Full Agenda For WHO: Reform, R&D Convention, Substandard Medicines, NCDs, Pandemics

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With just over two weeks until the annual UN World Health Assembly begins, member states face a substantive agenda, including a sweeping reform programme, an innovative public health proposal, the global strategy for the prevention and control of noncommunicable diseases, a mechanism to fight poor quality medicines, and progress in pandemic influenza preparedness.

In preparation for the 65th annual World Health Assembly (WHA), the annual WHO member gathering to be held on 21-26 May, country delegations are in the process of solidifying national and regional positions on a wide range of essential public health issues. These include spurring R&D for diseases primarily affecting developing countries, setting global targets on noncommunicable diseases (NCDs), and addressing substandard medicines.

Beyond these public health issues, member states will be asked to make decisions on organisational reform and confirm the nomination of Margaret Chan for a second term as director general.

All documentation for the 65th WHA is available here.

Member States Consider R&D Convention

“We all know that patent rights are not working as an adequate incentive mechanism for R&D of treatments for so many diseases affecting developing countries,” said Claudia Chamas, vice chair of the Expert Working Group on Research and Development: Financing and Coordination (CEWG). She presented the context of the group’s work during a Geneva-based permanent missions briefing held at the WHO on 27 April.

“Due to this market failure, we are proposing a supplementary measure,” said Chamas. In accordance with its mandate, set by the 63rd WHA in 2010, the CEWG has released its final report for the consideration of the upcoming Assembly (IPW, WHO, 20 April 2012).

During the recent briefing, John-Arne Røttingen, CEWG chair, summarised the report and its key recommendations. They include innovative approaches to stimulate R&D related to diseases specific to developing countries, suggestions on a funding mechanism, strategies for pooling resources and knowledge, and ideas on how to coordinate global efforts. Importantly, the report recommends setting negotiations in motion to establish a binding global instrument for R&D, innovation and health.

“We saw a convention as the best way to ensure that such a global framework is solid,” said Røttingen. Now, it’s up to member states to consider the recommendations and decide on the way forward.

Walking out of the briefing, several participants said that it was too early to comment on the report. A delegate from a Latin American country said, “We really do not have an opinion because the Spanish translation was just made available this week. So, we have two weeks to read and digest a 200-page report.”

Other countries were already enthusiastic about the key contents. A delegate from a different Latin American country said, “We do not yet have an official position, but I have heard positive reactions from a wide range of stakeholders from the capital.”

However, some countries showed signs of reservation. A delegate from a European country said, “Based on what they were asked to do, they came up with a good proposal that provides a good start to a problem that we are trying to tackle. It would be fine if that were the only health problem that we were facing. But, it’s not. There are other funding needs and other initiatives. We will have to wait to see what comes out of the WHA.”

[Update:] At least one country appears likely to request more time to review the convention recommendation. According to a draft copy of a Swiss proposal, the country may call for “informal, in-depth consultations with Member States on the appropriateness and feasibility of the recommendations contained in the report, in particular concerning a globally binding instrument on research and development, together with the funding implications of such an instrument.” Switzerland suggests that views be presented at next year’s Health Assembly, following the consultations and discussions in regional committees (IPW, WHO, 3 May 2012).

Exceptionally, the briefing session was open to all WHO observers. Several non-governmental organisations (NGOs) were in attendance, including Médecins Sans Frontières (MSF, Doctors without Borders), the Medicines Patent Pool, Knowledge Ecology International (KEI), and the Berne Declaration.

These groups have widely shown their support of the CEWG report since its publication on 5 April. The Medicines Patent Pool’s statement on the report is available here and the MSF’s Global R&D Convention issue brief is available here [pdf].

As member states work on forming official positions, the CEWG’s recommendations continue to be discussed in various settings. The Graduate Institute in Geneva will host a public seminar on “Strengthening the global R&D system: innovation for health needs in a developing countries” on 4 May. Speakers will include Chinese Ambassador Liu Zhenmin, Kenyan Ambassador Tom Mboya Okeyo, economist and recipient of the Nobel Memorial Prize, Joseph Stiglitz, and CEWG Chair John Røttingen.

Another missions briefing will be held for Member states and WHO observers on the second day of the WHA.

Toward Global NCD Targets

Another key agenda item is the “Prevention and control of noncommunicable diseases (NCDs).” It received numerous comments from stakeholders during a recent meeting organised by the US Department of Health & Human Services (HHS), charged with leading the US delegation, in preparation of the WHA.

Many public health groups such as the American College of Cardiology (ACC), the Preventive Health Partnership, and LiveStrong (the Lance Armstrong Foundation) gave their support of a global monitoring framework, including indicators and targets, for the prevention and control of NCDs. Informal discussions have been underway at the WHO this past year on the implementation of a global strategy. Some health advocates urged the US delegation to press for action and called to push for a timely implementation of targets.

On behalf of the ACC and the NCD Alliance, Neal Kovach, director of international affairs of the ACC, said, “We feel strongly that the WHO needs to pass ten targets this year in order to appropriately tackle NCDs in the years ahead. This must include the inclusion of the targets on access to medicines, transfats, alcohol, and obesity.” The ACC also backs the NCD Alliance’s position on the WHO NCD consultations which is available here [pdf].

Krista Cox, staff attorney for KEI, commented that the discussion underway is not giving enough attention to improving access to treatment, noting that the agenda item only refers to prevention and control. She also emphasised the importance of the use of flexibilities under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), such as compulsory licences, to address access inequalities. Cox raised concerns that the US has made efforts to keep the WTO Declaration on TRIPS and Public Health out of the NCD conversation.

“We were therefore extremely disappointed in the outcomes of the High Level Meeting of the General Assembly on the Prevention and Control of NonCommunicable Diseases (NCDs) in September 2011. Although early drafts of the Declaration on NCDs included clear references to the Doha Declaration on TRIPS and the Public Health and TRIPS flexibilities, the final Declaration removed any mention of the Doha Declaration. Reports have indicated that the United States played a key role in purging references to the Doha Declaration,” Cox said.

New SSFFC Mechanism for Approval

A high-profile decision on the table is the adoption of a resolution on poor quality medicines. After convening in Geneva on 25-28 October, the working group on Substandard/Spurious/ Falsely-Labelled/Falsified/Counterfeit Medical Products (SSFFC) proposed the establishment of a new WHO mechanism to fight substandard medicines. The group’s recommendations were transmitted, considered and adopted by the Executive Board at its 130th session in January 2012 (IPW, WHO, 11 January 2012).

This Assembly is invited to adopt the resolution as recommended by the Board. The resolution would “establish a new Member State mechanism for international collaboration among Member states, from a public health perspective, excluding trade and intellectual property considerations, regarding ‘substandard/spurious/falsely-labelled/falsified/counterfeit medical products’ in accordance with the goals, objectives and terms of reference annexed to the present resolution.”

The WHO’s role in the new mechanism would be to ensure the “the quality, safety and efficacy of medical products; in promoting access to affordable, quality, safe and efficacious medicines; and in supporting national drug regulatory authorities in this area, in particular in developing countries and least-developed countries.”

Trade and intellectual property issues were not included in the mechanism, ensuring a clear distinction between counterfeit and substandard medicines and legitimate generic medicines (IPW, WHO, 28 January 2012).

A potentially controversial issue, the WHO’s relationship with the International Medical Products Anti-Counterfeiting (IMPACT) still needs further clarification and could be discussed during this Assembly. The resolution states: “A way forward on this specific issue could emerge when the new mechanism is considered at the Sixty-fifth World Health Assembly.”

PIP Resource Allocation

The WHA is also an occasion to update member states on progress being made on mandated health initiatives and to provide an opportunity for them ask questions and make comments. One such key agenda item will be an overview of the work of the Pandemic Influenza Preparedness (PIP) Advisory Group and its recommendations to the director general.

In accordance with the “Pandemic Influenza Preparedness Framework,” which was approved during last year’s annual Assembly (IPW, WHO, 24 May 2011), the advisory group has developed a proposal on how partnership contributions should be allocated between preparedness and response based on consultations with various stakeholders. The director general will submit the proposal to the Executive Board, which should take a decision on the recommendations during its meeting following the Assembly.

The stakeholder consultations were held on 22-24 February in Geneva during which time the advisory group met with civil society organisations including KEI, People’s Health Movement, Third World Network, and South Centre. The group also met with over 15 participants from industry, including Abbott Biologicals, Baxter, Biotechnology Industry Organization, Developing Countries Vaccine Manufacturers Network, International Federation of Pharmaceutical Manufacturers Association (IFPMA), Novartis and Sanofi Pasteur.

Prof. Didier Houssin, PIP advisory group chair, told Intellectual Property Watch, “The meetings between the two categories of stakeholders were held separately. Civil society stressed the importance of capacity building in developing countries, while industry called for the demonstration of an efficient use of funds.”

“Despite some differences in priorities, both stakeholder groups agreed that a greater proportion of the resources should go toward preparedness measures,” Houssin told Intellectual Property Watch.

Based on these consultations, the advisory group has suggested that 70 percent of contributions be allocated for preparedness versus response activities. In case of a pandemic emergency, it allows the director general to modify this proportion. The advisory group is scheduled further define the breakdown of preparedness contributions during teleconference meetings scheduled on 3-4 May.

Beyond the allocation of contributions, the advisory group has advised the director general to develop a uniformed approach to sharing viruses to entities outside of the Global Influenza Surveillance and Response System (GISRS) prior to signing the Standard Material Transfer Agreement 2 (SMTA 2). In the meantime, the group also recommends the secretariat to commence SMTA 2 negotiations with industry before the upcoming Assembly.

Moving the WHO Reform Forward

While the 65th Assembly has a number of substantive public health issues to consider, it also has to move ahead on major reform of the organisation. The director general has submitted a report covering all areas of the WHO reform to the Assembly. Detailing the three reform areas (programmes and priority setting, governance and management), the report also provides an overview on the progress made over the past year and highlights where further guidance or decisions from the Assembly are needed.

As part of the reform discussion, the Assembly has been asked to consider “The Twelfth General Programme of Work” to guide the organisation from 2014-2019. A schema of the programme and notes has been submitted for consideration. Input from member states will be used to develop a first full draft, which will subsequently be presented to regional committees, the Programme Budget and Administration Committee of the Executive Board (PBAC) in November 2012, and the Executive Board in January 2013. A final document as well as the programme budget for 2014-2015 will be presented to the Assembly in May 2013.

Meanwhile, the nomination of Margaret Chan for a second term as director general of the WHO will also be submitted to the Assembly. Unopposed, Chan’s new term will likely start on 1 July 2012 and run through 30 June 2017. Her nomination was accepted by the 130th Executive Board during its meeting last January (IPW, WHO, 16 January 2012).

The Assembly will also be asked to consider progress in the achievement of the health-related Millennium Development Goals, global health goals after 2015, and a draft of a global vaccine action plan.

Related IP-Watch articles here, here and here.

Rachel Marusak Hermann may be reached at info@ip-watch.org.

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