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Import and export rules | Brussels, 29 January 2021

Commission puts in place transparency and authorisation mechanism for exports of COVID-19 vaccines

In an effort to ensure timely access to COVID-19 vaccines for all EU citizens and to tackle the current lack of transparency of vaccine exports outside the EU, the Commission has today put in place a measure requiring that such exports are subject to an authorisation by Member States.

President of the European Commission Ursula von der Leyen said: “The pandemic is having devastating effects in Europe and all around the world. Protecting the health of our citizens remains our utmost priority, and we must put in place the necessary measures to ensure we achieve this. This transparency and authorisation mechanism is temporary, and we will of course continue to uphold our commitments towards low and middle income countries.

Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “This time-limited and targeted system covers only those COVID-19 vaccines that were agreed by Advanced Purchase Agreements with the EU. The aim is to provide greater clarity on vaccine production in the EU and their exports – this transparency has been lacking and is vital at this time. This mechanism includes a wide range of exemptions to fully honour our humanitarian aid commitments and protect vaccines deliveries to our neighbourhood, and to countries in need covered by the COVAX-facility.

Commissioner for Health and Food Safety Stella Kyriakides said: “For the best part of the last year we worked hard to get Advance Purchase Agreements with vaccine producers to bring vaccines to the citizens, in Europe and beyond. We gave upfront funding to companies to build the necessary manufacturing capacity to produce vaccines, so deliveries can start as soon as they are authorised. We now need transparency on where the vaccines we secured are going and ensure that they reach our citizens. We are accountable towards the European citizens and taxpayers – that is a key principle for us.

The Commission has invested large amounts in the development of the production capacity of vaccine developers in the EU. This with the aim to ensure quicker delivery of vaccines to the European citizens, support planning and vaccination strategies with the ultimate goal to protect public health. It is therefore reasonable for the EU to monitor how the funds disbursed under the Advance Purchase Agreements (APA) have been used, especially in a context of potential shortages of essential COVID-19 vaccines. The main purpose is to offer public transparency to the European citizens. The transparency and authorisation system will require companies to notify the Member State authorities about the intention to export vaccines produced in the European Union.

The export authorisation scheme

This implementing act, adopted by urgency procedure and published today, provides for authorisations of exports outside the EU of COVID-19 vaccines until the end of March 2021. This scheme only applies to exports from companies with whom the EU has concluded Advance Purchased Agreements.

Based on the previous experience with a similar measure on personal protective equipment in Spring 2020, the Commission will assist Member States in setting up the relevant mechanism to ensure a smooth and coordinated implementation of the regulation.

This measure is targeted, proportionate, transparent and temporary. It is fully consistent with the EU's international commitment under the World Trade Organization and the G20, and in line with what the EU has proposed in the context of the WTO trade and health initiative. Committed to international solidarity, the EU excluded from this scheme vaccine supplies for humanitarian aid or destined to countries under the COVAX facility, as well as our neighbourhood.

About the EU's vaccine strategy

The European Commission presented on 17 June a European strategy to accelerate the development, manufacturing and deployment of effective and safe vaccines against COVID-19. In return for the right to buy a specified number of vaccine doses in a given timeframe, the Commission finances part of the upfront costs faced by vaccines producers in the form of Advance Purchase Agreements (APA). Funding provided is considered as a down-payment on the vaccines that will actually be purchased by Member States. The APA is therefore a de-risk investment upfront against a binding commitment from the company to pre-produce, even before it gets marketing authorisation. This should allow for a quick and steady delivery as soon as the authorisation has been granted.

For more information

Vaccine exports - Temporary transparency and authorisation mechanism: Factsheet
Commission Implementing Regulation

Commission statement
Questions and Answers
List of competent authorities in Member States
Frequently asked questions