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Parliamentary questions
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3 November 2019
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-002889/2019

The Commission supports EU citizens’ access to innovative medicines along the supply chain.

The pharmaceutical legislation(1) provides mechanisms for earlier access to promising medicines. A marketing authorisation can be granted to fulfil an unmet medical need based on limited evidence(2) and medicines of major interest for public health and therapeutic innovation may undergo an accelerated assessment.

The European Medicines Agency (EMA) offers developers opportunities for an early dialogue through scientific advice or the PRIority MEdicines (PRIME) scheme.

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

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

The EU Regulation on medicines for rare diseases (orphan medicines)(5) provides incentives for research, development and placing on the market of orphan medicines. The Commission is currently evaluating(6) the functioning of this regulation, including an assessment of measures at national and EU level ensuring accessibility to affordable medicines.

The public has been involved in this evaluation and many patients and healthcare professionals directly contributed to the work. The final report is expected in the beginning of 2020.

(1)Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1, as amended Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, as amended
(2)Conditional marketing authorisation or a marketing authorisation under exceptional circumstances
(4)Known as CAPR

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