Government response to AMS recommendations on regulation soon

Posted on March 14, 2011 by

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Last week the Lords were continuing to look at the public bodies bill in detail – the bill that will give the government the power to make changes to quangos including the Human Tissue Authority (HTA) and Human Fertilisation and Embryology Authority (HFEA) which regulate aspects of medical research. Earl Howe was the Health minister responding and confirmed the government’s plans to consult on these changes in late Summer 2011 before taking any action to change them. He also indicated that the government are still deciding whether to accept the AMS recommendation to establish a Single Research Agency regulating all research, but that we can expect an announcement on this shortly.

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.

The Bill reached its last day of committee stage – the House of Lords were debating the bill in detail, clause by clause – on Wednesday 9 March.

What happened on Wednesday?

Baroness Thornton, the Labour shadow health minister, tabled a few amendments (92 and 93 here) probing powers that would make it possible for the government to make changes to the HFEA and HTA by modifying or transferring their functions.

Many peers expert in medical research were involved in the debate including Lord Patel, Lord Walton, Baroness Deech, Lord Mackay of Clashfern and Lord Winston,

Lord Willis, AMRC Chair, took part in the debate questioning whether the case had been made to change the HTA and HFEA and emphasising the need for robust regulation in this area:

…[the government] have failed to present a convincing argument for changing from two well respected regulators to something that has not been explained well and clearly leaves a lot of questions to be answered. There is a need for an equivalent of the Human Tissue Authority. Sometimes we overplay the organ retention scandal. It happened in one hospital in one area. The practice was not rife through the whole research base; it is important to state that. Nevertheless, there is a need for a regulator. In the case of the Human Fertilisation and Embryology Authority, despite the fact that so much time has elapsed since the original regulator was put in place, science is changing dramatically and the research, particularly on cytoplasmic hybrid embryos-admixed embryos-was something that the HFEA rightly referred back to government to ask for a view, whereupon the legislation was updated.

…[the minister] must today make absolutely clear how tissue and embryos will be protected in the new regulatory and research environment. If you throw out the current organisations, it is clearly necessary for the Minister to clarify what will replace them.

Lord Willis also touched on the Academy of Medical Sciences recommendation for a single Health Research Agency, emphasizing that is should cover regulation of research AND research techniques. And caution should be taken to ensure that there should be no loss of expertise as the body doing the regulating is changed.

Will the Minister assure the Committee that regulation regarding research and research techniques will also reside with the health research agency? The idea of placing research under the new agency but putting the regulation of research techniques under a different agency is totally unacceptable. Will the Minister also confirm that the new health research agency does not require primary legislation and that it can be established relatively quickly without such legislation? If he is able to confirm that, can he assure the Committee that when the Bill goes to the other place there will be a clear timetable for setting up the agency? That will provide some clarity about the path ahead regarding research.

There was about two hours of discussion, following which the minister, Earl Howe, responded. He confirmed that any future plans to abolish the HFEA and HTA will need new primary legislation and there is no plan to change the regulations themselves, just how and by who they are enforced. He suggests that the powers clause 5 would give the government to transfer the powers of the HFEA and HTA are necessary to allow them to make changes without reopening the regulations themselves. These regulations have been updated recently, following considerable Parliamentary discussion, by the Human Tissue Act 2004 and the Human Fertilisation and Embryology Act 2008.

…Any future proposals to abolish these two bodies will be provided for in future primary legislation. I am happy to reiterate my assurance that there is no intention to revisit the provisions in either the Human Tissue Act or the Human Fertilisation and Embryology Act that provide the important ethical safeguards necessary to maintain public confidence in these sensitive areas.

…The powers that we are debating today will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the ALB review. In order to abolish the HFEA and HTA or to transfer their research-related functions to any new research agency we will require powers under future primary legislation

Earl Howe also outlined a rough timetable of what will happen next, confirming that there will be a period of consultation this summer before any changes are made:

It may help if I try to provide a rough outline as to how and when we expect things to happen. We intend publically to consult on proposals to transfer all of the HFEA and HTA functions to other bodies in the late summer of 2011. Then during 2012-13 we would prepare draft orders for formal consultation under the provisions of this Bill dealing with the transfer of functions other than research functions. If appropriate we would then be able to lay the orders before Parliament.

On the expertise contained within the regulators he confirmed that:

…expertise will not be lost. It is envisaged that expertise will follow functions; for instance, through staff transfers and expert reference groups.

And Earl Howe outlined a little more detail of the government’s thinking about the Single Research Agency recommended by the Academy of Medical Science’s (AMS) review of regulation (details of this review in my previous post here). At the time, the report recommended that action could be taken immediately to start putting the recommendations in place by establishing the proposed Single Research Agency as a special health authority (this wouldn’t need any legislation to do). Earl Howe indicated that the government is still deciding whether to accept this AMS recommendation to establish a Single Research Agency but we can expect an announcement shortly.

My noble friend Lord Willis asked about the possibility of setting up a single research agency without primary legislation. He is technically right; we could do that. I should emphasise that we have not decided whether to accept the AMS recommendation to establish a single research agency-we think that there are merits in the proposal and we will be making an announcement shortly-but if we were to propose setting up such an agency we could do so initially by creating a special health authority. However, we could not legally transfer the research-related functions of either the HTA or the HFEA to that body. We could not make a transfer of functions to a special health authority without amending the 2006 Act.

Following the discussion, Baroness Thornton agreed to withdraw the amendments, but indicated that she might look to raise these issues again as the Bill moves towards report stage (timeline here). She also emphasised her concern over public confidence in regulation, that it is important for the public to be able to clearly see how this research is being regulated and this should be at the heart of the government’s planned changes.

I am worried. A floating ethical framework sprang into my mind because I could not see where the ethical framework of what is being proposed will sit. If we cannot see where it will sit, what hope is there for the public? It seems to me that that is where the Government need to start. It is not a question of having a mechanical process and saying, “We will put this bit here and that bit somewhere else and have a regulation that will make sure that the research goes somewhere else”, because if we cannot understand where the ethics sit we are in very serious trouble.

What next?

The Bill will continue through the Lords and then head to the Commons; timeline here. The next debate will be report stage in the Lords on 23 March. And we’ll be looking out for the government’s announcement on how they plan to act on the AMS recommendations.

Posted in: Policy