In 2020, the European Commission signed Advance Purchase Agreements (APAs) with COVID-19 vaccine manufacturers on behalf of the European Union (EU) Member States to ensure affordable and timely access to COVID-19 vaccines for their population. Financial support had been given to vaccine manufacturers to enable them to increase production. At the end of 2020, some manufacturers announced that they would not supply the vaccine quantities which were destined for the Union and which they had pledged. This was in potential breach of their contractual commitments.
In January 2021, the Commission decided that exports of COVID-19 vaccine covered by an APA with the Union would be subject to authorization by Member States. This was in an effort to ensure timely access to COVID-19 vaccines for all EU citizens and to provide greater clarity on vaccine production in the EU and their exports. Commission Implementing Regulation (EU) 2021/111 making the exportation of COVID-19 vaccines subject to the production of an export authorization entered into force on 13 March 2021.
The Commission excluded from this scheme several particular types of exports, so as not to impact on the Union’s international commitments. Examples were exports in the context of humanitarian emergency response, exports of goods purchased or delivered through the COVID-19 Vaccines Global Access initiative (COVAX), the United Nations Children’s Fund (UNICEF), and the Pan American Health Organization (PAHO) with destination to any other COVAX participating country[1]. The Commission was also mindful of APAs contracted by non-EU countries, including the expectations of these countries that their deliveries would be met as much as possible. Moreover: “This Regulation should apply to exports of Union goods from the Customs territory of the Union. Therefore countries that form part of that Customs territory[2] need not be exempted in order to receive unrestricted shipments from within the Union.”
The export authorization was to be granted by the competent authority of the Member State where the vaccines were manufactured. It had to be produced when the goods were declared for export or, at the latest, at the moment of the release of the goods. In Belgium, the authority competent for granting the authorization was the Ministry of Economy, and the verifying authority was Customs.
The Regulation established the following procedure: the manufacturer was to send a request with the related shipment data to the competent authority in writing or by electronic means. An authorization was needed for each shipment. The competent authority had to process the application as soon as it received it and issue a decision no later than within two working days after reception of all required information. The ID-number of the authorization needed to be mentioned in the related export declaration, to be checked by Customs before the release of the goods.
Belgium hosts many pharmaceutical research and development centres and some major production sites, including the Pfizer-Biotech production site, one of the two sites from which the company makes its COVID-19 vaccines (the other site is in Michigan, United States). Many logistics companies specializing in handling pharmaceutical products are located near the airports of Brussels and Liège.
The country was therefore directly affected by the Regulation and was involved in its implementation. The challenge was to enable Pfizer to continue exporting its vaccine as quickly as possible, while implementing the new Regulation.
The key was to enable direct communication between the three stakeholders: the manufacturer (Pfizer), the competent authority for the granting of the authorizations (Ministry of Economy) and the authority supervising the export (Customs). Among other things, a direct line was set up between the Head of the Customs Department of Pfizer, the Head of the Authorizations Department at the Ministry of Economy and the Head of the Marketing and Customer Service Department of Customs. Each had the phone number and email of the others.
It was also important to ensure that the export authorization application process was efficient, and a mechanism to share advance data on shipments requiring an authorization was put in place. At the beginning of each week, Pfizer employees working in the department dealing with shipment planning provided data related to all shipments which were to be sent the same week, both to the Ministry of Economy and to Customs. The Ministry of Economy communicated its decision not only to Pfizer, but also immediately to Customs, directly to the officers in charge of verifying the shipments. This minimized the risk of delays.
Lastly, the IT Department of the Customs Administration developed a dashboard enabling Customs officers to visualize data related to exports of COVID-19 vaccines in real time. This greatly facilitated monitoring and verification of the shipments.
During the time the Regulation was in force, from 13 March 2021 until 30 June 2021, and as at the date of writing this article (February 2022), there have been no significant interruptions of Pfizer COVID-19 vaccine exports from Belgium.
More information
CORONA – Informations et mesures | SPF Finances (belgium.be)
[1] See EUR-Lex – 32021R0111 – EN – EUR-Lex (europa.eu)
[2] The Customs territory of the Union is defined in Article 4 of the Union Customs Code. See https://ec.europa.eu/taxation_customs/territorial-status-eu-countries-and-certain-territories_en
