On 23 June 2026, the European Parliament's Legal Affairs Committee (JURI) debated the Commission's communication on a simpler EU rulebook and the European Biotech Act, with Commissioner Valdis Dombrovskis presenting the proposals. MEPs diverged on key points, particularly over the removal of a proposed 12-month supplementary protection certificate (SPC) extension from the Biotech Act draft.
On the simplification package, Dombrovskis emphasised harmonisation, anti-gold-plating, a 25% administrative burden reduction target, and stronger enforcement. 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 are due 25 June; the next meeting is scheduled for 2 July.