TWN Info Service on Intellectual Property Issues (May12/01)
30 May 2012
Third World Network

Dear friends and colleagues,

Below is a news report on discussions that took place during the World Health Assembly on the report of the Consultative Expert Working Group (CEWG) report that called for WHO to being negotiations on a binding agreement on R&D.

Regards
Sangeeta Shashikant
Third World Network

Member States to discuss Expert recommendations on health R&D
Published in SUNS #7378 dated 30 May 2012

London, 29 May (Sangeeta Shashikant*) - The World Health Assembly (WHA) could only agree to a cautious approach to the recently-released recommendations of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) mainly due to opposition by the developed countries.

Several developing countries pushed for the setting up of an intergovernmental working group to begin discussions on implementation of the CEWG recommendations, particularly that called for a binding agreement on R&D relevant to the health needs of developing countries, but this move was vehemently opposed by developed countries, in particular the US, EU and Switzerland.

Thus, the WHA, which met from 21-26 May, agreed to a less ambitious outcome, i.e. to hold an open-ended Member States' meeting to analyse the CEWG report and the feasibility of its recommendations.

The meeting is also mandated to develop proposals or options relating to research coordination, financing and monitoring of R&D expenditures to be presented to the 2013 Executive Board in January and the Health Assembly later in May, taking into account the results of national consultations and regional committee discussions.

This compromise was reached after lengthy negotiations in a drafting group convened midway through the Assembly (on Wednesday, 23 May) to find a solution to four draft resolutions that had been submitted on the matter. Dr Viroj Tangcharoensathien of Thailand chaired the drafting group.

Two of the draft resolutions (presented by Kenya and the Union of South American Nations - UNASUR) proposed formal processes to discuss the implementation of the CEWG recommendations, in particular, developing a legally binding instrument on R&D.

The other two resolutions put forward by developed countries (i.e. Switzerland, and a group of developed countries - Australia, Canada, Japan, Monaco and the US) proposed informal consultations, without committing to the CEWG recommendations.

According to sources participating in the drafting group, the developed countries made attempts to marginalise and block implementation of the CEWG recommendations.

The US explicitly refused to accept the CEWG recommendations, particularly the recommendation that called for a binding agreement on R&D. The US also favoured language that "Notes the report of the Consultative Expert Working Group", and opposed language that "Welcomes the report of the Consultative Expert Working Group". Thus, the final agreed language reads: "Welcomes the analysis of the CEWG report".

According to sources, the US also apparently pronounced during the drafting group meetings that it did not favour the concept of "public goods".

The EU took a similar but more nuanced position in that it favoured more clarity on the outcome before discussing the legal nature of the outcome of the discussion. The EU, with the support of other developed countries, also attempted to push for a narrowing of the scope of diseases but this was firmly rejected by other developing countries.

The developed countries (the US, the EU and Switzerland) also favoured informal consultations to the holding of formal intergovernmental discussions to take forward the CEWG recommendations. However on this, according to sources, Switzerland showed least flexibility and only relented when it lost the support of the EU and the US.

The final resolution adopted by the WHA, in its preambular paragraph, "Welcomes the analysis of the CEWG report".

In the operative paragraphs, the Resolution:

"Urges Member States:

"(1) 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 actively participate 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;

"(4) to establish and/or strengthen mechanisms for improving coordination of research and development (R&D) in collaboration with WHO and other relevant partners, as appropriate;"

"Calls upon member States, the private sector, academic institutions and non-governmental organizations to increase investments in health research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type 1 diseases;"

"Requests regional committees to discuss at their 2012 meetings the report of the CEWG in the context of the implementation of the Global strategy and plan of action on public health, innovation and intellectual property in order to contribute to concrete proposals and actions;"

"Requests the Director-General to hold an open-ended Member States' meeting in order to analyse thoroughly the report and the feasibility of the recommendations proposed by the CEWG, taking into account, as appropriate, related studies. The meeting will also take into account the results from national consultations and regional committee discussions and develop proposals or options relating to (1) research coordination, (2) financing and (3) monitoring of R&D expenditures, to be presented under a substantive item dedicated to the follow up of the CEWG report at the Sixty-sixth World Health Assembly, through the Executive Board at its 132nd session."

CEWG: TIME FOR A BINDING R&D AGREEMENT

The creation of the CEWG follows a succession of initiatives in WHO going back to 2003. The CEWG was established in 2010, to address shortcomings in the report of the Expert Working Group (EWG) on R&D (A63/6 Add. 1) which was widely criticized by many Member States and public health NGOs. (See SUNS #6931 dated 27 May 2010 available at http://www.twnside.org.sg/title2/intellectual_property/info.service/2010/ipr.info.100509.htm)

The EWG was set up following resolution WHA 61.21, which adopted the Global Strategy and Plan of Action on Public Health, Innovation and IP and requested the Director-General to "establish urgently a results-oriented and time-limited expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type 1 diseases".

These initiatives arose from concerns that insufficient resources are being devoted globally to R&D to address diseases that principally affect developing countries. In particular, the concern centred on the failure of intellectual property rights to stimulate innovation in healthcare products needed by developing countries, and in relation to the constraints created by such rights for access to needed products, especially by the poor.

Nine years on, the R&D challenges remain and the matter unresolved, leading the CEWG to conclude in its recently-released report that "it is time to consider new ways forward to achieve the objectives that WHO Member States have been grappling with for so long", adding that "There is a need for a coherent global framework that combines the different elements and recommendations into a concerted mechanism."

More specifically, after a close examination of over 100 R&D proposals, the CEWG concludes that "a binding instrument on R&D is necessary to secure appropriate funding and coordination to promote R&D needed to address the diseases that disproportionately affect developing countries and which constitute a common global responsibility".

The CEWG report also outlines elements that should be part of the binding instrument on R&D.

For instance, it proposes that the binding instrument have as its objectives, among others: securing sustainable funding to address identified R&D priorities in developing countries; improving coordination of public and private R&D; enhancing the innovative capacity in developing countries and technology transfer to these countries; generating R&D outcomes as public goods, freely available for further research and production; and improving priority setting based on the public health needs of developing countries; and decision-making relying on governance structures that are transparent and giving developing countries a strong voice.

Specifically, on financing, it calls for a financing mechanism to be established based on government contributions. It concludes that all countries should commit to spend at least 0.01% of GDP on government funded R&D devoted to meeting the health needs of developing countries with a contribution of 20-50% of the total funding obligation to a pooled funding mechanism. (For a summary of the CEWG report, see SUNS #7350 dated 16 April 2012 available at http://www.twnside.org.sg/title2/intellectual_property/info.service/2012/ipr.info.120401.htm).

DIVERGENT VIEWS

Four draft resolutions were put before the WHA for consideration proposing different approaches to the CEWG recommendations.

Kenya and UNASUR proposed draft resolutions with language endorsing the development of a binding agreement on R&D, although the approach to the process differed.

Kenya, in its draft resolution (A65/A/Conf. Paper No. 1), proposed the establishment of an Intergovernmental Negotiating Body to develop the WHO Convention on Research and Development Financing and Coordination, taking into account the CEWG recommendations, in particular, the strengthening and securing of sustainable funding to address identified R&D priorities of developing countries; promoting R&D in diseases that disproportionately affect developing countries; de-linking R&D costs and prices of products; enhancing innovative capacity of developing countries and technology transfer; generating R&D outcomes as public goods; and strengthening R&D coordination mechanisms.

According to sources, mid-way through the discussions of the drafting group, Kenya withdrew its draft resolution and supported the draft presented by UNASUR.

UNASUR, in its draft resolution (A65/A/Conf. Paper No. 4), proposed the convening of an open-ended, Member State-driven process to make a detailed, in-depth study of the mechanisms proposed by the CEWG with a view to their implementation and "to achieve consensus on the principles, objectives and governance instruments that could form part of a binding agreement, and the necessary means of bringing this about..."

On the other hand, the developed countries favoured informal consultations between the Director-General of WHO (DG) and Member States, with no commitment to take the CEWG recommendations forward.

Switzerland (A/65/A/Conf. Paper No. 2) proposed informal consultations between the DG and Member States on the feasibility of the recommendations in the CEWG report, and the presentation of a compilation of views expressed to the next WHA.

The joint draft resolution of the US, Australia, Canada, Japan and Monaco (A65/A/Conf. Paper No. 5) also proposed the holding of informal consultations between the DG and Member States, on improving coordination and financing for research and development to better address the health-care needs of developing countries, including, but not limited to, the possible methods recommended by the CEWG in the context of the GSPOA (Global Strategy and Plan of Action on Public Health, Innovation and IP).

Divergent views were also expressed over the CEWG report during the plenary discussion in Committee A of the Assembly, prior to the convening of the drafting group.

Paraguay, speaking on behalf of UNASUR, noted that the CEWG report contains many valid suggestions and it is a clear call on Member States for action within a global framework.

Brazil highlighted the fact that enormous inequalities persist, and that technology is an opportunity, but if not adequately shared, it can become a threat. "We have a moral obligation", Brazil added. It said that Member States should initiate a debate on how to implement the recommendation by the CEWG with an open heart. "We should not fear controversy", Brazil added.

Congo, speaking on behalf of the African Regional Office (AFRO), said that most African countries favoured a legally binding instrument and called for accelerating the process in order to relieve the suffering of the African people. Congo stressed the need to find new ways of mobilising resources.

China said that intellectual property rights are not enough, and that developing countries lack effective health technologies. It supported WHO playing a leading role in health R&D and welcomed the CEWG report, adding that the recommendations deserve careful study and consideration.

Denmark, on behalf of the European Union, thanked the CEWG for its report, and acknowledged that current measures are insufficient. However, it stressed that "more clarity is needed on what we want to achieve before discussing the legal nature of the outcome of the discussion", adding: "The EU is confident that exploring practical and flexible solutions is likely to help set the components of a comprehensive approach. If its different parameters are clearly defined and agreed upon, this could lead to framing a global package".

It further stressed that there was a need to first agree on the exact scope of the initiative, including how to deal with the categories of diseases, and by which to possibly start; the need to have sufficient data on Member States' current R&D efforts and public spending on health research; and the need for the discussion to be put in perspective with the WHO reform process. It added that there was a need for feasibility studies and a clear assessment of where the item fits in the WHO priority-setting, its work and the next General Program of Work.

The EU also supported the draft resolution proposed by the US, Canada, Australia, Japan and Monaco.

The US expressed several concerns with regard to the CEWG recommendation. i.e. that it does not support a binding instrument on financing, adding that many other countries were also not prepared to commit 0.01% of their GDP under the binding instrument.

The US also said that it did not support putting in place a new financing mechanism that could be characterised as a globally-collected tax and proposal to establish a single pooled financing mechanism. It also did not favour establishing intergovernmental working groups. It further called for the Member States' discussion to include consideration of proposals passed over by the CEWG such as advance marketing and procurement agreements, orphan drug legislation, regulatory harmonization and priority review vouchers.

[The CEWG report did analyse and consider these proposals but found these proposals either unsuitable for stimulating R&D needed by developing countries or that they do not contribute to improved financing or coordination of R&D.]

Japan said that options in the CEWG report must be analysed in terms of feasibility and financial implications.

Switzerland, a proponent of one of the draft resolution texts, proposed consultations within and between countries, saying that there is no clear vision yet for an instrument, be it binding or non-binding.

(* This article has benefited from valuable contributions from Heba Wanis, Project Coordinator of People's Health Movement - PHM - Project on Democratising Global Health Governance, Alice Fabbri, PHM-Italy and Meike Schleiff, PHM-USA.)