Will you support a patient-centred R&D agreement?—Response from Sania Nishtar
Authors: Sania Nishtar
Journal: The Lancet Global Health (2017)

I would like to thank the authors1Barber 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 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. Access to medicines is influenced by many domestic and global factors. WHO has important roles to play in both cases. It has a norm-setting, oversight, and capacity-building role to promote the right policies and practices in countries and strengthen regulatory systems. Strong health systems are critical for ensuring sustainable access to medicines, and universal health coverage (UHC) is an important policy tool in this regard. Access to medicines is also a part of the Sustainable Development Goal (SDG) agenda along with UHC. With regard to global roles, promoting innovation and associated intellectual property is one avenue. Others include safety and vigilance; international regulatory oversight; surveillance and monitoring for substandard, spurious, falsely-labelled, falsified, or counterfeit medical products; regulation of biosimilars; access to controlled substances; strengthening production and regulation of medicines; country capacity building with regard to the use of TRIPS flexibilities; improving access through the inclusion of new medicines in the Essential Medicines List; and incentives for continued production and supply of older essential medicines. Intellectual property and innovation becomes relevant in relation to affordability or the failure of market mechanisms to incentivise innovation and the development of vaccines, medicines, and technologies based on public health needs, as in the case of neglected diseases of poverty and the development of new antibiotics and vaccines in the context of pandemic threats and antimicrobial resistance, respectively. To address this, the Global Strategy and Plan of Action (GSPOA) called for a pooled fund to catalyse R&D.2WHOGlobal Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.http://www.who.int/phi/publications/Global_Strategy_Plan_Action.pdfGoogle Scholar Several years later, resolution WHA69.23 urges its implementation.369th 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.pdfGoogle Scholar However, the Consultative Expert Working Group on Research and Development and the High-Level Panel on Access to Medicines call for a globally binding agreement,4Consultative 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, 5United Nations Secretary General's High-Level Panel On Access To MedicinesReport 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.pdfGoogle Scholar which requires Member States' consensus through a due process. While Member States consider such an agreement, innovation and access needs to be improved through multiple other legitimate ways. WHO already has a strong mandate for action, through the GSPOA and its associated resolutions and could do much more in support of Member States without waiting for the years that will be required for a new globally binding agreement to come into force. Action is needed now while we work collectively towards longer term solutions. It must be noted that the Access to Medicines Report also has several “asks” of other stakeholders. For example, it asks the UN to create an independent review body, a taskforce, and convene a special UN General Assembly session. It has several asks of Member States and the private sector. In addition to the recommendation regarding the R&D convention, the report also asks WHO to develop a price surveillance system. As Director-General, I will carefully explore existing gaps and strengthen WHO's role in all these areas, as a matter of priority. Access to medicines is an important SDG target. As Director-General I will ensure that WHO's normative and regulatory role in this area is both effective and continues to have strong public trust. 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