While European Union (EU) member states continue to oppose a waiver on intellectual property rights for COVID-19 vaccines and medicines, they may soon find themselves at odds with the European Parliament, which is expected to pass a resolution in support of the waiver on Wednesday.

Negotiations on the controversial waiver proposal, co-sponsored by India and South Africa, will resume again on Tuesday at the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council. 

The waiver would extend to patents, copyright, industrial designs, and “trade secrets” related to all COVID-19 “products and technologies”.  According to an amended version of the initiative, it would be time-limited to three years – with WTO  review annually.

The proposal has met with continued opposition from the European Union (the European Council and the European Commission) which tabled its own counter-proposal at the TRIPS council last week.  In contrast to the blanket waiver, the EU initiative would continue to rely upon the use of existing IP exceptions to allow countries to produce COVID-19 vaccines and medicines under compulsory licenses as needed. 

Last month, Ambassador Xolelwa Mlumbi-Peter, South Africa’s Permanent Representative to the WTO and co-sponsor of the proposal, condemned the “circular discussion” on the waiver proposal – which was made eight months ago.

Her Indian counterpart and co-sponsor, Ambassador Brajendra Navnit, says that waiver opponents have been using “delaying tactics” by  “changing goalposts” to raise new problems once their earlier concerns had been addressed.

Groundswell of European Parliamentary Support 

However, a groundswell of support for the broader waiver initiative is emerging among European parliamentarians.  The draft resolution due to go to the plenary on Wednesday calls for “a temporary TRIPS waiver for COVID-19 vaccines and related health technologies, and for the EU to actively participate in text-based negotiations at the World Trade Organization (WTO) to achieve this”.

A motion to approve the resolution already passed by a comfortable majority in the European Parliament’s Committee on International Trade on 19 May, and is widely expected to be carried by the plenary.

Proponents of the waiver say it is an essential tool to stimulate more vaccine production in countries and manufacturing sites that have idle capacity – and thus get 11 billion vaccines made and distributed as fast as possible to immunise 70% of the world’s adults against SARS-CoV2.

Vaccine dose-sharing has so far only yielded 200-million doses at most – and on Monday WHO launched another urgent appeal to G7 leaders, meeting this coming weekend, for donations of another 100 million doses now, and 250 million doses by September. 

The net result is that while the US and the EU are moving to normalise their societies as they mass-vaccinate, poor countries in Africa and Latin America, which lack vaccines, are facing third and fourth waves of the pandemic.  

In Latin America, the rate of new COVID cases is now three times that of India – and these swelling numbers could also give rise to more virus variants in a region that has already seen significant variants of concern emerge in countries like Brazil from uncontrolled infection spread.

At the same time, a number of reputable vaccine manufacturers – notably in Indonesia and Bangladesh – have stated that they have the capacity to produce COVID-19 vaccines – but cannot because none of the pharma companies that have successfully developed a COVID vaccine have signed them onto manufacturing deals. 

Compulsory Licenses Are a ‘Legitimate Tool’

Even so, the EU remains resolute in its opposition to the TRIPS waiver on COVID-19 products and technologies – despite the groundswell of support the waiver initiative has gained among 60 WTO members, including a US endorsement of a waiver on vaccine-related IP.

Last Friday, the EU made public its counter-offer to the waiver that proposed that WTO actions focus on three very modest fixes: 

• Lifting cross-border trade restrictions on COVID-19 vaccines, treatments and components; 
• Encouraging vaccine producers to voluntarily expand production; 
• Facilitating the use of compulsory licensing within the TRIPS Agreement.

“Voluntary licenses are the most effective instrument to facilitate the expansion of production and sharing of expertise,” the EU stated.

“Where voluntary cooperation fails, compulsory licenses, whereby a government grants a targeted license allowing a willing producer to make a vaccine without the consent of a patent-holder, are a legitimate tool in the context of a pandemic.” 

Current Rules for Compulsory Licenses Onerous – Critics Say

But critics say compulsory licenses designed to satisfy the domestic needs of a country in crisis – are too complicated and onerous for the kind of quick and large-scale global actions needed now to combat the pandemic. 

In particular, medicines or vaccines produced under a compulsory license by one country cannot easily be exported to another country – without the producers’ fulfilling yet another series of detailed conditions that only permit such exports under closely curtailed TRIPS “exceptions”.  

The WTO export restrictions on products manufactured under compulsory licenses bode ill, in particular, for vaccine producers – which use components procured from multiple suppliers, in processes that also may take place in diverse countries – from producing the active biological ingredients to “fill and finish”. 

Moreover, in order to ensure sustainability and even quality control, vaccine producers typically fabricate their products in large volumes for export to multiple countries – something difficult to do under existing TRIPS rules. 

Bolivia’s Compulsory License ‘Test Case’

Bolivia, for instance, is currently involved in a compulsory licensing “test case”.  The Bolivian government is trying to get the Canadian government to issue a compulsory license to the Canadian company Biolyse, so that it can export vaccines to Bolivia and other countries with vaccines. 

Biolyse says it has the capacity to produce 20 million COVID-19 vaccine doses for use by low and middle-income countries like Bolivia – but cannot do so because of IP restrictions.

A number of other manufacturers – notably in Indonesia and Bangladesh – have also indicated that they have the capacity to produce COVID-19 vaccines but cannot because they have not received voluntary licenses from the pharma companies that have successfully developed a COVID vaccines so far. 

Meanwhile, Médecins Sans Frontières (MSF) has documented examples of countries that issued compulsory licenses for domestic production medicines, as already allowed by TRIPS, have faced pressure from wealthier nations.

“Since India issued its first compulsory license on pharmaceutical patents, the US has applied continuous pressure on India to discourage any further compulsory licensing on patented medicines,” according to MSF.

“The US Trade Representative’s annual Special 301 report systematically criticises developing countries who either reform their IP law to include TRIPS flexibilities or make use of compulsory licenses,” MSF elaborated.

“The EU’s annual IP enforcement report also criticises a number of developing countries for compulsory licensing laws and other uses of TRIPS flexibilities. This kind of pressure continued at the peak of the COVID-19 pandemic in April 2020.”

EU Accused of Delaying Text-Based Negotiations

Last month, China and Russia voiced support for the waiver, and in a surprise move on 5 May, the US broke ranks with the EU and Japan, announcing its support for text-based negotiations on removing IP and patents for COVID-19 vaccines only – as opposed to “products and technologies” proposed by the waiver.

“The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” said US Trade Ambassador Katherine Tai. “We will actively participate in text-based negotiations at the WTO needed to make that happen.” 

In the wake of the United States announcement on 5 May that it would support an IP waiver, at least for COVID vaccines, waiver advocates have turned up the heat on the EU, whose member states are now widely perceived as the key remaining barrier to some kind of compromise text on the IP waiver initiative.  They also stress that time is of the essence.  

“In addition to muddying the water and diverting attention, the EU is also hoping that its empty-package compulsory licensing proposals will delay text-based negotiations of a waiver agreement so long that implementing the waiver would be economically impractical for alternative producers and countries,” said Professor Brook Baker, Senior Policy Analyst for Health GAP.

‘Necessary and Proportionate’ 

In an pre-print paper, London School of Economics Associate Professor of Intellectual Property Law Siva Thambisetty and colleagues argue that the TRIPS waiver “is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party’s IP rights and the attendant threat of litigation”.

“The phenomenon of COVID-19 ‘vaccine nationalism’ has brought into sharp relief the misalignment of current legal and financial incentives to produce and distribute vaccines equitably,” they argue. 

“The crisis further demonstrates the failure of high-income countries (HICs) to realise the promise they made at the time of the TRIPS negotiations in 1994, that by agreeing to the terms of TRIPS, lower and middle-income countries (LMICs) would benefit from technology transfer and the building of productive capacity.”

Widening Support in Global Health Community 

Broader recognition of the failure has also helped drive a series of high-level expressions of support for the waiver proposal from the mainstream global health community including the Bill and Melinda Gates Foundation. 

Even WTO Director-General Dr Ngozi Okonjo-Iweala has stressed the need to “get to a conclusion on this [TRIPS waiver] debate, promote technology transfer and know-how to get lasting increases in production capacity”. 

Whether the next two days of talks in the TRIPS Council go in circles yet again or make progress towards text-based negotiations depends largely on waiver opponents – most notably, the EU, Japan and Brazil.

Meanwhile, the easiest way for vaccine manufacturers to pre-empt the “threat” of the waiver would be for developed countries to massively share existing vaccine doses – and for manufacturers to pledge more production to the World Health Organization’s COVAX global vaccine facility. Calls for both were issued again on Monday by WHO Director General Dr Tedros Adhanom Ghebreyesus.  

Tedros also called upon pharmaceutical companies to join the WHO’s COVID-19 Technology Access Pool (C-TAP) and Technology Transfer Hub, sharing their know-how voluntarily and entering into licensing agreements with other global manufacturers to speed up vaccine production and access. 

With or Without Waiver – WHO Pushes Ahead on Vaccine Technology Transfers 

Meanwhile, said Tedros at Monday’s WHO press briefing, WHO is also moving ahead on measures that aim to build longer-term capacity for technology transfer to developing countries, including an “mRNA Vaccine Technology Transfer Hub”. 

“Two months ago, WHO also issued a call for expressions of interest to establish an mRNA technology transfer hub to facilitate increased global production of mRNA vaccines,” said Tedros, who added that a technical review of expressions of interest from companies interested in transferring their technology, and countries wanting to receive the technology was being conducted.

“We continue to call on companies with mRNA technology to share it through the COVID 19 technology access pool. The result can be a win-win for both the owner of the know-how as well as for public health,” added Tedros. 

“The biggest barrier to ending the pandemic remains sharing: of doses, of resources, of technology.”

Image Credits: Maxime Gautier/ Greenpeace, Twitter – Ursula von der Leyen.