Candidates for Director-General of the World Health Organization Outline Their Plans for Tackling Unaffordable Medicines and the Lack of Innovation in Priority Areas

[Joint press release from six civil society groups, Link] The six candidates for Director-General of the World Health Organization (WHO) – of whom one will be elected this May – have published responses to an open letter asking them to make clear their plans for the future of the WHO’s work in promoting a new system of equitable drug R&D. The original open letter was signed by 18 civil society organizations, and titled “Will you support a patient-centred R&D agreement?“. The WHO Executive Board convenes today to begin 9 days of meetings during which the candidates will be interviewed, and up to 3 of the 6 shortlisted for a final vote in May 2017.

The candidates recognised that urgent problems exist in the current system of drug R&D. Dr Douste-Blazy (France) wrote that “past failures to invest in research and development are killing millions today”. Dr Nishtar (Pakistan) recognised “the failure of market mechanisms to incentivise innovation” and asserted that the “WHO already has a strong mandate for action”. Dr Bustreo (Italy) noted that “high prices of health technologies and lagging innovation […] impede people’s access to quality health care”.

In her response, Dr Flavia Bustreo made the bold commitment to convening discussions with WHO member states on a “global agreement on research and development R&D for medicines, vaccines, and diagnostics” based on the decade of work undertaken at the WHO and the UN Secretary-General’s High Level Panel on Access to Medicines. Dr. Bustreo noted that the WHO had the moral imperative to exercise its unparalleled convening power to negotiate global norms on R&D that would ensure that “everyone has access to medicines and that no one is left behind.”

Dr Philippe Douste-Blazy reiterated his support for the “conclusions of the 2012 report on WHO’s Consultative Expert Working Group on Research and Development” and flagged the work of Lancet Commission on Essential Medicines, the O’Neill report on AMR and the United Nations Secretary-General’s High-Level Panel on Access to Medicines (UN HLP), and in particular, the submission by James Love and Judit Rius to the UN HLP on “delinking of R&D cost from product price”. Dr Douste-Blazy noted that access to medicines would be one of his five top priorities as Director General, and wrote: “A new generation of innovative financing tools should contribute to another leap forward […] The WHO I would like to lead would play a central role in this global progress.”

Dr Sania Nishtar highlighted the relevance of IP and innovation in relation to affordability or when the market failed to meet public health needs, providing the examples of antimicrobial resistance, pandemic threats, and neglected tropical diseases. While noting the recommendations of the Consultative Expert Working Group on Research and Development and the UN High Level Panel for a “globally binding” R&D Agreement, Dr Nishtar stressed the importance of using WHO’s current mandate to work on innovation and access without waiting for countries to reach consensus on an R&D agreement.

The commitments offered by the candidates varied substantially. While Dr Adhanom Ghebreyesus (Ethiopia) agreed that “…the [R&D] gap has not yet been addressed…”, he stopped short of commenting on plans to work towards an R&D agreement. In relation to testing out alternatives to the current R&D system, he noted, “[f]urthermore, WHO carries out demonstration projects with the intention of delinking the price of the final product from the cost of the R&D. It laid out options for sustainable financing of a voluntary R&D pool fund which will soon be discussed by its governing bodies.”

Dr Szócska wrote that a “sensitive balance” should be established between “serving patients needs and […] the smooth operation of the pharmaceutical market”.

Click here for a printable PDF of this press release

Thirukumaran Balasubramaniam, a co-author of the original open letter and Geneva Representative, Knowledge Ecology International, said:

“One area where leadership is much needed by the new Director-General is the reform of methods to pay for R&D for new drugs and other medical technologies. Drs Bustreo and Douste-Blazy were the most explicit in embracing the delinkage of R&D costs from product prices, and connecting R&D reform to concerns about access and fairness. Dr Nishtar also noted the WHO had a strong mandate in the area of innovation and access. ”

Mark Harrington, Executive Director of Treatment Action Group, an AIDS advocacy organization that signed the original open letter, said:

“Overall, the answers indicate that most of the candidates are aware of the more than a decade of prior discussions, reports, commissions, recommendations, and deliberations which have focused on issues of access and innovation for diagnosis, treatment, and prevention/vaccination for diseases of the developing world. Clearly, we are not doing enough, as indicated by the tuberculosis examples we cited in our original letter. It’s not yet clear to me that the countries which govern the WHO have the political will to address these issues at the scale and with the openness to new ways of doing things which is required, but Treatment Action Group hopes that the incoming WHO Director-General, whoever s/he may be, will ensure that the organization positions itself in a leadership role in convening the collaborations necessary to move us forward rapidly and ambitiously.”

Dr Germán Velásquez, Special Adviser for Health and Development at the South Centre, notes:

“Important issues on the future of the WHO have not yet been answered by the candidates, including their visions on the main current challenges of WHO’s core identity:

The dilemma between the public / private role of WHO: WHO’s most serious issue is the progressive loss of control of the regular, public budget. A privatization of the organization is currently taking place. How will the DG address this?

The dilemma between voluntary resolutions or binding instruments: WHO has only used its binding power once in 70 years. The new Director General will have to choose between managing projects financed by private and philanthropic sectors, or rebuilding a public and independent International Agency to watch over public health. Recommending or legislating is the dilemma of the WHO.

The dilemma between a normative agency and a humanitarian one: should the WHO focus on the formulation of international standards, codes, regulations and binding agreements, or should it act as a humanitarian or operational agency implementing projects while competing or duplicating efforts of other agencies?”

Dr Amit Sengupta, from the the People’s Health Movement, notes that PHM:

“welcomes the effort at promoting public accountability in the responses by five of the six candidates. We are extremely disappointed by Dr David Nabarro’s reluctance to clearly state his position. We note that 3 of the 6 responses address in varying degrees concerns regarding the broken system of innovation. We welcome Dr Flavia Bustreo’s commitment to convening discussions on a “global agreement on research R&D for medicines, vaccines, and diagnostics”. While Dr Sania Nishtar’s acknowledgment of the relevance of IP and innovation in relation to affordability is welcome, we are disappointed this relevance is seen only in situations of market failure. Dr Douste-Blazy’s reference to a new generation of innovative financing tools falls far short of a position that advocates the delinking of drug development costs from the prices of new medicines. The PHM is concerned that none of the candidates seem to have grasped the fundamental fact that the patent based system of innovation is failing to deliver needed medical products and that an alternative system needs to be built that replaces and not just supplements the current IP based system of innovation.”

Júlia Muntanyà, a co-author of the original open letter and member of Universities Allied for Essential Medicines, said:

“It is encouraging that the WHO Director-General candidates answered this important question that had become a taboo within the WHO. Patent-driven R&D has failed to address some public health needs, amounting to unnecessary deaths. The WHO’s lack of support for an R&D Agreement and for the UN High Level Panel on Access to Medicines (UNHLP) would neglect many people’s lives. The WHO could show strong leadership on access to medicines by pioneering the implementation of the UNHLP’s recommendations, including the R&D Agreement. In their responses, Dr Adhanom Ghebreyesus, Dr Nabarro, and Dr Szócska could have shown more commitment to take forward innovative models supported by numerous WHO committees and the UNHLP. New incentives are needed, delinking the price of medicines from the cost of R&D, to meet those needs that the current system has not met.”

Professor Brook Baker, senior policy analyst at Health GAP, an organization that signed the original open letter, said:

“To take forward promises to promote new incentive systems to focus R&D efforts on pressing health needs instead of private monopoly profits, whoever becomes the WHO Director-General will have to fight entrenched corporate power and the rich governments that support that power. Efforts that rely naively on cooperation and partnership will continue to result in neglected diseases and neglected populations. IP-based solutions will continue continue distort research outcomes and result in products that are increasingly unaffordable everywhere.”

ENDS

***

Notes to editor

The original open letter, published in December in The Lancet Global Health, is available here: http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(16)30353-9/fulltext

The responses from WHO Director General candidates are available at links listed below: