Regulatory Authority for Tissue and Embryos
In October 2007 the Government decided that the HTA should continue as a stand-alone regulator. This page provides background information about the proposal to form RATE and the Government's decision that it should not proceed.
Background to RATE
The conclusions of the Department of Health’s review of its Arm’s Length Bodies (the ALB review) were published in July 2004. They included the proposal to create a new regulatory body responsible for “the regulation and inspection of all functions relating to the whole range of human tissue – blood, organs, tissues, cells, gametes and embryos”. As such it would replace the HTA and the Human Fertilisation and Embryology Authority (HFEA). It would also take over from the Medicines and Healthcare Products Regulatory Agency (MHRA) the responsibility for the regulation of the donation, procurement and supply of blood and blood products. In this way, the new body – RATE – would become the single Competent Authority under the EU Blood and Tissue and Cells Directives, the purpose of which is to secure the safety and quality of blood and tissue and cells used for transplantation, and the sole body responsible for regulatory oversight of activities relating to the use of human bodily material.
RATE White Paper and draft Bill
A White Paper on RATE was published on 14 December 2006. As well the establishment of RATE, the White Paper proposed an overhaul of the 1990 Human Fertilisation and Embryology Act.
The draft Bill for RATE (called the Human Tissue and Embryos Bill) was scrutinised by a joint House of Lords and House of Commons Committee.
Joint Committee on the Draft Human Tissue and Embryos Bill
The RATE Scrutiny Commitee published their report on the draft Human Tissue and Embryos Bill on 1 August 2007.
Government response to Joint Committee
The Government then published a reponse to the report from the Joint Committee. It decided that the HTA would continue to operate as a separate Arm’s Length Body.
The HTA issued a response to the implications of the Joint Committee report on the draft Human Tissue and Embryos Bill, following the decision that plans to establish RATE should not proceed.