On 22 June 2023, the Court of Justice of the European Union ruled in the Joined Cases C-6/21 P and C-16/21 P on the impartiality requirement of the scientific committees’ members and experts involved in the European Medicines Agency’s activities.
On 23 June 2023, EMA’s GCP Inspectors Working Group updated the Q&A on Good Clinical Practices. In particular, the update has allowed for the possibility, if in compliance with applicable European regulations and the requirements of ICH E6 guideline, that the sponsor may support the investigator by identifying or contracting service providers or personnel to be directly involved in the conduct of the clinical trial (e.g., by providing additional resources to the clinical trial site or qualified personnel).
In the Official Gazette of 14 June 2023, the Decree of the Ministry of Health of 20 March 2023 regulating the requirements of facilities suitable for conducting clinical investigations and the Decree of the Ministry of Health of 20 March 2023 introducing provisions to ensure that persons in charge of evaluating and validating clinical investigation applications do not have a conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons financing the clinical investigation, and are free from any undue influence were published. These decrees, which are immediately applicable, are provided for in article 16, paragraphs 5 and 8 of Legislative Decree No. 137/2022.
On 13 July 2023, in Case C-106/22, the European Court of Justice delivered its decision in relation to a preliminary reference submitted by the Budapest High Court. In the context of companies that often have a cross-border ownership structure extending outside of the EU, the ECJ concluded that the fact that a parent company registered in a third country has a majority control over an EU-based investor does not mean that the EU FDI Screening Regulation applies.
On 18 July 2023, HM Treasury and HMRC published draft tax legislation for inclusion in the Finance Bill 2024 and certain policy papers. The draft legislation is open for technical consultation until 12 September 2023. Finance Bill 2024 is expected to be introduced to Parliament in Autumn 2023 and to receive Royal Assent in Spring 2024.
On 15 July 2023 the Italian National Anti-Corruption Authority issued the new interpretative Guidelines of Legislative Decree no. 24/2023, implementing the EU Whistleblowing Directive. The new Guidelines aim at providing practical guidance to those employers that, pursuant to the new law, are now required to implement their own internal reporting channels.
On 23 February 2022, the EU Commission proposed the Corporate Sustainability Due Diligence Directive (CSDDD). Later, on 30 November 2022 the EU Council adopted its negotiating position on the CSDDD. Recently, on 1 June 2023, the European Parliament voted in favor of the proposed CSDDD and adopted its position for negotiations with Member States on rules to integrate human rights and environmental impact into companies’ governance.
Baker McKenzie’s Sanctions Blog published the alert titled Dutch authorities make arrest over Russia sanctions circumvention on 20 July 2023. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
The EU’s Digital Operational Resilience Act (DORA) aims to promote, improve and ensure operational resilience within the financial services sector. It comes into effect on 17 January 2025. Last month, six months into the two-year implementation period, the European Supervisory Authorities published a consultation package regarding the first batch of certain draft regulatory technical standards and draft implementing technical standards on certain aspects of DORA.
The UK financial services regulator, the Financial Conduct Authority (FCA), has published a consultation to update its guidance on social media financial promotions.