Promoting research, innovation and competition: the reform of the clinical trials legislation in the EU

With changes proposed to the clinical trials regime in the EU, we look at the principal changes being considered and assess their potential impact on the conduct of research and clinical trials across the EU.

Amid a welter of new law and regulation in the UK healthcare and life sciences sector came the welcome news that this year will see the first reading of the European Commission’s proposal on reforming clinical trials legislation throughout the EU.

Whilst the current regime, which was implemented in the UK in 2004, has had a positive impact in providing a standardised framework for the conduct of clinical trials across the EU and in improving the safety and the ethical soundness of those trials, it has been criticised for an approach that increased, not only the bureaucratic burden of conducting trials, but cost and delay in launching them, restricting in turn, the competiveness of clinical research in the EU and therefore patients ability to access new medicines and treatments.


“…it has been criticised for an approach that increased, not only the bureaucratic burden of conducting trials, but cost and delay in launching them…”


The existing clinical trials Directive was intended to harmonise the administrative requirements for clinical trials across the EU and, in particular, to facilitate the conduct of multinational trials in more than one Member State. However, the practical effect of the legislation, once implemented, was almost the opposite. With Member States taking various differing stances on interpreting and implementing the Directive, its real impact was a disproportionately high administrative burden and vastly escalated costs. As a consequence the number of applications for clinical trials in the EU fell by a staggering 25% in the period from 2007 to 2011.

To address the decline in the EU’s attractiveness as a home for clinical trials, the European Commission entered into a lengthy consultation with Member States and stakeholders such as the NHS from across the EU and has now put forward a proposed Regulation to replace the existing Directive. The significance of the new legislation being framed as a Regulation is that the law, once agreed, will apply directly in each Member State. This eliminates the issue of each Member State interpreting and implementing the law in its own way and should ensure a more consistent application of the law across the EU. This should greatly assist with the administration of multinational trials.

As with the existing Directive, the proposed new Regulation will govern trials relating to “investigational medicinal products” i.e. research involving the development of new medicines or the use of medicines other than in accordance with their marketing authorisation or the improvement of existing medicines. It will not cover “non-interventional” trials or studies of medical devices or clinical procedures.


“…the number of applications for clinical trials in the EU fell by a staggering 25% in the period from 2007 to 2011.”


Significant changes are as follows:

(1) Simpler authorisation process – a streamlined procedure for multinational trials with submission of clinical trial data through an EU Portal which will act as a single entry point for all data. This should allow trials in separate EU jurisdictions to be conducted more efficiently and more economically.

(2) Simplified regime for “low intervention clinical trials” – the proposed Regulation introduces the concept of low intervention clinical trials. These are trials of drugs used within their marketing authorisation (or where their use is a standard treatment in any of the Member States concerned) and where the risk to patients is negligible. The Regulation proposes that these trials be subject to more proportionate rules and, to that end, waives or reduces certain obligations including shorter authorisation timelines and an exemption from the requirement to provide specific insurance or indemnification from harm for trial participants.

(3) Co- Sponsorship of trials – each clinical trial must have a sponsor responsible for initiating and managing the trial. The Regulation introduces a concept of co-sponsorship allowing the obligations of the sponsor to be shared between two or more organisations. This is particularly important to entities who may wish to lead clinical trials jointly with partner organisations such as universities and, in the UK, the NHS.

(4) Safety reporting – the procedures around safety reporting have been streamlined and simplified with direct reporting of suspected unexpected serious adverse reactions (SUSARs) by the sponsor to the European data base.

(5) Manufacturing and labelling of investigational medicinal products – the proposed Regulation brings together the rules on manufacturing , importing and labelling of medicinal products used in clinical trials which are currently contained in various different EU Directives and guidelines.

The proposed Regulation also deals with a number of additional issues which have occurred frequently in relation to clinical trials, such as the ability to obtain free and informed consent in circumstances where, due to the urgency of the situation, obtaining consent from the participant in the trial or their legal representative would not be possible. The Regulation lays down a strict set of conditions which must be met in these circumstances, specifying that consent may only be obtained after the start of a trial if all the conditions imposed by the Regulation are met.


“It is therefore unlikely that any Regulation will be adopted before 2014 or implemented before 2016.”


So what happens next?

The proposed Regulation will now be subject to the legislative process of the EU. It will be considered and debated by the EU Parliament and the Council of Ministers, a process that could last several months. It is therefore unlikely that any Regulation will be adopted before 2014 or implemented before 2016.

In conclusion

It is hoped that the proposals will provide the EU with a simplified, streamlined and more transparent process which will alleviate the competitive issues that the EU currently faces with regards to hosting clinical trials. Together with the recent commitment of the UK government to improving the general environment for clinical trials in the UK and with the launch of various databases and mobile applications designed to provide researchers, patients and the public with greater information about clinical trials, it is anticipated that more patients will register to participate in trials and over time that there will be an increase in the number of trials taking place in the UK and throughout the EU. If that is the case, then patients will benefit from earlier access to innovative treatments, and research, which is so vital a part of a high quality healthcare system, will continue to flourish in the UK and across the EU.



About the author:

Catherine McLoughlin is a partner in the corporate group at leading London law firm Marriott Harrison LLP. She specialises in corporate finance, M&A, private equity and venture capital with a focus on the healthcare and life sciences sector. She can be contacted at and on 0207 209 2003.

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