Executive Summary and Recommendations are below,
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EXECUTIVE SUMMARY
In September 2015, 193 Member States of the United Nations adopted the 2030 Agenda for Sustainable Development (2030 Agenda). This agenda includes Sustainable Development Goal (SDG) 3 that aims to ensure healthy lives and promote the wellbeing of all people of all ages. SDG 3 is an important vehicle for realizing the right to health and the right to share in the benefits of scientific advancements, whose affirmation dates back to the Charter of the United Nations (1945), the Universal Declaration of Human Rights (1948) and the Constitution of the World Health Organization (WHO) (1948). These rights are also enshrined in the International Covenant on Economic, Social and Cultural Rights (1966) and various other international treaties, declarations and national laws, including at least 115 constitutions.
Consistent with the vision of the 2030 Agenda and a recommendation by the Global Commission on HIV and the Law that the United Nations Secretary-General establish a high-level body to propose ways of incentivizing health technology innovation and increasing access to medicines and treatment, Secretary-General Ban Ki-moon, in November 2015, announced the appointment of a High-Level Panel on Innovation and Access to Health Technologies.
In keeping with the commitment of United Nations Member States to enhance policy coherence for sustainable development, the High-Level Panel’s terms of reference called for it 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,” among other things. In accordance with the principle of universality that underpins the 2030 Agenda and its aspiration to leave no one behind, the High-Level Panel views innovation and access to health technologies as a multi-dimensional and global problem that affects all countries.
Health technology innovation and access
Over the last few decades, medical innovation has dramatically improved the lives of millions of people across the globe. Vaccines have significantly reduced the prevalence of diseases, ranging from polio to human papillomavirus. Antiretroviral medicines have greatly improved the lives of people living with the Human Immunodeficiency Virus (HIV). Personalized strategies based on molecularly-targeted medicines are likely to become central to cancer treatment in the future. Despite this noteworthy progress, millions of people continue to suffer and die from treatable conditions because of a lack of access to health technologies.
Investment in research and development (R&D) of health technologies does not adequately address a number of important health needs. In some cases, the cause lies in inadequate resourcing of R&D for diseases where the market does not provide sufficient return on investment. Antibiotics typically offer little pecuniary reward for years of often costly research. In these circumstances, experts warn that drugresistant viruses, bacteria, parasites and fungi could cause 10 million deaths a year worldwide by 2050. The current model of medical innovation is ill-equipped to respond to the increasing emergence of infectious diseases, such as Ebola and Zika. Meanwhile, neglected tropical diseases (NTDs) continue to receive inadequate funding for R&D and access to health technologies, despite more than a billion people living with one or more NTD. The situation is driven by the relatively low purchasing power of people disproportionately affected by such conditions.
There are many reasons why people do not get the healthcare they need, including, inter alia, under-resourced health systems, a lack of sufficiently qualified and skilled healthcare workers, inequalities between and within countries, regulatory barriers, poor health education, unavailability of health insurance, exclusion, stigma, discrimination and exclusive marketing rights. The High-Level Panel acknowledges the importance of addressing these multiple determinants to health technology innovation and access. However, the High-Level Panel’s mandate is focused on one aspect of a complex challenge: the incoherencies between international human rights, trade, intellectual property (IP) rights and public health objectives.
Policies and agreements related to human rights, trade, intellectual property rights and public health were developed with different objectives at different times. State obligations include duties not only to respect, but to protect and fulfil the right to health. This requires taking proactive measures to promote public health. As reaffirmed by a recent Human Rights Council resolution, ensuring access to medicines, and particularly to essential medicines, is a fundamental element of these obligations. Trade rules and intellectual property laws were developed to promote economic growth and incentivize innovation. On the one hand, governments seek the economic benefits of increased trade. On the other, the imperative to respect patents on health technologies could, in certain instances, create obstacles to the public health objectives of World Trade Organization (WTO) Members.
The adoption of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1994 ushered in a new and unprecedented era of global intellectual property norms and created a new standard of intellectual property protection and enforcement. However, negotiators included safeguards, or ‘flexibilities,’ within the TRIPS Agreement that could be used by signatories to tailor national intellectual property regimes so that countries could fulfil their human rights and public health obligations (for instance, laws and regulations regarding competition, government procurement and medicines). The proliferation of free trade agreements containing expansive patent and test data protections on health technologies, which exceed the minimum standards for intellectual property protection required by the TRIPS Agreement (so-called ‘TRIPSplus’ provisions), may impede access to health technologies. Also, an uneven application of health and trade policy within and among states can create tensions that fuel policy incoherence.
Intellectual property laws and access to health technologies
Public health-sensitive intellectual property rules and mechanisms can help address the misalignment between profit-driven innovation models and public health priorities. Voluntary licences, entered into between right holders and third parties to facilitate the market entry of more affordable health technologies, have helped to lower treatment costs in many countries. TRIPS flexibilities – for example, the freedom to determine patentability criteria and further define concepts such as “novelty,” “inventive step” and “industrial applicability” – can ensure that patents are only awarded for genuine innovation. Similarly, the ability to determine the terms upon which compulsory licences are issued allows governments to fulfil their human rights obligations by securing the availability and affordability of health technologies. Many governments have not used the flexibilities available under the TRIPS Agreement for various reasons ranging from capacity constraints to undue political and economic pressure from states and corporations, both express and implied. Political and economic pressure placed on governments to forgo the use of TRIPS flexibilities violates the integrity and legitimacy of the system of legal rights and duties created by the TRIPS Agreement, as reaffirmed by the Doha Declaration. This pressure undermines the efforts of states to meet their human rights and public health obligations. The use of TRIPS flexibilities may also be impeded by the proliferation of bilateral and regional free trade agreements containing TRIPS-plus provisions.
The policies of public funders of health technology R&D can also play an important role in enhancing health technology innovation and access. The United States, for instance, holds a central position in health technology innovation. The country’s R&D and access policies influence other actors, including private and public sector donors and foundations, and have an impact on access to the fruits of technology worldwide. The introduction of the 1980 Bayh-Dole Act in the United States significantly changed academic research by allowing universities and public research institutions to patent the results of federally-funded research and license private enterprises to develop them. However, limiting access to academic discoveries can obstruct follow-on innovation and force taxpayers to pay twice for the benefits of publicly-funded research. Strong, enforceable policies on data sharing and data access should be a condition of public grants. Public funding agencies should strongly encourage patenting and licensing practices that benefit public health, including the use of non-exclusive licences, the donation of intellectual property rights, participation in public sector patent pools and other mechanisms that maximize innovation while promoting access. Open models of innovation can also lower entry hurdles and accelerate the pace of development of health technologies, including those needed to combat emerging infectious diseases.
New incentives for research and development of health technologies
Market-driven R&D has been credited by some for producing a number of important health technologies that have improved health outcomes significantly worldwide. However, significant gaps in health technology innovation and access persist. Under the prevailing model, the biomedical industry, with the help of intellectual property and data protections, in addition to benefiting from public funding for research, recoups the costs of its R&D and marketing through high product prices protected by patent monopolies and data and market exclusivities. As a result, new technologies are rarely developed for health conditions which cannot deliver high returns, such as bacterial infections that only require antibiotics. Rare diseases that affect comparatively small proportions of the population have not traditionally attracted investments although this is changing.
Various efforts are being undertaken by governments, philanthropic organizations, international entities, civil society groups and the private sector to resolve the incoherence between market-driven approaches and public health needs. However, such efforts tend to be fragmented, disparate and insufficient to deal with priority health needs on a sustainable, long-term basis. A much greater effort must be directed to supplementing the existing market-driven system by investing in new mechanisms that delink the costs of R&D from the end prices of health technologies.
Identification of global health priorities is necessary to efficiently distribute scarce health resources, to substantially improve the health status of populations and to enhance global preparedness for future health crises. The current patchwork of public, private and philanthropic funding cannot sufficiently and sustainably improve access to health technologies. Greater and more sustainable financial commitments are needed from both the public and private sectors and should be coordinated to achieve maximum utility and effect.
Governance, accountability and transparency
Good governance, strong and concrete accountability mechanisms and greater transparency are decisive enablers of the 2030 Agenda. An important factor behind the incoherence between human rights, trade, intellectual property and public health lies in the diverse accountability mechanisms and transparency levels of these different, but overlapping spheres. Trade- and intellectual property-related accountability mechanisms are typically regulated by the WTO Dispute Settlement Understanding and dispute settlement provisions found in free trade and investment agreements. In contrast, human rights and public health accountability mechanisms are characterized by varying and often limited degrees of precision, legal weight and enforceability.
Transparency is necessary to hold governments, the private sector and other stakeholders accountable for the impact of their actions on access to health technologies. However, accurate and comprehensive information on the costs of R&D, marketing, production and distribution, as well as the end prices of health technologies, can be difficult to aggregate. Existing public databases of health technology prices managed by international organizations and civil society groups, while laudable, tend to be limited in scope and accuracy, in part because of discounts, mark-ups, taxes and regional pricing differences. The absence of transparency in clinical trial data and a lack of coordination within national drug regulatory authorities can contribute to delays in the registration of new health technologies. Procurement decisions and generic manufacturing are often delayed by the absence of clear, accurate and up-to-date information on existing and expired patents. Moreover, trade and investment agreements containing TRIPS-plus provisions are often negotiated in secret. This lack of transparency makes it difficult to hold governments and other stakeholders accountable for the impact of their policies and actions on innovation and access to health technologies.
The incoherencies between the right to health, trade, intellectual property and public health objectives can only be resolved using robust and effective accountability frameworks that hold all stakeholders responsible for the impact of their decisions and actions on innovation and access to health technologies.
Recommendations
Intellectual property laws and access to health technologies
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:
TRIPS flexibilities and TRIPS-plus provisions
World Trade Organization (WTO) Members must make full use of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.
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 are in the best interests of the public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.
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 health-sensitive patentability criteria.
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.
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.
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.
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 reported to by the WTO Secretariat during the Trade Policy Review of Members. WTO Members must register complaints against undue political and economic pressure which includes taking punitive measures against offending WTO Members.
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.
Publicly-funded research
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.
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, non-exclusive licensing, donations of intellectual property and participation in public sector patent pools, among others. Sufficient 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 affordable prices that ensure broad availability.
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.
New incentives for research and development of health technologies
It is imperative that governments increase their current levels of investment in health technology innovation to address unmet needs.
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.
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. The 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.
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.
Governance, accountability and transparency
Governments
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.
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.
Multilateral organizations
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 governments, representatives from United Nations and multilateral organizations, civil society, academia and the private sector.
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, 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 on innovation and access to health technologies.
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.
Private sector companies
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.
Private sector companies should have 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 a governance system that includes direct board-level responsibility and accountability on improving access to health technologies.
R&D, production, pricing and distribution of health technologies
Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to: (1) the costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (2) any public funding received in the development of the health technology, including tax credits, subsidies and grants.
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.
Clinical trials
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, clinical trials.gov or in peer reviewed publications, regardless of whether their results are positive, negative, neutral or inconclusive.
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.
Patent information
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: (1) standard international common names for biological products; (2) international non-proprietary names for products, either as known at the time of application or after the granting of a patent; and (3) dates of grant and expiry.
