All questions

Pricing and reimbursement

i Medicines

EU Member States are responsible for establishing and organising of their national social security schemes, including healthcare policies to promote the financial stability of their healthcare insurance systems.25 Differential pricing and reimbursement of medicinal products in Member States, however, may affect the free movement of these goods in the internal market.

Directive 89/105/EEC26 lays down a general procedural framework to increase the transparency of national pricing and reimbursement measures to limit the potential impact on these measures on the internal market for medicinal products. This Directive does not harmonise national pricing and reimbursement measures in the EU, nor does it identify substantive criteria on which Member States must base their pricing and reimbursement decisions. This is in line with the limited competence of the EU in the field of management of healthcare resources and the principle of minimum interference in the organisation by Member States of their domestic social security policies, as confirmed by European case law. For example, in ABPI v. MHRA,27 the Court of Justice of the European Union (CJEU) confirmed that public bodies forming part of a national public health service are not precluded from implementing prescribing incentive schemes that offer financial inducements to doctors to prescribe or switch patients to generic medicines, to achieve cost savings provided that the schemes comply with Directive 89/105/EEC.

Directive 89/105/EEC lays down three key requirements with respect to national pricing and reimbursement decisions: (1) decisions must be made within a specific time frame (90 to 180 days); (2) decisions must be communicated to the applicant and contain a statement of reasons based on objective and verifiable criteria; and (3) decisions must be open to judicial appeal at national level.

ii Medical devices

There are no EU-harmonised rules governing the pricing and reimbursement of medical devices; this remains the competency of Member States. Directive 89/105/EEC does not apply to medical devices.