This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.
LATEST KEY DEVELOPMENTS
Competition & State Aid
- European Commission comments on transatlantic relations in post-pandemic world, including building resilient supply chains
- European Commission approves new and amended Member State measures to support the economy
Trade / Export Controls
- Executive Vice President and European Commissioner for Trade comments on access to COVID-19 vaccines ahead of WTO Ministerial Conference
Medicines and Medical Devices
- EMA ends rolling review of antibodies for treating COVID-19 following withdrawal by developer
Cybersecurity, Privacy & Data Protection
- European Commission adopts Delegated Regulation to the Radio Equipment Directive to strengthen cybersecurity
- European Commission adopts EU Digital COVID Certificate Equivalence Decisions for Armenia and the United Kingdom
COMPETITION & STATE AID |
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European Commission comments on transatlantic relations in postpandemic world, including building resilient supply chains (see here) |
On 12 November 2021, Executive Vice-President and Competition Commissioner Margrethe Vestager addressed EU-US relations, particularly in view of emerging from the COVID-19 crisis and the need for resilient supply chains. Commissioner Vestager reminded that at the pandemic's peak, European vaccine manufacturers were unable to source components from the US, creating shortfalls in production. To address EU dependencies in strategic sectors, in May 2021, the Commission assessed 5,200 products imported into the EU in sensitive sectors (see here). It is focusing on 34 of these products where the EU is considered to have strategic dependencies from third countries (notably in raw materials, chemicals and pharmaceutical ingredients) and where the Commission believes that the market cannot be expected to solve dependencies on its own through diversification. Similarly, the US also undertook a supply chain review, which identified vulnerable areas that largely overlapped with those identified by the European Commission. Commissioner Vestager's comments focused on the field of semiconductors, where she indicated that a serious current shortage is undermining recovery from the pandemic. She noted that both the EU and the US have set targets to expand innovative capacities in the design and manufacture of semiconductors. On EU initiatives, Commissioner Vestager referred in particular to: A proposal for a European Chips Act,
expected in the first half of 2022, which would aim to make Europe
more competitive by promoting a state-of-the-art European chip
ecosystem by strengthening innovation, production capacity, as well
as security of supply through a framework for international
cooperation and partnership. The proposed Act would also aim at
coordinating EU and national investment along the value
chain.
Investment through Important Projects
of Common European Interest (IPCEI). IPCEIs are intended to
facilitate, within the State aid framework, the emergence of
large-scale cross-border projects of significant benefit to the EU
economy and its citizens by addressing perceived market failures in
strategic value chains. A second IPCEI concerning semiconductors is
under preparation, following the first IPCEI , approved by the
Commission on 18 December 2018 following a joint notification by
France, Germany, Italy and the UK to give €1.75 billion in
public support to a joint research and innovation project in
microelectronics, to be completed by 2024 (see
here).
Commissioner Vestager also emphasized the importance of avoiding a detrimental subsidies race. State aid may be justified only if it is deemed necessary to get a project off the ground and provided that competition distortions are sought to be minimized and that benefits are to be shared widely and without discrimination across the European economy. In this respect, she indicated that the anticipated European Chips Act would seek to provide a coordinated EU approach. Finally, Commissioner Vestager referred to the Summit on Global Supply Chain Resilience chaired by US President Biden on 31 October 2021 in the context of the G20 Summit (see here), which she viewed as a "good start" towards "building more common ground... and find[ing] agreements that will outlast the crises of tomorrow." |
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European Commission approves new and amended Member State measures to support the economy (see here and here) |
Since the onset of the coronavirus outbreak, the Commission has adopted a significant number of State aid measures under Article 107(2)b, Article 107(3)b and under the Temporary Framework. The Temporary Framework, adopted in March 2020, is currently applicable until 31 December 2021.
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TRADE / EXPORT CONTROLS |
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Executive Vice President and European Commissioner for Trade comments on access to COVID-19 vaccines ahead of WTO Ministerial Conference (see here) |
On 11 November 2021, Executive Vice President and European Commissioner for Trade, Valdis Dombrovskis provided remarks following the Foreign Affairs Council (Trade) meeting of the Council of the European Union. In particular, Commissioner Dombrovskis commented on preparations for the 12th World Trade Organization (WTO) Ministerial Conference from 30 November to 3 December 2021 in Geneva. He reiterated that a strong WTO is vital for the global trading system, which is why the EU is actively engaged in the run-up to the Ministerial Conference. Commissioner Dombrovskis indicated that the EU has a particular interest in the issue of trade and health. Universal and fair access to COVID-19 vaccines is a top priority for the EU, which is engaged in intensive discussions on this issue. He emphasized the EU's view that intellectual property (IP) should not be a barrier to ramping up vaccine production, which could be achieved by facilitating the use of compulsory licenses (see also Jones Day COVID-19 Update No. 51 of 15 June 2021). The Foreign Affairs Council (Trade) indicated that the issue of how to provide a common IP response to COVID-19 would be part of the discussions at the WTO Ministerial Conference (see here). The two main proposals under discussion in anticipation of the Ministerial Conference are:
In addition, a draft Ministerial declaration on trade and health, crisis preparedness and resiliency may also be issued. The Foreign Affairs Council (Trade) will meet again in the margins of the Ministerial Conference in view of setting out the position to be taken on behalf of the EU. |
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