*This is an independent report prepared by the High-Level Panel on Access to Health Technologies, convened by the UN Secretary-General in November 2015. The report was submitted to the Secretary-General on Tuesday 12 September 2016. The opinions expressed in this report are the authors' own and do not necessarily reflect the views of the UN Secretary-General, the Executive Office of the UN Secretary-General or the United Nations.
United Nations Secretary-General’s High-Level Panel on Access to Medicines Calls For New Deal to Close the Health Innovation and Access Gap
Whether it’s the rising price of the EpiPen, or new outbreaks of diseases, like Ebola, Zika and yellow fever, the rising costs of health technologies and the lack of new tools to tackle health problems, like antimicrobial resistance, is a problem in rich and poor countries alike.
According to a High-Level Panel convened to advise the UN Secretary-General on improving access to medicines, the world must take bold new approaches to both health technology innovation and ensuring access so that all people can benefit from the medical advances that have dramatically improved the lives of millions around the world in the last century.
For decades, many international treaties and national constitutions have enshrined the fundamental right to health and the right to share in the benefits of scientific advancements. Yet, while the world is witnessing the immense potential of science and technology to advance health care, gaps and failures in addressing disease burdens and emerging diseases in many countries and communities remain. The misalignment between the right to health on the one hand and intellectual property and trade on the other, fuel this tension.
The UN Secretary-General established the High-Level Panel to propose solutions for addressing the incoherencies between international human rights, trade, intellectual property rights and public health objectives. The report recommendations come at the end of a ten-month process for the Panel under the leadership of Ruth Dreifuss and the former President of the Swiss Confederation and Festus Mogae, the former President of the Republic of Botswana.
“Policy incoherencies arise when legitimate economic, social and political interests and priorities are misaligned or in conflict with the right to health,” said President Ruth Dreifuss. “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 and the right to health.”
The Panel has formulated a set of concrete recommendations to help improve research and development of health technologies and people’s access to vital therapies that are currently priced out-of-reach of patients and governments alike. The Panel’s report points out that the cost of health technologies are putting a strain on both rich and poor countries.
“With no market incentives, there is an innovation gap in diseases that predominantly affect neglected populations, rare diseases and a crisis particularly with antimicrobial resistance, which poses a threat to humanity,” said Malebona Precious Matsoso, Director General of the National Department of Health of South Africa. “Our report calls on governments to negotiate global agreements on the coordination, financing and development of health technologies to complement existing innovation models, including a binding R&D Convention that delinks the costs of R&D from end prices.”
The Panel suggested that initially governments should form a working group to begin negotiating a Code of Principles for Biomedical R&D, and report annually on their progress in negotiating and implementing the Code in preparation for negotiating the Convention.
The Panel examined the way in which the application of the flexibilities found in the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has facilitated access to health technologies, and how WTO Members can tailor national intellectual property law, competition law, government procurement and drug regulatory laws and regulations to fulfil public health obligations.
The new report noted with grave concern reports of governments being subjected to undue political and economic pressure to forgo the use of TRIPS flexibilities. The Panel felt strongly that this pressure undermines the efforts of governments to meet their human rights and public health obligations and violates the integrity and legitimacy of the Doha Declaration.
“WTO Members must make full use of TRIPS flexibilities as reaffirmed by the Doha Declaration on TRIPS and Public Health. This is essential to promote access to health technologies,” said Michael Kirby, member of the High-Level Panel and chair of the Expert Advisory Group. “In particular, 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. WTO Members must register complaints against undue political and economic pressure. They need to take strong, effective measures against offending Members.”
Transparency was a recurring theme throughout the report of the High-Level Panel. The Panel repeatedly raised concerns regarding the negative impact of insufficient transparency on both health technology innovation and access. The Panel was also critical of the lack of transparency surrounding bilateral free trade and investment negotiations. The Panel views transparency as a core component of robust and effective accountability frameworks needed to hold all stakeholders responsible for the impact of their actions on innovation and access.
“A paradigm shift in transparency is needed to ensure that the costs of R&D, production, marketing, and distribution, as well as the end prices of health technologies are clear to consumers and governments,” said President Festus Mogae. “Governments should require manufacturers and distributors of health technologies to disclose these costs and the details of any public funding received in the development of health technologies, including tax credits, subsidies, and grants.”
The Panel also recommended the UN General Assembly 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 in line with the 2030 Agenda for Sustainable Development.
John Butler, GHS, email@example.com, +1 917 573 1339
Andrea Vogt, GHS, firstname.lastname@example.org, +1 561 602 8162