Elizabeth Sukkar

Date: 19 January 2011

Source: www.scripintelligence.com

A row has been sparked this week after a number of developing countries and NGOs rejected the nomination of Professor Paul Herrling, the head of corporate research at Novartis, as a member of the new World Health Organization expert group being set up to find ways to finance R&D into diseases affecting people in developing countries, citing direct conflict of interest.

Finding ways round the reputational blight - that only about 10% of global spending on health R&D is focused on diseases affecting 90% of the world`s population that lives in poor countries - has been an issue for the pharma industry for more than 10 years now,

Professor Herrling is known to be interested and highly committed to the cause of research into developing countries` healthcare. Indeed, he is behind one of the key financing proposals that the WHO expert group is expected to look at. And therein lies the problem. Advocates from NGOs do not believe that it is right for Professor Herrling to have a seat on the 21-member expert group as he would, in effect, be assessing his own proposal as well as competing ideas.

A decision on Professor Herrling`s appointment is expected to be reached by the WHO`s 128th executive board meeting this Friday. Thailand raised the conflict of interest matter on Monday, and has the support of Brazil and Ecuador, according to NGOs. It is understood that Dr Margaret Chan, the WHO`s director general, has defended Professor Herrling`s nomination, stating that the UN agency has often used people from industry on WHO advisory boards.

The new group, called the consultative expert working group (CEWG), is the successor to an earlier WHO group, the expert working group (EWG), which saw its final report marred by bad publicity. The EWG report had been leaked to the pharma industry, and there were claims of lack of transparency and due process and conflicts of interest (scripintelligence.com, 11 December 2009, 21 January 2010). The 63rd World Health Assembly (WHA) decided in May 2010 to create the CEWG to take forward the work of the EWG and to have another look at the financing proposals in its report, including ideas that were discarded; it will report to the 65th WHA in 2012 (scripintelligence.com, 24 May 2010).

The EWG report noted a number of proposals to stimulate funding for product development partnerships (PDPs), seen as one of the key drivers for R&D into neglected diseases but often lacking long-term funding. Three key proposals were highlighted, including Professor Herrling`s FRIND (Fund for R&D in Neglected Diseases) model (formerly called the IFPMA model), which would act as a pool for funds from donors ranging from industry, NGOs, private charities and governments.

It is estimated that the FRIND fund would be worth some $10 billion and would allocate funding on a stage-by-stage basis, rather than as a lump sum, according to a document on Novartis`s website. When an experimental drug passes one of six key decision points during development, sufficient funds are released to pay for activities needed to reach the next decision point, it adds.

James Love, director of the NGO, the Knowledge Ecology International, which saw his own R&D financing proposal based on a "prize" concept not meeting EWG criteria, is deeply concerned that Professor Herrling may have a place on CEWG.

Mr Love respects the work that Professor Herrling has done in neglected diseases - he is the chair of board of the Novartis Institute for Tropical Diseases in Singapore - but told Scrip: "I don`t know how you could have a more direct conflict [of interest]. He is the author of the FRIND proposal, and would be a recipient of the money from the proposal. Can`t they find someone else to evaluate his proposals? Does the public expect the UN to invite grant recipients to evaluate their own proposals? He is asking for $10 billion. That is quite a bit of money."

He also points out that, if this sort of conflict of interest is permissible in the group now, what level of conflicts could be expected when funds are actually disbursed from FRIND if it is set up.

Professor Herrling is nominated as Switzerland`s representative on the CEWG, and Mr Love perceived further conflicts of interest there: "Switzerland has two of the top big pharma companies, so their motivations are not that complicated. They are probably thinking: `What`s good for Novartis and Roche is good for the local economy.`"

Another NGO that campaigns for affordable medicines in developing countries agrees with Mr Love. Dr Tido von Schoen-Angerer, director of the campaign for access to essential medicines at Médecins Sans Frontières (MSF), told Scrip that "One of the purposes of the [CEWG] group is to review proposals. Inviting the proponent of a specific proposal is a direct conflict. If one is invited, then proponents of other important proposals should also be invited; in particular, James Love as one of the most brilliant thinkers on this issue, and other potential funding recipients and key R&D actors like PDPs."

CEWG members were chosen on the basis of WHO regional representation, gender balance and "diversity of expertise". Mr Love is not against industry representation on the CEWG per se, as long as the person is without conflicts of interest and can work independently. "We would like Paul [on the CEWG] if he did not have the FRIND proposal. He would have been a high choice for a lot of people."

Dr von Schoen-Angerer says it is important that the CEWG does get input from those with expertise. "It is also important because a number of the proposals seem similar but have important difference in approaches and effects. We consider that the work of the CEWG would be greatly enhanced if there was a public hearing where the proponents of different proposals, including Paul Herrling, could present and respond to questions."

A public hearing was seen as an effective and helpful mechanism into the original Commission group (CIPIH) - a predecessor to EWG - set up by the WHO to first look at the questions of innovation and access, he adds.


Industry view
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which lobbies on behalf of the pharma industry in Geneva, told Scrip that Professor Herrling was an "excellent candidate" for the CEWG because of his deep knowledge of developing world disease research, strong desire to achieve progress in this area, and personal credibility.

"His leadership of a major institute for research in neglected tropical diseases is broadly known, as is his personal engagement in the policy discussions around suitable funding models. We believe that inclusion of such a distinguished practitioner is highly relevant to ensure that proposals finally put forward are both politically acceptable and workable in practice."

The association believes that the industry should have a place in CEWG because of its scientific, technical and management expertise. "Industry is a particularly relevant stakeholder, as a leading practitioner and funder of R&D into diseases of the developing world. It is important that all CEWG members` interests are transparent, so they can be balanced by inclusion of a range of different stakeholder views - something that the WHO has visibly striven to achieve in this body." Novartis, Paul Herrling himself, and WHO were unavailable to comment.