UN Member States Briefed On Innovation And Access To Health Technologies: Part 1 14/03/2018 by William New, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)NEW YORK — A major event on innovation and access to health technologies took place at the United Nations in New York last week, in which UN member states were briefed on ideas and efforts to promote these issues at the forefront of global health policy. The UN Briefing on Promoting Innovation and Access to Health Technologies in the context of the 2030 Agenda for Sustainable Development took place on 6 March. This article is the first of two on the event, which included speakers from international organisations, governments, and a range of other agencies and perspectives. Ruth Dreifuss addresses the event, with a representative of WHO on her left and of the Netherlands government on her right Among the long list of speakers were: Mandeep Dhaliwal, director, HIV, Health & Development Group, BPPS, UN Development Programme (UNDP); former Swiss President Madame Ruth Dreifuss, co-chair of the UN Secretary-General’s High-Level Panel on Access to Medicines; and Michelle Gyles-McDonnough, director, Sustainable Development Unit, Executive Office of the UN Secretary General. [Note: the second story will report on the remaining speakers] Dhaliwal, who moderated the event, opened by saying the 2030 Sustainable Development Agenda is “a bold, interconnected agenda which pledges to leave no one behind. Health, wellbeing and healthy individuals are central to this agenda.” And innovation and access are key to that, she said. The event was a briefing for UN member states and interested stakeholders “to provide an update on the current situation with respect to access and innovation to medicines and other health technologies,” she said. The briefing responds to a resolution adopted by the UN General Assembly on 15 December 2016 (A/RES/71/159), Global Health and Foreign Policy: health employment and economic growth), which noted the September 2016 report of the UN Secretary-General’s High-Level Panel on Innovation and Access to Medicines and acknowledged “the need for further discussions on access to medicines among UN Member States and all relevant stakeholders.” Dhaliwal mentioned the High-Level Panel report, saying it contained recommendations relating to both innovation and access to medicines. The report “has helped to reinvigorate the dialogue globally on these critical issues,” she said, noting it has now been discussed at the World Health Organization Executive Board, UN Human Rights Council, and have become a standing agenda item at the World Trade Organization. ‘Health at Forefront of Global Agenda This Year’ Gyles-McDonnough laid out the global challenges around innovation and access to health technologies, and noted that the right to the “highest attainable standard” of health is a universal human right, and the burden of disease is “shared by all humanity.” She walked through specific SDGs related to health, development of vaccines and medicines for diseases primarily affecting developing countries, and to provide access to affordable essential vaccines and medicines for all. “Recent years have seen an intensification of the role of medical technologies,” she said, “both the innovation processes that lead to new technologies, and the ways in which these technologies are made accessible through health systems.” She hailed the remarkable achievements of innovations in health in past decades, highlighting vaccines reducing child mortality and disease, and the number of people with HIV who have access to lifesaving antiretrovirals through lower-cost generic medicines. However, she said, the growing disease burden worldwide creates a constant need for new technologies, “so innovation and access are inextricably intertwined.” She added, “It takes targeted policies and determined action to prioritize access to the benefits of these new technologies, and to quicker and more effective treatments for all people, particularly for the poor and most vulnerable.” And despite the exponential growth in new developments, many people cannot afford the new generation of treatments for some diseases, Gyles-McDonnough said, adding that people in low and middle-income countries are still largely excluded from access. She mentioned the problem of a lack of research and development into treatments for diseases where the market does not provide a sufficient return on investment, like antibiotics. This is one of the areas being addressed through the Interagency Coordination Group on Antimicrobial Resistance (AMR), which is co-chaired by the deputy UN secretary general and the director general of the World Health Organization, she said. Gyles-McDonnough also mentioned the High-Level Panel, which she noted came under the previous UN secretary-general and focused on innovation and access to health technologies (the subject of this event). She acknowledged the panel’s “important contribution in advancing this agenda,” and paid tribute to Dreifuss. Also in 2016, the Human Rights Council passed two “landmark” resolutions, she said, reaffirming that access to medicines and strengthening capacity building in health are fundamental to achieving the right to health. “This year, health will be at the forefront of the global agenda during the 73rd session of the UN General Assembly,” she said, bolstered by the High-Level Meeting on Tuberculosis, and the High-Level Meeting on Noncommunicable Diseases. These “will present a critical opportunity to adopt a multisectoral and multidisciplinary approach to integrate and address these health challenges in each country’s path toward achieving universal health coverage.” Innovation and access to health technologies is cross-cutting and should be linked to other health priorities, she said. For instance, multidrug-resistant TB accounts for one-third of all antimicrobial resistance deaths, “making the AMR agenda central to tackling TB.” Meanwhile, TB is a principal cause of death among people living with HIV and AIDS, she added. Among other issues, she mentioned the need to also improve delivery and other conditions in resource-poor settings. “Access to essential medicines and health technologies is a cornerstone of universal health coverage,” said Gyles-McDonnough, noting that medical devices, assistive devices and e-health are also important components. “The world must take bold new approaches to both health technology innovation and ensuring access so that all people can benefit from … medical advances. This will require greater investment, thinking and collaboration for stronger regulatory systems.” The Ambitious, Yet Narrow Mandate of the High-Level Panel Dreifuss gave a long presentation on the High-Level Panel, saying the scope of the panel mandate was on one side broad and ambitious, and on the other side it was narrow. It was narrow, she said, because the mandate was clearly to propose solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights laws, trade rules, and public health. “So the first question was to define how to bring this policy incoherence in line and how to overcome them,” she said. “It means clearly to make a priority … of the goals decision-makers have to achieve in human rights and public health on one side, and trade and intellectual property rights on the other side.” She noted that “the general frame of the mobilization of the world community to achieve the Sustainable Development Goals by 2030 has given a general envelope to all of our struggles, also in health. SDG 3 is here of the utmost importance.” Achieving universal health coverage includes access to safe, effective, quality and affordable essential medicines and vaccines for all, it states. “It is clear the availability at an affordable price for all in need depends in a large part on patent laws and criteria of patentability, and decisions taken by regulatory and procurement authorities,” said Dreifuss. “So if I said it is at the same time ambitious and narrow, it is clear there are a lot of other reasons that can be obstacles to the access to medicine and to achieve universal health coverage. But this is the issue on which we had to concentrate.” The aim of the right of health has to be defined, she said. For many years, it was concentrated on the issue of tropical disease and neglected diseases (“I would say of neglected patients also,” she added). But some new challenges came to be added, she said: the growing burden of non-communicable disease, the growing antimicrobial resistance, the high price of new treatments, which brought also rich countries for the first time perhaps to really be confronted with the threat or reality of rationing. Even in countries with universal health systems, not everything is now granted for all patients. Another issue is the “problematic gap” between the cost of research and development and the price of treatment, she said. “If you look, there is no clear connection. We do not know exactly what the structure of the finances of the pharmaceutical industry and the biomedical industry is,” Dreifuss said. “We know that the connection between the production and the R&D cost and the final price is no longer a reality.” We do not know exactly what the structure of the finances of the pharmaceutical industry and the biomedical industry is. We know that the connection between the production and the R&D cost and the final price is no longer a reality. – Ruth Dreifuss Still another issue she raised is the lack of use of the flexibilities to IP rights as allowed in the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), “which were a great achievement in the international discussions” to overcome barriers, she said. SDG 3 also includes supporting the R&D of vaccines and medicines for communicable and non-communicable diseases in coordination with 2001 Doha Declaration on TRIPS and Public Health, she said. “Here we have really a lack of biomedical innovation, which is not limited to neglected tropical disease. It became really a global challenge,” she said. “And it is clear that the public health response needs medicines, vaccines, diagnostics and all kinds of medical devices.” “In my experience as a former minister of health, for instance just in the field of vaccines we do not have enough research in the pharmaceutical industry, and diagnostics is a field where the costs are just beginning to be too high to be used largely,” Dreifuss said. “And in the field of medical devices, which is a very broad field, the question of intellectual property is as serious if not more serious than it is in medicines. The non-transparency of the system for medical devices is very great.” In the field of R&D and research, she added, “we have still the old challenges remaining: lack of research for diseases of the poor and diseases of the few” until the threat of the so-called emerging diseases is recognised by the whole community. “We have the bad adaption to settings and conditions of poor countries, we have still the lack of specialities for children, we have unaffordable prices for those who pay out of pocket.” In the field of medical devices, which is a very broad field, the question of intellectual property is as serious if not more serious than it is in medicines. The non-transparency of the system for medical devices is very great. – Dreifuss She also cited the question of “sustainability and the scope” of the progress made through public-private partnerships, and paid tribute to the progress that has been made in the past 15 years by such partnerships. But, she said, “This is always something that has to be more sustainable in the future. Research and development under the common collaboration of the public sector and the pharmaceutical and biomedical industries is often not guaranteed for the future.” Recap of High-Level Panel Report Recommendations Dreifuss took time to walk through a set of serious recommendations laid out in the report, which was developed by a global panel of experts over the course of a year and reported in September 2016. First, it focused on the TRIPS flexibilities and why they are not used enough to guarantee the aim of public health and also that member states should use the policy space available in the TRIPS agreement to stop evergreening and ensure only genuine innovation is rewarded, she said. Governments should adopt legislation that ensures the quick, fair and predictable use of compulsory licensing, she said. “It is first of all the responsibility of the state to make it also very clear how they intend to go further if they feel the need to issue a compulsory licence.” She also pointed to the so-called Paragraph 6 solution under the 2001 Doha Declaration – which she said allows the possibility for countries with production capacities to also export under compulsory licences the medicines needed in poor countries without the possibility of developing their own production – and said it should be “made efficient and useable, which is not the case now, so members should revise how to implement this very important tool.” Dreifuss also stressed the recommendation on the importance of balancing priorities in free trade agreements, and this is “a big change,” she said. “When we speak about Doha Declaration and flexibilities, it is important to know that this is no longer the basis of the trade relationship and intellectual property relationship between countries, but the free trade agreements play a big role in this field,” she said. “It is very important that governments and the private sector refrain from explicit or implicit threats, tactics or strategy that undermine the use of these TRIPS flexibilities.” It is very important that governments and the private sector refrain from explicit or implicit threats, tactics or strategy that undermine the use of these TRIPS flexibilities. While working on the High-Level Panel, they had some examples of pressure put on countries denying them the right to use these flexibilities, she said. “We call on governments involved in bilateral and regional trade and investment negotiations ensure they do not interfere negatively with the right to health and this is a responsibility for governments to undertake public health impact assessments before entering into these agreements.” Balancing the priorities in free trade agreements is also something that interests the World Trade Organization, Dreifuss noted, and “our call is to report to the WTO secretariat during the trade policy review of WTO members what happened in these negotiations, and to give the possibility to register complaints of political and economic pressures and take punitive measures against offenders.” She noted that the WTO TRIPS Council agenda has a debate about what should be done. In the report there are also “a lot of recommendations” involving publicly funded research, serving public health, and this is addressed mainly to the public funders who should increase the possibility of R&D and the universities working for the interest of public health in the first line when they receive public funding and put them at the disposal of the broader community, she said. She said a “very important” aspect of the recommendations, discussed in the World Health Organization, is to create new incentives for R&D. “It is absolutely important not only that government increase their level of biomedical investment to address unmet health needs, but it is very important also to think about new and additional models for financing and rewarding public health R&D,” she said. It is very important also to think about new and additional models for financing and rewarding public health R&D. “We hope that the UN secretary-general could initiate negotiations among governments on the coordination, financing and development of health technologies for a binding R&D convention that could bring other incentives than just IP alone, which cannot meet all the needs when there is no market that is ready to pay for this development,” she added. As a preliminary step, the panel proposed that a working group should begin negotiation a core set of principles for biomedical R&D. And Dreifuss added that, “For me as a former minister responsible for public health, the most important recommendation is about the accountability and coordination inside the governments, the necessity to review the situation of access to health technologies in the countries and to make them publicly available, to work with the civil society, and to create transparency of the biomedical sector.” Governments should require all manufacturers and distributors to disclose the cost of R&D, production of marketing and distribution of their products, and should also require the disclosure of public funding received in the development of health technology, she said. Governments should require all manufacturers and distributors to disclose the cost of R&D, production of marketing and distribution of their products, and should also require the disclosure of public funding received. WHO should establish and maintain a database of prices of patented and generic and biosimilar medicines in countries where they are registered, she said, adding that transparency in clinical trials is also very important, and the facilitated access to patent information. Governments should establish and maintain publicly accessible database with patent information, status of medicines and vaccines, with support from WIPO, including standard names for biological products, international non-proprietary names, dates of patent grants and expiry. “It is so important because so many products … for somebody who wants to enter in the market important to have clear information about what is in the public domain or not,” she said. “We need more coherence inside the UN system, governments’ assessment of what is going on, how the objectives can be realised or are they on their way to be realized,” said Dreifuss. The call is for the UN secretary general to establish an independent review body with broad membership from various constituencies, tasked with assessing health technology innovation and access, she said. There is also a call for the UN secretary general to establish an interagency task force to increase coherence between multilateral organisations working on health technology innovation and access, she added. And finally, she said there is also a call for the UN secretary general, supported by the member states, to convene a General Assembly special session on health technology, innovation and access, in a broad view. “We know we have now pieces that will be treated at the next General Assembly,” Dreifuss said, “but it needs really to have the global view on access to medicines and innovation for all.” Image Credits: UN Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related William New may be reached at email@example.com."UN Member States Briefed On Innovation And Access To Health Technologies: Part 1" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.