World Health Assembly: IP Considerations Play Key Role In Final Outcomes

Wrapping up one day early, the 66^th World Health Assembly adopted a range of public health resolutions and decisions, some with key intellectual property implications, including a decision to convene a technical meeting on new public health R&D projects, a compromise on advancing the poor quality medicines mechanism, and resolutions on both neglected tropical diseases and noncommunicable diseases. Importantly, the novel coronavirus situation drew attention to WHO’s progress in pandemic influenza preparedness.

At this WHA, which met from 20-27 May, the impact of IP rights in the context of public health was highlighted as Director General Margaret Chan took a particularly firm stance on the issue. In no uncertain terms she said, “No intellectual property should stand in the way of you protecting your people.”

Update on Influenza Preparedness

During the closing plenary session, Chan said in her address that the novel coronavirus was the “greatest concern right now.” She called on countries to work together to control the spread of the virus because “the novel coronavirus is not a problem that any single affected country can keep to itself or manage all by itself. The novel coronavirus is a threat to the entire world…. We need to bring together the assets of the entire world in order to adequately address this threat. We need more information, and we need it quickly, urgently.”

[Update – The WHO has accepted a new name for the novel coronavirus, the Middle East Respiratory Syndrome Coronavirus (MERS-CoV).]

In this context, the Assembly took stock of the organisation’s efforts to improve its preparedness in the event of a major global influenza outbreak. Member states took note of a report on its pandemic influenza preparedness (PIP) framework, which highlighted progress that has been made in negotiating standard material transfer agreements 2 (SMTA2), the contract providing for virus sharing outside the traditional WHO system, and in developing the Partnership Contribution, the formula used to charge companies benefiting from the virus sharing system (IPW, WHO, 27 May 2013).

During committee discussions on this report, some developing countries emphasised the need for fair access and benefit sharing of the resulting treatments, a longstanding issue, which the PIP framework seeks to address.

Advancing Health R&D Projects, NTD Strategies

On addressing gaps in global health R&D, the Assembly gavelled the resolution contained in the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) approved a decision proposed by the US (IPW, WHO, 27 May 2013).

Under the decision, the WHO will convene an expert meeting, open to member states, which will inform the selection of health R&D demonstration projects in accordance with some key principles, such as open-knowledge, de-linkage, and sustainable funding. Coming from the US, which has strongly opposed these concepts in earlier negotiations, the proposal to member states and public health advocates by surprise.

Meanwhile, member states approved a resolution (A66/20) on the prevention, control, and elimination of neglected tropical diseases (NTDs). Overlapping with the CEWG issue, NTDs primarily affect the world’s poorest communities and lack adequate diagnostics and treatments due to the lack of market incentive to develop products in this area.

Prior to its passage, some member states raised concerns with the NTD resolution, in particular the emphasis on the London Declaration, an initiative launched in January 2012 between some pharmaceutical companies, international agencies, and civil society to accelerate progress on eliminating or controlling 10 NTDs by the end of the decade.

In committee, the delegate of Zimbabwe noted concern about the “vested interests of industry” and recommended removing all mentions of the London Declaration. A delegate from a developing country told Intellectual Property Watch that while donations of medicines are helpful, they do not support the development of local pharmaceutical companies.

Some countries including Brazil, Thailand, and India suggested amendments to the resolution. One of the most debated put the Global Plan to Combat Neglected Tropical Diseases 2008-2015, a member state driven process, ahead of the declaration, a change that member states approved.

Commenting on debate, Chan made an intervention during the committee discussions, referring to the London Declaration as a “watershed moment.” She emphasised the importance of the initiative in addressing NTDs and said, “this is one area where we need new thinking and public private partnerships.”

Major Resolution on NCDs

The most time-intensive agenda item, noncommunicable diseases (NCDs) consumed some 27 hours of committee and drafting group discussion. The Assembly approved a resolution (A66/A/CONF./1Rev.1), which endorsed the WHO global action plan for the prevention and control of NCDs 2013-2020 (A66/9). NCDs include cancer, diabetes, cardiovascular and respiratory diseases.

The global action plan comprises a set of actions that will work towards achieving nine globally agreed targets for NCDs (A66/8), including a reduction in premature mortality from NCDs by 25 percent in 2025. The action plan also contains a monitoring framework, including 25 indicators to track mortality and morbidity, assess progress in addressing risk factors, and evaluate the implementation of national strategies and plans.

Oleg Chestnov, the assistant director general for NCDs and mental health, said the adoption of the global action plan moved the discussion around NCDs from the political realm to the practical, and that it’s now time for member states to take action.

Delegates requested WHO to develop draft terms of reference for a global coordination mechanism through a consultative process that will convene a meeting of member states in November 2013. WHO was also requested to provide technical support to member states and to develop a limited set of action plan indicators to inform on progress made with the implementation of the action plan starting in 2016.

WHO officials have said IPRs should not be a barrier to access for NCD treatment and prevention technologies the way they are in the realm of NTDs and other communicable diseases. In a press conference on NCDs held this week, Shanthi Mendis, director of management of NCDs at WHO, said that most important medicines to combat NCDs are already off patent.

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in a statement during committee discussions that despite many medicines in the pipeline to treat NCDs “further innovation will certainly be needed.” The representative also said that the R&D-based pharmaceutical industry “is a part of the solution to addressing NCDs.”

Vaccine Pricing Concerns

On the Global Vaccine Action Plan (GVAP), the Assembly took note of the report (A66/19) that included the proposed framework for monitoring, evaluation, and accountability. In committee discussions, member states widely expressed their support of the plan, however vaccine accessibility and prices were central areas of concern.

The Nigerian delegation said there was minimal global guidance for tracking vaccine prices and such a tool would be important to enable financing of vaccine programs, especially for countries graduating from GAVI Alliance pricing schemes (the GAVI Alliance was formerly known as the Global Alliance for Vaccines and Immunisation). Nigeria called for a “framework to track vaccine prices.”

The US delegation said that the issue of vaccines concerned “far more than technology” and encouraged active collaboration in order to reinvigorate discussion around the need for a robust programme to lower costs of vaccines.

Other member states also noted the considerable variation of prices and that defining one indicator to monitor pricing would be challenging. Plans have been made to establish a special working group to look into this matter in 2014.

Progress on Poor Quality Meds Mechanism

Called to review a report on the member state mechanism on poor quality medicines – covering all products that are substandard, spurious, falsely-labelled, falsified, or counterfeit (SSFFC) – delegates widely expressed frustration on the slow pace of progress. Established at last year’s Assembly, the mechanism addressed the global problem from a health perspective, not taking into account intellectual property or trade considerations.

Since its first meeting held in Buenos Aires in November, members were blocked over the selection of a chairperson. Breaking the deadlock, this Assembly gavelled a decision proposed by Brazil to rotate the steering committee chairmanship (IPW, WHO, 26 May 2013). In the coming months, the mechanism should move forward on: establishing a working group on the actions, activities, and behaviours that result in SSFFC medical products; convening a technical consultation on the work plan; and a steering committee meeting.

WHO Executive Board

Following the close of the 66^th WHA, the 133^rd session of the WHO Executive Board will convene in Geneva from 29-30 May. A topic of high interest to be discussed is the role of non-state actors and addressing conflicts of interest in light of the new WHO reform that was approved during this Assembly.

William New contributed to this report.

Brittany Ngo 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. She is a summer intern at Intellectual Property Watch.