Written evidence from the Department for Health

At the Public Accounts Committee hearing on 15 June about mental health, Chris Evans MP raised the matter of people released from prison with mental health problems being referred directly to the NHS, following an incident which occurred in his constituency in Wales.  Richard Bacon MP raised the issue of publishing the results of clinical trials and I undertook to respond concerning this issue.

I agreed to write to the Committee to clarify the position on both matters.

Mental Health of Offenders

The incident raised by Chris Evans MP is tragic.  It is critical that all relevant health and justice agencies co-operate effectively to ensure that people released from prison with mental health problems can be safely supported in the community.  These issues can be complex and each case should be considered on its own merits.  The investigation into this case found issues to be addressed about the effective sharing of information between agencies.

Department of Health officials have made enquiries with the National Offender Management Service (NOMS) about this case.  The Health Inspectorate Wales conducted a review of this incident and made recommendations for improvement which are being taken forward.  These recommendations included:

• ensuring that where a patient with a previous history of mental illness is discharged from prison, a follow-up mental health appointment is scheduled that allows further  evaluation of  all available information; and
• ensuring processes are in place for better sharing of information between relevant agencies prior to a prisoner’s discharge to ensure continuity of care.

In England, where a prisoner with mental health problems is eligible to be released and requires a continuing package of care in the community, we expect the prison to liaise with community mental health services and other relevant agencies such as the Probation Service. This should seek to ensure that appropriate arrangements are made including that the prisoner continues to engage with mental health services in the community.

Where a prisoner has been formally detained under the Mental Health Act 1983 in the past or has served part of their sentence in hospital, they are entitled to a package of after-care, free of charge, arranged by health and social care services. The prison is required to work with health agencies and local authorities to ensure that appropriate after-care arrangements are in place to support the offender in the community. The Mental Health Act 1983 applies to England and Wales but Wales has its own Mental Health Act 1983 Code of Practice.

However, we acknowledge that the same issues around the effective management and support for offenders in the community apply in both England and Wales. In England, the Department of Health, NHS England, Ministry of Justice and NOMS collaborate and cooperate at all levels within their organisations to ensure safe and effective care, which protects both the individual and others, and reduces reoffending.

Publishing Results of Clinical Trials

The Government’s policy is that together with its arm’s length bodies it is committed to transparency in the area of clinical trials. Transparency is important for patients, the public, researchers and the NHS, and can be achieved through ensuring that all clinical trials are registered on a public database. This means that everybody can see what trials are ongoing, the results of all clinical trials are published, and data from all clinical trials are made available.

To conduct a clinical trial of an investigational medicinal product (CTIMP) in the UK, a sponsor must obtain authorisation from the Medicines and Healthcare products Regulatory Agency and from a Research Ethics Committee legally recognised by the United Kingdom Ethics Committee Authority.

Under current governance arrangements, a European Medicines Agency (EMA) database registers all approved CTIMPs. Since March 2011 this information has been publicly accessible through the EU Clinical Trials Register (except adult Phase 1 trials) and since 2014 a summary of results is required to be uploaded into the register within one year of the trial completing.

The recent clinical trials Regulation (536/2014) provides for further transparency in that all data and documents submitted to support authorisation of trials will be accessible to the public, unless certain confidentiality criteria have been met.

In addition, clinical study reports which have been submitted in support of a marketing authorisation will have to be submitted to a database by the applicant within 30 days after a marketing authorisation has been granted, the decision making process has been completed or the applicant has withdrawn the application, and these will also be accessible to the public.

Chris Wormald, Permanent Secretary

28 June 2016