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India and South Africa proposal for WTO waiver from intellectual property protections

for COVID-19-related medical technologies

Briefing Document

Updated 18 November 2020

DIAGNOSTICS ..................................................................................................................................................... 7

CASE STUDIES EXAMINING IP BARRIERS IN THE CONTEXT OF COVID-19................................... 8

TESTING KIT REAGENTS ...................................................................................................................................... 8

VENTILATOR VALVES ......................................................................................................................................... 8

N95 RESPIRATORS .............................................................................................................................................. 9

ARTICLE IX WAIVERS................................................................................................................................... 10

INTRODUCTION

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.

Q&A

What has been proposed?

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.

countries with the policy space needed to collaborate in research and development (R&D),

manufacturing, scaling up, and supplying COVID-19 tools.

What were the outcomes of the 15-16 October WTO TRIPS Council meeting?

The waiver proposed by South Africa and India was presented and discussed on 16 October at a WTO

TRIPS Council meeting.

become official cosponsors to the proposal and nearly 100 countries welcomed and showed support

overall for the waiver, while nine WTO members, including the EU, did not support the proposal.

Multiple intergovernmental and international civil society and other organisations expressed their

support for the TRIPS waiver proposal either during the TRIPS Council meeting or outside of WTO,

What are the next steps in the process?

Discussions will continue at the upcoming WTO TRIPS Council meetings this year, 20 November

and early December in Geneva.

Between now and the end of the year, South Africa and India are seeking to increase support from

WTO members for the waiver proposal. Following the upcoming sessions of the TRIPS Council, a

report will be submitted to the WTO General Council ahead of a General Council session scheduled

for 16-17 December. It is anticipated that another round of discussions will take place during this 16-

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

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

Ministerial Conference (Article IV.2 of the WTO Agreement). In this case, a report will be submitted

to the WTO General Council ahead of a General Council session scheduled for 16-17 December.

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.

Has a consensus been reached by WTO members to grant waivers in the past?

Yes, many waivers have been adopted by WTO members.

For example, in 2003, WTO members reached a consensus for a waiver related to Paragraph 6 of the

Doha Declaration on the TRIPS Agreement and Public Health. The waiver established a mechanism

to allow countries producing generic medicines under a compulsory license to supply the medicines to

other countries that lacked the manufacturing capacity required to produce the medicines themselves.

discussed at the 15-16 October TRIPS Council meeting and will be discussed at subsequent sessions.

The request 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

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-as-

usual’ approaches either by maintaining rigid control over their proprietary IP rights or by pursuing

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 be in 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.

How do we know that overcoming intellectual property monopolies can help increase access to

medical tools? What can we learn from past?

worked. By overcoming the companies’ monopolies on these drugs and fostering generic production

and competition, the price of antiretroviral drugs dropped 99% over the next decade, paving the way

towards scaling up treatment for people living with HIV to over 25 million in 2019.

The situation today with the COVID-19 pandemic is similar. As countries scramble to ensure access

to the medical tools they need to respond to the pandemic, we are seeing business-as-usual approaches

from the pharmaceutical industry. If the TRIPS waiver proposal is approved, it could signal a major

turning point in countries’ response to the COVID-19 pandemic, ushering in a much-needed wave of

access to COVID-19 medical tools and technologies.

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

development, for example, more than 100 patents have been filed for the mRNA technology that

Moderna is using to develop a vaccine. Although Moderna recently announced that it would not

enforce its patents during the pandemic – the only vaccine corporation to do this thus far – the

company did so after losing an important patent dispute and failing to disclose the US federal funding

it received in the patent applications for its mRNA vaccine. In addition to following through on its

previous commitment to not enforce its patents, Moderna must share all IP, including the necessary

technology, data and know-how, so that other manufacturers can scale up production of these

potentially lifesaving vaccines. Many COVID-19 vaccine developers, including Pfizer/BioNTech,

have taken no steps towards licensing or transferring IP-protected technologies to enable increased

from basic research, starting materials, vaccine composition and final products, to the methods of

vaccination, including vaccination schedules. These practices and experiences should not be repeated

in this pandemic as they would delay the availability and universal access to future COVID-19

vaccines.

Why do countries need a waiver when they can already use TRIPS flexibilities for public

health?

The waiver and existing TRIPS flexibilities are not mutually exclusive.

The proposal for a waiver on certain IP provisions offers an expedited, open and automatic global

solution that allows for uninterrupted collaboration in development and scale-up of production and

supply and that collectively addresses the global challenge facing all countries.

Countries should continue to use TRIPS flexibilities to safeguard public health, including issuing

compulsory licenses and placing limitations on or making exceptions to exclusive rights. However,

Given these common challenges, and the pharmaceutical industry’s refusal to routinely offer non-

exclusive licenses with worldwide coverage to facilitate global access, it is critical for governments to

address this global crisis as they did nearly 20 years ago under the Doha Declaration on the TRIPS

Agreement and Public Health amidst the HIV/AIDS epidemic and support this landmark move by

India and South Africa.

patent protection in many developing countries such as Brazil, South Africa, India, Indonesia, China

and Malaysia. This means that if some of these therapeutics show clear efficacy, production and

supply by diverse manufacturers in different countries would be challenging unless governments take

early actions to address these barriers. Preliminary patent data shows that primary and secondary

lobby groups of the pharmaceutical industry stating that IP is not an issue in the context of addressing

the possible scarcity of vaccine supplies. Such a statement is at odds with what MSF has documented

with other essential vaccines prior to COVID-19, and with what has been observed and analysed

during this pandemic.

In 2017, MSF published a report documenting the effects of patents in hindering the introduction of

affordable vaccines in developing countries, with a focus on pneumococcal conjugate vaccines (PCV)

and the human papillomavirus (HPV) vaccine. The report summarises that patents have been applied

for or granted across the entire process of vaccine development, production and use. Patents were

In 2016-2017, MSF filed a patent opposition and later a writ petition to challenge Pfizer’s vaccine

composition patent that has blocked India from developing alternative versions of Pfizer’s PCV13

vaccine. The equivalent patent has been granted in South Korea, which compelled a Korean vaccine

developer to close their development of an alternative PCV13.

In the context of COVID-19, IP barriers have been reported in vaccine patent disputes and can hinder

vaccine development. Research has revealed that a large portfolio of background IP, such as more

than 100 patents on mRNA platform technologies that are used for COVID-19 vaccines, has already

been granted on key technology platforms used for COVID-19 vaccine development. Several bilateral

voluntary agreements have been signed between vaccine developers and producers since the start of

the pandemic on possible vaccine candidates, but most of the agreements have not been made publicly

available to allow for an assessment of the scope and conditions.

While Brazilian public research institution Fundação Oswaldo Cruz (Fiocruz) has taken an important

step to publish the license signed with pharmaceutical corporation AstraZeneca (who acquired IP

rights on the vaccine from the Oxford University), important terms and conditions around the scope of

Governments must learn from these past experiences and take the appropriate steps to ensure that

access to new vaccines in developing countries is not compromised or blocked due to IP and

monopolies.

Diagnostics

The lack of access to affordable, adapted and simplified diagnostic tests for infectious diseases such

as tuberculosis (TB), HIV and hepatitis C (HCV) in resource-limited settings has been an ongoing

struggle. Starting in 2017, MSF conducted a series of analyses on the causes of market monopolies in

the field of diagnostics for infectious diseases, especially concerning TB, HIV and HCV, and

examined the patent landscape of three point-of-care diagnostics that are important in MSF’s medical

programmes: Xpert MTB/RIF (produced by Cepheid), AlereQ HIV-1/2 Detect (produced by Abbott)

and OraQuick HCV Rapid Antibody Test (produced by OraSure).

to buy both the device and the assays from the same company. Although it’s not possible to say that

one or two access-blocking patents are the key barrier, the analysis shows that major diagnostics

companies hold a considerable number of patents, often bundled into thickets for various

instrumentation, assays, methods and software, related to different aspects of the technologies,

methodologies and devices. This proliferation of patents may contribute to discouraging the

development of open platforms for interoperable diagnostics.

Following the story, a law firm warned that “[m]anufacturers should be aware of the complex

intellectual property issues concerned with this 3D printing technology. In scanning a component such

as a valve, and manufacturing a part using 3D printing equipment, there is a risk that this action will

infringe an existing patent, design or copyright which protects the component, leading to an injunction

are willing to permit the parts to be manufactured (including the terms and conditions that the right

holder will impose). This is a costly, time-consuming, and complex process as there could be multiple

IP holders, and an IP holder may refuse to license its IP.

In March 2020, WHO noted a shortage of ventilators around the world. Removing IP barriers,

including those around 3D printing, can be critical to address life threatening shortages during this

pandemic.

N95 respirators

not released its patent to date.

IP barriers, including patents, have exacerbated the shortages of N95 respirators faced by hospitals

around the world. Companies and others holding patents on important tools, including masks, should

announce now that they will not enforce their patents so that healthcare workers on the frontline of

this pandemic can be protected.