Global Access to Medicines Bulletin: Innovative R&D Reform Agenda adopted at WHO

On May 24 in Geneva, World Health Organization member countries took an important step forward in advancing an innovation reform agenda, adopting a Global Strategy on Public Health, Innovation and Intellectual Property at the organization’s annual meeting following several rounds of negotiations over a two-year period. 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.

The latest issue of Essential Action’s Global Access to Medicines Bulletin discusses which measures were adopted, which were dropped, and whether the final strategy could contribute to bridging the R&D gap in developing countries.

An .rtf version of the bulletin is available here. The text of the bulletin follows on the continuation of this post.
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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 [email protected]
Robert Weissman [email protected]

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