On Wednesday, 9 November 2016, the World Health Organization (WHO) delivered the following statement at the World Trade Organization’s (WTO) TRIPS Council’s discussions of the United Nations Secretary-General’s High Level Panel Report on Access to Medicines.
COUNCIL FOR TRIPS
8-9 NOVEMBER 2016
13. THE UNITED NATIONS SECRETARY-GENERAL’S HIGH LEVEL PANEL REPORT ON ACCESS TO MEDICINES
“Thank you very much for giving WHO the opportunity to share our feedback on the Report of the High-Level Panel on Access to Medicines.
In 2016, the UN Secretary General convened the High-Level Panel on Access to Medicines “to review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies.” WHO was not part of the Secretariat to the Panel, but the Organization had the opportunity to participate in discussions through membership in the Expert Advisory Group, and made two submissions to the Panel, one jointly with UNIDO focusing on local production.
The HLP issued its report on 14 September 2016, and its conclusions are sobering. “Millions of people continue to suffer and die from treatable conditions,” the report observes, “because of a lack of access to health technologies.” Pharmaceutical research still focuses disproportionately on the treatment of diseases that are common in the developed world, neglecting those that primarily afflict the world’s poor.
The report thus echoes conclusions of previous reports done under the auspices of the WHO, which draw attention to disparities in the R&D system and lack of access to essential medicines.
I will go through the different recommendations, in particular those that are directly addressed to WHO and share with you information on relevant WHO activities and future plans:
Let me start with the recommendations on intellectual property laws and access to health technologies:
The Report reiterates many recommendations that can be found in in the WHO Global Strategy and plan of action on public health, innovation and intellectual property. Many of its recommendations are in line with a number of WHO resolutions, including those that encourage WTO Members to make full use of TRIPS flexibilities. Consistent with its mandate, WHO will continue to provide support to its Member States—upon request, and in coordination with other intergovernmental organizations—on implementing and using TRIPS flexibilities to facilitate access to essential medicines.
The Panel recommends that UNCTAD, UNDP, WHO, WIPO, and WTO should cooperate with other relevant bodies with the requisite expertise to support governments to apply patentability criteria that are sensitive to public health concerns. We welcome that recommendation; indeed, we are already working closely with our UN partners. Most recently, we have joined with WTO, WIPO and UNCTAD to provide advice to the South African government as it rethinks its intellectual property policy. In 2007, ICTSD, UNCTAD, and WHO published draft guidelines on how to bring a public-health perspective to bear on the examination of pharmaceutical patents. We will continue to work closely with our partner agencies and entities that have relevant expertise, including national or regional patent offices.
I will now turn to the recommendations with respect to publicly funded research. Here too, we applaud the recommendations of the Panel that public funding should be better-targeted to support public health needs. We also agree that the fruits of that publicly financed research should be made as widely available as possible.
WHO shares the view of the Panel that new incentives for R&D of health technologies are needed.
The Report positively acknowledges two recent major WHO initiatives:
- the Global Antibiotic Research and Development Partnership a joint venture of WHO and the Drugs for Neglected Diseases initiative, which we presented yesterday, as well as
- the R&D Blueprint, a global strategy and preparedness plan that fosters R&D activities with respect to pathogens with pandemic potential. The aim of the Blueprint is to accelerate the development of effective tests, vaccines and medicines to save lives, prevent large scale epidemics and minimize socio-economic disruption of an outbreak.
The Panel furthermore urges the UN Secretary-General to initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies, including a binding R&D Convention that delinks the cost of R&D from end prices to promote access. The Panel thus reiterates the main recommendation of the WHO Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). The Panel is optimistic that an R&D treaty has “increasingly gathered support” since it was first proposed by the CEWG. An R&D treaty has indeed earned strong support from civil society organizations, and may be again discussed in the coming months in WHO Governing Bodies’ meetings.
In the framework of the follow-up of the CEWG, WHO member states have taken action to improve priority-setting and coordination of R&D activities. They have requested the WHO Secretariat to establish a Global Health R&D Observatory to provide data on R&D activities and allow the identification of R&D gaps. Once gaps are identified, priority-setting will be undertaken by a new, independent WHO Committee on R&D Coordination that will be established in the first quarter of 2017. The Observatory and the new R&D Coordination Committee will be discussed by the upcoming Executive Board meeting in January 2017.
Under the chapter on governance, accountability and transparency the Panel calls on governments to review the situation of access to health technologies in their countries in light of human rights principles and to strengthen the national level policy and institutional coherence between the different policies by establishing national inter-ministerial bodies. The latter reiterates a recommendation of the WHO Global Strategy.
With respect to Multilateral organizations, the Panel recommends setting up an independent review body to assess progress on health technology innovation and access under the 2030 SDG agenda. The Panel also recommends establishing an inter-agency taskforce to work towards increasing coherence among international organizations. WHO jointly with WIPO and WTO has already established a trilateral working group on questions pertaining to access to medicines, leading to increased coherence and collaboration among the three organizations. An informal all-agency discussion on trade, health, and intellectual property policies is planned for December 2016 in Geneva.
With respect to R&D, production, pricing and distribution of health technologies, we welcome the call of the Panel for more transparency of production and R&D costs, including contributions of the public sector. The Panel also calls for an expansion of the WHO Global Price Reporting Mechanism, which has already been expanded to include hepatitis C. WHO will consider expanding the GPRM to include more patented essential medicines. However, it is not practically feasible to establish a database of all prices worldwide of all patented and generic medicines in the public and private sector and given that many prices currently are not transparently available; it may not be meaningful. WHO has already moved forward on assessing the production cost of essential medicines which will allow procurement agencies to better assess their performance and contribute to the overall objective of transparency.
The WHO supports the Panel’s recommendation to require the disclosure of unidentified data from all completed and discontinued clinical trials, regardless whether the results are positive, negative, neutral, or inconclusive. The WHO’s Clinical Trials Registry Platform is one of the international instruments facilitating such disclosure.
With respect to the recommendation on Patent information, we again fully support the move toward more transparency. WHO has published a number of patent reports—including on Hepatitis C. In enhancing transparency, however, it is important to draw on the experience of other organizations that work in this area in order to meet the needs of particular users. Efforts should be made to build on existing databases, in particular the one managed by the Medicines Patent Pool, to avoid duplication of effort and ideally create a one-stop shop for the public-health community.
I would like to end my intervention by reiterating WHO’s commitment to continue to work at the intersection of public health, trade and intellectual property, in collaboration with all relevant partners.”