The Italian Government has blocked the export of 250,700 doses of COVID-19 vaccine to Australia. This decision represents the first application of the newly enacted EU transparency and authorization mechanism for exports of COVID-19 vaccines provided for by Implementing Regulation (EU) 2021/111 of January 29, 2021.
This mechanism establishes that, until March 31, 2021, exports of COVID-19 vaccines are subject to the prior authorization by the Member State where 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 proposal for refusal was submitted to the European Commission and, following its approval, the decision rejecting the export authorization has been formally notified to the manufacturer on March 2, 2021.
Author
Roberto Cursano
Roberto Cursano focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. He is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. Roberto advises primarily on pharmaceutical and healthcare matters. These include product licensing and marketing, clinical trials, pricing and reimbursement, promotions, interactions with healthcare professionals, distribution of products, and public procurement issues. Additionally, he assists in anti-bribery matters and related investigations, and helps set up internal compliance models preventing corruption-related crimes, money laundering and corporate crimes (so-called Law 231 Models). He also advises on administrative/public law, including export control law and public procurement law.
Author
Riccardo Ovidi
Riccardo focuses his practice on pharmaceutical and healthcare law issues, advising on regulatory matters concerning the manufacturing, marketing, distribution and import of medicinal products and medical devices. Additionally, he assists multinational companies on a wide range of trade matters relating to the import, export, transfer, brokering and transit of controlled goods, including the obtainment of authorizations from the Italian Government for activities subject to sanctions regulations and EU export control regulations. Riccardo's practice extends to assistance in setting-up compliance programs aimed at preventing corruption-related and corporate crimes and in developing internal policies and procedures and codes of conduct.