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HFEA and HTA to remain separate

The government has announced that the Human Fertility and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) will remain as separate regulators following a review of their functions. The review made 18 recommendations on how they could work more efficiently, which the government has accepted, including working with the other bodies to streamline regulation.

Background

In June 2012, the Department of Health consulted on three proposed options for the future of the HFEA and HTA:

  • All functions should transfer to the Care Quality Commission (CQC) except the HFEA functions relating to research that would pass to the Health Research Authority (HRA); and the HFEA and HTA be abolished.
  • All functions should transfer, as set out above, but a limited number of functions that would transfer to organisations other than the CQC.
  • The HFEA and HTA should retain their functions but deliver further savings.

You can read our response here. The responses to the consultation were pretty mixed, with 75% disagreeing with a  transfer of function to CQC and HRA. So in January the government said that the two would stay separate whilst a review was conducted by Justin McCracken.

The announcement

The HFEA and HTA will continue as separate bodies.

In his report, Justin McCracken found there was little overlap between the two organisations and rather than merging them it would be more efficient to cut red tape and merge back-office functions. He made 18 recommendations, all of which have been accepted by the government. These included:

  • Review and strengthen arrangements for consulting with stakeholders on their approach to regulation
  • Reduce license application bureacracy and costs, including cooridinating with other bodies such as the HRA
  • Review regulation to ensure it is proportionate and alligned with other policies and countries
  • Reduce running costs

Recommendation 9 particularly caught our eye as it picks up on the Academy of Medical Science's report calling for a one stop shop to help researchers navigate regulation:

[the Care Bill currently going through parliament] establishing the HRA... should ensure that it has a duty to provide a “one stop shop” for advice for those intending to undertake health research, and should ensure that the legislation includes a “duty to cooperate” among all regulatory bodies.

Announcing the decision to the House of Commons, the health minister Anna Soubry said:

I’m pleased to say we’ve accepted his recommendations which will ensure the HFEA and HTA continue to provide effective and expert regulation in complex and sensitive fields, but as efficiently as possible in line with this government’s aim of reducing bureaucracy.... DH will now begin implementing other recommendations for government, including a review of human tissue legislation.

What does this mean for AMRC members?

As funders of medical research, our members are concerned primarily that regulators do their job well to ensure research is conducted safely and ethically. And that the process of regulation is streamlined so that research projects do not suffer long delays, lack of coordination and escalating costs. Proposals to improve coordination among regulatory bodies and give the HRA a statutory duty to act as a "one stop shop" to guide applicants through the system are all helpful to ensure regulatory processes are easy for funders and researchers to navigate.  Increased coordination will also help our regulatory system to be more agile and responsive to advances in science which may pose new challenges for regulators.

Tags: HFEA, HTA