The Council has agreed its position on targeted amendments to health legislation that seek to boost innovation in the EU’s biotechnology sector. The draft European Biotech Act I directive updates the rules on genetically modified micro-organisms (GMMs) and the processing of organs.
"Today’s agreement sends a clear signal that Europe is committed to remaining a global leader in biotechnology. By modernising rules on genetically modified micro-organisms and organ processing, we are creating a regulatory environment that supports innovation while maintaining high standards of safety, transparency and public trust."
- Neophytos Charalambides, Minister for Health, Republic of Cyprus
Aim of the Directive
The proposed directive accompanies the European Biotech Act I regulation, which seeks to strengthen Europe’s biotechnology potential by making it quicker and easier for innovative ideas to move from the laboratory to the market. The proposal amends two existing directives, with the aim of:
- streamlining the rules on the placing of certain GMMs on the market
- updating the rules on organ processing to reflect recent scientific advances
The proposed changes will enable the EU to benefit from the innovation potential of GMMs by introducing a more efficient regulatory process for certain GMMs that comply with predetermined safety standards.
Regarding organs, the latest scientific and clinical developments extend the amount of time that can elapse between procurement and transplantation of organs. These developments create opportunities for innovative approaches to processing organs.
The Council’s Position
Greater Clarity and Precision
The Council’s mandate increases the clarity, precision and level of detail of the directive, including by:
- aligning the terminology with that used in other relevant legislative acts
- reorganising text elements and clarifying provisions to ensure effective implementation
- clarifying the respective competences of the Commission and the member states
For example, the Council has replaced the term “low-risk GMMs” with “GMMs eligible for an expedited procedure” to reflect the overall intention of the act and avoid giving the impression that GMMs not falling within this category are “high risk” by definition.
Autologous Use of Organs
Regarding organ processing, the Council has clarified the distinction between the “autologous” use of organs (i.e. transplantation within the same person) and the transplantation of organs to another person. As autologous transplantation often takes place in emergency situations, the new provisions ensure that surgeons’ actions will not be impeded by restrictive regulatory requirements.
Validity of Consent
The Council’s position also clarifies the rules relating to the validity of consent with regard to GMMs. Under the Commission’s original proposal, once consent had been granted to place a GMM on the market, such consent would be valid indefinitely. The Council has introduced an added safeguard, by limiting the validity of the initial consent to a maximum of 10 years. Upon renewal, and unless certain exceptions apply, the consent will be granted indefinitely.
Processing of Personal Data
The Council’s position introduces new provisions to take account of the fact that, in the context of organ transplants, personal data may need to be processed to ensure patient safety and high healthcare standards, as well as to facilitate cross-border data sharing to help analyse transplant outcomes across a wider group of patients. As a result, it includes provisions specifying that in such cases, processing of personal data can be deemed to be in the public interest.
Next Steps
Once the European Parliament has established its position, the two institutions will enter into negotiations to agree on the final text.
Background
The European Biotech Act I directive was published on 16 December 2025 as part of the Commission’s Health Package. It supports the wider objectives of the European Biotech Act I regulation by introducing targeted amendments to directive 2001/18/EC as regards the placing on the market of GMMs and directive 2010/53/EU on the processing of organs, with the aim of facilitating innovation, enhancing legal certainty, ensuring coherence between existing EU legislative acts, and taking account of scientific and technical developments.
EU Biotech Mandate: Regulatory Simplification and Innovation
The European Council's agreement on a mandate to advance biotechnology innovation represents a significant policy shift aimed at strengthening the EU's competitiveness in the global life sciences landscape. The mandate focuses on simplifying regulatory approvals for biotechnology products, reducing administrative burdens for clinical trials, and supporting the development of advanced therapies (ATMPs) within member states.
By establishing harmonized pathways and boosting funding for regional biotechnology clusters, the EU aims to prevent innovation flight to the US and Asia, ensuring that European patients have rapid access to breakthrough medical and agricultural technologies.
Frequently Asked Questions
What is the primary goal of the EU Biotech Mandate?
The mandate aims to accelerate regulatory timelines, simplify clinical trial authorizations, and increase funding for biotechnology research and manufacturing across the EU.
What are ATMPs?
Advanced Therapy Medicinal Products (ATMPs) are medicines based on gene therapy, somatic cell therapy, or tissue engineering, representing the cutting edge of personalized medicine.
How does the mandate support small biotech startups in Europe?
By providing administrative support, fee reductions for regulatory advice, and simplified market access pathways to help startups transition from research to commercial phases.
