Spain is developing a proposal for European procurement of innovative medicines during the interval between EU marketing authorisation and national pricing and reimbursement. Secretary of State for Health Javier Padilla said the government intends to present the concept to other Member States from September.
Padilla outlined the proposal on 13 July during a Complutense University summer course on biopharmaceutical innovation. Under the envisaged ‘early procurement’ model, the European Commission would establish framework arrangements allowing medicines to enter participating European markets following European Medicines Agency authorisation while national pricing and reimbursement procedures continued.
Spain presents the approach partly as an alternative innovation incentive to extending supplementary protection certificates by another year under the developing Biotech Act. Padilla argues that additional commercial access at the beginning of a medicine’s protected lifecycle could provide a stronger incentive than extending exclusivity at its end, while also bringing patient access forward.
Spain has said it intends to present the early-procurement concept to other Member States from September 2026. Javier Padilla is due to speak at the European Parliament on 9 September at a meeting on health innovation, access, affordability and public benefit, where the Biotech Act and future EU innovation policy are among the themes under discussion. This provides an early opportunity to discuss the proposal in a wider European policy setting. The next substantive test will be whether Spain publishes a detailed framework covering participation, funding, price-setting and the transition into national reimbursement, and whether other Member States or the European Commission engage with it formally.
For European procurement to be implemented it would require an agreed price or other commercial terms before national negotiations were completed. Even if Member States retained formal authority over subsequent reimbursement and pricing, that European agreement could become an important reference point in later negotiations.
EU collaborative procurement is already expanding under the Critical Medicines Act, including for medicines of common interest. Spain’s proposal would apply the principle differently – using collective purchasing as a routine bridge to earlier access for newly authorised innovative medicines.
Source: Diariofarma
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