The HFEA and HTA’s regulatory functions will only move once

Posted on May 10, 2011 by

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The public bodies bill had its third reading in the Lords yesterday afternoon, it’s now heading for debate in the Commons. A few amendments had been tabled to probe the government’s plans to reorganise the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) both of which have a role in regulating research among other things.

The Government is planning to move their research regulation functions into a single Health Research Regulatory Agency which they will set up in the first instance as a special health authority (which they can do through regulations rather than primary legislation). This would only be temporary and the agency would eventually have to be established properly through primary legislation.

There were concerns that regulatory functions could be chopped and changed about as they were moved into a temporary agency and then again into a permanent agency. Yesterday the government addressed these concerns and confirmed that they won’t move the research-regulation functions of the HFEA and HTA into the agency until it has been set up properly through primary legislation. They plan to introduce the primary legislation to do this in the second session of this Parliament.

Background

The government has introduced the  Public Bodies Bill to create a legal framework to enable them to make changes to quangos, modifying their constitutions, funding arrangements or transferring their functions elsewhere, without opening up the original Act that created them. This includes the research regulators – the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA). In their review of Department of Health arm’s length bodies published back in the summer, the government proposed to put their research regulation functions (they do more than just regulate research) together into a single regulator of research.

For more background and a summary of previous discussions on the reorganisation of the HFEA and HTA – check out my earlier blog.

What happened yesterday?

The Public Bodies Bill reached its third reading in the House of Lords yesterday. This will be the bill’s final discussion in the Lords for a while –  it will then head over to the Commons, coming back once they have scrutinised it. Timeline here.

As the bill has made its way through the Lords, the issues around the reorganisation of the HFEA and HTA have been discussed at each stage but not resolved. Baroness Deech and Lord Harries, with the support of several other peers, tabled three amendments tackling this. Amendments 7, 8 and 9 here.

Baroness Deech summarised the aim of the amendments as she introduced them:

…in a nutshell what I and others are calling for is that the HFEA and the HTA should remain untouched until a new research regulatory body is in place with its own statute ready to receive those functions, and that in the mean time there should be a wholly independent external review of the HFEA.

The government have already announced that they will be a consultation on the transfer of the functions of the HFEA and HTA in the late summer but Baroness Deech was calling for a review that went further with the aim of:

reducing bureaucracy, increasing accountability and saving money

She also made the point that the HFEA and HTA play a very important role in protecting patient safety and maintaining public confidence in research and it was important to maintain this. As Lord Willis later spelt out, moving their regulatory functions into an interim Health Research Regulatory Authority (there are proposals to establish this regulator initially as an interim special health authority) could undermine public confidence in the quality of regulation.

A number of other peers spoke to support Baroness Deech including Lord Walton, Baroness Warwick, Lord Winston, Lord Patel, Lord Willis and Lord Newton of Braintree

Many referenced a letter that Earl Howe  had written to the shadow health minister, Baroness Thornton, clarifying the government’s position on the changes to the HFEA and HTA following earlier debates. Gleaned from their references to it, this letter stated:

  • that the HFEA and HTA functions will be transferred to the Care Quality Commission (CQC) except for the research-related functions.
  • the research -related functions will be transferred to the Health Research Regulatory Authority.
  • an interim Health Research Regulatory Authority will be established through secondary legislation as a special health authority in 2011-12.
  • following this, primary legislation will be brought forward in the second session of this Parliament to properly establish the agency.

All pushed for Earl Howe to outline a timetable for establishing the new Health Research Regulatory Agency and for government to hold a process of consultation and assessment, introducing primary legislation to then set up the Health Research Regulatory Agency before moving the HFEA and HTA functions into it.

Back in report stage, Lord Willis had proposed that the Health Research Regulatory Authority should be established in primary legislation by adding a clause to the Health & Social Care bill currently being debated in the Commons. However Earl Howe had at the time resisted this option – see my summary of that discussion here.

Earl Howe’s response was really interesting, confirming the government’s plans and most importantly confirming that the government would not transfer the research-regulation functions of the HFEA and HTA into the new Health Research Regulatory Agency until it had been properly set up by primary legislation going through parliament.

In summary:

  • confirmed that the government intend to consult in the late summer on the options as to where the functions of the HFEA and HTA would be best transferred. They will also publish an impact assessment including a view about the cost-effectiveness of various options for transferring functions.
  • Their preferred option is  for all the HFEA and HTA functions to be transferred to the Care Quality Commission (to address concerns that spreading functions across several agencies would fragment expertise) except for certain research-related functions that will be transferred to the proposed Health Research Regulatory Agency.
  • Ethical safeguards will remain firmly in place – the CQC would conduct ethical consideration of treatment licensing. The Health Research Regulatory Authority will separately conduct ethical scrutiny of research techniques.
  • The government do not want to use the Health & Social Care Bill to establish the Health Research Regulatory Agency in primary legislation. They feel that the changes could be better dealt with separately. They are also keen not to reopen the Human Tissue Act and Human Fertilisation and Embryology Act – hence the use of the Public Bodies Bill to give them the power to make the changes to who regulates what without doing so.
  • They plan to establish the Health Research Regulatory Agency as a special health authority. They will consult on the draft regulations to do this before they are laid. The work of the National Research Ethics Service will initially be moved into this new agency. They will then build the “fully fledged research regulator” on this.
Our desire to maintain momentum is why we plan to establish a special health authority to continue and strengthen the work of the National Research Ethics Service and to be a starting point for the simplification of research approval processes. That special health authority would be the platform on which we would build the fully fledged research regulator.
  • Made a firm commitment that, subject to the will and views of Parliament, the Government will proceed on the basis of transferring functions from the HFEA and HTA only once the research regulatory agency is established in legislation. (Earl Howe held back from including this commitment in the text of the bill as it refers to an agency that doesn’t exist yet so is tricky to refer to in legislative language without inadvertently introducing restrictions on what that new agency can look like).
  • Confirmed that the new Research Regulatory Agency would not lose current wealth of expertise in the HFEA and HTA but would have access to “expert peer reviewers and others in the relevant fields that are currently available to the HFEA and HTA.” Again, he did not want to put that in the text of this bill as it might restrict future debate on how the agency would look.

Following Earl Howe’s response and these commitments, Baroness Deech thanked him, particularly welcoming his commitment that there will be only one transfer of the functions of the HTA and HFEA directly into a new regulator. But she still had concerns about the review the government was planning to undertake – she had called in her amendment for an independent external review of the HFEA which the government had not committed to doing, instead they plan to hold consultations in the late summer on transfer of functions and conduct an impact assessment – so she chose to push the amendment to a vote. The amendment did not pass, 199 supported it but 209 voted against. The other two amendments, 8 and 9, were not pushed to a vote.

What now?

The Bill is now heading over to the Commons to go through the same process of debate and scrutiny there. Once it has finished, it will return to the Lords with all the amendments made in the Commons and there may be a bit of ping pong as the Lords and Commons come to agreement over the amendments. So these discussions are likely to continue – although some of the major concerns about changes to the HFEA and HTA have been addressed now.

The government is still planning to set the Health Research Regulatory Agency up as a Special Health Authority during 2011-12. So we can expect draft regulations to do this soon. They’ve said they will consult on these.

And there will be consultations on the HFEA and HTA’s functions in the late summer.

Posted in: Policy