The EU Clinical Trials Directive (Directive 2001/20/EC), implemented in the UK in 2004, aimed at simplifying and harmonising the administrative requirements for clinical trials across the EU, whilst ensuring the safety of clinical trial participants, the ethical soundness of trials and the reliability and robustness of data generated. The European Commission released a proposal for a new EU Regulation on clinical trials in July 2012.
Proposal for an EU Regulation on clinical trials
On 17 July 2012 the European Commission published a proposal for a Regulation on clinical trials. The Regulation, once agreed and implemented, will repeal the existing Directive on clinical trials. This is the first revision of the EU Directive and responds to widespread criticism of the current regulatory framework voiced by many stakeholders.
The new legislation proposed by the Commission takes the form of a Regulation, meaning that the rules for conducting clinical trials will be more consistent throughout the EU. The NHS European Office has been pressing for changes to the existing Directive for a number of years and is pleased to see that the proposal reflects a number of amendments we have called for on behalf of the NHS.
Our briefing outlining the changes in the proposed Regulation and the key issues they raise for the NHS, can be read here.
Both the Health Service Journal and Eurohealth magazine have published articles by the European Office on the new proposals. You can access the HSJ article here and the Eurohealth article here.
Joint Statement of non-commercial and commercial organisations
The NHS European Office has joined 25 other non-commercial and commercial organisations to issue a joint statement on the proposal for an EU Regulation on Clinical Trials. The statement reiterates the areas of agreement within the health and research communities where the Regulation will improve the research environment and highlights aspects of the Regulation which require improvement to further support clinical research. Read the joint statement here.
Key issues for the NHS
The central issues for the NHS are:
Co-sponsorship - the draft Regulation explicitly introduces the concept of co-sponsorship for clinical trials. While the vast majority of EU Member States require a single sponsor for each trial, co-sponsorship is allowed in the NHS, meaning the sponsor's responsibilities may be shared between two or more organisations. This model is widely used by NHS trusts who often lead clinical trials in partnership with universities. In light of this we have pushed for this to continue to be allowed and are very pleased to see this concept included in the draft Regulation.
Risk-based approach - the proposal attempts to balance the risk and safety elements of clinical trials in a more proportionate way, meaning low-intervention clinical trials, which pose only minimal risk to subject safety compared to normal clinical practice, would be subjected to a lighter regime.
Authorisation procedure - the proposed authorisation procedure for clinical trials will now allow for a fast and thorough assessment of the application by all Member States concerned and will ensure one single assessment outcome. We are hopeful this will significantly reduce delays for launching clinical trials.
Simplified reporting procedures - the draft Regulation intends to spare researchers from submitting largely identical information on the clinical trial separately to various bodies and Member States.
Compensation for damages - the proposal requires Member States to set up a national indemnification mechanism working on a not-for-profit basis to help non-commercial sponsors comply with insurance/compensation requirements for trials.
You can view the full European Commission proposal here and our press release here.
The draft Regulation will be discussed by the European Parliament and the Council of Ministers who can introduce amendments before it is agreed. Once agreed, the Regulation will repeal Directive 2001/20/EC. Nevertheless, in order to ensure smooth transition to the new regulatory regime, it is suggested that both sets of rules will apply in parallel for a period of three years after the date of entry into force of the Regulation.
MHRA consultation on EU clinical trials proposals
The NHS European Office responded on behalf of the NHS to the public consultation on the new clinical trials proposals launched by the Medicines and Healthcare products Agency (MHRA).
You can read the response to the consultation here.
Whilst it is widely accepted that the Clinical Trials Directive has improved the safety and ethical soundness of trials across the EU, a number of issues have also emerged which have contributed to making the EU a much less attractive location to carry out clinical trials. The European Commission's own figures show that from 2007 to 2011, the number of applications to carry out clinical trials in the EU fell by 25 per cent, while costs have increased significantly and the delays for launching a clinical trial have risen by 90 per cent.
In a bid to improve the functioning of the Directive, the European Commission carried out two consultations with stakeholders looking in detail at several areas of the Directive. The NHS European Office responded to both consultations and you can view both responses in ‘related documents’.
Clinical Trials Database
In March 2011, the European Commission launched a public register of all clinical trials underway within the European Union, with the aim of making medical research on drugs more transparent for patients. This register is part of EudraPharm, the public database on drugs, a central register of drugs authorised by the EU.
Every year, around 4,000 clinical trials are authorised within the European Union. As the process for most of them takes two or three years, some 10,000 trials are underway at any one time. The clinical trials register gives information on trials carried out by industry and research institutes. The information is published once the authorisation for these tests has been granted. The day‐to‐day online management of the register is the responsibility of the European Medicines Agency (EMEA).
For more information about the register, please visit: https://www.clinicaltrialsregister.eu/about.html