Open letter to the candidates for Director-General of WHO: will you support a patient-centred R&D agreement?

Melissa J Barber, Dzintars Gotham, Júlia Muntanyà, Thirukumaran Balasubramaniam

on behalf of 18 other signatories

The Lancet Global Health – 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.

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).2 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.3 In a recent report,4 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.5, 6

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,7 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.

References

  1. World Health Organization. Process to elect next Director-General of WHO begins.http://www.who.int/mediacentre/news/releases/2016/election-process/en/. ((accessed Sept 25, 2016).)
  2. Consultative Expert Working Group on Research and Development: Financing and Coordination.Research and development to meet health needs in developing countries: strengthening global financing and coordination. http://www.who.int/phi/CEWG_Report_5_April_2012.pdf. ((accessed Sept 25, 2016).)
  3. Sixty-Ninth World Health Assembly. Follow-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.pdf; 2016. ((accessed Sept 25, 2016).)
  4. Report 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.pdf; 2016. ((accessed Sept 25, 2016).)
  5. MSF Access Campaign. First 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-them; 2015. ((accessed Sept 25, 2016).)
  6. MSF Access Campaign. DR-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.pdf. ((accessed Sept 25, 2016).)
  7. Love, J and 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-love; 2016. ((accessed Sept 25, 2016).)
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