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.