EDPB-EDPS Opinion on Biotech Act Privacy Implications

EDPB Documents (GDPR)

Published March 12th, 2026

Detected March 13th, 2026

Summary

The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have issued a joint opinion on the privacy implications of the proposed European Biotech Act. The opinion provides guidance on the GDPR compliance aspects of the proposed legislation.

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What changed

The European Data Protection Board (EDPB) and the European Data Protection Supervisor (EDPS) have released a joint opinion (3/2026) addressing the privacy implications of the proposed European Biotech Act. This opinion scrutinizes the legislative proposal, offering insights and recommendations to ensure alignment with existing data protection frameworks, particularly the General Data Protection Regulation (GDPR). It highlights potential challenges and areas requiring clarification regarding the processing of personal data within the biotechnology sector under the new proposed law.

This document serves as guidance for stakeholders involved in the development and implementation of the Biotech Act, including legislative bodies, companies in the biotech and pharmaceutical sectors, and data protection officers. While non-binding, it signals the data protection authorities' interpretation and expectations regarding privacy safeguards. Regulated entities should review the opinion to understand potential compliance considerations and advocate for privacy-protective measures during the legislative process. No specific compliance deadlines are provided, as this is a consultative opinion on a proposed act.

What to do next

Review the EDPB-EDPS Joint Opinion 3/2026 for privacy implications related to the proposed European Biotech Act.
Assess current data processing activities against the concerns and recommendations outlined in the opinion.
Engage with legal and compliance teams to ensure future compliance with potential data protection requirements under the Biotech Act.

Source document (simplified)

EDPB-EDPS Joint Opinion 3/2026 734.9KB English Download Topics:
- EU Legislative proposal and strategy
- GDPR
- Health
- Artificial intelligence
- Controller
- Legal basis

Latest publications

#### EDPB-EDPS Joint Opinion 3/2026 on the Proposal for a European Biotech Act

12 March 2026 Publication Type:
- EDPB/EDPS Joint Opinion

EDPB letter to the European Commission on the privacy implications of recent proposed legislative changes regarding entry conditions to the United States for EEA citizens

12 March 2026 Publication Type:
- Letters

Data brokers market study

4 March 2026 Publication Type:
- Support Pool of Experts projects
The Data brokers market study provides a methodology to identify data brokers and presents a typology of data brokers, together with an analysis of their business models and an initial risk assessment.
In addition, the report provides an in-depth overview of a number of data brokers and providers identified in Belgium, ranked by type. Possible data brokers were assessed against the criteria outlined in the report. Overall, the study shows that the data broker and provider market in Belgium is highly diverse, with varying levels of risk related to personal data usage.
The EDPB launched the project in the context of the Support Pool of Experts programme at the request of the Belgian Data Protection Authority (DPA).

The project was completed by external SPE expert Ruben d'Hauwers in November 2025.

Objective

This study aims to give greater insights into the ecosystem of personal data providers and data brokers operating in Belgium, while also offering a framework to detect likely high-risk data providers and brokers across Europe.