It its report, 'Reconfiguring the Department of Health's Arm's Length Bodies', the Government states that the RAFT will be "…responsible for the regulation and inspection of all functions relating to the whole range of human tissue – blood, organs, tissues, cells, gametes and embryos." It will replace the HFEA which has the role, under the Human Fertilisation and Embryology Act 1990, for licensing and monitoring clinics that carry out in vitro fertilisation, donor insemination and human embryo research, as well as regulating the storage of gametes and embryos.
The Human Tissue Authority will be created under the Human Tissue Bill, now being considered in Parliament, to act as licensing authority for activities involving the removal, storage, use and disposal of human material as well as advisors to Government on issues related to human tissue. While its duties will be taken over by RAFT, until RAFT can be set up the Human Tissue Authority will come into existence to cover these areas.
Suzi Leather, HFEA Chair, has welcomed the creation of RAFT. "It is vital that patients and the public have complete confidence in the effective regulation of the use in treatment and research of all tissues, embryos and organs and this new organisation will bring these fields together."
'Arm's length bodies' are, as their name suggests, organisations 'at arm's length' from the Government departments but which act on its behalf to carry out necessary duties. Department of Health arm's length bodies regulate aspects of public healthcare, maintain and improve standards, protect public welfare and support local services. This review of arm's length bodies and the changes proposed reflect the Government's ongoing plan to devolve many responsibilities from central government to 'the frontline'. However, it was decided that there was too much bureaucracy and duplicated efforts. There is an expectation that the changes will reduce the cost of Department of Health arm's length bodies by £0.5 billion and the number of posts by 25 per cent.
There will be some changes for other Department of Health agencies but not for others. For example, the Medicines and Healthcare Products Regulatory Authority will remain as is. The National Patient Safety Agency will take the Central Office for under its auspices, taking the national lead for the development of ethics committees that review the ethics of clinical trials as well as for the review of all other research studies involving NHS patients.
Background: Research Ethics Committees
The new Blood and Transplant Authority will combine the roles of the National Blood Authority and UK Transplant. The Commission for Patient and Public Involvement will be abolished in favour of Patients' Forums, which will enable people to influence health services. Implementation plans for these and other changes will begin over the next few months.
The full implementation will take several years as some changes will need to be made through primary or secondary legislation.
Article courtesy of the Public Health Genetics Unit .
Image credit: Yorgos Nikas