WHO Experts On R&D Financing Aim To Find Solutions, With Short Timeline

The search for innovative solutions to engage research and development of health products for diseases that particularly affect developing countries is the core mission of a World Health Organization working group that met this week in a mostly open session. The group of experts will assess proposals and deliver its recommendations next year.

Over the next few months, the working group will analyse a range of complex proposals coming from different stakeholders and will submit their report at the World Health Assembly (WHA) in May 2012. During their first meeting, this week, the working group did not discuss any proposals but better defined their mandate, work plan, and approach to addressing potential conflicts of interest.

The Consultative Expert Working Group on Research and Development: financing and coordination (CEWG) met from 5-7 April. It was the first meeting of the group, set up at the last WHA, to succeed to a previous group, the Expert Working Group (EWG), whose work was criticised by member states and stakeholders as lacking transparency and being tainted with conflict of interest.

The mandate given by the WHA to the CEWG was to take the work of the EWG forward, CEWG Chair John Arne Røttingen, an adjunct professor in health policy at the Faculty of Medicine, University of Oslo, Norway, said at a briefing closing the meeting yesterday.

However, the group discussed the mandate given to them by resolution WHA 63.28 [pdf], “to understand how to take the work forward,” said Røttingen. The group decided that its core mandate was to help deliver on two elements of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA). These are element 2 on “promoting research and development”, and element 7 on “promoting sustainable financing mechanisms.” The EWG’s work was mainly focused on element 7 of the strategy.

Beyond those two core elements, the group also sees its work as an integral part of the global strategy and will take into account the interrelation with other elements of the strategy, like element 1 “prioritising research and development needs,” element 3 “building and improving innovative capacity”, element 4 “transfer of technology,” element 5 “application and management of intellectual property to contribute to innovation and promote public health, and element 6 “improving delivery and access,” and in particular how proposals address the availability issue, Røttingen said.

Proposals that were considered by EWG will be analysed by the group, which will also consider new submissions. The invitation for submissions should be open by the end of April and remain open until mid-June.

CEWG will work differently than EWG, the chair said, as it will not categorise proposals but rather include all proposals after their qualitative assessment. EWG had a scoring system of proposals, with a large number of criteria and a threshold of acceptability, Røttingen said. “We will have a more flat analysis,” he said. All proposals will be assessed and an overall assessment of strength and weaknesses for each proposed mechanisms will be given by the group.

The group will also look at potential synergies between proposals, how they would fit together in the “broader picture,” if possible, he said. Independent assessments of existing proposals are also welcomed by the group.

Regional Meetings to be Organised by WHO

The WHA resolution calls for the group to examine regional feasibility of the proposals. “This is a challenging task,” the chair said, given the timeframe of the working group. The group decided to use consultations as side events to WHO regional committee meetings in all WHO regions, starting at the end of August, until early October. The WHO secretariat will have the main responsibility to organise those consultations with the regional offices, he said.

“There is a need for further analysis for local and regional applicability, but it needs to done by local policymakers, and not by global experts, because those are local policy issues,” Røttingen said.

The group will reconvene on 7-8 July, and on 17-18 November. According to WHA resolution 63.28, the CEWG should submit its work plan and inception report to the 129th WHO Executive Board in May, and a progress report to the 130th WHO Executive Board meeting in early 2012, and submit its final report to the 65th WHA in May 2012.

The co-chair of the group is Claudia Inês Chamas, coordinator of the area of innovation, intellectual property and programme development of the Economic Institute of the Federal University of Rio de Janeiro, Brazil. The group also elected four rapporteurs: Bongani Mawethu Mayosi, professor and head of the department of medicine of the Groote Schuur Hospital and the University of Cape Town, South Africa; Leizel Lagrada, division chief, Health Planning Division, Health Policy Development and Planning Bureau of the Philippines; M.C. Goyal, additional secretary and director general of the Department of Health and Family Welfare of India; and Hilda Harb, head of the Department of Statistics, Ministry of Public Health, Lebanon. All WHO regional offices are represented with these nominations.

WHO Director General Margaret Chan, in her opening speech to the meeting, said that “fair access to essential medicines has been a high priority for WHO since its inception in 1948.” And although this priority has been expressed in a large number of programmes and initiatives, she said, those did not “tackle the root causes of inequitable access to medicines.”

Referring to the conflict of interest issue, she said, “In my view, if there is any bias in your work, it should be to give a louder voice and a bigger say to the health needs of the poor.”

Managing Conflicts of Interest

On the first day of the meeting, members discussed how to best handle the issue of potential conflicts of interest. The WHO legal counsel gave a presentation on key points of the revised WHO Guidelines for Declaration of Interest issued in June 2010.

After assessing potential conflict of interest among CEWG members, according to the declaration of interest form that were completed by all experts, the legal counsel found four cases of potential conflict. In one of those cases, it has been recommended that the expert, an employee of Novartis and a sponsor of one of the proposals, excuse himself from the part of the meeting during which that proposal is discussed.

The WHO secretariat publicly disclosed the following: Paul Herrling of Switzerland is an employee of Novartis (which stands to gain considerably from recommendations of the expert group); Moroccan expert Rajae El Aouad Berrada holds a patent relating to tuberculosis vaccine; Japanese expert Shozo Uemura is a patent attorney and works in a law firm which provided legal advice to pharmaceutical clients (and is a former World Intellectual Property Organization deputy director general); and South African expert Bongani Mayosi, is head of a department which has several times received funding from the pharmaceutical industry.

Carlos Correa, the expert from Argentina, said in this week’s meeting that in the case of Herrling, the conflict of interest could go well beyond his sponsoring of a particular proposal. Correa proposed that the conflict of interest strategy be broadened so that any member of the group has the right to make a petition at any time saying that a member of the group has a conflict of interest in connection with the issue being discussed.

During the briefing, the chair said the group would follow the advice of the legal counsel, that when a member has been involved in a proposal, he/she should excuse themselves from the discussion on that proposal. That would apply to any members submitting new proposals or mechanisms. Members of the group can also denounce potential conflicts of interest at any time, he said.

The second day of the meeting was devoted to an open forum where stakeholders presented their proposals, many of which had already submitted their project to the EWG.

Among the submitters were the Drugs for Neglected Diseases initiative (DNDi), Medicines Patent Pool, Council on Health Research for Development (COHRED), Knowledge Ecology International (KEI), Third World Network (TWN), Médecins Sans Frontières (MSF), and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).