One of the greatest challenges of the life sciences industry is the ever-changing regulatory landscape. Amid various planned reforms this year, one of the most welcome is the proposed reform of the law on clinical trials currently being debated by the EU Parliament.
The current law (a Directive implemented in the UK in 2004) introduced a standardised framework for clinical trials and has had positive effects from a safety and the ethical soundness standpoint. However, it has been criticised for increasing the costs and bureaucratic burden of conducting trials which in turn has lead to delays in launching them and has adversely impacted the competiveness of clinical research and patients’ ability to access new medicines and treatments. As a consequence, the number of applications for clinical trials in the EU fell by 25% in the period from 2007 to 2011.
To address this, 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 multi-national 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.
Significant changes are as follows:
- 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 piont entry for all data. This should allow trials in separate EU jurisdictions to be conducted more efficiently and with greater economy.
- Simplified regime for “low intervention clinical trials”- a new 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 tht 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.
- 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.
- 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 database.
- 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 is expected to be implemented in 2016. If adopted, the Regulation will provide the EU with a simplified, streamlined and more transparent process which it is hoped 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, it is hoped that there will be an increase in the number of trials taking place in the UK. If that is the case, then patients will benefit from earlier access to the innovative treatments and research which are so vital a part of a high quality healthcare system.