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DRAFT REPORT (2025/2087(INI))

On public health aspects of biotechnology and life sciences

SANT-PR-773198

Committee on Public Health · Rapporteur: Margarita de la Pisa Carrión

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A draft report by Parliament's Committee on Public Health on the public health aspects of biotechnology and life sciences. It highlights biotech therapies such as CAR-T, mRNA, CRISPR and ATMPs, and calls for the EU Biotech Act to simplify regulation while keeping high safety standards. It asks for support for biotech SMEs, more public and private investment, IP protection, and better transfer of research to the market. It also calls for ethical oversight, protection of genetic data, and a precautionary but innovation-enabling approach. It calls on the Commission to run an impact assessment before publishing the EU Biotech Act, to speed up permitting, and to support Member States with programmes such as industrial parks.

Committee position. The rapporteur proposes that Parliament call for a simplified regulatory framework under the EU Biotech Act, more investment and support for biotech SMEs, and strong ethical oversight, with an impact assessment before the Act is published.

Key points

  1. Highlights that biotechnology therapies such as CAR-T, mRNA, CRISPR and ATMPs are transforming care and targeting previously untreatable diseases.
  2. Emphasises the growing impact of biotechnology therapies on cancer, cardiovascular, rare, neurodegenerative, psychiatric, autoimmune, infectious diseases and metabolic disorders.
  3. Stresses the potential of biotechnology for research into genetic conditions such as Down syndrome, and the role of lab-grown tissues in regenerative medicine and drug testing.
  4. Recalls that molecular diagnostics using genomic and proteomic biomarkers are key for early detection and personalised treatment, and stresses the value of functional epigenomics and multi-omics.
  5. Calls for the EU Biotech Act to simplify the regulatory framework while ensuring high security standards, and for support mechanisms such as the EU biotech hub and next-generation regulatory sandboxes.
  6. Notes the growing role of artificial intelligence in healthcare and calls on the Commission to create sector-specific guidelines for AI in diagnosis and treatment.
  7. Stresses the need for traceability of research outcomes, collaboration between universities, research centres and industry, IP protection, and increased public and private investment, especially in early-stage development.
  8. Welcomes the STEP programme but notes that current funding remains lower compared to global competitors, and stresses the need for affordable therapies and career opportunities to address brain drain.
  9. Calls for strategic international cooperation in biotechnology and for regulators, healthcare providers, researchers and industry to collaborate on ATMPs through reporting systems.
  10. Highlights the challenges biotechnology SMEs face and stresses the need for flexible financing models and tailored IP support, including evaluation of potential IP rights extensions.
  11. Calls on Member States and the Commission to adopt a precautionary yet innovation-enabling approach, ensure strong ethical oversight, protect health-related personal and genetic data, and address ethical concerns on gene editing.
  12. Calls on the Commission to conduct an impact assessment before the EU Biotech Act, support Member States in launching programmes such as industrial parks, accelerate permitting, and consider the sector's financial needs.

Who is affected

  • Biotechnology SMEs, which make up the majority of biotech actors and face high regulatory and operational costs.
  • Patients, who should benefit from affordable and innovative biotechnology therapies.
  • People with disabilities, who must be protected from discrimination and trait-selection.
  • Member States, which are asked to strengthen protection of health-related personal and genetic data.
  • The Commission, which is asked to act on regulation, AI guidelines, ethics cooperation and funding.

Figures and deadlines

  • SMEs represent over 99 % of EU businesses.
  • A strategy for European life science will be presented in 2025 and an EU Biotech Act in 2026.
  • The sector's economic growth rate is 5.3 %.

Legal basis: Articles 9, 151, 168, 173 and 179 of the Treaty on the Functioning of the European Union; Article 5(3) of the Treaty on European Union and Protocol No 2 thereto.