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In brief

The Italian government has blocked the export of 250,700 doses of the COVID-19 vaccine to Australia. This decision represents the first application of the newly enacted European Union (EU) transparency and authorization mechanism for exports of COVID-19 vaccines provided for by Implementing Regulation (EU) 2021/111 of 29 January 2021.


  • Said mechanism establishes that, until 31 March 2021, exports of COVID-19 vaccines are subject to the prior authorization of the member state where the products are manufactured with the purpose of ensuring timely access to COVID-19 vaccines for all EU citizens. The above-mentioned authorization regime only applies to exports of vaccines manufactured by pharmaceutical companies that have entered into advance purchase agreements with the EU.
  • The Italian government justified its decision on the shortage of vaccines in the EU and Italy, the alleged delay of the vaccine manufacturer in its supply to Italy and the EU, and the high number of vaccines to be exported to a “non-vulnerable” country, pursuant to the EU regulation.
  • The proposal for refusal was submitted to the European Commission and, following its approval, the decision rejecting the export authorization was formally notified to the manufacturer on 2 March 2021.
Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.