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Parliamentary questions
25 May 2017
Question for written answer
to the Commission
Rule 130
Maria Spyraki (PPE)

 Subject:  Delays in clinical investigations into medicines

Article 87 of Law 4472/2017 on the Reimbursement for Medicines Dispensed under Prescription Protocols lays down a particularly time-consuming bureaucratic procedure for the authorisation of new medicines. This procedure can cause significant delays, often doubling the time needed to sign a contract for the authorisation of a clinical study — where such authorisation is granted — thereby further delaying the introduction of new medicines on the Greek market.

According to the official data of the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than EUR 75 billion are invested worldwide and more than EUR 30 billion across Europe every year in pharmaceutical research, of which Greece accounts for less than EUR 80 million.

In view of the above, can the Commission say:

What position does Greece occupy in the take-up of Community funds for pharmaceutical research in Greece?

Is Law 4472/2017 compatible with the guidelines of Regulation 536/14 on the avoidance of administrative delays for the initiation of clinical trials?

Original language of question: EL 
Last updated: 9 June 2017Legal notice