13.14 Consultative Expert Working Group on Research and Development: Financing and Coordination

Posted Mon, 2012-04-02 09:01

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The issues before the Assembly

Before the Assembly is the report of the Consultative Expert Working Group (CEWG) established as part of the implementation of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA). The CEWG brief is to recommend alternative ways of funding R&D for medical products for diseases and conditions disproportionately affecting developing and least developed countries. These conditions do not represent lucrative markets for big pharma and as a consequence do not attract appropriate levels of investment.  Accordingly the policy goal is to delink the cost of R&D from the final over the counter cost of the product, which is borne by the patient.

In the 130th EB session in January, a shorter version of the CEWG report was discussed although the full report came out later in April. The CEWG recommended working towards a binding agreement on financing and coordination of R&D.

There was some reluctance among some Member States regarding the binding character of the proposed instrument on health R&D and reluctance to see it discussed at this Assembly.

The CEWG report lists the elements of the proposed binding agreement, providing a framework for negotiations. The proposed elements include, among others: Promoting R&D for developing new health technologies for addressing the global challenges constituted by the health needs of developing countries by securing access and affordability through de-linking R&D costs and the prices of the products; Securing sustainable funding to address identified R&D priorities in developing countries; Improving the coordination of public and private R&D; Enhancing te innovative capacity in developing countries and technology transfer to these countries; Improving priority-setting based on the public health needs of developing countries.

In its report, the CEWG proposes: (i) the establishment of a working group or technical committee to undertake the preparatory work on the elements of a draft agreement; (ii) the establishment of an open-ended inter-governmental working group with appropriate technical support (as in the case of the WHO Framework Convention on Tobacco Control). The CEWG also recommends the allocation of sufficient resources to support the working group.
On balance we consider that the time has come for Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries. This would also be in order to put on a secure footing the implementation of the GSPA-PHI which Member States agreed in 2008, and in particular the sustainable financing of R&D

[T]he time has now come for WHO Member States to begin a process leading to the negotiation of a binding agreement on R&D relevant to the health needs of developing countries, and this would be under Article 19 of the WHO Constitution.

PHM Comment

We commend the CEWG for its work and for maintaining a balanced and comprehensive approach, which is obvious in the elements it proposed and the recommendations put forward.

PHM supports working towards a binding instrument on health R&D focusing on diseases disproportionately affecting developing and least developed countries.

Big pharma’s arguments in support of the patent system as the principal driver for pharmaceutical innovation has left millions around this world without necessary medication. We believe there is a need to materialise the global moral obligation towards the poor, knowing that they do not represent attractive markets for big pharma R&D undertakings.

For this reason, a binding instrument is a strategy worth pursuing.
 
We are optimistic about this process; however, we were worried during the last EB session to see some countries attempting to slow down the process. We sensed reluctance among some member states which may reflect the pressures of Big Pharma.

The WHO should ensure full transparency when undertaking this exercise. The setting up of committees and working group should be protected against vested interests of for-profit organisations. Identification of the different partners and non-State actors should be managed and overseen by Member States. We expect to see the principles articulated in the WHO Reform documents regarding conflict of interest being expressed in relation to the CEWG work (particularly because the very reason the CEWG now exists is an episode of corporate penetration of the WHO’s supposedly independent processes.  

Watchers' Report of Discussion at WHA65

Member states at the 65th World Health Assembly (WHA) adopted a resolution calling for increasing investments in health research and development (R&D) which corresponds to the needs of developing countries.

The resolution, however, was far from suggesting a binding instrument as recommended by the report of the Consultative Expert Working Group (CEWG) on R&D financing and coordination, which was under discussion during this WHA, and as proposed in drafts submitted by some delegations.

Besides calling for increased health R&D investments, the resolution requests the regional WHO committees to discuss the CEWG report at their 2012 meetings, and requests the Director General to hold an open-ended Member States meeting to analyse the feasibility of the recommendations contained in the report.

The adopted resolution text was developed by a drafting group established during the WHA to work on several proposed drafts submitted by a number of delegations and country groups: 1) Kenya; 2) Switzerland; 3) Union of South American Nations (UNASUR); 4) Australia, Canada, Japan, Monaco and USA.

The draft by Kenya suggested a “WHO Convention” on R&D financing and coordination, while that of UNASUR suggested a “binding agreement”. The other two resolutions shared an operational paragraph on analysing the feasibility of CEWG recommendations at national level, with no reference to a binding instrument.

Despite this reluctance from a relatively large number of countries to proceed towards a binding instrument, the resolution was considered a positive step in the view of Member States wishing to take this issue forward.

Creating a drafting group was suggested by Switzerland, proponent of one of the texts proposed. After suspending discussions on this agenda item for some time till the reporting of the drafting group, Argentina made a point of order saying that this was an important issue and should be discussed before the start of this working group.

Paraguay speaking on behalf of UNASUR, noted that the report underlined the importance of the regional and national strategy to promote generic medicines and comprised a clear call for action for MS to act within a global framework.

Congo, speaking on behalf of the African Region, stated that most African countries are in favour of a legally binding instrument, and called for accelerating the process in order to relieve the suffering of African people. Congo emphasised the need of finding new ways for mobilising resources also from the private sector are needed.

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 said.

Brazil said MS should initiate a debate on how to implement the recommendation by CEWG with an open heart. “We should not fear controversy”, Brazil assured.

Libya, speaking on behalf of EMRO, supported the draft proposal submitted by UNASUR, hoping that this will be the end of debate on this matter.

Denmark speaking on behalf of the European Union, asked for more clarity on R&D expenditure, and on where the issue of the CEWG will be

The USA said they did not support a binding mechanism on financing. The USA noted that many other countries were not prepared either. According to the USA, history does not suggest that a central mechanism would support innovation.

China said that intellectual property rights are not enough, and that developing countries lack effective health technologies, and supported the WHO in playing a leading role in health R&D by establishing a global finance and coordination mechanism in order to avoid duplication and confusion.

Japan, a cosponsor of one of the draft texts, said that some options in the report must be analysed in terms of feasibility and financial implications. Japan also highlighted the need to combine technical cooperation, knowledge transfer and capacity building.

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

Several public interest non-governmental organisations intervened on this issue. They noted that the patent system as the principal driver of pharmaceutical innovation has failed to deliver the medications needed for conditions faced in developing countries. They said the proposed instrument would give a material reality to the global moral obligation towards the poor.

NGOs expressed their concern to see certain reluctance among some Member States regarding the binding character of the proposed instrument. They called on Member States to adopt and implement the recommendations of the CEWG with all urgency and to ensure full transparency at all levels of this process.

Despite the absence of reference to a binding agreement on health R&D in the final resolution, the text was welcomed by all MS. The process and will of MS was commended.

Paraguay, speaking on behalf of UNASUR, appreciated the will of all Member States to achieve consensus and expressed its satisfaction towards the result.

Denmark, speaking on behalf of the EU, welcomed the outcome of the drafting group, and reaffirmed its support to the WHO Secretariat to find the most appropriate and cost effective sequence of solutions.

Resolution WHA65.22 adopted.

Post-debate comment

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