[Ip-health] WHO: EU draft Resolution for WHA on “COVID-19 Response” lacks clarity

K.M. Gopakumar kumargopakm at gmail.com
Mon May 4 23:51:28 PDT 2020


*WHO: EU draft for WHA on “COVID-19 Response” lacks clarity*
*Published in SUNS #9113 dated 5 May 2020*

*https://twn.my/title2/health.info/2020/hi200501.htm
<https://twn.my/title2/health.info/2020/hi200501.htm>*

Geneva, 4 May (TWN*) – The European Union’s draft resolution on “COVID-19
Response” for the upcoming Seventy-third World Health Assembly (WHA) lacks
clarity on the way forward with regard to shortages on access to medical
products, according to civil society groups active on health issues.

The draft is also unclear on access to new products, currently under
development.

[The Executive Board of the World Health Organization has decided to hold
the Seventy-third WHA through video conferencing. Besides its normal agenda
under Article 18 of the WHO constitution, including organisational matters
such as the selection of new Board members, the WHA, set to meet at 12:00
CET on 18 May, has one substantive agenda item, i.e. COVID-19.]

Various Member States of the WHO appear to have submitted comments or
textual suggestions to the 6-page EU draft resolution dated 15 April 2020,
which is now a 19-page draft.

Virtual negotiations on the draft, aimed at reducing the length of the
document, began since 27 April. After 4 days of informal negotiations, the
EU has agreed to produce a shorter version for further negotiation on 4 May.

The original draft has 21 preambular paragraphs and 5 operational
paragraphs (OP), with each OP containing several sub-paragraphs.

OP1 commends the dedication of health workers and all other frontline
personnel including WHO staff involved in the COVID-19 response.

OP2 “Recognizes population-wide immunization against COVID-19 as a global
public good for health and the crucial role of quality, safe, and
efficacious vaccines therein”.

OP3 has 12 sub-paragraphs on the commitments of Member States.

OP4 with 4 sub-paragraphs calls for the support of non-State actors.

OP5 contains 19 sub-paragraphs that set out the obligations of the WHO
Secretariat through a request to the Director-General (DG) of the
Organization.

*SHORTAGE OF MEDICAL PRODUCTS*

Many countries are facing problems with shortage of medical commodities
such as medicines, as well as medical devices including diagnostic kits and
personal protective equipment (PPE).

This is due to supply chain disruptions and increased global demand.

Countries are invoking national laws, such as the United States invoking
its Defence Production Act, to direct its companies to supply to the US on
a priority basis, superseding previous orders from other countries.

Increased global demand have predictably resulted in price hikes of raw
materials and finished products, which also adversely affects access to
these products in the developing countries.

To address this situation, the UN General Assembly on 20 April 2020 adopted
a Resolution on “International cooperation to ensure global access to
medicines, vaccines and medical equipment to face COVID-19” (A/74/274),
suggesting a number of actions.

The UNGA resolution requests the UN Secretary-General to work with the WHO
and other multilateral agencies to identify and recommend options,
including approaches to rapidly scaling manufacturing and strengthening
supply chains that promote and ensure fair, transparent, equitable,
efficient and timely access to medical products including future vaccines.

Further, it establishes an inter-agency task force for the coordination and
follow up “on the efforts of the United Nations system to promote and
ensure global access” of medical products.

The General Assembly resolution provides a clear direction to the UN and
WHO to take measures to ensure access to medical products.

As against this, the EU’s draft resolution, however, does not contain any
concrete measures to take forward the mandate provided in the UN resolution.

OP5.10 requests the WHO Secretariat through the Director-General to
“Update, as the situation evolves, the list of critical items for COVID-19
response and continue assessing the magnitude and nature of global
shortages and supporting national authorities in their supply-related
planning”.

But there is no guidance with regard to such support.

OP5.17 requests the Secretariat to prepare a plan in consultation with
Member States to achieve equitable access to quality, safe, and efficacious
COVID-19 vaccines and other health technologies necessary for COVID-19
response and submit it to the consideration of WHO Governing Bodies.

This draft plan is to be prepared with inputs from relevant international
organizations including WIPO, GAVI, UNITAID, the Medicines Patent Pool,
CEPI, the Global Fund to Fight AIDS, TB and Malaria, and UNICEF.

What is missing here is that there is no explicit mention of ramping up
production. However, the US is said to have proposed consultation with the
private sector to “scale up manufacturing and distribution capacities
needed”.

There could be many ways of ensuring equitable access of medical products,
starting with a needs assessment and scaling up of manufacturing
capabilities.

It is also important to take measures to ensure the products are not sold
at high prices and are not exported only to the profitable markets as well
as to take measures to prevent cartelisation.

In this regard the measures taken by India on hydroxychloroquine (HCQ)
tablets are worth noting.

The Government of India stepped in to ban the exports of HCQ by private
companies without the permission of the government and insisted that
importing entities route their requests through their respective
governments.

In other words India converted the export of HCQ into a
government-to-government transaction to manage access by putting in place
need-based supply of HCQ tablets to various countries.

It is important that WHO carries out assessment requirements and production
capacities and obtain commitments from manufacturers, through Member
States, to guarantee supply of medical products to developing countries for
the COVID-19 response.

Further, though the UN General Assembly resolution calls for the ramping up
of production, the EU’s draft resolution for the WHA is silent on the role
of Member States and WHO in enhancing local production.

*INTELLECTUAL PROPERTY PROTECTION*

Unlike the HIV/AIDS crisis, patents are not the only intellectual property
(IP) barrier affecting COVID-19 response.

News reports show that a range of IP, especially patents but including also
industrial designs and trade secrets, can hinder access to existing and
future medical products.

Use of the flexibilities in the Agreement on Trade-Related Aspects of
Intellectual Property Rights is an important strategy to overcome these
barriers.

The EU draft resolution does not make any explicit reference to IP barriers
or the use of TRIPS flexibilities though OP3.8 indirectly urges Member
States to “As far as existing international treaties allow, remove the
existing barriers in access (sic) quality protective equipment, medical
devices and other technologies, medicines, and vaccines related to
COVID-19”.

While it can be argued that the phrase “as far as existing international
treaties allow” implies the TRIPS flexibilities, a positive formulation to
make use of TRIPS flexibilities to address the access barrier would be
preferable.

This would give a clear and unequivocal message to WHO Member States to
make use of the TRIPS flexibilities rather than create ambiguity and
confusion.

The EU’s draft formulation is thus a weak proposition given that many
existing UN and WHO resolutions ask States to make use of TRIPS
flexibilities to address access to medical products.

For instance, the WHA resolution on Hepatitis (WHA 67.6) urged Member
States “to consider, as necessary, national legislative mechanisms for the
use of the flexibilities contained in the Agreement on Trade-Related
Aspects of Intellectual Property Rights in order to promote access to
specific pharmaceutical products”.

Similarly, the Sustainable Development Goal on health has target 3.b that
states: “Support the research and development of vaccines and medicines for
the communicable and non-communicable diseases that primarily affect
developing countries, provide access to affordable essential medicines and
vaccines, in accordance with the Doha Declaration on the TRIPS Agreement
and Public Health, which affirms the right of developing countries to use
to the full the provisions in the Agreement on Trade-Related Aspects of
Intellectual Property Rights regarding flexibilities to protect public
health, and, in particular, provide access to medicines for all”.

It is interesting to note that while pitching for IP-driven innovation, the
Director-General of WIPO has also acknowledged IP as a barrier and endorsed
a qualified use of TRIPS flexibilities: “Intellectual property may also
constitute a barrier to access, if innovation produces effective results
and if countries are not able to obtain the innovation on appropriate and
affordable terms. In this regard, provisions exist at the national and
international levels to facilitate access where intellectual property is a
barrier. The application of these provisions should be targeted and
time-bound, in other words, related specifically to demonstrated
intellectual property barriers to access in the course of the COVID-19
pandemic and bearing in mind that, without innovation, there will be
nothing to have access to”.

In line with this WIPO line of reasoning, the US proposed language to
OP5.17 that equitable access to medical products should be based on “while
ensuring there are appropriate incentives for innovation”.

Though there is no evidence-based direct link between IP and innovation,
the US and WIPO are pushing the IP agenda in the same direction.

Another missing link is compliance with the access and benefit sharing
obligations with regard to genetic materials, especially sharing of virus
samples, contained in the Convention on Biological Diversity and its Nagoya
Protocol. All countries (except the US) are Parties to the Convention.

The EU should take a lead to ensure fair and equitable benefit sharing of
medical products arising from sharing of virus samples and digital sequence
information, for COVID-19 response.

WHO can operationalise benefit sharing by seeking binding commitments from
manufacturers for supply of existing and future medical products,
especially diagnostics, therapeutics and vaccines, to developing and least
developed countries at an affordable price.

*OPEN INNOVATION*

Though the pandemic situation demands expeditious development of new
products, the EU’s draft resolution is silent on open innovation and R&D
models and the role of WHO.

The UN General Assembly Resolution “Encourages Member States to work in
partnership with all relevant stakeholders to increase research and
development funding for vaccines and medicines, leverage digital
technologies, and strengthen scientific international cooperation necessary
to combat COVID-19 and to bolster coordination, including with the private
sector, towards rapid development, manufacturing and distribution of
diagnostics, antiviral medicines, personal protective equipment and
vaccines, adhering to the objectives of efficacy, safety, equity,
accessibility, and affordability”.

However, the draft resolution has nothing on furthering such international
cooperation.

OP3.9 only urges Member States to “Invest in and support research and
development of diagnostics, treatments, therapeutics, medicines, and
vaccines as appropriate and to sustainably strengthen national R&D
capacities for the current and future outbreaks, and collaborate in order
to harmonise efforts as appropriate, with all relevant international actors
in this field”.

OP5.8 requests the Secretariat to “Compile, share and exchange knowledge of
academic and other research on the COVID-19 pandemic and leverage the role
of the WHO Academy in this regard”.

TWN learned that the US has already proposed amendments to the draft text
to qualify this mandate. The US proposed that the sharing should be “With
the voluntary consent of the relevant right holder(s), including authors
and publishers, compile, and as appropriate …” as well as added the phrase
“while respecting any intellectual property rights in this work”.

OP5.15 further requests the Secretariat to “Continue to work with
researchers, research funding organisations, the private sector,
philanthropic organisations and further partners to ensure a focussed and
coordinated R&D effort to develop and scale up countermeasures, including
treatments and diagnostic tests for COVID-19′.

The US has proposed that the coordination should be “through
mutually-agreed upon knowledge sharing”.

However, the governing principles of R&D are not clear i.e. whether access
to new products is ensured without IP barriers.

Previous WHA resolutions on Ebola explicitly delinked R&D cost from the
price of the product to ensure access.

The resolution adopted at a special session of the WHO Executive Board
called on Member States “to continue to collaborate as appropriate, on
models and approaches that support the delinkage of the cost of new
research and development from the prices of medicines, vaccines, and other
diagnostics for Ebola and other emerging and neglected tropical diseases,
so as to ensure their sustained accessibility, affordability, availability,
and access to treatment for all those in need”.

Such a clear and bold direction is missing from the EU’s draft resolution.

Thus, the draft resolution is not adding anything qualitatively to change
the status quo to address shortages, access and fair and equitable benefit
sharing, IP protection and R&D models in the context of COVID 19.

On the contrary, it dilutes previous resolutions on access to medical
products, worsened by the proposed US changes to the draft text.

(* With inputs from health sector CSOs.)


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