[Ip-health] Health Policy Watch: WHO May Host Virtual World Health Assembly Meeting May 18 – With COVID-19 Main Agenda Topic

Thiru Balasubramaniam thiru at keionline.org
Tue Apr 28 13:09:04 PDT 2020


https://www.healthpolicy-watch.org/who-may-host-virtual-world-health-assembly-meeting-may-18-with-covid-19-main-agenda-topic/

WHO May Host Virtual World Health Assembly May 18 – COVID-19 To Be Main
Agenda Item
Pandemics & Emergencies 28/04/2020 • Elaine Ruth Fletcher & Svĕt Lustig
Vijay

Colorized electron micrograph of a human cell (green) heavily infected with
SARS-COV-2 virus particles (purple)

For the first time ever, the World Health Assembly appears set to meet in a
one-day virtual session on May 18, which would be devoted largely to debate
the global COVID-19 pandemic, sources told Health Policy Watch on Tuesday.

European Union member states are hopeful that a draft WHA resolution to
create a voluntary patent pool of new COVID-19 health technologies could be
approved in the rapid-fire session – and they are holding daily worldwide
consultations with WHO member states online, with the hopes of sealing a
deal on the potentially game-changing resolution in time for the WHA
meeting.

In the 73rd session of the one-day virtual WHA, 10 new members of the WHO’s
34 member governing body, the Executive Board (EB), will be elected,
sources said.

“The current COVID-19 pandemic and related public health restrictions
preclude the feasibility of holding the governing body meetings scheduled
for May 2020 in their traditional format,” states an excerpt of the draft
proposal for the WHA meeting, obtained by Health Policy Watch. “At the same
time, convening WHA73 in May would afford Member States the opportunity to
collectively address the single most pressing global health issue in a
moment of crisis and effectively build global solidarity and strengthen the
response.”

The proposed agenda would “provide crucial international focus on Covid-19,
while recognizing that consideration the nearly 60 items on the full WHA73
agenda would not be appropriate at this time,” states the proposal by the
WHO senior leadership for the virtual meeting. The proposal, has been under
review by the WHO Executive Board  – and would become operative by tonight,
if no EB member opposition has been expressed.

In anticipation, informal EU-led consultations with Member States already
began yesterday to hammer out the nuts and bolts of the patent pool
resolution, with over 130 member states getting online for the first remote
debate. The closed-door country negotiations will attempt to reach a
polished agreement on the controversial issues associated with access to
medicines and patent rights – to avoid airing disputes publicly at WHA.

Following on calls from Costa Rica and other countries, the EU first tabled
the draft resolution on the COVID-19 patent pool to the World Health
Assembly (WHA) about two weeks ago. On May 4, the European Commission will
also host a fundraiser that aims to raise 7.5 billion Euros to support
broad access to COVID-19 health products as well as to prop up the WHO’s
efforts to coordinate and lead the response.

The EU draft WHA resolution calls on Member States to “work collaboratively
at international level to develop, test and produce safe, effective,
quality diagnostics, medicines and vaccines for the COVID-19 response, and
to facilitate the equitable and affordable access of people to them,
including through voluntarily pooling their intellectual property for all
COVID-19-related medical interventions…under the leadership of the WHO.”

Other key sections of the resolution are directed at the WHO
Director-General to draft a plan to achieve equitable access to COVID-19
health products for consideration of the WHO Governing Bodies, in
consultation with Member States, the United Nations Secretary-General, as
well as from “relevant international organizations including WIPO, GAVI,
UNITAID, the Medicines Patent Pool, CEPI, the Global Fund to fight Aids, TB
and Malaria, and UNICEF.”

The patent pool, which aims to share any information, data or intellectual
property rights (IPRs) for innovations, would enable competitive and rapid
production of needed technologies, and thus supposedly increase their
affordability.

Civil society groups have also welcomed the initiative overall

However, some groups have leveled criticism that the proposal needs to be
strengthened considerably to give it teeth.

Notably, Médecins Sans Frontières (MSF), Drugs for Neglected Disease
initiative (DNDi), Health Action International (HAI), and Knowledge Ecology
International (KEI) – all civil society groups in “official relations” with
WHO have submitted comments to the EU and member states about WHA
proposals, making some key recommendations with respect to the draft.

Their amendments aim to strengthen key provisions around:  the WHO’s
leadership role;  the specific definition of the IP rights to be pooled;
 funding of government “buyouts” of essential patent rights on existing
products; and “market entry rewards” or other financial inducements for
innovators that openly access new drugs or vaccines; and price transparency
for products.

Among the most key points, they proposed:


   - Definition of IP rights to be pooled, which should include regulatory
   test data, know-how, cell lines and other biologic resources, copyrights,
   blueprints and designs for manufacturing diagnostic tests, devices, drugs,
   or vaccines.
   - Creation of an innovation reward fund, or other market entry
   incentives, to compensate innovators that create open-source products.
   - A global database of prices paid for COVID-19 diagnostic, drugs and
   vaccines and public contributions to new product R&D.


The KEI proposal also calls for more explicit reference to other existing
legal avenues that can facilitate access to therapeutics, notably, the so
called “TRIPS flexibilities” created by the World Trade Organization, in
the Doha Declaration. These provide mechanisms, like compulsory licenses,
that can be used lawfully by countries, to locally produce or import
patented health products at a reduced price when a justifiable need exists.

The WHO could also be mandated to help build IP capacity of Member States
to ensure that they make more effective use of TRIPS ‘flexibilities’, and
gain timely and affordable access to technologies, KEI suggested.

“The WHO could organize a series of virtual workshops to share expertise
and best practices on various technical and practical aspects of compulsory
licenses and other related topics [like] patent infringement,” said the KEI
proposal.

As for other comments, the Netherlands-based Health Action International
(HAI) also issued a statement on Tuesday, commending the EU draft proposal.
HAI also recommended that WHO undertake  a feasibility study of the
proposed patent pool.

Access to medicines is not the main policy challenge right now, says WIPO

While the World Health Assembly prepares to debate the Draft Resolution
from the EU, the World Intellectual Property Organization (WIPO) has said
that intellectual property law is not the key barrier to accessing
essential medicines, and breaking patent law principles could
“disincentivize innovation.

The WIPO statement last Friday also comes on the heels of a joint statement
by the WHO and the World Trade Organization (WTO) which sounded a more
positive note on the need to exercise available legal flexibilities in
patent law to ensure equitable access to COVID-19 health technologies.

WIPO’s statement argues that the key policy challenge right now is the
total absence of proven therapeutics for COVID-19, as well as limited
manufacturing capacity for essential medical equipment, or even disrupted
supply chains.

“The main policy challenge is to encourage the innovation that may lead to
a vaccine and treatments and cures, as well as innovation that assists in
managing the crisis,” said the WIPO assessment.

“At the present time, it may be noted that there does not appear to be any
evidence that IP is a barrier to access to vaccines, or to treatments or
cures.”

Given that the pharmaceutical industry contributes over 70% of the funding
for R&D, WIPO also notes that access-focused initiatives, particularly at
this stage, could even harm the private sector’s incentive to innovate.

“Focusing on access, rather than the encouragement of needed innovation, at
this stage, may not only represent a misunderstanding of the sequencing of
innovation and access, but also create a disincentive to investment in
needed innovation.”

WIPO’s statement also seems to run against the current not only of the
European Union draft WHA resolution, but also initiatives like last
Friday’s European Commission and WHO-led COVID-19 Tools (ACT) Accelerator,
which commits to equitable global access to innovative tools for COVID-19
for all, observed Ellen ‘t Hoen, from Medicine Law & Policy, in an
interview with Health Policy Watch.

The ACT Accelerator, together with the European Commission, aims to raise
some 7.4 billion Euros in support of broad access to COVID-19 technologies.
It will hold a major fundraising on 4 May. The ACT Accelerator has been
backed by prominent global health organisations, like the Bill and Melinda
Gates Foundation, as well as 11 heads of state, including Germany, France,
South Africa, as well as other leaders across Africa, Asia, and the
Americas, and Europe.

The statement also appears to diverge from recent legislative measures that
various countries have taken, like Israel, Germany, Canada, Chile, Colombia
and Ecuador, to promote emergency access to potential COVID-19 technologies
by facilitating the use of compulsory licenses, as well as other legal
flexibilities allowed by TRIPS.

WIPO’s assessment also does not acknowledge the huge public sector
investment in R&D, including for potential coronavirus drugs, noted,
Yuanqiong Hu, Senior Legal and Policy Advisor of MSF’s Access Campaign, in
an interview with Health Policy Watch.

“R&D for remdesivir [an antiviral candidate for COVID-19] was almost
entirely funded by the government and performed by university scientists
and affiliates. You cannot claim that R&D initiatives like remdesivir are
mostly funded by the private sector,”  she said.


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