India and South Africa proposal for WTO waiver from intellectual property protections for COVID-19-related medical technologies – Briefing Document by MSF

In a landmark move, India and South Africa on 2 October asked the World Trade Organization
(WTO) to allow all countries to choose to neither grant nor enforce patents and other intellectual
property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies for the
duration of the pandemic, until global herd immunity is achieved.

This briefing document aims to provide further details related to this important development,
including a Q&A; an overview of the impact of IP barriers on access to therapeutics, vaccines and
diagnostics; three case studies examining IP barriers in the context of COVID-19; and examples of
Article IX waivers that have been granted with respect to provisions under the Trade-Related Aspects
of Intellectual Property Rights Agreement (TRIPS) Agreement in the past.

What has been proposed?
On 2 October 2020, South Africa and India submitted a joint communication to the TRIPS Council at
the WTO, titled “Waiver from certain provisions of the TRIPS agreement for the prevention,
containment and treatment of COVID-19”. The Council, which includes all WTO members, will meet
15-16 October 2020 at WTO headquarters in Geneva.

The proposal requests a waiver to be granted to WTO members so that they do not have to implement,
apply or enforce certain obligations related to COVID-19 products and technologies under Section 1
(copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed
information) of Part II of the TRIPS Agreement.

The proposed waiver would be applicable only to COVID-19. It does not suggest a waiver from all
TRIPS obligations, nor does it suggest a waiver beyond what is needed for COVID-19 prevention,
containment and treatment.

What would it mean if the waiver was granted?
If the waiver was granted, it would allow countries who are WTO members to choose to neither grant
nor enforce patents and other IP related to all COVID-19 drugs, vaccines, diagnostics, and other
technologies, including masks and ventilators. This would provide countries with the policy space
needed to collaborate in research and development and manufacturing, scaling up and supplying
COVID-19 tools.

Is it legal to request a waiver from obligations under the TRIPS Agreement?
Yes. Article IX 3 and 4 of the Marrakesh Agreement Establishing the WTO (WTO Agreement),
affirm that in exceptional circumstances, a waiver from certain obligations under WTO treaties, such
as TRIPS, can be decided at the WTO Ministerial Conference (during the interval of the Conferences,
the WTO General Council would perform this function). The waiver needs to contain a justification
based on the exceptional circumstances, the conditions and the time when the waiver terminates.
Waivers longer than one year will be reviewed by the Ministerial Conference annually until its
termination.

Does the waiver proposed apply only to developing countries?
No. The proposal calls for a waiver to be applicable for all WTO members – including developing,
developed, and least-developed countries (LDCs).

How is a final decision reached at WTO on a waiver?
According to the decision-making rules of WTO (Article IX of WTO Agreement), the application for
a waiver must be submitted to the TRIPS Council first and then decided at the Ministerial Conference
or the General Council.

After receiving the application for a waiver, the TRIPS Council must consider it within 90 days, and
then submit a report to the Ministerial Conference – the highest decision-making body that consists of
all WTO members – for a decision. The Ministerial Conference is held every two years, with the next
one planned for June 2021. In the interim, the General Council of WTO functions on behalf of the
Ministerial Conference (Article IV.2 of the WTO Agreement).

The decision to grant the waiver will be reached based on consensus of all WTO members. If
consensus cannot be reached, the decision can be made by voting. A three-fourths majority is needed
for a decision to be made through voting.

Transition periods and waivers granted to LDCs:
LDCs enjoy special exemptions from implementation of the TRIPS Agreement under Article 66.1 of
the Agreement. LDC members do not have to implement any aspect of the TRIPS Agreement (other
than Articles 3, 4 and 5) until July 2021. As this transition period is coming to an end, the LDC Group
in WTO has submitted a request to extend the period for as long as a country remains an LDC, plus an
additional period of 12 years once they graduate from the LDC status. This request (IP/C/W/668) will
be discussed at the upcoming TRIPS Council meeting on 15-16 October and should be supported by all
members.
In addition, more specifically with respect to pharmaceutical products, LDCs do not have to implement,
apply or enforce Section 5 (on patents) and Section 7 (on protection of undisclosed information) of
TRIPS until 1 January 2033. Linked to this decision, LDCs have been granted waivers under Article IX
of the WTO Agreement from obligations pertaining to exclusive marketing rights and mailbox
obligations (Article 70.8 and 70.9 of TRIPS Agreement).

Is the waiver permanent?
The proposal submitted by South Africa and India suggests that the waiver should remain valid until
the majority of the world’s population has access to effective vaccines and has developed immunity to
COVID-19. The actual duration of the waiver is unknown, but it will depend on negotiations by
members and is time-limited based on WTO rules.

Why is the waiver important at this moment in the pandemic?
All governments are facing challenges ensuring timely, sufficient and affordable access to effective
medicines, vaccines, diagnostics and other essential medical tools. This is especially challenging,
however, for many developing countries that face limitations developing and scaling up
manufacturing capacity due to IP barriers. The unprecedented situation today requires that all IP,
knowledge, technology and data related to COVID-19 health technologies can be utilised by everyone
to ensure uninterrupted production and supply by any competent country or manufacturer worldwide.
To achieve this, governments have a collective responsibility to address IP and technology barriers.

Since the start of this pandemic, pharmaceutical corporations have continued with their ‘business-asusual’

approaches either by maintaining rigid control over their proprietary IP rights or by pursuing
secretive and monopolistic commercial deals and excluding countries heavily affected by COVID-19.
The pharmaceutical industry as a whole has also chosen not to engage the World Health Organization
(WHO) COVID-19 Technology Access Pool (C-TAP) initiative that aims to encourage the voluntary
contribution of IP, technologies and data to support global sharing and scale up of manufacturing and
supply of COVID-19 health technologies.

Despite having received at least US$70.5 million of public funding to develop remdesivir, one of the
candidate drugs for COVID-19 treatment, pharmaceutical corporation Gilead has signed secretive
bilateral deals with a few generic companies of its choosing that exclude nearly half of the world’s
population from its licensed territories.

These recent actions by pharmaceutical corporations show that relying on their exclusive rights and
limited voluntary actions is not the solution in a global pandemic. Governments need to take back the
driver’s seat and fulfil their core obligations of protecting public health and ensuring access to
medicines for all. The waiver proposal by India and South Africa presents an important opportunity
for all governments to unite and stand up for public health, global solidarity, and equitable access
through a concrete step at the international level that can provide an automatic and expedited solution
to address IP and technology challenges collectively.

Some people say IP is not an issue for COVID-19 tools. If that is true, why is a waiver needed?
We disagree with this claim. Both past experiences and current actions have shown concretely that IP
does pose a challenge in ensuring global equitable access to the effective tools needed in response to
COVID-19, including vaccines.

In the last few months, treatment providers and governments have faced IP barriers
over drugs, masks, ventilator valves and reagents for testing kits. Countries are facing shortages of
remdesivir, which is widely patented but licensed in a manner that allows generic supply only in a
limited number of countries. In addition, multiple patents have been filed for COVID-19 vaccines in
development, for example, more than 100 patents have been filed for the mRNA technology that
Moderna is using to develop a vaccine. A report by MSF found that patents pose a serious threat to
access to affordable versions of newer vaccines like pneumococcal conjugate vaccines (PCV) and
human papillomavirus (HPV) vaccines.

The rest of the document is available here

 

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