vLex European Union

Competition & State Aid • EU approves new and amended Member State measures to support the economy Trade / Export Controls • EU and India launch the High-Level Dialogue on Trade and Investment, with a particular focus on COVID-19’s impact • EU adopts Joint Communication on new Agenda for the Mediterranean, particularly in view of Southern Neighbourhood recovery from the COVID-19 crisis • The EU’s Association Implementation Report on Georgia welcomes Georgia’s commitment to continue its reform process, despite COVID-19’s impact Medicines, Medical Devices, and Personal Protective Equipment • European Commission and EMA update Guidance on management of clinical trials ... (See Article)

Financial investors, including private equity businesses, can be held liable for competition law infringements committed by one of their portfolio companies. (See Article)

Almost a year ago now, the pandemic outbreak disrupted the worldwide entertainment industry – and in particular, film and television production. Similar to the US, European audio-visual productions were halted, movie theaters were closed, events, premieres and entire marketing and distribution campaigns were postponed or cancelled... (See Article)

Hogan Lovells litigation partners Matthew Felwick and Valerie Kenyon took part in a panel discussion on the EU Representative Actions Directive, at the British Institute of International and Comparative Law (BIICL) on 3 February 2021. The panellists included Augusta Maciuleviciute (BEUC - the EU consumer organisation), Neil Purslow (Therium Capital Management), and Rhonson Salim (Aston Law School). Please see full Publication below for more information. (See Article)

On February 19, 2021, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “eREACHNano helps you to register nanoforms under REACH” by Dorte Rasmussen, Ph.D., who has been working on the exposure and risk assessment of chemicals at DHI A/S for almost 25 years. Rasmussen describes eREACHNano, a tool developed to explain Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requirements for nanoforms. (See Article)

On November 20, 2020, the working group on euro risk-free rates (the Euro Working Group) published two consultations on fallback rates to EURIBOR. Market participants were invited to provide their views on the potential events that could trigger fallback measures and the fallback rates based on the euro short-term rate (€STR) and spread adjustment methodologies. The results of the consultations show that market participants are not in agreement on all matters relating to transitioning from EURIBOR to €STR. (See Article)

In a solid step forward for EU to UK personal data transfers, the European Commission has published its draft adequacy decision that will (if finally adopted) permit personal data to flow freely from the EU to the UK. As we wrote in January (when the UK’s exit from the EU took practical effect), the EU agreed to continue to let personal data flow to the UK for a temporary period while the adequacy of the “UK GDPR” was under evaluation. (The UK had already committed to allowing UK personal data to be transferred to the EU freely on the basis that the EU’s GDPR provides adequate protection for the transferred data.) (See Article)

AVIATION REGULATORY AND POLICY - Aviation Policy: European Commission Presents its “Sustainable and Smart Mobility Strategy” - The European Commission (Commission) presented its “Sustainable and Smart Mobility Strategy,” together with an action plan listing a set of measures to be adopted over the next four years on 9 December 2020. (See Article)

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 • EU approves new and amended Member State measures to support the economy Trade / Export Controls • European Commission issues FAQs on export requirements for COVID-19 vaccines • European Parliament welcomes appointment of new Director-General of the World Trade Organization Medicines, Medical Devices, and Personal Protective Equipment • Janssen-Cilag applies to EMA for conditional marketing authorization for a COVID-19 vaccine • EMA starts rolling review of CureVac’s COVID-19 vaccine Cybersecurity, Privacy & Data Protection • No noteworthy items for this issue Please see full Newsletter below for more information. (See Article)

PAL-V, the first flying car to be allowed on the road in Europe, is now also the first flying car to complete full certification with the European Union Aviation Safety Agency (EASA). (See Article)

A team led by Christelle Coslin, Liam Naidoo, Julia Marlow and Kevin O’Connor has submitted a response to a European Commission consultation on their sustainable corporate governance initiative. Please see full Publication below for more information. (See Article)

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in part 2 of our series of articles, in this part 3, we now turn to the issue of risk classification of such MDSW under the MDR... (See Article)

On January 29, 2021, Canada and the European Union (the “EU”) took additional steps to establish the EU-Canada Comprehensive Economic and Trade Agreement (the “CETA”)[i] by adopting four decisions required to implement its new dispute resolution system. Pending ratification, the CETA will transform investment protection for Canadian companies and nationals investing in the EU, as well as EU companies and nationals investing in Canada. (See Article)

With the United Kingdom’s withdrawal from the European Union, companies must reconsider the implications of doing business in the UK and the EU, including how Brexit affects the company’s intellectual property rights. Included below is a summary of the effects of Brexit on trademark rights held in the EU and the UK, and steps which may be taken to maintain coverage in the UK. (See Article)

Now that the COVID-19 vaccine contract between the EU and AstraZeneca has been published, we take a look at it and the “Best Reasonable Efforts” provisions. (See Article)

This 1970 hit by Simon & Garfunkel is a beautiful song about giving a helping hand to someone caught in a situation of distress. And there is also broad consensus around the world that the digital platform markets are caught in troubled waters. A few mighty rivers run so high and so fast that they are drowning smaller creeks around them and carrying away anyone riding them. Different attempts to contain these massive flows have been made, but they were not strong enough... (See Article)

In an ideal world, we were supposed to be well beyond Brexit by now. On February 23rd the UK consented to the EU’s request for further time to ratify the EU-UK Trade and Cooperation Agreement (TCA). The TCA has been applied provisionally in the EU since January 1 and was supposed to be ratified by February 28th. This extension to April 30, 2021 should allow the EU decision-makers time to ratify the TCA as things have been sidetracked in combatting COVID-19 and borrowing perhaps from the Banking Union to build a Health Union. The EU Council have committed to strengthen future health resilience and financing – especially now that Next Generation EU (NGEU) and common debt based refinancing of the recovery efforts are now approved. A report on lessons learned from the present pandemic has been commissioned by June 2021.  (See Article)

A resource has been added European Management Review (from the number 1-1, March 2004)

A resource has been added European Law Journal (from the number 1-1, March 1995)

A resource has been added European Financial Management (from the number 1-1, March 1995)

Many supervisory authorities across Europe have reported increasing numbers of data breach notifications since the introduction of GDPR. While most companies are now familiar with the 72-hour reporting obligation for controllers to supervisory authorities, whether such obligation has been triggered continues to present unique and complex questions in each specific security event. To help aid companies sorting through these potential legal notification obligations in the aftermath of a security event, the EDPB recently released draft guidance, which is open for comment until 2 March 2021... (See Article)

The Competition and Distribution team of BCLP's Paris office reviews some key news from the end of 2020, in particular: ..The “Dammann Frères” decision of 3 December 2020 concerning the tea manufacturer's online sales practices. The French Competition Authority (the "FCA") vigorously emphasises that the prohibition of fixed prices also applies to online sales. The FCA also points out that the prohibition of sales on marketplaces does not necessarily constitute a hardcore restriction; ..The Court of Cassation's (French civil Supreme Court) ruling of 25 November 2020, which unfortunately validates the seizure of attorney/client correspondence by the FCA or the DGCCRF when it is not clearly established by the raided company that this correspondence is directly related to the exercise of its defence rights. (See Article)

At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas.  Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. (See Article)

Earlier today, The Dubai International Financial Centre Courts (DIFC) and Dubai Future Foundation announced the creation of a “Space Court” to provide legal solutions in commercial-related space disputes. As space becomes more commercialized and globalized, it will be increasingly important to be able to rely on a venue for resolving disputes involving complex commercial agreements, and multiple treaties governing space law... (See Article)

An ambitious plan to enhance the geopolitical strength of the EU? On 19 January 2021, the European Commission presented its new strategy to foster the “openness, strength and resilience” of the EU’s economic and financial systems into the future (the Strategy). Two of the most important issues underpinning the Strategy are the former Trump administration’s extensive use of secondary sanctions to influence the conduct of non-U.S. persons and the EU’s desire to promote its green finance agenda. In that light, the Strategy has three complimentary pillars: first, it aims to promote a stronger international role for the euro; second, it will seek to further develop the EU’s financial market infrastructures and improve their resilience; and third, it aims to promote the uniform implementation and enforcement of the EU’s own sanctions. (See Article)

The European Court of Justice has confirmed that financial investors can incur parental liability for the anticompetitive practices of portfolio companies, even after an IPO that left the investor holding only a minority stake in the company, provided that they still have sufficient representation at the board of directors. This judgment is of major interest… (See Article)

We hope you’re settling in well in to what is already quite an eventful 2021. While the European Commission continues to focus on combatting COVID-19 including clarifying confusion in contractual arrangements with vaccine providers, it is also pressing ahead with its longer-term plans to future-proof against further pandemics, drive the economic recovery as well as add a Health Union, some of which builds of lessons learned from its Capital Markets Union and Banking Union efforts.  (See Article)

On January 27, 2021, the Court of Justice of the European Union (“CJEU”) issued an important ruling regarding an investment fund’s liability for the cartel behaviour of an affiliate. The CJEU confirmed that an investment fund is liable under Article 101 of the Treaty on the Functioning of the European Union based on holding 100% voting rights over an indirect affiliate that participated in a cartel, even though the fund held well below 100% equity in that affiliate during part of the relevant period. (See Article)

As we began exploring last week in Part I of our Post-Brexit, Schrems II, and the GDPR: Privacy Compliance Priorities in Early 2021 series, significant developments in late 2020 charted a course in privacy/cyber compliance for companies doing business in the European Economic Area (EEA) to take in early 2021. New guidance was issued by the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS), and the European Commission released new versions of Standard Contractual Clauses (SCCs) for public comment... (See Article)

The European Court of Justice (the "ECJ") has confirmed1 the EU General Court’s (and the European Commission’s) finding that Goldman Sachs was jointly liable for the conduct of a former subsidiary, Prysmian, which the Commission fined for its involvement in the high voltage power cables cartel during Goldman Sachs' period of control. The ECJ judgment constitutes a stark warning to institutional investors to ensure portfolio companies that they acquire and control comply with competition law. (See Article)