Consultation on the future of the HFEA and HTA this summer

Posted on February 2, 2011 by

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The Lords had a really interesting debate yesterday about the future of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA), which are both marked for abolition in the big reorganisation of health regulators. They focused on the role these bodies currently play in maintaining public confidence around potentially controversial issues and ensuring public safety and pressed the government on how they were going to guarantee that this was still being done well following reorganisation.

Earl Howe was responding and said masses of interesting things, giving us an insight into the government’s thinking and what the process going forward might look like. Most interesting, he announced that there is going to be a consultation on where the functions of the HFEA and the HTA should be transferred and how this should be done this summer; so plenty more opportunities for us to get involved in the debate.

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 Fertilisation and Embyrology Authority (HFEA) and Human Tissue Authority (HTA)) and bringing all their research functions together. 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 embryos and tissues, just how these regulations are applied and carried out in practice.

What happened yesterday?

The Lords had a short debate about the proposed abolition of the HFEA and the HTA, kicked off by a question from Baroness Thornton.

To ask her Majesty’s Government how they will maintain public confidence and patient safety following the abolition of the Human Fertilisation and Embryology Authority and the Human Tissue Authority.

Read it here

Baroness Thornton focused on the important work the HFEA does on ethical and safety issues around research and treatments using human embryos and asked how government will ensure any new arrangements for regulation will do this well, maintaining public safety and public confidence.

The discussion took in the reasons the HFEA and HTA were originally established to ensure the public could have confidence that highly tricky and potentially controversial areas of research and treatment, using human embryos and tissues, were being regulated carefully and with consideration for people’s concerns. This followed poor practice in the use of human tissues at Alder Hey and challenges posed by the new embryo and fertility advances of the 1980s creating a need for an arena in which to openly discuss and regulate complicated ethical issues.

A number of issues were raised:

  • Concerns that not having a discrete body regulating human embryo research will not accord it the status the human embryo deserves. But are we pretty mature about this area and has IVF become pretty routine, no longer needing separate regulation?
  • What does ‘lighter touch’ mean in practice? Not a reduction in the quality and thoroughness of the regulation?
  • The importance of safeguarding principles of informed consent. Have the reasons that the HFEA and HTA were set up gone away? Does transferring and splitting up functions risk undermining the progress they have made so far?
  • These are complicated and continually developing areas, a single body home to considerable expertise is valuable in navigating this. Any changes must not lose expertise.
  • Will the changes maintain clear accountability and ensure openness and opportunities for scrutiny? All of which are valuable to maintaining public confidence.

Earl Howe was the Health minister responding to all these questions. Read his response in full here. He recognised the need for any changes to the system to maintain public confidence. He emphasised that the government is not planning to revise the legislative provisions governing embryo and tissue research, just a reorganisation of the functions; i.e. who is doing this regulation and how they are doing it.

..there is no intention to revisit the ethical provisions and safeguards in the HFE Act, the principles set out in the Warnock report, or the principles of consent underpinning the Human Tissue Act.

…the HFE Act provisions that recognise the special status of the human embryo will remain in place, entirely as they are now, as will the provisions in the Human Tissue Act that ensure that donors’ and families’ rights and safety are protected.

The deadline they have set themselves for putting these changes into practice is the end of the planned Parliament; so with the five year term agreed as part of the coalition, there is until May 2015 to bash this out.

On the detail of the reoganisation of functions, Earl Howe stated that it is there intention:

that the healthcare-related licensing functions of the HFEA and HTA will transfer to the Care Quality Commission

He also referred to the Academy of Medical sciences recent report which took a snapshot of how research is regulated in the UK and recommended changes to improve the system (see my previous post here for more details on what that said). He restated that the Government welcome this report and are considering their response to its recommendations. We’re hoping the government’s response will give us more detail of the next steps and how the government is planning to act on the Academy’s recommendations.

A few years back, the government published a white paper ahead of the most recent Human Fertilisation and Embryology Bill being introduced and eventually passed in 2008 (see timeline here). This proposed merging the HFEA and HTA to create a single organisation called RATE (Regulatory Authority for Tissue and Embryos); an idea that, following scrutiny, was scrapped. Earl Howe clarified that the government’s current approach for a single research regulator is very different to this proposal, focused more on streamlining and cohesion rather than just merging functions. Another idea that has been discussed before, creating a national bioethics committee, was also touched on and Earl Howe clarified that the government felt this was not necessary,

…consideration of specific ethical issues by bodies such as Nuffield and parliamentary scrutiny committees remains the preferred approach.

In response to concerns he clarified that the concept of a ‘lighter touch’ approach to regulation applied more to the design of the systems regulating rather than the substance of the regulations themselves.

Earl Howe did give us a bit more information on some of the next steps, namely two consultations:

my department is planning to undertake a public consultation exercise this summer about where HFEA and HTA functions are best transferred. We regard this as a key part of the process. We will consult on any subsequent use of powers agreed in the Public Bodies Bill to effect those transfers. Effectively therefore, there will be two consultations.

He indicated that no final decisions had yet been made how the powers in the Public Bodies Bill – which if passed in their current form would give the government power to abolish the HFEA and HTA without further primary legislation (see my previous post here for more about this Bill) – will be used.

…if we cannot secure a place for the HFEA and HTA with the Public Bodies Bill then we will have to look to a future Health Bill to support the transfer of functions, however we decide that the transfer should be conducted. However, to move into primary legislation would mean that the safeguards enshrined within the HFEA and HTA Acts would then be open to parliamentary scrutiny and vulnerable to amendment. I know that very few noble Lords would relish that scenario.

What next?

We’re waiting for the government’s response to the Academy of Medical Sciences report on regulation which Earl Howe referred to. This should give us more insights into the government’s plans. And we’ll be looking out for those consultations on the HFEA and HTA planned for this summer. Debate will no doubt continue raging over the proposed changes as this moves forward, both inside and outside Parliament.

Posted in: Policy