WHO: Past, Present and FutureWHO's role in the global health system: what can be learned from global R&D debates?
Introduction
Recent global debates on the research and development (R&D) of health technologies, such as drugs, diagnostics and vaccines, can be seen as a microcosm of discussions on the role of the World Health Organization (WHO) in the global health system more broadly. The global R&D system has come under heightened scrutiny with the publication of a 2012 report by the WHO Consultative Expert Working Group on Research and Development (CEWG), which made a number of recommendations to more equitably meet global health needs. Among its conclusions was a call on WHO Member States to improve monitoring and coordination of R&D efforts through the establishment of a Global Health R&D Observatory, and to ensure sustained public R&D financing governed by public health norms through a binding treaty on R&D.1 These proposals were intended to build a long-term system for ‘the development of effective, safe, quality, suitable and affordable health technologies that existing market mechanisms and public policies fail to deliver’.2
The CEWG report followed a decade-long process of debate, analysis, and negotiation at the WHO on the weaknesses of the global R&D system. The development of health technologies relies heavily on market-incentives, secured through the time-limited monopolies afforded by patents. Indeed, patent laws were the first set of R&D ‘rules’ that were globalized when the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) came into force in 1995, requiring minimum standards of patent protection. In many developing countries, TRIPS meant establishing patents on medicines for the first time.
While the current system has delivered impressive lifesaving advances, such as drugs to treat HIV/AIDS, vaccines to prevent a range of childhood killers, and medicines that can drive certain cancers into remission, it also suffers from significant shortcomings. Namely, the existing system can result in new medicines priced at a level unaffordable for the majority of the world's population, 85% of which lives in low- and middle-income countries. It can also drive too little research into areas where market returns are small or uncertain, such as the ‘neglected diseases’ that predominantly affect the world's poorest or diseases poorly understood by science. It is also characterized by secrecy and a lack of coordination, allowing for inefficient duplication of effort and delaying scientific progress. Finally, it can encourage the overuse of medicines such as antibiotics, where the drive to generate higher sales volumes runs counter to the public health objective of limiting use to preserve drug efficacy against the inevitable emergence of resistance.3
Addressing these weaknesses requires robust public policies. And because pharmaceutical R&D is now a global endeavor – characterized by global markets, global research networks, and potentially global public health impact – rules to govern the system are needed not only at the national level, but increasingly also at the global level. An expert consultation concluded that a global framework would need to perform three interrelated functions: sustainable financing; coordination for efficiency; and monitoring for accountability.2 The CEWG proposed that sustainable financing for needs-driven R&D be generated through binding Member State commitments to contribute 0.01% of GDP to create push-funding and pull-incentives for R&D, a proportion of which would be aggregated into one or more pooled international funds. It also called for strengthened coordination to improve the collective efficiency of the many actors engaged in R&D, which would include setting priorities, building collaborative networks, and knowledge-sharing. Finally, accountability for the performance of the overall system would be monitored by a Global Observatory that would gather timely information on global R&D efforts and assess the technology outputs and health impacts that result.2 These three functions are closely inter-related: improved information is needed to inform coordination and to make strategic investments; priority-setting must be linked to financing to have real effect; and all efforts risk being wasted without an accountability framework in place. In short, the CEWG report called for a global normative framework for R&D to deliver both innovation and globally equitable access to medicines.3
Since the publication of the CEWG report, active and sometimes divisive debates have arisen around what a new global R&D framework could entail. There was insufficient appetite among Member States to launch treaty negotiations at a November 2012 follow-up intergovernmental meeting, and treaty discussions seem to have been put on hold for at least several more years.4 Nevertheless, efforts to develop a global R&D framework (albeit one that may rely less on formal international law) gained momentum with the passage of Resolution 66.23 and attached ‘decision point’ at the May 2013 World Health Assembly (‘WHA66.23’ for brevity). WHA66.23 laid out several concrete steps, including: the establishment of an Observatory at the WHO Secretariat to monitor global R&D efforts, demonstration projects to test the feasibility of new approaches (including new approaches to incentives, financing and governance5) to be selected at a December 2013 intergovernmental meeting, and standardized classification of R&D efforts. Significantly, the resolution also included progressive norms and principles to guide the demonstration projects, such as ‘open-knowledge’ approaches and ‘de-linkage of the cost of R&D from the product price’, which would enable competitive production of medicines. It also stated clearly that the demonstration projects should ‘provide evidence for long term sustainable solutions’, which could be interpreted as keeping the door open for future treaty negotiations.6 Finally, Member States left undetermined which entity would manage coordination and financing, and called for an assessment of existing mechanisms by the 2014 WHA. Member States are to review overall progress before the 2016 WHA, at which point the recommendation for a treaty may again be put on the agenda.
These developments overlap with WHO's budget crisis and the Director-General’s reform efforts,7 as well as a marked slowdown in global health financing after a decade of major expansion.8 The R&D debate has raised interesting and sometimes difficult questions regarding the role of WHO within a new global R&D framework, which may also shed light on broader issues regarding WHO reform. What do these developments tell us about the role of WHO in the global health system? And what are the implications for WHO and the prospects of an R&D treaty? The remainder of this article examines these two questions in turn.
Section snippets
WHO's role in the global R&D system
These recent R&D debates underscore two important functions that WHO plays in the global system: strategic convening for negotiation, consensus-building and rule-making; and the provision of global public goods such as standards and information.9
As an organization built on the membership of nearly all sovereign states, WHO has a unique form of political legitimacy that can be marshaled to convene all major stakeholders. Indeed, a central function of WHO is to provide the global community with
WHO and the prospects for an R&D convention
While currently on the back burner, the recommendation to build a more permanent global R&D framework embedded in a treaty may come back onto the global agenda before the 2016 WHA. In that case, would WHO be the right arena to negotiate such a convention?
In many ways, WHO seems the natural choice. First, and most obviously, the objective is of direct relevance for health, has been framed in health terms, and has emerged out of a multiyear political process at the WHO. Indeed, while IP used to
Conclusions
Building a more equitable, efficient and effective global R&D system is a challenge for the global health community. Recent developments have re-affirmed that WHO's unique political legitimacy give it a central role in the global health system as a convener and provider of certain global public goods. But they have also highlighted the challenges WHO faces in coordinating largely autonomous and sometimes very powerful actors. Strengthening WHO's capacity to coordinate R&D actors will require
Ethical approval
Not required.
Funding
None.
Competing interests
None declared.
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