Presentation Key Points on Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use

/ / Legal x-rays, Media & Events

The Regulation 536/2014’s purpose is the growth acceleration of pharmaceutical research via clinical trials in the European Union. Its provisions are directly applicable in the legal systems of the Member States (without requiring integration) and replace the national procedure of notification and approval by the permit authorities. This process will be assisted through a new Clinical Trial Data Portal Gateway, with the cooperation of the European Medicines Agency (EFPIA) and the Commission; this will be a unique entry point where the member states will submit information and data about clinical trials, making the EU an attractive place for conducting clinical studies.


The new approval process foresees:


A)     The exclusive application submission by the sponsor, accompanied with the relevant dossier, to the EU Portal. When the application concerns a clinical trial planned to be conducted in more than one member states, the sponsor will propose one of the Member States as reporting Member State. If the sponsor is not established in the Union, he has to nominate another natural or legal person to be his legal representative.

B)      The declaration that that the persons validating and assessing the application do not have conflicts of interest, are independent of the sponsor, of clinical trial site, of investigators involved and of those financing the clinical trial, as well as free of any other undue influence.

C)      The initiation of the concept of tacit authorization (introduced by the Directive 2001/20/EU). This will ensure that timelines are adhered to by the member states which assess and authorize a clinical trial approval application. Substantial application modification(s) by the sponsor are permitted insofar as it has been approved in accordance with the procedure the regulation set out. Temporary or early termination by the sponsor is permitted.

D)     Clinical trial participation will be allowed following full content information disclosure on the drugs investigated, the efficiency, start and end of the trial and the associated free and informed consent of the subject. Participation without consent is only possible in emergencies; for example, when the patient faces a sudden, life-threatening clinical condition because of multiple injury, heart stroke or heart attack, requiring immediate medical intervention. Specific regulations are introduced for pregnant or breastfeeding subjects. The sponsor must notify each Member State of the beginning and end of the clinical trial within 15 days. Results of the clinical trial should be reported within one year after the end of the clinical trial.

E)      An adequate level of transparency is required in clinical trials and for public access to EU databases. The Regulation also establishes the compliance of Member States with the Regulation no 45/2001 on protection of personal data and national legislation. Any disclosure of clinical patient data will be in such a way that does not reveal their identity, or provide any direct or indirect correlation to the subject(s).

F)      The sponsor must report to the database all information on serious and unexpected adverse reactions. Also, he or she has the responsibility to annually submit to the database a report on the safety of each medicinal product under investigation at his/her clinical trial. Medicinal products under investigation will be tracked, stored, returned and/or destroyed in an appropriate and proportionate way in order to ensure the safety of participants and the validity of data from a clinical trial.

G)     The new Regulation procedure will also include a compensation system for subjects suffering any damage that results from participating in a clinical trial and the appointment of inspectors who will supervise compliance with this Regulation and the clinical trial overall conduct. Liability terms, amounts of damages and penalties will continue to be governed by national law.


Comment from our Office

This Regulation and the new clinical studies portal promise full adherence to the binding principles of prompt access to new, innovative medicines. Provisions concerning transparency of clinical trials for the benefit of the scientific community and patients are also far-reaching and should be studied at length by the interested parties. The general EU legislative trend towards safeguarding patient personal data of the patients is also observed.

Published on Health Daily on June 20 2014