IP-Watch Guide To 2017 World Health Assembly: Election, Budget, Antibiotics, Cancer, R&D And More 16/05/2017 by Catherine Saez, Intellectual Property Watch 1 Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)In a few days, the 70th World Health Assembly will open its doors in Geneva with a marathon agenda, and over 4,000 registered delegates. The election of a new director general, the approval of the budget for the next biennium (2018/2019) are set to capture the attention of member states. However, many other subjects require their consideration, such as a resolution on cancer treatment costs, research and development for epidemic diseases, for new antibiotics, for medicines affecting primarily poor populations, access to medicines, and the influenza pandemic preparedness framework. A view of the 69th World Health Assembly The 70th World Health Assembly is taking place from 22-31 May. The provisional agenda is here [pdf]. A preliminary journal [pdf] lays out a potential programme for the week. The election process for the new WHO director general is explained in a recent Intellectual Property Watch story (IPW, WHO, 12 May 2017). Some agenda items of interest Budget, Financial Gap Research and Development for Epidemic Diseases Antimicrobial Resistance Review of the Pandemic Influenza Preparedness Framework Access to Medicines, Shortages Review of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property Global Observatory, R&D projects, Lack of Funding Substandard and falsified medical products, End of Wording Fight 2030 Agenda for Sustainable Development WHO Reform, Relationship with Outside Actors Financial Gap to Close 2017, New Budget Modest Raise The overall WHO budget for the 2016-2017 biennium was US$4.385 billion, according to the report [pdf] by the secretariat providing an overview of the financial situation in 2016-2017. This budget was divided into two parts: a base programme component of US$3.194 billion, and a component on polio eradication, outbreak and crisis response, tropical disease research, and research in human reproduction of US$1.191 billion. That budget was adopted in 2015. The last WHA, in May 2016, approved an increase of US$160 million to fund the new WHO Health Emergencies Programme, bringing the total budget to US$4.545 billion. At the end of March 2017, there was a financing gap of US$456 million in the budget segment for base programmes, says the report. The “significant and persistent imbalance between assessed and voluntary contributions and the decrease in core voluntary contributions” were acknowledged as critical issues during the last WHO Executive Board (EB) meeting in January. The WHO secretariat has pledged to a tightening of its belt to achieve a fully financed budget for 2016-2017 but efforts are needed from contributors too, the report states. The proposed programme budget 2018-2019 [pdf] presents a modest increase of 3 percent, far from the 10 percent proposed by WHO Director Margaret Chan at the Board meeting in January, and would amounts to US$4,421 billion (IPW, WHO, 26 January 2017). That would include increased investments proposed for the full implementation of the WHO Health Emergencies Programme, and for combating antimicrobial resistance. To balance those increases, a decrease in the budget for corporate services, non-communicable diseases, and health information and evidence programme area, is proposed. R&D for Epidemic Diseases Also on the agenda is a report [pdf] from the secretariat on research and development (R&D) for potentially epidemic diseases, in particular on the development of a blueprint for research and development preparedness and response (the R&D Blueprint). The 2017 revised WHO list of pathogens for priority R&D only includes pathogens for which there are no medical countermeasures available, and excludes pandemic influenza. Pandemic influenza preparedness is dealt with the Pandemic Influenza Preparedness (PIP) Framework . According to the report, which is expected to be noted by the WHA, WHO has completed the mapping of all relevant global stakeholders and a database of research preparedness resources has been created, to be integrated into WHO’s Global Observatory on Health Research and Development. On the sharing of biological samples, the WHO has initiated a process to reach consensus on principles of open-access repositories of samples, and “the principles for a shared system of governance and decision-making are currently being elaborated,” the report says. Separately, a material transfer agreement capacity-building tool has been prepared to inform negotiations at country level on sharing biological samples, it says. The sharing of biological samples of pathogens is under ongoing discussions at the WHO, in particular in the context of the Pandemic Influenza Preparedness Framework, and the consequence of the implementation of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. In a post of 12 May, the Third World Network (TWN) raised questions about the sharing of biological samples in the context of the R&D Blueprint. “The most glaring gap in WHO’s approach to handling of biological samples and data is the absence of a transparent and inclusive intergovernmental process driving the development of appropriate norms and standards in a cohesive manner,” they said. TWN asks what will be the terms for accessing biological samples, how will the shared samples be recorded and tracked, who will have ownership over the biological material, and how intellectual property will be dealt with. They also ask what form of benefit-sharing will be realised. Antimicrobial Resistance, New UN Coordination Group According to the WHO’s report, the United Nations secretary general established an inter-agency coordination group on antimicrobial resistance in March. The group co-chaired by the UN deputy secretary-general and the WHO director general is tasked in particular with providing “practical guidance for approaches needed to ensure sustained effective global action to address antimicrobial resistance.” It includes UN agencies, such as the World Intellectual Property Organization, the UN Environment Programme, UNICEF, the World Customs Organization; other international organisations such as the South Centre, the World Farmers Organization; and individual experts across different sectors, such as animal health, agriculture, and environment. An update on the first meeting of the group is expected to be given during the WHA, the report says. The report notes that the WHO has also issued a list of priority antibiotic-resistant bacterial pathogens where new medicines are most urgently needed (in March), and sets tuberculosis as a major global priority. “Work is ongoing to monitor the pipeline for new antibiotics under development, and antimicrobial resistance is now more explicitly considered as a factor in prioritizing new vaccine development,” the report says. The report is expected to be noted by the WHA. Separately, the health ministers of the G20 are expected to meet in Berlin on 19-20 May to discuss a range of issues. An IP-Watch story on the meeting will follow. Review of PIP Framework One of the issues expected to be discussed at the WHA regarding the Pandemic Influenza Preparedness (PIP) Framework is the proportional division of funds between pandemic preparedness measures and response activities, according to the secretariat’s report [pdf]. The first review of the 2011 PIP Framework was carried out in 2016 by a Review Group, which provided a report in November 2016, with a number of recommendations (IPW, WHO, 23 November 2016). The WHA is expected to address questions such as how to deal with the sharing of the genetic information of influenza viruses (genetic sequence data or GSD), which were not included in the framework. A decrease of the sharing of biological samples of influenza virus with pandemic potential has been noted last year by the WHO. Also on the discussion table is the annual partnership contribution paid by pharmaceutical manufacturers using the WHO Global Influenza Surveillance and Response System (GIRSR). In particular, the system of calculation of the partnership contribution, and its potential revision. Other questions on the subject of the PIP Framework are whether the PIP Framework can be recognised as a specialised international instrument of access and benefit-sharing under the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits, and whether the WHO should undertake a study to determine if the PIP Framework should include seasonal influenza viruses. Also in the report of the secretariat for the WHA is the issue of whether the PIP Framework can be recognised as a specialised international instrument of access and benefit-sharing under the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. The report notes that the Nagoya Protocol does not expressly identify a mechanism to recognise such an instrument. More information on the expected discussions on the PIP Framework in a separate Intellectual Property Watch story to follow. Access to Medicines, Shortages The WHO report [pdf], describes the efforts conducted by the WHO to address access to medicines and vaccines, and the global shortage of medicines. In particular, the report mentions the report of the UN Secretary-General’s High Level Panel on Access to Medicines. The report of the High-Level Panel “echoes conclusions of previous reports prepared under the auspices of WHO, which drew attention to disparities in research and development and lack of access to essential medicines (in particular the reports of the Commission on Intellectual Property Rights, Innovation and Public Health, and the Consultative Expert Working Group on Research and Development),” the report says. Efforts by some countries, such as Brazil, during the January Board meeting to have the report of the High-Level Panel discussed there fell through, and after those countries pressed on to have an item during the WHA on the report, it was decided that the report could be discussed under the agenda item on shortages of medicines (IPW, WHO, 23 January 2017). The High-Level Panel focused on “policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health,” raising a lot of protest from the pharmaceutical industry, and some countries, such as the United States and those in the European Union. The WHO report lists a number of initiatives carried out by WHO with other agencies, such as the World Trade Organization, the World Intellectual Property Organization, and the UN Conference on Trade and Development (UNCTAD). In December 2016, says the report, “WHO called for an ‘all-agency meeting’ with UNAIDS, UNCTAD, UNDP, UNITAID, WTO, WIPO and the High Commissioner for Human Rights to discuss the different activities and plan for the future, including how to best follow up on the High-Level Panel’s report.” Review Global Plan Action Public Health, IP After the WHA in 2015 decided to extend the timeframe of the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) from 2015 to 2022, an evaluation of the comprehensive implementation of the GSPOA was agreed upon. The WHA is expected to note the report [pdf] of this evaluation. The comprehensive evaluation looked at the prioritisation of R&D needs, the promotion of R&D, the build-up and improvement of innovative capacity, transfer of technology, the application and management of IP to contribute to innovation and promote public health, the improvement of delivery and access, the promotion of sustainable financing mechanisms, and the establishment of monitoring and reporting systems. The evaluation is expected to identify achievements, gaps, and remaining challenges, as well as inform the overall programme review planned for 2017, according to the WHA document. The evaluation also provides recommendations. Among the key gaps and challenges identified are insufficient investments in health research, in particular in traditional medicines, and the fact that current market mechanisms and publicly-funded research result “in far too little” investment in R&D for diseases affecting mainly lower-middle-income and low-income countries. Implementation of policies to promote the development of health capacity remain fragmented in many countries, and R&D is “generally still not a major priority for lower-middle income and low-income countries, which face daunting issues stemming from a lack of skilled researchers and financial resources, together with competing, seemingly more urgent, priorities,” the report found. It also found that resources and know-how required for the implementation of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “are still scarce in most countries, coupled with reluctance to use these or other legitimate mechanisms to advance access to medicines.” According to the report, the availability and accessibility of health products is still limited in many lower-middle-income and low-income countries. Global Observatory, Lack of Funding for R&D Projects The WHA document [pdf], which is a follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG), provides the terms of reference and a costed workplan of the Global Observatory on Health Research and Development, which was released on 19 January 2017. Also included in the document is the proposal for a voluntary pooled fund to support health R&D developed by UNICEF/UNDP/World Bank, and the WHO Special Programme for Research and Training in Tropical Diseases. The document underlines the lack of funding for the Global Observatory, and the financing of six R&D demonstration projects. The estimated total financial requirement over the period of 2014-2017 for those projects and the observatory is US$85 million. As of January 2017, US$2.5 million had been contributed or pledged by France, Germany, Switzerland, the United States and the European Commission to the Global Observatory, the document says (IPW, WHO, 31 January 2017). Some US$10.49 million has also been contributed by Brazil, Germany, India, Norway, South Africa, and Switzerland to the voluntary funds for the demonstration projects. Some US$70.59 million is still missing. The WHA is requested to note the report and provide guidance on “future strategic directions.” Substandard and Falsified Medical Products The WHA document [pdf] includes a draft decision to change the name of the definition of bad quality medicines from substandard/spurious/falsely-labelled/falsified/counterfeit medical products, to substandard and falsified medical products. The new wording approved at the last EB in January closes a fight over the wording of the definition that lasted for years (IPW, WHO, 30 January 2017). The WHA is also expected to take note of a summary of the review report [pdf] of the Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products. 2030 Agenda for Sustainable Development Also on the agenda of the WHA is a report [pdf] of the progress in the implementation of the 2030 Agenda for Sustainable Development. In particular, the report notes that “The majority of health research is focused on biomedical and clinical interventions, while health systems research remains underfunded globally.” According to the report, the Alliance for Health Policy and Systems Research, an international partnership hosted by WHO, has developed an innovative model of embedded research led by decision-makers that addresses context-specific factors relevant to health system priorities.” The report also says that to stimulate international cooperation on access to health science, technology and innovation, the UN Development Group has established a South-South and triangular (South-South-North) cooperation task team, including WHO. The task team issued a report in 2016 on good practices in South–South and triangular cooperation for sustainable development, according to the report, which states that the WHO, WIPO and WTO “are also strengthening their cooperation and practical coordination on issues around public health, intellectual property and trade.” WHO Reform, Relationship with Outside Actors The 2016 WHA decided, following recommendations of the Open-ended Intergovernmental Meeting on Governance Reform, that a number of actions should be taken regarding the methods of work of WHO’s governing bodies, according to the WHA document [pdf]. In particular, the WHA is expected to take a decision on proposed amendments to rules of procedure of the WHA (annexed to the WHA document) with effect from the closure of its 70th session. The amendments concern rule 5 of the rules of procedure of the WHA, and in particular the proposals for inclusion of agenda items on the provisional agenda of the WHA. On the agenda is also an overview [pdf] of WHO reform implementation, with a document [pdf] particularly focusing in WHO’s performance in countries, and another document [pdf] providing an evaluation of WHO reform in leadership and management. Answering calls by a number of countries wishing more transparency in the relationship WHO is entertaining with a number of outside actors, such as industry, civil society, the academia, and funders, a Framework of Engagement with Non-State Actors (FENSA) was adopted at the WHA in 2016. Following this adoption, the WHO was requested to establish a register of non-state actors by the 70th WHA, and fully operationalise implementation of the framework within a two-year time frame. According to the WHA document, the WHO register of non-state actors has been built and is currently “being piloted and rolled out.” Separately, another document [pdf] details a set of criteria and principles for secondments from nongovernmental organisations, philanthropic foundations and academic institutions at the WHO. According to the document, the WHO opened an electronic consultation for member states between 18 November and 1 December 2016 on a set of proposed criteria and principles. Image Credits: WHO/L. Cipriani Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at email@example.com."IP-Watch Guide To 2017 World Health Assembly: Election, Budget, Antibiotics, Cancer, R&D And More" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.