The WTO’s Belated Efforts to Understand if Intellectual Property Hampers Access to COVID-19 Tests & Treatments [Update: Extension of TRIPS Decision]
The WTO’s Belated Efforts to Understand if Intellectual Property Hampers Access to COVID-19 Tests & Treatments [Update: Extension of TRIPS Decision]
Newsletter Edition #199 [The Files In-Depth]
Hi,
The WTO continues to discuss its policies to address COVID-19. Though no longer a pandemic, the disease itself continues to thrive. Many continue to go without tests and treatments, less than 30% are vaccinated in some low and middle income countries, according to WHO.
After more than 15 million deaths from COVID-19, one contentious matter that has divided countries and powerful stakeholders in global health for decades, continues to debilitate WTO’s policy response to this health emergency. And that is the question of whether intellectual property is a barrier to the access to medical products. The debate continues to be hoisted at the WTO, and is being resisted at WHO.
Today we bring you an update on a recent event at the WTO, that sought to seek evidence specifically on implications of IP for tests and treatments for COVID-19.
There are some questions: one is why did some countries shy away from “evidence-gathering” when South Africa and India, first brought this proposal, three years ago.
Why did WTO members want this recent day-long session behind closed doors? (We were told that it was the decision of the members to keep the discussions closed.) Are WTO members scared of evidence being shared in public? May be the larger question is, does evidence even matter?
As we discuss in the story below, the US-ITC examining this same matter had public hearings earlier in the year. It was for the first time in 3 years, one was able to witness the materiality in these complex discussions, revealing the tone and tenor in the arguments made by stakeholders.
Look no further, than up the hill in Geneva, to the WHO, where small windows from otherwise closed-doors negotiations are sometimes opened up even if briefly. They reveal geopolitics, the stresses and strains shaping multilateralism. Why would tax-payer funded international organizations want to impinge on transparency in this day and age?
We believe this was a missed opportunity for the WTO to be truly inclusive particularly around sensitive discussions on global health, as surely this isn’t only about trade.
The architecting of narratives is critical for governments, as it is for international organizations. We are paying attention.
Consider supporting our journalism that ensures nuance, detail, and accuracy. Readers paying for our work helps us meet our costs. Thank you for reading.
Until later!
Best,
Priti
I. STORY OF THE WEEK
The WTO’s Belated Efforts to Understand if IP Hampers Access to COVID-19 Tests & Treatments [Update: Extension of TRIPS Decision]
WTO members were presented with an evidence-gathering exercise last week, to inform their on-going deliberations, to extend clarifications of existing IP rules as applicable to the production of COVID-19 vaccines, to also tests and treatments.
A number of speakers representing industry, international organizations, the private sector, academia and civil society organizations brought their perspectives to bear in a thematic session on IP on September 28 at the WTO in Geneva. In contrast to the US-ITC hearings that could took place earlier in the year which was webcast, this day-long affair was behind closed doors.
This story looks at key elements and arguments made by the different categories of speakers who analysed the merits and demerits of such an extension. (The information cited here is based on the presentations made at the meeting, seen by Geneva Health Files.)
While the US-ITC report will be released in the coming days, no decision on the question of extension is expected anytime soon. But WTO members must reach a decision ahead of, or at the Ministerial Conference in Abu Dhabi in February 2024, Ambassador Pimchanok Pitfield from Thailand, TRIPS Council Chair said at the meeting last week.
Recall that paragraph 8 of the Ministerial Decision on the TRIPS Agreement, from June 2022, had mandated WTO members to make a decision within six months, on whether to extend the decision to cover the production and supply of COVID-19 diagnostics and therapeutics. This initial deadline concluded on December 17, 2022.
THE CONTEXT FOR THE THEMATIC SESSION
WTO’s efforts to gather evidence has been going on for more than 12 months now. It was a strategic win for developed countries who opposed the TRIPS Waiver proposal, when the decision from the previous ministerial in June 2022 excluded tests and treatments. For many developing countries, it has been an irreparable set back as the access to tests and treatments remains challenging. This has been pointed out by numerous delegations in Geneva over the years. (Remember that in 2021, the US had initially supported a narrow waiver limited to vaccines only. In 2022, the U.S. said WTO had no mandate with respect to extension of the decision)
More than 100 countries had lent support to the proposal advocating for a temporary suspension of rules in order to boost manufacturing capacity for medical products at the height of the pandemic of COVID-19. Limiting the proposal to vaccines, and with minor clarifications on existing rules, the two year negotiations effectively ground to a halt - the WTO’s efforts to address the pandemic.
As predicted by seasoned trade watchers and some activists, WTO members have dithered and have been unable to reach a decision on this matter since June 2022. Domestic consultations on the matter continued in many jurisdictions, notably in the U.S., among others.
Earlier this year, under the aegis of the new TRIPS Council Chair, Ambassador Pitfield, countries decided to conduct a thematic session to not only supplement their discussions on the potential extension of the TRIPS Decision, but also drawing from Para 24 of the Ministerial Declaration on the Response to the COVID-19 Pandemic and Preparedness for Future Pandemics, which mandates members to analyse lessons learned from and challenges experienced during the COVID-19 pandemic.
THE DISCUSSION ON EVIDENCE
WHAT DOES THE DATA SAY: SESSION 1
In a segment of the discussion called data collection and analysis on vaccines, therapeutics and diagnostics, the speakers included Rasmus Bech Hansen, CEO, Airfinity, Predictive Health Intelligence and Data Analytics, and Emma Hannay, Chief Access Officer, FIND, Global Alliance for Innovation in Diagnostics, co-convener of the ACT Accelerator Diagnostics Pillar.
The speakers suggested that the extent of demand and supply mismatched during COVID-19 is not entirely clear, according to Geneva-based trade sources.
It is understood that there are data gaps including on assessing how many people have died as a result of the lack of therapeutics. Without surveillance and effective diagnostics, it is difficult to make such an assessment, the speakers said.
The Lancet Commission on Diagnostics was cited highlighting the trend that in many countries the diagnostics gap has exceeded the treatment gap for key diseases including COVID-19. So while diagnostics science improved during COVID-19, there was a failure with respect to those to needed access to the tests, speakers said. A highly concentrated manufacturing base and shortage of raw materials contributed to the problem.
According to a presentation made by FIND, “there are unique IP concerns in the diagnostics industry. Patents, patent families, licensing, know-how, trade secrets, and manufacturing processes play a different role in diagnostics. Disruptive innovation in the diagnostics industry has generally been episodic, leading to brief periods of time where patents are key barriers to global access. Under COVID-19, the RDTs and PCR-based tests in widespread use were based on older technologies, and the IP-related barriers were largely in manufacturing know-how and the lack of technology transfer.”
On treatments, Airfinity said in its presentation that “WHO recommended treatments have widespread regulatory authorisations, but low coverage in Africa.”
PERSPECTIVES FROM THE INSTITUTIONS
Another session saw participation from the following speakers including John Reeder, Director, Research for Health Department, World Health Organization; Erika Dueñas Loayza, Technical Officer, Department of Essential Medicines and Health Products, WHO; Edward Kwakwa, Assistant Director General, Global Challenges and Partnerships Sector, World Intellectual Property Organization (WIPO); Amy Dietterich, Director, Global Challenges Division, WIPO; Nirmalya Syam, Senior Program Officer, The South Centre; Charles Gore, Executive Director, Medicines Patent Pool (MPP).
WHO ON THE NEED FOR EXTENSION TO TESTS AND TREATMENTS:
In a presentation, WHO officials said, “On 5 May 2023, more than three years into the pandemic, the WHO Emergency Committee on COVID-19 recommended to the Director-General, who accepted the recommendation, that given the disease was by now well-established and ongoing, it no longer fit the definition of a PHEIC. This does not mean the pandemic itself is over, but the global emergency it has caused is, for now. A Review Committee to be established will develop long-term, standing recommendations for countries on how to manage COVID-19 on an ongoing basis.”
The official added that WHO promotes an integrated approach for health to include prevention, detection and treatment. “Health systems strengthening and efforts towards health security need to be integrated, avoiding vertical and siloed approaches, to promote sustainability, efficiency and effectiveness at national and subnational level,” she said.
WHO highlighted that access to diagnostics and therapeutics remains a challenge and in many cases the challenges with availability and affordability of products remain. Also presented was a recent briefing on some of the legal instruments that countries can use to promote public health and access to COVID 19 therapeutics in the framework of their multilateral trade obligations and rights, and according to their national legislation and level of development. The document covers the therapeutics landscape and WHO recommendations, overview of the Medicines Patent Pool licenses for oral antivirals and the implications for country access, information on the WHO COVID-19 Technology Access Pool, other licenses relevant to COVID-19 therapeutics and a guidance on the use of TRIPS flexibilities.
The speaker from WHO also referred to various strategies and resolutions adopted by WHO member states in the context of IP and health, including the implementation of the Global Strategy and Plan of Action of Public Health Innovation and Intellectual Property (GSPA-PHI) (that was extended to 2030) that emphazies among others prioritizing R&D needs, building and improving innovative capacity, transfer of technology, application and management of intellectual property to contribute to innovate and promote public health, improving delivery and access. A resolution on transparency for patent status information and licensing, and on local production was also mentioned.
CURRENT STATUS OF THE COVID-19
SARS-CoV2 is regarded by WHO as a pathogen of pandemic potential, even as new variants continue to emerge – such as XBB.1.16, EG.5, FL1.5.1.
Presenting facts on COVID-19, Syam from South Centre said, from 31 July to 27 August 2023, over 1.4 million new COVID-19 cases and over 1800 deaths were reported to WHO. According to WHO reported cases do not accurately represent infection rates due to the reduction in testing and reporting globally. It was pointed out that US CDC has authorized broad use of updated vaccines to target new variants. Citing Para 1 of the MC12 Decision, there is scope for eligible Members to take measures in accordance with the Decision to address a potential pandemic, he said.
He also added that the patent applications for COVID-19 therapeutics were 4 times more than vaccine patent applications. But new variants would require new generation of vaccines, diagnostics and therapeutics. The rise in infections accompanied by supply shortage is particularly challenging for countries with insufficient manufacturing capacity, he noted.
Only 43 countries – less than a quarter of WHO Member States – are reporting deaths to WHO, and only 20 provide information on hospitalizations, WHO DG Tedros Adhanom Ghebreyesus said recently.
WIPO ON INNOVATION DETERMINANTS
WIPO is putting together evidence on innovation determinants with respect to COVID-19 medical products and on manufacturing. The organization is also working on research on trade secrets and patents, voluntary licensing practices and a study on approaches to public funding research conditions and IP.
Kwakwa from WIPO said that “IP must be seen broadly as a powerful tool to ensuring timely and equitable access to COVID-19 vaccines, as well as diagnostics and therapeutics.”
POOLING AND LICENSING APPROACHES
Gore from MPP said that COVID-19 therapeutics reached regulatory approval in record time, but there is a need to shorten timelines further. (It took 1 year as against 3-4 years pre-pandemic times, he said.)
He suggested a list for measures for future emergencies:
“Relevant access provisions in funding agreements on research and development (R&D) could help set the stage for licensing and technology transfer to happen sooner. Pre-selection of manufacturers, building on the existing network of manufacturers established in the context of COVID-19 as recently proposed by the G20 health ministers removes the need for the process during a crisis
The use of pre-agreed licence templates could have significant effect in reducing the time for negotiations
MPP facilitated access to reference listed drugs (RLD) which were not freely available during the pandemic, to support bioequivalence studies and fast-track product development
Possible collaborative mechanism that could enable the sharing of starting materials and RLDs with generics even before innovator products are proven to be effective could be explored to save time in future pandemics
MPP-facilitated provision of technology transfer package by innovators created an opportunity for accelerated product development for manufacturers that needed it.
Although MPP’s criteria enabled the selection of manufacturers from a broad range of jurisdictions, very few applications for licenses were received from certain regions of the world
To ensure more diversified manufacturing, stakeholders would need to provide necessary support to local/regional manufacturers from regions with less developed capacities.
Demand projections for the therapeutics did not materialize and several sublicensees have either terminated their agreement with MPP or put further investment in the products on hold
It would be critical to de-risk early development and manufacturing of generics in future health emergencies to stimulate manufacturer interest and investment.”
VIEWS FROM ACTIVISTS
Another session included speakers from Civil Society Organizations including Tahir Amin, Initiative for Medicines, Access & Knowledge; Ellen t'Hoen, Director, Medicines Law and Policy; Sangeeta Shashikant, Third World Network; James Love, Director, Knowledge Ecology International (KEI); Fatima Hassan, Health Justice Initiative.
(The session also saw interventions by Jennifer Brant, Innovation Council, who reportedly shared perspectives from the industry.)
A number of activists discussed the feasibility and applicability of the existing mechanism to tests and treatments.
Sashikant from Third World Network said:
“….extension of the TRIPS Decision will make available to developing countries an important flexibility to facilitate timely affordable access to therapeutics and diagnostics. In particular, waiving the limitation on exports contained in Article 31(f) of TRIPS will allow manufacturers to achieve economies of scale, and to supply developing countries with insufficient manufacturing capacity with much needed affordable therapeutics and diagnostics.
The Decision should apply to existing and future COVID-19 diagnostics and therapeutics.
I would like to stress that the Decision is limited in scope as in COVID-19 and time-bound as well as only applicable to ‘developing countries’, thus it does not affect sales of pharmaceutical companies in developed country markets.
I have heard concerns about extending the TRIPS Decision, because it is argued that it may be used beyond COVID-19. These are unjustified as the Decision text is very specific to COVID.
Importantly extension of the TRIPS Decision to COVID therapeutics and diagnostics does not mean that patent protection of all COVID-19 therapeutics and diagnostics is automatically waived.
A developing country govt that intends to use the decision will have to issue a compulsory license to address the patent barrier and Article 31(c) of TRIPS makes clear that “the scope and duration of such use shall be limited to the purpose for which it was authorized”.
This means a compulsory licensee will have to operate within the parameters of the license granted. And in situations where the TRIPS Decision is invoked, within the parameters of the Decision.
Further the TRIPS Agreement provides safeguards for the patent holder. Article 31(g) of TRIPS provides that on request of the patent holder, the competent authority shall have the authority to review, the continued need for the compulsory license.
Article 31(i) of TRIPS provides that the “legal validity of any decision relating to the authorization of such use shall be subject to judicial review or other independent review” meaning that legal avenues are available to a patent holder, that has concerns with respect to the compulsory license granted.
It is also equally important to note that Article 31(h) of TRIPS conditions the use of compulsory license to the right holder being paid “adequate remuneration”, an element also elaborated in the Decision.”
She also pointed out that the COVID-19 emergency committee has repeatedly recognized the lack of access to therapeutics and diagnostics as a key primary factor driving transmission of COVID-19. In addition, WHO’s 12th IHR Emergency Committee on COVID-19 emphasized local production related to therapeutics and diagnostics increased production capacity can contribute to global equitable access.
“Shortages and prohibitively high prices was seen across all biotherapeutics recommended by WHO and these were mostly not available in developing countries,” she added.
USE OF TRIPS FLEXIBILITIES BY HIGH INCOME COUNTRIES DURING COVID-19
Knowledge Ecology International pointed out the use of TRIP flexibilities by high-income countries.
Love from KEI said:
“Under the COVID-19 Emergency Response Act, S.C. 2020, (Part 12) Canada amended the Patent Act to, among other things, provide that the Minister of Health could authorize the Government of Canada and any person specified in the application to make, construct, use and sell any patented invention to the extent necessary to respond to a public health emergency that is a matter of national concern.
Germany used the Protection of the Population in Case of an Epidemic Situation of National Significance (Gesetz zum Schutz der Bevölkerung bei einer epidemischen Lage von nationaler Tragweite) of 27 March 2020. It confers upon the Federal Ministry of Health additional powers to control the epidemic situation, or order or instruct a subordinate authority to order patents used to manufacture and sell COVID 19 counter measures be used in the interest of public welfare. The German act applied to a wide set of countermeasures, including: Medicines, the active ingredients, starting materials and auxiliary materials for them, with medical devices, laboratory diagnostics, aids, as well as personal protective equipment and disinfection products.
United States made a very aggressive use of 28 USC 1498(a) / FAR 52.227-1 (Authorization and Consent.)
(a) The Government authorizes and consents to all use and manufacture, in performing this contract or any subcontract at any tier, of any invention described in and covered by a United States patent
European Union: COM(2023)224 - Proposal for a regulation of the European Parliament and of the Council on compulsory licensing for crisis management and amending Regulation (EC) 816/2006 [Publication date, 27 April 2023]”
Use of TRIPS exceptions in developing countries was limited he said. India and South Africa issued no compulsory licenses. Efforts to get compulsory licenses in Chile, Peru, Colombia and Dominican Republic were rejected, by those governments. Bolivia request required cooperation from Canada, and Canada would not even put COVID-19 on the Schedule to activate its much hyped access to medicine law, Love explained.
Love told Geneva Health Files, “None of the emergency pandemic legislative actions in Canada, Germany, the USA or EU were restricted to vaccines, and indeed, they included in addition to therapeutics or diagnostics other countermeasures. It is astonishing how these countries can complain about therapeutic or diagnostics being included, particularly since the June 17, 2022 deal would make more sense for drugs than vaccines. The EU legislation is being considered right now and covers any emergency or pandemic, and not just COVID. It is surreal that the WTO is hesitating to do something that is far less ambitious and important than what the EU is trying to adopt right now.”
(As this story went to print, STAT reported that Colombia is set to issue a compulsory license for an HIV medicine sold by GSK’s ViiV.)
THE HISTORY OF THE TRIPS AGREEMENT AND ITS IMPACT ON LICENSING
One speaker also put the extension discussions in a wider historical context of the TRIPS agreement.
Amin from I-MAK said:
“The facts, evidence and experiences relevant to the production of, and access to vaccines, therapeutics and diagnostics and the case for extending the decision to such products need to be considered in the context of the history of how the WTO TRIPS Agreement was imposed on many of today’s member states that previously did not have IP regimes, and the impact it has had over the last 28 years when it comes to the lack of access to medicines and technology transfer.
Without such context, the framing of the current debate is misleading and allows the Global North and its pharmaceutical manufacturers that hold the IP rights on many COVID-19 technologies to control the narrative and set the terms of the debate. Even though the TRIPS Agreement provides members with flexibilities to manage IP issues in public health emergencies, opposing political pressure from the United States, Europe and other Global North nations, as well as lobbying from their pharmaceutical manufacturers, has created a chilling effect.
As a result, many countries that would benefit from utilising such flexibilities have refrained from doing so. Alongside the imposition of TRIPS, these constant trade threats have squeezed the sovereignty and policy space within which Global South members can serve their national needs – something wealthy Global North countries never had to face as they developed technologically. This squeezing of the policy space through TRIPS and other free trade agreements has, by design, led to an increasing reliance on the voluntary measures of IP holders.
These voluntary measures, such as licenses, not only undermine the flexibilities a country may want to use or have tried to use, they also manage the competition by heavily restricting the territories where Global South manufacturers can sell their products.”
THE LIMITATIONS OF VOLUNTARY LICENSING DEALS
Hassan from Health Justice Initiative, whose efforts have forced the South African government in releasing unredacted COVID-19 vaccine procurement contracts said:
“We cannot broadly access COVID therapeutics, Paxlovid, for example, because decisions regarding access and price are left to a handful of corporate executives and manufacturing is highly concentrated:
a. Private sector access in SA to a single course Paxlovid regimen is approximately ZAR 14 000 (US $ 728)– making it unaffordable for most South Africans.
b. The public sector cannot afford the price offered to the SA health department and no generic versions have been submitted for registration / use as yet.
c. And there are MORE treatments in the development pipeline for COVID-19, dozens of which are in late-stage clinical trials.
d. Many of these could even be more effective than Paxlovid. But we fear, once again, we will be at the back of the line, our African lives not considered important enough to benefit from breakthrough science.
That is the crux of the issue here: the drugs and treatments in the pipeline. Without easing limits to enable wider production and export of generic versions and easier access to testing kits/consumables, we cannot manage to contain COVID, treat it, or even diagnose it in an optimal manner. The time to act is passing the WTO by, rapidly. The WTO does not have to be deferential to the market alone. Please use this opportunity to make a late, but much needed difference.”
The contracts from South Africa show “ the market, with its voluntary deals and bi-lateral agreements extracted secrecy at the cost of our sovereignty in the Global South. The terms and conditions are extremely onerous and make it difficult to plan effective public health mitigation responses, because TIMING of supply delivery is critical, but it was not guaranteed,” Hassan told WTO members.
THE INDUSTRY POSITION
The following speakers were part of the industry segment of the proceedings: Julia Spencer, AVP, Global Multilateral Engagement, Strategic Alliances, and International Relations, MSD; Elsie Soto, VP Supply Chain, Emerging Markets, Pfizer; Cheik Tidiane Diagne, Head of Operations, DIATROPIX, Institute Pasteur, Dakar, Senegal; Osman Khalid Waheed, CEO, Ferozsons Laboratories Ltd., Pakistan; Morena Makhoana, CEO, The BioVac Institute, South Africa; Alejandro Gómez López, Health Secretary of the District of Bogota, Speaker of BogotáBio, Colombian Public Enterprise for the local production of vaccines.
Representatives from the industry cited research to say that IP was a critical enabler of the innovation during the pandemic. They also cited research that over 380 vaccine and therapeutic partnerships were forged in 2022, compared to 50 in 2021.
They cautioned that putting at risk protection of IP could compromise future pandemic response. They reportedly underscored WTO’s role in addressing “problematic trade policies” that could compromise public health objectives.
VIEWS FROM ACADEMICS
Three speakers from academia included Daria Kim, Senior Research Fellow, Max-Planck Institute for Innovation and Competition, Munich, Germany; Yangmu Huang, Deputy Director, Department of Global Health, Research Professor, Beijing University, China; William Fisher, Harvard University, Cambridge MA, United States of America.
Some of the speakers pointed out that the term waiver should not be used for the TRIPS decision since in their view “the text does not waive rights but gives members greater scope to take direct action to diversify production of COVID-19 vaccines and to override the exclusive effect of patents through a targeted measure over the next five years.” The suggested the same level of flexibility of rules for all categories of medical products.
They also pointed out that although the legal impact of the TRIPS decision is limited, it has “provided interpretative guidance for countries”.
Some of the speakers were of the view that availability of transparent voluntary licensing agreements, can be more efficient and rapid than using compulsory licenses while responding to public health emergencies.
DOES EVIDENCE MATTER?
Some trade diplomats in Geneva believe that these extension discussions are “dead in the water” and do not expect this to be adopted by the WTO. “There is not enough support”, a developing country diplomat said along the sidelines of the meeting last week.
Nevertheless, participants of the meeting, said that the sessions were “useful”. It is important that these discussions were held, one of the speakers told us.
IMPLICATIONS OF THE WAIVER TALKS IN NEGOTIATIONS AT WHO
As a rule-making entity, what happens at the WTO, will ultimately have an impact in other forums. Whatever will be decided with respect to COVID-19 tests and treatments will have ramifications for how IP matters are discussed at WHO in the context of a new Pandemic Accord and for expanding the International Health Regulations to reflect more response provisions including access to medical countermeasures.
To be sure, the circuitous two year negotiations at the WTO on the TRIPS Waiver have primed some countries to not touch IP in current global health negotiations. There is rising fatigue even among developing countries to push the envelop on this at WHO. Early indications suggest that language on waivers during health emergencies might be one of the ultimate compromises that countries could make as global health negotiations continue.
At the WTO meeting, Ellen t’Hoen from Medicines Law and Policy said, WHO Pandemic Accord should address access to know how/ trade secrets.
She suggested the following language:
“Where the Director-General of the World Health Organization has determined that: (i) a pandemic outbreak, or the threat of a pandemic outbreak, represents a public health emergency of international concern (PHEIC); (ii) the urgent manufacture by qualified third parties of a pharmaceutical product is necessary to respond to the pandemic outbreak, or the threat of the pandemic outbreak; and (iii) the manufacture is prevented or hindered through lack of access to undisclosed information as defined in Art. 39.2 TRIPS possessed by one or more entities located in one or more Parties, that or those Parties shall compel that or those entities to share the undisclosed information with the third parties.”
TAILPIECE: ARE SOME COUNTRIES SCARED OF EVIDENCE?
There has been some resistance among a few developed countries in reflecting their use of TRIPS flexibilities during COVID-19, in the recently released trilateral report, sources told Geneva Health Files.
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