Care Bill [HL]

Baroness Thornton Excerpts

Wednesday 12th June 2013 Lords Chamber

[Baroness Thornton]

My Lords, it is a great pleasure to be back on the Front Bench as part of my noble friend’s health team, even if it is for a short time. I join other noble Lords in sending best wishes to the noble Lord, Lord Willis, for a speedy recovery.

As noble Lords will know, I have been interested in the future of the HFEA and HTA both as a Minister and during the course, in the early days of this Government, of the slash and burn Public Bodies Act, which both these bodies survived. The idea of merging the HFEA and HTA is not new, as my noble friend Lord Warner said, and has been rejected on more than one occasion. I am puzzled by the noble Lord, Lord Patel, raising it now, especially in the middle of yet another review. What I waited to hear, particularly from noble Lords with scientific and research backgrounds, was what the public thought. The right reverend Prelate was right when he said that this is also about how people feel about these issues, not just how the great doctors and scientists think things should be done. In fact, that was how we started out with all these issues.

As my noble friend Lord Warner said, this was first raised by my Government. We proposed establishing a new arm’s-length body called RATE—the regulatory authority for tissue and embryos. According to my research, in 2007 the Government wisely decided not to proceed with that following criticism from a Joint Committee set up to scrutinise that draft Bill. The arguments advanced against RATE then were just as persuasive as they are today. Many of us have held that there is little overlap in the work of the two bodies and that the specialist expertise each provides should be maintained to ensure that regulation remains effective and public confidence is maintained. The discussion we have had so far today has not convinced me that this proposal is the best way forward at the moment. The independence of the HTA and HFEA is important for a number of reasons, not least because of the public confidence needed in both the areas they cover.

In 2010, the Government proposed as part of their bonfire of the quangos that the functions of the HFEA and the HTA should be transferred largely to the CQC. Noble Lords will remember the debate about that during the passage of the Public Bodies Act. Following an extensive public consultation, that proposal was also rejected by the Government in January this year. Once more, a clear majority of those who responded thought that the risks involved in such sensitive areas of medicine were just too great. Instead, the Government decided that an independent review of the way the HFEA and HTA carry out their functions should be undertaken by Justin McCracken. I understand that Mr McCracken’s review is complete and Ministers have yet to decide what to do. Perhaps we will have a sneak preview of that today.

Is there new evidence that there is an advantage in merging these two distinct and expert organisations? As I said, they have different roles. According to the brief I was sent, there are fewer than 10 organisations jointly regulated by both organisations. As context, around 130 organisations are regulated by the HFEA and 800 by the HTA across diverse sectors. On these Benches we are nervous that the amendment tabled by the noble Lord, Lord Patel, to merge the boards of both these organisations risks losing specialist expertise held by the HTA and HFEA and the unique roles in law that their respective boards have.

During the committee scrutiny of the Bill in its draft form—as the Care and Support Bill—the committee advised against a full merger of the boards. In its call for evidence, the committee asked for views on precisely this question. As far as I know, respondents unanimously opposed the abolition of either body or the transfer of their functions. The Academy of Medical Sciences replied:

“There is a great deal of support among our community for the HFEA and the HTA; both are perceived as having developed the experience to respond in a balanced, practical way to the changing landscape that reflects the evolving risks and benefits of research. The relatively small savings to be made through disbanding the HFEA and the HTA need to be balanced against the inevitable period of disruption and uncertainty, and any potential risk of loss of expertise, efficiency, effectiveness and coherence that could hinder research and practice and result in the loss of public and professional confidence … We therefore support retaining both the HFEA and the HTA, providing they work closely with the HRA and other regulators to further streamline the regulation, inspection and governance process for patient and public benefit”.

I accept precisely the point made by my noble friend Lord Winston and others that there are unnecessary delays and that there are clearly issues to be addressed in the way that these bodies operate.

The committee concluded that Ministers should not have the power to abolish the HFEA or HTA and recommended that the relevant clause should be deleted. While its conclusions were about abolition, these same points apply to the merger of the boards: expertise would be lost, there would be huge disruption and all for relatively tiny cost savings at the moment. The work of the HTA and HFEA is of enormous scientific and ethical importance. We accept entirely that there is always room for improvement and we should never be complacent. The review led by Justin McCracken will no doubt make recommendations for further efficiencies. We would be jumping ahead of his proposals by agreeing this amendment at this time.

[Earl Howe]

My Lords, this has been a very instructive debate and one to which I have listened with enormous care and interest. It takes us back to a well-worn area, as noble Lords have been keen to point out. The amendment proposed by the noble Lord, Lord Patel, would abolish the HFEA and HTA and replace them with a new regulatory body, the human tissue and embryo authority. It would also transfer responsibility for the regulation of infertility treatment involving embryos, sperm and eggs to the CQC.

I listened with great care, as I always do, to the noble Lord, Lord Patel, when he moved the amendment. As has been amply demonstrated in the course of this debate, the prospect of the merger of the HFEA and HTA, or of the transfer of their functions elsewhere and the subsequent abolition of the two bodies, is by no means a new one. It has been considered carefully and consulted on on a number of occasions over recent years, including by Members of this House.

In 2007, as we were reminded, a Joint Committee of both Houses of Parliament, chaired by my noble friend Lord Willis, considered a proposal to replace the HFEA and HTA by the regulatory authority for tissue and embryos—RATE. The committee roundly rejected that proposal. It recognised concerns expressed by stakeholders about the risk of losing the specialist expertise that the HFEA and HTA individually hold and the small extent to which the two bodies actually cover common ground. That point was made very powerfully by the noble Lord, Lord Walton, today.

The Government are as keen as anybody to minimise the number of arm’s-length bodies when we possibly can. A substantial exercise was undertaken across government when the coalition was new to do exactly that and a great number of bodies were abolished. Within that framework, last year the Department of Health undertook a public consultation on a proposal to transfer the functions of the HFEA and HTA to the Care Quality Commission and the Health Research Authority, as part of our review of the arm’s-length bodies. Across the full range of respondents, a majority of three-quarters disagreed with the proposal. The main reason cited was that the HFEA and the HTA have developed considerable expertise in their highly specialised fields. They were said to be trusted and respected by the regulated sectors. Respondents believed that this expertise and trust would be lost were a transfer of functions to take place. That point was well made by the noble Baroness, Lady Thornton, who I am delighted to see on the Front Bench opposite. The noble Lord, Lord Patel, indicated that in his view it was unnecessary to have two separate organisations, but that was not the view of those who responded to the consultation.

Respondents also said that they did not believe that the CQC was well-placed at the time to take on the functions of the two bodies and they feared that those functions would be subsumed by the CQC’s other responsibilities. Another strong message from the consultation was that the small size of the two bodies and the small overall anticipated savings did not warrant the risks involved in abolishing them and transferring their functions. I recall that the noble Lord, Lord Warner, made that very point when we debated these issues during the passage of the Public Bodies Bill. The Government listened to the responses and decided not to proceed with the transfer and abolition. However, we also recognised the clear message from the consultation that there is scope for the HFEA and the HTA to achieve further efficiencies in the way that they operate. That much, I hope, all noble Lords agree on.

The noble Baroness, Lady Thornton, asked whether there was any new evidence about the value of a merger. It was with that very question in mind that we commissioned an independent review of the two bodies by Justin McCracken, former chief executive of the Health Protection Agency, in January this year. The review included looking at the scope for shared membership and leadership of the HFEA and HTA and for their merger. The report of the review was submitted to Ministers in April and is currently under consideration, so I am afraid that I am not in a position to share any conclusions quite yet. I will give way.

[Baroness Thornton]

Will we see the white smoke before we get to Report?

[Earl Howe]

I sincerely hope and anticipate that we will, but I am afraid I do not have a particular date in my brief. If I am able to supply the noble Baroness with that information, I will be happy to do so. The noble Lords, Lord Winston and Lord Patel, cited the number of different regulators involved in the organisational arrangements and the regulation of regenerative medicine in the UK and pointed to the complexity of these arrangements. I understand that point of view, but we are now in a world where the regulators in this area work very closely together to provide regulatory clarity to the sector and to ensure that the system actually works. I know, for example, that the MHRA and the HTA work closely together and have carried out joint inspections.

The department, along with the UK regulators, worked together to produce a regulatory map for stem cell research and manufacture, and I think that too has been helpful. I fully understand and appreciate the interest of noble Lords in this matter and their desire to streamline regulation. We all welcome that aim. I hope that noble Lords will appreciate that the Government have given this matter consideration in some depth, including through public consultations. The strong message we have consistently received from stakeholders is that the HFEA and the HTA should not be abolished or merged or their functions transferred elsewhere. Our latest consideration of this is the scope for regulatory streamlining that the McCracken review looked at, including the scope for regulators to work closely together. That consideration is currently taking place. As soon as the Government’s position on it is determined I will ensure that noble Lords are informed. I am additionally told by a most reliable source that we do not yet have a confirmed date for that announcement.

I am always loath to disappoint the noble Lord, Lord Patel, but I hope he will understand that we did not reach this position without due deliberation and indeed without taking extensive soundings among the stakeholders who are most concerned in this area. I hope he will feel, if not exactly comfortable in withdrawing his amendment, at least satisfied that the matter has been fully debated.