In April 2012, the WHO released the Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). One of its primary recommendations called upon member states to began formal negotiations on a binding global convention on R&D. At the World Health Assembly in May 2012, the WHA Resolution 65.22 urged member states “to hold national level consultations among all relevant stakeholders in order to discuss the CEWG report and other relevant analyses resulting in concrete proposals and actions; 2) to participate actively in the meetings at regional and global level referred to in this resolution; 3) to implement, where feasible, in their respective countries, proposals and actions identified by national consultations.” The WHA resolution also called foro regional discussions regarding the CEWG report “in order to contribute to concrete proposals and actions.
On Thursday, 20 September 2012, discussions over the CEWG report were held at PAHO. Countries outside the Americas, including France and the United Kingdom, were present and provided their views as well.
The United States was given the first opportunity to speak and noted that other than the election of the director, the most important agenda item was the CEWG report. He noted that far more needs to be done for research and development and developing countries and noted that the US is the only WHO member state that has met its funding goals.
While the United States did acknowledge that market forces alone are not sufficient and there is a need for alternatives for the world’s poor, the United States noted opposition to two ideas that came out of the CEWG report. First, the United States stated opposition to a binding global treaty with minimum levels of contribution (as a percentage of a country’s GDP). Second, the United States opposed putting a set amount of this funding toward pooled funding mechanisms. The United States suggested moving forward on the non-contentious items of the CEWG report, asserting that few donor countries could support a binding global instrument on research and development. The United States praised the Global Fund model with measurable results and targets. The United States also called to move forward, stating that there is no need for formal negotiations which can drag on and provide “negative incentives.” Instead, the United States supported the following ideas: increased funding of R&D in developing countries, creation of a global reserach observatory, consideration of voluntary pooled funding, direct grants to small and medium businesses and to nonprofits, advanced market commitments, procurement agreements, and the use of prizes to reward R&D (noting that prizes can be used as a complimentary system). The United States also issued a concern regarding paragraph 34 of the report, noting that it was not in agreement on the characterization on open approaches. The United States stated that consensus was not reached on open approaches and that only “some countries” supported. Additionally, the United States raised concerns on paragraph 36 related to repatriated earnings. The United States noted that taxation of repatriated profits could be problematic and exacerbate access issues because it becomes a trade issues. He noted that health rarely benefits when handed over to trade negotiators. The United States concluded once again emphasizing voluntary contributions.
After the United States’ lengthy intervention, Brazil noted that access to medicines is a crucial part of its national health policy as it is a part of the Brazilian constitution. Brazil called for a focus on innovative financing mechanisms.
France took a less aggressive approach than the United States, suggesting instead that a global R&D framework needs to be considered and discussed further. France focused on short-term solutions, such as strengthening drug regulatory frameworks in developing countries. France drew attention to cooperation platforms, such as the EU platform in helping with clinical trials in developing countries. It noted the report of the working group focused only on drugs, but R&D extends to much broader areas. Additionally, France pointed to the lack of data regarding R&D with respect to the needs of developing countries and called for a mapping of needs. France also noted that other initiatives exist currently, such as those to pool patents.
Argentina provided a strong statement in support of a global R&D convention, noting the commitment by Latin American countries to this issue. Argentina pointed to the fact that research and development is focused on market/commercial interests, leading to lack of access to medicines. Argentina noted that a treaty is possible and the enormous opportunity a convention provides cannot be ignored. Recognizing it will be a difficult process to reach consensus, Argentina called for states to work together and create a multilateral convention.
Barbados called for mechanisms that can lead to quick results. It also called for PAHO to lead them to a consensus, noting that Barbados supports many recommendations of the CEWG report in principle (without naming specific proposals).
El Salvador called for cooperation, including the exchange of research or personal.
Canada opposed a global R&D convention, suggesting that WHO member states have the ability to create their own plans. Canada called instead of efforts to identify funding mechanisms which it views as a limiting factor for developing countries.
Suriname noted that it is mostly an importer of medicines and that small countries experience the failure of innovative medicines as well as the failure of access to existing drugs because of lack of interest in the markets of smaller nations. Suriname reference the Global Strategy and Plan of Action, and requested better PAHO continuity in the region in implementing the recommendations of CEWG, including a global convention on R&D.
The United Kingdom, like the United States and Canada, expressed opposition to a binding global instrument. The United Kingdom suggested that binding convention would delay the process and that there is a need to move more quickly than formal negotiations would allow. The United Kingdom instead suggested that greater consideration be given to coordinating mechanisms, which should include multilateral organizations.
After the interventions of WHO member states, two NGOs were permitted to provide interventions. The first intervention came from Judit Rius of MSF/Doctors Without Borders. MSF noted that it welcomed the CEWG report and that current R&D ignores innovation for the developing world, a problem that it cannot ignore. MSF noted also that R&D priorities are not well defined and that there is an overdependence on donors and corporate social responsibility. MSF pointed to increasing access barriers and stated that delinkage is key. With respect to ideas like a global observatory, MSF noted that while this idea is important, it is not new and has too little impact. MSF called for an overarching framework in the form of a binding R&D convention, noting that it should be evidence based, set priorities for R&D, provide sustainable funding options, and create global norms that address access and affordability. MSF also observed that experience demonstrates that soft law is insufficient; while binding norms exist to protect private actors (such as through TRIPS), so too are binding norms necessary to protect patients and governments. MSF noted that member states need not reach consensus on all issues to move forward to a negotiation and called for collective action on this issue, led by governments and PAHO.
Next, Reshma Ramachandran of the International Federation of Medical Students Association spoke, also welcoming and supporting the CEWG report. Calling the proposal for a global R&D convention a “rare opportunity,” IFMSA called for member states to enter into formal negotiations. IFMSA pointed to a new law in Argentina placing all research funded by the government into open access repositories and also the United States NIH policy requiring open access. IFMSA called for member states to contribute 0.01% of GDP and asserted that this work cannot be done through voluntary contributions. IFMSA used the Global Fund as example, stating that there was no accountability which has led to the recent funding shortfalls. Additionally, IFMSA noted the dangers of the United States proposals for the Trans-Pacific Partnership Agreement which it believed would undermine the CEWG proposals.