Biggest World Health Assembly Ever Kicks Off Next Week With A Loaded Agenda 18/05/2016 by Catherine Saez and William New, Intellectual Property Watch 3 Comments 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)Next week the annual assembly of World Health Organization member states will take place with a heavy agenda and its largest attendance ever. The lack of new antibiotics to address bacterial resistance, global shortages of vaccines and medicines, the fight against substandard drugs, and a framework to guard against undue influence of outside actors on the work of the WHO are part of a picture where there is an increasing blur between developed and developing countries in terms of access to medicines. And then there is the matter of electing a new WHO director general. The 69th World Health Assembly is taking place from 23-28 May. The provisional agenda [pdf] is here. WHA documents are available here. A preliminary journal [pdf] lays out a potential programme for the week. Committee B at the Sixty-eight World Health Assembly, Palais des Nations, Geneva. Photo by Violaine Martin The first day opens in a plenary (all participants) gathering at which WHO Director General Margaret Chan will make her annual address to the Assembly. She will be followed by a long list of countries speaking on the United Nations 2030 Agenda for Sustainable Development, the theme of this year’s Assembly. The invited speaker to address the Assembly this year will be Christiana Figueres, the executive secretary of the UN Framework Convention on Climate Change (UNFCCC). This year’s Assembly is expected to have record-setting attendance of some 3,500 people, Chan told a 17 May press briefing. There are 76 agenda items, and some 74 documents with over 1,200 pages for delegates to read and discuss. In addition, there are 21 resolutions expected to be proposed by member states. And there are about 30 side events, plus breakfast, lunch and dinner meetings. And the secretariat will have to keep up with all of it. “It is good that global health is taking such a prominent position,” Chan told reporters. “Especially in the context of the Sustainable Development Agenda for the next 15 years. So we’re very happy with this rather crowded meeting.” In addition to issues pertinent to followers of intellectual property, innovation, research and development, medicines access the like, there are broader issues of importance to health diplomacy, such as the UN Sustainable Development Agenda – of which health is a top priority – and health emergencies, for which WHO is being asked to move from a policy body to being operational. For that new role, it is seeking an additional US$ 160 million in its budget (IPW, WHO, 18 May 2016). When not in plenary, the work of the World Health Assembly (WHA) is divided between two committees. Committee A deals predominantly with programme and budget matters, and Committee B mainly deals with administrative, financial and legal matters. Global Action Plan on Antimicrobial Resistance At the last WHA, member states endorsed a global action plan to address the issue of rising resistance of bacteria to antibiotics. According to the WHO, antimicrobial resistance is occurring everywhere in the world and the goal of the action plan is to “ensure, for as long as possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.” The objective of the Global Action Plan [pdf] on Antimicrobial Resistance is to have multisectoral national action plans in place by the 2017 World Health Assembly, according to the WHO. For antimicrobial resistance, the WHA documents are A69/24 [pdf] and A69/24 Add.1 [pdf] CEWG – R&D Financing At the WHA, member states are being asked to set up a drafting group during the week to complete a draft decision on alternative financing for research and development into diseases disproportionately affecting poor populations. This relates to the WHA agenda item on follow-up to the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG). The recommendation for a drafting group came from the Open-Ended Meeting of Member States to Assess Progress and Continue Discussions on the Remaining Issues in Relation to Monitoring, Coordination and Financing for Health Research and Development, which took place from 2-4 May. The outcome report and draft decision from the open-ended meeting are available here. Sections marked yellow indicate a relative degree of agreement, according to a source, but most of the document is in brackets indicating lack of agreement so far. Member states effectively had one day for negotiations, and the draft decision grew from two pages to eight pages as it filled with proposed language. Members in the open-ended meeting left the draft decision largely without agreement, and recommended to this WHA to set up a drafting group to finalise discussions. Some 60-70 member states attended the open-ended meeting, along with perhaps 45 NGOs and international organisations on the first two days, according to officials (IPW, WHO, 9 May 2016). Global Observatory on Health R&D In a related area, the WHA is expected to note a report [pdf], A/69/29, on “Options for strengthening information-sharing on diagnostic, preventive and therapeutic products and for enhancing WHO’s capacity to facilitate access to these products, including the establishment of a global database, starting with haemorrhagic fevers.” The report was updated to include the Zika virus. A review was conducted of existing WHO databases on research and development for diagnostic, preventive and therapeutic products, and their relationship with the Global Observatory on Health Research and Development. The review “pointed to the potential value” of the Global Observatory for filling the proposed mandate, the report said. According to the document, the Global Observatory was mandated by the WHA in 2013 “to monitor and analyse relevant information on health research and development, building on national and regional observatories (or equivalent functions) and existing global data collection mechanisms, with a view to contributing to the identification of gaps and opportunities for health research and development , especially for diseases that disproportionately affect developing countries, particularly the poor.” The first phase of the Observatory’s platform was launched in January 2016, according to the document, which states that the “platform includes data on funding for health research and development, products in the pipeline for various diseases, clinical trials and research publications.” According to the report, the Observatory is the ideal place to host the global database, “and for meeting the associated information-sharing and capacity-building needs.” The database is set to help address situations such as the Ebola outbreak, for which there were limited options available for diagnostics and disease interventions. No framework existed then for carrying out research and development activities in the event of an epidemic, the report said. In June 2015, WHO started work on the development of a blueprint for research and development preparedness and rapid research response during future public health emergencies due to highly infectious pathogens. According to the document, “The objective of the blueprint is to develop options to accelerate the testing and increase the availability of medical countermeasures during outbreaks by: identifying priority infectious disease threats and research and development gaps and priorities; improving collaboration between stakeholders; and promoting an enabling environment for the conduct of research and development during outbreaks.” Also on the agenda is a report [pdf], A69/30, on the reform of WHO’s work in health emergency management. Global Vaccine Action Plan A report [pdf] A69/34, is expected to be considered by the WHA, which is invited to take note of the report and ” to consider the recommendations for actions to be taken by the various stakeholders of the global vaccine action plan, in particular by Member States.” The Strategic Advisory Group of Experts on Immunization (SAGE) met from 12-14 April [pdf]. According to the report of the April session, there is a need to have a global view of vaccine shortages, as various countries, over the past couple of years, across regions and income groups, have reported shortages of vaccines. In the report, SAGE noted that “information collection and sharing was a major area for potential further investment to pre-empt and manage vaccine shortages,” and this is also aligned with the draft resolution on ‘Addressing the global shortages of medicines’ to be presented at the WHA. A report [pdf] A69/42, on “Addressing the global shortages of medicines, and the safety and accessibility of children’s medication,” is expected to be noted by the WHA. At the last Executive Board meeting in January, a draft resolution [pdf] was proposed by China, Italy, Pakistan and Thailand on this issue and discussions are expected to continue at the WHA (IPW, Public Health, 2 February 2016). According to the report, “Shortages of essential medicines are being documented in most parts of the world with increasing frequency. Many shortages have been linked to products that are older, off-patent or difficult to formulate and that have a tightly-defined shelf life and few manufacturers (or a sole manufacturer).” At the global level, a set of essential medicines could be identified for which shortages have been reported or there exists a risk of shortages, and an international agreement about ensuring continuity of manufacturing and supply could be investigated, the report stated. In particular, the international agreement could seek to answer the following questions, according to the report: “What is the core problem? What incentives are appropriate to create and maintain stability in the global market? Could a multiyear global advance purchase commitment be worked out? Would an agreed global minimum price that is commercially attractive help to keep a medicine on the market? How would such a price be set?” Substandard Medical Products The fourth meeting of the Member State Mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC), took place from 19-21 November. A document [pdf], A69/41, for the WHA presents the report of that meeting. The document includes the terms of reference for the “Global Focal Point Network” for SSFFC, as a basis for discussion, according to the document, which explains that “the Member State mechanism has identified the need for a global network of focal points within WHO Member States to improve the flow and exchange of information from a public health perspective in a safe, secure and efficient environment.” “The creation of such a network has the potential to improve reporting and alerting of SSFFC medical products, learn from the experience of other Member States and provide access to a reliable source of information in a timely and efficient way,” the document said. Pandemic Influenza Preparedness The WHO Pandemic Influenza Preparedness (PIP) Framework was adopted in 2011. The objective was to improve timely sharing of flu viruses with pandemic potential with the WHO Global Influenza Surveillance and Response System (GISRS). The second was to ensure access to vaccines and other life-saving products during a pandemic. The PIP Advisory Group recommended in October 2015 that a small independent group of experts be established to review the implementation of the PIP Framework. The review group met from 30 March to 1 April (IPW, Public Health, 5 April 2016). On 30 March, the group sought views from different stakeholders on the achievement of the framework. Several issues were raised by stakeholders, such as the importance of clarifying a trigger mechanism for switching from seasonal to pandemic vaccine production in the event of a pandemic. Another question was how to address a perception among some stakeholders that partnership contribution funds are being used too slowly. Also discussed during the meeting was the issue of genetic sequence data (GSD). Technological progress now allows access to genetic material that has been sequenced into data, and the reproduction of this material without the need to access the physical form of the material (IPW, Public Health, 31 March 2016). WHA delegates are expected to note the report [pdf] A69/22, by the WHO Director General on the PIP Framework, and the report [pdf], A69/22 Add.1, of the October session of the advisory group. The review group met in a closed meeting on 9-11 May. The WHO told Intellectual Property Watch that the chair of the group plans to make a presentation during the PIP framework segment of the WHA to brief member states and stakeholders. The next meeting of the review group is scheduled for 27 June to 1 July, according to the WHO, and a briefing is planned on this occasion. The final report of the group is expected to submitted by the group on 31 October, and is expected to be presented at the WHO Executive Board meeting and at the WHA in 2017. Engagement of WHO with Non-Government Actors The Framework of Engagement with Non-State Actors (FENSA) is part of the overall reform of the WHO, which started in 2010. It seeks to address concerns by member states that WHO could face undue influence by non-state actors, and to help avoid conflicts of interest. The framework has been discussed for some time and an Open-Ended Intergovernmental Meeting on FENSA was convened from 25-27 April. It had the task of breaching differences on the draft framework and presenting a consensus text and a draft resolution to the WHA. A new confidential version [pdf] of the draft text was issued at the end of the April session, bearing the same colour-code as the previous version of the draft text [pdf]. The text highlighted in green had been agreed upon, text in yellow was non-consensual, and text not highlighted had not been considered yet (IPW, Public Health, 29 April 2016). Overview of Reform Implementation WHA delegates are expected to note the Report by the Director-General [pdf], A69/4, on the progress of the WHO reform. According to the report, “The majority of reform outputs (84%) have now reached the implementation stage, a proportion that has not changed significantly since May 2015, owing to the postponement of work on several outputs as a result of WHO’s response to the outbreak of Ebola virus disease.” “Governance reforms are often the most challenging of organizational reforms, which is reflected in the relatively slow progress in this area, with only 50% of reform activities completed,” the report said. Also on the agenda of the WHA is the annual report on the implementation of the International Health Regulations of 2005, and the report of the Review Committee on the Role of the International Health Regulations in the Ebola Outbreak and Response. Election of the Next Director General The process for electing the next director general of the WHO has begun and will take a year. Current Director General Margaret Chan will complete her term in June 2017. The WHA will consider a document, A69/57, [pdf] on the process for the election of the director-general of the WHO. Chan represents the Asia-Pacific region, and there is an informal understanding of geographical rotation for WHO directors, so it will likely rotate away from Asia, observers say. In general, in WHO history, Asia and Europe have been well-represented. For the list of past WHO directors, see here. The resolution setting out the election process is available here. Names of possible candidates will certainly be buzzing in the hallways of the WHA, but the names of nominees do not officially go public until next September. IP-Watch will bring you an update of possible names as they arise. Non-Communicable Diseases Another issue of importance to the WHO in recent years is non-communicable diseases, such as cancer or diseases related to unhealthy diet, smoking, or lack of exercise. The WHA will look at steps toward the 2018 UN High Level Meeting on NCDs. Side Events to WHA A number of side events are listed in the preliminary programme of the WHA. For example, on Monday 23, the delegations of Burkina Faso, Ethiopia, Ghana, Guinea-Bissau, Mali, Mozambique, Nigeria, South Sudan, Uganda, Tanzania, Zambia and the WHO Secretariat are organising an event to launch the Expanded Special Project for the Elimination of Neglected Tropical Diseases (ESPEN) (Room IX 12:45 – 14:45). The same day the BRICS countries (Brazil, Russia, India, China and South Africa) are holding an event on access to medicines and regional trade agreements (Room XII 17:45 – 19:15). On 24 May, Health Action International, Medicines for Malaria Venture and Oxfam are organising a session on achieving affordable access to health technologies (Room IX 17:45 – 18:45). The delegations of Australia, Egypt, Ethiopia, Germany, Kenya, Namibia, Rwanda, Sierra Leone, Singapore, the United States, Zambia and Zimbabwe are organising and event on World Intellectual Property Organization “WIPO re:Search” and sharing innovation in the fight against Neglected Tropical Diseases (NTDs) “An example of a multi-stakeholder platform for NTDs, its achievements and lessons learned” on 26 May (Room IX 12:15 – 13:45). On the same day and same time in Room XXIII, the delegations of Australia, Canada, Colombia, Japan, the Netherlands, Norway, Sweden, South Africa, Thailand, the United Kingdom and Zambia are holding an event on Global action in antibiotic research and innovation. The International Federation of Pharmaceutical Manufacturers and Associations and the International Pharmaceutical Students’ Federation will hold an event on 27 May on SSFFC – strategies towards safe universal access to quality (Room IX – 18:00 – 19:30). Image Credits: WHO 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 firstname.lastname@example.org.William New may be reached at email@example.com."Biggest World Health Assembly Ever Kicks Off Next Week With A Loaded Agenda" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.