EU Regulation 536/2014/EU regulating clinical trials in Europe was enacted in May 2014 to make the EU more attractive for pharmaceutical clinical research. The new Regulation will introduce significant changes to the administrative procedures governing the authorisation and conduct of clinical trials in the EU. From a practical perspective, the new regime is expected to fulfil the main objectives of lowering administrative burdens, streamlining processes and increasing transparency. At the same time, it poses signiicant challenges to the pharmaceutical industry.
The Regulation has the same scope as the Directive, which it replaces, and applies to all clinical trials conducted within the EU for medicinal products with the exception of non-interventional studies. The authorisation procedure will involve a single regulatory and ethics application made by the sponsor in respect of all target Member States through a single submission portal operated by the European Medicines Agency, whether for single centre or multi-centre studies. One of the key challenges will be meeting the tight deadlines for the sponsor to provide additional information requested by the Member States during the authorisation procedure.
Ex-EEA sponsors must establish at least a contact person in the EU though Member State(s) may also require the legal representative to be responsible for ensuring compliance with the sponsor’s obligations under the Regulation. Legal representatives should therefore clarify in advance what their direct potential liability exposure could be in relevant Member States and should ensure adequate intra-group controls, arrangements and possibly insurance are in place to protect them.
Under the Regulation’s co-sponsorship rules co-sponsors can allocate legal responsibility amongst themselves by a written contract. If responsibility for a particular aspect of the trial is not speciically attributed to a co-sponsor, all co-sponsors will be deemed to have joint responsibility. Co-sponsorship agreements must therefore adequately address allocation of responsibility. Outsourcing agreements, e.g. with sites, should then relect this.
Although May 2016 is the earliest entry into force date, companies should start preparing now for the new regime focussing on frontloading of preparation for trial authorisations and amendments; checking responsiveness of global and local teams (both internally and externally); ensuring completeness of clinical trial registration and data filing and reviewing contractual templates and patient consent documentation - to check compliance but also to ensure potential liability exposure is adequately managed under the new regime.