TRIPS waiver gains more support despite efforts to stall its passage

The India-South Africa proposal for a waiver from certain obligations under the TRIPS Agreement is increasingly gaining support inside the WTO despite relentless attempts by the US, the EU, Japan, Switzerland, Canada and other developed countries to stall its passage. D Ravi Kanth reports.

ATTEMPTS to avert an emerging ‘vaccine apartheid’ through an intellectual property waiver for combatting the COVID-19 pandemic have gained support from more countries at the World Trade Organization (WTO) as well as international civil society groups, despite what are seen as efforts by the United States and a handful of its allies to protect the monopoly profits of the leading Western pharmaceutical companies at the expense of people’s lives.

At a formal meeting of the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) held virtually on 10 December, the proponents of the waiver proposal – South Africa, India, Kenya, Eswatini, Mozambique, Pakistan and latest co-sponsor Bolivia – answered a maze of questions raised by countries where Big Pharma is located such as the US, the European Union, Japan, Canada and Switzerland, said a delegate who asked not to be quoted.

India and South Africa had tabled a proposal at the TRIPS Council in October for a ‘waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19’. The waiver would suspend implementation, application and enforcement of the relevant provisions of the WTO’s TRIPS Agreement for a defined period, opening the door to more research and development as well as production of needed COVID-19 medical products, including diagnostic kits, medicines for treatment, vaccines and also personal protective gear.

International civil society groups have mounted increasing pressure on governments to swiftly approve the waiver to combat the extraordinary health crisis that has claimed more than 1.5 million lives. In a signature campaign launched by these groups, more than 900,000 people from around the world have called for the passage of the waiver and for putting lives before the profits and patents of Big Pharma.

At the TRIPS Council meeting on 10 December, the proponents of the waiver provided a robust response to the questions and claims raised by opponents, said a negotiator who preferred not to be quoted.

South Africa said that ‘ad hoc, non-transparent and unaccountable bilateral deals that artificially limit supply and competition, cannot reliably deliver access during a global pandemic’.

‘These bilateral deals do not demonstrate global collaboration but rather reinforce “vaccine apartheid” and enlarge chasms of inequity,’ the South African delegate Mustaqeem Da Gama said, according to several negotiators who were present at the meeting.

‘Disparity in access is certain to continue unless concrete steps are taken to address intellectual property barriers,’ warned Da Gama.

He said claims by the EU, the US and Japan that the IP system is responsible for delivery of vaccines in record time ‘fly in the face of the heroic efforts of ordinary people, researchers, scientists and government support and funding to enable this monumental feat’.

Further, ‘not companies, but ordinary people have generously donated their skills and efforts to enable global collaboration by participating in vaccine trials, many in developing countries, putting their lives at risk for the greater good of mankind,’ Da Gama said. ‘Yet, the irony does not escape us, these very people are denied priority access despite the enormous sacrifices they made.’

India said the waiver proposal ‘presents an open and expedited global solution to allow uninterrupted collaboration in development, production and supply of health products and technologies required for an effective COVID-19 response’.

The Indian delegate emphasised that the proposal ‘is targeted and proportionate as it seeks waiver for a limited time from four specific sections of TRIPS Agreement, namely patents, copyrights, industrial designs and undisclosed information, in so far as they hinder the production of health products and technologies for prevention and treatment of COVID-19 pandemic’.

Pakistan said the waiver ‘not only promises to help large populations in developing countries, but would also allow export of medicines and medical equipment back to developed countries where poorer segments of their population could also benefit’.

Tanzania, on behalf of the Africa Group of countries in the WTO, stressed its support for the waiver proposal, adding ‘that the TRIPS Agreement has to ensure all the member states are not prevented in any way; they are not having difficulties to obtain the vaccine or treatment of COVID-19. This is the challenge we are having at the moment, and should be a priority for all member states’.

Indonesia voiced its support for the waiver on grounds that it offers a ‘different perspective to address global public health crisis by addressing one of the core challenges in rapid, equitable and affordable access to health caused by protection of intellectual properties to much-needed diagnostic kits, therapeutics, vaccines and other medical equipment to combat COVID-19 pandemic’.

Indonesia also related its own experience, stating that it ‘recently failed to convince Gilead to expand its production in Indonesia through voluntary licensing, to address shortages and affordability of the medicine’. Importing the medicine was costlier and more difficult due to limited supply and higher prices, Indonesia said, adding that ‘selective and secretive production agreement is one of the prime examples of the business-as-usual model’.

It also recalled that during the spread of H5N1 influenza in 2006, despite sharing virus samples and sequence data that were used for analysis and preparation for vaccine production, ‘the resulting vaccines produced by pharmaceutical companies were in fact unavailable for developing countries such as Indonesia’. 

Bangladesh said that the ‘pandemic is of course a health issue primarily, but this has evidently far-reaching impacts on education, human rights, food security and our economies everywhere’. Therefore, ‘unconditional affordable and timely access to vaccine and other cure measures must be a priority of the time’. It added that ‘production and distribution of vaccines and other medical equipment for containment and treatment of COVID-19 should be open to all … and the TRIPS regulatory framework should not be a hindrance to the most stark needs of humanity’.

China supported further engagement on the waiver proposal, stating that ‘promoting the availability of COVID medicines and vaccines and ensuring useful and timely access to safe and effective medicines and vaccines for all members, especially the developing members and [least developed countries], is still an urgent call for the global community’.

Mozambique highlighted that ‘a positive consideration of the requested waiver would be a substantial contribution for the achievement of the Sustainable Development Goals’, which advocate the need to collectively advance and leave no one behind.

However, opponents of the waiver, particularly the US and the EU, where Big Pharma is located, continued to adopt ‘obdurate and stonewalling’ tactics by raising extraneous questions as well as unsustainable claims, said a developing-country delegate who asked not to be quoted. They are using every option to block the negotiations by constantly shifting the goalposts, the delegate said.

Finding ‘common ground’

The TRIPS Council Chair, Ambassador Xolelwa Mlumbi-Peter from South Africa, urged WTO members to find ‘common ground’, suggesting that there was an emerging agreement for sending a factual and neutral communication to the WTO’s governing General Council that would reflect the state of play of the discussions and the lack of consensus at this juncture, according to a negotiator who asked not to be quoted.

Mlumbi-Peter underscored the need to find ‘common ground in regard to the subject matter of the waiver request, including in relation to scope and substance, as indicated by proponents in order to achieve the common objective you all share’.

An oral status report would be presented at the next General Council meeting on 16-17 December indicating the need for further discussions on this issue, the negotiator said.

Members agreed to keep the waiver proposal on the agenda of upcoming TRIPS Council meetings so that the discussions could continue. Informal meetings of the Council are expected to take place in January and February 2021 followed by a formal session on 10-11 March.

Addressing questions posed

During the discussions on 10 December, South Africa and India called on members to work together to ensure that patents, industrial designs, copyrights and protection of undisclosed information do not become barriers to timely access to affordable medical products including vaccines and medicines or to scaling up of research, development, manufacturing and supply of medical products essential to combatting COVID-19, according to negotiators present at the meeting.

South Africa suggested that while an effective response to the pandemic requires rapid access to affordable medical products – diagnostic kits, medical masks, other personal protective equipment and ventilators, as well as vaccines and medicines – the outbreak has led to a swift increase in global demand, with many countries facing shortages, constraining the ability to effectively respond to the outbreak.

Given the worsening global shortages of these products, South Africa argued that putting the lives of health and other essential workers at risk has led to many avoidable deaths while prolonging the pandemic.

South Africa said while the efforts to develop COVID-19 vaccines successfully and in record time are commendable, these efforts remain insufficient to address the needs and underlying problems.

Responding to a question as to why the scope of the proposed waiver extends to patents, trade secrets, copyrights and industrial designs and what is the evidence that a waiver from these aspects is important to contain, prevent and treat COVID-19, South Africa said that the co-sponsors of the proposal had presented elaborate answers during the last TRIPS Council meeting on 3 December.

As regards which measures would fall within the scope of the waiver, whether measures that are indirectly related would also be included within the scope and who would make this determination, South Africa said the proponents have clarified that ‘the issue is not whether a measure is directly related or indirectly related. It is a matter of what is needed to prevent, contain and treat COVID-19’.

Assuring the opponents that any measure that is not in relation to COVID-19 would not be covered, South Africa said that ‘for instance, a therapeutic for cancer treatment would not fall within the scope of the waiver’. The waiver, it said, is very specific to COVID-19 for its ‘prevention, containment and treatment, and therefore, is proportionate’.

In response to US concerns about the waiver resulting in counterfeit medicines, South Africa said the waiver request does not extend to trademarks and ‘counterfeit trademark good’ as defined in Article 51, footnote 14 of the TRIPS Agreement. It urged WTO members ‘not to confuse and conflate issues of quality of a product with issues of intellectual property of medical products’.

As regards questions concerning the need for the waiver given the establishment of the COVAX facility to secure vaccine supplies, South Africa said the targets set by the World Health Organization (WHO)’s Access to COVID-19 Tools Accelerator (ACT-A, which includes COVAX) to provide 2 billion vaccine doses (for 1 billion people) to the world by the end of 2021, 245 million courses of treatment and 500 million diagnostic tests in 2021 ‘are insufficient to meet global needs of the 7.7 billion people of this world’.

‘As we have seen vaccine rollouts in the developed world, we cannot but continue to wonder when equitable and timely access will become a reality, with more than 90% of all future production of likely vaccine candidates being reserved for rich developed countries,’ South Africa said.

South Africa also addressed claims by Brazil, the EU and Switzerland that the mere existence of patents or patent applications does not amount to a barrier. It pointed to its submission to the TRIPS Council in November which presented ‘a preliminary non-exhaustive snapshot of the patent filing and granting status’ of five therapeutics candidates that are under review by the ACT-A’s therapeutics pillar. The patent list includes:

i. Regeneron’s monoclonal antibody therapy REGN10993 + REGN10987 was granted a patent in the US in June 2020 which expires only in 2040;

ii. Merck’s Molnupiravir (MK-4482) has primary patent applications filed in at least 28 jurisdictions, including two regional patent offices, expiring between 2035 and 2038;

iii. Atea Pharmaceuticals’ AT-527 has primary and secondary patents filed or granted in nearly 60 jurisdictions, expiring between 2036 and 2038;

iv. Incety Corp’s baricitinib has primary and secondary patents filed or granted in nearly 50 jurisdictions, expiring in 2029; and

v. Roche’s monoclonal antibody therapy tocilizumab has primary and secondary patents filed or granted in nearly 30 jurisdictions, expiring between 2022 and 2028.

South Africa added that its submission also includes the patent landscape for the Pfizer/BioNTech and Moderna vaccines.

Drawing attention to the exclusive and monopoly rights that a patent holds during the patent period, South Africa said that ‘with this monopoly, the patent holder is able to prevent other competent manufacturers from producing and supplying the patented subject matter, as well as to charge exorbitant prices for the patented medicines, hence hindering the timely access to affordable treatment’.

Therefore, it said, the patent landscape presented in its submission is ‘a warning shot of the existing and emerging patent barriers to access and the need for the international community to take urgent action to overcome these barriers so that supply may be diversified and scaled up’.

Commenting on the US assertion that ‘where intellectual property rights exist, they can be licensed to companies around the world to scale up manufacturing’, South Africa asked: ‘If VL [voluntary licensing] mechanisms work, why do various licence agreements concluded by companies exclude half of the world’s population from supply and only license to a few very specific manufacturers? Why is it that no one knows the full terms of the licence?’

South Africa asked whether the companies can ‘provide full details of all voluntary licences signed with companies all over the world to scale up manufacturing and for global supply that have been signed by Pfizer/BioNTech and Moderna with respect to their vaccines, and the therapeutics of Regeneron and Eli Lilly that recently received emergency approval in the US’. It sought to know ‘the full terms of the licences, with whom these licences have been signed, which countries will be supplied, when will they be supplied etc’.

It also asked: ‘Why are there geographical restrictions in the VL to limit supply only to low- and middle-income countries (LMICs) under the agreements, excluding supply to other developing countries?’, taking note that the issue of classification of countries based on singular criteria such as per capita GDP ignores the deep and persistent structural deficits between developed and developing countries.

To a question raised by the US about the data regarding how certain obligations have systematically hindered prevention, treatment and containment of COVID-19 so that a waiver is needed, South Africa said that ‘the discussion of the current proposal is to acknowledge the limitation of the existing legal options and to provide additional flexibility at the international level’.

It said that Canada, Germany and Hungary must provide information as to why they ‘swiftly [amended] national laws to enable quicker use of compulsory licence, what kind of data was relied upon at that time demonstrating the necessity of revising the laws’. Maintaining that ‘TRIPS flexibilities are important to increase access to medicines and other medical products not just in a pandemic’, South Africa asked ‘why pressure has been applied on developing countries for implementing and supporting public health safeguards in their intellectual property laws and policies under the EU’s annual IP enforcement report and the [US’] annual “Special 301 Report”, which was released in the midst of a raging COVID-19 pandemic’.

Pointing to the EU IP Action Plan released in November, South Africa said the plan ‘reiterates the exigent need to deploy COVID-19 technologies, not only in Europe but also on a global basis’. It noted that the plan calls for voluntary pooling and licensing of intellectual property related to COVID-19 therapeutics and vaccines, in line with the recent resolution of the World Health Assembly to promote equitable global access as well as a fair return on investment. It then asked the EU to ‘elucidate further on how they intend to transform this lofty rhetoric into concrete action’.

According to South Africa, ‘the EU IP Action Plan notes that the [European] Commission is working on mechanisms that would enable and incentivise the rapid pooling of critical IP in times of crisis. Could the European Union please explicate on these mechanisms that would enable the rapid pooling of critical IP in times of crisis?’

India said the time has come to agree on a global solution for a global pandemic. Challenging the assertion that the IP system provides sufficient tools to ensure swift and equitable access to vaccines and medical products for all, the Indian delegate said the availing of flexibilities under the TRIPS Agreement on a case-by-case basis entails many problems. India said the waiver would provide greater certainty to manufacturers by providing them freedom to operate.

India replied to a question from the EU ‘as to how the waiver could operate with regard to the vaccine production, including the transfer of the required technology and know-how and how it would affect the existing licensing mechanisms and COVAX in general’. India said ‘in the area of vaccines, there are two primary barriers, patents and protection of undisclosed information. Patents are used to protect various aspects of the underlying technology as well as the product’. In addition, ‘manufacturing know-how, test data and cell lines are needed to facilitate diversification of vaccine production. Hence the importance of addressing protection of undisclosed information under Article 39 of [the] TRIPS [Agreement]’.

The wide range of patents and patent applications as well as exclusivity related to undisclosed information create a complex and uncertain legal environment for scaling up vaccine development, production and supply, India pointed out.

India said that ‘to date most multinational corporations holding COVID-19 vaccine IP have not shown any willingness to openly license or transfer technologies to all competent vaccine developers globally’. The pharmaceutical industry, it added, has objected to participation in WHO’s COVID-19 Technology Access Pool.

‘The waiver is about lifting the legal barrier, it does not preclude the possibility of companies agreeing to voluntary licences,’ India said, suggesting that the COVAX facility ‘will also benefit from the waiver as production will expand with more manufacturers engaged in manufacturing’. ‘With robust competition, prices can also be expected to be substantially reduced.’

Challenging the argument of developed countries that the IP system provides the necessary incentives for product development and commercialisation, Eswatini said research and development (R&D) for emerging infectious diseases has typically been dependent on public funding and not the IP system. It argued that COVID-19 is no different, with billions of dollars of public funds spent on R&D and manufacture of vaccines.

It cited the case of the Pfizer-BioNTech vaccine, for which BioNTech secured public funds to the tune of $546 million, as well as more than $6 billion spent on supply deals, while Moderna secured more than $1 billion for R&D. It noted that AstraZeneca has gone so far as to state that the development of the vaccine will have no financial implications for the company since expenses to progress the vaccine are anticipated to be offset by funding from governments and international organisations.

In response to the EU justifying its use of advance purchase agreements on the grounds of expanding production, Pakistan said that such agreements are ‘in fact reinforcing inequitable access to vaccines’, and even ‘if production is being expanded, it seems to be for the benefit of a few wealthy nations’. Pakistan referred to reports that ‘wealthy nations representing just 14% of the world’s population have bought up 53% of all the most promising vaccines so far’ and that ‘some countries have already made arrangements to acquire up to 9 doses per person, while among 70 developing or poor countries, only one out of every 10 people will be vaccinated by the end of 2021. It is also estimated that many lower-income countries could have to wait until 2023 or 2024 for vaccination’.

Pakistan emphasised that the ‘situation reveals a lack of global cooperation and solidarity to ensure equitable access and allocation. More specifically, IP monopolies are limiting vaccine production and equitable access’.

Referring to the EU’s emphasis on AstraZeneca’s licence, Pakistan said ‘the licence is limited and insufficient to meet global need’ and that their ‘pledge to provide doses to developing nations can only reach 18% of the world’s population next year at most’. ‘Besides, AstraZeneca’s CEO has reportedly opposed any public sharing of technology and IP.’

Opposition to waiver

The US, which has been fiercely opposing the waiver proposal, said that the IP system plays a key role in developing partnerships with respect to manufacturing, transportation and distribution. These partnerships, it said, can help facilitate access to innovative products; in particular, voluntary agreements on mutually agreed terms and conditions have effectively served to advance access to key innovations throughout this pandemic.

The US drew attention to exclusive voluntary licensing agreements signed by one company with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture its drug for distribution in 127 countries.

The US suggested that it is manufacturing capacities and problems with supply chains which remain the most significant concerns, especially for vaccines. It added that WTO members should also be concerned about the pandemic creating the opportunity for an increase in counterfeit health and safety-related products.

It called for paying more attention to ‘other factors that are relevant to the access question, [including] pricing and procurement policies, taxes mark-ups, and tariffs and other national policies that result in higher costs for consumers and for health systems’. It said that some countries continue to apply tariffs of up to 20% on pharmaceuticals and 10% on vaccines – an issue that is not explored in the waiver proposal.

Despite sharp concerns expressed by several EU parliamentarians about the hurdles posed by IP rights, the EU reiterated that the IP system as it stands now is part of the solution to the challenge of universal and equitable access to vaccines and COVID-19 treatments.

According to the EU, the development of vaccines was largely due to the unprecedented work done in collaboration among governments, pharmaceutical innovators, foundations and researchers. In suspending the relevant IP rights, collaboration and manufacturing will not be enhanced – to the contrary, it would be slowed down or even decline to the detriment of all.

Despite growing disparities in the access to the new COVID-19 vaccines, the EU went on to highlight that many pharmaceutical companies have committed publicly and are already working closely with governments to ensure that the vaccines will be available and affordable to all who need them.

Canada suggested that solutions can be found within the flexibility provisions of the TRIPS Agreement, particularly Article 31bis. Canada, which has purchased enough to vaccinate its population five times over, also said it is committed to a global effort to address the pandemic.

Canada, jointly with Australia, Chile and Mexico, also presented a paper entitled ‘Questions on Intellectual Property Challenges Experienced by Members in Relation to COVID-19’.  These co-sponsors claim that they are ‘committed to fully understanding the nature and scope of any concrete IP barriers experienced by Members related to or arising from the TRIPS Agreement’.

However, although South Africa, India and others have pointed out the difficulties in using TRIPS flexibilities such as Article 31 and Article 31bis, these concerns have been ignored. Canada now claims that the concerns raised are mostly ‘in relation to the domestic implementation’ and not ‘suggestive of issues with the TRIPS regime such that would necessitate a waiver’.  

In conclusion, it is clear that the proponents of the waiver are increasingly gaining support inside the WTO despite the relentless efforts by the US, the EU, Japan, Switzerland, Canada and other developed countries to stall its passage. The proponents have ensured that the battle continues into next year when issues relating to the disparities in access to vaccines and therapeutics will become crystal clear.                                          

D Ravi Kanth writes for the South-North Development Monitor (SUNS) published by the Third World Network. An earlier version of this article was published in SUNS (No. 9253, 14 December 2020).

*Third World Resurgence No. 345/346, 2020, pp 28-32