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Parliamentary questions
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15 February 2018
E-007713/2017(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-007713/2017

The Commission is aware of the study(1) mentioned by the Honourable Member.

The European Medicines Agency’s (EMA) evaluations of cancer medicines take into account a wide range of measures, including overall survival, quality of life, progression-free survival, response rate and duration of response. Though not all are directly linked to increased longevity, they are important indicators of how patients might benefit from treatment(2). EMA regularly consults its cancer experts(3), including patients, to make sure that these measures are meaningful for the patients concerned.

A marketing authorisation is granted to a medicinal product only after its quality, safety and efficacy have been evaluated and a positive benefit-risk balance has been concluded(4). A conditional marketing authorisation, which addresses an unmet medical need, though based on limited data, contains specific obligations on further studies which the marketing authorisation holder has to fulfil.

Marketing authorisation holders are obliged to submit periodically(5) summaries of data relevant to the benefits and risks of the product and results of all studies with potential impact on the authorisation. The Commission can suspend or withdraw a marketing authorisation if the benefit-risk balance of a product is negative.

The Commission adopted on 31 January 2018 a proposal on Health Technology Assessment aiming at supporting national decision-making by providing timely and high quality joint scientific clinical assessments on innovative cancer drugs, to be complemented, depending on national requirements, by an economic assessment carried out at Member State level(6).

(1)http://www.bmj.com/content/359/bmj.j4530
(2)More detail in the reply of EMA’s Head of Oncology, Haematology and Diagnostics published in BMJ on 12 October 2017 ‘Re: Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13 (views published in BMJ on 12 October 2017’, http://www.bmj.com/content/359/bmj.j4530/rr-3)
(3)Inter-Committee Scientific Advisory Group on Oncology: http://www.ema.europa.eu/ema/index.jsp?curl=pages/contacts/CHMP/people_listing_000031.jsp&mid=WC0b01ac0580028dd2
(4)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, 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.
(5)Periodic safety update reports (PSUR)
(6)https://ec.europa.eu/health/technology_assessment/policy_en

Last updated: 7 June 2018Legal notice