World Health Assembly: R&D, NCDs, Pandemics Top Agenda

With just days before the UN World Health Assembly opens, member states once again face a packed agenda with key decisions to be taken on some highly-politicised public health and intellectual property matters, including how to move forward on the research and development draft resolution. The spotlight will also be on pandemic influenza preparedness, a resolution of size on noncommunicable diseases, the health-related Millennium Development Goals, and putting some reform decisions into practice.

The sixty-sixth session of the World Health Assembly (WHA66) is taking place in Geneva from 20-28 May.

On many fronts, this WHA is shaping up to be a defining meeting in public health decision-making. With the emergence of two new viruses, the world will pay particular attention to WHO pandemic preparedness, while the public health authority’s role in coordinating global efforts to prevent noncommunicable diseases (NCDs) may be strengthened. From an IP and public health perspective, the question of whether or not to open the draft resolution on R&D for diseases primarily affecting developing countries will be central. Other key issues include moving forward on the Global Vaccine Action Plan, preventing neglected tropical diseases, and the contentious issue of addressing substandard medicines.

An Urgent Call to Re-Open the R&D Resolution

Among public health and intellectual property circles, the future of the resolution on the work of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) is one of the most important issues before member states next week. Namely, whether it (A66/23) should be re-opened, or not.

An issue with a long history at WHO, the CEWG report, submitted in April 2012, stated that action was required to address the current incentive system’s failure to generate the research and development, in either the private or public sectors, needed to meet urgent healthcare needs in developing countries. In the follow-up to the report, an open-ended meeting of member states was held last November, resulting in a late-night consensus on a draft report and a draft resolution, which was deemed weak by many developing countries and advocates fighting for equitable access to medicines.

In particular, critics have taken issue with the line in the report that “strongly recommends…the adoption of the draft the resolution by the World Health Assembly without reopening it.” During the last Executive Board meeting in January, a particularly heated debate erupted over whether or not the Assembly, the WHO decision-making body, could be told what to do. Legal counsel advised that the WHA could indeed re-open it (IPW, WHO, 28 January 2013).

Currently, the resolution contains three areas for action: establishing a global health R&D observatory, setting up ‘demonstration projects’, and developing norms and standards to better collect data on health R&D. Some member states including China, Cuba, and 11 members of UNASUR (The Union of South American Nations), have already expressed support for re-opening it to strengthen this operative section.

Civil society widely supports this position. A joint letter signed by over 40 organisations including Health Action International (HAI), Knowledge Ecology International (KEI), Médecins Sans Frontières (MSF, Doctors Without Borders) Access Campaign, Oxfam, Peoples’ Health Movement, Third World Network (TWN), and Universities Allied for Essential Medicines (UAEM) was published today. It calls on countries to amend the resolution by clarifying and broadening the scope of the proposed actions.

In particular, the letter urges member states to anchor the resolution in the CEWG report, noting, “more clarity is needed to provide assurances that these demonstration projects are predicated upon the principles outlined in the CEWG report, including de-linking the cost of R&D from the price of health products.”

This proposal is likely to get pushback from countries including the US and Australia, which said during the last Executive Board meeting that the resolution was the “best outcome possible,” warning that re-opening it could lead to stalemate and no agreement at all.

New Viruses Shine Spotlight on Pandemic Preparedness

With the increasingly worrisome outbreaks of two new viruses – avian influenza A(H7N9) in China and novel coronavirus in the Mediterranean region and France – the importance of WHO’s Pandemic Influenza Preparedness (PIP) and the sharing of influenza viruses and access to vaccines will be all the more apparent during this WHA.

Effective as of May 2011, the PIP Framework addresses a longstanding North-South inequity when it comes to virus and vaccine sharing. Developing countries have frequently expressed concern that if they share virus strains with the WHO network, they may not have access to the treatments that are developed, or be forced to pay high prices for them if a northern company gets a patent.

Next week, member states will review the PIP Framework 2013 biennial report (A66/17) and the report of the most recent PIP Advisory Group meeting (A66/17 Add.1), which was held in Geneva from 20 to 22 March. During this meeting, this WHO panel of influenza experts reviewed progress by the secretariat in closing standard material transfer agreements (SMTA-2, the contract providing for virus sharing outside the traditional WHO system) and in developing the Partnership Contribution (the formula used by WHO to bill companies benefiting from the virus sharing system). Additionally, the PIP Advisory Group met with industry and civil society to further discuss the Partnership Contribution.

Many Unknowns on WHO Efforts to Prevent Substandard Medicines

Progress by the newly formed member state mechanism working on the infamously poorly named issue of “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products is much more difficult to come by. At the time of writing, documentation (A66/22) on the SSFFC agenda item is not available on the WHO website. Queries to WHO secretariat as to the reason why remain unanswered.

The mechanism held its first meeting in Buenos Aires last November and the Executive Board noted its report in January. As a final agreement on the mechanism was not reached in Argentina, the mechanism was due to meet again before this Assembly (IPW, WHO, 28 January 2013).

When it comes to defining the scope, however, one aspect has been made very clear: the WHO’s role in preventing the circulation of these often dangerous medical products is limited to the public health dimension and will not get into trade or intellectual property considerations. Nonetheless, it’s a fine line to tread considering that IP rights are inherent in the reference to counterfeit products, which concerns trademark violations.

Toward a Resolution on Neglected Tropical Diseases

On the prevention, control, elimination and eradication of neglected tropical diseases (A66/20), the Assembly is invited to adopt the draft resolution recommended by the Executive Board in January (EB132.R7). Efforts by some countries to include a reference to the CEWG report on R&D were met with strong resistance from Europe and the US and it was left out in the end. However, a reference to the WHO Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property, the initiative that led to the CEWG, was included (IPW, WHO, 28 January 2013).

The resolution contains a wide range of recommendations to countries on how to take on the problem, including encouraging initiatives for the discovery and development of new diagnostics and medicines. Additionally, it calls for the expansion and implementation of targets established by WHO and other stakeholders, including industry and the Gates Foundation, in the 2012 London Declaration.

A central element of the initiative has involved major contributions by pharmaceutical companies of medicines to treat these diseases, which primarily affect some of the world’s poorest communities. Some civil society organisations, such as MSF, warn that while donations are an important part of the solution, charity is not sustainable and a long-term solution is urgently needed (IPW, WHO, 16 January 2013).

Identifying Gaps in the GVAP

In a big year – and decade – for vaccines, the Assembly is invited to take note of a report (A66/19) on the Global Vaccine Action Plan (GVAP), including a proposed framework for monitoring and evaluation and accountability.

The Decade of Vaccines (DoV) was launched in 2010 by a range of stakeholders including WHO and the Gates Foundation and is more focussed on health and delivery systems than intellectual property rights to improve access to high-quality vaccines. As part of the DoV process, member states approved the GVAP at last year’s Assembly, providing a roadmap on how countries should scale up vaccination activities in the coming years.

The Monitoring and Evaluation Framework, which member states will review next week, provides indicators and targets for the Decade of Vaccines. MSF has been particularly vocal about gaps in the framework, notably that it needs an indicator to track vaccine prices and a more ambitious goal on developing new and improved vaccine technologies (IPW, WHO, 22 April 2013).

Noncommunicable Diseases: A Big Agenda Item

Addressing NCDs is once again high on the Assembly agenda. Since the adoption of the United Nations Political Declaration on NCDs in September 2011, the WHO has taken a leading role in coordinating global efforts in addressing the four main NCDs, which are cancer, diabetes, cardiovascular, and chronic respiratory diseases. In fact, according to a recent WHO perception survey, addressing NCDs is seen as the organisation’s most important area of work.

Member states have several decisions to take on NCDs and are considering combining them in an “omnibus resolution”. It could seek to adopt the Global Monitoring Framework (A66/8), which includes a set of 25 indicators to assess progress made at the national level and nine voluntary targets for preventing and controlling NCDs globally. The outcome of a formal member state meeting held in November 2012, this framework was endorsed during the last EB meeting.

Additionally, member states will consider endorsing the Global NCD Action Plan 2013-2020 (A66/9), which provides a roadmap via policy options at the local, regional, and global level, to achieve the voluntary targets. One option that has garnered particular attention is a Global Monitoring Mechanism, which would solidify WHO’s key role in addressing NCDs as lead coordinator.

Discussions on establishing a mechanism may be the cause of some debate as some member states have already been calling for more time to discuss the initiative, while others are concerned about the resource implications. Meanwhile, the NCD Alliance, an international network of non-governmental organisations which receives some private sector funding, is calling on member states to move forward on the mechanism sooner rather than later. Katie Dain, director of Policy & Campaigns for the NCD Alliance, told Intellectual Property Watch “we cannot afford to delay this decision any longer. Member States made a promise at the UN High-Level Meeting on NCDs in 2011 to strengthen and facilitate global multisectoral action on NCDs, and at WHA they must fulfil that promise.”

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) also supports the NCD action plan and the establishment of a Global Monitoring Mechanism. Mario Ottiglio, director of Public Affairs and Global Health Policy at the IFPMA, told Intellectual Property Watch that it is “an encouraging example of how involving the expertise of multiple stakeholders is an effective approach to global public health challenges.”

IFPMA is also encouraging a collaborative approach in how the WHO addresses mental health disorders, a topic member states will address when member states consider adopting the draft comprehensive mental health action plan 2012-2020 (A66/10). The industry association will host a side event on 20 May on the impact of mental and neurological disorders in global health.

Reform, Work Programme, and Budget

When it comes to WHO reform, one of the key issues to be discussed for approval will be the general programme of work (A66/6) for the period of 2014-2019. Streamlined and more closely tied to the budget, this strategic plan provides a vision for the organisation, focussing on six areas of leadership. They include accelerating the achievement of the health-related Millennium Development Goals (MDGs), addressing NCDs, implementing the International Health Regulations, increasing access to medicines, and addressing social determinants of health.

To finance the first two years of this programme, member states have a 2014-2015 budget (A66/7) on the table. For the first time, the Assembly will be asked to approve the organisation’s entire budget, from all sources, not just the assessed contributions made by member states. The proposed budget of about US$ 4 billion keeps the organisation’s projected income and spending at about the same level as 2012-2013.

Once the budget is approved, a new financing dialogue open to member states and other major WHO financial contributors – such as the Gates Foundation – could be held to coordinate the rest of the financing. Only 23 percent of the organisation’s financing comes from membership fees, while the rest is derived from voluntary contributions, including non-state actors. In the end, the new budgeting system is meant to give member states greater financial oversight.

While some of the key areas of governance reform including WHO’s role in global health governance and coordination of engagement with non-state actors are not on this agenda, member states could open discussions on these topics, according to the Secretariat during a WHA briefing earlier this week. These items will be formally discussed during the Executive Board meeting, which will be held immediately following the Assembly from 29-30 May.

Brittany Ngo contributed to this article. Brittany is currently completing her Master’s in Health Policy and Global Health at the Yale School of Public Health and previously obtained a Bachelor’s of Arts in Economics from Georgetown University. Through her studies she has developed an interest in health-related intellectual property issues.

Other related articles:

http://www.ip-watch.org/2012/05/25/world-health-assembly-agreement-reached-on-neglected-disease-rd-process-but-no-convention/

http://www.ip-watch.org/2012/05/24/world-health-assembly-rd-drafting-group-documents-show-country-differences/