Guide To The WHO Executive Board: Access To Medicines, Noncommunicable Diseases, Non-State Actors 15/01/2018 by Catherine Saez, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)The World Health Organization Executive Board meets next week. On the agenda are recommendations of a review group on the WHO Global Strategy on Public Health, Innovation and Intellectual Property, and WHO proposed actions to increase access to affordable and safe medicines and diagnosis. The Executive Board is also expected to consider a report on noncommunicable diseases, new possible organisations to enter into official relationships with WHO, and how to address the global burden of snakebites, including access to treatment. WHO Executive Board meeting last year One of the two governing bodies of the organisation, the January Executive Board meeting prepares the annual World Health Assembly held in May and forwards decisions to the Assembly to be adopted. The 142nd WHO Executive Board (EB) meeting will take place from 22-27 January. The Board is composed of 34 rotating member states of the WHO. The annotated agenda for next week is here [pdf], and the preliminary daily timetable is here [pdf] On 5 January, the WHO issued the edited version of the draft 13th WHO general programme of work [pdf] for 2019-2023. The EB is expected to consider it before it goes to the World Health Assembly (WHA) (IPW, WHO, 08 January 2018). The EB is expected to take note of a report [pdf] on a strategy and implementation plan for “value for money” in WHO, and provide further guidance. According to the EB document, value for money requires a combination of three key dimensions: economy (keeping inputs as lean as possible); efficiency (using those inputs to obtain or “buy” as much output as possible); and effectiveness (keeping the quality of the Organisation’s output as high as possible, in order to have the greatest possible impact). The WHO conducted a mapping of current practices in other multilateral organisations, both within and outside the United Nations system, and found that all the organisations had incorporated value-for-money principles to varying extents, according to the document. The mapping also revealed that there was no “off-the-shelf” solution that could be directly imported to WHO, but shed light on elements and initiatives that could be considered, the secretariat said. The document concluded that rather than introducing complex processes, the WHO should focus on building on existing value-for-money practices and recent achievements. Annex 1 of the document includes an implementation plan, and guiding principles can be found in Annex 2. Access to Medicines, Fair Pricing, and UN High-Level Panel After several countries, including Brazil and India, asked that the issue of access to medicines be included in the WHO governing bodies meeting agenda, it was decided that this issue would be coupled with the global shortage of medicines and vaccines. The WHO issued a report [pdf] last week addressing both issues. According to the document, the report is based on a review of WHO reports, and of other United Nations bodies, including the report of the 2016 UN Secretary General’s High-Level Panel on Access to Medicines, and work carried out by partners and non-state actors in relation with the WHO. The report includes a section on access to essential medicines and vaccines (Appendix 1), along with a review of the recommendations of the High-Level Panel report and WHO’s activities in the area of access to medicines (Appendix 3). Appendix 3 lists recommendations of the High-Level Panel addressed to several organisations, and entities, such as the World Trade Organization, WHO, governments, industry, and universities, and pairs them with actions undertaken by the WHO in relation to those recommendations. The WHO, said the report, should prioritise and invest in areas in which the global health organisation has an advantage compared with other organisations. After undertaking a review of major challenges to ensuring access to safe, effective and quality medicines and vaccines, and analysed progress made to take, the WHO identified actions which could be prioritised. Those actions include the facilitation of development of political will at the national and regional levels to ensure the affordability and availability of safe, effective and quality medical products through effective regulation and policy implementation, in particular the implementation of pricing and financing policies encouraging fair pricing. The actions also include the support of the expansion of the Medicines Patent Pool to include all patented medicines on the WHO Model List of Essential Medicines and antimicrobial medicines; and capacity building for the proper implementation of intellectual property laws that are in line with the TRIPS, and that make adequate use of its flexibilities. The report also says that scaling up certain activities could have a potentially high impact on access to medicines. These include: supporting development and implementation of systems at the national level for collecting and monitoring key data on medicines and vaccines, such as availability, price, and safety; and the development of policies promoting transparency throughout the value chain, including public disclosure of clinical trial data, R&D and production costs, and procurement prices and procedures. Those actions may involve greater complexity and require additional resources, according to the report. Some other actions, such as tackling undue influence and corruption in the pharmaceutical system, in particular in procurement and supply chain management, and facilitating discussion on unifying principles for biomedical research and development, would have a potentially high impact but are “highly complex and require significant additional resources,” the report says. The EB is invited to note the report, and consider the priorities and strategic direction. Review of GSPA-PHI, Tech Transfer, IP The EB is expected to consider a report of a panel of experts which reviewed the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPA-PHI, or GSPOA). The review panel, composed of 18 experts, issued its report [pdf] in November. According to the EB document [pdf], the 2015 WHA requested the WHO to establish the panel to review the global strategy as a complement to the comprehensive evaluation done by the secretariat. The experts were asked to provide a more “policy-oriented, forward-looking exercise” than the evaluation. The experts found that “while there have been some positive developments since 2008, the fundamental concerns that justified the development of the GSPA-PHI remain.” Research and development (R&D) is not sufficiently directed at health products for diseases that mainly affect developing countries, and R&D resources have not sustainably increased, they said. Lack of access to health products “remains an acute problem for millions of people, in spite of considerable achievements in some areas such as expanding treatment coverage for HIV,” the report said. New treatments, in particular cancer or hepatitis treatments, “can be prohibitively expensive, even in relation to the resources available in developed countries,” the report notes, adding that some new drugs do not show significant benefits to survival or quality of life, putting into question the need for a “more appropriate balance between R&D versus marketing investments.” Since 2008, the report explains, “there has been concern in both developed and developing countries about the price of new patented medicines and, in some cases, also of medicines whose patents have expired.” “While there are many new medicines to treat cancer, most cost over US$100,000 per treatment, and treatments for some rare diseases cost US$500,000 per year.” The 108 action points of the GSPA-PHI are too many and lack precision, according to the experts, and too little effort has been devoted by all stakeholders to implement them. The report notes a lack of comprehensive data on access to medicines and other health products in developing countries, adding that improved access relies on several factors, including effective regulation, public health-oriented IP and trade policies, pricing and reimbursement policies, and integrity and efficiency in procurement and supply. In the area of IP, the report says, the flexibilities of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) “should be properly incorporated into local legislation.” The report underlined the lack of transparency on the cost of R&D and manufacturing and said one fundamental issue is the lack of negotiating power of developing countries and in particular middle-income countries to secure affordable prices. That lack of transparency makes it difficult for purchases to determine a “fair price” striking the right balance between a reasonable return on investment and affordability, it said. One of the means of addressing pricing, according to the experts, is health technology assessment (HTA), “which can provide evidence on the relation between health benefits and cost, whether products should be purchased or whether they might be purchased if the price were lowered.” HTA has been successfully used in several developed countries, but is more difficult to apply in developing countries for lack of clinical and economic expertise, they said. They also advised joint or pooled procurement at national, regional and global levels, but said procurement strategies are hindered by supply chain challenges in developing countries, such as unreliable transport, inadequate storage, and lack of appropriately trained workforce for supply chain management. The experts provided a list of recommendations, including the prioritization of R&D needs, the promotion of R&D, research capacity building, transfer of technology, the management of IP to contribute to innovation and public health, promoting sustainable financing mechanism, and the establishment of a monitoring and accountability mechanism. In the suggestions to promote sustainable financing mechanisms, the experts recommended that member states encourage the implementation of schemes that partially or wholly delink product prices from R&D costs. Knowledge Ecology International issued an analysis of the GSPA-PHI today. The EB is asked to note the report and consider a draft decision [pdf], asking the WHO to take forward the recommendations of the review panel, and report on progress at the 2020 WHA. Global Vaccine Action Plan In 2017, an assessment of the WHO Global Vaccine Action Plan was carried out by a group of experts on immunization, which gave a number of recommendations. The report of the group of experts is in Annex 1 of the EB document [pdf]. Although some progress was made towards the goals set out in the Global Vaccine Action Plan in 2016, the experts found, progress remains too slow for most goals to be reached at the end of the Decade of Vaccines in 2020. The Board is expected to consider the recommendations of the Strategic Advisory Group of Experts on immunisation. The group recommended in particular that WHO regional offices and UNICEF work with countries to identify and systemically address procurement and other programmatic issues affecting vaccine access, and that WHO regional offices should work with regional and global partners to support national technical capacity-building. Pandemic Influenza Preparedness Contributions Sharing The Board is expected to consider a decision on the use of the monetary contribution of industry for the use of the WHO Global Influenza Surveillance and Response System (GISRS), made through the Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza viruses and access to vaccines and other benefits. According to the EB document [pdf], for the period 2012-2016, approximately 70 percent of the contributions should be used for pandemic preparedness measures, with approximately 30 percent reserved for response activities. This repartition was extended to 28 February 2018. The PIP Framework Advisory Group discussed the proportional division of contributions for the period 2018-2022 at its latest meeting, from 8-10 November, and concluded that most of the contributions should continue to be used for pandemic preparedness measures, the document says. The Board is invited to approve the continuation of the proportional division of contributions as it stands from 2018-2022. However, the director general “shall continue to be able to modify temporarily the allocation of Partnership Contribution resources as required to respond to said emergencies,” the draft decision says. The division shall be reviewed again in 2022, it said. Non-Communicable Diseases In preparation of the third High-level Meeting of the United Nations General Assembly on the Prevention and Control of Non-Communicable Diseases, to be held in 2018, the WHO prepared a report [pdf] on the current situation. The EB is asked to note the report. According to the report, “the global epidemic of premature deaths form noncommunicable diseases” is driven by several factors, including poverty leading to lack of access to affordable medicines; the impact of the globalisation of marketing and trade of products “deleterious to health,” such as tobacco, and unhealthy diets; and population ageing. The report listed a number of obstacles in the way of the implementation of recommended interventions for the prevention and control of noncommunicable diseases in five main categories: weakness of health systems, including the lack of access to affordable, safe, effective, and good quality essential medicines and vaccines; political choices; national capacities; international finance; and industry interference. In October, the WHO director general established an Independent High-level global Commission on Nonommunicable Diseases, to make recommendations for the preparatory process leading to the third High-level Meeting of the General Assembly. According to the EB document, the commission “intends to submit its first report to the Director General in May 2018.” The WHO also organised a Global Conference on Noncommunicable Diseases in Montevideo (Uruguay) from 18-20 October. According to the EB document, member states committed themselves to the “Montevideo Roadmap 2018-2030 [pdf] on Noncommunicable Diseases as a Sustainable Development Priority.” The EB is invited to note the report. Implementation of the International Health Regulations (2005) Following a request made at the last WHA in May 2017, the WHO secretariat developed a draft five-year global strategic plan [pdf] to improve public health preparedness and response. The EB is expected to consider the strategic plan and the proposed draft decision. The draft strategic plan is based includes the following guiding principles: consultation; country ownership and leadership; WHO’s leadership and governance; broad partnerships; intersectoral approach; integration with the health system; community involvement; and domestic financing. According to document, the strategic plan presents the WHO’s approach to strengthening member states’ ability to implement the core capacities required under the International Health Regulations (IHR) (2005) “as a legally binding obligation and the means to ensure national and global preparedness and response to public health events, including emergencies.” The draft decision asks that the WHA endorses the five-year global strategic plan, and that the WHO provides the necessary financial and human resources to support the implementation of the plan. It also asks that the WHO continues to provide support to countries to build, maintain and strengthen core capacities under the IHR. Engagement with Non-State Actors, Some In, Some Out In 2016, the WHO agreed on a Framework of Engagement with Non-State Actors (FENSA) in order to answer to concerns of undue influence of actors interacting with the WHO, such as the industry, civil society, philanthropic organisations, and academia. The second annual report on FENSA [pdf] to be presented to the Board next week says a number of milestones have already been achieved, as implementation started immediately after FENSA was adopted in May 2016. A separate EB document [pdf] proposed a number of actions on potential new non-state actors to be in official relations with WHO, such as Childhood Cancer International, Médecins du Monde, PATH, the Wellcome Trust, and the United States Pharmacopeia Convention. The document also suggests deferring decision to the 144th EB for some organisations, such as CropLife International, the International Agency for the Prevention of Blindness, the International Eye Foundation, and the World Blind Union. The Board will have to consider the proposed discontinued relations with four organisations: the European Centre for Ecotoxicology and Toxicology of Chemicals, the Foundation for Innovative New Diagnostics; and the International Federation of Business and Professional Women; and Rehabilitation International. Global Snakebite Burden a Newcomer The WHO included snakebite envenoming in the list of neglected tropical diseases in June 2017. According to the WHO report [pdf] on the global snake bite burden, presented to the EB, recent analysis based on available data estimates that between 81,000 and 138,000 people die from snakebite envenoming, resulting from 1.8 to 2.7 million cases of snakebite envenoming. Surviving victims of snakebites, which are mainly from developing countries, are pushed further into poverty because of the high cost of treatments, and loss of income, according to the report, which adds that in sub-Saharan Africa in 2010 and 2011 the direct cost of antivenom ranged from US$55 to US$640. In India, the report says, the cost of initial treatment in 2010 was reported to be as high as US$5,150, with an additional US$5.890 in long-term costs. Elaborating a public health strategy for the prevention and control of snakebite envenoming “will require significant investment in a multifocal reduction and control strategy, so that cost-effective prevention, diagnosis, early treatment and case management can be practiced in low-resource settings,” the report says. The EB is invited to note the report and provide further guidance on the issue. 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