On January 30, 2021, the European Commission published the Regulation establishing an export authorization and notification scheme relating to COVID-19 vaccines and their active substances.  It applies “for a limited duration” to COVID-19 vaccines covered by Advanced Purchased Agreements (“APAs”) concluded with the Union.  As regards APAs contracted by third countries, “the Commission will endeavour that the expectations of these countries to obtain their deliveries will be met as much as possible.”  This post briefly outlines the key elements of the export authorization and notification scheme that require further scrutiny.

The export authorization scheme applies to vaccines against SARS-CoV coronaviruses, as well as active substances including master and working cell banks used for manufacturing these vaccines.  The member state authority to grant the license is that of the jurisdiction “where the products covered by the Regulation are manufactured.”  Given complex pharmaceutical supply chains, there may be multiple competent authorities.

An export license is refused if (i) the “volume of exports”, (ii) “poses a threat”, (iii) to “the execution”, of (iv) any of the Union APAs concluded with vaccines manufacturers.  The Regulation requires the Member State to issue a draft decision on the authorization within two working days (extendable by two working days) upon receipt of the required documentation.  The Commission can issue an opinion on the draft decision if it disagrees with the Member State.  The Commission appears to have the final word since the national authority should make a final decision on the request “in accordance with the Commission’s opinion.”

As regards enforcement, the Regulation states that national “authorities may verify the information submitted [by the pharmaceutical company on the threat to the APAs] on the premises of the applicant, even after authorization.”

When vaccine manufacturers first apply for an export license, those companies that have concluded APAs must provide information on their exports (i.e. precise product description, volume, final destination, final recipients) in the last three months prior to the entry into force of the Regulation, i.e., since 30 October 2020.  Failure to provide this information “may” lead to refusal of export authorizations.

The Regulation excludes a number of countries from the scope of the export authorization scheme such as EU overseas territories, EEA and EFTA countries, neighboring countries (e.g., Ukraine, Israel and Egypt), humanitarian emergency supplies and COVAX countries.  In the earlier draft of 29 January 2021, it was stated that vaccine supplies to Northern Ireland would be treated as “exports”, in derogation of the Protocol agreed with the UK.  That provision was removed in the final Regulation.

The Regulation entered into force on the day of its publication, January 30, 2021.  According to the recitals of the Regulation and the Commission’s Q&A, the measure will run until March 31, 2021.

The Commission also published a list of the national competent authorities and their contact details, available here.

Tags: COVID-19, EU pharma, European Commission, Pharmaceutical Companies, Vaccines
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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

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