How the HFEA and HTA will be reorganised is still under debate

Posted on March 30, 2011 by

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The future reorganisation of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) were being discussed in the Lords again late on Monday night as the public bodies bill hit report stage. The Bill would give the government the power to transfer the functions of these bodies elsewhere. Peers raised a lot of concerns about whether the government should be given this power when we currently have limited detail on how they plan to reorganise and how a good standard of regulation which the public can have confidence in will be maintained. Earl Howe was the health minister responding and gave a bit more detail on the government’s planned timetable and why they are taking this approach. He also referred to the plans outlined in the strategy for growth published alongside the budget last week.

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), from which the government proposed to to create a single regulator of research in their review of Department of Health arm’s length bodies published back in the summer.

In a debate on this bill in February, Earl Howe announced that the government plan to consult on where the functions of the HFEA and the HTA should be transferred and how this should be done this summer.

Back on 9 March, the Bill was in committee in the Lords and  Baroness Thornton, the shadow health minister, tabled some amendments probing powers that would make it possible for the government to make changes to the HFEA and HTA by modifying or transferring their functions. A lot of peers joined the debate and Earl Howe, the health minister responded, trying to address some of their concerns including suggesting that the government would be responding to the Academy of Medical Sciences (AMS) recommendations on how to improve research regulation soon (I’ve summarised the discussion in my previous post).

Following that debate, Earl Howe wrote to Lord Warner on 22 March to clarify some of the issues raised – that letter is referred to in the debate.

And last week, alongside the 2011 budget, the government published a Strategy for Growth which announced that they plan to set up a single Health Research Regulatory Agency (in line with the AMS recommendations). They didn’t give much detail of what this would look like and what would be in its remit just yet. This is the likely home for many of the research regulation functions of the HFEA and HTA if the government continues with its plan to disband these. (detail of this announcement in my previous post here)

Monday’s discussion

Baroness Thornton tabled two amendments (49 and 50) which would stop the government from having the power to modify or transfer the functions of the HFEA and HTA.

The discussion centred on peers’ concerns that the government should not be given the power to reorganise these bodies before they had given a bit more detail on how they plan to do this.

Lord Warner summed the problem up:

On the Minister’s own admission the Government cannot say at this stage what approach they prefer to take on transferring functions. That is a fairly big lacuna in the Government’s thinking. If they cannot say how they want to change these functions with some degree of clarity and when this new agency will be set up, it is asking quite a lot of Parliament to take it on trust that we should plonk a couple of organisations of some standing and good functioning in Schedule 5 of the Bill and hope it all will all turn out okay eventually.

Concerns were also raised over how the organisations can be changed without risking eroding public confidence in the quality of their regulation. Baroness warwick – chair of the HTA – emphasising her concerns that change to the HTA would erode public confidence:

I fear that separating the HTA’s functions would risk undermining the progress that has been made in building public and professional confidence. Leading thinkers have voiced profound concerns about dismantling the HTA. Senior legal academics have said in theSunday Times:

“The proposals to abolish the Human Tissue Authority-HTA and the divisions of its functions among larger, non-specialist regulators-risk confusion and error in the implementation of the Human Tissue Act 2004, which in turn will erode public confidence”.

And Baroness Deech talked about the importance of maintaining the regulators independence from government to retain public confidence

…we must keep independence in this sensitive, ethical area. It must be free from government. As a freestanding organisation, the HFEA is much more accountable and transparent than the new proposals for structure would be.

The peers also expressed doubt over whether the HFEA and HTA can be rearranged without also opening up debate over how they regulate, even with the new powers the government is aiming to create in the public bodies bill:

[Lord Warner] I found the penultimate paragraph of the Minister’s letter to me of 22 March particularly puzzling. He claims that the mechanism in this Bill reduces the risk of opening up the whole HFEA primary legislation for debate. Like other noble Lords, I view that with deep, deep scepticism. The idea that we can open up a debate about the functions of the HFEA being transferred from it to another body without opening up many of the public concerns around that body and similarly with the HTA seems to me, if I may put it as brutally as this, extremely naive. It is not going to happen. Once you start tinkering with these two bodies of great sensitivity, as I am well aware of from taking the HTA legislation through this House, you are actually opening Pandora’s box. You cannot be sure what the outcome will be in terms of public concerns.

Earl Howe, the health minister with responsibility for research, responded.

He stressed certain points he has mentioned when this issue has been discussed previously:

  • the need to rationalise multiple regulators that is driving the government’s plan.
  • he provided assurances that reorganisation would not lead to the loss of expertise.
  • And that reorganisation would lead to financial savings (he mentioned that the government plan to develop an impact assessment which will be available for the consultation process)
  • He restated that the government plan to consult on where and how the functions of the HFEA and HTA are best transferred (although he clarified that the question of whether they should in fact be kept as they are will not be up for debate in the consultations)
  • He echoed the announcements in last week’s strategy for growth that the government will start work now establishing a single Health Research Regulatory Agency in line with the recommendations made by the AMS. He clarified that, in line with the AMS report, the government believe it would be beneficial to bring the HFEA and HTA into a single Health Research Regulatory Agency but said that this would be one of the issues they will invite people to comment on in the consultations they plan for the summer.

Addressing concerns that the way the government is approaching this reorganisation is not very joined-up, Earl Howe outlined their planned timetable. This includes the planned consultations we already know about, and he suggested that the government might aim to lay the orders to reorganise the HFEA and HTA that they develop from this consultation before Parliament so MPs and peers can scrutinise them (although if they have the powers in the public bodies bill that would mean that they don’t have to do this):

It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress.

Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.

We’ll have to wait ’til after the consultation in the summer for further detail on how they plan to redistribute the functions of the HFEA and HTA.

Earl Howe also clarified why the government were taking this approach and not including the reorganisation in the Health & Social Care bill currently on its way through parliament. They have decided not to do this as they think that bill is effectively big enough already…

Lord Willis of Knaresborough: Would it not be possible to include a new clause in the Health and Social Care Bill to set up the new medical research agency and leave to consultation and secondary legislation the details that would follow? That would at least give certainty to that organisation and, with a new Bill in the second part of the Parliament, put it into the parliamentary timetable much earlier than envisaged.

Earl Howe: In theory, my noble friend makes a constructive suggestion. We have considered that option and, I am afraid, rejected it on the grounds that the Health and Social Care Bill is big enough as it is, and contains a substantial programme of modernisation. It would be possible to Christmas-tree that Bill almost ad infinitum, and we have decided that that would not be helpful. With the Health and Social Care Bill, we seek to focus on the modernisation agenda, pure and simple. I am sorry to disappoint my noble friend, who makes a perfectly sound point, but I am afraid that we are not going to do that.

What next?

Baroness Thornton withdrew the amendments at this stage but there was some dissatisifaction with whether the ministers answers addressed the concerns raised and why this reorganisation could not better be dealt with in Health & Social Care bill.

At this point in our consideration, I do not think that we have reached a satisfactory and conclusive point in our discussions about the HFEA and HTA. I hope that we can resolve and clarify the remaining and outstanding uncertainties on this issue before Third Reading, and I very much welcome the fact that the Minister has said that he will be responding to certain points. I am sure that he is prepared to continue those discussions and I hope that we can resolve them before Third Reading. Otherwise, I fear that we may have to return to this issue. I beg leave to withdraw the amendment.

So it is likely that this topic will be discussed again at third reading.

There are further days scheduled for report stage, the bill will then progress to third reading and then it’s off to the Commons. (timeline here)

Posted in: Policy