Science and Technology CommitteeWritten evidence submitted by NHS European Office

The NHS European Office has been established to represent NHS organisations in England to EU decision-makers. The office is funded by the strategic health authorities and is part of the NHS Confederation.

In submitting our response we have limited our comments to those questions that are most relevant to our role and remit representing the interests of NHS organisations to EU decision-makers.

Q.1 Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and the EU?

1. The NHS European Office welcomes many of the changes in the proposed Clinical Trials Regulation, as overall it addresses a number of the areas in the current EU Clinical Trials Directive which form barriers to conducting clinical trials in the UK and across the EU.

2. The revision of the Clinical Trials Directive is particularly important to the NHS as over 99% of NHS hospital trusts are involved in research studies, which often take the form of clinical trials. Involvement in these studies allows NHS trusts to develop new treatments and to improve the quality of healthcare they provide. In addition clinical trials allow participating patients to benefit earlier from innovative drugs and treatments to which they would not otherwise have access.

3. While the Clinical Trials Directive has improved the safety and ethical soundness of clinical trials, it has led to a significant increase in the cost and administrative burden for conducting these studies and has significantly extended the time required for launching new trials. These difficulties have contributed to making the EU a less attractive location to conduct clinical trials, which has, in turn, resulted in a significant fall in clinical trial activity in the UK.

4. The proposed Regulation represents a significant improvement to the current Directive and takes positive steps to streamline the existing rules to reduce the administrative burden and speed up time for the authorisation of new clinical trials. Of the proposed changes, in particular we welcome:

(a)A simplified authorisation process: The Regulation proposes that a single application dossier is submitted via an EU portal. While all countries in which the sponsor intends to conduct the trial will be involved in the assessment of the application, they will have to cooperate in several areas of the process with one Member State leading and coordinating on their behalf. We believe that these changes should reduce the bureaucratic burden, speed up the authorisation process and reduce the lengthy delays that have hindered many clinical trials applications.

(b)A lighter regime for “low risk” trials: Another positive proposal is the recognition that trials which pose no or very limited additional risk to participants compared to normal clinical practice should be subject to a lighter regulatory regime. The Regulation identifies a new category of clinical trials, called “low intervention”, which would be subject to more proportionate rules for different aspects of the clinical trial process, including timelines for authorisation, monitoring, reporting, and insurance requirements. This is a positive step forward especially for non-commercial bodies, such as NHS trusts, which often sponsor non-commercial trials that aim to compare the efficacy of medicines which are already authorised and for which there exists extensive knowledge of their safety and tolerability.

(c)Enabling co-sponsorship: The explicit introduction of the concept of co-sponsorship is also a very positive development, particularly for non-commercial sponsors like NHS trusts, which often are unable to lead clinical trials on their own due to different regulatory and practical difficulties and, therefore, decide to share the sponsor’s responsibilities with their partner university to overcome these obstacles.

5. The NHS European Office has consulted extensively with organisations across the NHS to identify areas where further improvements can be made to the proposed Regulation and have briefed EU decision-makers on NHS views.

Q.4 How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?

1. The EU database proposed in the new EU Clinical Trials Regulation will achieve greater transparency of the results of clinical trials. It will contain much more data and information on clinical trials, which will have to be made publically available through it.

2. Overall NHS organisations are in favour of making the results of clinical trials more accessible, provided that all appropriate steps are taken to ensure that necessary personal confidentiality is maintained, and also to ensure that results are only published when it is certain that the results of the clinical trial are both robust and reliable. In order to achieve this, consideration would have to be given to the following:

(a)Sufficient information would need to be provided in a format which is accessible to the public, as well as practitioners, while maintaining sufficient levels of personal and commercial confidentiality.

(b)The required format for the presentation and publication of the results of clinical trials data should be consistent across all member states.

(c)Appropriate steps should be taken to ensure that the amount of clinical trials data sets housed on the EU database will be manageable. It is likely that the European Commission database would not be able to store unlimited amounts of information.

(d)Full consideration would need to be given to who would have access to full datasets to ensure that personal confidentiality would be maintained at all times.

(e)For more detailed information, relevant interested parties would have to contact the sponsor directly.

3. If non-commercial sponsors of clinical trials, such as NHS organisations, were to be required to undertake additional measures to ensure greater transparency of the results of their clinical trials than currently required, careful consideration should be given to the cost implications that additional administrative requirements would bring.

4. In the proposals for a new EU Clinical Trials Regulation, significant efforts have been made to reduce the costs and administrative burden for sponsors. It is important to ensure that significant costs and administrative requirements will not be introduced as a result of new requirements to publish the results of clinical trials. This is especially important for non-commercial sponsors not seeking marketing authorisation at the conclusion of their clinical trial.

5. The sponsor should always be responsible for making the results of clinical trials more accessible, while ensuring appropriate safeguards with regards to confidentiality are maintained.

February 2013

Prepared 16th September 2013