What does the HTA think about plans to reorganise regulators?

Posted on July 26, 2011 by

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I just nipped over for a bit of the Human Tissue Authority’s (HTA) review of the year. Hot topic was the planned reorganisation of the regulation of health research in the UK and what this might mean for the HTA and the job it is doing now. Although the exact mechanics of the changes are very much still up in the air and being decided, the HTA confirmed that they are expecting a consultation on the movement of their functions (previously announced for late summer 2011) ‘later this year’ and that they would expect reorganisation to be nearing completion sometime in 2014 (the original timeline was by April 2013).

Background

In their review of Department of Health arm’s length bodies published last July, the government proposed to put the research regulation functions of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) together into a single regulator of research.

The Academy of Medical Sciences review of the regulation of health research in the UK in January went on to recommend a single regulator of health research be established and in the Plan for Growth published alongside the 2011 budget, the government committed to setting this up as the Health Research Regulatory Authority (HRRA).

The government is planning to establish the HRRA as a special health authority shortly, introducing primary legislation in the next parliamentary session to make it an official independent body.

The government have undertaken to consult on the movement of the research regulation functions of the HFEA and HTA and not to move them before the HRRA has been set up in primary legislation.

The Public Bodies Bill has been introduced to give government the necessary powers to reorganise the HFEA and HTA without opening up the original legislation which established them. This has been debated by the Lords and is currently in the Commons.

What is the HTA’s position?

The HTA has argued that it is important that its functions are kept together.

We believe the best way to maintain focus and ensure public and professional confidence in the safe and ethical use of tissues and organs, with proper consent, is to keep all our functions together.

The HTA currently governs all uses of human tissue including for research. Other uses of human tissue include for patient treatment, post-mortem examination, teaching, and public exhibitions. The HTA also give approval for organ and bone marrow donations from living people.

Concerns were voiced today that if the regulation of research was moved separately from the HTA’s other functions, where human tissue is being collected and used for several purposes, including research, several regulators may need to be involved to license the tissue’s use, rather than just the HTA.

The HTA is confident that the government aims to keep its functions together:

The signs from Government are positive as this is now their preferred solution, though there are still some issues to settle in research. We will continue to support decision-making to help ensure the best possible outcome. We expect any transfer will happen over the lifetime of this Parliament, most likely in 2014. In the meantime it is business as usual.

And there was a strong focus today on the increasing collaboration with other regulators including the Human Fertilisation and Embryology Authority (HFEA which regulates research involving embryos), the Medicines and Healthcare Regulatory Authority (MHRA) and the National Research Ethics Service (NRES which considers the ethics of proposed research projects and ensures the well-being of participants, and will be the main constituent of the new HRRA when it is first established)

What next?

The HTA have a regularly updated page as this progresses.

The Public Bodies Bill is still on its way through parliament – the debates will resume after the summer recess. Also after the summer recess, the government will be able to table the necessary statutory instruments to start establishing the HRRA as a special health authority.

We’re also waiting for the planned consultation on how the functions of the HFEA and HTA should best be reorganised.

Posted in: Policy