Deregulation Bill

Lord Hunt of Kings Heath Excerpts

Wednesday 11th February 2015 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

43: Clause 88, page 70, line 29, at end insert—
“( ) This section does not apply to the following—
(a) Care Quality Commission,(b) Human Tissue Authority,(c) Medicines and Healthcare Products Regulatory Agency,(d) Professional Standards Authority,(e) General Medical Council,(f) Nursing and Midwifery Council,(g) Health and Care Professions Council,(h) General Chiropractic Council,(i) General Dental Council,(j) General Pharmaceutical Council,(k) Human Fertilisation and Embryology Authority, and(l) any persons exercising a regulatory function with respect to health and care service that the Secretary of State specifies by order.( ) An order under this section must be made by statutory instrument.
( ) A statutory instrument containing an order under this section may not be made unless a draft has been laid before, and approved by a resolution of, each House of Parliament.”

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[Lord Hunt of Kings Heath (Lab)]

My Lords, I am concerned about the unintended consequences of the economic growth clauses on a number of health regulatory bodies. The clauses on the impact of economic growth specify that regulators must consider the promotion of economic growth in exercising their regulatory functions. The Government have said that the health regulators likely to fall under Clauses 88 to 90 are as follows: the Human Fertilisation and Embryology Authority, the Human Tissue Authority, the Medicines and Healthcare Products Regulatory Agency, the Professional Standards Authority and the Care Quality Commission.

The noble Lord, Lord Wallace of Saltaire, has said that the economic growth duty will complement existing duties and will not override or reduce the protection of the public. However, I put the question to him: if the economic growth duty does not impinge on the prime responsibility of the regulator, why bring in the clause at all?

The Minister then said that the economic growth duty sits alongside any other factor that a regulator must consider. However, “sitting alongside” suggests that it has some weighting and cannot simply be ignored. Indeed, the noble Lord has also pointed out that regulators must understand and consider the impact of their policies on individual businesses. That is of course reinforced by the provisions in the Bill.

Clause 88(2) states that “the person”—that is, the regulator—must,

“consider the importance for the promotion of economic growth of exercising the regulatory function in a way which ensures that … regulatory action is taken only when it is needed, and … any action taken is proportionate”.

In Committee my noble friend Lord Tunnicliffe specifically asked about the position of the Care Quality Commission —the principal health quality regulator, to which the noble Earl, Lord Howe, has just been referring—as regards whistleblowing. My noble friend asked,

“do we want a situation where, when the CQC is contemplating putting a requirement on a failing nursing home that may close it down to protect the residents of that home, the operator of the home can say, ‘Closing me down is against growth. Please prove that this regulation, which you may have used elsewhere, is both needed and proportionate’?”.—[Official Report, 20/11/14; col. GC 206.]

I have to say to the noble Lord that I do not detect any enthusiasm from the health regulators themselves about the economic growth duty. The CQC’s briefing to me can hardly bring itself to mention the duty.

The Professional Standards Authority, in line 1, says that it supports the intention behind Clause 88, and then spends the rest of its briefing critically examining the clause. It concludes that Clause 88 ought to be restricted by excluding from the duty any regulatory function the prime purpose of which is to protect the public. I must say that I am surprised to see the Professional Standards Authority included. It is not a regulator. Its job is to oversee the nine statutory regulators, including the General Medical Council, and I do not understand why the GMC and the NMC are not on the Government’s list of organisations to be included within this clause.

Can we come to the Human Fertilisation and Embryology Authority? The noble Lord will know that that body has a crucial and difficult task, and this responsibility could make that duty even more difficult. On 24 February we will have a debate about regulations on mitochondrial donation. Currently, the law only allows these techniques to be used in research. For the IVF techniques to be used in patients, Parliament must pass new regulations.

Both the Nuffield Council on Bioethics and the HFEA held extensive public consultations in 2012. They identified broad public support for the use of these techniques with a “robust regulatory framework”. I stress those words. As the noble Earl’s honourable friend the Minister Jane Ellison told the other place when it debated the regulations:

“The HFEA is highly respected across the globe as a model for the regulation of fertility and embryology treatments and research. Many other countries do not have such a framework”.—[Official Report, Commons, 3/2/15; col. 163.]

Indeed, if the regulations are passed by Parliament on 24 February, the HFEA will be expected to introduce a robust regulatory process, as it has in other areas of fertility treatment. I know that not all noble Lords think that it is as robust as they would wish it to be. None the less, many of us would say that it is a robust process.

The question that I put to the noble Lord is about where the economic growth considerations come in. There is no provision in the Human Fertilisation and Embryology Act for the HFEA to have regard to the imperative to promote economic growth when making its decisions. If a clinic does not meet statutory requirements, it cannot grant a licence or allow a certain activity to take place, regardless of how economically desirable it might be thought to be. Similarly, if there had been gross failings at a clinic, regardless of the economic impact of closing it down the HFEA would be bound to say so in the interests of ensuring patient safety and maintaining public confidence in it as a regulator. Surely the economic growth duty is inconsistent with those requirements. The HFEA’s own website has often acknowledged that it is not an economic regulator. This has been confirmed by Ministers in Written Answers. Peter Thompson, the chief executive officer of HFEA, has recently been quoted as recognising a responsibility by that authority to take action against what he described as rampant commercialisation of IVF in the UK.

The Minister has prayed in aid the draft guidance during the passage of this Bill, but it only adds to concern. The guidance summary states:

“The growth duty does not automatically take precedence over or supplant existing duties held by regulators”.

The term “not automatically” must by implication mean that it is entirely possible for it to take precedence.

The decision about mitochondrial donation is of huge importance. It must be made in the absolute certainty of the regulatory process. There is no time for ambiguity. Will the Minister agree to give this further consideration? I find it very difficult to understand why any of these bodies are going to be included in the list for which regulations will be brought forward. Why on earth has the Human Tissue Authority been brought in scope of this provision, or the Care Quality Commission? I certainly do not understand why the PSA is included. I hope that the Minister will bring some words of comfort that the Government have reconsidered this issue, and I beg to move.

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I hope that that provides the assurance that the noble Lord seeks and that he will therefore be able to withdraw his amendment.

[Lord Hunt of Kings Heath]

My Lords, I am very grateful to all noble Lords who have spoken. However, I am disappointed with the Minister’s response because I thought that at the least he would have been prepared to give this matter further consideration between now and Third Reading. With my noble friend Lord Winston here to talk about the Human Fertilisation and Embryology Authority and the noble Lord, Lord Alton, also present, I knew that we would have an interesting debate.

The point is that, however effective or not the HFEA is at the moment, the one thing that unites us all is that we do not want to see its regulatory function weakened. My noble friend Lord Winston spoke about London becoming the centre of a healthcare market, and the Minister welcomed that. When I took through the 2001 regulations that extended the purposes of research in the original 1990 Act, which was based very much on the extraordinary work of the noble Baroness, Lady Warnock, we clearly had in mind that there was research potential for the UK. That was one of the factors behind taking through those original regulations. The argument that we put forward then was that the UK would be able to attract research investment because, despite some of the doubts that noble Lords have expressed today, we were considered to have a first-rate regulatory function. I put it to the noble Lord that he is putting that reputation at risk by allowing ambiguity in the nature of the regulatory process.

My noble friend talked about the dangers of commercialisation in this field and he is surely right. It is interesting that the chief executive of the HFEA has recently been quoted as recognising the responsibility to take action against rampant commercialisation of IVF in the UK. That statement is very welcome. My noble friend has argued that at the moment it does not have the powers to do anything about it, but the noble Lord comes here with a proposal to weaken its already inadequate powers. That is quite remarkable.

The Government are very keen for the mitochondrial donation regulations to be approved on 24 February. I support them, but has the noble Lord considered the risk to that decision from the impact of this Bill? This will be a big issue when we debate those regulations. When the noble Earl, Lord Howe, comes to make proposals for the regulations, he will say that your Lordships can have confidence in passing the legislation because of the robustness of the HFEA. However, I, who support those regulations, will have to get up and say that actually the noble Earl is incorrect because of what the noble Lord here is proposing to do.

[Lord Alton of Liverpool]

I entirely agree with what the noble Lord is saying, but does it not also undermine the noble Earl, Lord Howe, who has consistently said that the HFEA is not an economic regulator, to now put him in that invidious position?

[Lord Hunt of Kings Heath]

That is absolutely right. The noble Lord then went on to say that we should be fine because the provisions in the Bill say that all the regulator has to do is to “have regard to” the desirability of promoting economic growth. However, the moment you include those words, the regulator becomes liable if it can be shown that he does not have regard to that, even though the noble Lord recognises that in many cases he ought not to have regard to it.

It is quite inadequate to say that we are consulting on this. This is absolutely wrong. We need to know by Third Reading whether the Government are going to keep in the HFEA and the PSA. I think that the noble Lord ought to allow further discussions to take place between now and Third Reading, and he ought to discuss this with his colleague—particularly the impact on the new regulations on mitochondrial donations that will be coming forward. As for his assurance that any of these bodies will be included by an affirmative resolution, how many times has an SI been defeated in Parliament? It is fewer than 10 times, so it is a meaningless safeguard in effect. I invite the Minister to say that he will at least give this further consideration before Third Reading before I make my decision.

[Lord Wallace of Saltaire]

I will be glad to take this back and confer with others, but I cannot give any assurances that the Government will come back with anything different on Third Reading. However, I am always open to conversations off the Floor.

[Lord Hunt of Kings Heath]

My Lords, that is very handsome of the Minister and I beg leave to withdraw the amendment.

Amendment 43 withdrawn.