(1)

The COVID-19 virus continues to spread rapidly within the Union, with severe consequences in terms of public health – in particular with a dramatic number of fatal outcomes – as well as economic and societal disruption. A permanent solution to this crisis depends on the deployment of an effective and safe vaccine against the virus.

(2)

Under its vaccines strategy, the Commission has financed and secured the production of a sufficient quantity of vaccines in the Union and forged agreements with individual vaccine manufacturers on behalf of Union Member States in order to ensure affordable and timely access to COVID-19 vaccines for all Member States and their population, while leading the global solidarity effort. It is essential that these supplies are effectively delivered by the manufacturers, as production of vaccines in the Union takes place only in a limited number of Member States.

(3)

Despite the fact that financial support has been given to increase production, certain vaccine manufacturers have already announced that they would not be in a position to supply the quantities of vaccine destined to the Union that they had pledged, in potential breach of their contractual commitments. Furthermore, there is a risk that vaccines produced in the Union are exported from the Union, in particular to non-vulnerable countries. Such a potential breach of contractual commitments made by the pharmaceutical industries, carries the risk of shortages and therefore delays within the Union. Such delays severely disrupt the Union’s plan to inoculate its population.

(4)

In the current situation that is marked by the fact that the production and delivery of vaccines is still in the building-up phase and the ensuing temporary global shortage, it is important to ensure the necessary level of transparency about the quantities of vaccines covered by this Regulation produced and the quantities delivered in order to further support the orderly implementation of the vaccination campaigns in the Member States but also elsewhere in countries that depend on Union produced COVID-19 vaccines produced in the Union.

(5)

In order to remedy a critical situation and to ensure transparency, it is in the Union interest to take immediate action for a limited duration to ensure that exports of COVID-19 vaccine covered by Advanced Purchased Agreements (APA) with the Union are subject to a prior authorisation so that they are adequate supplies in the Union to meet the vital demand, but without impacting on the Union’s international commitments in this respect. The Commission is also mindful of APAs contracted by third countries, and will endeavour that the expectations of these countries to obtain their deliveries will be met as much as possible.

(6)

In order to avoid the risk that measures are circumvented, vaccines should be covered by this regulation irrespective of their packaging and active substances including master and working cell banks used for the manufacture of such vaccines.

(7)

Export authorisation should be granted by the Member States where products covered by this regulation are manufactured to the extent that the volume of exports is not such that it poses a threat to the continuous supply of the vaccines necessary for the execution of the APAs between the Union and vaccines manufacturers. In order to ensure an adequate coordinated decision at Union level, the Member States should seek in advance the opinion of the Commission and decide in accordance with that opinion

(8)

The administrative modalities for these authorisations should be left to the discretion of the Member States during the time of this temporary system.

(9)

It is not the intention of the Union to restrict exports any more than absolutely necessary, and the Union remains fully committed to international solidarity and strongly supports the principle that any measures deemed necessary to prevent or relieve critical shortages are implemented in a manner that is targeted, transparent, proportionate, temporary and consistent with WTO obligations.

(10)

Based on the principle of international solidarity, exports to enable the provisions of supplies in the context of humanitarian emergency response, exports to the COVAX facilities, and in particular to low and middle-lower income countries given their vulnerability and limited access to vaccines, exports of COVID-19 vaccines purchased and/or delivered through COVAX, UNICEF and PAHO with destination to any other COVAX participating country and exports of COVID vaccine purchased by Member States under the Union’s APAs and resold or donated to a third country should be excluded from the export authorisation requirement.

(11)

The single market for medical products is closely integrated beyond the boundaries of the Union, and so are its production value chains and distribution networks. This is particularly the case with regard to the neighbouring countries and economies, the member States of the European Free Trade Area, and the Western Balkans which are engaged in a process of deep integration with the Union. Subjecting exports of COVID-19 vaccines to these countries to an export authorisation requirement would be counterproductive due to their proximity and dependency on Union supplies of vaccines (most of them do not have their own production capacity for the vaccines in question in adequate quantities) and the fact that vaccines are an essential product necessary to prevent the further spreading of the pandemic. It is therefore appropriate to exclude such countries from the scope of application of this Regulation.

(12)

It is likewise appropriate to exclude from the export authorisation requirement the overseas countries and territories listed in Annex II to the Treaty, as well as the Faeroe Islands, Andorra, San Marino and the Vatican City since they have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively.

(13)

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 need not be exempted in order to receive unrestricted shipments from within the Union. This is the case notably for the Principality of Monaco (2). Conversely, territories of Member States specifically excluded from the customs territory of the Union should not fall under the requirement of export authorisation and should therefore be exempted as well. This concerns the territories of Büsingen, Helgoland, Livigno, Ceuta and Melilla. Likewise, exports to the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to United Nations Convention on the Law of the Sea (UNCLOS) should be exempted from the application of this regulation. All these territories, likewise, have a particular dependency on the supply chains of the Member States which they are part of or of neighbouring Member States, respectively

(14)

To assess the situation in regular intervals, and in order to ensure transparency and consistency Member States should report their decisions to grant or reject requests for export authorisations to the Commission. The Commission should make such information publicly available on a regular basis, due account being taken of their confidential nature.

(15)

In order to ensure an effective monitoring of the situation and to assess whether the objectives of this regulation are met when the export authorisations are requested, the manufactures that have concluded APAs with the Union should provide to the Member States and to the Commission relevant data concerning their exports in the last three months. This information should include the volume of exports of COVID-19 vaccines, the final destination and final recipients and a precise description of the products. The absence of such information may lead to refusals of export authorisation.

(16)

Due to the urgency of the situation, justified by the fast spreading of the COVID-19 pandemic, the measures provided for in this Regulation should be taken in accordance with Article 3(3) of Regulation (EU) 2015/479.

(17)

It is considered that measures should remain in force until 31 March 2021, when full production capacity for COVID-19 vaccines in the EU has been installed and the risk of shortages and diversion of supplies will be reduced.

(18)

This Regulation should enter into force on the day following that of its publication. Having regard to Article 5(5) of Regulation (EU) 2015/479, the initial measures should have a duration of six weeks. In order to cover the period until 31 March 2021, the Commission intends to propose an extension of these measures pursuant to Article 6 of Regulation (EU) 2015/479,