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ANNOUNCEMENT 25 Mar 2021
In March 2021, the European Union announced another modification of the transparency and export authorisation scheme for COVID-19 vaccines put in place in January 2021 (see related state act).
NUMBER OF INTERVENTIONS
2
SOURCE
EUR-lex. Official Gazette. Commission Implementing Regulation (EU) 2021/521 of 24 March 2021 making specific arrangements to the mechanism making the exportation of certain products subject to the production of an export authorisation. 25/03/2021. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.104.01.0052.01.ENG&toc=OJ%3AL%3A2021%3A104%3ATOC
European Commission. Speech. "Remarks by Executive Vice-President Dombrovskis at the press conference on the export transparency and authorisation mechanism and an accelerated approval of adapted vaccines against COVID-19 variants". 24/03/2020. Available at: https://ec.europa.eu/commission/presscorner/detail/en/speech_21_1383
Bloomberg. Politics. 22/03/2021. "U.K.’s Johnson Says EU Doesn’t Want Vaccine ‘Blockades’". 22/03/2021. Available at: https://www.bloomberg.com/news/articles/2021-03-22/u-k-politicians-unite-in-criticism-of-eu-vaccine-export-threat
Update May 2021
EUR-Lex. Official Gazette. Commission Implementing Regulation (EU) 2021/734 of 5 May 2021 amending Implementing Regulation (EU) 2021/521 making specific arrangements to the mechanism making certain products subject to the production of an export authorisation. 06/05/2021. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.158.01.0013.01.ENG&toc=OJ%3AL%3A2021%3A158%3ATOC
Update June 2021
EUR-Lex. Official Gazette. Commission Implementing Regulation (EU) 2021/1071 of 29 June 2021 amending Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 related to the mechanism making certain products subject to the production of an export authorisation. 30/06/2021. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.230.01.0028.01.ENG&toc=OJ%3AL%3A2021%3A230%3ATOC
Update September 2021
EUR-Lex. Official Gazette. Commission Implementing Regulation (EU) 2021/1728 of 29 September 2021 amending Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 related to the mechanism making certain products subject to the production of an export authorisation. 30/09/2021. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2021.345.01.0034.01.ENG&toc=OJ%3AL%3A2021%3A345%3ATOC
Update November 2021
EUR-Lex. Official Gazette. "Commission Implementing Regulation (EU) 2021/2071 of 25 November 2021 subjecting certain vaccines and active substances used for the manufacture of such vaccines to export surveillance". 26/11/2021. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2071&from=EN
On 25 March 2021, the EU adopted Commission Implementing Regulation (EU) 2021/442 that modifies the temporary export authorisation mechanism for the export of COVID-19 vaccines from certain producers put in place in January 2021 and modified early in March 2021 (see related state acts).
The first set of modifications include previously exempted jurisdictions into the regime. Article 1 of the amending regulation suspends the application of point (a) of Article 1(9) of Implementing Regulation (EU) 2021/442 through which a list of countries was exempted from the scheme (see related state act). It replaces it with a shortlist of countries that continue to benefit from the exemption (primarily covering EU overseas countries and territories). As exports to low- and middle-income countries supplied through the COVAX facility remain unconditionally exempted, only the countries that were explicitly listed in point (a) of Article 1(9) before, but are not part of the aforementioned COVAX list, were added to the regime. In this sense, among the newly affected countries are Armenia, Bosnia and Herzegovina, Belarus, Georgia, Israel, Jordan, Macedonia and Libya.
In this context, Executive Vice-President Dombrovskis explains that "the new act includes some countries, previously exempted, in the scope of the regulation".
The measure will be valid for 6 weeks after its entry into force, namely until 7 May 2021.
Update
On 6 May 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/734 which extends the validity of the aforementioned measure until 30 June 2021.
On 30 June 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/1071 which extends the validity of the measure until 30 September 2021.
On 30 September 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/1728 which extends the validity of the measure until 31 December 2021.
On 26 November 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/2071 modified the export licensing requirement for the aforementioned products. In particular, it discontinued the export authorization and introduced an export declaration obligation to ensure market surveillance. The new measure is in force for 24 months starting from 1 January 2022.
On 25 March 2021, the EU adopted Commission Implementing Regulation (EU) 2021/442 that modifies the temporary export authorisation mechanism for the export of COVID-19 vaccines from certain producers put in place in January 2021 and modified early in March 2021 (see related state acts).
The second set of modifications develop two components to assess export authorisations. Article 2.2 of the amending measure specifies the following two factors to be assessed by the Member States when facing requests for export authorisations:
According to President von der Leyen, there was a need "for reciprocity and proportionality to be introduced in (the) transparency and authorisation regime", given that the EU was continuously exporting these goods to countries that do not export back to the EU. Moreover, according to a statement from a senior European official to Bloomberg, this amendment is expected to single out and affect future approvals of export authorisations for vaccines and their components destined to the United Kingdom, highlighting that "the bloc will likely reject authorizations to export AstraZeneca’s vaccines and their ingredients to the UK until the drugmaker fulfils its contracts".
The measure will be valid for 6 weeks after its entry into force, namely until 7 May 2021.
Update
On 6 May 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/734 which extends the validity of the aforementioned measure until 30 June 2021.
On 30 June 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/1071 which extends the validity of the measure until 30 September 2021.
On 30 September 2021, the Commission adopted Commission Implementing Regulation (EU) 2021/1728 which extends the validity of the measure until 31 December 2021.