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.

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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive…

Bart Van Vooren has a broad life sciences practice supporting innovative pharmaceutical, food, medtech and biotech companies on EU regulatory, commercial and strategic policy assignments. He is widely recognized for his expertise on general EU law and procedure, as well as his extensive litigation experience before the EU Court of Justice in dozens of cases.

Over the past seven years, Mr. Van Vooren has developed a niche practice on compliance with the Biodiversity Convention and the Nagoya Protocol, a set of rules to combat bio-piracy worldwide. He has accumulated unique, practical experience in dozens of jurisdictions around the world, and has handled everything from benefit-sharing negotiations, over compliance programs, to inspections by authorities.

Finally, Mr. Van Vooren has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation.