North-South Split over R&D Financing and Counterfeits at World Health Assembly
Controversial issues related to intellectual property rights (IPRs), innovation, and access to medicine dominated debates at last week's meeting of the World Health Assembly, the top decision making body of the World Health Organization (WHO).
Particularly contentious were discussions on the implementation of a 2008 plan to create new incentives to drive innovation and to finance health research and development for diseases afflicting the world's poorest people.
Talks on the implementation of the plan, called the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, witnessed a wide divergence of views between developed and developing countries about how to move forward the WHO's activities.
A separate issue, WHO policies to combat counterfeit medical products, polarised countries along similar lines. The issue has been in the spotlight over the past year and a half, after customs authorities in Europe seized and temporarily held several shipments of generic medicines that were en route from India to Brazil, inaccurately claiming they were counterfeit. Brazil and India recently launched a WTO case against the EU, arguing that its customs regulations violated WTO rules on freedom of transit.
Pandemic flu preparedness
Also discussed during the World Health Assembly was pandemic influenza preparedness and the related policies for sharing influenza viruses and access to vaccines.
Responding to criticism that the WHO had overreacted to the H1N1 outbreak, Director-General Margaret Chan defended the organisation's response, noting that it had simply been a matter of chance the virus did not mutate to become more lethal, and that cases of drug resistance remained rare. "Sometimes, we are just plain lucky," she said.
Countries praised the WHO for its efforts on pandemic influenza preparedness in their statements at the WHA.
During the proceedings, member states stressed the need for timely and equal access to vaccines. Several developing countries expressed the view that considerations about intellectual property rights should be set aside when dealing with a pandemic.
For several years, WHO members have been seeking to finalize a pandemic influenza preparedness framework for sharing influenza viruses and access to vaccines and other benefits. Pending issues include a Standard Material Transfer Agreement (SMTA) and relations with influenza vaccine manufacturers, as well as intellectual property rights. Consensus was easily attained on a resolution calling for the WHO to continue deliberations in an ‘open-ended working group' on these issues with a view towards reaching a final agreement.
Research and development financing
Talks on the WHO-led efforts to find options for financing research and development, and for creating new incentives for medical innovation to address the health needs of poor countries, were considerably rockier.
Early in the week, discussions began on the report of a WHO Expert Working Group on R&D Financing (EWG), established in November 2008 as part of the implementation of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property,
Many developing countries including India. Brazil, Thailand, and the Union of South American Nations (UNASUR) bloc expressed dissatisfaction with the report. They argued that the EWG had not properly followed its mandate, and that the report lacked detail and clear justification for its recommendations.
Furthermore, they said, the EWG report failed to address important IP-related issues such as the idea of de-linking the R&D costs from the price of medical products. It also did not do enough to present developing countries with options for sustainable funding mechanisms.
Amidst the discontent, regional groupings of developing countries tabled two different proposals for future efforts in this area. The Union of South American Nations proposed establishing an intergovernmental working group to continue and deepen the work on R&D financing. The African Union and the Eastern Mediterranean region called for the creation of a new expert working group.
In contrast, the European Union and the US welcomed the EWG's report, noting that the panel's mandate was subject to interpretation. They expressed reservations about spending more resources on an intergovernmental process.
With member states split on how to take the work forward, a drafting group was created, chaired by Switzerland. Following intensive consultations, the group reached agreement on Friday afternoon on a draft resolution calling for the establishment of a ‘consultative' expert working group. This new group will take forward the work of the EWG by deepening the analysis on proposals included in the report as well as on those that were left out. The consultative group will also look at brand new proposals. WHO members are to nominate experts for appointment to the new group by the WHO Executive Board. The group is scheduled to submit its report to the 2012 World Health Assembly.
Several civil society organisations that had been critical of the EWG report welcomed the outcome of last week's discussions.
Health Action International (HAI), for instance, sees the consultative expert working group as a real chance to "address some of the inefficiencies and flaws of the current R&D system, which does not meet the health needs of many people in the developing world."
We now have a "brand new opportunity and a fresh and strong mandate to de-link R&D costs from product prices," said James Love on behalf of Knowledge Ecology International (KEI).
Counterfeit medical products
Discussions on counterfeit medical products centered on the WHO's role in combating counterfeit medical products, particularly its partnership with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
As with the EWG report on R&D financing, the week opened with member states unable even to agree on the way forward. Small groups of countries met informally to hash out some ideas on how and where to discuss the issue.
The heated, sometimes aggressive, discussions were largely led by Brazil and India with the support of some African countries such as Kenya.
Brazilian Ambassador M.N. Farani Azevêdo was applauded for insisting that "we must call a spade a spade," by which she meant that countries should not promote commercial interests under the guise of combating medical products of compromised quality, safety and efficacy.
There was widespread agreement among delegates that the term "counterfeit" in the context of the discussions should be replaced so as not to be confused with patent-related issues. Since agreement on a new definition during the WHA was impossible, delegates followed WHO chief Chan's suggestion to use the term "spurious/falsely-labeled/falsified/counterfeit medical products" in the meantime.
Developing countries stressed that the WHO's role should strictly be to look at counterfeits from a public health perspective, and that it should stay away from intellectual property aspects. They also complained about the WHO's relationship with IMPACT, with some suggesting the WHO "divorce" itself from this partnership, which includes groups that represent the interests of major pharmaceutical firms.
"The role of IMPACT is controversial," said India, adding that governments should be the ones in charge of the fight against counterfeit medicines.
Despite the initial standstill, members were ultimately able to reach a compromise on the way forward. An informal drafting group chaired by Iran finally proposed a single draft decision late on Friday afternoon. As per the decision, a time-limited and result-oriented intergovernmental working group will be established to address, from a public health perspective: a) the WHO's role in ensuring availability of safe efficacious and quality medical products, b) its relationship with IMPACT, and c) its role in the prevention and control of medical products of compromised quality, safety, and efficacy. The working group will report back to next year's session of the World Health Assembly.
In her closing remarks, the WHO director-general thanked countries for reaching consensual outcomes on the two contentious issues. "We have just seen two examples, shall I say hot off the press, of this spirit of collaboration and consensus-seeking," she said. "Thank you for finding a way forward on the issues of research and development financing and substandard, spurious, falsely-labelled, falsified, counterfeit medical products."
The decisions reached during the WHA open a new programme of work for the WHO on R&D financing and counterfeit products. Both are likely to be the subject of increased interest in light of the controversy at this year's assembly.