Regulatory & International Trade | RIT - Helping Businesses Clear Regulatory Hurdles in Europe

Quarterly Sanctions Update | Q1 2024

by Raminta Dereskeviciute, Sabine Naugès and Michal Chajdukowski | Apr 8, 2024 | Sanctions & Export Control, Trade Control & Customs

The EU and the UK continue in their efforts of tightening sanctions against Russia, particularly in the context of the second anniversary of the Russia’s invasion of Ukraine and the sudden death of the Russian opposition leader Alexei Navalny. In this Quarterly Sanctions Update, McDermott Sanctions and Export Controls team summarizes the most recent and significant legislative amendments, as well as changes to the existing guidance, introduced between December 2023 and April 2024.

Notably, EU companies with presence in Russia will no longer be able to rely on the “partner countries subsidiary” exemption after 20 June 2024 and will be required to obtain individual licences to provide business services to their Russian entities. The processing time, information and documents relating to licence applications may vary depending on the EU Member State; for example the French competent authority requires operators to provide company specific information as well as description of services as of April 20, 2024 via Téléservice platform. Licences will also be required under a new prohibition relating to the provision of software for the management of enterprises, industrial design, or manufacture. Finally, EU exporters will need to ensure that they insert “no Russia clauses” in their agreements, prohibiting [...]

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Conflict of Interest in Drug’s Evaluation by the European Medicines Agency

by Sabine Naugès and Dr. Deniz Tschammler | Apr 4, 2024 | Compliance

In a judgment dated March 12, 2024, the Court of Justice of the European Union (the “Court of Justice“) was asked to clarify the scope of the principles that must be respected in the procedure conducted by the European Medicines Agency (EMA) for the evaluation of medicinal products.

Background

The appeal to the Court of Justice follows an application for a conditional marketing authorization submitted to the EMA on June 26, 2018, for Hopveus, a drug for the treatment of alcohol dependence.

On October 17, 2019, the Committee for Medicinal Products for Human Use (CHMP), which is part of the EMA, issued a negative opinion on this application.

In response, the applicant submitted a request for re-examination, for which the CHMP convened an ad hoc expert group, which included an expert who was also an investigator for another medicine also intended for the treatment of alcohol dependence (AD 04). Following a new unfavorable opinion dated April 30, 2020, the European Commission rejected the conditional marketing authorization.

To challenge this rejection, the applicant brought an action against the Commission and the EMA before the General Court of the European Union (the “General Court“), seeking annulment of the [...]

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Foreign Investment Control in Germany | New Administrative Fees Regime

by Dr. Deniz Tschammler, Alexandra Heberle and Dr. Laura Stammwitz | Mar 25, 2024 | Foreign Investment

Since January 1, 2024, the German Government now charges administrative fees for foreign invest-ment control (FIC) proceedings.

Under the German FIC regime, the competent federal ministry, the Bundesministerium für Wirtschaft und Klimaschutz (BMWK), may review foreign investments in domestic target companies above certain thresholds. Based on a filing submitted by the direct acquirer, BMWK has two months to review the transaction and issue a clearance certificate (Phase I). In the event of remaining queries or concerns, BMWK may initiate formal investigation proceedings, which may take several months or in certain cir-cumstances even longer (Phase II). In around 90% of cases, foreign investments are cleared in Phase 1.

French Ministry of Economy Publishes List of New Dual-Use Items & Technologies Subject to Approval Before Export

by Sabine Naugès | Mar 25, 2024 | Sanctions & Export Control

Regulation (EU) 2021/821 of May 20, 2021 is known as the “Dual-Use Regulation” and its purpose is to establish an EU regime governing the export, brokering, technical assistance, transit and transfer of dual-use items. According to Article 9 of this regulation, EU Member States must, for reasons of public security (e.g. prevention of terrorism, protection of human rights), prohibit the export of dual-use items not listed in Annex I of the Dual-Use Regulation, or at the very least make any such export subject to an authorization requirement.

Given this legal requirement, Member States might decide to adopt a national control list of any such items and so on February 2, 2024the French Ministry of Economy published an order (arrêté) establishing a national list of dual-use items and technologies subject to prior authorization. The Ministry focuses on exports to third countries of goods and technologies related to quantum computing and its enabling technologies, as well as equipment for the design, development, production, testing and inspection of advanced electronic components.

European Economic Security Strategy

by Sabine Naugès | Mar 22, 2024 | Foreign Investment, Outbound Investment

A Step Towards Regulating Outbound Investment in the European Union

On June 20, 2023, the European Commission and the High Representative for Foreign and Security Policy published a Joint Communication on a European Economic Security Strategy. The strategy highlighted that new economic security risks are emerging as a result of rising geopolitical tensions and the acceleration of technological developments. The strategy also underlined the need to develop a common EU approach.