Under the German Foreign Investment Control regime, the Government may review foreign investments in domestic target companies above certain thresholds. The Government has only recently published interesting statistics about the development of German investment screening over the past three years (available in German only). These statistics show that foreign investments across all industries have come under heavy scrutiny by the Government. Therefore, it has become indispensable for foreign investors to review potential FDI filing obligations or consider a voluntary FDI filing during legal due diligence, regardless of the investor’s place of origin, the size of the domestic target business or the industry affected by the contemplated investment.
First Dawn Raid Carried Out by The European Commission | Another Investigative Tool Deployed Under the Foreign Subsidies Regulation
Since the Foreign Subsidies Regulation (FSR) entered into force on July 12, 2023, the European Commission has increasingly started to wield the powers granted to it. It opened its first in-depth investigation into a public procurement process in Bulgaria in a case involving locomotives on February 16, 2024 (read more in our previous post here) which led to the withdrawal of the Chinese from the public tender. Subsequently on April 3, 2024, the Commission initiated two new in-depth investigations, again in a public procurement matter, this time concerning solar panels. On April 9, 2024, the Commission initiated its first ex officio investigation in the wind turbine sector.
How to Determine Which Investors Should be Disclosed Under the Foreign Direct Investment Screening Regime in France, the United Kingdom and the United States
Where a transaction is carried out by an investment fund, the question of which investors should be disclosed under Foreign Direct Investment will eventually surface. We consider the necessary disclosures under French, US and UK FDI screening.
There is significant potential for divergence as to how new(er) FDI rules are applied in practice, in particular in relation to common structures used by private equity. One question that arises regularly is whether the FDI regimes are catching the limited partner investors (LPs) in the same way as any other direct investors.
Quarterly Sanctions Update | Q1 2024
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
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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