The resumed session of the 73rd session of the World Health Assembly (WHA) meets this week from 9 November 2020 to 14 November 2020. As the Republic and Canton of Geneva has imposed a lockdown since 2 November 2020, the Assembly will take place in virtual format. Earlier in May 2020, the World Health Organization (WHO) convened a shortened “de minimis” session of the WHA which focused exclusively on the COVID-19 response.
On 3 August 2020 the World Health Assembly adopted decision WHA73(11) on the global strategy and plan of action on public health, innovation and intellectual property through a written silence procedure. The resolution endeavors, inter alia, to carry forth WHO’s work on the progressive implementation of delinkage of R&D costs from the prices of and incentives to invest in products, WHO’s provision of technical assistance to Member States on the use of TRIPS flexibilities, and strengthening the expansion of the Medicines Patent Pool (MPP) to “cover other diseases or technologies where the Medicines Patent Pool model can have the most impact.” (Source: Recommendation 18, Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property, https://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_13-en.pdf).
As noted by knowledge Ecology International (KEI) in January 2018, the 140th session of the Executive Board (EB 140) witnessed contentious negotiations in relation to recommendations of the overall programme review of the global strategy and plan of action on public health, innovation, and intellectual property on the transparency of R&D costs, shortages of essential medicines, and a proposal for Member States to dedicate at least 0.01% of their gross domestic product to basic and applied research relevant to the health needs of developing countries.
It should be stressed however that recommendation 21 which asked the WHO Secretariat to provide guidance to Member States on promoting and monitoring transparency in medicine prices and on implementation of pricing and reimbursement policies met consensus.
Paragraph 2 of decision EB142(4) proposed the following modalities for the three recommendations of the expert review panel that did not meet consensus; the decision urged Member States “to further discuss the recommendations of the review panel not emanating from the global strategy and plan of action on public health, innovation and intellectual property.” (Source: EB142: KEI statement on WHO’s decision on the Global strategy and plan of action on public health, innovation and intellectual property, 26 January 2018, https://www.keionline.org/who/eb142-KEI-GSPoA). Just before the adoption of the decision, Brazil requested the Secretariat to note for the record, the three recommendations (4, 27, and 28) which fell into this category. In May 2018, WHA 71 adopted decision WHA71(9); the language of this decision matched EB142(4).
On 23 December 2019, the WHO secretariat published a progress report on its implementation of decision WHA71(9).
The WHO secretariat report proposed the following course of action:
The Board is invited to take note of the report. In its discussions, the Board is invited to:
Foonote 2 of page 7 of the WHO report EB146/15 specifically referred to Recommendations 4, 27 and 28 in the annex to document A71/13. As a reminder, the text of these recommendations read as follows.
4. Member States to support the WHO Secretariat in promoting transparency in, and understanding of, the costs of research and development. (Indicator: Reports on the costs of research and development for health products prepared in 2019 and 2021.)
27. Member States to identify essential medicines that are at risk of being in short supply and mechanisms to avoid shortages, and disseminate related information accordingly. (Indicator: Lists of medicines at risk of being in short supply and information on mechanisms for preventing shortages made available and disseminated by 2020.)
28. Member States to commit to dedicating at least 0.01% of their gross domestic product to basic and applied research relevant to the health needs of developing countries. (Indicator: Percentage of gross domestic product dedicated to basic and applied research as reported by G-Finder by 2021.)
On 6 February 2020, the WHO’s Executive Board adopted decision EB146(10) which contained an unfortunate drafting error in paragraph 3 which read:
to call on Member States to further discuss, in informal consultations to be convened by the Director-General in 2020, the recommendations of the review panel on promoting and monitoring transparency of medicines prices and actions to prevent shortages;
This inclusion of a reference to “promoting and monitoring transparency of medicines prices” along with the recommendation on “actions to prevent shortages” gives the misleading and incorrect impression that recommendation 21 of document A71/13 did not meet consensus in 2018. As a reminder, recommendation 21 states:
21. The WHO Secretariat to provide guidance to Member States on promoting and monitoring transparency in medicine prices and on implementation of pricing and reimbursement policies.
During the separate 2019 WHA negotiations on transparency, the subject of price
transparency met with consensus. After the passage of the transparency resolution, James Love (Director, Knowledge Ecology International) provided the following commentary.
“The price transparency issue was perhaps the most concrete issue for many government negotiators, and here the resolution represents an impressive achievement, at a time when non-disclosure agreements have become increasingly common and problematic.
The largest failure was in the area of clinical trial costs. This was strongly opposed by US Health and Human Services Secretary Alex Azar (the former President of Lilly USA), and a few other countries. There was broad and enthusiastic support for the disclosure of trial costs from many countries, but a small number of industry-friendly countries blocked a consensus on mandates for trial cost disclosures.”
Decision WHA73(11) adopted through written silence procedure on 3 August 3020 contains the identical drafting error as EB146(10. Paragraph 3 of decision WHA73(11) reads as follows:
(3) to call on Member States to further discuss, in informal consultations to be convened by the Director-General in 2020, the recommendations of the review panel on promoting and monitoring transparency of medicines prices and actions to prevent shortages;
This drafting error renders violence to the consensus achieved on the transparency of medicines prices achieved in 2018, during the adoption of decisions EB142(4) and WHA71(9), and the consensus achieved on price transparency achieved through the passage of the WHO transparency resolution in 2019. As WHO member states have adopted decision WHA73(11) on a Global strategy and plan of action on public health, innovation and intellectual property on 3 August 2020 through a written silence procedure, it remains to be seen how the virtual session of November’s World Health Assembly can course correct this glaring own goal.