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OPINION (COM(2025)1022 – C100363/2025 – 2025/0406(COD))

On the proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act)

JURI-AD-789902

Committee on Legal Affairs · Rapporteur: Tiemo Wölken

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The Committee on Legal Affairs gives its opinion on the proposed European Biotech Act, a regulation to strengthen the Union's biotechnology and biomanufacturing sectors, especially in health. It proposes amendments to allow makers of biosimilars in the Union to make and store products for an unlimited period before the certificate expires, so they can enter the market on day one. It also proposes a twelve-month extension of the supplementary protection certificate for medicinal products and veterinary medicinal products developed by biotechnology, under conditions. It strengthens provisions on the ethical use of artificial intelligence, including transparency, human oversight, prevention of bias and data protection. It adds safeguards for health data, biosecurity and the monitoring of AI models in biological applications.

Committee position. The Committee on Legal Affairs proposes amendments to the proposed regulation, including unlimited stockpiling of biosimilars during the SPC term, a twelve-month SPC extension for biotechnology medicinal products, and stronger ethical safeguards for artificial intelligence and health data.

Key points

  1. The rapporteur wants to extend the stockpiling provisions under the Supplementary Protection Certificate (SPC) Manufacturing Waiver.
  2. Allowing unlimited stockpiling of biosimilars during the SPC term would let biosimilars made in Europe enter the Union market immediately upon expiry of the certificate or basic patent.
  3. The rapporteur says the Biotech Act should not reopen discussions on additional exclusivity-based incentives, as the recent pharmaceutical legislation already addresses them.
  4. The rapporteur has strengthened provisions on the ethical use of artificial intelligence, including transparency, accountability, prevention of algorithmic bias, data protection and human oversight.
  5. A new recital requires a coherent, transparent and proportionate framework supporting research, innovation, scale-up and manufacturing while maintaining high standards for health, ethics and biosecurity.
  6. A new recital allows makers of biosimilars established in the Union to make and store products for an unlimited period pending expiry of the certificate, for EU day-one entry.
  7. New recitals state that makers of biosimilars in the Union are at a competitive disadvantage compared with third-country makers, and that timely entry of biosimilars increases competition and patient access.
  8. Amendments require the ethical use of AI in biotechnology, including in data mapping, guidance, testing environments and clinical trials, with safeguards for genetic data and biosecurity.
  9. Amendments add safeguards for personal electronic health data, prevent discriminatory impacts and unfair biases, and require robust evidence on safety and effectiveness of medicinal products for women.
  10. Amendments require the Advisory Group to cooperate with the AI Office and AI Board and to monitor the capabilities, risk profile and ethical use of AI systems and models in biological applications.
  11. Amendments provide a twelve-month extension of the supplementary protection certificate for medicinal products and veterinary medicinal products developed by biotechnology, under conditions including new active substance, clinical trials in more than two Member States and a manufacturing step in the Union.
  12. An amendment to Regulation (EC) No 469/2009 allows making a biosimilar product for storing in the Member State of making, and making a generic product no earlier than six months before expiry of the certificate.

Who is affected

  • Makers of biosimilars established in the Union, who could make and store products for unlimited periods before certificate expiry.
  • Holders of supplementary protection certificates, whose exclusive rights are to be balanced against a level playing field.
  • Small and medium-sized enterprises, start-ups, scale-ups and small mid-caps, which would receive regulatory support and assistance.
  • Patients in the Union, who would have better access to affordable medicines through timely entry of biosimilars.
  • Data subjects, whose electronic health data would be protected by safeguards at Union and national level.

Figures and deadlines

  • twelve-month extension of the duration of the Supplementary Protection Certificate for medicinal products developed using innovative biotechnologies.
  • twelve-months extension of supplementary protection certificate for veterinary medicinal products developed by biotechnology processes.
  • twelve-month extension of the periods referred to in Article 13, paragraphs (1) and (2), of Regulation (EC) No 469/2009.
  • clinical trials conducted in more than two Member States.
  • no earlier than six months before the expiry of the corresponding certificate for generic medicinal products.
  • no later than six months after the entry into force of this Regulation for the strategic mapping of the biotechnology ecosystem.