UN Health Update #58
Multilateral Consulting, LLC
November 1, 2017 UN HEALTH UPDATE #58 NOVEMBER 1, 2017
Table of Contents
WHO Breaks Precedent with New Leadership Team ...... 1 Female majority, inclusion of conservatives in line-up WIPO Showcases Agency’s Work, Highlights IFPMA Project ...... 5 At Assemblies: committees report, "Pat-INFORMED" presented “Montevideo Roadmap” Issued by Leaders at WHO NCD Confab ...... 8 High-level attendance at October Uruguay meeting WHO Establishes High-Level NCD Commission ...... 9 Headed by Sania Nishtar, will include Peruvian president WHO Issues GCM/NCD Progress Report ...... 9 Aims to achieve Global Monitoring Framework's 9 targets WHO EURO, LSE Scholars: Hurdles are Prices, IP ...... 10 Slams failure to implement HLP recommencations, including "punishment' Comments Submitted on WHO GPW 2019-2023 ...... 10 Lays out D-G's vision and priorities; NGOs make suggestions PAHO Elects Carissa Etienne to 2nd Term ...... 12 Directing Council takes up usual list of topics Regional Director Presides Over First/Last EMRO Meeting ...... 12 Ministers debate range of pressing challenges WPRO Takes Up Broad Range of Issues ...... 13 Health Promotion a major discussion topic The Union World Conference Highlights TB ...... 14 Guadalajara confab highlights access issues, new products UN Agencies Launch “HIV Prevention 2020 Road Map” ...... 15 Global HIV Prevention Coalition to cut new HIV infections by 75% by 2020 EDCTP, WHO AFRO, TDR Fund Implementation Research ...... 15 New partnership to strengthen research capacity in Africa New Research, Projects Launched for World Sight Day ...... 16 "Lancet" study, two new financing mechanisms A Legal Innovation to Address Firms’ Access Challenges? ...... 16 Special contribution from Michele Forzley, JD, MPh UNHRC Convenes Annual Social Forum ...... 17 New this year: heads of UN agencies present Meetings & Events Held ...... 19 Forthcoming Meetings & Events ...... 21 People ...... 22 Briefs ...... 24
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WHO Breaks Precedent with New Leadership Team
On October 3, WHO Director-General Tedros Adhanom Ghebreyesus announced the appointment of 14 senior officials to fill posts at the agency’s Geneva HQ. The group represents 14 countries, including all WHO regions. Nine of the appointees are women, the first time ever women have outnumbered men in senior posts at a UN agency, leading several observers to suggest that global health perspectives are bound to change. “The Lancet” on October 14 said the announcement “has brought additional and valuable momentum to the renewal of WHO.” In a departure from the agency’s usual practice, two of the appointees are conservatives. With one exception, the appointees replace Chan administration officials who held approximations of those positions. Included in the new top management team are two posts of particular interest to the industry: • Dr. Mariângela Batista Galvão Simão (Brazil), Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals (DAP)—the same acronym used for the program’s first iteration: Drug Action Program. It appears that the remit of this new group is focused more precisely on the pharma industry matters than that of her predecessor, Marie-Paule Kieny, who was ADG for Health Systems and Innovation. Several of Kieny’s very broad responsibilities have been assigned to other ADGs in the new lineup. Most recently, Batista Galvão was Director of Community Support, Social Justice and Inclusion at UNAIDS. Between 2006 and 2010, she served as Director of the National STD/AIDS (NAP) and Viral Hepatitis Department in the Brazilian Ministry of Health, where she led price negotiations with pharmaceutical companies to lower the price of HIV medication. During this time, she also represented the Brazilian Ministry of Health in the 2006 negotiations that led to the constitution of UNITAID, where she served as a board member until 2008. She told the “NEJM”, in May 2006, that Brazil may issue compulsory licenses for some imported drugs, as “It’s possible and it’s legal.” In her work she has always emphasized the role of human rights and the importance of working with civil society. She was trained as a pediatrician in Brazil and holds an MSc degree in public health from University of London (now University College), UK. From her background in advocating for lower prices and in questioning IP protections, it seems likely that the new DAP ADG will present significant challenges for innovative pharma companies. • Dr. Svetlana Akselrod (Russia), Assistant Director-General for Non-Communicable Diseases and Mental Health, succeeding Oleg Chestnov. She brings more than 15 years of experience in public health coordination and global health diplomacy. Prior to this role, Dr. Akselrod was Coordinator at the WHO European Office for the Prevention and Control of Non-Communicable Diseases, where she oversaw WHO’s regional work to prevent and control NCDs in eastern Europe and the central Asian countries. In addition, she served as Deputy Director of the Department of International Cooperation and Public Affairs within the Ministry of Health of the Russian Federation between 2012 and 2016, and represented Russia at the WHO Executive Board and the WHA. In July, Axelrod, then-Coordinator of Integrated Country Support Programs at the WHO Europe NCD Office in Moscow, received an award for achievements in international health policy from Vladimir Putin. Akselrod was named in time to lead WHO participation in the October 18-20 Global Conference on NCDs in Montevideo, Uruguay, and the agency’s preparations and role in the UN High-level Meeting on NCDs next year. She recently tweeted, “Health is not a lottery for those who can afford it—it’s a human right.” The new ADG is trained as a pediatrician and holds a doctorate degree in public health, as well as a diploma in international law. In a departure from custom, the D-G appointed two Deputies Director-General to free up the DG’s time to play political leadership and build coalitions: • Dr. Soumya Swaminathan (India), Deputy Director-General for Programs (DDP). A pediatrician and a globally-recognized researcher on tuberculosis and HIV, she brings 30 years of experience in
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clinical care and research and has worked throughout her career to translate research into impactful programs. The Organization of Pharmaceutical Producers of India (OPPI) touted her remarks on World IP Day 217, at which she spoke about how innovation can give a boost to public health in the country. In an interview with an Indian publication following her WHO appointment, she stated, “India will be at the back of my mind while addressing public health issues.” Swaminathan holds a MBBS from Armed Forces Medical College (India) and MD from All India Institute of Medical Sciences, along with a Diplomate of National Board from National Board of Examinations. She subsequently held a Post-Doctoral Medical Fellowship in Pediatric Pulmonology at the Children’s Hospital Los Angeles, Keck School of Medicine at the University of Southern California. • Jane Ellison (UK), Deputy Director-General for Corporate Operations (DDC). A Conservative Party politician, she has more than 30 years of experience in politics, commerce and change management in both the public and private sectors, including as Treasury Minister, an MP and as Parliamentary Under-Secretary of State for Public Health from 2013-2016. Prior to her career in government, she worked in the private sector (John Lewis Partnership, LLP), where she was involved in several change management programs. Ms. Ellison has a degree in Politics, Philosophy and Economics from Oxford University. The other appointments are: • Dr. Bernhard Schwartländer (Germany), Chef de Cabinet and Assistant Director-General. Since 2013, he has served as WHO’s representative in China. Before the position at WHO-China, Schwartländer held the positions of: Director for Evidence, Policy and Innovation at UNAIDS in Geneva; UN Country Coordinator on AIDS in Beijing; Director for Performance Evaluation and Policy at the Global Fund and Director of the WHO HIV Department, and Director of Evaluation and Strategic Information at UNAIDS. In 2000, Schwartländer undertook a special assignment at the World Bank to perform economic analyses on the cost and impact of the HIV/AIDS epidemic. Schwartländer is a medical doctor and holds a doctorate in medical epidemiology, having received his education and professional training in Germany and the U.S. at the Centers for Disease Control and Prevention (CDC). He holds appointments as adjunct professor with Peking and Tsinghua Universities in Beijing. • Dr. Naoko Yamamoto (Japan), Assistant Director-General for Universal Health Coverage and Health Systems Cluster (UHC), part of the portfolio previously held by Marie-Paule Kieny. The new position elevates the importance of this work. Yamamoto brings nearly 30 years of experience working on health in Japan and most recently served as Senior Assistant Minister for Global Heath in Japan’s Ministry of Health, Labor and Welfare. In this capacity, she was heavily involved in Japan’s global health leadership, including hosting and organizing the International Conference on Universal Health Coverage in 2015 and supporting the compilation of the G7 Ise-Shima Vision for Global Health and Kobe Communique of the G7 Health Ministers’ Meeting in 2016, both of which highlighted the importance of promoting UHC. She also has been a member of the Global Health Innovation Technology Fund (GHIT) Council. On occasion of the fifth anniversary of GHIT this year, she expressed a positive view of the innovative pharmaceutical industry: “… we have great expectations for this industry as one which will be important for Japan’s economic growth.” Yamamoto holds an MD, a PhD in epidemiology and a Masters in Public Health from Sapporo Medical University. • Professor Lubna A. Al-Ansary (Saudi Arabia), Assistant Director-General for Metrics and Measurement, previously covered by the Health Information, Evidence and Research Unit of Health Systems and Innovation, which was part of the portfolio held by Marie-Paule Kieny, a function first instituted as Evidence and Information for Policy by then-Executive Director, Julio Frenk. Al-Ansary is well-known in the Gulf countries for her extensive experience promoting and supporting evidence-based health care. She is a Professor of Family Medicine at the College of Medicine and head of the Clinical Practice Guidelines Committee at King Saud University (KSU)
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and is head of the Clinical Practice Guidelines Committee. In addition, she currently holds the Bahamdan Research Chair for evidence-based health care and knowledge translation at KSU, which focuses on evidence-generation and implementation. In eight years as the Bahamdan Chair, she has published more than 40 papers. She was one of the first female MPs ever to join Saudi Arabia’s Consultative Council and represented female MPs at the Inter-parliamentary Union for two years. In 2015, she co-authored “Guidelines International Network: Principles for Disclosure of Interests and Management of Conflicts in Guidelines” in the “Annals of Internal Medicine.” Al-Ansary holds MBBS, MSc, MRCGP, FRCGP certifications. • Ambassador Michèle Boccoz (France), Assistant Director-General for External Relations. A career diplomat, Boccoz has had an atypical career path. After holding several diplomatic posts— primarily multilateral: the European Union (EU), UN and the Organization for Security and Cooperation in Europe (OSCE) in posts in Paris, Vienna and Geneva, Boccoz entered the private sector when she became Director of International Affairs at Institut Pasteur, where she headed the Institut Pasteur International Network, and then became Director of International Communications at the Paris-based headquarters of Veolia Environnement. She returned to France’s Ministry of Foreign Affairs as Deputy Chief of Staff to the Minister. From 2009 to 2012, she was Ambassador to Belgium, and from 2013 to 2016, Ambassador to Croatia. She has served as the French Government’s Ambassador for the fight against HIV/AIDS and communicable diseases since 2016. Her involvement in health diplomacy dates back to her term of office in Geneva, during which she served on Dr. Gro Harlem Brundtland’s transition team. She also was instrumental supporting the International Health Regulations and emergency preparedness and response efforts. During the French presidency of the EU, she coordinated the EU’s positions for the negotiations on the Framework Convention on Tobacco Control. Ambassador Boccoz holds degrees from the French Ecole Normale Supérieure de Fontenay and the Ecole Nationale d’Administration. • Dr. Ranieri Guerra (Italy), Assistant Director-General for Special Initiatives. A physician, he has more than 30 years of public health experience, having served as Science and Technology Attaché at the Embassy of Italy in Washington, D.C.; Director of the WHO Collaborating Center for health education; Director of the Office of External Relations of the President’s Cabinet at the Istituto Superiore di Sanità (ISS), the national research organization of the Italian Ministry of Health, where he was responsible for the External Relations Office (URE); and Medical Director of the UN Relief and Works Agency (UNRWA). Guerra has significant experience in the integration of participation by NGOs in national health programs, monitoring and evaluation of health activities, epidemiological research applied to health system management, strategic planning, telematics in health, health systems design and appraisal, training in public health, multi-sectoral HIV/AIDS responses and diseases of poverty. He has been consultant and team leader for UNICEF, UNDP, the Global Fund, WHO and the Italian Ministry of Foreign Affairs on various projects. Said to be industry-friendly, he has been “a member of the Board of Directors of the Smith Kline Foundation (not Glaxo)”, and stressed that distinction when conflict-of-interest charges were raised earlier this year by the consumer group, Codacons. (Shading) He earned an MS at the London School of Hygiene and Tropical Medicine, a degree in Medicine and Surgery at the University of Padua and other certifications from universities in Milan and Verona. • Dr. Ren Minghui (China), Assistant Director-General for Communicable Diseases. Dr. Ren has served as ADG for HIV/AIDS, Tuberculosis, Malaria and Neglected Tropical Diseases since January 2016, and is continuing this work under his new title. Prior to this role, he was Director-General for International Cooperation in the National Health and Family Planning Commission of the People’s Republic of China. He brings nearly 30 years of public health experience, working on health policy and health reform in China’s Ministry of Health, where he focused primarily on health systems research and health insurance reform. He delivered opening remarks at a March, 2017 meeting in Geneva that focused on MPP-WHO joint forecasts for HIV medicines as well as the progress of hepatitis C treatment uptake. Dr. Ren has a Medicine Degree from Xian Medical University, China,
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a Master of Public Health from the Harvard School of Public Health, an executive training certificate in public policy and administration from the Harvard JFK School of Government, U.S., and a PhD in Social Medicine and Health from Peking University, China. He received an honorary award by the Russian Federation for his contribution to health cooperation in 2006. • Dr. Princess Nothemba (Nono) Simelela (South Africa). Assistant Director-General for Family, Women, Children and Adolescents, succeeding Flavia Bustreo. Dr. Simelela has more than 30 years of experience as an obstetrician, academic, advocate and government official. Most recently, she served as Special Advisor to the Vice President of the Republic of South Africa, where her work spanned supporting the implementation of the country’s National Strategic Plan for HIV, TB and Sexually-Transmitted Infections to reviewing the country’s Expanded Public Works Program. She was the first and only African female in the Senior Management of International Planned Parenthood Federation (IPPF) and served as a WHO Executive Board member from 2004-2009, representing the IPPF as a technical expert on maternal and child health, adolescent sexual and reproductive health issues, increasing access to safe abortion services. She was the first black South African woman to qualify as a Specialist Obstetrician Gynecologist in 1990. Given her activist background, South African observers doubt she will be supportive of pharma firms. • Stewart Simonson (U.S.), Assistant Director-General for General Management, succeeding Bruce Aylward, who was named last year ADG for Change Management. Simonson brings more than 20 years of experience in corporate governance, risk management and administration that spans across the government, non-governmental and private sectors. Most recently he was Corporate Secretary and Legal Advisor, CRUDEM Foundation; General Counsel, Futures Group Global, LLC; and VP at SRA International. Under President George W. Bush, Simonson was instrumental in building the preparedness and response organization in the U.S. Department of Health and Human Services (HHS) that grew out of the September 11th attacks, serving as the Secretary’s principal advisor on matters related to bioterrorism and other public health emergencies, and coordinating the development of the U.S. Government’s position on the revision of the International Health Regulations. In the face of criticism around the Hurricane Katrina response and allegations of Bush cronyism, leading scientists weighed in with support for Simonson: Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, commented, “Here’s the guy who has really done a terrific job under very complicated, adverse circumstances”; Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota said “Of all the people I’ve worked with over my career, no one is more competent”; and the revered champion of smallpox elimination, Dr. Donald (“D.A.”) Henderson, added “this is a dedicated person.” Simonson earned a JDat the University of Wisconsin–Madison. While he is likely to effectively move WHO reform forward, if the U.S. were to have been accorded one post, the DAP position would have been best for the industry. • Dr. Joy St. John (Barbados), Assistant Director-General for Climate and Other Determinants of Health, an elevation and expansion of the Public Health and Environment function held by Director Maria Neira. The new ADG brings more than 20 years of experience in public health management and health diplomacy, including serving as the Chief Medical Officer of Barbados for more than ten years. Dr. St. John has also served as Director of the Caribbean Public Health Agency (CARPHA), during which time she fostered greater regional collaboration on health. St. John chaired the WHO EB during 2012-2013. During a stint as Senior Advisor with the WHO UN Office in NY supporting the co-facilitators of the UN General Assembly NCD review from 2014-2015, she co-authored an opinion piece in the “WHO Bulletin” in 2014 with other WHO officials including Oleg Chestnov and Werner Obermeyer, titled “Towards the world we want.” She holds BSc, MBBS and MPh degrees from the University of the West Indies and additional certifications in medicine and public health from institutions in Barbados, Jamaica and the U.S.
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• Dr. Peter Salama (Australia), Executive Director of the Health Emergencies Program. A medical epidemiologist, Salama has served in the same post since 2016. Before joining WHO, Dr. Salama was UNICEF’s Regional Director for the Middle East and North Africa. He has worked for Doctors Without Borders (MSF), the Irish NGO Concern and the U.S. Centers for Disease Control and Prevention (CDC), which lent him to the UN High Commissioner for Refugees after the September 11 attacks. In January, 2016, he told “IP Watch” that WHO is “at the core of partnership” that involves UN, civil society, member states, private sector, adding “That will be the power of what we do” and noting that WHO’s Emergency Medical Teams work with “GAVI, and with the manufacturing and pharmaceutical sectors.” Salama completed his medical and public health degrees at Melbourne and Harvard Universities, where he was also a Fulbright and Harkness fellow in public policy. Media outlets published differing accounts of the transition process. “IP Watch” reported that a working group on the transition, drawn from existing WHO staff, advised the D-G on the “high- priority” changes. The internal group, the publication said, was headed by Elil Renganathan, who leads the WHO evaluation office, and included others understood to be: Tim Armstrong (NCDs and Mental Health); Andreas Mlitzke (Office of Compliance, Risk Management and Ethics); Jean- Marie Okwo-Bele (Vaccines); Maria Neira (Public Health, Environmental and Social Determinants of Health); Marc Touitou (Chief Information Officer); Agnès Soucat (Health Systems, Governance and Financing); Ruediger Krech (Ethics and Social Determinants of Health); Mubashar Sheikh (Global Health Workforce Alliance); Gottfried Hirnschall (HIV and Hepatitis); Etienne Krug (NCDs, Disability, Violence and Injury Prevention); Bente Mikkelsen (Global Coordination Mechanism on the Prevention and Control of NCDs); Peter Graaff (Emergency Operations and Ebola Response); Jennifer Linkins (Management and Administration); Shambhu Acharya (Country Cooperation and Collaboration); and Françoise Nocquet (Human Resources), among others—several of whom might have envisioned themselves in the new leadership roles. But the “CMMD Observer”, on October 9, described a very different “rather substantial transition team”, chaired by Tedros’ long- standing ally, Dr. Senait Fisseha, an Ethiopian physician with strong U.S. connections, based in the state of Michigan, who also chaired his campaign. A wide network of development experts also contributed, including Dr. Peter Singer, the CEO of Global Challenges in Canada, as reported by ”The Wire“, in addition to several others with extensive careers in fighting poverty. “The Lancet” reported on October 14 that “Reports suggest that [Tedros] is likely to appoint a transformation czar and hire McKinsey consultants to manage the change.” Knowledge Ecology International (KEI) referred to this in “Comments Submitted on WHO GPW 2019-2023” (below). At the WHO Western Pacific Annual Meeting in Brisbane, Australia, Dr. Tedros also announced an appointment of a new Chief Nursing Officer post and appointed Elizabeth Iro, a registered nurse who is currently Health Secretary of the Cook Islands. The position has been downplayed, and not always filled, during the past several administrations.
WIPO Showcases Agency’s Work, Highlights IFPMA Project
The 57th series of the annual World Intellectual Property Organization (WIPO) Assemblies took place in Geneva during October 2-11, under the chairmanship of Ambassador Jānis Kārkliņš, who is also Representative of Latvia to the UN in Geneva. The gathering coincided with the 50th anniversary of the 1967 WIPO Convention—the treaty which established WIPO as an international organization and the foundations of its governance system. During the ten-day meeting, WIPO delegations took stock of progress and charted a future path for the agency’s work and noted the various committees’ reports. In opening remarks, WIPO Director-General (D-G) Francis Gurry set forth the Assembly’s themes. Key messages in his upbeat address included the strong financial position of the organization and the central role of innovation for WIPO’s mission. He pointed to the accelerating rate of innovation as a force decisive in shaping future policy directions for the agency. Innovation “lies at the heart of the
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mission of intellectual property”, said Gurry. “Innovation has become a central element of the economic and industrial strategies of a wide spectrum of countries, not just the most advanced technologically.” Referring to WIPO’s mandate, he further added that innovation’s “fundamental importance has been recognized in the Sustainable Development Goals (SDGs) in SDG 9. As a capacity and a strategy that applies to all sectors of the economy and society… innovation provides an opportunity for the Organization to contribute to all the SDGs”, he added. Commenting on the fundamental technological changes of recent decades, Gurry noted “the rapidly-developing area of big data, the Internet of Things and artificial intelligence” (AI) and their implications and multifaceted dimensions, “many of which lie well beyond the focus of intellectual property”, adding, “our knowledge base is only just developing.” He looked to the future with new orientations on the judicial administration of IP, the WIPO Knowledge Network and the challenging arenas of big data, the Internet of Things and AI. WIPO should begin “tentative engagement” on these matters, the D-G said. WIPO raises almost 95% of its income through fees paid by IP right-holders and applicants in exchange for global IP protection services established by treaties, such as the Patent Cooperation Treaty (PCT) (which alone generates 75% of WIPO’s income). This arrangement makes WIPO one of the most financially stable of UN organizations, with a recurring budget surplus, sizeable reserves and negligible Member State contributions (which combined account for less than 5% of its budget). The membership agreed at the October Assemblies on a program and budget for the 2018-2019 biennium that foresees a 10.9% increase in revenue from growing demand for WIPO’s global IP-filing and other services, without an increase in user fees. This represents an increase of 2.7% over the previous two-year period. Revenue in this period is expected to reach 830 million Swiss francs, with a projected surplus of approximately 65 million Swiss francs. Despite the expected revenue growth, no new staff posts are planned. Member States approved special funding for capital investments, with a particular emphasis on strengthening information and communication technology. Members also agreed to consider establishing up to four external offices during 2018/2019, including in Colombia, expanding the organization’s network of overseas offices. The Asia and Pacific Group that does not include China, Japan, Australia or New Zealand, which wants more seats, challenged the composition of the Program and Budget Committee (PBC). The budget and program were not agreed without intense debate: the U.S. initially opposed the budget—a decision Member States normally take by consensus. The U.S. has long insisted that no revenue from the PCT or Madrid Treaties should be used to subsidize Lisbon Union activities. “IP Watch” reported on October 5, that “The United States has posed conditions on approval, particularly that they would like to keep discussing a potential change in WIPO’s budget allocation to prevent the treaty they pay most into from having to fund other less-financially-viable treaties. They also asked that the WIPO treaty protecting geographical indications eliminate its deficit, and that no high-level negotiating meeting be provisioned for without the whole WIPO membership agreeing to it.” Delegates eventually found a way to address requests made by the U.S., notably on the financing of the WIPO agreement protecting geographical indications. Committee reports were presented and discussed. Participants took note of the report on the Committee on Development and Intellectual Property (CDIP) and review of the implementation of the Development Agenda Recommendations, while commending resolution of two long standing issues— the implementation of the CDIP mandate and the implementation of the Coordination Mechanisms and Monitoring, Assessing and Reporting Modalities. They noted the report of the Committee on WIPO Standards (CWS), including the adoption of two new standards: for the greater clarity in the exchange of patent legal status data in a standardized manner; and concerning the authority file of published patent documents to ensure the completeness of the patent collection of a given country. Members took note of the report by the Advisory Committee on Enforcement (ACE), which enables member states to exchange and build upon each other’s practices on institutional arrangements on IP enforcement policies and regimes, awareness-raising, as well as the legislative assistance and capacity-building provided by WIPO in the area of IP enforcement and building respect for IP. The Standing Committee
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on the Law of Patents (SCP) had already agreed on a work program at the last session of the committee and the Assembly just took note of the report of the committee. During the SCP discussion, Knowledge Ecology International (KEI) proposed that WIPO establish an instrument that would create reciprocal rights in government funded inventions, so that the countries that were members of such an agreement would agree to the terms and modalities under which they could share access to government-funded inventions. On the last day, delegates agreed on a mandate and a work program for the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) for the biennium that seeks ways to protect genetic resources, traditional knowledge and folklore from misuse and misappropriation. According to agreed mandate, the IGC will “continue to expedite its work with the objective of reaching an agreement on an international legal instrument(s), without prejudging the nature of outcome(s), relating to intellectual property which will ensure the balanced and effective protection of genetic resources, traditional knowledge and traditional cultural expressions.” “IP Watch” reported on October 3 that on the sidelines of the Assemblies, WIPO Director General Gurry and the Director-General of IFPMA, Thomas Cueni, signed an agreement establishing the “Patent Information Initiative for Medicines” (Pat-INFORMED), a new partnership to promote the accessibility of patent information for health agencies tasked with procurement of medicines, an idea originally brought to WIPO by a group of companies in February of this year. IPW also published an interview with Dr. Gurry and Mr Cueni about this new initiative. The WIPO D-G explained: “The aim of Pat-INFORMED is to promote accessibility to public patent information on registered medicines via a new online global gateway. This gateway consists of a database specially designed to make it easier for medicine procurement experts in public health agencies to determine the existence of medicine patents.” The IFPMA head added, “This initiative stems from the pharmaceutical industry’s desire to help make medicine patent information clearer for people involved in procurement of medicines, who are highly skilled in certain areas, but not always in patent searches and analysis. It couples our research-based biopharmaceutical companies’ know-how with WIPO’s well-established expertise in collecting and organizing patent data from across the globe… Information about granted patents and, in many cases, patent applications is already public, but data and resources that directly link patents to marketed medicines are more limited in scope: they are generally available publicly only in select countries or through private third-party databases. Some companies already self-publish such links to patent information, but there is no consistent approach.” Cueni added, “We can proudly say that this collaboration with WIPO shows the private sector’s initiative to propose practical solutions to reduce the costs of patent information.” Expected to be operational by mid-2018, the project will initially provide patent information for small molecule products within oncology; hepatitis C, cardiovascular, HIV, diabetes and respiratory therapy areas; and any products on the WHO essential medicines list that are not within these therapy areas. In the second phase, the initiative will expand to all therapeutic areas and explore the inclusion of complex therapeutics. A Panel discussion on “Patent Information Initiative for Medicines” was organized on October 3 by IFPMA and WIPO following the “Pat-INFORMED” announcement. Gunilla von Hall, Correspondent, “Svenska Dagbladet”, moderated the panel, and participants were Dr. Peter Beyer, Senior Advisor, Department of Essential Medicines and Health Products, WHO; Esteban Burrone, Head of Policy, Medicines Patent Pool (MPP); and Roy Waldron, Chair, IFPMA IP and Trade Committee, Senior Vice President & Associate General Counsel, Chief Intellectual Property Counsel, Pfizer. On 4 October, the South Centre held an event on the achievements and evolution of the WIPO Development Agenda that featured Professor Carlos Correa, Special Advisor on Trade and
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Intellectual Property at the South Center and Director of the Center for Interdisciplinary Studies on Industrial Property at the Law Faculty of the University of Buenos Aires. Correa gave an academic perspective on the relationship between intellectual property and development, arguing that general assumptions saying that intellectual property protection leads to economic development are flawed. For countries that do not have large sectors of high R&D intensity, IP protection has little importance, in particular patents, because the sector that would need patents does not exist, he said. Delegates participated in a series of symposia, exhibits and performances sponsored by member states during the WIPO Assemblies, including by members of the Association of Southeast Asian Nations (ASEAN), Australia, Colombia, Georgia, Italy, Mexico and Paraguay. Side events and exhibitions also included: • Exhibition—ASEAN @ 50—Intellectual Property, Innovation and Development • Exhibition—Furthering Intellectual Property in Colombia • Panel discussion on IP Toolkit for Academic Institutions—Connecting Academic Research with Economy and Society • Presentations and Discussions on The WIPO Development Agenda • Information session on WIPO External Offices • Panel discussion on Women, Innovation and Intellectual Property • Leadership Workshop for Female Delegates on Empowering Women in Intellectual Property In three years, WIPO will celebrate 50 years since the organization first opened its doors in 1970. The Annual Assemblies in 2020 will also mark the end of Dr. Gurry’s term as Director-General and the appointment of a new head of the agency.
“Montevideo Roadmap” Issued by Leaders at WHO NCD Confab
The October 8-20 “WHO Global Conference on Noncommunicable diseases: Enhancing policy coherence between different spheres of policy making that have a bearing on attaining SDG target 3.4 on NCDs by 2030” in Montevideo, Uruguay was attended by WHO Director-General Tedros Adhanom Ghebreyesus, UN International Telecommunication Union (ITU) Secretary-General Houlin Zhao and Presidents Tabare Vazquez (Uruguay), Mauricio Macri (Argentina), Michelle Bachelet (Chile) and Horacio Cartes (Paraguay), and WHO NCD Ambassador Michael Bloomberg, as well as ministers of health, agriculture, development cooperation, finance, foreign affairs, planning and trade; public policy decision-makers; UN organizations’ representatives; and global experts and advocates. The discussions concentrated on heart and lung diseases, cancers and diabetes. The focus was on enhancing policy coherence between different spheres of policy-making that have a bearing on attaining SDG target 3.4 on NCDs by 2030.The leaders pledged to take bold action to reduce suffering from NCDs by endorsing the “Montevideo Roadmap 2018-2030 on NCDs as a Sustainable Development Priority.” The pledge follows world leaders’ agreement to reduce by one-third “premature” NCDs deaths by 2030, as part of the UN’s 2030 Agenda for Sustainable Development. The Roadmap highlights the need for coordinated and coherent action from all sectors and the whole of society, as many of the main drivers of ill health lie beyond the control of health ministries, systems and professionals. Non-State actors, including civil society and industry, have important roles to play, said WHO. Among challenges identified in the Roadmap are uneven and insufficient progress to reduce premature deaths from NCDs; influence of the private sector on governments to prioritize trade over public health goals; and lack of high-level political leadership to ensure that health promotion and NCD prevention/control are addressed in all areas of government policy.
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Dr. Tedros, who the previous week announced the launch of a new WHO high-level commission on NCDs, commented, “This conference is a critical opportunity to accelerate efforts to get ahead of non- communicable diseases. We must be prepared to have some tough conversations, and to take brave action… Governments must act on pledges to prevent these diseases in the first place, and to ensure that people can obtain services to treat them.” He added. “Failure do to this imposes massive costs on individuals and communities. It totally contradicts global commitments to sustainable development.” The WHO head met with representatives of 20 civil society organizations, chaired by the NCD Alliance (NCDA), to discuss the UN High-level Meeting, the WHO General Program of Work and strengthening collaboration with civil society. Dr. Vasquez stated, “Trade and investment agreements should not be used as an excuse to look the other way, wash our hands and not protect the public health of our citizens.” The Montevideo Roadmap will guide global preparations for the UN General Assembly’s third High- level Meeting on NCDs next year to assess progress in meeting the target of reducing premature NCD deaths by 25 per cent by 2025 and then by one-third by 2030.
WHO Establishes High-Level NCD Commission
WHO Director-General Tedros Adhanom Ghebreyesus announced the formation of a new High- Level Commission on NCDs at the WHO Regional Committee for the Eastern Mediterranean (EMRO) held in Islamabad from October 9-12. He appointed as chair former WHO Director-General candidate, Sania Nishtar of Pakistan. (See “People” below.) President of Peru, Tabare Vázquez, was appointed co-chair of the Commission. The aim is to identify innovative ways to cut deaths from non- communicable diseases (NCDs) and extend the life expectancies of people suffering from the world’s deadliest diseases. “We urgently need new approaches and action on a dramatically different scale if we are to stop people dying unnecessarily from non-communicable diseases”, stated Dr. Tedros. Added WHO, “The commission’s aim is to identify innovative ways to curb the world’s biggest causes of death and extend life expectancy for millions of people. The commission will support ongoing political efforts to accelerate action on cardiovascular disease, cancers, diabetes and respiratory disease, as well as reducing suffering from mental health issues and the impacts of violence and injuries.” “IP Watch” reported on October 10 that “Commission membership details are still being finalized, according to a WHO spokesperson.” The agency added that Nishtar is “a prominent global advocate for action against NCDs, former Federal Minister of the government of Pakistan and civil society leader.” She also previously served as co-chair of the WHO Commission on Ending Childhood Obesity.
WHO Issues GCM/NCD Progress Report
On October 11, a 69-page “WHO Global Coordination Mechanism for the Prevention and Control of Non-communicable Diseases (GCM/NCD) Progress Report for 2014-2016” was released. The electronic version of the report has been published online and a hard copy of the report will be made available in the coming weeks. This report highlights the achievements of the GCM/NCD over the period 2014 to 2016, in collaboration with Member States, UN agencies, WHO staff from all slusters and levels, and other stakeholders, in helping countries to achieve the nine voluntary targets of the Global Monitoring Framework and reduce the burden of NCDs and their shared risk factors. Prepared by the WHO GCM/NCD Secretariat, headed by Dr. Bente Mikkelsen, the Progress Report concluded, “The GCM/NCD will work to more fully engage [its] online pool of distinguished experts in order to come up with innovative ways of capturing, disseminating and promoting best practices and country experiences in the prevention and control of NCDs.”
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WHO EURO, LSE Scholars: Hurdles are Prices, IP
In the October issue of the “WHO Bulletin” a “Perspective”, titled “Strategic procurement and international collaboration to improve access to medicines”, was authored by Alessandra Ferrario and Panos Kanavos, LSE Health and Social Care, London School of Economics and Political Science; and Tifenn Humbert and Hanne Bak Pedersen, WHO Regional Office for Europe (EURO), Copenhagen, Denmark. The authors provided examples of the experiences of countries in the WHO European Region in improving the efficiency of procurement of medicines and identified as obstacles: high prices, IP enforcement and failure to implement recommendations of the UN High-level Panel on Access to Medicines (HLP), including “punishment and reporting mechanisms.” Among the recommendations of the team of authors: Off-patent market—“The efficiency of procurement of medicines that are no longer covered by patents can often be improved by switching from branded products to non-branded generic or biosimilar products”; On-patent market—“In procurement from on-patent markets, negotiation, therapeutic tendering and the use of the flexibilities offered by the agreement on trade-related aspects of intellectual property rights may all be beneficial”; Quality of care—cites as an example Norway, where “the national procurement body for hospitals does not contract volume, only price”; Looking beyond lowest costs—“The unit cost of a medicine should not be the only consideration when deciding which product to procure. If the use of a more expensive medicine or formulation has spillover effects that benefit the health system, it may be more cost-effective than the use of the cheapest option”; and on Collaboration in procurement—“As few countries perform well in all areas of strategic procurement, international collaboration and experience sharing can be beneficial. In Europe, there are several well-established networks for the regular sharing of experiences and information on pricing, reimbursement and/or rational use of medicines.” Ferrario, Kanavos, Humbert and Pederson concluded: “The increasing calls from multiple stakeholders about the unacceptability of the high prices of new medicines require action. Some concrete initiatives have been launched and are being implemented. Improving access to medicines and patients’ outcomes is not just about prices. A process of managed entry of new medicines through horizon- scanning and health technology assessment and a life-cycle approach to ensure supply security through strategic procurement are needed. In this context, increased collaboration between countries—in terms of sharing information relevant to health technology assessment, the managed introduction of new medicines and procurement practices—may be the first step in the right direction. However, a conducive policy environment is needed at multinational and, ideally. global levels. We need a revision of European Union directive 2004/48/EC—on the enforcement of intellectual property rights—that takes into account the need to provide equitable access to medicines. Such a revision, together with uptake of recommendations—made by the United Nations’ Secretary-General’s high- level panel on access to medicines—on the use of the flexibilities offered by the agreement on trade- related aspects of intellectual property rights and the implementation, punishment and reporting mechanisms could provide the policy space needed to strengthen existing global, regional and national initiatives to improve access to medicines.”
Comments Submitted on WHO GPW 2019-2023
A Draft concept note on “WHO’s 13th General Program of Work 2019–2023 (GPW13”) was published on WHO’s website in late August 2017. GPW 13 will serve as the organizing framework for two Program Budgets, 2020-2021 and 2022-2023, as well as the strategic basis for resource mobilization. In addition, concrete change projects that will engage all WHO staff are currently being developed, based on the proposals from staff and aligned with the Director-General’s priorities. GPW13 lays out the WHO Director-General’s vision and priorities, with a focus on its governance role, operational capacity and impact on broad health and development goals. It aligns the direction of WHO
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with the SDGs and focuses on outcome and impact. Innovation, partnership, transparency and improved use of resources are priorities of the new WHO, which aims to place countries and the will of the people firmly at the center of its work. The tentative timeline for adoption is as follows: 1) The initial draft will be considered at a special WHO Executive Board session, possibly to be held during November 22-23; 2) The next draft will be presented at the January 22–27, 2018 WHO Executive Board meeting; and 3) The draft will be considered as an agenda item for the May World Health Assembly, where endorsement is expected. WHO’s six regional committees have been reviewing and providing feedback on the draft. Consultations on the draft concept note were held at the regional meetings. Consultation with Member States will continue following the Regional Committees—through WHO country offices and other mechanisms— and consultation with partners and other non-State actors will also occur—including a web-based consultation. The November 22-23 Special Executive Board meeting will consider the draft GPW, and a final draft will be submitted to the January EB. The concept note “does not touch upon the prickly and growing global issue of the affordability and accessibility of medicines; in particular, new innovations”, commented “IP Watch on October 25. Nonetheless, KEI’s submitted comments to WHO on the Draft stressed de-linkage: “In relation to universal health coverage, KEI welcomes the spirit of change embodied in the Draft Concept Note, but finds it lacking in specificity and avoidant of an explicit recognition of the crisis of high prices for medical technologies, and of the threat that the policy incoherence recognized in the United Nations Secretary-General’s High-Level Panel on Access to Medicines (HLP) places on the ability to actualize universal health coverage.” It also called on the WHO to lead negotiations on a global R&D agreement, adding, “If drugs are medically effective, but expensive, they should be placed in an EML category for drugs that are medically essential, but face challenges regarding affordability. Governments and patients would take this as a signal to implement policies to make these medically-effective drugs affordable. KEI is completing a review of 56 new, anti-cancer drugs approved by the U.S. FDA from 2010 to 2016. Forty-five of the new drugs received a priority review status by the U.S. FDA. None of the 56 new drugs are on the WHO EML.” It suggested that Member States can seek technical assistance from the WHO or other entities in order to use lawful pathways to ensure treatments are affordable and widely available—including through the granting of compulsory licenses—and urged WHO to step up its actions and assistance in this area. Finally, referring to the reported selection of McKinsey as a “WHO Transformation Czar”, KEI said it “is concerned that McKinsey has other clients, most notably research-based drug and vaccine manufacturers, the Bill and Melinda Gates Foundation and Microsoft, which create conflicts, as regards certain policies relating to intellectual property rights and drug pricing.” IBFAN, on behalf of “all those who have closely followed the development and adoption of FENSA”, noted in its comments to WHO that “FENSA’s ability to protect WHO’s ‘integrity, independence and credibility’ remains an unresolved issue, with much depending on WHO’s approach on Conflicts of Interest and its willingness to evaluate it… The dtGPW makes no mention of the need to protect evaluation of impact from undue commercial influence and to guard against Conflicts of Interest… FENSA contains a conflict of interest concept that redefines legal conflicts of interest, and legitimize problematic, multi-stakeholder arrangements.” It concluded, “With the sheer number of PPPs and multi-stakeholder initiatives now being encouraged, we fear that it will be impossible for WHO to apply the due diligence and scrutiny needed to prevent commercial exploitation and allow it to fulfil its prime constitutional function to protect health for all.“ In its nine pages of comments to the health agency, the NCD Alliance (NCDA) stated, “Countries around the world are off track in implementing effective, multisectoral, NCD responses to protect the health of their citizens and economies. The WHO needs to be able to respond more effectively and at scale to Member State requests for technical assistance and prioritize NCDs within its collaborative arrangements with other UN agencies, international organizations and other relevant partners.
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NCDs are a social justice issue, driving and driven by poverty; they are a human rights issue; and cost-effective interventions exist to prevent millions of premature death and disability, and treat disease and pain throughout the lifecourse.” The NCDA also called for more clarity on “how WHO seeks to place countries at the center and become more operational, provide strong attention to the broader determinants of health, including social, commercial and environmental determinants, and aim to improve policy coherence for health within the 2030 Agenda for Sustainable Development.” The Alliance additionally called for WHO to work with relevant experts from across sectors “to develop more strategic thought leadership and action on the commercial determinants of health and WHO should include this dimension in its program of work.”
PAHO Elects Carissa Etienne to 2nd Term
At the September 25-29 meeting of the PAHO Directing Council in Washington, D.C., Carissa Etienne was elected Regional Director for a second term. The opening was somber, as officials took stock of the devastation from hurricanes in the Caribbean and earthquakes in Mexico. A new report on “Health in the Americas 2017”, was launched, which updates the health situation, as well as progress and challenges in improving health in the region and in each of the 52 countries and territories of the Americas. Under the “Sustainable Health Agenda for the Americas 2030”, Members unanimously endorsed a wide-ranging agenda for fighting diseases and making their countries’ health systems universal and sustainable by the year 2030. The Agenda included goals ranging from achieving universal health coverage to ending the HIV/AIDS epidemic and covering areas deemed essential for strengthening countries’ health systems. Knowledge Ecology International (KEI) intervened at the PAHO meeting under the “WHO Global Program of Work 2019–2023” agenda item, reiterating points made in its written submissions to WHO (See: “Comments Submitted on WHO GPW 2019-2023” above.) KEI asserted: as “long as governments rely upon the grant of a monopoly to induce investments in R&D, there will be monopolies on new drugs and the high prices that come with monopolies. We would like to see policy-makers and organizations, like the WHO and PAHO, consider the practical measures needed to change the business model, and delink R&D financing incentives from high prices and monopolies.” The Caribbean Public Health Agency (CARPHA) signed a memorandum of understanding (MOU) with the U.S. Department of Health and Human Services (HHS) on September 25. The MOU aims to strengthen cooperation in health on initiatives that prevent disease, promote health and respond to public health emergencies. The agreement was signed by CARPHA Executive Director, Dr. James Hospedales, and then-Secretary of HHS, Dr. Thomas Price.
Regional Director Presides Over First/Last EMRO Meeting
The annual meeting of the 22 countries of the WHO Regional Committee for the Eastern Mediterranean (EMRO) took place Islamabad, Pakistan during October 9-12, the first since Dr. Mahmoud Fikri was elected WHO Regional Director (RD). (Shortly after the meeting, he died.) The RD presented a roadmap setting out strategic actions to guide WHO’s work with Member States for the next five years that focus on five priority areas of public health: 1) emergencies and health security, communicable diseases; 2) non-communicable diseases; 3) maternal, neonatal, child and adolescent health; and 4) health system strengthening—which align with the targets of the Sustainable Development Goals (SDGs) that will ensure country progress in 5) moving towards universal health coverage. WHO Director-General Dr. Tedros Adhanom Ghebreyesus took part in the session. Non-communicable diseases (NCDs) were given special attention during the discussions. EMRO members endorsed a proposed regional framework for action on cancer prevention and control. By
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2030 the Region will have the highest increase in cancer burden among all six WHO regions. In EMRO, most cases of cancer are diagnosed at a late stage when treatments are less effective, which results in a poor outcome for patients. In its final resolutions, the Regional Committee endorsed a regional framework for action on cancer prevention and control to scale up guidance to Member States in support of international commitments and to guide country decision-making on policy options and priority interventions for cancer prevention and control according to national contexts. Delegates applauded the selection of Sania Nishtar from Pakistan as the Chair of the new WHO High-level Global Commission on Non-communicable Diseases (NCDs). (See “People.”) The adolescent mortality rate in low- and middle-income regions of EMRO is the second-highest in the world, and adolescent health has for too long been neglected, but is now being recognized by EMRO as central to the achievement of the SDGs in the region. Dr. Fikri expressed support for the “Health-in-all- Policies” model, and described the global, school-based, student health survey, designed to help countries measure and assess the behavioral risk factors and protective factors of young people, as an important policy-making tool. Members recognized that the “Global Accelerated Action for Health of Adolescents” (AA-HA) will provide guidance for country implementation and will assist national policy- makers and program managers in planning, implementing, monitoring and evaluating adolescent health programs. Member States were urged to translate the commitments made in the “Global Strategy for Women’s, Children’s and Adolescent Health 2016-2030” into action by developing and implementing national strategic plans for adolescent health. Also on the agenda was antimicrobial resistance (AMR). While countries of the Region recognized AMR as an important public health matter that they are committed to addressing, they face a range of challenges, particularly a lack of data on the extent of the problem. Members adopted a resolution that calls for the development of national action plans in alignment with the global action plan, establishing a high-level coordination mechanism, allocating adequate resources and developing and enforcing policies and regulations to prevent purchase of antibiotics without prescription. Considered additionally, among other topics, were implementation of the Eastern Mediterranean vaccine action plan 2016-2020, civil registration and vital statistics systems, prevention and control of non-communicable diseases, mental health care, implementation of the International Health Regulations (IHR 2005) and implementation of the regional malaria action plan. Progress reports also were discussed on health security, tobacco control, tuberculosis, hepatitis, traditional medicine and gender and health. The next session of the Regional Committee will be held in Khartoum, Sudan, from October 15- 18, 2018.
WPRO Takes Up Broad Range of Issues
The WHO Annual Meeting of the Regional Committee for the Western Pacific (WPRO) took place in Brisbane, Australia, from October 9 to 13, the first time the country hosted the event since 1997. Dr. Shin Young-soo, WPRO Regional Director, welcomed Dr. Tedros Adhanom Ghebreyesus, who travelled to Australia for the first time in his new role. Affordable health care and raising the bar for clear and timely communication during emergencies were chief among the regional priorities presented. Among other matters, decisions were taken on: eliminating measles and rubella; eliminating mother-to-child transmission of HIV, hepatitis B and syphilis; strengthening health promotion in the Sustainable Development Goals (SDGs); transitioning to sustainable financing of priority public health services; regulatory strengthening—including ensuring the safety of medicines—and convergence for medicines and the health workforce. WPRO members addressed the WHO’s proposed “General Program of Work 2019 to 2023” (GPW). The new directions and operational aims of WHO need to be better-defined and understood, said delegates for Australia and New Zealand, to ensure member states can clearly communicate the work of WHO to
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their governments, partners and other key stakeholders. Delegates also wanted information on how changing priorities could impact existing work, as well as staff funding. Japan, in particular, flagged concerns over the potential fallout. Dr. Tedros explained that Members States need to play an important role in helping WHO to prioritize initiatives. “Prioritization is going to be tough”, he said, adding “If we have many priorities, we don’t have a priority.” In the debate on WHO’s goal to leave no one behind, Pacific Island countries pressed for details on how WHO would respond to the high cost of access to health care services and medicines in their countries— and how it could provide greater support to those requiring mental health care, disability, ageing, and other high-need health support. Communicating health initiatives across government, across sectors and with private sector partners was an important issue for member states. Delegates pressed WHO leadership to provide clear and concise information and advice. Singapore, in particular, called for timely advice from WHO in times of outbreaks, epidemics and emergencies, saying past emergencies have seen member states respond to rumors, rather than facts, with decisions unnecessarily impacting trade and cross-border movements. Delegates endorsed a “Regional Action Plan on Health Promotion in the Sustainable Development Goals (2018–2030)” that aims to translate commitments into practical action with timelines to address policy gaps and misalignments, weak infrastructure and poor health literacy that hinder progress on health promotion and slow countries’ overall progress towards sustainable development. The Action Plan focuses on building healthy cities and communities, and enhancing people’s knowledge of how to protect their health. This follows a commitment of counties to the “Shanghai Declaration on Promoting Health in the 2030 Agenda for Sustainable Development”—adopted as an outcome of the recent 9th Global Conference on Health Promotion. Ministers endorsed a regional action plans for eliminating measles and rubella, as well as mother-to- child transmission of HIV, hepatitis B and syphilis. A number of side events took place during the week, and Australia launched an Indo-Pacific Health Security initiative.
The Union World Conference Highlights TB
The “48th Union World Conference on Lung Health”, on the theme, “Accelerating Toward Elimination”, took place during October 11-14 in Guadalajara, Mexico. Participants included WHO and World Bank officials, government officials and representatives of universities, medical and research institutions, NGOs and a few from industry. Medicines Sans Frontieres (MSF) focused on people with drug-resistant tuberculosis (DR-TB) who are still not receiving two newer medicines—bedaquiline (Janssen) and delamanid (Otsuka). Dr. Isaac Chikwanha, HIV and TB Medical Advisor at MSF’s Access Campaign, commented, “The pathetic rollout of newer drugs is unjust for people who now have a chance at effective treatment. The global TB community, governments and donors must collectively take urgent steps to increase access to these two newer, promising drugs in order to save the lives of people with DR-TB.” MSF and End TB issued a 17-page booklet at the conference, titled “Four Years and Counting Slow scale-up of newer MDR-TB drugs covers less than 5% in need.” On October 12, WHO issued a 38-page “Compendium of WHO guidelines and associated standards: ensuring optimum delivery of the cascade of care for patients with tuberculosis.” WHO describes this as “a clear, concise instrument that will facilitate the understanding and planning of delivery of the standards for the care of everybody affected by tuberculosis. The document will be regularly updated, including in its digital format, to allow incorporation of all new evidence that will emerge out of the development pipeline in the years to come.”
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The Center for Global Health Policy’s “Science Speaks” issued a series of blogs on the conference, titled: “Children have the same rights as adults to benefit from tuberculosis care and research”; “Global TB goals gain momentum, while challenges among marginalized people, nations continue”; “Ukrainian policymaker takes on tuberculosis”; “Sex workers and drug users with HIV in rural Kenya have high death rates from tuberculosis”; “Good participatory practice guidelines come to TB vaccine development”; and “New vaccine needed to eliminate TB, researchers say.” On the eve of the conference, the TB Alliance announced that two novel drugs, TBA-7371 and sutezolid, have entered Phase 1 clinical trials. Both compounds have proceeded through early preclinical development and were granted “Investigative New Drug” status by the U.S. Food and Drug Administration. Said Dr. Mel Spigelman, president and CEO of TB Alliance. “As resistance to current TB treatments continues to grow, the need for compounds with no pre-existing resistance has become stark.” TBA-7371, part of a novel class—DprE1 inhibitors—was developed by the TB Alliance in collaboration with AstraZeneca. In March 2017, TB Alliance and the Medicines Patent Pool announced a sublicensing agreement for the development and commercialization of sutezolid, an oxazolidinone, for treatment of TB.
UN Agencies Launch “HIV Prevention 2020 Road Map”
The Joint UN Program on HIV/AIDS (UNAIDS), the UN Population Fund (UNFPA), and other partners launched on October 10 the “HIV Prevention 2020 Road Map” at the first meeting of the Global HIV Prevention Coalition to reduce new HIV infections by 75% by 2020. Despite a 50% drop in AIDS- related deaths since the peak of the epidemic, new HIV infection declines among adults are lagging, prompting the UN to launch a ten-point plan that lays out immediate, concrete steps countries can take to accelerate progress as part of global efforts to end AIDS as a public health threat. The Road Map encourages countries to develop a 100-day plan for immediate actions, including setting national targets, reviewing progress made, reassessing national prevention programs and taking immediate remedial action. It identifies factors that have hindered progress, including political leadership gaps, punitive laws and a lack of HIV prevention services in humanitarian settings, and highlights the importance of community engagement to advocate for service delivery and accountability. “Scaling up treatment alone will not end AIDS“, said Michel Sidibé, Executive Director of UNAIDS, adding, “We need more energy and action put into HIV prevention—stronger leadership, increased investment and community engagement to ensure that everyone, particularly people at higher risk of HIV, can protect themselves against the virus.” Despite a 50% drop in AIDS-related deaths since the peak of the epidemic, new HIV infection declines among adults are lagging. New HIV infections among children have fallen by 47% since 2010, but new HIV infections among adults have declined by only 11%. In 2016, in the UN Political Declaration on Ending AIDS , countries committed to reduce new HIV infections by 75%—from 2.2 million in 2010 to 500,000 in 2020. The new Road Map will fast-track countries to achieve this target.
EDCTP, WHO AFRO, TDR Fund Implementation Research
A new partnership was announced on October 9 among European & Developing Countries Clinical Trials Partnership (EDCTP), the WHO Special Program for Research and Training in Tropical Diseases (TDR) and the WHO Regional Office for Africa (AFRO) in recognition of a mutual interest in strengthening the capacity for health research in African countries The collaboration was realized through a call, the “Joint WHO-AFRO/TDR/EDCTP Small Grants Scheme for implementation research on infectious diseases of poverty”, which will close on November 30. The call is aimed at strengthening capacity for implementation research conducted through close
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collaboration between researchers and national disease programs, and covers malaria, TB, diarrhea, lower respiratory tract infections, yellow fever and neglected tropical diseases. “EDCTP is pleased to be able contribute to small start-up grants that would facilitate collaborations between researchers and health professionals in national disease programs in sub-Saharan Africa”, said Professor Moses J. Bockarie, EDCTP Director of South-South Cooperation and Head of Africa Office.
New Research, Projects Launched for World Sight Day
Some 253 million people are visually impaired worldwide, including 36 million who are blind, according to WHO, and 80% of global blindness is preventable, notably from cataracts. But progress on ending the leading cause of blindness is at near standstill, according to data published in tandem with World Sight Day (WSD) on October 12. “The Lancet Global Health” published on the eve of WSD new research that found “The past 30 years have seen little to no reduction in the leading cause of blindness among people aged 50 and over in developing regions.” The research paper, conducted by the Vision Loss Expert Group, was titled, “Global causes of blindness and distance vision impairment 1990–2020: a systematic review and meta-analysis.” Refreshment of the Global Vision Database with recently published data sources permitted modelling of cause of vision loss data from 1990 to 2015, further disaggregation by cause, and forecasts to 2020. The researchers concluded, “While it is the leading cause of blindness and visual impairment in developing countries, the disease is both preventable and curable” and “A large scale-up of eye care provision to cope with the increasing numbers is needed to address avoidable vision loss.” “Devex” reported on WSD that two new financing mechanisms to inject private capital and creativity into reducing preventable blindness in developing countries. One, launched at the beginning of October, and the other, a few months ago, aim to test whether development impact bonds and a private investor-funded holding company can help bring an injection of capital and new partners to address the dearth of eye care in many places around the world. The recently-launched Cameroon Cataract Development Impact Loan aims to deliver 18,000 cataract surgeries over five years in Cameroon. The U.S. Overseas Private Investment Corporation (OPIC) will invest $2 million to finance the project, through a hospital run by the Africa Eye Care Foundation. The Netri Foundation will also inject upfront capital. The Conrad N. Hilton Foundation, The Fred Hollows Foundation, and Sightsavers are the outcome payers that will provide returns for investors based on the success of the hospital. Established in June, a new holding company, Global Vision, was launched with the aim to build and scale a network of surgical eye care centers, providing sustainable care for some of the leading causes of vision loss and blindness. The company will work to either open its own hospitals with local teams or partner with local organizations and help them scale with funding and training on operational best practices. The structure mirrors a model that has been successful in microfinance, through which companies create networks of institutions to provide consistent governance, operations, support and oversight from international teams to ensure the quality of services. By creating a brand, companies can more easily attract financing while still deploying the model in local operations.
A Legal Innovation to Address Firms’ Access Challenges?
Special contribution from Michele Forzley, JD, MPH, Forzley & Associates; Global Public Health Lawyers, Bethesda, MD, U.S. A new book may hold some answers to the challenges presented by the global health goals of access to medicines at affordable prices (SDG3) and traditional role of corporations to increase shareholder value. That book is “Social Enterprise Law: Trust, Public Benefit and Capital Markets” by Brooklyn Law
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School Professors Dana Brakman Reiser and Steven A. Dean. Author Reiser, Professor of Law, has been teaching and writing about social enterprise and nonprofit law as a member of the Brooklyn Law School faculty since 2001. She was an Associate Reporter for the American Law Institute’s Principles of the Law of Nonprofit Organizations. Dean is Vice Dean and Professor of Law. Several fronts have been in play for the past 15 years or so in an effort to find ways to increase access to medicines. They have included the ideas of imposing human rights standards on for-profit corporations, the activist refrain “patients not profits”, discussions on flexible pricing models, and others. Almost universally, corporations have only a binary choice between a for- and not-for-profit form. Neither is flexible enough to be used to accomplish social goals. So, what has been missing is a consideration of the new forms of corporation that allow for a primary social purpose, rather than profit. This book explores available options. Only a few states and countries have implemented any substantive changes to corporate law, and only since around 2008. Thus, so-called “social enterprises” or “hybrid organizations” are a recent phenomenon. The concept of hybrid is, in fact, not new and can be traced to the 19th century, if not earlier. Not surprisingly, the idea took hold in European countries where the borders between state, market and society were flexible. This led to a tradition of using hybrid forms that mixed public, private and societal elements in the provision of what are now called “public goods.” Many schools, hospitals and housing associations were established at the turn of the 19th century at the initiative of groups of socially-concerned citizens and/or religious groups. In the UK, for example, one could organize a community interest company (CIC) that allows profits to be used for public good. In 2015, Italy became the first country in the world to legally recognize benefit corporations. And in February 2016, Australia began to draft its own version. The names do differ and there are variations on the characteristics of each. In the U.S., a number of versions exist. Washington State allows the social purpose corporation (SPC), a for-profit, that enables, but does not require, consideration of social issues in decision-making, instead of only profit- maximizing goals. Another for-profit form is the B Corps, or benefit corporation, available in New York and some 30 or more other states, including D.C., has a dual purpose to create general public benefit by creating value for its’ stakeholders—such as the community, local and global environment, employees, suppliers and customers—and create a profit for shareholders. Social purpose and flexible purpose corporations are similar to benefit corporations (B Corporations) and are available in Florida. The main difference is that B corporations must pursue a “general public benefit”, which applies to all of the company’s activities, while SPCs and FPCs may pursue a public benefit in a limited area. A fifth form, the L3C (low-profit limited liability company), possesses the same liability protection and pass-through tax treatment as an LLC, but must have a primarily charitable purpose with profit-making as a secondary purpose. The book offers a thesis on how law can provide possible pathways for corporations to address the increasing pressure to provide access to medicines. It explores popular hybrid legal forms, as described above, and offers solutions on how corporate governance, contract and tax law can be harnessed to balance public good against private profit. As the metrics that measure the social impact of corporations become more sophisticated, the use of legal innovations, such as social enterprises, may increase and the new forms may become the viable stakeholder in medicines access conversations.
UNHRC Convenes Annual Social Forum
The “2017 Social Forum”, an annual meeting convened by the UN Human Rights Council in Geneva during October 2-4, focused on “The promotion and protection of human rights in the context of the human immunodeficiency virus (HIV) epidemic and other communicable diseases and epidemics.” The event gathered civil society, governments and intergovernmental organizations. Unlike previous sessions, held since 2002, this one was substantive and featured agency heads and other high-powered
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speakers. Keynote speakers included: Michel Sidibé, Executive Director, Joint UN Program on HIV/AIDS (UNAIDS); Tedros Adhanom, Director-General, WHO; and Roberto Azevêdo, Director-General, WTO—termed an “IGO triumpharite.” In attendance were the High Commissioner for Human Rights, Zeid Ra’ad Al Hussein; the Executive Director of UNAIDS, Michel Sidibé; and the interim head of the Global Fund to Fight HIV/AIDS, Malaria and TB, Marijke Wijnroks, together with the strong participation of civil society leaders, but sparse representation from the private sector. Present were representatives from the International AIDS Society, the International HIV/AIDS Alliance, Foundation for AIDS Research, Medicines Sans Frontiers (MSF), the International Committee of the Red Cross (ICRC), Partners in Population and Development, the International Treatment Preparedness Coalition, the World Hepatitis Alliance (WHA), Helen Keller International and a number of human rights groups, including sexual and reproductive health advocates. Dr. Tedros emphasized in his presentation the campaign for universal health coverage as a top priority for WHO, but stressed that this must take into account the inequities in capacity and access among the diverse social groups in any society. WTO’s Azevêdo underscored the need for a “coherence agenda” that includes integrating a human rights dimension into trade policy. Marilena Viviani, head of the UNICEF Office in Geneva, spoke about the particular health and human rights challenges of adolescents, emphasizing that even in the campaign to fight HIV/AIDS, “adolescents have been neglected.” She documented that aggregate statistics show an impressive decline in AIDS deaths for the population at large because of improved access to information and treatment, but NOT for adolescents. The number of adolescents (aged 10 to 19) living with the virus actually rose, she said, to 1.2 million in 2015—a 28% increase from 2005. Sessions were held on building campaigns for improving access to medicines, mobilizing civil society and community action, involving health care workers in human rights training, recruiting a diversity of partners, mobilizing international cooperation and identifying recommendations for the way forward. At one session, titled, “Translating principles into action: Access to medicines, diagnosis, vaccines and treatment in the context of the right to health”, Ellen t’Hoen, senior researcher at the University Medical Center, Groningen, The Netherlands, called for a mechanism to systematically assess trade agreements from a public health perspective—including accession agreements of the WTO and European Patent Office’s validation agreements. This is needed, she said, to safeguard the measures countries have under the TRIPS Agreement to protect and advance human rights. “IP Watch” reported on October 10 that the session was moderated by Susan Mathews, a human rights officer in the Right to Development Section of the UN High Commissioner for Human Rights. She said that the way pharmaceutical research, development and innovation is currently organized, increased intellectual property protection particularly disadvantages developing countries and poor, vulnerable, marginalized populations within these countries. Also speaking was Elena Villanueva Olivo, innovation and access policy adviser for Médecins Sans Frontières (MSF), who asserted, “we are concerned that the standards to promote access; namely, transparency, intellectual property and pricing, are not sufficient; in particular, given that nearly all the R&D costs are being paid for by governments and philanthropies.” Othoman Mellouk, intellectual property and access to medicines lead for International Treatment Preparedness Coalition (ITAC)-Morocco, referred to a “dangerous game of haves and have-nots” that he said are created by big pharma companies. Raquel Peck, CEO of the UK-based World Hepatitis Alliance, also spoke at the session A general take-away from the Social Forum was that the right to health has a symbiotic relationship with all of the other human rights, and that these human rights are themselves the determinants of health and wellbeing. Bringing the health and human rights communities together in similar settings, participants suggested, can advance the understanding and actual implementation of their inter- connectedness. The HRC will issue a final report on the Forum and its recommendations.
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Meetings & Events Held
During September 18-19, the “ReAct Africa Node (RAN) 2017 Conference” was held in Kenya. Discussion centered around “Moving Beyond Antimicrobial Resistance (AMR) National Action Plans Development to Implementation.” Keynote speaker was Dr. Marc Sprenger, Director, WHO Antimicrobial Resistance Secretariat. The conference brought together AMR Champions from 14 African countries. Discussions centered around implementation of the AMR National Action Plans, progress made, common challenges faced and possible solutions. Conference participants came from various government Ministries, civil society organizations (CSOs), non-governmental organizations (NGOs), academia and Faith-based Organizations (FBOs). In the follow-up to the 2017 Meeting of OECD Health Ministers, the Business at OECD “Forum on Health, Growth and Productivity”, held October 27 in Paris, France, brought together senior business representatives—including selected CEOs, high-level government officials, OECD leadership and academia, as well as relevant OECD stakeholders—to discuss the proactive role of the private sector in attaining better health, growth and productivity. The 2017 Annual Meetings of the World Bank Group and the International Monetary Fund (IMF) took place in Washington, D.C., during October 13-15. During October 6-8, two UN offices organized a three-day event in NY to improve women’s involvement in the fields of science, technology and mathematics, especially in developing countries. The Expert Meeting was organized UN Office for Outer Space Affairs (UNOOSA) and UN Women, which also launched during UN Week a partnership to advance gender equality and women’s empowerment through innovation and technology, and the Global Innovation Coalition for Change (GICC), that aims to make innovation and technology work better for young women and girls. On October 16, Human Rights Council elections by members of the UN General Assembly in NY resulted in the appointment of Qatar, Pakistan, DR Congo, Afghanistan and Angola to the UN’s highest human rights body in a virtually uncontested race, flouting U.S. Ambassador Nikki Haley’s June warning to stop electing “the world’s worst human rights offenders” and despite a recent pledge not to do so by a Dutch-led coalition of 47 nations. The four new members will join existing members, such as Saudi Arabia, China, Cuba and Venezuela. The annual WTO Public Forum was held in Geneva from September 26 to 28 , under the theme, “Trade: Behind the Headlines.” Over a hundred sessions took place, organized by international organizations, governments, NGOs and private sector entities. In opening remarks, WTO Director-General Roberto Azevêdo remarked on the high attendance, with 2,250 registered participants, the highest so far. Most attendees were NGOs. A session on “The critical role of competition in promoting access to medicines and Sustainable Development Goal 3” was sponsored by the International Generic and Biosimilar Medicines Association (IGBA). The organizer stated that the session would focus on “the relevance of competition, conceived in its broader sense, on the trade of generic and biosimilar medicines. Ensuring that competition rules are included more significantly in preferential agreements is essential for a stronger access to generic and biosimilar medicines”, adding, “Punctual enforcement of competition law and monitoring of a proper competitive dynamic on the market are essential elements to increase access to generic and biosimilar medicines for patients worldwide. IPR protection needs to be counterbalanced by strong competition rules. Seeking harmonization at WTO level between IPRs and competition is fundamental.” Moderated by Roger Kampf, Counsellor, Intellectual Property, Government Procurement and Competition Division, WTO, panelists were representatives of IGBA, the Mission of South Africa to the WTO, the International Alliance of Patents’ Organizations (IAPO) and Guilherme Cintra, Senior Manager, Innovation, Intellectual Property and Trade, IFPMA.
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Public Citizen’s Access to Medicines Program organized a September 27 event in Washington, D.C., titled, “We Rise and Fall Together: Affordable Medicines at Home and Abroad” that focused on “A recently-leaked Trump Executive Order [that] blames high U.S. medicine prices on other countries, including the world’s poor. Washington pressure on developing countries to raise prices could lead to the deaths of many, while missing an historic opportunity to make medicines affordable for everyone, here in the United States and abroad” and the U.S. Trade Representative’s call for comments in a special review of Colombia’s patent practices. Featured speakers were Dr. Francisco Rossi, Director of IFARMA Fundacion in Colombia; and Alejandra Alayza, Advocacy and Campaigns Manager for Oxfam in Peru. A global “Call to Action” conference held October 12-13 in Berlin aimed to accelerate action on tackling drug-resistant infections. Organized by the Wellcome Foundation, in partnership with the UK, Ghanaian and Thai governments and the UN Foundation, the gathering, attended by scientists, health officers, pharma company executives and politicians, supported the work of the Antimicrobial Resistance Inter-Agency Coordination Group (IACG). Said Wellcome’s Director of Policy and Chief of Staff, Ed Whiting, “Politicians and scientists have an urgent role to play, but they cannot solve the problem alone. Tackling drug-resistant infection is everyone’s business. The threat transcends that of HIV, TB and cancer. To achieve real progress, those already suffering from untreatable infections need a voice. So far they have been too quiet.” The Global Health Center (GHC) of the Graduate Institute, Geneva; the Global Commission on Drug Policy and the Geneva Platform on Human Rights, Health and Psychoactive Substances organized a discussion in Geneva on October 3—“Leaving No One Behind in International Drug Policy” —with three members of the Johns Hopkins University (JHU)-Lancet Commission to draw attention to this policy area that directly impacts over 250 million people globally. The GHC noted that the Commission examined the scientific evidence from around the world and reconfirmed in March 2016 that drug policies often have detrimental outcomes for public health. Yet, a consensus on drug policy reform is still far from reached, and many challenges remain in protecting the health and human rights of people who use drugs, especially within a changing global political context. The UN High Commissioner for Human Rights (UNHCHR) convened the Intergovernmental Working Group on Transnational Corporations and Other Business Enterprises with Respect to Human Rights in Geneva during October 23–27. On the eve of the gathering, Ecuador released “draft elements” for a binding instrument. In response, Business at OECD, the International Organization of Employers (IOE), the International Chamber of Commerce (ICC) and the Brussels-based Foreign Trade Association (FTA) produced a joint business statement. A WHO High-level meeting of the “Evaluation of the International Coordinating Group on Vaccine Provision” (ICG) took place on October 17 in Geneva. On October 6, “The National” (Papua New Guinea) reported that the UN launched an NCD office in the country at an event attended by UN Assistant Secretary-General and Regional Director for Asia and the Pacific, Haoliang Xu. The Global Task Force on Cholera Control (GTFCC), a network housed at WHO of more than 50 organizations, met on October 4 in Veyrier-du-Lac, France, to launch a new “Global Roadmap”, supported by the Bill and Melinda Gates Foundation, the Fondation Mérieux and WaterAid. Attendees from around the world committed to preventing 90% of cholera deaths by 2030, the first time governments, WHO, aid agencies, and donors have made such a pledge. The 32-page Roadmap focuses on 47 countries affected by the disease with a strategy centering on early detection and quick response, a multisector effort to prevent recurrence, coordination at the local and global levels and use of oral vaccines. The Center for Strategic and International Studies (CSIS) organized an event on October 16 in Washington, D.C., on the “History and Future of the Global HIV/AIDS Response: A Conversation with
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Dr. Michael Merson and Dr. Stephen Inrig.” The event marked the launch of a new book, “The AIDS Pandemic: Searching for a Global Response”, by the featured speakers: Dr. Merson, the first Director of the WHO Global Program on AIDS (GPA), is now Professor of Global Health and Vice President and Vice Provost for Global Strategy and Programs Duke University; and Dr. Inrig is Associate Professor at Mount Saint Mary’s University. The book provides history of the WHO GPA, “using it as a unique lens to trace the global response to the AIDS pandemic”, said CSIS, which added, “The authors describe how WHO came initially to assume leadership of the global response, relate the strategies and approaches WHO employed over the years and expound on the factors that led to the Program’s demise and subsequent formation of the Joint United Nations Program on HIV/AIDS (UNAIDS).” The book also examines the global impact of this transition, portrays the current status of the global response to AIDS, and explores the precarious situation that WHO finds itself in today as a lead UN agency in global health. The UN Office of the High Commissioner of Human Rights (OHCHR), in partnership with WHO, organized an event on October 24 in NY titled, “Healthy lives, well-being and the human right to the highest-attainable standard of physical and mental health.” Co-sponsors were the Missions of Chile, Ecuador, and South Africa. Trans Pacific Partnership TPP leaders, who met in Tokyo in September, met again in in Japan at the end of October to facilitate preparatory process for a planned meeting along the sidelines of the November 6-11 Asia-Pacific Economic Cooperation (APEC) Leaders’ Week in Vietnam this November. Work on intellectual property was reported to be relatively advanced, according to the International Center for Trade and Sustainable Development “Bridges” newsletter on September 28.
Forthcoming Meetings & Events
WIPO’s Global Challenges Division is convening a November 8 “Seminar on Vaccines: Accelerating Innovation and Access.” The aim is to examine the role of vaccine manufacturers, issues around innovation and access, key hurdles, the vaccine market, how companies measure up to stakeholder expectations and the role of product development partnerships. The seminar will also launch the new Global Challenges Report “Vaccines: Accelerating Innovation and Access” and discuss the “Access to Vaccines Index” by the Access to Medicine Foundation. During November 13-15, the Global Health Center at the Graduate Institute, Geneva, is organizing an Executive Course on Global Health Diplomacy on “Global Health Instruments.” Course Directors are Gian Luca Burci, former WHO Legal Advisor and current Adjunct Professor of International Law, Senior Fellow, Global Health Center at the Graduate Institute; and Haik Nikogosian, Senior Fellow, Global Health Center, the Graduate Institute; Former Head of Convention Secretariat, WHO Framework Convention on Tobacco Control. Said the Center, WHO “has adopted during the last decade the two most prominent, contemporary, legal health instruments: the WHO Framework Convention on Tobacco Control (FCTC), as a landmark in addressing the factors of non- communicable diseases, and a thoroughly revised International Health Regulations, as the main legal framework to prevent and control the international spread of disease, including notably the outbreaks and pandemics of communicable diseases. These two ‘hard’ instruments will be discussed during the course, and the range of ‘soft’ international instruments and standards will be highlighted. The regulation of crucial aspects of contemporary global health governance has been driven by such codes, frameworks, strategies, classifications, etc. which often carry in practice as much weight as formally-binding instruments, but raise delicate questions of legitimacy and accountability.” The 39th meeting of the Expert Committee on Drug Dependence (ECDD) will be held in Geneva, Switzerland, during November 6-10. The ECDD will review a number of substances with potential for dependence, abuse and harm to health, and will make recommendations to the UN Secretary-General, on the need for and level of international control of these substances.
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The WHO Collaborating Center for Pharmaceutical Policy and Regulation at the University of Utrecht, The Netherlands, in collaboration with the WHO Department of Essential Medicines and Health Products, are organizing a Winter Meeting during January 9-10 for researchers in the field of pharmaceutical policy analysis and regulatory science. The Center’s Scientific Director is Professor Dr. Bert Leufkens, former Chairman of the Dutch Medicines Evaluation Board (MEB). The second day of the meeting will focus on Vaccines as major topic, as “issues, often highly controversial, e.g. whom to vaccinate, (long-term) safety, confidence in regulators or economics, that make vaccines a powerful, crosscutting learning device for pharmaceutical policy and regulation.” On December 8, the Global Health Council (GHC) is convening in Washington, D.C., a “2017 Global Health Landscape Symposium” (GHLS17) titled, “A New Normal for Global Health: Navigating Today’s Challenges and Opportunities.” The aim is to take stock of changes—from emerging priorities and investors to new ownership and messaging—and understand the road ahead. The Government of Japan will host the Universal Health Coverage “UHC Forum” in Tokyo from December 13-14, in cooperation with the World Bank, WHO, the UN Children’s Fund (UNICEF), the Japan International Cooperation Agency (JICA) and the UHC2030 partnership. Attendance at the forum is by invitation only. Guests will include heads of State and ministers of health, finance and other senior officials, as well as development agency heads, civil society, academic institutions and the private sector. WHO and the World Hepatitis Alliance (WHA) are convening the “World Hepatitis Summit 2017” in São Paulo, Brazil during November 1- 4.
People
On October 17, Dr. Tedros Adhanom Ghebreyesus announced the death of Dr. Mahmoud M. Fikri, WHO Regional Director for the Eastern Mediterranean Region (EMRO). Dr Fikri had just assumed his duties as Regional Director on February 1 and was on his way to attend the Global NCD Summit in Montevideo, Uruguay, when he died. Dr. Fikri had previously served as Advisor to the Minister of Health of United Arab Emirates, and had been a prominent regional public health figure for many years. On October 20, UNICEF Executive Director Anthony Lake announced his departure “within the weeks ahead”, and certainly by the end of the year which would finalize his second five-year-term. The Secretary-General has initiated the process of identifying a successor for the post, which customarily has been held by an American. On October 24, the Global Fund Board announced four finalist candidates for Executive Director, and expects to select one at a November 14 Board meeting. Simon Bland (UK), Director of the NY Office of the Joint UN Program on HIV/AIDS (UNAIDS), for three decades worked at the UK Department for International Development and led its operations in Kenya. Frannie Leautier (Tanzania) previously was Senior Vice President of the African Development Bank, CEO of the African Capacity Building Foundation and a World Bank official, during which she spent time as Chief of Staff to President Jim Wolfensohn, and ran the World Bank Institute. Peter Sands (UK), since 2006, has been Group Chief Executive, Lead Non-Executive Director, British Department of Health. Formerly, he held posts with the UK Foreign and Commonwealth Office, was Group Chief Executive of Standard Chartered Bank, an executive at McKinsey & Company and a Harkness Fellow at the Harvard School of Government. Anil Soni is a senior executive at Mylan responsible for medicines to prevent and treat HIV/AIDS, tuberculosis, malaria and hepatitis C. He was closely involved in the early years of the Global Fund as an adviser to Richard Feachem, led the advocacy work of Friends of the Global Fight in Washington, D.C. and came to know industry representatives during his six years at the Clinton Health Access Initiative (CHAI), where he rose to Chief Executive.
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On October 3, UN Secretary-General António Guterres appointed Dr. Natalia Kanem of Panama as the new head of the UN Population Fund (UNFPA). Family planning advocates and women’s rights groups welcomed the appointment and called on Kanem to take a strong and supportive stance on divisive issues, including abortion, comprehensive sexuality education and rights for sexual minorities. Kanem already had four months on the job after being made Acting Executive Director of UNFPA in June after the sudden death of her former boss, Babatunde Osotimehin. She started her career in academia with the Johns Hopkins and Columbia University schools of medicine and public health. Before that, she was with the Ford Foundation, becoming Deputy Vice-President for its worldwide peace and social justice programs in Africa, Asia, Eastern Europe, Latin America and North America. Anatole Krattiger, Director of the Global Challenges Division at WIPO, has made it known he plans to leave by the end of the year. WIPO has posted a recruitment announcement for the Director of the Global Challenges Division, Department for Traditional Knowledge and Global Challenges, Global Issues Sector. The “Wall Street Journal” reported on October 17 that financier George Soros has turned over nearly $18 billion to his Open Societies Foundation (OSF), making the philanthropic body second to the Bill and Melinda Gates Foundation by assets. For years, OSF has advocated for policies to enable greater access to medicines, including through diminished IP—particularly access to HIV and pain medication—grounding its advocacy in human rights. The Foundation says it works to “to challenge the health establishment to advance human rights, to shift power dynamics in health-related decision- making and to influence the funding environment for health and rights” and is active in countries around the world. In February, to strengthen its voice at the UN, the OSF posted a recruitment for a NY-based position: “Director, Access to Medicines and Innovation, Public Health Program.” On October 18, WHO appointed the Zimbabwean tyrant Robert Mugabe, Africa’s oldest ruler at 93, as Global Health Ambassador to work with national and local politicians to highlight the economic and health burden of NCDs. Human Rights Watch (HRW) instantly noted that Mugabe’s “mismanagement of the economy has devastated health services” in his country. But WHO head Tedros Adhanom Ghebreyesus praised Mugabe’s leadership in Zimbabwe, calling it a nation that “places universal health coverage and health promotion at the center of its policies.” UK officials called the choice “surprising and disappointing.” In response to extreme global outrage, WHO on October 22, withdrew the appointment. The “Washington Post” commented on October 25 that an inquiry is needed: “We must find out what was behind it. If an investigation proves that giving this prestigious appointment to a brutal human rights violator was the result of corruption, Tedros must leave. In fact, Tedros’s tenure should already be regarded as probationary, and his judgment in question,” and added “Some speculate that Tedros’s decision to appoint Mugabe was a pay-off to China, which worked tirelessly behind the scenes to help Tedros defeat the United Kingdom candidate for the WHO job, David Nabarro.” On September 26, the Human Vaccine Project announced that former WHO Assistant Director-General for Health Systems and Innovation, Dr. Marie-Paule Kieny, was appointed to its Board of Directors. The Project is a nonprofit, public-private partnership focused on decoding the immune system to improve human health. Dr. Kieny is currently Director of Research at Institut National de la Santé et de la Recherché Médicale (INSERM) and Board Chair of the Medicines Patent Pool (MPP). She also is a member of the World Bank International Working Group on Financing Preparedness (IWG) Guy Ryder began his new mandate as Director-General of the International Labor Organization (ILO) on October 1. During the month, ILO published a new report, “VCT@WORK: voluntary confidential counselling and HIV testing for workers”, that shows the campaign, conducted in partnership with UNAIDS and others to scale up HIV testing in the workplace, has reached more than 6 million workers with HIV information, tested more than 4 million and referred more than 100,000 employees to HIV treatment.
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António Campinos of Portugal was elected on October 11 to serve as the next president of the European Patent Office (EPO). He will succeed Benoît Battistelli, who has served since 2010. Campinos is currently executive director of the European Union Intellectual Property Office (EUIPO), which handles EU trademarks and is a past president of the Portuguese Patent Institute (INPI). On October 7, “La Revue Prescrire”, an “independent” French journal, chose “Private Patents and Public Health”—a 2016 book written by Ellen ‘t Hoen—as one of four winners of its 2017 Prescrire Prize Book Award. Calling it “a major reference work on access to medicines and the patent system”, Prescrire praised ‘t Hoen’s book both for its extensive collection of data and examples, as well as its readability.
Briefs
A comprehensive report published by the Australian Commission on Safety and Quality in Health Care, issued in August, “Antimicrobial Use and Resistance in Australia 2017: Second Australian report on antimicrobial use and resistance in human health” (Aura 2017), has revealed increasing antibiotic resistance of various types of bacteria in the country. It highlighted a number of specific types of bacteria as major emerging healthcare problems, with one type in particular causing resistance to last- resort antibiotics in just over half of hospital samples. Despite some recent gains in efforts to encourage more careful use of antibiotics, the new report finds as much as 56% of samples of enterococci can be resistant to the antibiotic vancomycin—a level higher than in any European country. A new book published in August by the Oxford University Press, “Coalitions and Compliance: The Political Economy of Pharmaceutical Patents in Latin America.” The author, Kenneth C. Shadlen, states his research interests concern “conflicts over the ownership, control and use of knowledge and information in developed and developing countries.“ The book provides systematic comparative analysis of pharmaceutical patent politics in Latin America’s three largest countries over two time periods, with chapters on developments in Argentina, Mexico and Brazil. Shadlin is a Professor in Development Studies, LSE Department of International Development and a Fellow at the Tufts University Global Development and Environment Institute and at the Institute of the Americas, University College London (UCL). On September 17 at a meeting of the UN Broadband Commission in NY, participants concluded that telecommunication companies’ assets, such as connectivity and big data, have great force that can solve common problems, such as infectious diseases. A working group for the prevention of the spread of infectious diseases based on information and communication technology (ICT) was formed at the meeting, comprised of ten organizations—telecommunication business operators, such as KT and Intel, the Novartis Foundation and related organizations of six countries, including Kenya, Argentina, Malaysia and the GSM Association (GSMA). The report released by the UN Global Compact (UNGC) and the Global Reporting Initiative (GRI) at the UN Global Compact Leaders Summit at the UNGA in NY on September 21, “Business Reporting on the SDGs: An Analysis of the Goals and Targets”, provides a corporate framework to measure and report contributions to the UN Sustainable Development Goals (SDGs) as the first step toward a uniform tool of comparison across businesses. Business reporting on the impacts and contributions to the SDGs is set to become less complex as a result, say the sponsors. Developed by the Global Reporting Initiative (GRI) and the UNGC, with the support of Price Waterhouse Coopers (PwC), as part of a three- year initiative established to encourage and assist corporate reporting on the SDGs, the report aligns with companies’ regular reporting cycles as they work towards their SDG objectives. The Analysis provides an inventory of possible disclosures per SDG at target level and is a first step towards a harmonized set of indicators and methodology for business to report on. Launching in January 2018, its sister document, “A Practical Guide to Defining Priorities and Reporting”, will offer a structured approach to help businesses prioritize and report on relevant targets, using the Analysis to drive action.
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“Reuters” reported on September 25 that Venezuela’s doctors, fed up with what they called the WHO’s “passive attitude toward the country’s deep medical crisis”, protested at the agency’s PAHO Caracas office to demand more pressure on the government and additional assistance. “Venezuela is suffering from a roughly 85% shortage of medicines, decrepit hospital infrastructure and an exodus of doctors during a brutal recession. Once-controlled diseases, like diphtheria and measles, have returned due in part to insufficient vaccines and antibiotics, while Venezuelans suffering chronic illnesses, like cancer or diabetes, often have to forgo treatment”, Reuters reported. South Korea had 2.2 medical doctors per 1,000 people in 2015, the fewest among member states of the Organization for Economic Cooperation and Development (OECD), health authorities in Seoul said on September 25. The figure is far lower than the average 3.3 medical doctors of OECD member states, according to data from the Ministry of Health and Welfare. The PhRMA news service reported on September 25 that “A recent study from NDP Analytics finds that intellectual property (IP)-intensive manufacturing industries have an outsized positive impact on the economy and support 57.6 million American jobs. The study also finds that the biopharmaceutical industry leads as a critical sector, driving economic progress and supporting quality jobs.” The study, by Nam D. Pham, PhD, also found that “Recent R&D and economic data across industries once again confirm the crucial role of innovation on long-term economic productivity and growth. IP- intensive industries outperformed non-IP intensive industries across key economic measures. Workers in innovative industries disproportionately create more economic value and earn higher wages than their counterparts in other manufacturing industries. IP-intensive industries cut less jobs during the economic downturn and added more jobs during the economic recovery than their counterparts non-IP-intensive industries.” The UN Technology Bank for least-developed countries, aimed at growing technology transfer and intellectual property infrastructure across the 48 poorest nations, became operational at the September UN General Assembly in NY. According to a fact sheet it issued, the Bank will: “Strengthen the STI capacity of LDCs, including the capacity to: identify, absorb, develop, integrate and scale-up the deployment of technologies and innovations—including indigenous ones—as well as the capacity to address and manage intellectual property rights issues.” In the September 25 newsletter of the Council for Multisectoral and Multistakeholder Diplomacy (CMMD), Executive Director Katherine Hagen laid out the implications for Geneva of the reform effort underway at UN headquarters. She wrote, “We conclude that the WHO is likely to survive unscathed, given its central role in coordinating responses to epidemics and pandemics… The WTO, on the other hand, seems to be in some trouble regarding U.S. support, especially when it comes to trade policy with China... UNCTAD remains forever under attack for things like mandate duplication or redundancy...” Hagen added, “The Human Rights Council is definitely under attack—but in a way that may serve it well. Without naming specific countries, the U.S. did persuade both the UK and The Netherlands to co-convene a meeting on reform of the Human Rights Council on the margins of the UN General Assembly on September 19. The three co-hosts also issued a joint statement in support of reforms to exclude ‘serial human rights violators’ from serving on the Council. And the event reportedly attracted participants from 37 other countries” (See October 16 “Meetings & Events Held). “At the latest session of the Human Rights Council, the U.S. condemned the delegations of Venezuela and China for harassing or threatening civil society organizations and blocking their participation in Council proceedings.” “The Canadian Press” reported on September 27 that the Ontario Government has introduced a new bill it says will improve transparency in the province’s health care system. The wide-ranging changes would amend ten existing pieces of legislation, if passed, including mandatory disclosure of any payments pharmaceutical companies and medical device manufacturers make to health care professionals.
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On September 29, “The Olive Press” (Spain) reported that police in the country, in an operation coordinated by Interpol and involving several national Spanish ministries, confiscated more than 4.5 million counterfeit pills, including Viagra, slimming aids and muscle enhancers. On September 29, “IP Watchdog” reported that the U.S. House Budget Committee released a non- binding budget blueprint titled, “Building a Better America: A Plan for Fiscal Responsibility.” As a part of the proposed fiscal year 2018 budget, the Budget Committee is proposing that the U.S. Patent and Trademark Office (USPTO) be made an independent agency. On World Heart Day, September 29, the International Diabetes Federation (IDF) and Novo Nordisk launched the first-ever Global Survey on Cardiovascular Disease Awareness among people with Type 2 Diabetes. The study, “Taking Diabetes to Heart” is a global online survey for people with type 2 diabetes to gain important insights about their awareness of cardiovascular disease (CVD). Globally, CVD is the most common cause of death in people with type 2 diabetes. ‘thepharmalatter” reported on September 29 that Medicines for Europe, representing manufacturers of generics and biosimilars industry that supply more than 60% of Europe’s medicines, complained about the low prices being paid for these drugs. It stressed that “A shrinking number of suppliers is recognized by the European Medicines Agency as posing a risk of medicine shortages”, and warned that the prices being paid for off-patent drugs have reached “unsustainably low levels, causing manufacturers to withdraw from the market.” In support of the International Day of the Older Person (IDOP), October 1, WHO called for a new approach to providing health services for older people. WHO highlighted the role of primary care and the contribution community health workers can make to keeping older people healthier for longer, and WHO also emphasizes the importance of integrating services for different conditions. “By the year 2050, one in five people in the world will be aged 60 and older”, noted Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, adding, “It’s our goal to ensure that all older people can obtain the health services they need, whoever they are, wherever they live.” WHO’s new “Guidelines on Integrated Care for Older People” recommend ways community-based services can help prevent, slow or reverse declines in physical and mental capacities among older people. “The world’s health systems aren’t ready for older populations”, said Dr. John Beard, WHO Director of the Department of Ageing and Life course. “Business in Cameroon” reported on October 1 that an agreement signed by the Cameroonian ministry of health and Novartis introduces the company’s program to enable access to chronic non- communicable disease drugs at $1 per treatment each month, transport, insurance and taxes excluded. Cameroon is the sixth country to benefit from this program launched in 2015 after Kenya, Ethiopia and Rwanda, Pakistan and Uganda. The first treatments in the framework of this program are already available in Cameroon’s western region, Novartis said. According to the WHO, 30% of deaths in Cameroon are due to chronic diseases. “University World News” reported on October 2 that “Half of the public does not trust research”, according to the latest biennial survey commissioned by the Research Council of Norway. Almost half of the public—46%—agree or strongly agree that research results published by industry or public offices cannot be trusted. The results were presented on September 19 at the opening of “Research Days” in Oslo, in conjunction with Norwegian newspaper, “Aftenposten.” Two out of five think that the research results reported to a large degree are affected by the researchers’ own attitudes and points of view. Half think that journalists are only presenting research results that correspond with their own views. On October 2, the Center for Strategic and International Studies (CSIS) announced the establishment of a Commission on Strengthening America’s Health Security. The Commission aims to bring together leaders who bridge the health and security fields—drawing from Congress, past administrations, industry, foundations, universities and nongovernmental organizations—“to chart a bold vision for the future of U.S. leadership in global health security.”
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On October 4, “The Rio Times” (Brazil) reported that about 150 petitions filed with Brazilian courts by Cuban doctors ask to either remain in Brazil practicing medicine after their contract with the “Mais Medicos” program is terminated, or to receive their full salaries while still in the program. According to these Cuban doctors working in Brazil via an arrangement through PAHO, they receive only one-fourth of what the Brazilian government pays the Cuban government for their services, with the rest going to the government, leaving little to send home to family members and to live on in Brazil. The Medicines Patent Pool (MPP) announced on October 4 a license with Gilead Sciences for its integrase inhibitor bictegravir (BIC), now under review in the U.S. and Europe as part of a once-daily, single-tablet HIV regimen. The license allows manufacturers to develop and sell generic medicines containing BIC, if approved in the U.S., in 116 low- and middle-income countries where more than 30 million people live with HIV. On October 4, PAHO issued a brief, “Schistosomiasis for the General Public.” It noted that four countries in the Americas are considered endemic for schistosomiasis: Brazil, St. Lucia, Suriname and Venezuela. Approximately 25 million people are at risk of contracting the infection, and it is estimated that nearly 1.6 million school-aged children need preventive medicine (in foci in northeastern Brazil and central Venezuela). In 2012, the WHO member countries approved the goal of eliminating the transmission of schistosomiasis. The October issue of “Drug Information Bulletin” featured a piece on “Prequalification process quality improvement initiatives: 2010–2016.” In the past six years the WHO Prequalification Team (WHO- PQT) organized a total of four surveys to evaluate client satisfaction among manufacturers that have applied for prequalification of their medicines, vaccines or in vitro diagnostic products. The article provides an overview of the survey findings and some other initiatives to improve prequalification process quality. The prequalification process is a pathway for quality assurance of key medical products purchased by UN agencies, national agencies and international organizations. A 2016 follow-up survey on medicines prequalification showed that manufacturers were more satisfied with the prequalification service than in 2010. According to the latest survey for vaccines, undertaken in 2010, manufacturers rated the vaccine prequalification service as “acceptable.” The report noted that while the sustainability of the prequalification program is critically dependent on manufacturers’ continued participation. a new prequalification fee structure was implemented. On October 5, the Access to Medicine Foundation (ATMF) published its good practice framework: methodology for the “2018 Access to Medicine Index” that pinpoints where pharmaceutical companies have the greatest potential to make medicine more accessible. The 2018 Index will measure the same 20 companies as in 2016, and the Foundation will begin collecting data for this in January, 2018. Companies’ efforts to improve access to medicine will be assessed across 106 low- and middle-income countries and in relation to 77 high-burden diseases, conditions and pathogens. The 2017 methodology comprises 69 indicators: four are mergers of pre-existing ones and 15 have been removed. Five new indicators were developed in response to changes in global health priorities, including one that specifically recognises R&D targeting priority R&D gaps or needs, as identified by stakeholders, such as WHO. Key changes are: “Targeted analysis of priority R&D”; “Cancer is now in scope”; “Closer analysis of behaviors that facilitate access to medicine”; and “New metrics for capturing the quality and impact of access initiatives.” Former WHO medicines group head and a long-time industry critic, Hans Hogerzeil, remains Chair of the Expert Review Committee. Major funders are the Bill & Melinda Gates Foundation, the UK Government and The Netherlands Ministry of Foreign Affairs. “Bloomberg Business” reported on October 5 that “The Lawyer Who Beat Big Tobacco Takes on the Opioid Industry.” In 1994, Mike Moore, then Mississippi’s attorney general, using an untested and widely-derided legal strategy, became the first state attorney general to sue tobacco companies for lying about nicotine addiction and to hold them accountable for sick smokers’ health-care costs. He marshaled attorneys general from around the country, along with private plaintiffs’ lawyers who reaped massive fees. (WHO HQ provided support for the filings.) Moore then negotiated the largest corporate
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legal settlement in U.S. history: a 50-state, $246 billion agreement. A number of alumni of the tobacco wars turned their sites on to Merck’s Vioxx in the early 2000’s. The current rash of suits allege that companies making painkillers—including Purdue Pharma, Endo and J&J’s Janssen unit—triggered the opioid epidemic by minimizing addiction and overdose risks. “Devex” reported on October 5 that UK aid chief Priti Patel “signaled a crackdown on the Department for International Development’s contracting partners, which she hopes will improve transparency and accountability, while fostering more competition among potential DFID suppliers. Speaking at the Conservative Party Conference on Tuesday, Patel announced a set of reforms her department is putting in place, including ‘open-book accounting’ policies and a ‘name and shame’ accountability measure that will reveal which DFID contractors aren’t delivering value for money.” Patel added, “I am setting out tough reforms that will encourage the private sector to work with DFID and end the appalling practice of fat cats profiteering from the aid budget.” On October 24, she confirmed that foreign aid would not be taken over by the Foreign Office, something that had been suggested by Boris Johnson. “The Wire” ran an October 5 headline, “India Plans to Achieve Full Immunization by 2018 Instead of 2020, Begins Acceleration This Week.” In an April address, Prime Minister Narendra Modi told the Union Health Ministry to “buck up” and not to wait until 2020 to achieve the goal of 90% immunization, but to make it happen two years earlier—by 2018. The government announced an October 8 start to embark on the “Intensified Mission Indradhanush” to achieve full immunization. On October 5, EFPIA responded to the October 4 publication in the “BMJ” of “Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13” that questioned the clinical benefit of a number of new cancer medicines. EFPIA noted that “The study predominantly focused on clinical trials, rather than on real world data on actual patient outcomes. The gathering together of overall survival data on new cancer medicines, generated in clinical settings, continues to represent a significant challenge both in terms of complexity and time. To help determine how medicines will function in a real world setting surrogate endpoints (often laboratory tests indicative of an expected improvement), are often employed as clinical endpoints in more complex diseases, such as cancer.” A European Medicines Agency (EMA) spokesperson told “Politico” on the same day, “Restricting approvals of cancer medicines only to situations where there is indisputable evidence of improvement in overall survival or quality of life will not improve the outlook for cancer patients in the EU. On the contrary, such an approach may deprive patients of early access to effective medicines for patients in urgent need. New therapies in Europe undergo rigorous cost-effectiveness assessments and are only reimbursed if they meet the cost-effectiveness criteria against existing standards of care. In cancer, the value of many treatments has tended to increase over time through impact on survival, or use in earlier lines of therapy and stages of a disease.” The Bretton Woods Project announced on October 6 the launch of an International Monetary Fund (IMF) website, the first comprehensive and transparent database of IMF-mandated policy reforms (“conditionality”) available to researchers and civil society organizations. The database systematizes the 58,406 conditions applicable to IMF programs over the 1980-2014 period extracted from countries’ loan agreements with the IMF. This resource enables nuanced explanations of the economic, social and political determinants and implications of IMF conditionality. The IMF has three channels through which its programs are linked to strengthening of health systems. Among other things, the reforms address public health spending, especially tax reforms, that increase revenues to give governments more money to spend on health care in a sustainable way. Oxfam commented in an October 10 report, “Great Expectations: Is the IMF turning words into action on inequality?”, concerning the IMF’s series of pilots that integrate inequality analysis into its economic surveillance of countries: “in none of the pilots can the analysis be seen to constitute a ‘systematic inclusion of inequality in policy discussion’.”
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The unique and controversial arrangement between Allergan and a native American tribe has become the topic of a national political row. “IP Watchdog” reported on October 6 that on the previous day, U.S. Senator Claire McCaskill (D-MO) introduced legislation that would strip Native American Indian Tribes of the ability to assert sovereign immunity in inter partes review (IPR) proceedings at the U.S. Patent and Trademark Office (PTO) conducted by the Patent Trial and Appeal Board (PTAB). “McCaskill’s seemingly calculated ploy to get out in front of other Senators, all alone in her demand for a legislative solution that strips Native American Indian Tribes of sovereign immunity, may backfire”, said the newsletter. The Saint Regis Mohawk Tribe, which acquired the Allergan Restasis patents and then granted back to Allergan an exclusive license, issued a scathing statement, saying the Tribe is “outraged” that the legislation specifically targets Indian tribes, while exempting state universities and other sovereign governments. “Creative avoidance of PTAB will continue to flourish as long as PTAB is permitted to discriminate against patent holders”, noted “ipstrategic.com.” A few days later, on October 9, in a commentary in “IP Watchdog”, Paul Morinville, Managing Director of US Inventor, Inc., described how an accused infringer can file an unlimited number of petitions for PTAB review of a patent, requiring the outlay of hundreds of thousands (or even millions) of dollars for legal fees and expenses for defense at the PTAB, while having the patent locked up (district courts routinely stay parallel district court proceedings while PTAB review and the subsequent Federal Circuit appeal are on-going). “The PTAB is so popular with infringers because over 90% of patent claims that are subjected to the PTAB review are invalidated, which renders such claims worthless for purposes of licensing.” He concluded, “Native American tribal sovereign immunity thwarts… these dilatory infringer tactics and repositions the negotiation to where it needs to be— outside of the courthouse. The tribe can inform detailed information to the infringer of their infringement and offer to enter into licensing negotiations without fear of being subjected to a DJ Action. Thus, the tribe can inform the infringer of their infringement and unless the tribe sues the infringer, the infringer will not be able to play the litigious gamesmanship or file the unending and procedurally unfair PTAB procedures. In sum, sovereign immunity equalizes the bargaining power between the inventor and the infringer and sets the negotiation table fairly.” The “New York Times” reported on October 7 on “a remarkable initiative modeled on the campaign against AIDS in Africa, two major pharmaceutical companies, working with the American Cancer Society, will steeply discount the prices of cancer medicines in Africa.” Under the agreement, Pfizer and Cipla promised to charge very low prices for 16 common chemotherapy drugs. “The deal, initially offered to a half-dozen countries, is expected to bring lifesaving treatment to tens of thousands who would otherwise die”, commented the NYT. “Reuters” reported on October 9 that “China said it plans to accept data from overseas clinical trials to speed up approvals of drugs, a potential boon for international drugmakers, as well as patients who often face lengthy delays for new medicines to reach the market.” In the past 15 years, China has approved just over 100 innovative new drugs, about one-third the number in developed markets. On October 10, 2017, the Union for Affordable Cancer Treatment (UACT), and 22 other NGOs working on cancer in South Africa, submitted comments on the Draft South Africa IP Policy. The signatories applauded recommendations in the draft “on the use of compulsory licensing reflecting steps needed to make the process more streamlined and less encumbered by a litigation process; government use licenses as a viable legal tool relevant to the state’s obligation ‘to take reasonable legislative and other measures to progressively realize the right to have access to health care services…[including] the utilization of TRIPS flexibilities, such as Article 31 (b), in full accordance with South African law;’ and engaging with WTO to streamline the cumbersome Paragraph 6 mechanism on compulsory licensing for export.” The NGOs applauded the work at the WHO on addressing “issues, such as lack of affordability and limited research where market returns are small or uncertain”, noted that delinkage is one of the core principles of the WHO Consultative Expert Working Group (CEWG) and underscored that the use of TRIPS flexibilities and the principle of delinkage were recommended as key strategies to
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improve policy coherence in the UN’s 2030 Agenda for Sustainable Development and in the 2016 Report of the UN High-Level Panel on Access to Medicines. They proposed that the grounds for licensing should include some that are mandatory, “so the compulsory licensing process is self- executing when a need is presented” and called for limitation on the remedies for infringement. UACT also recommended that South Africa adopt royalty guidelines for non-voluntary licenses, “considering, for example, the 2005 WHO and UNDP royalty guidelines as a model.” On October 10, Medicines San Frontieres (MSF) posted a recruitment for U.S. Advocacy Adviser, Access Campaign. “The aims of MSF’s Access Campaign are to: push for price cuts to medicines, vaccines and diagnostic tests by stimulating the production of more affordable generic products; act as a watchdog to ensure that the corporate interests don’t win out over public health needs; steer the direction of medical research toward urgently-needed new drugs, vaccines and tests that don’t exist yet, or are not tailored to the needs of people in developing countries; and scope out, support and monitor new models to fund medical research that respond to medical, rather than corporate, needs, and do not rely on charging sky-high prices for the final product to pay for the research.” The “Kaiser Daily Global Health Policy Report” on October 10, citing “Lancet Global Health”, reported that “African heads of state and government issued a declaration and committed to accelerating implementation of the 2005 International Health Regulations (IHR) and tasked the Africa Centers for Disease Control and Prevention (Africa CDC), the African Union Commission (AUC) and WHO with supporting the venture. The IHR is a global legal agreement that aims to prevent and respond to the spread of diseases to avoid their becoming international crises... The declaration is not only a reaffirmation of Africa’s determination to scrupulously implement the IHR, but should also serve as a new African public health order in addressing health security and inequities on the continent. Here we argue that a new public health order should address two broad categories of barrier that have challenged the implementation of IHR (2005) in Africa: health systems and systems for health.” The Declaration serves as an opportunity for “renewed engagement” from the global community. A new campaign aimed at reversing the “dangerous rush to promote expensive and high-risk public- private partnerships (PPPs)” was launched on October 11 by civil society organizations from all over the globe. The campaign’s manifesto—launched during the World Bank and International Monetary Fund annual meetings in Washington, D.C.—demands that western governments, the World Bank and other development banks stop prioritizing PPPs over traditional public borrowing to finance social and economic infrastructure and services. The 146 organizations behind the manifesto asserted that “experience of PPPs has been overwhelmingly negative and very few PPPs have delivered results in the public interest”, and suggested that PPPs often cost more in the long run than conventional public funding, expose governments to financial risk and can have a disproportionally negative impact on women and children, and undermine democracy, human and environmental rights. The U.S. notified the Paris-based UN Educational, Cultural and Scientific Organization (UNESCO) on October 12 that it plans to withdraw from the agency at the end of 2018, citing financial reasons, as well as what it said was its anti-Israel bias. The State Department said the U.S. would like to remain involved as a nonmember observer state. The U.S. previously withdrew its membership, in 1984, for what it believed was a pro-Soviet bias, and, in 2011, pulled its funding after Palestine was granted full membership. The UK also withdrew from the agency from 1985-1997. UNESCO has long been involved in health education, and in supporting national education sector responses to HIV and promoting comprehensive sex education. It also has had a Bioethics Program since 1993 and manages two advisory bodies: the International Bioethics Committee (IBC), and the Intergovernmental Bioethics Committee (IGBC). UNESCO members are preparing to vote on a successor for its Director-General, Irina Bokova. On October 12, the National Institutes of Health (NIH) and 11 leading biopharmaceutical companies launched the “Partnership for Accelerating Cancer Therapies” (PACT), a five-year, public-private, research collaboration totaling $215 million as part of the “Cancer Moonshot.” PACT will initially focus
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on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH). PACT partners include AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Genentech (Roche), Gilead Sciences, GSK, Janssen/J&J, Novartis Institutes for Biomedical Research and Pfizer. Additional support was provided by PhRMA. The 11 partner organizations will contribute up to $1 million per year for five years through the FNIH for a total private sector contribution of $55 million. NIH will contribute $160 million over the five years of the partnership, pending availability of funds. On October 12, the Stanford University Center for Innovation in Global Health gathered 400 people from around the world gathered in Palo Alto, CA, for the inaugural “Women Leaders in Global Health” conference. The aim was to discuss the dearth of women in global-health leadership positions, to highlight the accomplishments of women in the field and to begin a movement to empower the next generation of leaders to fill the gap of women at the top. Some 400 female leaders participated from 68 countries, representing 250 universities, companies and nonprofits. The London School for Hygiene and Tropical Medicine has agreed to host the next conference in 2018. Peru’s former minister of health Patricia Garcia, MD, PhD, MPH, and Agnes Binagwaho, MD, PhD, former Minister of Health for Rwanda, also have offered to host future conferences. The UN Conference on Trade and Development (UNCTAD) published in October an 88-page “BioTrade and Access and Benefit Sharing: From concept to practice. A handbook for policymakers and regulators”, written by developing country authors and UNCTAD staff. The agency states, “Contrary to the widely-accepted legal precept that biodiversity is a ‘common heritage of humanity’, individual States can now fully assert their exclusive entitlement to regulate and set up conditions for the access and use of their biodiversity, particularly their genetic resources through ‘access and benefit sharing’ (ABS) regulations. The adoption of the CBD’s Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (Nagoya Protocol), detailing the ABS and compliance obligations relating to genetic resources, and associated traditional knowledge (ATK), has only fortified this new ethos. The challenge now is how the Parties develop and implement the provisions of the Nagoya Protocol so that legal, regulatory and administrative measures contribute to and fulfil the objectives of the CBD while facilitating the emergence and scale up of BioTrade.” A 21-page WIPO publication issued on October 13, “Antimicrobial Resistance (AMR) and Multidrug Resistance (MDR): Overview of current approaches, consortia and intellectual property issues: Global Challenges Report” was authored by Andrew Jenner (JS Consulting Ltd., UK), Niresh Bhagwandin (Executive Manager, Strategic Research Initiatives, South African Medical Research Council-SA MRC, South Africa) and Stanley Kowalski (Director, International Technology Transfer Institute-ITTI, Franklin Pierce Center for Intellectual Property, University of New Hampshire, School of Law). Based on a review of recent literature, the report includes a broad overview of current approaches and consortia designed to meet the challenge of research and development (R&D) investment for new treatments. It also examines patent applications by both the public and the private sectors as an indicator of innovative activity. “Agencia Brasil” reported on October 15 that the estimated aging of the Brazilian population and a rise in medical costs should increase health insurance prices by 2030. Leandro Fonseca, head of the National Regulatory Agency for Private Health Insurance and Plans (ANS), indicated this as a forum organized by the American Chamber of Commerce (Amcham) in Sao Paulo. ANS estimates that one of every four Brazilians has a health insurance plan. By 2060, the 80-plus age group will have skyrocketed to 19 million people, according to the Brazilian Institute of Geography and Statistics (IBGE), and Brazil’s public health system “must be ready for the rise in the prices of medication targeted at older people with chronic diseases.” Leonardo Paiva, a representative from the Brazilian Health
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Regulatory Agency (Anvisa), anticipates an increased number of court cases forcing the government to pay for medication. In 2015 and 2016, $310 million were spent per year on “the ten most-requested drugs in court.” “The Korea Times” reported on October 25 that “Healthcare business exports increased 13.4% in the first half of this year, generating 6.1 trillion won ($5.4 billion) in profit, according to [new] government data… The sector generated 1.1 trillion won [$97 million] in annual surplus last year. Nearly a 500 billion won [$441 million] surplus has been recorded in the first half of this year.” The latest edition of an annual report, “Levels and Trends in Child Mortality 2017”, was released October 26 by the Inter-agency Group for Child Mortality Estimation (IGME)”, composed of the WHO, the UN Children’s Fund (UNICEF), the World Bank and the Population Division in the UN Department for Economic and Social Affairs (DESA). The number of children who die before reaching their fifth birthday has fallen to an all-time low; yet, children around the world continue to die at an alarming rate, with 5.6 million deaths recorded last year—and many of the deaths, “which averaged 15,000 a day in 2016”, were from preventable diseases. It also indicated that 7,000 newborns die every day worldwide. The report called for making available most-needed, life-saving know-how and technologies “particularly in Southern Asia and sub-Saharan Africa.”
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