Special Report: Guide To This Week’s WHO Board Meeting – Budget, Medicines Access, Antimicrobial Resistance, NCDs, More

The World Health Organization Executive Board this month will consider an 8 percent WHO budget increase for 2020-2021, discuss environment health risks, the high price of cancer drugs, and how to facilitate access to medicines and vaccines. Also on the agenda is the fight against antimicrobial resistance, rising noncommunicable diseases, and tuberculosis.

In another area, the Board is also expected to discuss its pandemic influenza framework, in particular access to influenza viruses 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 Board will further be asked to consider new entities seeking to enter into official relationships with the WHO, and those with whom relations should be discontinued.

The 144^th session of the WHO Executive Board (EB) is taking place from 24 January – 1 February. The EB is composed of 34 members elected for three-year term. The Board is one of the governing bodies of the organisation and most decisions are prepared and pre-approved ahead of the May World Health Assembly.

The annotated agenda is here [pdf]. All the documents for the 144^th session are here.

Proposed Programme Budget 2020/2021

Among the many items on the 144^th session agenda, member states are expected to consider a draft proposed biennial programme budget for 2020-2021 that represents an increase of about 8 percent over 2018-2019.

According to the meeting document [pdf], the total proposed budget amounts to US$ 4.785 billion, including US$ 3.987 billion for base programmes, and US$ 798 million for the polio eradication programme., according to the document.

“The draft Proposed programme budget 2020–2021 marks a major step forward in the transformation of WHO,” the document states. “It aims to turn the bold vision of the Thirteenth General Programme of Work, 2019–2023 (GPW 13) into reality,” it states.

GPW 13 seeks to achieve three strategic priorities through “the triple billion targets”: 1 billion more people benefiting from universal health coverage; 1 billion more people better protected from health emergencies; and 1 billion more people enjoying better health and well-being.

The base component of the proposed 2020-2021 budget has increased by 13 percent compared to 2018-2019, “reflecting the need for strategic investment in several major areas in line with the objectives of GPW13.” Those objectives include the strengthening of WHO’s capacity to deliver at the country level, and increased investment for polio transition.

The Polio Oversight Board approved a new five-year strategy for the period 2019-2023 to achieve global certification of eradication of wild poliovirus, the document says.

The draft budget will be amended based on member states’ comments during the EB.

Along with the draft proposed programme budget, a three-level Impact Framework [pdf] has been developed, and a strategy and implementation plan for value for money established. A meeting document [pdf] provides the current status of initiatives of the strategy and implementation plan.

Health, Environment and Climate Change

WHO Director General Tedros Adhanom Ghebreyesus (Dr Tedros) is expected to present a draft comprehensive global strategy [pdf] on health, environment and climate change.

According to the meeting document, “environmental risks to health, in the framework of this strategy, are defined as all the physical, chemical, biological and work-related factors external to a person, and all related behaviours, but excluding those natural environments that cannot reasonably be modified.”

Known avoidable environmental risks cause about one quarter of all deaths and disease burden worldwide, the document says, “amounting to at least a steady 13 million deaths each year.” Air pollution, for example, is responsible for seven million preventable deaths each year.

Gaps in institutional capacities for health protection through legislation, management of chemical and other hazards, persist, the document says, adding that new environmental, climatic, and health issues are emerging and “require rapid identification and response.” Examples provided in the document include electronic waste, nanoparticles, microplastics, and endocrine-disrupting chemicals.

An estimated 10 percent of global gross domestic product is being spent on health care, according to the WHO, “but very little goes to prevention.”

According to the document, strategic objectives include: primary prevention, strengthened health sectors, enhanced evidence and communication, and monitoring.

Access to Medicines and Vaccines

The WHO was requested by the 71^st WHA in May 2018 to elaborate a roadmap report, outlining the programming of WHO’s work on access to medicines and vaccines for the period 2019-2013. The Board is invited to consider the draft roadmap and provide further guidance.

According to the meeting document [pdf], “access is a global concern, given the high prices of new pharmaceuticals and rapidly changing markets for health products.”

The roadmap prepared by the WHO outlines the principles of WHO’s work on access to health products, and is structured around two interlinked strategic areas: ensuring the quality, safety and efficacy of health products; and improving equitable access to health products.

The document stresses the importance of unbiased and transparent information, and says activities in the roadmap address the transparency of clinical trials and price transparency through the Market Information for Access to Vaccines (MI⁴A).

“The relationship between government and the private sector, such as pharmaceutical companies and medical device companies, requires particular attention,” the document says, adding that a “question of growing importance is how to support governments to work effectively with the private sector and develop public policy while avoiding the risks of undue influence and maximizing benefits.”

The WHO is working to develop a list of indicators across all areas involved in improving access to quality health products, the document says.

Challenges for improving access occur throughout the system, according to the WHO “ranging from inadequate investment in research and development, lack of effective policies, weak procurement and supply chain management, and inappropriate prescribing and irrational use of health products.” The document also notes that research and development investments in neglected diseases have shown an annual decline of 2 to 3 percent from 2012.

Local production, which has been suggested as a strategy to improve access, meets a number of barriers such as policy incoherence, unreliable financing, lack of affordable, quality-assured materials, and unavailable skilled workforce, the document says.

Another activity area for the WHO is supporting countries by “fostering innovation and access to health products through appropriate intellectual property rules and management and by providing technical support and capacity-building.”

The WHO is set to support countries for appropriate selection of medicines, vaccines, diagnostics and other health products, transparent and fair pricing, and implementation of policies to reduce costs to both governments and individuals while ensuring quality, safety and efficacy and sustainable supply.

The WHO will continue to engage with donors, academia, civil society, and the private sector for better access, according to the document.

Access to Cancer Medicines

In December, the WHO published a Technical report [pdf] on Pricing of cancer medicines and its impacts (Health Policy Watch, WHO, 27 November 2018). The EB next week is expected to note the report.

According to the EB meeting document [pdf], providing a summary of the report, “Data from multiple sources show that the rate of growth of expenditure on cancer medicines greatly exceeds the rate of growth of newly diagnosed cancer cases.” Existing approaches to managing the prices of cancer medicines have not been conclusive, with prices of cancer medicines on a rising slope, and stakeholders continue to voice concerns about the lack of adequate access to both new and off-patent essential cancer medicines, which high prices cited as the main culprit, the report says.

The report also points out the marginal benefits of some newer cancer medicines and their high rates of toxicity, calling for a comprehensive evaluation of all evidence. Experts, the report states, have noted significant inefficiencies of cancer drug trials due to duplication of research efforts “and the pursuit of marginal therapeutic indications with non-clinically significant health outcomes.”

The report found that four broad determinants of medicine prices are used by industry: (a) costs of research and development; (b) costs of production and commercialization; (c) the “value” of medicine; and (d) sufficient returns on research and development. The report underlined the lack of transparency of R&D cost for cancer medicines, and that estimating a value of medicine depends on different technical approaches, incomplete evidence, and a different perception of value.

According to the report, a set of options might enhance affordability and accessibility of cancer medicines, including strengthening pricing policies at the national and regional levels; improving the efficiency of expenditure on cancer medicines; improving the efficiency of expenditure on cancer medicines; and realignment of incentives for R&D.

Universal Health Coverage

The meeting document [pdf] mentions the Global Conference on Primary Health Care, co-organised by the WHO, UNICEF and the government of Kazakhstan, which took place in October in Astana, during which the Declaration of Astana was adopted. The Declaration of Astana reaffirms the commitments expressed in the Declaration of Alma-Ata of 1978 and the 2030 Agenda for Sustainable Development.

The meeting document underlines the progress made in improving health and well-being over the past 40 years, but also that progress has been uneven across and within countries. There has been a “dramatic shift in the global patterns of disease and demographics,” the document says, adding that across all countries, the proportion of disability-adjusted life years lost to noncommunicable diseases grew from 47 to 60 percent between 2000 and 2016, with the fastest increases in low and middle-income countries.

According to another meeting document [pdf] focusing on the preparation for the high-level meeting of the UN General Assembly on universal health coverage, a least half the world’s population still lacks access to essential health services, some 800 million people spend more than 10 percent of their household budget on health care, and almost 100 million people are pushed into extreme poverty each year because of out-of-pocket health expenses.

The document includes the scope, modalities, format and organisation of the high-level meeting on universal health coverage due to take place in 2019 after a UN General Assembly resolution (72/139).

The overall theme of the high-level meeting will be “Universal health coverage: Moving together to build a healthier world, and it is scheduled to take place in New York, on the day before the opening of the general debate of the 74^th session of the UN General Assembly. The high-level meeting is expected to approve “a concise and action-oriented political declaration, agreed in advance by consensus through intergovernmental negotiations.”

Antimicrobial Resistance

The meeting document [pdf] provides an update on the implementation of the 2015 WHO global action plan on antimicrobial resistance and the 2016 UN General Assembly political declaration on the high-level meeting of the General Assembly on antimicrobial resistance.

According to the document, member states have developed and started implementing their national action plan for combating antimicrobial resistance, based on guidance and tools developed by WHO, the UN Food and Agriculture Organisation (FAO), and the World Organization for Animal Health (OIE).

The EB is invited to note the report and provide guidance on how to move forward with the global development and stewardship framework, how to accelerate member states’ implementation of national actions plans, and on how to strengthen linkages at country level between plans for combatting antimicrobial resistance and plans for universal health coverage, health security, and multisectoral action.

The meeting document notes that as of July 2018, 68 countries (10 low-income countries, 16 lower-middle-income countries, 15 upper-middle-income countries, and 27 high-income countries) provided data to the WHO Global Antimicrobial Resistance Surveillance Systems (GLASS), launched in October 2015. At the end of its initial phase (2015-2019) GLASS will be revised with new targets and datasets, the document says.

According to the document, the Global Antibiotic Research and Development Partnership (GARDP), a joint initiative of WHO and the Drugs for Neglected Diseases Initiative (DNDi), has “launched programmes addressing sepsis in newborns through an observational study in 11 countries and a partnership to develop a new first-in-class treatment for drug-resistant gonorrhoea that is entering clinical phase.”

A memorandum of understanding was signed in May 2018 between WHO, FAO, and OIE and a joint tripartite work plan was elaborated for 2019-2020, which focuses on five areas and 20 specific outputs, the document says.

Prevention and Control of Non-Communicable Diseases

The EB is also expected to note a report [pdf] on the outcome of the third High-level Meeting of the UN General Assembly on the Prevention and Control of Non-communicable Diseases and its follow-up. A Political Declaration was adopted during the high-level meeting in October.

The political declaration in particular recognises that “action to realize the commitments made for the prevention and control of non-communicable diseases is inadequate and that the level of progress and investment to date is insufficient to meet target 3.4 of the Sustainable Development Goals.”

The declaration includes 14 new commitments, and broadens the scope of the commitments from the four major non-communicable diseases (NCDs) (cardiovascular, cancer, chronic respiratory disease, and diabetes) and four main risk factors (tobacco use, unhealthy diets, physical inactivity, and harmful use of alcohol) to include commitments to reduce air pollution and promote mental health and well-being. A first Global Conference on Air Pollution and Health was convened on 29 October-1 November.

The WHO will develop a delivery plan to meet “the rapidly increasing demand for technical assistance,” according to the report. Every six months, the WHO will convene dialogues with representatives from international business associations representing the food and non-alcoholic beverage industries; pharmaceutical industries; economic operators in the area of alcohol production and trade; and sports industries, the report states.

Also for EB delegates to consider is a proposed work plan [pdf] for the global coordination mechanism on the prevention and control of non-communicable diseases for 2020, which is expected to be noted by the Board. The proposed work plan includes strategic priorities, including fostering multi-stakeholder collaboration, partnerships and accountability; piloting capacity-building approaches with a view to developing a technical package on how to establish or strengthen national multi-stakeholder dialogue mechanisms for non-communicable diseases while giving due regard to managing conflicts of interest.

Ending Tuberculosis

According to the EB meeting document [pdf] on ending tuberculosis, expected to be noted, tuberculosis is the leading cause of death worldwide from a single infectious agent, and the leading cause of death of people with HIV infection, as well as death due to antimicrobial-resistant infections.

The first high-level meeting of the General Assembly on the fight against tuberculosis, convened by the President of the UN General Assembly, was held on 26 September 2018, and resulted in an action-oriented political declaration on 10 October. The declaration “reaffirms commitment to meet the targets for 2030 set for ending tuberculosis under the Sustainable Development Goals and in the End TB Strategy.”

Among actions carried out by the WHO, the organisation will continue the development of a global strategy for tuberculosis research and innovation and a roadmap for the development of the strategy has been prepared, according to the meeting document.

Pandemic Influenza Preparedness

The EB report on the Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza viruses and access to vaccines and other benefits details the implementation of the high-level Partnership Contribution Implementation Plan 2018-2023. The Partnership Contribution is paid by industry to the WHO for accessing influenza virus with pandemic potential from the WHO global influenza surveillance and response system (GISRS).

In the biennium 2018-2019, some US$31 million is being used to strengthen capacities in 72 countries, and support regional and global preparedness and response capacity-building, according to the report.

The document also reports on issues raised by the 2016 PIP Framework Review Group’s recommendations. Two main issues were at stake: whether to include seasonal influenza in the PIP Framework, and how to deal with influenza virus sequences. Another issue was the public health implication of the implementation of the Nagoya Protocol. Among the recommendations of the review group was a suggestion that the PIP Framework be considered as an access and benefit-sharing specialised instrument under the Nagoya Protocol.

According to the document, in September, the WHO published a draft analysis on those issues. In October, a consultation was held to receive views on the draft analysis, the document says.

During the consultation, participants underlined the fact that the discussions within the Nagoya Protocol on the criteria and process for recognising specialised international access and benefit-sharing instrument was slow, and until the outcomes of this process are known, it may be difficult to identify or develop the best approach to the sharing of seasonal influenza viruses.

According to the document, participants found that the PIP Framework should not be expanded to seasonal influenza at this time. On genetic sequence data (virus genetic information), the WHO agreed on a recommendation by the PIP Advisory Group to amend language of a footnote (1 of Annex 2) of the PIP Framework, to address “a loophole that has arisen in connection with indirect use of PIP biological materials by companies with the result that they do not provide fair and equitable benefit sharing for the use” of those materials.

The Board is invited to note the report and consider a draft decision asking the WHO to work with GISRS and other partners to address the challenges related to the sharing of seasonal influenza viruses that have emerged as countries implement the Nagoya Protocol, and to monitor instances where the implementation of the Nagoya Protocol may be affecting the sharing of seasonal influenza viruses.

The draft decision also requests the WHO to “to assess the utility of the prototype search engine developed to identify products that potentially have made use of genetic sequence data of influenza viruses with pandemic potential and have not been subject to the benefit-sharing system,” and to amend footnote 1 in the Standard Material Transfer Agreement 2, in Annex 2.

Substandard and Falsified Medical Products

An EB document [pdf] reports on the 6^th and 7^th meetings of the Member State mechanism on substandard and falsified medical products. The 6^th meeting took place from 30 November to 1 December 2017, and the 7^th meeting from 29-30 November 2018. The proposed date of the 8^th meeting of the mechanism is during the week of 21 October 2019.

During those meetings updates on the implementation of the agreed list of prioritised activities for the period 2016-2017 were discussed, and a new list of prioritised activities for the period 2018-2019 was agreed, according to the document.

Engagement with Non-State Actors

The WHO Framework of Engagement with Non-State Actors (FENSA) [pdf] was adopted in 2016. According to the EB meeting document [pdf] on FENSA implementation, “the Register of non-State actors now contains profiles of all non-State actors in official relations, WHO’s engagements, and the collaboration plans and annual reports of non-State actors in official relations.”

“The more systematic assessment of engagements under the Framework has, however, brought to the surface several implementation challenges that need to be tackled. For example, with respect to the requirement that non-State actors confirm that they have no engagement with the tobacco industry and that their activities do not further that industry’s interests, it has proven difficult to come up with a consistent definition of how broadly “furthering the interests” should be interpreted.,” the document says.

The EB is expected to approve applications which have been approved by WHO, those the WHO has suggested deferring the decision to 2020, and institutions with which the WHO suggests discontinuing relations. The WHO recommended the EB renew official relations for 71 of the 79 non-State actors (list in annex 2 of the EB meeting document [pdf]).

Entities for which the WHO recommends the applications be accepted: The Albert B. Sabin Vaccine Institute, Inc., the International League of Dermatological Societies, the Royal National Lifeboat Institution, the Task Force for Global Health, United Nations Foundation, Inc., Women Deliver, Inc., and World Federation of Nuclear Medicine and Biology.

The WHO suggested deferral to 2020 of the decision on the following entities: Commonwealth Pharmacists Association, CropLife International, Global Health Council, and Save the Children.

According to the document, relations should be discontinued with the four following non-state actors: International Catholic Committee of Nurses and Medico-Social Assistants, International Eye Foundation, International Organization for Standardization, and International Union of Microbiological Societies.

WHO Health Emergencies Programme

The Board also is expected to consider the report [pdf] of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme. The report provides observations and recommendations based on its review of WHO’s work in major outbreaks and other health emergencies during the period from May to December 2018.

According to the report, “The recent Ebola outbreaks in the Democratic Republic of the Congo provinces of Equateur and later of North Kivu have demonstrated that WHO’s health emergency management reforms have had significant positive impact.”

 

Image Credits: Flickr – Elaine Smith