Thursday, 1 April 2021
Department of Enterprise, Trade and Employment
6. To ask the Minister for Enterprise, Trade and Employment if his attention has been drawn to possible plans at EU level to impose bans on exports of Covid-19 vaccines to certain non-member states due to similar restrictions in certain countries; and the way in which this may impact on international agreements and on the supply chains of pharmaceutical companies based here. [17838/21]
My Department has been engaged on the matter of the EU vaccination authorisation mechanism since the EU's initial Implementing Regulation (EU 2021/111) was adopted in late January, 2021. This Implementing Regulation sought to monitor vaccine exports from the EU to 3rd countries for an initial period of 6 weeks. It was succeeded by Implementing Regulation (EU 2021/442) which extended the monitoring and authorisation period to 30 June 2021.
The European Commission has since adopted a third Implementing Regulation (EU 2021/521) which provides additional authorisation criteria that Competent Authorities within each Member State must consider when assessing any vaccine authorisation request received, including exports to 3rd countries with large vaccine manufacturing capacity and exports to 3rd countries with a higher vaccination rate than the Union, or where the epidemiological situation is less serious than in the Union.
Export authorisation requests for vaccine exports are submitted to the Competent Authority where the vaccine or its active ingredients are manufactured. Currently, Ireland does not manufacture final vaccines for export, however, in fulfilment of our legal obligations, my Department's Trade Licensing & Control Unit has been designated Ireland's "Competent Authority".
Commission President, Ursula von der Leyen, has been clear that the mechanism underpinned by the Regulation(s) is focused on export monitoring and transparency and is not designed to be an export ban. The export authorisation mechanism has been adopted to preserve the security of EU and global supply chains by introducing the principles of reciprocity and proportionality. The new legal act gives Member States the necessary degree of flexibility to authorise exports unless they cause concern, on a case-by-case basis.
The Commission has stated that the application of the authorisation mechanism should be carefully considered by the Competent Authorities, in conjunction with the Commission, to ensure that decisions are made in a balanced way in order to maintain complex supply chains while safeguarding the availability of vaccines for EU citizens on an equitable basis. Competent Authorities will assess the situation in the EU regarding Advanced Purchase Agreement (APA) commitments, but also the situation in the destination countries. It is also important to record that the most vulnerable countries, including least developed countries and dependent countries within the EU's geographic sphere continue to be exempt from the mechanism.
The Commission is eager to ensure that EU citizens receive a fair share of vaccines, having regard to the Union's €2.7b investment in vaccine development, and to invite other vaccine producing 3rd countries to open their own exports of vaccines. In this regard, I am pleased to record that export data resulting from the mechanism's monitoring function demonstrates that the EU is the main exporter of vaccines globally. Export figures up to 25 March 2021, show that 77 million vaccine doses were exported out of the EU since 1 December. Moreover, virtually every application within the EU for an authorisation has been granted.
As the Deputy will be aware, Ireland supports the pursuit of open, free trade rooted in the multilateral, rules-based system and the WTO. From first principles, we require a very high burden of justification for the introduction of any export monitoring or control measure. We endeavour to ensure that when any such measures are introduced that they are very tightly focused and timebound. Ireland appreciates the highly integrated and global nature of supply-chains for vaccine manufacturing and the vital importance of unrestricted movement of goods to the viability of multinational manufacturing. Accordingly, my Department will continue to advocate for the earliest feasible conclusion of the existing measures, which are currently designed to run until 30 June 2021, as well as for the highest thresholds of justification to be applied when assessing export authorisations received from industry.
Finally, I might also note that in light of the worldwide need for vaccines in the context of COVID-19, the Commission is also working with industry to endeavour to ensure maximum manufacturing capacity is committed to vaccine production.