Ebola R&D, Antibiotic Resistance, Neglected Diseases Among Issues At This Year’s World Health Assembly 14/05/2015 by Catherine Saez, Intellectual Property Watch 2 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)The annual World Health Assembly opens next week with a focus on antimicrobial resistance, the Ebola outbreak, and research and development. Other subject of interests will be World Health Organization engagement with outside stakeholders, such as non-governmental organisations and the private sector, and a potential pooled fund for research and development for neglected diseases. The 68th Health Assembly is taking place from 18-26 May. The Provisional Agenda is here. A preliminary version [pdf] of the WHA Journal gives a tentative programme of work of the WHA. The guest keynote speaker on the first day this year will be German Chancellor Angela Merkel. Germany is currently the chair of the Group of 7 (G7) industrialised nations, which is likely to take up issues such as antimicrobial resistance and the Ebola emergency response, according to a WHO source. Antimicrobial Resistance The WHA is expected to consider a draft global action plan [pdf] on antimicrobial resistance (the growing resistance to existing antibiotics and lack of research on new ones), and a summary report [pdf] on progress made in implementing resolution WHA 67.25 on antimicrobial resistance. According to the WHO, speaking at a press briefing earlier this month, the draft global action plan includes five strategic objectives: “(1) to improve awareness and understanding of antimicrobial resistance; (2) to strengthen knowledge through surveillance and research; (3) to reduce the incidence of infection; (4) to optimize the use of antimicrobial agents; and (5) to ensure sustainable investment in countering antimicrobial resistance” (IPW, WHO, 29 April 2015). The draft action plan says most major pharmaceutical companies have stopped research in the area of antibiotics, and new processes are needed to facilitate renewed investment in research and development. It also states that the use of antibiotics should then be regulated by a public health framework so that the effectiveness and longevity of the products are maintained. Factors limiting research include fears that resistance will develop rapidly, limiting returns on investment, it said. Communicable Diseases: Ebola, Malaria, Vaccines Ebola reports Ebola will be a big issue at this year’s Assembly. The WHA is expected to consider the first report [pdf] of the Ebola Interim Assessment Panel. The panel was established following a decision of the special session of the Executive Board in January. The resolution called for an interim assessment of WHO’s response in the Ebola outbreak. The report found in particular that “WHO does not have the operational capacity or culture to deliver a full emergency public health response.” The panel recommended that investments should be made so that the operational capacity of WHO for emergency response is fully in place. This will require resources and political will from member states, the panel added. The report also notes that only 25 percent of WHO’s biennial programme budget currently comes from assessed contributions. The remainder, the report says, “comes from voluntary funds that are largely restricted for purposes specified by donors. There are no core funds for emergency response as such, although every year a considerable amount of money is spent as donor contributions for emergencies.” As a result, the report says, “WHO is put at a severe disadvantage by the fact that the core funds are so limited and do not allow an appropriate base for response.” There is also a secretariat report on its response to Ebola, including R&D and health systems, and a recommendation on establishing an International Health Regulations review committee on this, a WHO official said at a press briefing this week. Furthermore, there is a paper on a global health emergency workforce, and discussion of a contingency fund for “surge” (not core) health emergencies to come in a paper drafted by the secretariat expected this week. Ebola R&D roadmap Meanwhile, the WHO is working to learn from the fast and effective response on R&D for Ebola that led to effective treatments in a short time. An Ebola R&D development forum was held at WHO on 11-12 May. Actions taken by the international community in response to the Ebola virus spread demonstrated that R&D can be accelerated, WHO Assistant Director General Marie-Paule Kieny said at a 12 May press briefing. The WHO is trying to develop a roadmap for R&D for diseases with epidemic potential and other health threats. A preparedness plan could provide clear rules, platforms for information sharing, and established processes to expedite development and clinical trials, she said. Malaria, Vaccines Also on the WHA agenda is the draft global technical strategy [pdf] for malaria from 2016-2030, and the Global vaccine action plan [pdf]. Engagement with Non-State Actors [Updated] In the reform process of the organisation, a framework of engagement with non-state actors is expected to be discussed. Non-state actors include private sector, foundations, non-profits (non-governmental organisations) and academics. The draft of the framework showing the areas agreed and remaining to be agreed was included in the draft WHA agenda here [pdf]. An “advanced” draft reflecting progress made in the past two weeks was posted to a different location of the WHO website here [pdf]. A working group was set up to work on the basis of this advanced text during this week’s Assembly. From 30 March to 1 April, a meeting of the Open-Ended Intergovernmental Meeting on the draft Framework of engagement with non-State actors was organised. The outcome of the meeting was a revised version of the draft framework, according to the WHO. The document reflects discussions in the meeting, with text highlighted in green, which has been agreed upon, text in yellow on which no consensus was found, and text in grey, which is the chairperson’s proposal for compromise language. The WHA is invited to note the report and provide guidance on the revised draft framework. Main issues remaining in the draft framework include the management of conflicts of interest, with several options. One is that member states may have access to the full documentation related to each engagement with non-state actors, and may ask WHO for clarification on the assessment. Another issue is due diligence and risk assessment to be carried out by WHO, as well as risk management. Member states submitted textual proposals on the draft framework after the January session of the WHO Executive Board meeting, which were considered by the Open-ended Intergovernmental Meeting on the draft framework in March. Budget This is a budget year. The WHA is expected to undertake the mid-term review of the implementation and financing of programme budget 2014-2015, and consider the proposed programme budget 2016-2017. The proposed programme budget foresees three strategic shifts: the strengthening of core capacities in “preparedness, surveillance and response, in order to prevent, detect and respond to disease outbreaks,” such as Ebola. The second shift is “the response to the post-2015 agenda, with a focus on universal health coverage,” and the third is to “tackle emerging threats and priorities, such as antimicrobial resistance, hepatitis, ageing and dementia.” The 2016-2017 proposed budget “amounts to nearly US$4,400 million overall.” The “base” budget has increased by US$ 236.6 million for the biennium, an 8 percent increase over the 2014-2015 biennium. WHO Director General Margaret Chan proposed “a 5% increase of assessed contributions, which will contribute an additional US$ 47 million over the biennium, as part of the overall 8% increase.” The draft resolution [pdf] foresees a budget allocation for the financial period 2016-2017 as follows: communicable diseases US$765 million; non communicable diseases US$340 million; promoting health through the life course US$382 million; health systems US$594 million; preparedness, surveillance and response US$380 million; and enabling functions/corporate services US$734 million. Some US$986 million would be devoted to polio, tropical disease research, and research in human reproduction, and US$204 million would go to outbreak and crisis response. Substandard/Fake Medical Products Following its third meeting, the member state mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC), which met in Geneva from 29-31 October 2014, asked that the review of the mechanism [pdf] be postponed by one year, until 2017. The request was made at the WHO Executive Board meeting in January, which agreed. Annex 2 of the document contains activities on which no consensus could be achieved at the October meeting (IPW, WHO, 30 January 2015), in particular the issue of in-transit medical products. Financing R&D for Neglected Diseases The WHA is expected to consider the Follow-up of the report [pdf] of the Consultative Expert Working Group on Research and Development: Financing and Coordination, as well as the Health research and development demonstration projects [pdf]. In decision WHA67(15), the WHA last year requested the WHO Director General “to further explore with the UNICEF/UNDP [United Nations Development Programme]/World Bank/WHO Special Programme for Research and Training in Tropical Diseases the possibility of hosting a pooled fund for voluntary contributions towards research and development for type III and type II diseases and the specific research and development needs of developing countries in relation to type I diseases.” According to the WHO, Type I diseases are “incident in both rich and poor countries, with large numbers of vulnerable populations in each;” Type II diseases are “incident in both rich and poor countries, but with a substantial proportion of the cases in poor countries;” and Type III diseases are “those that are overwhelmingly or exclusively incident in developing countries.” The report to be considered by the WHA this year describes the establishment of the fund, its relationship with the Global Health Research and Development Observatory, and the future coordination mechanism. Global Strategy and Plan of Action on Public Health, Innovation and IP The extension of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA) is expected to be discussed at the WHA. In January, the Executive Board agreed to an extension of the GSPA until 2022, and an extension of an overall programme review until 2018 (IPW, WHO, 3 February 2015). The Executive Board recommended that the WHA confirm its decision. Progress Reports, Other Issues Pandemic Flu Also on the agenda are progress reports [pdf] on a variety of topics, including the pandemic influenza preparedness: sharing of influenza viruses, and access to vaccines and other benefits. The report includes: global influenza vaccine production capacity, agreements with industry, and the use of Use of the Partnership Contribution. The report notes that “for 2013, WHO received contributions from manufacturers of over US$ 27.2 million; by 31 December 2014, nearly US$ 15 million had been received against 2014 contributions.” Non-Communicable Diseases (NCDs) Another issue of enormous significance to WHO is non-communicable diseases (NCDs), which include cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. It was not clear at deadline how the work of the WHA would address these in terms of issues of relevance to Intellectual Property Watch. Separately, there will be many side events led by NGOs, industry, and others during the WHA. If the calendar of these events becomes available from WHO, it will be posted here. William New contributed to this report. 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