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.1World Health OrganizationProcess to elect next Director-General of WHO begins.http://www.who.int/mediacentre/news/releases/2016/election-process/en/Google Scholar 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. The imbalances in the current R&D system were the subject of the 2012 report of WHO's Consultative Expert Working Group on Research and Development (CEWG).2Consultative Expert Working Group on Research and Development: Financing and CoordinationResearch and development to meet health needs in developing countries: strengthening global financing and coordination.http://www.who.int/phi/CEWG_Report_5_April_2012.pdfGoogle Scholar The CEWG recommended a global binding agreement that provides a needs-driven and evidence-based framework for R&D, guided by the core principles of affordability, effectiveness, efficiency, and equity, and grounded in the concepts of delinkage and knowledge-sharing approaches. On the basis of the report, the 69th World Health Assembly passed resolution WHA69.23 to request the development of a plan for implementation of a pooled fund for R&D.3Sixty-Ninth World Health AssemblyFollow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination.http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_R23-en.pdfDate: 2016Google Scholar In a recent report,4Report of the United Nations Secretary General's High-Level Panel On Access To Medicines.http://www.unsgaccessmeds.org/s/UNSG-HLP-Report-FINAL-12-Sept-2016.pdfDate: 2016Google Scholar the UN Secretary-General's High-Level Panel on Access To Medicines restated the need for negotiating a binding convention and called on governments to take action. We would like to invite the candidates to take a clear position on the future of WHO's work in supporting a patient-centred R&D system. Consider for example tuberculosis, the world's leading infectious cause of death: only two new drugs against tuberculosis have been brought to market in the last five decades. In addition to the lack of investment in tuberculosis R&D, when innovation has occurred, only 2% of those in need of these new treatments have received them. The other 98% were unable to access them due to exorbitant prices or the originator companies' unwillingness to register them in high-burden countries.5MSF Access CampaignFirst new TB drugs in half a century reach just 2% of people who need them.http://www.msfaccess.org/about-us/media-room/press-releases/first-new-tb-drugs-half-century-reach-just-2-people-who-need-themDate: 2015Google Scholar, 6MSF Access CampaignDR-TB drugs under the microscope: sources and prices for drug-resistant tuberculosis medicines.http://www.msfaccess.org/sites/default/files/TB_report__DR-TB_DRUGS_UTM__4th_edition_2016.pdfGoogle Scholar These gaps in innovation and access are seen across diseases. A lack of public-health-driven priorities and incentives to develop much-needed new drugs such as antibiotics and vaccines is coupled with a tradition of using patent monopolies to set prices beyond what even high-income health-care systems can bear, as currently seen in hepatitis C and cancer treatments. Committed leadership by the new Director-General will be instrumental in following up on the CEWG's recommendations and carrying through the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property. We therefore invite the candidates, the Executive Board, and Member States to consider the following points throughout the election process: (1)What are the candidates' visions for WHO's work in supporting R&D, in line with the WHO Constitutional principle that “[t]he extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health”?(2)Do the candidates support WHO's further exploration of alternative pharmaceutical R&D systems based on the principle of progressive delinkage,7Love J Rius J Contribution to the United Nations Secretary-General's High Level Panel On Access To Medicines: the need for global negotiations on agreements to fund R&D within the context of a progressive de-linking of R&D costs from product prices.http://www.unsgaccessmeds.org/inbox/2016/2/29/james-loveDate: 2016Google Scholar wherein governments reform R&D incentives so that they no longer rely upon high prices and patent monopolies?(3)Will the candidates commit to convening further discussions by member states on a global R&D agreement, based on the principles set out by the CEWG, to correct failures in the current system that neglect pressing public health needs and result in unaffordable prices? We look forward to reading the candidates' ideas and plans for this pressing area of WHO's future work. Signatories of this letter are: Richard Elliott (Canadian HIV/AIDS Legal Network); Yanni Natsis (European Public Health Alliance); Brook Baker (Health GAP); Brian Citro (University of Chicago Law School); Wame Mosime (International Treatment Preparedness Coalition); Thirukumaran Balasubramaniam (Knowledge Ecology International); Françoise Sivignon (Médecins du Monde); Edward Low (Positive Malaysian Treatment Access & Advocacy Group); Peter Maybarduk (Public Citizen); Mike Podmore (STOPAIDS); Lotti Rutter (Treatment Action Campaign); Mark Harrington (Treatment Action Group); Manon Ress (Union for Affordable Cancer Treatment); Merith Basey (Universities Allied for Essential Medicines); Jordan Jarvis (Young Professionals Chronic Disease Network); Andrea Carolina Reyes Rojas (Alianza LAC - Global por el Acceso a Medicamentos); Germán Holguín Zamorano (Misión Salud); Koen Block (European AIDS Treatment Group); Diarmaid McDonald (Just Treatment); John H Amuasi (African Research Network for Neglected Tropical Diseases). MJB and DG declare no conflicts of interest. JM is employed by Universities Allied for Essential Medicines, a non-governmental organisation that has advocated for some of the policies mentioned in this article. TB is employed by Knowledge Ecology International, a non-governmental organisation that has advocated for some of the policies mentioned in this article. Will you support a patient-centred R&D agreement?—Response from Flavia BustreoAs outlined in The Lancet in October, 2016,1 my vision for WHO can be summed up in five words: equity, rights, responsiveness, evidence, and partnership. In this context, I am pleased to respond to the authors of the open letter in The Lancet Global Health,2 on the leadership role that WHO must play in tackling the high prices of health technologies and lagging innovation that impede people's access to quality health care. Full-Text PDF Open AccessWill you support a patient-centred R&D agreement?—Response from Tedros Adhanom GhebreyesusI read with great interest the open letter published on Dec 9, 2016 in The Lancet Global Health1 to solicit the ideas and views of candidates for WHO Director General on advancing the research and development (R&D) of diagnostics, medicines, and vaccines of public health importance. I have high regard for civil society's advocacy to address big challenges in global health. Full-Text PDF Open AccessWill you support a patient-centred R&D agreement?—Response from Sania NishtarI would like to thank the authors1 for raising the critical issue of access to medicines and to approach the specific proposal for a research and development (R&D) convention in that broader context. Full-Text PDF Open AccessWill you support a patient-centred R&D agreement?—Response from David NabarroI have received several letters inviting me to express my views on specific issues in global health, including the open letter published in The Lancet Global Health.1 My general position is that as Director-General, I will operate at all times within the context of decisions made by the WHO's Member States in the Governing Bodies. In preparing myself for serving as WHO Director-General, I anticipate my future responsibilities in a way that reflects the priorities that I have set out in the vision statement that I have submitted to the WHO. Full-Text PDF Open AccessWill you support a patient-centred R&D agreement?—Response from Philippe Douste-BlazyFirst I would like to thank the authors of the open letter published in The Lancet Global Health1 that highlights one of the key priorities that WHO should address in the coming years: affordable medicines and innovation against commercially unattractive diseases. Full-Text PDF Open AccessWill you support a patient-centred R&D agreement?—Response from Miklós SzócskaIn response to the open letter on patient-centred research and development (R&D),1 failures and imbalances that characterise the global pharmaceutical market have long been recognised and dealt with, although no breakthrough has been reached in finding real solutions to these problems. While accessibility and affordability challenges in lower income countries still persist and call for reinforced actions, developments of recent years have brought about or revealed further unfavourable phenomena, such as extremely high, unaffordable prices, sometimes limited therapeutic advances brought about by innovative drugs or in certain cases lack of real innovation. Full-Text PDF Open Access

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