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Parliamentary questions
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20 December 2018
Answer given by Ms Malmström on behalf of the European Commission
Question reference: P-005442/2018

The organisation and delivery of the health services and medical care fall within the competence of each Member State(1), including the funding. Member States are fully responsible for the decisions on pricing and reimbursement of medicinal products. However, they have to comply with the ‘EU Transparency Directive’(2) that lays down a series of procedural rules applicable to any national measure regulating prices of medicines and their inclusion in the scope of public health insurance systems. This directive, without touching upon the substance of pricing and reimbursement, aims at ensuring that national decisions in the area of prices of medicines are taken in a transparent way and within certain time limits.

To date, the issue of pricing and reimbursement has not been raised in the current discussions with the United States (US). As the European Commission considers that the issue of pricing and reimbursement should not be covered in any trade negotiations with the US in light of the significant differences in EU and US healthcare systems, it does not intend to seek an authorisation to negotiate on this matter.

(1)Article 168 (7) of the Treaty on the Functioning of the European Union.
(2)Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems [1989] OJ L40/8.

Last updated: 7 January 2019Legal notice