EU Privacy Regulators Issue Opinion on Proposed Biotech Act

JD Supra Healthcare

Published March 10th, 2026

Detected March 28th, 2026

Summary

The European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issued a joint opinion on the proposed EU Biotech Act. The opinion supports the act's goals but calls for clarification on GDPR compliance, data processing, consent, AI obligations, and data retention for clinical trials involving medicinal products.

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What changed

The European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) have issued a joint opinion on the European Commission's proposed EU Biotech Act, which aims to update legislation governing clinical trials and the use of advanced technologies like AI in the medicinal product lifecycle. The opinion supports the initiative but seeks greater clarity on GDPR compliance, particularly concerning informed consent, data processing responsibilities (identifying sponsors and investigators as controllers), data retention periods, and the formal recognition of electronic informed consent. It also highlights new obligations for sponsors regarding AI risk assessment and data integrity, urging alignment with the EU AI Act.

Life sciences companies involved in clinical trials in the EU should review this opinion as it will inform the European Parliament's review of the proposed Act, expected to be adopted in late 2027 or 2028. The opinion suggests potential shifts in data governance, consent management, and AI deployment strategies. Companies should proactively assess how these proposed changes might impact their trial designs, data reuse policies, and contractual arrangements with investigators and trial sites to ensure future compliance.

What to do next

Review joint opinion for impact on clinical trial data governance and AI use.
Assess potential changes to informed consent procedures and data retention policies.
Evaluate alignment of AI risk assessment obligations with the EU AI Act.

Source document (simplified)

March 27, 2026

EU Privacy Regulators Weigh in on the Proposed EU Biotech Act: Key Takeaways for Life Sciences Companies

LinkedIn Facebook X Send Embed On March 10, 2026, the European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) issued a joint opinion on the European Commission’s proposed EU Biotech Act – a forthcoming legislative framework expected to materially affect how clinical trials are designed, conducted, and governed in the EU.

The proposal, introduced in December 2025, would amend key EU life sciences legislation, including the EU Clinical Trials Regulation (CTR), and introduce new requirements for the use of advanced technologies such as artificial intelligence (AI) across the medicinal product lifecycle.

Why This Matters for Life Sciences Companies

The joint opinion broadly supports the Commission’s initiative but highlights several areas where clarification is needed to ensure compliance with the GDPR and to provide legal certainty for sponsors, investigators, and trial sites. If adopted largely as proposed, the Biotech Act could significantly reshape data governance expectations for clinical trials in the EU.

Key points of relevance include:

Greater clarity – but also higher expectations – around clinical trial data processing. The EU regulators support harmonizing GDPR legal bases for processing sensitive personal data in clinical trials, including secondary use for scientific research. However, they call for clearer rules on informed consent under the CTR and the impact of consent withdrawal, which may affect how sponsors structure data reuse strategies and long‑term research programs.
Clearer allocation of GDPR responsibility. The opinion confirms that sponsors and investigators act as controllers under the GDPR, but urges further clarification on whether they qualify as joint or independent controllers at different stages of a trial. This has direct implications for contractual arrangements, liability allocation, and data subject rights management.
More precise data retention rules. The EU regulators support limiting the CTR’s 25‑year retention period to data contained in the clinical trial master file, rather than all personal data processed during a trial. This clarification could reduce long‑term data storage burdens and compliance risk for sponsors.
Formal recognition of electronic informed consent. While the EDPB and EDPS welcome explicit recognition of electronic consent under the CTR, they stress the need to distinguish it from GDPR consent and to ensure accessibility for participants without digital access – an important consideration for trial design and patient engagement strategies.
New AI‑related obligations for sponsors. The opinion endorses requirements for sponsors to assess patient safety and data integrity risks arising from the use of AI in clinical trials. The EDPB and EDPS also call for clarity on how these obligations align with the EU AI Act, signalling increased scrutiny of AI‑enabled trial tools and analytics.
Expanded EU‑level support for innovation. The EU regulators encourage additional guidance, regulatory sandboxes, and testing environments to support advanced biotechnology development – potentially offering new opportunities for compliant innovation in the EU. What’s Next?

The joint opinion will inform the European Parliament’s ongoing review of the proposed Biotech Act. Legislative discussions are expected to continue through 2027, with adoption anticipated in late 2027 or 2028.

Life sciences companies conducting clinical trials in the EU should begin assessing how the proposed framework could affect trial governance models, data strategies, AI deployments, and contractual arrangements with investigators and trial sites.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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