New R&D Group entangled in conflict-of-interest issues

2 Feb 2011

Geneva, 27 Jan (Heba Wanis) -- The Executive Board of the World Health Organization (WHO) accepted the appointment of a major pharmaceutical company executive as a member of the new WHO Consultative Expert Working Group (CEWG) set up to find ways to finance research and development (R&D) into diseases afflicting developing countries despite "conflict of interest" concerns.
These concerns had surfaced during a discussion on this agenda item last week, where it was announced that Mr Paul Herrling, the head of corporate research at the Swiss-based pharmaceutical giant Novartis, has been appointed as a member of the CEWG.
Not too long ago, a separate WHO-appointed Expert Working Group on Research and Development Financing (EWG) found itself embroiled in controversy, with its legitimacy in question on account of charges of conflicts of interest, as well as being perceived to be under the influence of Big Pharma. It was also criticized for failing its mandate and for lack of transparency in its work.
The Executive Board, which held its 128th session from 17-25 January, found itself having to deal with similar issues, as it worked to set up the CEWG to rectify the perceived shortcomings of the EWG.
[The CEWG was established as part of the roadmap negotiated at the 2010 World Health Assembly (WHA) in a bid to address the gaps in the EWG report, as well as to take forward the work of the EWG. The roadmap identifies an extensive process for the selection of experts for the formation of the CEWG, placing particular emphasis on the transparent management of potential conflicts of interest as well as full transparency in the implementation of the CEWG\\\'s work-plan. This was in order to establish a more credible process and to avoid concerns of conflicts of interest and lack of transparency over the method of work employed, which had dogged the last EWG.
[The EWG was set up following WHA Resolution 61.21, which adopted the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property and requested the WHO Director-General to "establish urgently a results-oriented and time-limited expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type 1 diseases".]
The Members of the Executive Board (EB) were presented last week with a list of 21 experts that would form the new CEWG, short-listed by the Secretariat from a total of 79 potential experts nominated by the various WHO regions. Except for country, current affiliation and area of expertise, little other information was provided to the EB. (See document EB128/6).
The list that was prepared by the Secretariat however generated some controversy, as it lacked information on the experts selected, as well as included Mr Herrling, the Novartis executive, on the recommendation of Switzerland as part of the EURO region nomination.
Mr Herrling is also the author of the proposal for "The Fund for R&D in Neglected Diseases (FRIND)" that was rated highly by the EWG and will be evaluated by the new CEWG.
At the beginning of the discussion at the Executive Board on this agenda item, the Chair of the Board, Dr M. Kokeny, Former Minister of Health of Hungary, announced, without any explanation, that the Sri Lankan expert, Mr Ravinda Prasan Rannan-Eliya, would be replaced by Mr L. C. Goyal from India.
During the discussion, a number of developing countries expressed their concern over the issue of pharmaceutical-industry representation in the roster of experts and questioned the selection criteria of the 21 experts. Concerns were also voiced over the lack of information on the 79 nominees, as well as the selected experts.
Brazil expressed its discomfort about having an expert from the pharmaceutical industry on the CEWG.
"Let us be candid", said Brazil, "they are guided by commercial motives". It noted the conflict between private and collective interests, given the industry\\\'s allegiance to its shareholders. Brazil also said that industry can participate in workshops and meetings, but having them as group members is "inappropriate".
Brazil stressed that the GSPOA (Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property) seeks to promote "new thinking", and that it is in the hands of the CEWG to make a more equitable and fair new public health system, without "undue external influence".
Brazil also requested access to the names of the 79 nominees, along with an explanation of the method of selection, and that their CVs be made available to Executive Board Members. It added that all proposals should be examined through a "public health lens", and recommended transparent and full compliance with the guidelines on conflict of interest, particularly in relation to those who have "clear legal [and] ethical incompatibilities".
It voiced its disappointment over the lack of reporting on the implementation of the GSPOA as a whole. "We hope that absence of reporting on GSPOA does not mean absence of progress," Brazil said.
Bangladesh echoed the concerns highlighted by Brazil over conflict-of-interest issues.
Supporting the statement by Brazil, Thailand also voiced similar concerns. It said that Mr Herrling\\\'s CV was "impressive", but queried: "How can the EB ensure that conflict of interest is avoided and that he does not speak on behalf of the corporation he belongs to?" Mr Herrling can be an "invitee" rather than a Member of the CEWG, suggested Thailand.
Thailand noted that the private sector was interested in profit, whereas civil society is interested in the public interest, thus necessitating a transparent process of management of conflict of interest. It also pointed to the specific conflict in that Mr Herrling was also the author of the funding proposal that will be examined by the CEWG, of which he will be a part of.
On the other hand, developed-country positions were in support of the roster of experts selected by the WHO.
Hungary, speaking on behalf of the European Union, welcomed the composition of the CEWG, adding that it looked forward to deliberations that are free from conflicts of interest.
The US said that it did not accept the assertion that the WHA found the work done by the EWG to be "inadequate", and remained "concerned about the unprecedented decision by the WHA" to establish a new CEWG.
Soon after the deliberations, WHO Director-General Dr Margaret Chan came in to express support for Mr Herrling\\\'s inclusion on the basis of the "expertise" that he would bring on R&D and the pharmaceutical industry.
The Director-General strongly defended the presence of a Pharma representative in the CEWG, saying: "I cannot see how a group of this nature can totally exclude people from the Pharma sector". Her grounds for support were that any biases within the CEWG would be detected and questionable members "picked out".
"Why people of pharmaceutical background cannot be members? If that\\\'s the case, many of the expert working groups in the house will be turned down," Dr Chan added.
The deliberations were brought to an abrupt halt, as the Chair appeared to rush to adopt the roster by a "fast gavel", leading Brazil to raise a point of order for the agenda item to be kept open for a few more days of the Board session.
In the following days, informal negotiations ensued among WHO member states.
Civil society also raised its concerns. A letter dated 20 January was addressed to Kokeny and Dr Paulo Buss from Brazil, respectively, the Chair and the Vice-Chair of the Executive Board, in which civil society groups unequivocally opposed the appointment of Mr Herrling.
The groups included CIDEPRO, Declaration de Berne - Berne Declaration, HAI Europe, HAI Global, Health GAP (Global Access Project), Knowledge Ecology International, Medecins Sans Frontieres, Campaign for Access to Essential Medicines, Oxfam International and the Third World Network.
The NGO letter states: "In collaboration with Novartis and the industry trade association IFPMA, Dr Herrling is the author of the Fund for R&D in Neglected Diseases (FRIND) proposal. Dr. Herrling is also the co-author of the PDP Plus proposal. The CEWG is expected to evaluate the FRIND and the PDP Plus proposals. The appointment of Dr. Herrling creates a conflict of interest. We note that a conflict of interest may exist even if no unethical or improper act results from it, and also that both actual and perceived conflicts of interest can undermine the reputation and work of the CEWG."
[PDP Plus is an attempt to "merge" three different proposals that were endorsed by the WHO Expert Working Group (EWG), i. e. proposals by Novartis, International AIDS Vaccine Initiative (IAVI) and Mary Moran (a member of the EWG)].
However, despite these attempts, Mr Herrling\\\'s nomination was given the stamp of approval on 21 January. But this approval was premised on a general understanding among Board members to improve the transparency of the CEWG process via disclosure of conflict of interest, by conducting regional web-based consultations, as well as web-casting CEWG meetings.
According to sources that participated in the negotiations, developed countries threatened to remove a highly-respected individual in the field of intellectual property and public health, Professor Carlos Correa from Argentina, if Mr Herrling were to be substituted.
This suggestion was however not acceptable to developing countries, leading to the approval of Mr Herrling as a member of the CEWG.
[Commenting on the appointment of Mr Herrling, James Love, the Director of Knowledge Ecology International, said in his blogpost: "This is not a fine moment for the WHO as an institution, as the action reinforces negative stereotypes about the WHO being penetrated by the pharmaceutical industry, and insensitive to actual and perceived conflicts of interests."]
The following is the list of 21 experts representing six WHO regions that have been short-listed and approved for forming the CEWG.
WHO Regional Office for Africa (AFRO): 1. Mr Kovana Marcel Loua, Director General of the National Institute of Public Health, Republic of Guinea; 2. Mr Jean de Dieu Marie Rakotomanga, Secretary General of the Ministry of Health, Madagascar; 3. Mr Mayosi Bongani Mawethu, Professor and Head, Department of Medicine, Groote Schuur Hospital and University of Cape Town, South Africa; 4. Mr Samuel Ikwaras Okware, Director General, National Health Research Organisation, Uganda.
WHO Regional Office for the Americas (AMRO): 5. Mr Carlos Maria Correa, Director of the Centre for Interdisciplinary Studies on Industrial Property and Economics Law, University of Buenos Aires, Argentina; 6. Ms Claudia Ines Chamas, Coordinator of the focal area of Innovation, Intellectual Property and Programme Development of the Masters and Doctoral Programme in Public Policy, Strategy and Development, Economics Institute of the Federal University of Rio de Janeiro, Brazil; 7. Mr Steven George Morgan, Associate Professor, University of British Columbia, School of Population and Public Health, Canada; 8. Ms Christy Hanson, Senior Public Health Advisor Infectious Diseases Division, USAID, United States of America.
WHO Regional Office for South-East Asia (SEARO): 9. Mr Laksono Trisnantoro, Director of the Post Graduate Programme in Health Policy and Management, Gadjah Mada University, Indonesia; 10. Mr L. C. Goyal, Additional Secretary and Director-General, Department of Health and Family Welfare, Ministry of Health and Family Welfare, India; 11. Mr Pichet Durongkaveroj, Secretary General, National Science, Technology and Innovation Policy Office, Ministry of Science and Technology, Thailand.
WHO Regional Office for Europe (EURO): 12. Ms Meri Tuulikki Koivusalo, Senior Researcher in the National Research and Development Centre for Welfare and Health, Finland; 13. Mr John Arne Rottingen, Adjunct Professor in Health Policy at the Department of Health Management and Health Economics, Institute of Health and Society, Faculty of Medicine, University of Oslo, Norway; 14. Mr Paul Linus Herrling, Head of Novartis Institutes for Developing World Medical Research at Novartis Pharma AG, Switzerland; 15. Mr Albrecht Jahn, Professor for Public Health at the Institute of Public Health, University of Heidelberg, Germany (European Union).
WHO Regional Office for the Eastern Mediterranean (EMRO): 16. Mr Hossein Malekafzali, Former Deputy Minister for Research and Technology, Ministry of Health and Medical Education, Islamic Republic of Iran; 17. Ms Hilda Harb, Head of Department of Statistics, Ministry of Public Health, Lebanon; 18. Ms Rajae Hossein El Aouad Berrada, Member of the Steering Committee of the Royal Institute of Strategic Studies, Morocco.
WHO Regional Office for the Western Pacific (WPRO): 19. Mr Peilong Liu, Senior Advisor to the Department of International Cooperation of the Ministry of Health, China; 20. Mr Shozo Uemura, Vice-President and Tokyo Office Manager, Aoyama and Partners, Japan: 21. Ms Leizel Lagrada, Division Chief, Health Planning Division, Health Policy Development and Planning Bureau, Philippines.

Published in SUNS #7076 dated 28 January 2011
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