Forthcoming legislative changes

Several legislative changes are being discussed at the European Union level. With overarching aims of bringing timely and equitable access to safe, effective, and affordable health products for all patients across the EU, they will impact on the development of gene and cell therapy. 

You will find below an overview of the legislative changes that are being discussed at the European Union level by May 2026, as well as analysis of some of the proposed changes that will impact on gene and cell therapy. 

Of note, several EuroGCT key resources cover forthcoming legislative changes for a targeted topic. They are generally presented and discussed in the sections on ‘Opportunities and Incentives’ and/or ‘Challenges’ where relevant. For instance, the forthcoming legislative changes have been covered in the EuroGCT key resources on Clinical Trials of ATMPs and Genetically Modified Organisms-based Advanced Therapy Medicinal Products. 

Overview of the legislative changes being discussed at the European Union level by May 2026

Of note, this overview does not cover recent developments and current discussions linked to data and Artificial Intelligence, such as :

• The Artificial Intelligence Act, so-called ‘AI Act’: Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act). It will apply mainly from 2 August 2026.
• The Cloud and AI Development act (so-called ‘CADA’): A European Commission proposal is expected to be published soon. More information on the European Parliament website here, and on the ‘EU Cloud and AI Development Act’ website here.

Forthcoming Implementation of the EU regulation 2024/1938 on substances of human origin intended for human application

• The EU regulation 2024/1938 on substances of human origin intended for human application was adopted on 13 June 2024.
• It will be applicable from 7 August 2027 except some specific provisions
• It will repeal, from 7 August 2027:
  • Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30).
  • Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).

The Reform of EU pharmaceutical legislation

• In 2021, the European Commission started to work on revising the pharmaceutical legislation.
• After various consultation activities, studies, and evaluation and impact assessment of the general pharmaceutical legislation which are detailed on the European Commission website here, the legislative process for the revision started on 26 April 2023 with the publication of several documents.
• Two texts were the centrepieces of the proposed reform, and will impact on ATMPs development
  • A European Commission proposal for a new Regulation (COM(2023) 193 final) and
  • A European Commission proposal for a new Medicines Directive (COM(2023)192 final).
• In December 2025, a Political Agreement was reached on the content of this reform by the Council and the European Parliament. For more information, please see Commission welcomes political agreement on major reform of EU pharmaceutical rules, 11 December 2025.
• The full legislative process, including positions of the European Parliament and Council can be followed on the ‘EU law tracker’ tool:
  • Here for the proposed new Regulation
  • Here for the proposed new Directive
• The final texts are expected to be adopted by the end of 2026.

The European Commission Proposal for a European Biotech Act

• On 16 December 2025, the European Commission adopted a Proposal for a so-called ‘European Biotech Act’: Proposal for a Regulation - strengthening the Union's biotechnology and biomanufacturing sectors (COM/2025/1022 final)
  • The full legislative process, including positions of the European Parliament and Council, can be followed on the ‘EU law tracker’ tool here.
• The Proposal for a ‘European Biotech Act’ has been accompanied by a Proposal for a Directive modifying the existing legislations for placing on the market of genetically modified micro-organisms and processing of organs: Proposal for a Directive - placing on the market of genetically modified micro-organisms and processing of organs (COM (2025) 1031)
  • The full legislative process, including positions of the European Parliament and Council, can be followed on the ‘EU law tracker’ tool here.

For more information on the potential impact on ATMPs of the proposal for a European Biotech Act, please see below a poster entitled 

“The European Commission proposal for a new regulation on biotechnology: why does it matter for ATMP?”

presented by A. MAHALATCHIMY, V. ROBY, C. CHABANNON, at ISCT 2026, 6-9 May 2026, Dublin, Ireland.