European Union: Commission Amends Authorization Mechanism for Exports of COVID-19 Vaccines

European Union: Commission Amends Authorization Mechanism for Exports of COVID-19 Vaccines

(Apr. 1, 2021) On March 26, 2021, the European Commission’s Implementing Regulation (EU) 2021/521, which amends the authorization mechanism for exports of COVID-19 vaccines adopted on January 30, 2021, entered into force. The regulation adds the principles of reciprocity and proportionality as new criteria to be considered when a European Union (EU) member state authorizes exports.

EU Regulations are binding in their entirety and directly applicable in all EU member states. (Treaty on the Functioning of the European Union art. 288, para. 2.)

In announcing the new regulation, the President of the European Commission, Ursula von der Leyen, remarked: “[O]pen roads should run in both directions. . . . The EU has an excellent portfolio of different vaccines and we have secured more than enough doses for the entire population. But we have to ensure timely and sufficient vaccine deliveries to EU citizens. Every day counts.”

Content of the Authorization Mechanism

Common Rules on Exports

Regulation (EU) 2015/479 on Common Rules for Exports sets out the basic principle that the export of products from the EU to third countries is not subject to any quantitative restriction. (Art. 1.) However, the European Commission may make the export of a product subject to the production of an export authorization “in order to prevent a critical situation from arising on account of a shortage of essential products, or to remedy such a situation.” (Arts. 5, 6.)

COVID-19 Export Authorization Mechanism

In January 2021, the European Commission used this legal basis to make exports of COVID-19 vaccines and the active substances used to manufacture them subject to an export authorization until March 31, 2021. On March 11, 2021, these measures were extended until June 30, 2021. The COVID-19 vaccine export authorization mechanism applies only to exports from companies with which the EU has concluded Advance Purchase Agreements (APAs), meaning companies that are required to deliver a pre-agreed number of vaccines to EU countries. (Commission Implementing Regulation (EU) 2021/111, recital 5.) The European Commission has concluded APAs with six companies, namely Astra Zeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac, and Moderna. (Id. Annex II.)

Requests for export authorization are processed within two working days. The draft decision of the member state authority is forwarded to the European Commission and reviewed by it. The European Commission publishes information on the export authorizations. (Implementing Regulation (EU) 2021/442, art. 2, paras. 2-4, art. 3.)

Exports to certain low and middle income countries on the COVAX AMC list and for humanitarian purposes, among others, are not subject to the export authorization mechanism. (Id. art. 1, para. 9.)

Criteria to be Considered for Export

When a company that manufactures COVID-19 vaccines in an EU country applies for an export authorization, the member state’s authorities must consider whether the export poses a threat to the execution of EU APAs concluded with vaccines manufacturers. (Implementing Regulation (EU) 2021/521, art. 2, para. 1(a).) In addition, under the amended rules, member states’ authorities must consider whether the export would otherwise pose a threat to the security of supply of COVID-19 vaccines within the EU, meaning it must consider reciprocity and proportionality. Reciprocity means that the competent authority must assess whether the country of destination restricts its own exports to the EU of COVID-19 vaccines or of the raw materials from which they are made. Proportionality includes a review of the current COVID-19 situation in the export country in comparison to the EU, in particular a review of the epidemiological situation, vaccination rate, and vaccine supply. (Art. 2, para. 1(b), art. 2, para. 2.) The review of the draft export authorization decision by the European Commission includes a review of the reciprocity and proportionality criteria. (Art. 2, para. 3.)

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