What does the HTA think about plans to abolish it?

Posted on February 4, 2011 by

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The Human Tissue Authority (HTA – which licenses and regulates all uses of human tissue including for medical research) newsletter just popped into my inbox (you can sign up here) and it’s full of detail on their position about the changes afoot in regulating research.

They are arguing against the government’s proposal to abolish the HTA and split its functions across several new organisations, including a single regulator of research. They argue that keeping all the HTA’s functions together in one body is important for good regulation that the public can be confident in.

Background

The government is changing the system of regulation, including creating a single regulator of research. This involves getting rid of some of the separate arm’s length bodies that currently play a role in regulating research (like the Human Tissue Authority (HTA)) bringing all research functions together. The HTA does more than just regulate research, licensing and inspecting organisations that store and use human tissue for purposes including treatment, post-mortem examination, teaching and public exhibitions. They also give approval for organ and bone marrow donations from living people. The reorganisation will mean all these current functions will actually be split across three or four organisations.

Focusing on research, at the beginning of January, the Academy of Medical Sciences published a report suggesting how a single research regulator might look (more here). We’re now waiting for the government to respond to that report and reveal the details of how they will change the regulatory system.

The government is not planning to revisit the actual principles of regulating the use of human tissues, just how these regulations are applied and carried out in practice.

What is the HTA position?

The HTA concluded at a meeting on 25 January that:

…The reasons we were set up have not gone away…

…keeping our functions together as a focused single entity would be the best way to protect this hard-won confidence. The Authority believes that the most effective way to ensure that tissues and organs are used safely and ethically and with proper consent, is through a single organisation with the focus and expertise to act effectively and consistently across all sectors.

The Authority believes keeping our functions together would:

• maintain a clear focus on the safe and ethical use of human tissue and organs across all our sectors;
• maintain a consistently rigorous approach to consent across all our sectors to ensure that an individual’s right to decide what happens to their bodies in life and death and the bodies of their loved ones is paramount;
• avoid duplication and ensure continuity of intelligent and effective regulation. The HTA’s approach promotes improved standards and has been praised by the Better Regulation Executive and the Department of Health. It supports the strong interrelationships between the sectors we regulate;
• preserve the independence, expertise and credibility of our non-executive lay and professional Members which are essential to effective regulation in this field. This would be difficult if not impossible to replicate in three or four different organisations;
• give better value for money. The Department of Health recognises we are a cost effective organisation. We plan to reduce our costs by 14% in cash terms in 2011/12. And our funding from the Government amounts to £1m – about 1/6 of our income;
• ensure the Government’s own aims of transparency and accountability are better supported through a single body responsible for implementing the Human Tissue Act with a strong track record in communicating effectively with the public and professionals.
• the HTA believes that keeping all functions together will maintain focus and ensure that the public continue to be confident that human tissues and organs are always used safely, ethically and with proper consent.

They have set up a webpage here which they are keeping updated with all the discussion and changes as they happen.

What next?

The government is planning to use the public bodies bill to give it the power to officially close the HTA and reassign its functions to different organisations (more in my previous post here).  This bill is currently being debated in the Lords – see details and timeline on the bills page here. There are several amendments down for debate about the impact of these changes to the HTA so this is likely to be discussed.

Earl Howe announced at a debate on 1 February that the government is planning to consult this summer on where the functions of the HTA should be transferred and how this should be done. More details in my previous blog here.

And we’re waiting for the government’s response to the Academy of Medical Sciences report on regulation. This made recommendations on how the HTA’s research regulation functions could become part of a single regulator of research – a Health Research Agency so this response should give us more insights into the government’s plans and how/whether they will address some of the concerns outlined by the HTA above.

Posted in: Policy