On 23 June 2026, the European Parliament's Legal Affairs Committee debated the Commission's communication on a simpler EU rulebook and the European Biotech Act, revealing divergences on the scope of harmonisation and the length of supplementary protection certificates (SPCs) for biotech products. Commissioner Valdis Dombrovskis presented the communication, emphasising harmonisation, anti-gold-plating, a 25% administrative burden reduction target, and stronger enforcement. MEPs differed on key points: Marion Walsmann (EPP) questioned when full harmonisation is justified, while Ton Diepeveen (PfE) defended stricter national rules as democratic choices. Dainius Žalimas (Renew) warned against box-ticking simplification and asked for lessons from past efforts. Jörgen Warborn (EPP) argued Parliament often fails to require impact assessments for amendments and pressed for wider cost discipline beyond administrative burdens. Mario Mantovani (ECR) sought more concrete SME attention.
On the Biotech Act, the rapporteur's draft removed the proposed 12-month SPC extension, broadening the stockpiling waiver for biosimilars and strengthening AI ethics safeguards. Mario Mantovani (ECR) and Lukas Mandl (EPP) criticised the removal, advocating 24-month extensions to boost innovation. Dainius Žalimas (Renew) backed longer SPCs but stressed legal certainty and coherence with the AI Act. Cristina Modoran (DG SANTE) defended the Commission's balance between innovation incentives and affordability, noting the SPC extension was conditional and targeted. Jörgen Warborn (EPP) highlighted the missing initial impact assessment; Modoran cited geopolitical urgency and provided cost estimates. Consensus emerged on the need for simplification, SME focus, better enforcement, and biotechnology's strategic importance. Amendments were due 25 June; next meeting 2 July.
The debate exposed a cleavage between those prioritising regulatory simplification and burden reduction (EPP, Renew, ECR) and those defending national discretion (PfE). On the Biotech Act, the split ran between MEPs seeking longer SPCs to boost innovation (ECR, EPP) and the Commission's more balanced approach emphasising affordability and legal certainty. Stakeholders most impacted include EU biotech firms (potential loss of extended market exclusivity), biosimilar producers (benefiting from broader stockpiling waiver), national regulators (facing harmonisation vs. gold-plating tensions), and patients (affected by affordability vs. innovation trade-offs). The committee's next meeting on 2 July will consider amendments.