[Ip-health] TWN Info: WHO: Member States to decide on legally binding R&D agreement

Chee Yoke Ling yokeling at twnetwork.org
Mon May 2 03:38:17 PDT 2016

TWN Info Service on Health, IP 
2 May 2016
Third World Network

WHO: Member States to decide on legally binding R&D agreement 

Geneva, 2 May (K M Gopakumar) – World Health Organization (WHO) Member States are expected to take a decision on a legally binding agreement on research and development (R&D) to address the unmet health needs of developing countries.

The open-ended meeting of Member States is taking place 2-4 May at the WHO headquarters in Geneva.  The meeting will be chaired by India and Switzerland is the Co-Chair.

The meeting is taking place almost three and half years after a 2012 recommendation of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). Member States are expected to reach consensus on mechanisms to ensure sustainable financing and coordination to address unmet health needs, especially the health R&D needs of developing countries, based on the CEWG recommendations.

In 2012 the CEWG recommended a binding agreement based on Article 19 of the WHO Constitution (R&D treaty). According to the CEWG, “the proposed convention aims at providing effective financing and coordination mechanisms to promote R&D. We see a convention not as a replacement for the existing intellectual property rights system but as a supplementary instrument where the current system does not function. R&D under the convention should focus on the development of health technologies for Type II and Type III diseases as well as the specific needs of developing countries related to Type I diseases”.

The rationale for the recommendation is the failure of the current R&D framework, based on intellectual property rights, to attract investments in those areas where the return of investment is very low. As a result there is underfunding of R&D activities on many disease conditions prevailing in developing countries.  Increased R&D investment to meet the health needs was projected as an advantage of the Agreement on the Trade Related Aspects of Intellectual Property Rights (TRIPS). However, even after more than 20 years of the TRIPS Agreement there is no improvement in R&D investment.

A study by Médecins Sans Frontières(MSF) and Drugs for Neglected Diseases (DNDi) shows that out of 336 new chemical entities approved for treating human beings from 2000 to 2011 only 4 (i.e. 1.2%) were approved for treating neglected diseases including malaria. Thus the compulsory product patent regime under the TRIPS Agreement not only compromises access to medicines in developing countries by eliminating potential generic competition but also does not result in any R&D investment to meet health needs.  Patents cannot bring the R&D investment to those disease areas that affect poor people because the patent holder cannot charge a high price due to the poor purchasing power of people and governments in the developing countries. (http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/R&D_report_LivesOnTheEdge_ENG_2016.pdf)

[The problem was identified decades ago through many reports. During the last 25 years many reports starting with the report of the Commission on Health Research for Development (1990) already identified this failure of the current intellectual property-based R&D system.  WHO itself has commissioned three reports during this decade. The report of the CEWG recommended the establishment of a global R&D observatory and a binding legal instrument to address the financing and coordination of R&D.]

However, one could not find the discussion on the proposed R&D treaty in the agenda of this week’s open-ended meeting because it is listed as the last item on technical issues as sub-item 5(l) on discussion “on the remaining issues in relation to monitoring, coordination and financing for health research and development”.  The open-ended meeting of WHO Member States on the recommendation of the CEWG in 2012 did not agree to take forward the recommendation on R&D treaty. 

The World Health Assembly (WHA) resolution WHA 66.22 that was adopted based on the decision of the open ended meeting of 2012, requested the WHO Director-General “to convene another open-ended meeting of Member States prior to the Sixty-ninth World Health Assembly in May 2016, in order to assess progress and continue discussions on the remaining issues in relation to monitoring, coordination and financing for health research and development, taking into account all relevant analyses and reports, including the analysis of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination”.

Most parts of the agenda item 5, which covers substantive issues, are focussed on the progress in implementation or plans for implementation. Out of 12 substantive discussion themes there is no focussed discussion on an R&D treaty. It will be discussed as a remaining issue along with another issue of prioritisation and coordination of R&D.  All these discussions are taking place outside the framework of the proposed R&D treaty. One senior developing country diplomat commenting on the agenda item said that the aim is to keep engaging in marginal issues without discussing the core issue of an R&D treaty.

The record of implementation is also not very impressive. For instance, one of the important decisions taken under WHA 66.22 is the establishment of a global R&D observatory. WHA 66.22 requests the Director-General to “to establish a global health research and development observatory within the Secretariat in order to monitor and analyse relevant information on health research and development, building on national and regional observatories (or equivalent functions) and existing data …”

The observatory is still in development and the Secretariat is citing the lack of resources as a reason for the slow implementation of the decision of the WHA, the highest decision making body of WHO.

Another decision under WHA 66.2 is “the implementation of a few health research and development demonstration projects to address identified gaps that disproportionately affect developing countries, particularly the poor, and for which immediate action can be taken”.

The Secretariat in consultation with various stakeholders has identified six demonstration projects.  However, these projects are underfunded. According to a Secretariat report submitted to the 138th meeting of the WHO Executive Board in January 2016, “The estimated total financial requirement for implementation of these two activities for four years 2014–2017 is US$ 85 million. Member States were contacted to contribute to this voluntary fund and to date US$ 7.65 million have been contributed”. As a result, out of six demonstration projects financial resource is available only for 3.

[The purpose of the demonstration project is to carry out R&D activities based on a new R&D approach using the principle of delinking the cost of R&D from the price of the product, and open innovation.]

A former WHO staffer closely observing the implementation of CEWG recommendations told Third World Network that the demonstration project so far clearly demonstrated only one thing beyond doubt, i.e. that the financing of R&D through voluntary funding does not work and there is little expectation from the demonstration projects due to underfunding. 

Meanwhile the developed countries are following a strategy to avoid any progress towards an R&D treaty and prefer to use the existing mechanisms or create new mechanisms outside the treaty framework to prevent an R&D treaty.  This fear is mainly due to the potential threat of an R&D treaty to the current R&D model based on intellectual property, especially patents, which provides monopoly rights to transnational pharmaceutical corporation, compromising access and needs-based R&D.  Towards this end WHA 66.22 mandated the Secretariat to work in parallel for a fragmented implementation of the CEWG recommendations. WHA 66.2 requests the Director-General:

“… (5) to review existing mechanisms in order to assess their suitability to perform the coordination function of health research and development;

(6) to explore and evaluate existing mechanisms for contributions to health research and development and, if there is no suitable mechanism, to develop a proposal for effective mechanisms, including pooling resources and voluntary contributions, as well as a plan to monitor their effectiveness independently.”

The progress report of the Secretariat citing various subsequent decisions of WHO governing body meetings proposes the setting up of a voluntary pool fund hosted at the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR).  The Secretariat’s progress report is primarily based on a McKinsey study proposing such a fund: “The scenarios range from WHO acting primarily as a convener to set priorities to the management by the Special Programme of a pooled fund of various sizes (from US$ 15 million to US$ 500 million per annum) to finance product development of needed health products, diagnostics, vaccines and treatments, from promising leads through to the launch of a new Product” (http://www.who.int/phi/progress-report.pdf?ua=1).

A decision to establish such a mechanism would effectively kill the recommendation of the CEWG on an R&D treaty.

Similarly, the progress report also shows that the Secretariat is proposing the WHO Advisory Committee on Health Research as a mechanism for the prioritisation and coordination of R&D. It states that “in its new role as the Global Research and Development Coordination Mechanism, the Advisory Committee on Health Research could review the analyses provided by the Global Observatory on Health Research and Development and the conclusions of the proposed annual conference of global health research and development stakeholders in order to articulate global priorities for research and development. These priorities would be presented to Member States through the statutory annual report of the Advisory Committee on Health Research to WHO’s governing bodies. They would be reviewed annually and would form the basis for the work of the scientific working group managed by the Special Programme for Research and Training in Tropical Diseases” (http://www.who.int/phi/progress-report.pdf?ua=1).

Developed countries are expected to support this fragmented approach of the implementation of the CEWG recommendation, without an R&D treaty framework. The developing countries, on the other hand, are expected to push for a decision supporting a treaty framework.

The public will have only a glimpse of these exchanges on the second day of the open-ended meeting when Member States discuss the agenda item “on the remaining issues in relation to monitoring, coordination and financing for health research and development”.

The real discussion will take place behind closed doors on the third day of the meeting, which is not open to observers.

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