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March 21, 20260 citationsOpen Access

Rare Diseases, Cross-Border Healthcare and Fundamental Rights: Improving Patient Protection through the Charter.

BLBarend van Leeuwen

Key Points

  • The study aims to address the lack of specific protections for patients with rare diseases within EU cross-border healthcare regulations.
  • Analyzed EU laws governing cross-border healthcare and their implications for rare diseases.
  • Examined the Orphan Medicinal Products Regulation and its relevance to patient rights.
  • Reviewed the CJEU's case A v Veselības Ministrija for non-discrimination principles.
  • Identified a legal gap in protections for rare disease patients in current EU policies.
  • Highlighted the need for mechanisms to ensure non-discrimination during prior authorisation requests.
  • Suggested the application of Charter of Fundamental Rights to enhance patient protections.

Abstract

In the EU rules on the right to reimbursement of cross-border healthcare, no specific or additional protection is provided to patients with rare diseases. This approach is inconsistent with other EU measures in the field of rare diseases, such as the Orphan Medicinal Products Regulation. This "gap" in legal protection should be filled by relying on the Charter of Fundamental Rights. The CJEU has developed a non-discrimination "frame" for cross-border healthcare cases in A v Veselības Ministrija, which should be applied to patients with rare diseases. This means that, to avoid discrimination on the ground of disability, additional protection mechanisms should be developed for patients with rare diseases in the procedure for requesting prior authorisation of cross-border medical treatment. Patients can rely on these mechanisms throughout the procedure for prior authorisation.

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Cite This Study

Barend van Leeuwen (2026) studied this question.

synapsesocial.com/papers/69be37506e48c4981c676eachttps://doi.org/10.1163/15718093-bja10159
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