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Following calls by the European Parliament for potentially far-reaching changes, the European Commission has now kicked off the EU legislative process to revise the European Works Council Directive. This alert provides an update on the Commission’s proposals, and we will issue further alerts as the legislative process continues.

On 23 January 2024, the European Medicines Agency published an updated version of the user guide for micro, small and medium-sized enterprises in the pharmaceutical sector. The revised guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorization of medicines for human and veterinary use.

On 24 January 2024, the European Commission published a package compromising five initiatives aimed at bolstering the EU’s economic security amidst growing geopolitical tensions and profound technological transformations. Central to this package is a proposal for a reform of the existing EU foreign investment review screening framework as it currently exists on the basis of Regulation (EU) 2019/452 and essentially provides for a notice-and-comment procedure in its current form.

Hot on the heels of the unanimous vote by Ambassadors for the EU Member States approving the EU AI Act on 2 February, on 13 February, lawmakers from the EU Parliament have also overwhelmingly voted in favor of the Act as it continues on its legislative journey. The joint internal market and civil liberties committee of the Parliament voted 71 to 8 to approve the Act, with 7 abstentions. This now leaves the path to bringing the Act into force only requiring a final vote by the European Parliament and national ministers, likely to be in April, which is now seen very much as a rubber-stamping exercise, given the votes that have taken place.

On 7 February 2024, the European Parliament voted on the proposed Directive amending the Alternative Investment Fund Managers Directive (2011/61/EU) (AIFMD) and the UCITS Directive (2009/65/EC) relating to delegation arrangements, liquidity risk management, supervisory reporting, provision of depositary and custody services, and loan origination by alternative investment funds.

The text of the directive will now be voted by the European Council. Once fully voted upon, the directive will enter into force on the 20th day of its publication in the Official Journal of the European Union.

EU member states will have two years from the directive’s entry into force to transpose it within their national law.

A key step towards the adoption of the EU AI Act was reached on 2 February 2024 as the draft text received unanimous approval from the European Council’s main preparatory body. There are further votes to follow before the Act is adopted, but it’s looking likely that the final vote will take place in April and some substantive provisions of the Act could be in force soon after that, possibly by the end of the year.

On 17 January 2024, the European Parliament adopted a proposal for a new EU Directive empowering consumers for the green transition introducing new rules to ban misleading advertising and to provide consumers with better product information. To achieve this, a number of marketing practices related to greenwashing will be added to the EU list of prohibited commercial practices. In addition, new rules on informing consumers on a product’s durability will be introduced.

Artificial Intelligence (AI) is revolutionizing the human resources landscape, offering unprecedented opportunities for efficiency and innovation. However, this rapid adoption of AI also brings forth critical ethical considerations, particularly in the fields of employment law and human rights protection. Several laws and regulations on AI governance are currently on the way. At the EU level, for example, the AI Act is currently in the legislative process.

8 December 2023 was a historic moment for AI regulation in Europe. Following three days of extensive debates, the EU Parliament, Council and Commission finally announced a provisional agreement on the EU AI Act, the bloc’s landmark legislation regulating the development and use of AI in Europe. It is one of the world’s first comprehensive attempts to regulate the use of AI.