A competitive EU biotech sector should not rely on longer monopolies (Joint Statement)
European pricing and reimbursement authorities, payers, patients, consumers and doctors signed a joint statement calling on decisionmakers to reject the 12-month extension of supplementary protection certificates (SPCs) in the EU Biotech Act.
Intellectual property extensions without demonstrated added value for patients, healthcare systems or European research and production are a poorly targeted measure. The EU should not rely on delayed competition to finance competitiveness. This would postpone affordable and timely access, healthcare savings, thus constraining resources available for other essential healthcare services.
Together with the European Patients' Forum (EPF), The European Consumer Organisation (BEUC), the Association International de la Mutualité (AIM) and the Standing Committee of European Doctors (CPME), ESIP calls to:
Reject the proposed SPC extension.
According to estimates by the German Social Insurance, the proposed extension could increase pharmaceutical expenditure by approximately €1.7 billion per year across the EU, placing a substantial additional burden on healthcare budgets.
Furthermore, possible benefits on relocation of R&D or manufacturing to Europe are not substantiated by the available evidence.
Prioritise direct, targeted policy instruments and regulatory measures that support investment, innovation and sustainable competition throughout the biotech and biosimilar ecosystem.
A competitive European biotech sector needs policies that deliver demonstrable benefits for patients and healthcare systems. Longer exclusivity without clear returns for public health does not serve this objective.