome. References to the right to
health and the World Intellectual Property Organization's Development
Agenda were also cut from the text.
For the promise of IGWG to be realized, member countries and the WHO
must actually implement the innovative approaches to R&D agreed upon. At
an earlier round of negotiations, Bolivia and Barbados tabled a number
of concrete proposals to advance experiments with new institutional
arrangements for R&D, such as a proposal to create a sizeable prize fund
to spur the development of a low-cost rapid diagnostic test for
tuberculosis. [9] Whether countries have the political will to back such
proposals remains to be seen. The World Health Assembly also left
unfinished the estimation of funding needs for priority R&D and the
creation of a framework for sustainable sources of funding.
Consideration of these issues will begin very soon, when the WHO
Director-General convenes the expert working group to consider
sustainable sources of financing for developing country-focused R&D
mechanisms that was mandated by the global strategy document.
MSF's Dr. von Schoen-Angerer urged the upcoming expert working group to
"take serious steps to move forward" on the strategy, and "to take on
more ambitious proposals to change the way essential health R&D is
financed, including for example through the creation of prize fund to
boost the development of tuberculosis diagnostics." [10]
Despite these shortcomings, there is a broad sense of optimism about the
work that has been done to date. "The strategy, if implemented, will
address equitable access and address a long-term need for sustainable
innovation," said Elil Renganathan, who leads the IP and public health
work of the WHO, days after the assembly adopted the IGWG resolution.
"We are very encouraged." [11]
Web links:
[1] For more information see http://www.who.int/phi/en/ and
http://www.essentialaction.org/access/index.php?/archives/140-Global-Access-to-Medicines-Bulletin-Medical-RD-that-works-for-the-developing-world.html
[2] To see the final Global Strategy document, click here:
http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf
[3] See the following articles for more information:
http://www.ictsd.org/weekly/08-05-28/story6.htm;
http://www.ip-watch.org/weblog/index.php?p=1067; and
http://www.twnside.org.sg/title2/wto.info/twninfo20080602.htm
[4] http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
[5]
http://www.keionline.org/index.php?option=com_content&task=view&id=177&Itemid=1
[6] http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf
[7]
http://www.accessmed-msf.org/msf-statement-at-the-close-of-the-61st-world-health-assembly/
[8] http://www.ip-watch.org/weblog/index.php?p=1067 and
http://www.twnside.org.sg/title2/wto.info/twninfo20080602.htm
[9] To see the Bolivia and Barbados proposals, go to:
http://www.keionline.org/index.php?option=com_content&task=view&id=175
[10]
http://www.accessmed-msf.org/msf-statement-at-the-close-of-the-61st-world-health-assembly/
[11] http://www.ip-watch.org/weblog/index.php?p=1067
Essential Action is a public health and corporate accountability group
located in Washington, DC. Essential Action's Access to Medicines
Project has worked on global access to medicines issues for more than a
decade.
For more information on our work go to www.essentialaction.org/access/
Published by Essential Action's Access to Medicines Project
P.O. Box 19405, Washington, DC, 20036, USA
Tel: (1) (202) 387-8030
www.essentialaction.org/access/
Editors: Sarah Rimmington srimmington@esssentialinformation.org
Robert Weissman rob@essential.org
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Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/