Pricing and reimbursement: national decisions on price and public funding

Pricing and reimbursement remain national competences under Article 168(7) of the Treaty on the Functioning of the European Union. EU law only sets procedural rules: Directive 89/105/EEC, the Transparency Directive, requires Member States to decide on a price application within 90 days, on inclusion in a reimbursement list within 90 days, and within 180 days where both are decided together. Decisions must rest on objective and verifiable criteria, be reasoned, and be open to judicial remedy. Each Member State then applies its own system, from external reference pricing against a basket of countries to internal reference groups and value-based negotiation.

In practice the regulatory team hands over to market access once the marketing authorisation is granted, but the two are linked. The approved indication wording, the comparator in the pivotal trials and the agreed product information shape the health technology assessment and the price negotiation. Timing matters as well: the first launch price in one country can become the reference price for others, so launch sequencing is planned around reference baskets and reimbursement clocks. Germany allows marketing at a free price for the first six months after launch while the AMNOG benefit assessment runs, after which the negotiated reimbursement price applies, whereas France, Italy and Spain negotiate before reimbursement begins. In France the HAS rates clinical benefit and the improvement over existing treatments before the CEPS fixes the price.

What goes wrong: launch sequencing that sets a low reference price early, a reimbursement dossier built on a comparator that national bodies do not accept, and regulatory variations that change the indication without telling market access, so the reimbursement scope and the authorised indication drift apart. The 90 and 180 day clocks are also widely exceeded in practice because they stop while the applicant answers questions, and the time from EU authorisation to patient access still varies by years between Member States.

Since 2025 the EU HTA Regulation provides joint clinical assessments for some medicines, which national pricing and reimbursement bodies must take into account, although the pricing decision itself remains national. Companies now plan the regulatory submission, the joint assessment and the first national reimbursement filings as one sequence rather than three.