Will you support a patient-centred R&D agreement?—Response from Philippe Douste-Blazy

First I would like to thank the authors of the open letter published in The Lancet Global Health1Barber MJ Gotham D Muntanyà J Balasubramaniam T on behalf of 18 other signatoriesOpen letter to the candidates for Director-General of WHO: will you support a patient-centred R&D agreement?.Lancet Glob Health. 2017; 5: e135-e136Summary Full Text Full Text PDF PubMed Scopus (6) Google Scholar that highlights one of the key priorities that WHO should address in the coming years: affordable medicines and innovation against commercially unattractive diseases. I support the conclusions of the 2012 report on WHO's Consultative Expert Working Group on Research and Development and will pay close attention to the resolution of 69th World Health Assembly. I have followed up closely the work of the High-Level Panel on Access to Medicines, and in particular the paper by Love and Rius on “delinking of R&D cost from product price”, The Lancet Commission on Essential Medicines and the excellent report by O'Neil on antimicrobial resistance. I note that delinkage is one of the options put forward in the O'Neil report that can obviously address the specific challenge of the development of new antibiotics (or new approaches to fight microbial resistance), together with a mechanism to encourage best practices for more rational use of antibiotics, in particular non-volume incentives for medicine marketers. I also recognise that we are currently lacking a proper pipeline of medicines to fight tuberculosis. People are currently dying every day from the lack of better and shorter tuberculosis drug regimens that are effective against multiple and extremely resistant strains. In short, past failures to invest in research and development (R&D) are killing millions today. As sketched in my platform for the future of WHO, access to medicines and the fight against antimicrobial resistance are two of the five top priorities that I propose to Member States. I have learned through my experience as founder and Chair of the Board of UNITAID that innovative approaches are key to transforming access to medicines for people in need. New tools are needed, and business as usual will not work. New ideas should be tested and rolled out. When UNITAID invested in the development of child-adapted versions of HIV and tuberculosis medicines—an early form of delinkage, via a public/private partnership—we triggered a sea change in the reality of treatment access for millions of children. That is the difference between life and death for them and their families. The success of the Medicines Patent Pool—working at first in HIV and now expanded to hepatitis C virus (HCV) and tuberculosis—is now well established and recognised. This is the kind of innovative approach that is needed today to make a difference. And this is why I fully endorse and support a “patient-centred” or public-health-driven approach to R&D of new therapeutic tools, especially where solvent demand or commercial potential are insufficient to allow market forces to play their normal part. Fortunately, 2017 offers unprecedented opportunities to make progress on this topic. Firstly, we now have a shared diagnosis on the need to strengthen the approach to R&D, and to ensure the price of innovation in health remains sustainable for countries both in the South and in the North. Indeed, beyond the World Health Assembly and resolution 69.23, it was world leaders themselves who decided to put access to medicines on the G7 agenda, and antimicrobial resistance on the agenda for the G20. This has become possible thanks to the global mobilisation of non-governmental organisations, activists, academics, and philanthropists who are working together to promote new tools and new approaches to innovation in health. This also constitutes an opportunity for industry, as the companies who will take the chance on new approaches today will be tomorrow's leaders in this emerging market, and will contribute greatly to sustain access to real innovation. The trend is there for all to see, and I for one find it quite encouraging—for example, companies like Gilead or BMS are putting their HIV and HCV blockbusters into the Medicines Patent Pool, and allowing generic access not only in low-income countries, but also most lower-middle-income countries, and increasingly in upper-middle-income countries as well. Likewise, a global R&D leader like GSK has recently announced it is expanding its participation in the Patent Pool for non-communicable diseases like cancer, and is exploring ways to segment public and private markets in order to assist poor people in middle-income countries. What world health needs now is leadership and resources. A new generation of innovative financing tools should contribute to another leap forward—as when there is a will, there is a way. The WHO I would like to lead would play a central role in this global progress. I look forward to further opportunities to address these important points during the interviews of the WHO recruitment panel this month. Open letter to the candidates for Director-General of WHO: will you support a patient-centred R&D agreement?Less than a year from now, a new Director-General will be elected to lead WHO.1 The next Director-General should commit to developing a global agreement on the research and development (R&D) of medicines, vaccines, and diagnostics of public health importance. This is critical in order to address the dual challenges posed by unaffordable medicine prices and a lack of innovation in neglected diseases, antimicrobials, and other public health priorities. Discussions at WHO on how to address failures of the current monopoly-based R&D system have been ongoing for over a decade, but R&D policy change is yet to occur and the will to address the root causes of the access and innovation crisis is still lacking. Full-Text PDF Open Access

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