As of 31 January 2022, Regulation (EU) 536/2014 is now in force. The new Regulation sets out new and harmonised requirements for clinical trials with a view to establishing the EU as major hub for clinical research.
Clinical trials are a vital part of the development of new and safe medicines and medical treatment. Prior to 31 January 2022, the conduct of clinical trials was regulated under Directive 2001/20/EC. The Clinical Trials Directive represented an important step towards the harmonisation of experimental research, but has seen recent criticism by stakeholders (ranging from patients to researchers and industry players). This is largely due to the disproportionate regulatory requirements and high costs imposed under the Directive, which also required multiple submissions and authorisations to be filed at each Member State level. Under the old Directive, there was a decline in the competitiveness of the EU as a preferred location for clinical research.
The new Clinical Trial Regulation now reshapes the applicable regulation with the objective of cutting red tape and boosting EU competitiveness in the clinical research field. Importantly, the changes now take the form of a Regulation, which is directly applicable in all Member States and, thus, keeps national divergences to a minimum.
The starting point is the replacement of multiple national submissions with a single streamlined application and authorisation procedure for all clinical trials via a single EU web portal, which is centrally managed by the European Medicines Agency (EMA). Another key focus is on transparency: the new Clinical Trials Regulation requires sponsors to submit periodic reports containing all relevant data pertaining to their trials. These data are then shared in the European database (also managed by EMA) and made publicly accessible, with the exception of personal data and commercially confidential data. In addition, the new Regulation tailors the requirements to each trial, lowering the paperwork and regulatory burdens for those studies that pose only minimal additional risks to subject safety compared to normal clinical practice (i.e. the so-called low intervention clinical trials). This will make access to such trials easier, while preserving highest safety standards for patients.
It is now crucial for sponsors, legal representatives of sponsors based outside the EU, contract research organisations, and other players in the field of clinical trials to familiarise themselves with this new regulatory landscape, and in particular with the expanded responsibilities that the new Clinical Trials Regulation places on these entities – some of which (such as liabilities in case of co-sponsorship) have been defined and included within the scope of the legislation for the first time.
The Clinical Trials Regulation entered into force on 16 June 2014 but its application was postponed until six month after publication of the European Commission's notice that the EU Portal and Database were fully functional. Due to difficulties with IT system the go-live date has been delayed over the years until 31 January 2022. Still, the new Clinical Trials Regulation foresees a transitional application period so that the previous Clinical Trials Directive will still apply for three years to clinical trials applied for before 31 January 2022 or within one year from 31 January 2022 (in such case if applicant opts for the older system).
While this new system is in the form of a Regulation and, as such, is directly applicable, some of the issues it covers are strictly a matter for national laws and are left to the Member States. This is the case for civil and criminal liability of actors involved in the trials and for the design of template agreement between sponsors and trial sites (which have been identified as an appropriate measure to speed up access to clinical trials by stakeholders during the consultation phase leading to the new Regulation).
Taking Italy as an example, Italy has yet to implement measures adapting its national legislation to the new clinical trials Regulation. That said, between January and February, the Italian Medicines Agency and the Italian Coordination Centre for Ethics Committees issued provisions for the interim management of trials pending full alignment of the national legislation, and revised the previous template agreement for trial contracts to make it compliant with the new Regulation.
The new Regulation does not apply in the UK following Brexit, which is still largely following the old EU legislation. However, an overhaul of the UK clinical trial legislation is on the cards – the UK government on 17 January 2022 announced a consultation with a view to "to design a world-class sovereign regulatory environment for clinical trials that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as world leading base for life sciences, generating opportunities for skilled jobs in the UK". The consultation seeks input in a number of key areas such as patient and public involvement, research transparency, the clinical trial approval process, informed consent and safety reporting.
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