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Parliamentary questions
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21 May 2019
E-001239/2019(ASW)
Answer given by Vice-President Katainen on behalf of the European Commission
Question reference: E-001239/2019

The Commission supports proactively EU citizens’ access to innovative cancer medicines along the steps from product discovery to a patient.

The EU plays an important role in supporting cancer research, including funds for the development of innovative cancer drugs. Overall, EU’s long-term investment in cancer research totals more than EUR 2.8 billion since the beginning of the 7th Framework Programme in 2007.

The pharmaceutical legislation(1) provides mechanisms for earlier access to promising medicines, including treatments for cancer. A marketing authorisation can be granted to fulfil an unmet medical need based on more 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, under which 14 oncology products have been granted access(3).

The pricing and reimbursement of medicines are competency of the Member States. However, the Commission has adopted a proposal for a regulation on cooperation on Health Technology Assessment, which is being negotiated in the European Parliament and Council(4).

The proposal provides for joint clinical assessments of new health technologies, including innovative cancer medicines. High quality, timely joint clinical assessments would support Member States in taking timely and evidence-based decisions on patient access, and contribute to improving patient access to innovative health technologies across the EU.

The relocation of EMA was handled efficiently and will not impact the high quality and safety of medicines that patients in the EU expect.

(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
(3)Until March 2019, 14 oncology products have been assessed as eligible for the PRIority MEdicine (PRIME) scheme (https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines)
(4)COM(2018)51; 2018/0018 (COD).

Last updated: 23 May 2019Legal notice