[Ip-health] The drafting error plaguing decision WHA73(11) – Global strategy and plan of action on public health, innovation and intellectual property

Thiru Balasubramaniam thiru at keionline.org
Sun Nov 8 22:21:21 PST 2020


https://www.keionline.org/34448

The drafting error plaguing decision WHA73(11) – Global strategy and plan
of action on public health, innovation and intellectual property
Posted on November 9, 2020 <https://www.keionline.org/34448> by Thiru
<https://www.keionline.org/author/thiru>

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
<https://apps.who.int/gb/ebwha/pdf_files/WHA73/A73_R1-en.pdf>.

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>,
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 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)
<https://apps.who.int/gb/ebwha/pdf_files/WHA71/A71(9)-en.pdf>; 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:
- comment on progress reported herewith,includingthe development of the
draft implementation plan for 2020–2022;1
- take stock of further discussions and actions that have taken place to
implement decision WHA71(9), in particular operative paragraph (2) in which
Member States were urged 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

Foonote 2 of page 7 of the WHO report EB146/15
<https://www.keionline.org/apps.who.int/gb/ebwha/pdf_files/EB146/B146_15-en.pdf>
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)
<https://apps.who.int/gb/ebwha/pdf_files/EB146-REC1/B146_REC1-en.pdf#page=42>
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 commentar <https://www.keionline.org/30887>y.

“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.


-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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