WHO CEWG to pave the way for binding global convention on biomedical R&D

On Friday, 18 November 2011, the WHO Consultative Expert Working Group on research and development: financing and coordination (CEWG) held an open briefing on the results of its work thus far. This meeting was attended by delegates from Bangladesh, Brazil, the European Union, Germany, the Holy See, the Netherlands, Nigeria, Tanzania, United States in addition to representatives from the Global Fund, South Centre, WHO, WIPO, UNITAID, Berne Declaration, HAI, KEI, IFPMA, MPP, MSF and TWN.

The Chair of the CEWG, John Arne Røttingen, presented the group’s work and recommendations. He noted that at its third meeting (16 November 2011 to 19 November 2011), the WHO Legal Counsel presented the experts different mechanisms for making normative instruments under the WHO constitution including Article 19 (conventions), Article 21 (regulations) and Article 23 (recommendations) and the secretariat of the WHO Framework Convention on Tobacco Control (FCTC) presented the norm-setting history of the FCTC.

The chair listed the following six proposals as meeting the criteria established by the CEWG.

Proposals meeting CEWG criteria

  • A globally binding instrument
  • Direct grants to companies in developing countries
  • Equitable licensing
  • Patent pools
  • Pooled funds
  • Precompetitive R&D platforms/Open source and access
  • Prizes

The Chair noted that the CEWG concluded that “because current funding is insufficient and global coordination is necessary to find solutions to the global disease burden”, the CEWG recommended a binding convention for R&D related to Type II and III diseases and the specific R&D needs of developing countries in relation to Type 1 diseases using the authority vested in WHO under Article 19 of the Constitution.

The Chair noted that the principles undergirding a binding instrument on R&D included the following: de-linkage, open knowledge, competition, access and strengthening innovation in developing countries. The instrument would involve a global coordination mechanism, a call for increased public investment and a mechanism for redistributing resources. He noted that the instrument would not be a replacement for the existing IPR system but instead complement the IPR system when the IPR system did not function. In terms of preliminary financing recommendations, the CEWG report (to be released during the first quarter of 2012) would provide figures for recommended government commitments in terms of public funding of health R&D, public funding of R&D on technologies for type II and type III disease as a proportion of GDP, and public funding to a global pooled fund as a proportion of GDP.

In terms of methods of financing, the Chair noted that while the CEWG would not be prescriptive in its recommendations for financing, it would recommend governments consider different forms of revenue generation including taxes on activities deemed harmful to health including taxes on tobacco and alcohol. If member states introduce any international indirect tax like the financial transaction tax, the CEWG would recommend a portion of the revenues should be dedicated to global health R&D. The CEWG recommended voluntary private funding to a global pooled funding mechanism.

In terms of next step, the Chair stated that the CEWG would complete the analytical work as a means of building a platform for the commencement of formal negotiations. The CEWG expected to finalize its report by the first quarter in 2012 and “propose the establishment of an intergovernmental body and a technical committee to specify the content and begin formal negotiations” on a binding treaty on R&D.

In the discussion that followed the presentation, Tido von Schoen-Angerer, Médecins Sans Frontières, and German Velasquez, South Centre, both underscored the historic nature of the CEWG’s recommendation that WHO commence formal intergovernmental negotiations on a binding convention on R&D. Today, the CEWG has provided the WHO the road map to reassert its primacy in public health and fulfill the promise of the WHO Global Strategy on Public Health, Innovation and Intellectual Property (WHA61.21) in providing a transformative architecture for enhancing sustainable, needs-driven medical innovation.