The 146th session of the World Health Organization’s (WHO) Executive Board will take place from 3 February 2020 to 8 February 2020 in Geneva, Switzerland. Rule 8 of the Rules of Procedure of the Executive Board of the World Health Organization dictate the following:
The Director-General shall draw up a draft provisional agenda for each session of the Board, which shall be circulated to Member States and Associate Members within four weeks after the closure of its previous session.
Any proposal for the inclusion on the agenda of any item under (c), (d) and (e) of Rule 9 shall reach the Director-General not later than 12 weeks after circulation of the draft provisional agenda or 10 weeks before commencement of the session, whichever is earlier.
The provisional agenda of each session shall be drawn up by the Director-General in consultation with the Officers of the Board, on the basis of the draft provisional agenda and any proposals received under the second paragraph of this Rule.
Where the Director-General and the Officers find it necessary to recommend the deferral or exclusion of proposals received under the second paragraph of this Rule, the provisional agenda shall contain an explanation for such recommendation.
An annotated provisional agenda, together with any recommendations referred to in the fourth paragraph of this Rule shall be dispatched with the notice of convocation to be sent in accordance with Rule 5 or Rule 6, as the case may be.
Pursuant to Rule 8, WHO convened a meeting in Manila on 5 October 2019 to 6 October 2019 between the WHO Director-General and the Officers of the Board. Participants included the Director-General (Tedros Adhanom Ghebreyesus) and Dr Hiroki Nakatani (Japan) Chairman of the Board, Dr Anil Jasinghe (Sri Lanka) for Vice-Chairman of the Board, Dr Päivi Sillanaukee (Finland) Vice-Chairman of the Board, Dr Codjo Didier Agossadou (Benin) Vice-Chairman of the Board,, Mr Colin McIff (United States of America) for Rapporteur, Mr Björn Kümmel (Germany), Chairman of the Programme, Budget and Administration Committee of the Executive Board, and Mr Nilo Dytz Filho (Brazil) Vice-Chairman of the Programme, Budget and Administration Committee of the Executive Board.
The Director-General and Björn Kümmel participated by teleconference on 5 October 2019; Colin McIff participated by teleconference on 5 October 2019 and 6 October 2019. Observers included Ms Outi Kuivasniemi (Finland), Dr Hiroshi Matsumura (Japan), Dr Sathasivam Sridharan (Sri Lanka), and Ms Gabrielle Lamourelle (United States of America). The members of the Secretariat who participated included: Dr Zsuzsanna Jakab, Deputy Director-General (on 5 October, by teleconference), Mr Bernhard Schwartlander, Chef de Cabinet (on 5 October, by teleconference), Ms Jane Ellison, Executive Director, External Relations and Governance, Dr Timothy Armstrong, Director GBS (on 5 October, by teleconference), Mr Nicolas Ashforth, Senior Editor, GBS, Mr Issa Matta, Senior Legal Officer, Ms Gina Vea, External Relations Officer, GBS, and Ms Laurence Vercammen, Protocol Assistant, GBS (on 5 October, by teleconference).
The purpose of this meeting was to review the “draft provisional agenda of the 146th session of the Board to be held in February 2020, in accordance with Rule 8 of the Rules of Procedure of the Executive Board.” The eight page Note for the Record 2019 is a comprehensive record of this meeting; prior to Dr. Tedros’s tenure as Director-General, the WHO secretariat did not circulate Notes for the Record to the general public.
On 17 September 2019, South Africa submitted a proposal for inclusion at the 146th session of the Executive Board entitled, “Expanding access to effective medical treatments for cancer, including drugs, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies, and other health technologies.” South Africa provided the following rationale for inclusion of its proposal:
(1) assess the progress toward the implementation of WHA70.12, Cancer prevention and control in the context of an integrated approach,
(2) invite a discussion of the development of and access to new cell and gene therapy technologies, and the response of the global community to the apparent severe inequality of access to such technologies, and
(3) to discuss the role of the public sector and charities in funding research for new cell and gene therapies, and measures to promote more transparency of the licensing of intellectual property rights from public sector research, and concrete measures in licenses to address the objective of universal access.
On 18 September 2019, Peru submitted a proposal for inclusion at the 146th session of the Executive Board entitled, “Access to medicines and vaccines with emphasis on rare or orphan diseases”. Peru provided the following justification for inclusion of its proposal:
Peruvian Law 29698 enacted in June 2011 declares that the treatment of persons with rare or orphan diseases is a national interest and priority. Article 6 of the law states that the Ministry of Health shall adopt the necessary measures to ensure the procurement of medicines to treat persons with rare or orphan diseases, in accordance with current statutes and regulations.
Rare or orphan diseases including of genetic origin are those which expose the persons who live with them to the risk of death or disability. As these diseases are extremely uncommon, they are hard to diagnose and monitor. They are of unknown origin and in many cases result in multiple social problems.
Afflicting only a small number of persons, most of these diseases are of genetic origin, infrequent forms of cancer, autoimmune diseases, toxic and/or infectious diseases, congenital deformities, etc. The persons who live with them have problems getting a precise diagnosis and require highly complex health services for diagnosis and treatment, all of which tend to be scarce and costly.
The growing number of rare diseases awaiting treatment is an important public health issue because they require medicines which have also been termed “orphans”. This is because the pharmaceutical industry has little interest in developing and marketing products intended solely for a small number of patients with very rare medical conditions. A good medicine for a patient with a rare disease is an affordable medicine that is available in the country where they live.
Because these medicines are so costly, the situation around accessibility is getting worse. Even without a uniform definition, their characteristics are determined by a range of elements and procuring these medicines represents a significant charge on the public health financing system and/or out-of-pocket expenditure by families and individuals.
Therefore, with a view to treating patients with rare or orphan diseases in our countries, there is a need to establish mechanisms to register unavailable medicines and promote them, thereby giving visibility to the supply and marketing of medicines for the treatment of orphan diseases and guaranteeing their availability at health facilities.
The 2019 Note for the Record indicates that the Director-General stressed the “Executive Board’s heavy agenda, the reduced intersessional period with little time to prepare reports for the Health Assembly and the fact that the Health Assembly itself had been shortened to four-days. He told the Officers that they had the opportunity to improve the efficiency of governance processes.”
In relation the South Africa’s proposal on “Expanding access to effective medical treatments for cancer, including drugs, vaccines, medical devices, diagnostics, assistive products, cell- and gene-based therapies, and other health technologies” and Peru’s proposal on “Access to medicines and vaccines with emphasis on rare or orphan diseases”, the Officers of the Executive Board decided the following:
merge and defer to the 148th session of the Board the items proposed by the Governments of Peru and South Africa on, respectively, Access to medicines and vaccines with emphasis on rare or orphan diseases and Expanding access to effective medical treatments for cancer, including drugs, vaccines, medical devices, diagnostics, assistive products, cell-and gene-based therapies, and other health technologies
Consequently, discussions on cell and gene therapies to treat cancer will be kicked down the road to 2021 and merged with discussions on rare and orphan diseases.
The Brazilian proposal for the inclusion of an agenda item on the global strategy and plan of action public health, innovation and intellectual property was accepted by the Officers of the Board.
In relation to neglected tropical diseases, the Officers of the Board decided the following:
to accept for addition to the provisional agenda of the 146th session of the Board the item on Road map on neglected tropical diseases (NTDs) 2021–2030, proposed by the Governments of Brazil, Burkina Faso and Togo,and the item on Neglected tropical diseases: extending the strategy to 2030, proposed by the Government of the United Republic of Tanzania on behalf of the 47 Member States of the African Region, the Governments of Costa Rica, Mexico and the United States of America, and the European Union and its 28 Member States, merging them in a single standalone item on Neglected tropical diseases.
James Love, the director of Knowledge Ecology International (KEI), provided the following comment to Health Policy Watch:
The challenges of providing equal access to the new technologies are significant, and the WHO needs to engage now. That said, the deferral to the 2021 Executive Board gives everyone more time to prepare and reflect on the measures needed to address the shocking inequalities of access.