TWN Info Service on Intellectual Property Issues (Feb17/02)
London, 2 February (Sangeeta Shashikant*) – The forthcoming 70th World Health Assembly (WHA) will discuss access to medicines including the United Nations Secretary General’s High Level Panel Report on Access to Medicines (UNHLP report).
The inclusion of this agenda item has been a topic for debate. The 140th meeting of the Executive Board of the World Health Organization (WHO) agreed to amend an existing agenda item on shortage of medicines of the 70th WHA that will convene in May this year, to hold discussions on access to medicines.
The Executive Board is composed of 34 WHO members on a rotation basis, primarily mandated to facilitate the work of the WHA. It met at the WHO headquarters in Geneva from 23 to 31 January 2017.
The Board’s move follows a proposal by Eritrea on behalf of the Africa Group to have on the agenda of the WHA a stand-alone agenda item on access to medicines to give WHO Members an opportunity to deliberate on the problems Member States face on access to medicines.
However, Eritrea’s proposal was not agreeable to the Chairman of the Executive Board, Ray Busuttil from Malta who instead proposed re-naming agenda item 14.3 of the WHA from “Addressing the global shortage of medicines and vaccines” to “Addressing the global shortage and access to medicines and vaccines”.
The Director-General of WHO, Dr. Margaret Chan, intervened to clarify that the Secretariat’s paper on shortage of medicines will be expanded to cover all issues concerning access to medicines, including comments made on the UNHLP report during the Executive Board meeting, the adopted Global Strategy and Plant of Action on Public Health, Innovation and Intellectual Property (GSPOA), and the Follow-up to the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG).
Chan also said that the document would provide a platform to WHO Members to
make interventions again. “I really want my Member States to take a
comprehensive view of what can be acted on and what needs further discussion”,
she said, further adding, “What are some of the things not done because of the
lack of resources and no consensus. It’s time we bring the issues together”.
During the course of its proceedings, the Executive Board also heard multiple calls from WHO Members for in-depth discussions on the recommendations of the UNHLP report.
The UNHLP report was not listed as a separate agenda item on the Board’s programme of work mainly because its recommendations were not acceptable to some developed countries, in particular the United States.
On 12 September 2016, eleven WHO Member States of the South-East Asia Region supported by Brazil, Iran and South Africa requested to place an item entitled “Report of the UN Secretary-General’s High-Level Panel on Access to Medicines” on the agenda of the 140th Executive Board session. However, the WHO Secretariat and five Officers of the Board (which includes the US) rejected this request without providing any valid reason.
At the start of the Board meeting, India again highlighted its concern over the non-inclusion of a specific agenda item on the UNHLP report.
India pointed out that “The report of the High Level Panel addresses some of the long-standing problems facing medical innovation and access to medicines. The UN Secretary General has welcomed the report and called for broader discussions on its findings and recommendations. The recent (UN General Assembly) resolution on Global Health and Foreign Policy also encourages Member States and relevant UN agencies to discuss the report.”
It stressed that a number of international bodies, such as the UN General Assembly (UNGA), the World Trade Organization Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), and UNAIDS have initiated discussions on the report” and thus “[i]t would be simply inconceivable and inexcusable that WHO, which has a constitutional mandate to set and coordinate global R&D efforts and which is the main UN agency that should be at the forefront of the access to medicines agenda, does not discuss and take appropriate follow-up actions on the UN High Level Panel report”.
also said that “If the EB140 does not discuss the report, WHO risks losing its
leadership on such a vital global health issue. This would be a serious setback
to its credibility and integrity, particularly when it is trying to justify an
increase in its programme budget,” adding that “We believe that an informed
discussion, with an open mind, on the UN High-Level Panel will allow Member
States to consider potential innovative approaches to address some of the
persistent challenges to access to medicines and provide appropriate directions
to WHO to carry forward its work on health innovation and access.”
Busuttil, the Board Chairman, offered a weak explanation. He said the Bureau (of the Executive Board) was of the view that sufficient items on medicines were already on the agenda and the UNHLP report could be considered one of those. He added that the report generated divergent views and so the chances of reaching any substantial conclusions on a way forward seemed elusive, thus it was decided to retain the decision to discuss the topic under existing agenda items. Member States can then express their opinion on the report, he said, and those opinions can be collated and for a possible way forward to consensus and constructive discussions.
Civil society organizations (CSO) have also advocated through multiple letters to Dr. Chan, Chair Busuttil and Executive Members for WHO to convene discussions on the UNHLP recommendations.
During the Executive Board session itself, a letter addressed to Board Members signed by 26 CSOs, urged WHO to facilitate the implementation of the UNHLP recommendations. The CSO letter argued that “WHO is the primary global agency with responsibility for global health and it should see the UNHLP work and its recommendations as an opportunity to revive and facilitate WHO’s work on innovation and access.”
The letter also echoed the words of the eminent jurist and UNHLP member Michael Kirby: “… unless the UNHLP’s recommendations impinge on our hearts and minds, a vital opportunity may be lost, perhaps forever,” and that the WHO “cannot shirk that responsibility or surrender it to others – trilateral or otherwise. It thus has the primary responsibility to lead for attainment of Sustainable Development Goal 3. WHO must find its own voice and powerfully support action on the UNHLP (report)”.
(“Trilateral” refers to cooperation among the WHO, WTO and WIPO.)
Although the UNHLP report was not reflected as a specific agenda item of the Executive Board’s programme of work, discussion on the report was taken up following the agenda items of GSPOA and the CEWG.
on behalf of the European Union said it was committed to increasing access to
affordable medicines and finding solutions to the world’s public health
challenges and inequities based on a human rights approach, adding that these
challenges apply to all countries in all regions. It said that the current
innovation process has delivered consistent progress in global public health,
but it also recognized the challenges of high costs of medicines for the
sustainability of health systems.
Malta referred to the agreement among EU health ministers to explore obstacles for deploying existing medicines and to consider new solutions to address market failure. It noted that the UNHLP Report is a “new element” in global discussions of a complex issue. It further remarked that the EU is ready to engage in a constructive manner within the context of GSPOA, but also recommended WHO to continue the useful trilateral cooperation with WTO and WIPO on these issues.
The Netherlands said it was more than ready to discuss the follow up and implementation of the UNHLP recommendations in an open and constructive manner. “After all the challenges described apply to all countries from all regions”, it added, “The proliferation of high cost medicines and rising drugs are increasing pressure on public health spending also in our countries.” It stressed on the need to discuss the profit margins of the pharmaceutical industry vis-à-vis other business sectors, and the conditions under which public money is put in the development of new medicines, as is often the case in European R&D programme. It also said it would continue efforts to prevent TRIPS Plus provisions in free trade agreements that are negotiated and to provide for safeguards against the abuse of intellectual property (IP) measures and procedures for enforcing IP rights.
However the Netherlands particularly highlighted a fair price initiative that it is being undertaken with WHO.
Colombia said that recommendations of the UNHLP report give viable alternatives to access to medicines and called for it to be listed on the agenda for further discussion.
Thailand highlighted that there were two UN High Level reports before the Executive Board and “We need to treat them fairly” referring to the UN High-Level Commission on Health Employment and Economic Growth which was added to the agenda of the Board and the UNHLP report that was not.
“The majority of the report is acceptable”, and the Board should consider both with the same treatment, Thailand added, further calling for a decision point and to emerge with a 5-year action plan. “We are not saying that every recommendation has to have action but we need to consult widely,” Thailand said, adding that we may not want to act on some recommendations.
Algeria on behalf of the Africa Group said that access to medicines is a problem that affects developed nations as well as developing and puts intolerable pressures on governments due to budgetary pressures.
Algeria stressed the difficulties faced by doctors and patients due to lack of access to medicines that are readily available but are too expensive. It noted that the UNHLP gives an opportunity to address this issue and that the conclusions of the report were very important and needed to be considered as soon as possible.
India requested WHO to adequately respond to the UNHLP since the report is directly relevant to the GSPOA and the follow up to the CEWG.
India highlighted a number of UNHLP recommendations that merited immediate consideration, such as countries making full use of TRIPS flexibilities; using licensing agreements that ensure public health returns for publicly-funded research; creating new incentives for R&D beyond patent monopolies; coordinating and sustainably financing R&D through innovative models; de-linking the costs of R&D from the price of medicines; negotiating a binding R&D Convention or Agreement based on de-linkage and other principles promoting public health, and ensuring transparency, accountability and governance in the R&D process; governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and any public funding received in the development of the health technology including tax credits, subsidies and grants.
The UNHLP report recommends inter alia that building on the current discussions at the WHO the UN Secretary-General should 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 costs of R&D from end prices to promote access to good health for all.
India emphasized that without comprehensively addressing the issue of access to medicines and vaccines guided by the principles of affordability and equity, we would not be able to achieve the Sustainable Development Goals and Universal Health Coverage.
India proposed a web-based consultation with Member States before the 70th WHA, on the UNHLP recommendations and the convening of an open-ended meeting of Member States by the 70th WHA to discuss the recommendations and other relevant recommendations in the CEWG report.
Iceland speaking also on behalf of Norway said that there was a need for a public health approach to intellectual property.
Brazil stressed that the UNHLP report was convened by the Secretary-General of the UN and has a broad constituency, adding that that the UNHLP report relates to several agenda items of the WHO that were discussed, such as GSPOA, Sustainable Development Goal alignment process with health targets, and shortage of medicines. It pointed out that the development of the report included an advisory group of experts, which was enlarged to appease some Member States.
Brazil further said “We aren’t seeking an endorsement of the content of the report” or for it to become an official document of the WHO, adding that, “certain issues that are in there we would like to be in a position to find a venue within WHO to have a discussion. That is basically it”.
Iran stressed that access to medicines a right and intellectual property impedes access to affordable drugs. It said that there is a need to seriously consider the UNHLP recommendations and to make them a reality. It urged the convening of an open-ended meeting to discuss the recommendations of the UNHLP.
South Africa said that the UNHLP report is an opportunity to improve access to medicines. It called for consideration of the report adding that it did not expect all the recommendations to be adopted. It further said that discussing the report may help find solutions to current problems.
The US, Japan and Switzerland were the few countries that opposed taking forward the UNHLP report.
The US said that the report had a narrow mandate and does not address critical facets of the complex problem of promoting innovation and access to medicines. It added that the panel was unable to find consensus on key recommendations with two of the panelists which had the most extensive experience in managing R&D portfolio warning that the report’s recommendations could result in serious negative unintended consequences for R&D.
The US countered that the UNHLP was not a Member State-driven process and had no mandate from the UN General Assembly, adding that the report’s criticism of US policy on management of IP for research in the public sector was “misguided”.
Japan and Switzerland offered arguments similar to the US, arguing that the UNHLP report does not recognize the central role of IP in biomedical research and development.
A source closely following developments around the UNHLP observed in relation to the US statement that the arguments put forward by the US were flawed. “The UNHLP report is the UN Secretary General’s report which was undertaken through an extensive transparent, inclusive and participatory process. To appease the US and the pharmaceutical industry, the advisory group to the panel of experts was expanded to include industry representatives. The panel also includes industry friendly representatives. Several members of the panel offered additional commentaries to the main high level report, and it is unreasonable to object to discuss the recommendations of the report based on the views of two industry friendly panelists.”
“The critique of the UNHLP report on US policy on management of IP is accurate as the introduction of the 1980 Bayh-Dole Act in the United States allows universities and public research institutions to patent the results of federally-funded research and license private enterprises to develop them. This results in limiting access to the results of the research and taxpayers paying twice for the benefits of publicly-funded research.”
(*With inputs from Mirza Alas and the WHO Watch team of the People's Health Movement.)