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Parliamentary questions
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6 February 2019
Joint answer given by Mr Andriukaitis on behalf of the European Commission
Written questions: E-006147/18 , E-006153/18
Question references: E-006147/2018, E-006153/2018

The main objective of the EU Regulation on orphan medicinal products(1) is to provide incentives for the research, development and placing on the market of orphan medicines in order to ensure that patients suffering from rare conditions have the same quality of treatment as any other patient. These incentives, however, are one of the factors influencing prices for orphan medicines, and, hence, potentially, access to such medicines.

The Commission is currently evaluating the functioning of the regulation(2). The example of the orphan medicine Chenodeoxycholic acid Leadiant is part of this evaluation.

Pricing policies for medicinal products fall under the Member States’ competence. However, the Commission is promoting the exchange of information among Member States on their pricing policies. This can enhance price competition for medicines and help minimising potential negative effects on the accessibility of medicines.

The Commission supports the strengthening of Member States’ cooperation on a voluntary basis in this context, in particular through tools such as a European medicine price database(3). It also facilitates the exchange of best practices and knowledge among Member States through the Network of competent authorities responsible for pricing and reimbursement(4).

Furthermore, as part of its competition policy, the Commission monitors pharmaceutical markets and is ready to take action, where appropriate, against breaches of the EU competition rules, including excessive pricing that may be in breach of Article 102 of the Treaty on the Functioning of the EU.

The Commission is also supporting national competition authorities across the EU (within the European Competition Network) that also investigate into excessive pricing concerns.

(4)Known as CAPR.

Last updated: 6 February 2019Legal notice