The European Union’s riposte to the WTO TRIPS waiver

Knowledge Ecology International (KEI) has obtained an document authored by the European Union which outlines a counter-proposal to the proposed TRIPS waiver. It is expected that the European Union will formally submit its counter-proposal to the World Trade Organization (WTO) prior to its next meeting from 8-9 June 2021.

The full text is reproduced below.

Global access to vaccines

The EU is committed to securing global access to vaccines. It has been a leading supporter of COVAX from the beginning. And it will continue to lead on the challenge of ensuring timely and equitable access to vaccines worldwide.

Team Europe (the Commission working with Member States) has contributed a total of just over €40 billion for international support in the fight against COVID-19. It is also one of the lead contributors to COVAX with over €2.7 billion, and is also supporting the humanitarian buffer.

However, funding alone is not sufficient, as can be seen by how the COVAX roll out has been hampered by global supply constraints and delays. The critical question here is how to ramp up production.

How vaccine production within the EU supports global needs

The EU has already taken significant steps to increase production of vaccines within the EU. Funding provided to vaccine producers under the EU Vaccines Strategy accelerated the manufacturing ramp-up. And the Task Force headed by Commissioner Breton has been accompanying and assisting companies as they ramp up production.

Unlike other regions, the EU did not demand exclusive access to vaccines when it invested in vaccines. As a result, as of 26 May, the EU exports had reached some 227 million doses of vaccines, supplying 46 countries [1]. This compares to just 261m doses delivered to Member States.

From the outset, the ability to share doses beyond the EU factored into the thinking. All Advance Purchase Agreements signed under the EU’s Vaccines Strategy allow Member States – as owners of any doses purchased – to share doses with other countries through resale or donations. There is also now a clear target, with the May 2021 European Council agreeing on the aim of at least 100 million doses donated by the end of the year.

The Commission is also working to operationalise an EU mechanism for this vaccine sharing, in particular through COVAX. Donations should initially benefit health workers, as well as meet humanitarian needs.

Supporting vaccine production beyond the EU

Regarding production of vaccines outside the EU, much of the debate has centred on the question of intellectual property.

Possessing the IP of a product is not the only factor, which determines whether a given vaccine can be produced, let alone that it can be manufactured quickly and safely. It needs expertise, trained personnel, investment, and time to set up new production lines for vaccines, even where the producer already has the technology and know-how. Where they do not, getting to the stage of production risks coming far too late to address the need for Covid-19 vaccines. Intellectual property is thus not the main obstacle to the fast ramping up of vaccine production.

We also know that COVID-19 vaccines rely on many components and have very complex supply chains: it is very unlikely that these can be replicated quickly.

Voluntary solutions and public-private cooperation are the most effective way of ensuring global equitable access to COVID treatments and vaccines in the shortest time possible. This is the core of the “third way” called for by the Director General of the WTO.

Many such partnerships are already under way, including with many producers in the developing world. We need more of these. And it is also crucial to ensure that all producers can get the inputs they need to manufacture vaccines as swiftly as possible.

This is the swiftest way to ramp up vaccine production. However, such voluntary agreements might not always be possible. This is why compulsory licensing is an important and perfectly legitimate fallback.

Next steps

To deliver on this approach, the Commission will be submitting a proposal to the WTO focusing on three strands: first, trade facilitation and disciplines to limit export restrictions; second, expansion of production, including through pledges by vaccine producers and developers, and third, clarification and facilitation of TRIPS Agreement flexibilities relating to compulsory licences.

The first strand would limit the application of export restrictions and keep supply chains open. Vaccine producing countries should export a fair share of their domestic production. The EU has done this throughout the pandemic and will continue to do so. In addition, it should be clear that no restrictions of any kind are applied on supplies to the COVAX Facility, and no measure should be taken that limits trade in materials necessary for COVID-19 vaccine and therapeutics production.

Under the second strand, governments should strongly encourage and incentivise vaccine manufacturers and developers to expand production and ensure adequate and affordable supply of vaccines to low and middle income countries during the pandemic. Such actions could include licensing agreements, providing for the sharing of know-how, tiered pricing, contract manufacturing, and new investments in manufacturing facilities in developing countries.

In support of this approach, and as announced at the Global Health Summit on 21 May, a Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies will support local vaccine and other health products manufacturing in Africa, backed by €1 billion from the EU budget, the European Investment Bank (EIB) and European development finance institutions. This amount will be further enhanced by contributions by Member States.

Finally, the third strand would relate to intellectual property, and would entail WTO members agreeing on the following:

a) the pandemic is a circumstance of national emergency and therefore the requirement to negotiate with the rights holder may be waived;

b) To support manufacturers ready to produce vaccines or therapeutics at affordable prices, especially for low- and middle-income countries, on the basis of a compulsory licence, the remuneration of the patent holder should reflect such affordable price;

c) the compulsory licence could be used by a country for production for either domestic use or for export to countries that lack manufacturing capacity, including via COVAX.

[1] These figures only include doses exported under the authorisation scheme authorisation scheme and not those exported before its introduction or exported through COVAX, so, total numbers are higher.