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DRAFT REPORT (2025/2206(INL))

With recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare

SANT-PR-790010

Committee on Public Health · Rapporteur: Giorgos Georgiou

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This is a draft report by the Committee on Public Health, with recommendations to the Commission, on modernised rules for patients' rights in cross-border healthcare. It calls on the Commission to propose a revision of Directive 2011/24/EU by the end of 2027, and sets out detailed recommendations in an annex. The report asks for reform of prior authorisation, minimum European standards for patients' rights, direct financial compensation between institutions to avoid upfront payments, and reimbursement of travel and accommodation costs. It calls for sustainable funding and a distinct legal status for the European Reference Networks, mandatory expansion of MyHealth@EU and the European Health Data Space, and multiannual authorisations for patients with chronic conditions. It asks that rare and complex diseases be treated as a structural feature of the Union's healthcare system, that clinical trials be covered, and that children get priority paediatric care, reimbursed travel costs for parents, and national cross-border navigator services. The annex contains the text of a proposed directive amending Directive 2011/24/EU, with changes to Articles 4, 6, 7, 9, 10 and 12.

Committee position. The rapporteur proposes that Parliament call on the Commission to revise Directive 2011/24/EU by the end of 2027, and sets out detailed recommendations in an annex covering prior authorisation, reimbursement, European Reference Networks, digital health, rare diseases and children's care.

Key points

  1. Calls on the Commission to present a modernised legislative framework on cross-border healthcare, mobilising financial instruments, to guarantee equitable and timely access to quality care across the Union.
  2. Stresses that patient organisations must be formally involved in the operation and governance of National Contact Points, with sustainable, objective and transparent public funding.
  3. Calls on the Commission and Member States to introduce safeguards, including addressing upfront payments, so access does not depend on nationality, socioeconomic status, disability, gender identity or place of residence.
  4. Calls for reform of the prior authorisation system and for Member States to publish explicitly detailed public lists of the specific treatments subject to prior authorisation.
  5. Calls on the Commission to set minimum European standards for patients' rights, including timely treatment, informed consent and non-discrimination, and mandatory implementation of the European Health Data Space.
  6. Calls on Member States to set up direct financial compensation between competent institutions across borders, applying the payment models of Regulation (EC) No 883/2004, and to simplify reimbursement of costs such as travel and accommodation.
  7. Urges the Commission to propose a framework granting European Reference Networks a distinct legal status so they can apply for EU funding, sign contracts and work as unified entities.
  8. Stresses the need for multiannual, renewable cross-border care authorisations for patients with chronic, long-term or progressively deteriorating conditions, replacing repeated individual authorisations.
  9. Calls for rare and complex diseases to be recognised as requiring cross-border care as a structural feature of the Union's healthcare system, with dedicated legal provisions and guaranteed funding.
  10. Calls on the Commission to extend EU cross-border healthcare legislation to cover participation in clinical trials for rare and complex diseases, including early-phase trials.
  11. Calls for child-specific provisions guaranteeing priority paediatric specialist care, expedited authorisation, mandatory reimbursement of travel and accommodation for the child and accompanying parents or guardians, and national cross-border navigator services.
  12. Requests that the Commission submit, by the end of 2027, a proposal to revise Directive 2011/24/EU based on Articles 114 and 168 of the Treaty on the Functioning of the European Union, following the annex recommendations.

Who is affected

  • Patients seeking cross-border healthcare, who would gain from direct compensation between institutions, simplified reimbursement and multiannual authorisations.
  • Patients with rare and complex diseases, whose cross-border access would be treated as a structural feature and who could join clinical trials.
  • Children needing paediatric specialist care, who would get priority access, expedited authorisation and reimbursed travel for accompanying parents or guardians.
  • Member States, which would have to publish lists of treatments subject to prior authorisation, set up direct compensation mechanisms and establish navigator services.
  • European Reference Networks, which would receive sustainable financing, a distinct legal status and integration into national healthcare systems.

Figures and deadlines

  • The Commission should submit a proposal to revise Directive 2011/24/EU by the end of 2027.

Legal basis: Articles 114, 168 and 225 of the Treaty on the Functioning of the European Union.