Biotech Act

New legislation on the way

In 2024, the European Commission announced that it is working on new legislation: the Biotech Act. This upcoming regulation will create rules to:

• Make biotech products easier to develop and bring to market
• Maintain high safety standards, and
• Improve the size and competitiveness of the EU biotech sector

While the legislative proposal is only expected in 2026, the work has already started—and so has EHA’s involvement.

Through its advocacy and engagement, EHA represents hematologists at every step of the legislative procedure.

Impact on hematology

Biotech innovation is redefining patient care in hematology—think of CAR T-cell therapies. The Biotech Act therefore provides an opportunity to deliver a robust and harmonized framework, capable of delivering:

• Continued innovation
• Equitable access across the EU
• Improved patient outcomes

Ensuring that biotech medical products are safe, effective, and accessible is critical for the treatment of hematological diseases across Europe.

EHA’s involvement

In June 2025, EHA responded to the Commission’s call for evidence on the Biotech Act. A call for evidence gathers stakeholder input regarding the scope, objectives, and potential impact of (future) legislation.

In our submission, we included our recommendations for delivering a fit-for-purpose Biotech Act that is valuable for hematology professionals and patients.

Summary of our recommendations

1. A harmonized and future-proof regulatory framework

EHA calls for a harmonized, science-based regulatory environment that reduces the administrative burden and supports long-term innovation.

2. Public investment with public return

EHA advocates for transparency in biotech funding and pricing, ensuring that public investments yield tangible benefits for healthcare systems and patients.

3. Equitable access across member states

The legislation should include mechanisms to address disparities in access to biotech products.

4. Health impact assessments

EHA recommends embedding health impact assessments, including patient-reported outcomes, into the legislative framework.

5. Systematic stakeholder engagement

A stakeholder forum should be established to ensure recurring input from health professionals and patients.

6. Interaction with other EU legislation

The interaction with other legislation such as the European Health Data Space (EHDS) legislation and the Medical Devices Regulations must be clarified to ensure legal certainty.

You can find out more about EHDS on our ‘Health data’ page.