Most respondents to the consultation favoured retaining the HFEA and HTA because of the skills and expertise within each body, but the consultation highlighted that the respondents feel there is scope for streamlining of regulation and so closer examination is needed into how the regulators operate.
The Department of Health will now:
- retain both the HFEA and HTA and launch an independent review, to report by April, into how they can carry out their regulatory and statutory safeguarding functions in a more streamlined and efficient way. For example, looking into reducing the burden of inspections, information collection and process of research approvals; and
- look at whether more back office resources can be shared with other health regulators or the Department of Health so resources can be focused on specialist duties.
The consultation was part of broader plans to cut NHS administrative costs by more than a third by 2015. This will partly be achieved by looking at the benefits of streamlining functions of NHS bodies, including arms length bodies (ALBs) - which should deliver savings of over £180 million by 2014/15.
Public Health Minister Anna Soubry said:
“As the use of techniques like IVF and tissue engineering increase the scope for therapies and treatments, we need to support our regulators’ vital role in keeping patients safe.
“We have a duty to taxpayers to make sure that services are delivered in the most efficient way possible. By making sure that responsibilities are being carried out at the right level, we can free up savings to support front-line NHS services.
“We have listened to the views of those who responded to this consultation and it’s clear further work is needed to ensure they offer taxpayers the best value.”
NOTES TO EDITORS
The consultation ran from 28 June to 28 September. A copy of the consultation can be found at the Department of Health website.
Human Fertilisation and Embryology Authority
The HFEA was established by the Human Fertilisation and Embryology Act 1990 and came into operation on 1 August 1991. The HFEA is the UK’s independent regulator responsible for overseeing the use of gametes and embryos in fertility treatment and embryos in research. It licenses fertility clinics carrying out in vitro fertilisation (IVF) and other assisted conception procedures involving the use of donated gametes and embryos, and centres carrying out human embryo research. As part of its regulatory role, the HFEA maintains a register of all treatment cycles regulated by the Human Fertilisation and Embryology Act 1990 which includes information about every patient, their partner if they have one, all gamete and embryo donors and all children born as a result of such treatment. The HFEA is one of the competent authorities (an authority, body or organisation and/or institution responsible for implementing the requirements of a European Directive) for the quality and safety aspects of the EU Tissue and Cells Directives as they apply to reproductive cells (gametes and embryos).
Human Tissue Authority
The HTA was established by the Human Tissue Act 2004. It regulates organisations that remove, store, use and dispose of tissue for purposes including research, medical treatment, post-mortem examination, teaching and display in public. The HTA also gives approval for organ and bone marrow donations from living people. The HTA is one of the competent authorities (an authority, body or organisation and/or institution responsible for implementing the requirements of a Directive) for the EU Tissues and Cells Directive. It is also the competent authority designate for the EU Organ Donation Directive.
Care Quality Commission
CQC is the independent regulator of health and adult social care providers in England and has a key responsibility in the overall assurance of essential levels of safety and quality of health and adult social care services. Under the Health and Social Care Act 2008 (the 2008 Act) all providers of regulated activities, including NHS and independent providers, have to register with CQC and meet a set of essential requirements of safety and quality.
Health Research Authority
The HRA was established by the Health Research Authority (Establishment and Constitution) Order 2011 as a Special Health Authority on 1 December 2011. Its central purpose is to protect and promote the interests of patients and the public in health research. The HRA has the National Research Ethics Service (NRES) as its core and has taken on the functions, which were formally the responsibility of the National Patient Safety Agency. In due course, it will perform the Secretary of State’s function of approving the processing of patient information for medical research. The HRA will cooperate with others to combine and streamline the current approval system and promote consistent, proportionate standards for compliance and inspection.
The independent review will be undertaken by Justin McCracken. Justin is currently Chief Executive of the Health Protection Agency. He has substantial experience of regulation, having previously been the Deputy Chief Executive of the Health and Safety Executive and a Regional Director of the Environment Agency. Prior to that Justin, a physicist by background, worked in industry.