On September 14, 2016, the United Nations Secretary-General’s High-Level Panel on Access to Medicines released its report, in which they had a mandate 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.”[1]
The High-Level Panel (HLP) report addressed four major areas:
- Health Technology Innovation and Access
- Intellectual Property Laws and Access to Health Technologies
- New Incentives for Research and Development of Health Technologies
- Governance, Accountability and Transparency
The Panel also issued 30 recommendations for the United Nations, other multilateral organizations, the governments of member nations, and private businesses involved in research and development (R&D). The 30 recommendations are available at the end of this post.
The Panel consisted of 15 members:
- Festus Mogae, co-chair, former President of Botswana
- Ruth Dreifuss, co-chair, former President of Switzerland
- Awn Al-Khasawneh, former Prime Minister of Jordan
- Celso Amorim, former Minister of Foreign Relations of Brazil
- Jorge Bermudez, former Executive Director of Unitaid
- Winnie Byanyima, Executive Director of Oxfam International
- Maria C. Freire, President of the Foundation for the National Institutes of Health
- Sakiko Fukuda-Parr, Professor of International Affairs at The New School (Chair, KEI Board of Directors)
- Kinga Göncz, former Minister of Foreign Affairs of Hungary
- Yusuf Hamied, Chairman of Cipla
- Michael Kirby, former Justice of the High Court of Australia
- Malebona Precious Matsoso, Director General of the South Africa National Department of Health
- Ruth Okediji, Professor of Law, University of Minnesota
- Shiba Phurailatpam, Director of the Asia Pacific Network of People Living With HIV (APN+)
- Andrwe Witty, CEO of GlaxoSmithKline
Health Technology Innovation and Access
In the first chapter of its report, the HLP analyzed “asymmetries of power between institutions and the incoherencies in law, policy and practice between the right to health, international trade and intellectual property rules and public health objectives and their effect on health technology innovation and access.”[2]
The Panel broadly addressed two topics with this chapter: (1) barriers to access to affordable medical technologies, and (2) the policy incoherencies that arise between public health goals, intellectual property norms, international human rights law, and global trade rules.
The Panel described cost as a “key determinant of access,” citing the budget constraints of “national health and treatment programmes” as well as out-of-pocket costs for patients, amongst other concerns related more directly to the direct provision of care.[3]
In regards to the incoherencies in health policy, the Panel described “the misalignment between market-based models that incentivize innovation and the need to obtain treatment for patients” as a conflict that creates “severe burdens on health systems and individual patients, in wealthy and resource-constrained countries alike.”[4]
In conclusion, the Panel argued that intellectual property rights should be put at risk when in conflict with fundamental human rights, echoing civil society concerns:
“Policy incoherence is not always a matter of law. It is also a matter of interpretation and application, shaped by priorities and politics. Human rights are fundamental, universal entitlements that people inherently acquire by virtue of their birth. In comparison, intellectual property rights are ‘one policy tool among many for encouraging innovation and technological research and development.’ Intellectual property rights are temporary, revocable, transferable privileges granted by states and can be suspended or revoked under certain conditions laid out in the TRIPS Agreement when it is in the interest of the state or society. The international community must unite to build sustainable solutions so that policy incoherencies between trade and intellectual property rules on one hand and human rights and public health on the other do not impede innovation and access to needed health technologies that sustain health, well-being and life.”[5]
Intellectual Property Laws and Access to Health Technologies
Chapter two of the report addressed the following topics related to national and international governance, including through trade agreements and at multilateral fora, of intellectual property:
- Voluntary licenses
- TRIPS flexibilities
- Patentability criteria
- Compulsory licenses
- Competition law
- National coherence
- Limitations to the use of TRIPS flexibilities
- Intellectual property generated from publicly-funded research
In the sections on compulsory licenses and the limitations on the use of TRIPS flexibilities, the Panel argued for increased use of compulsory licenses and an end to the use of trade and other pressures to prevent countries from exercising their national laws that implement compulsory licenses.
The Panel urged all member nations to draft laws “that facilitates the prompt and expedient use of a compulsory licence or government use for non-commercial purposes of a patent, including criteria to determine the remuneration for the right holder.”[6]
The Panel also addressed the use of trade pressures, particularly from the United States, designed to prevent countries from exercising their authorities to issue compulsory licenses under the TRIPS. The Panel criticized the attempts of the United States and drug companies to prevent Thailand from issuing compulsory licenses in 2007, as well as threats from the U.S. Senate, Novartis, and U.S. Trade Representative to put pressure on the Colombian peace process in response to the threat of a compulsory license on imatinib.[7]
Additionally, the Panel adopted the line of critique advanced by civil society against trade agreements like the Trans-Pacific Partnership (TPP), attacking the inclusion of TRIPS-plus provisions in trade agreements and arguing that trade agreements significantly ramp up IP enforcement and “exacerbate” the extant incoherencies between trade liberalization and public health goals. Earlier, in the first chapter, the Panel had criticized the Trans-Pacific Partnership as “emblematic of the new generation of bilateral and multilateral trade and investment agreements that progressively ratchet up intellectual property protection and enforcement.”[8]
Regarding the public funding of research, the Panel explored its significance, citing the Bayh-Dole Act and similar national laws as important technology transfer provisions that have advanced innovation and allowed broader commercialization of university research in particular.
However, the Panel also discussed the “unintended consequences” of intellectual property rights in publicly-funded research.[9] The Panel likewise suggested that nations consider both licensing government-owned patents to patent pools and limiting the grant of exclusive licenses on patented inventions. The Panel also directed one recommendation to the public funders of research, that they “require that knowledge generated from such research be made freely and widely available through publication in peer-reviewed literature and seek broad, online public access to such research,” and two recommendations to universities and research institution, that they prioritize “public health objectives over financial returns in their patenting and licensing practices,” and that they adopt collaborative models to “advance biomedical research and generate knowledge for the benefit of the public.”[10]
New Incentives for Research and Development of Health Technologies
The third chapter of the report discussed the implementation of delinkage mechanisms and priority setting and coordination for and financing of research and development.
In describing the problem with the monopoly system of funding R&D, the Panel noted that it “has created important tensions because of high prices, and fuelled policy incoherencies through the application of exclusivity-driven business models.”[11] Specifically, the Panel cited the development of new antibiotics as an example of a market failure in the monopoly system. Conversely, they cited the growth of development of drugs for rare diseases as a success for increased funding and the “realization by private sector companies of the significant profit potential that rare disease treatments can have, particularly in wealthy countries.”[12]
After identifying the problem — market inefficiencies and misaligned incentives — the Panel explored recommendations related to delinkage, priority setting and coordination, and financing.
The recommendation that member countries, the United Nations, and other multilateral fora move towards the implementation of delinkage represents a key endorsement of the idea that the costs of R&D should not be determinative of the price of new drugs, vaccines, and diagnostic tools.
The report avoided in-depth analysis of particular delinkage proposals, instead providing a basic overview of the broad categories of delinkage mechanisms and recommending that the Secretary-General should build upon the Consultative Expert Working Group (CEWG) process and other discussions at the World Health Organization and “initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies.”
The recommendation gave support for a decades-long discussion at the WHO calling for “negotiations on a binding R&D Convention that delinks the cost of research and development from end prices to promote access to good health for all.”[13]
Regarding priority setting and coordination, the Panel urged increased attention to emerging infectious diseases, like the Zika and Ebola viruses. The Panel blamed the lack of vaccines and treatments for Zika and Ebola on the lack of investment in R&D, noting that they “offer a stark reminder of the need for delinkage.”[14]
In terms of funding, the Panel called from greater funding commitments from governments. The Panel described various proposals for funding mechanisms without explicitly endorsing any of them. They cited as examples the Review on AMR suggestion for a $2 billion Global Innovation Fund for antibiotic development, the TDR Health Product R&D Fund, WHO demonstration projects, and the CEWG recommendation for government funding targets based upon GDP.[15]
Concrete recommendations related to funding included the creation of an R&D Convention and a “Code of Principles for Biomedical R&D” to apply to public funding, with voluntary adoption encouraged for private and philanthropic funders, product development partnerships, universities, the biomedical industry and other stakeholders.”[16]
Governance, Accountability and Transparency
Within its chapter on “governance, accountability and transparency,” the HLP engaged broad conversations about governance and accountability at various levels, including international and multilateral organizations, national governments, and corporations.
In terms of international and multilateral governance and accountability, the Panel called for the creation of a body to monitor follow up on the HLP recommendations, citing various examples of effective monitoring mechanisms in other UN bodies.[17]
The Panel supported increased interagency or interministerial coordination at the national level to ensure that policy incoherencies between trade and economic goals, and human rights and public health concerns, are addressed.[18]
The Panel also urged national governments and corporations to adopt the “Ruggie Principles” in relation to the right to public health. The Ruggie Principles are a core set of human rights norms that describe binding obligations on the state and the “responsibilities” of corporations to limit and remedy human rights abuses.[19]
The transparency section of this chapter addressed three separate areas where transparency is needed in the pharmaceutical sector:
- R&D costs and pricing of health technologies.
- Clinical trials.
- Patent information.
The Panel cited the disparity in estimates of R&D costs as key evidence of the need for transparency of R&D costs. One recommendation called on governments to require disclosure of R&D costs and public funding to “drug regulatory and procurement authorities:”
(a) Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to:
(i) The costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and
(ii) Any public funding received in the development of the health technology, including tax credits, subsidies and grants.[20]
Lack of international coherence and enforcement of rules related to the disclosure of the results of clinical trials prompted the Panel to recommend disclosure of “unidentified data” for “all completed and discontinued clinical trials” in a publicly accessible database.[21]
Finally, the Panel called for national disclosure of all patent information on “medicines and vaccines,” which would be compiled by WIPO into an international database. Importantly, the Panel called for the disclosure of patent information on biologic drugs.[22],[23]
The report also included additional commentary from several members, making diverse points and expressing differences with specific parts of the panel’s report.
Footnotes
1. United Nations Secretary-General’s High-Level Panel on Access to Medicines, “The Process,” available at: http://www.unsgaccessmeds.org/the-process/ (accessed September 13, 2016).
2. “Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies” (hereinafter High-Level Panel Report), page 12.
3. High-Level Panel Report, page 15.
4. High-Level Panel Report, page 16.
5. High-Level Panel Report, page 20.
6. High-Level Panel Report, page 23.
7. High-Level Panel Report, pages 23-24. More information on the pressure on Colombia available here: /colombia.
8. High-Level Panel Report, page 19.
9. See more on this issue here: /government-funded-inventions.
10. High-Level Panel Report, pages 26-28.
11. High-Level Panel Report, page 29.
12. High-Level Panel Report, page 29.
13. High-Level Panel Report, pages 30-31.
14. High-Level Panel Report, page 30.
15. High-Level Panel Report, page 31.
16. High-Level Panel Report, page 32.
17. High-Level Panel Report, page 33-4.
18. High-Level Panel Report, page 34.
19. High-Level Panel Report, page 34.
20. High-Level Panel Report, page 37.
21. High-Level Panel Report, page 37.
22. High-Level Panel Report, page 37.
23. Among the submissions focusing on transparency was: “Increasing the Transparency of Markets for Drugs, Vaccines, Diagnostics and Other Medical Technologies,” February 28, 2016, available at: /wp-content/uploads/UN-HLP-A2M-Transparency-28Feb2016-Final.pdf.
Annex 1: High-Level Panel Recommendations
2.6 Recommendations
2.6.1. TRIPS flexibilities and TRIPS-plus provisions
World Trade Organization (WTO) Members should commit themselves, at the highest political levels, to respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health, refraining from any action that will limit their implementation and use in order to promote access to health technologies. More specifically:
(a) WTO Members should make full use of the policy space available in Article 27 of the TRIPS Agreement by adopting and applying rigorous definitions of invention and patentability that curtail the evergreening to ensure that patents are only awarded when genuine innovation has occurred.
(i) The United Nations Conference on Trade and Development (UNCTAD), the United Nations Development Programme (UNDP), the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO) should cooperate with one another and with other relevant bodies with the requisite expertise to support governments to apply public healthsensitive patentability criteria.
(ii) These multilateral organizations should strengthen the capacity of patent examiners at both national and regional levels to apply rigorous public health-sensitive standards of patentability taking into account public health needs.
(b) Governments should adopt and implement legislation that facilitates the issuance of compulsory licenses. Such legislation must be designed to effectuate quick, fair, predictable and implementable compulsory licenses for legitimate public health needs, and particularly with regards to essential medicines. The use of compulsory licensing must be based on the provisions found in the Doha Declaration and the grounds for the issuance of compulsory licenses left to the discretion of governments.
(c) WTO Members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license. WTO Members should, as necessary, adopt a waiver and permanent revision of the TRIPS Agreement to enable this reform.
(d) Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities. Instances of undue political and commercial pressure should be formally reported to the WTO Secretariat during the Trade Policy Review of Members. WTO Members must register complaints against undue political and economic pressure, and take punitive measures against offending Members.
(e) Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health. As a first step, they must undertake public health impact assessments. These impact assessments should verify that the increased trade and economic benefits are not endangering or impeding the human rights and public health obligations of the nation and its people before entering into commitments. Such assessments should inform negotiations, be conducted transparently and made publicly available.
2.6.2 Publicly-funded research
(a) Public funders of research must require that knowledge generated from such research be made freely and widely available through publication in peer-reviewed literature and seek broad, online public access to such research.
(b) Universities and research institutions that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices. Such practices may include publication, nonexclusive licensing, donations of intellectual property and participation in public sector patent pools, among others. Suficient incentives must be in place in these practices to make it attractive for developers to underwrite the cost of bringing a product to market at a$ordable prices that ensure broad availability.
(c) Universities and research institutions that receive public funding should adopt policies and approaches that catalyse innovation and create flexible models of collaboration that advance biomedical research and generate knowledge for the benefit of the public.
3.4 Recommendations
(a) It is imperative that governments increase their current levels of investment in health technology innovation to address unmet needs.
(b) Stakeholders, including governments, the biomedical industry, institutional funders of healthcare and civil society, should test and implement new and additional models for financing and rewarding public health research and development (R&D), such as the transaction taxes and other innovative financing mechanisms.
(c) Building on current discussions at the WHO, the United Nations Secretary-General should initiate a process for governments to negotiate global agreements on the coordination, financing and development of health technologies. This includes negotiations for a binding R&D Convention that delinks the costs of research and development from end prices to promote access to good health for all. Such a Convention should focus on public health needs, including but not limited to, innovation for neglected tropical diseases and antimicrobial resistance and must complement existing mechanisms.
(d) As a preparatory step, governments should form a Working Group to begin negotiating a Code of Principles for Biomedical R&D. The Principles would apply to public R&D funds and should also be adopted by private and philanthropic funders, product development partnerships, universities, the biomedical industry and other stakeholders. Governments should report annually on their progress in negotiating and implementing a Code of Principles as a preparatory step to negotiating the Convention in the United Nations General Assembly.
4.3 Recommendations
4.3.1 Governments
(a) Governments must review the situation of access to health technologies in their countries in light of human rights principles and States’ obligations to fulfil them, with assistance from the Office of the United Nations High Commissioner for Human Rights (OHCHR) and other relevant United Nations entities. The results of these assessments should be made publicly available. Civil society should be financially supported to submit their own shadow reports on innovation and access to health technologies. Such national reviews should be repeated at regular intervals.
(b) Governments should strengthen national level policy and institutional coherence between trade and intellectual property, the right to health and public health objectives by establishing national inter-ministerial bodies to coordinate laws, policies and practices that may impact on health technology innovation and access. Appropriate member/s of the national executive who can manage competing priorities, mandates and interests should convene such bodies. The deliberations and decisions of such groups should operate with a maximum of transparency. Civil society should be financially supported to participate and submit their shadow reports on innovation and access to health technologies.
4.3.2 Multilateral organizations
(a) The United Nations Secretary-General should establish an independent review body tasked with assessing progress on health technology innovation and access. Challenges and progress on innovation and access to health technologies under the ambit of the 2030 Agenda, as well as progress made in implementing the recommendations of this High Level Panel, should be monitored by this body. Membership should comprise of representatives from United Nations and multilateral organizations, civil society, governments, academia and the private sector.
(b) The United Nations Secretary-General should establish an inter-agency taskforce on health technology innovation and access. This taskforce, operating for the duration of the SDGs, should work toward increasing coherence among United Nations entities and relevant multilateral organizations like the WTO. The taskforce, also charged with overseeing the implementation of the High-Level Panel’s recommendations, should be coordinated by the United Nations Development Group and report annually to the United Nations Secretary General on progress made in enhancing United Nations system-wide coherence.
(c) The United Nations General Assembly should convene a Special Session no later than 2018 on health technology innovation and access to agree on strategies and an accountability framework that will accelerate efforts towards promoting innovation and ensuring access as set out in the 2030 Agenda. Civil society should be financially supported to participate and submit their reports on innovation and access to health technologies at this Special Session.
4.3.3 Private sector companies
(a) Biomedical private sector companies involved in health technology innovation and access should report, as part of their annual reporting cycle, on actions they have taken that promote access to health technologies.
(b) Private sector companies should implement the following:
(i) a publicly available policy on their contribution to improving access to health technologies setting out general and specific objectives, timeframes, reporting procedures and lines of accountability; and
(ii) a governance system that includes direct board-level responsibility and accountability on improving access to health technologies.
4.3.4 R&D, production, pricing and distribution of health technologies
(a) Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to:
(i) The costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and
(ii) Any public funding received in the development of the health technology, including tax credits, subsidies and grants.
(b) Building on the Global Price Reporting Mechanism (GPRM), V3P and others, WHO should establish and maintain an accessible international database of prices of patented and generic medicines and biosimilars in the private and public sectors of all countries where they are registered.
4.3.5 Clinical trials
(a) Governments should require that the unidentified data on all completed and discontinued clinical trials be made publicly available in an easily searchable public register established and operated by existing mechanisms such as the WHO Clinical Trials Registry Platform, clinicaltrials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive.
(b) To facilitate open collaboration, reconstruction and reinvestigation of failures, governments should require that study designs and protocols, data sets, test results and anonymity-protected patient data be available to the public in a timely and accessible fashion. Those undertaking clinical trials must not prevent researchers from publishing their findings.
4.3.6 Patent information
(a) Governments should establish and maintain publicly accessible databases with patent information status and data on medicines and vaccines. This information should be periodically updated and consolidated by WIPO in collaboration with stakeholders to develop an international, easily searchable database which should include:
- standard international common names for biological products;
- international non-proprietary names for products, either as known at the time of application or after the granting of a patent; and
- dates of grant and expiry.