The Lowest Common Denominator: The Quad Text on the TRIPS Waiver
Newsletter Edition #129 [The Curated Primer]
Hi,
Close to 18 months after South Africa and India, stormed the IP establishment seeking a temporary suspension of IP rules, a much-compromised, shrunken version of their proposal has emerged in the form of a compromise text agreed by the Quad members (the EU, the US, India and South Africa). This text which was leaked earlier this week, now looks similar to what the EU, a leading opponent of the waiver, had proposed in June 2021.
Even though the new text is a shadow of the original waiver proposal, it excited and then, disappointed supporters of the waiver. It is fascinating to observe how much emotion a much-contested legal mechanism can generate. In today’s edition, we bring you a quick analysis on how this text is being viewed.
We are happy to have first reported on a potential compromise between the four quad members a week ago. (Of course, we would have liked it if mainstream media also linked to our work. But we also know that independent publishers are often taken less seriously. Hopefully this will change.)
Our story from last week has now been made free to read. We are proud of our TRIPS Waiver coverage of more than 40 comprehensive stories during the last year and a half. This is mostly due to the time and effort spent by many of our sources in educating us on every nuance and detail. Thank you for those countless hours of conversation.
This illustrates the need for inter-disciplinary reporting on global health when the rules are being redrawn. Help sustain our work. You can become paying subscribers. You could also donate to fund our reporting projects.
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Until next week!
Best,
Priti
Feel free to write to us: patnaik.reporting@gmail.com or genevahealthfiles@protonmail.com; Follow us on Twitter: @filesgeneva
I. POLICY UPDATES
TRADE - STORY OF THE WEEK
The Lowest Common Denominator: The Quad Text on the TRIPS Waiver
A developing country ambassador told us a few months ago that the best outcome on the waiver proposal would be to persuade the Americans and Europeans to have a solution that would include all kinds of medical products not just vaccines, and waiving all kinds of IP protections not just patents, underlining the positions of these key WTO members respectively. Now, as a potential for a compromise is beginning to emerge, it seems that the proponents of the waiver might have lost out on both accounts.
While scholars and access to medicine advocates have already panned the compromise text, these are early days, considering that the text will now be taken up by a wider WTO membership. For now, it may have helped let off steam steadily building in the WTO fuelled by unmet expectations, and has given its members something to play around with, as they will embark on arduous negotiations, weighing quid pro quos in their consultations in the run up to the Ministerial Conference in June 2022.
What is also noteworthy is that the leading pharma industry association, the IFPMA has also “condemned” this text.
In our conversations with diplomats, it appears most of the Quad members are not happy with the text. But a compromise by definition is often an unhappy outcome.
A developed country trade diplomat told us that the certainty around patents have to be preserved. “We have offered deep concessions,” the source said.
Here is a quick analysis of the text based on views from relevant experts.
Experts are of the view that the proposal as it stands, does not go far enough in ensuring a freedom to operate by not addressing existing cumbersome authorization procedures. It is limiting on both accounts - the kinds of medical products can be included in a waiver (only vaccines), and the types of IP protections that can be waived (only patents). Worse, it also limits by countries that can benefit from a potential waiver (a function of vaccine exports and status). (See WTO-IMF COVID-19 Vaccine Trade Tracker)
As we first reported last week, the essential structure of this proposed text has two parts, one on patents, and the other on trade secrets.
TRIPS COVID-19 solution: dated March 14, 2022
1. Notwithstanding the provision of patent rights under its domestic
legislation, an eligible Member[1] may limit the rights provided for under
Article 28.1 of the TRIPS Agreement (hereinafter “the Agreement”) by
authorizing the use of patented subject matter[2] 2 required for the production
and supply of COVID-19 vaccines without the consent of the right holder to
the extent necessary to address the COVID-19 pandemic, in accordance with
the provisions of Article 31 of the Agreement, as clarified and waived in
paragraphs 2 to 6 below.
2. For greater clarity, an eligible Member may authorize the use of
patented subject matter under Article 31 without the right holder’s consent
through any instrument available in the law of the Member such as executive
orders, emergency decrees, government use authorizations, and judicial or
administrative orders, whether or not a Member has a compulsory license
regime in place. For the purpose of this Decision, the ” law of a Member”
referred to in Article 31 is not limited to legislative acts such as those
laying down rules on compulsory licensing, but it also includes other acts,
such as executive orders, emergency decrees, and judicial or administrative
orders.
3. Members agree on the following clarifications and waivers for eligible
Members to authorize the use of patented subject matter in accordance with
paragraphs 1 and 2:
(a) With respect to Article 31(a), an eligible Member may issue a single
authorization to use the subject matter of multiple patents necessary for
the production or supply of a COVID-19 vaccine. The authorization shall
list all patents covered. In the determination of the relevant patents, an
eligible Member may be assisted by WIPO’s patent landscaping work,
including on underlying technologies on COVID-19 vaccines, and by other
relevant sources. An eligible Member may update the authorization to
include other patents.
(b) An eligible Member need not require the proposed user of the patented
subject matter to make efforts to obtain an authorization from the right
holder for the purposes of Article 31(b).
(c) An eligible Member may waive the requirement of Article 31(f) that
authorized use under Article 31 be predominantly to supply its domestic
market and may allow any proportion of the authorized use to be exported to
eligible Members and to supply international or regional joint initiatives
that aim to ensure the equitable access of eligible Members to the COVID-19
vaccine covered by the authorization.
(d) Eligible Members shall undertake all reasonable efforts to prevent the
re-exportation of the COVID-19 vaccine that has been imported into their
territories under this Decision. All Members shall ensure the availability
of effective legal remedies to prevent the importation into their
territories of COVID-19 vaccines produced under, and diverted to their
markets inconsistently with, this Decision.
(e) Determination of adequate remuneration under Article 31(h) may take
account of the humanitarian and not-for-profit purpose of specific vaccine
distribution programs aimed at providing equitable access to COVID-19
vaccines in order to support manufacturers in eligible Members to produce
and supply these vaccines at affordable prices for eligible Members. In
setting the adequate remuneration in these cases, eligible Members may take
into consideration existing good practices in instances of national
emergencies, pandemics, or similar circumstances.[3]
4. Nothing in Article 39.3 of the Agreement shall prevent a Member from
taking measures necessary to enable the effectiveness of any authorization
issued as per this Decision.
5. For purposes of transparency, as soon as possible after the adoption of
the measure, an eligible Member shall communicate to the Council for TRIPS
any measure related to the implementation of this Decision, including the
granting of an authorization.[4]
6. An eligible Member may apply the provisions of this Decision until
[3][5] years from the date of this Decision. The General Council may extend
such a period taking into consideration the exceptional circumstances of
the COVID-19 pandemic. The General Council will review annually the
operation of this Decision.
7. Members shall not challenge any measures taken in conformity with this
Decision under subparagraphs 1(b) and 1(c) of Article XXIII of the GATT
1994.
8. No later than six months from the date of this Decision, Members will
decide on its extension to cover the production and distribution of
COVID-19 diagnostics and therapeutics.
HOW EXPERTS READ THE COMPROMISE TEXT:
ON PATENTS
Sangeeta Shashikant, Legal Advisor, Third World Network
“The text needs improvement. There are some shortcomings. For example, we need to know whether the waiver will be applicable when the situation is no longer a pandemic. Also, there is no clarity on whether the decision will apply to products that have pending patent applications. The text now limits itself to patented subject-matter. COVID-19 products have many pending patent applications.
The requirement that the authorization “shall list all patents covered” is TRIPS-plus. Article 31 does not require the listing of patents. It is often not possible to know the patent landscape because patent applications are confidential for the first 18 months. Similarly, the requirement in footnote 4 of the text, creates additional conditions with respect to use of Article 31 that do not exist in the TRIPS Agreement. These TRIPS-plus requirements have the potential to hinder effective use of the decision.
In addition, the approach to Article 39 is flawed for it fails to deal with protection of undisclosed information (Article 39) as an independent barrier irrespective of the patent status.
We also need a decision that only requires a one-time authorization on the part of the government that creates a certain pathway for follow-on manufacturers to enter the manufacture and enter the market for all COVID vaccines, therapeutics and diagnostics for the duration of the waiver decision.
(See below: Footnote 4 of the compromise text seeks additional details including on the authorized entity, the product(s) for which the authorization has been granted and the duration of the authorization. The quantity(ies) for which the authorization has been granted and the country(ies) to which the product(s) is(are) to be supplied shall be notified as soon as possible after the information is available.)
ON TRADE SECRETS:
Hyo Yoon Kang, Reader in Law, Kent Law School, University of Kent said:
The leaked text mentions TRIPS Art. 39 (3) which concerns the exclusive treatment of regulatory data about pharmaceutical and agricultural chemical products. But Art. 39 (3) is in itself not necessarily connected to existing patents. One can have data exclusivity of various time lengths of time in different domestic/regional jurisdictions separately from patent rights.
Also Art. 39 (3) already contains the provision of public interest protection: “Members shall protect such data against disclosure, except where necessary to protect the public”. This is only relevant for jurisdictions which have a high level of data exclusivity in place, such as US and EU for example, but these countries would not be included in the proposed waiver compromise proposal in any case, because it would only cover self-declared developing countries, and even amongst those, being restricted to countries that have exported less than 10% of global vaccines doses in 2021. My sense is that very few countries would be affected by Art. 39 (3) in this carved out category in any case.
The issue of data exclusivity - from a legal point of view - is not necessarily connected to patents or to the practical and legal technical challenge to devise ways to mandate know-how and technology transfer. The leaked text offers no mechanism or a mandate to share the data available at a regulatory agency outside one’s jurisdiction for making vaccines - the already existing public interest provision in Art. 39 (3) is not elaborated or expanded towards non-domestic publics. For example, there is no mechanism by which a generic manufacturer in India could access European regulatory data.
The leaked text does not mention Art. 39 (1) and (2) which are about undisclosed information more broadly and incorporate the provisions of the Berne Convention Art. 10bis regarding the fair treatment of commercially valuable information. TRIPS Art. 39 (1) and (2) need to be understood in the broader contexts of the meanings of fair or unfair competition, confidential commercial information and trade secrets. There is nothing in the current draft compromise text which indicates that 39 (1) and (2) could be waived on grounds of countervailing public interest. This is a missed opportunity.
WHAT IT MEANS FOR IMPLEMENTATION
A view from India: Murali Neelakantan, Principal Lawyer, amicus. Former Global General Counsel, Cipla
“This is a welcome move even if it is delayed. If this waiver doesn’t happen, it would be an acknowledgement that the TRIPs flexibilities and the Doha Declaration were impotent. This waiver acknowledges that they are meaningful.
India will have challenges implementing this as stated for the following reasons:
1. Getting a list of all patents attaching to a vaccine, it’s raw materials and everything else required to make the vaccine (consumables like bio reactor bags) will be a huge exercise especially when we don’t have a list of all patents attaching to the vaccine or any product in India.
2. Indian patent law doesn’t require that each specific patent is listed for CL or government use during an emergency. This waiver now restricts the flexibility.
3. There is no mention of trade secrets being shared. Given the poor quality of disclosure in Indian patents, the patents in themselves may not be adequate for the production of vaccines.
In effect, this waiver doesn’t add to the TRIPs flexibilities. In fact, limiting it to vaccines and the requirement to list all patents for each product adds restrictions to Indian law incorporating the TRIPs flexibilities.
Finally, without a waiver for diagnostics and treatment would be a huge loss for patients in these negotiations”
WHAT COMES NEXT
It is unclear when the next TRIPS Council meeting is scheduled. But the Quad members are cautious about the response to the text from the wider WTO membership. Not only will vociferous opponents to the waiver proposal such as the UK and Switzerland will fight to protect their positions, diplomats are also wary about countries such as China, excluded from the current proposal of the waiver, and even other developing countries that are manufacturing hubs.
Media reports suggest that following the leak of the text, some WTO members met to discuss the compromise text. There are efforts to link the outcome on the TRIPS Waiver to other deliverables at the WTO.
CAN THE TEXT BE STRENGTHENED?
Supporters of the waiver would like to see the compromise text be strengthened. But it may be difficult to introduce new features to the existing text at this stage. If anything, the possibility of this text to be watered down further is very real.
Nevertheless nostalgic trade observers look to the past. In the decades old fight to improve the access to medicines, a number of suggestions are often cited. Experts and activists suggest other provisions in the TRIPS Agreement that could offer more efficient ways to boost local manufacturing of medical products. One such route is the use of Article 30, and not Article 31 that the current text features. Some countries have said in the past that Article 30 is more substantive in nature, as opposed to Article 31, which is more procedural. These provisions seek to qualify the limits to exclusive patent rights available under the TRIPS Agreement.
Article 30, advocates believe offers an elegant solution. It simply states:
Article 30 Exceptions to Rights Conferred
Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.
Other alternatives to the existing approaches include the use of Article 44 that governs the use of injunctions when a patent has been infringed. This has also been brought up in the context of discussions at WIPO.
No matter what the final outcome, the TRIPS waiver talks have entered a defining phase. The next few weeks will be crucial to see how the other co-sponsors of the proposal step in to shape these negotiations at the WTO.
Also see:
‘Quad’ raise hopes of a COVID-19 deal and revival for the beleaguered WTO: Trade β Blog
The WTO Touts Progress in Covid Vaccine Waiver Talks But No Agreement Yet: Bloomberg
WTO DG Okonjo-Iweala welcomes breakthrough on COVID-19 vaccine waiver: WTO
QUAD’s tentative agreement on TRIPS and COVID-19: Knowledge Ecology International
Statement: Leaked Proposal on COVID Medicines Waiver Helps No One But Floundering WTO: Public Citizen
[1] For the purpose of this Decision, an “eligible Member” means any
developing country Member that exported less than 10 percent of world
exports of COVID-19 vaccine doses in 2021.
[2] For the purpose of this Decision, it is understood that ‘patented subject
matter’ includes ingredients and processes necessary for the manufacture of
the COVID-19 vaccine.
[3] This includes the Remuneration Guidelines for Non-Voluntary Use of a
Patent on Medical Technologies published by the WHO (WHO/TCM/2005.1)
[4] The information provided shall include the name and address of the
authorized entity, the product(s) for which the authorization has been
granted and the duration of the authorization. The quantity(ies) for which
the authorization has been granted and the country(ies) to which the
product(s) is(are) to be supplied shall be notified as soon as possible
after the information is available
HEALTH
In U-turn, U.S. backs WHO budget overhaul, but LatAm is opposed - sources: Reuters
CBD: Non-Paper on biodiversity and health undermines benefit sharing norms: Third World Network
CBD: Biodiversity - Proposed criteria for “Specialised Instruments” on access and benefit sharing raise concerns: Third World Network
Medicago Covid Shot Faces WHO Rejection Over Company’s Tobacco Links: Bloomberg
35 generic manufacturers sign agreements with MPP to produce low-cost, generic versions of Pfizer’s oral COVID-19 treatment nirmatrelvir in combination with ritonavir for supply in 95 low- and middle-income countries: Medcines Patent Pool
Attacks on Health Facilities Are Becoming ‘Part of War Strategy’ in Conflict Zones, Warns WHO: Health Policy Watch
Health groups press for more wildlife SARS-CoV-2 tracking: Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota
II. WHAT WE FOUND INTERESTING
My colleague Rithika has brought this together for you:
NEWS:
Top Pfizer, Moderna execs at odds on need for 4th COVID-19 vaccine dose: Fierce Pharma
Moderna vows never to enforce Covid jab patents in policy U-turn: Financial Times
How drug companies are sidestepping the WHO’s technology transfer hub in Africa: The Conversation
Moderna CEO Bancel set for a soft landing as his golden parachute swells to $926M: Fierce Pharma
The Pandemic After the Pandemic: The Atlantic
The Pandemic Is Following a Very Predictable and Depressing Pattern: The Atlantic
Is Covid Over? No, But Global Health Funders Are Moving On: Politico
Uncertainty for Biden’s Covid Plan After Aid Is Dropped From Spending Bill: The New York Times
Health experts plead with Biden to 'reverse course' in global pandemic response: Politico
How a Cape Town company made an mRNA vaccine and what happens next: Spotlight
Medicago's homegrown, plant-based COVID-19 vaccine approved by Health Canada: CBC
The lessons learned from 1918 flu fatigue, according to historians: National Geographic
Billions required to prevent next pandemic, warns epidemic expert: Financial Times
Architect of Sweden’s no-lockdown Covid strategy resigns: Financial Times
How can genomic sequencing spot the next coronavirus variant?: Financial Times
EU COVID vaccinations fall as pandemic worries ebb, Ukraine grabs spotlight: Reuters
United Nations advises staff against using ‘war’ or ‘invasion’ regarding Ukraine: The Irish Times
Polio Makes a Comeback in Ukraine as War Halts Vaccination Campaign: TIME
‘Science sanctions on Russia should not stop exchanges between scientists’: Geneva Solutions
The west v Russia: why the global south isn’t taking sides: The Guardian
The case against punishing Russia at the WTO: Financial Times
Paul Farmer (1959–2022): Nature
JOURNALS/REPORTS:
Centralizing and decentralizing governance in the COVID-19 pandemic: The politics of credit and blame: ScienceDirect
Global health and health security – conflicting concepts for achieving stability through health?: Global Public Health
Travel restrictions and variants of concern: global health laws need to reflect evidence: WHO Bulletin
COVAX, vaccine donations and the politics of global vaccine inequity: BMC Globalization and Health
Apartheid logic in global health: The Lancet
III. PODCAST CORNER
Reflections on Season 1, Global Health Matters Podcast:
A conversation with listeners
Throughout the first season of Global Health Matters, a range of topics were covered including research during the COVID-19 pandemic, tackling racism within global health, science communication and implementation research. For this bonus episode, host Garry Aslanyan sat down with two of the podcast’s listeners who shared their reflections on various episodes from Season 1:
Teresa Soop, Senior Research Advisor, Swedish International Development Cooperation Agency (Sida)
Mohammad Al Safadi, Senior Health Officer, Global Polio Eradication Initiative
Listen here.
Garry Aslanyan is the host and moderator of the Global Health Matters podcast. You can contact him at: aslanyang@who.int
This podcast promotion is sponsored by the Global Health Matters podcast.
If you wish to promote relevant information for readers of Geneva Health Files, for a modest fee, get in touch with us at patnaik.reporting@gmail.com.
IV. WHAT WE ARE WATCHING
Intergovernmental Negotiating Body Meeting at WHO: 14, 15 March
Informal consultation on clinical trials (organized by the United Kingdom): 16 March
Informal consultation related to amending the IHR (2005), (organized by the United States of America): 16 March
WGPR Intersessional Informal Meeting (Equity / Leadership and Governance): 18 March
Virtual technical consultation session on the WHO BioHub System: Access and benefits sharing and the WHO BioHub System: 22 March
WGPR Intersessional Informal Meeting (Systems and Tools / Finance): 24 March
Resumed Meetings of the Convention on Biological Diversity: March 22
V. TWEET OF NOTE
James Love, Knowledge Ecology International:
Global health is everybody’s business. Help us probe the dynamics where science and politics interface with interests. Support investigative global health journalism.
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