My Lords, on Report I committed to giving further consideration to whether the Professional Standards Authority, the PSA, and the Human Fertilisation and Embryology Authority, the HFEA, should be within the scope of the growth duty—that is, whether they should be required, in the exercise of their regulatory functions, to have regard to the desirability of promoting economic growth.
Since Report, officials from the Department for Business, Innovation and Skills have met with the Department of Health and the PSA to explore whether the functions carried out by the PSA meet the definition of “regulatory function” at Clause 106 of the Deregulation Bill. Officials have also considered the nature of the PSA’s regulatory role as oversight body for the nine statutory regulators of health and social care professionals.
Following those discussions, the Government have concluded that, while the PSA exercises functions that fall within the definition of “regulatory function” as per the Deregulation Bill, its specific role means that the PSA’s regulatory functions are far removed from individual businesses. The PSA would have limited economic impact on business even if it were to apply the growth duty. In the course of taking this Bill through the House and on a number of other occasions, I have learnt to respect the immense diversity of regulatory functions and regulatory bodies, and that is one of the things that the very helpful and positive speech of the noble Earl, Lord Lindsay, took us a little further into. Anything that attempts to apply an overview to the vast mass of regulatory bodies is likely to be wrong. The Government therefore do not currently propose to bring the PSA in scope of the duty but will review this decision in the future should the PSA’s regulatory role change.
Moving on to the HFEA, I start by saying that the Government understand that there are aspects of the HFEA’s role that are ethically sensitive and unique, as we have recently debated in this House. Therefore, perhaps I may offer a number of preliminary reassurances and commitments to noble Lords, which I hope will assure the Opposition Front Bench. I should say that we had an extremely positive and constructive discussion with the noble Lord, Lord Hunt of Kings Heath, and others earlier in the week.
The growth duty is not a duty that would require the HFEA to drive the growth of one of the industries that it regulates—for example, the fertility sector—and it is not a duty to achieve or pursue economic growth at the expense of patient protections, such as those involved in the sensitive sectors regulated by the HFEA, as the noble Earl, Lord Lindsay, has already set out.
I take this opportunity to repeat once again that the growth duty will not impede the independence of regulators and will give them discretion in how to apply the duty. It is certainly not the Government’s intention that the growth duty should weaken the HFEA’s regulatory role. I also assure noble Lords—especially the noble Lord, Lord Tunnicliffe, who is not here at the moment but has had helpful meetings with a number of Ministers to discuss this policy—that the duty is about reducing, for example, the regulatory burden of bureaucracy on business. It is not a duty that loosens or undermines important duties of protection. Statutory duties concerning the protection of vulnerable women and men in seeking help in this sector remain of fundamental importance.
The duty requires regulators to have a regard to the desirability of promoting economic growth among those they regulate when they carry out regulatory processes and make regulatory decisions—for example, writing guidance, planning or changing intervention strategies, designing or revising processes, and carrying out inspections of those who are regulated.
The Government commit to continuing to work with regulators, including the HFEA, to ensure that the statutory guidance is fit for purpose, robust and principles-based to assist them in avoiding the risks of challenge. We are all aware of the problem of judicial review and that the HFEA has already been subject to a number of challenges via judicial review. We will therefore make particular efforts to ensure that the guidance is as clear as possible. It will be clear that regulators can have regard to the growth duty, balance it against their other statutory duties and decide not to afford any weight to growth where it is not appropriate or relevant.
I can also give noble Lords the commitment to publish a revised version of the guidance on GOV.UK before or at the time the guidance is laid in draft before Parliament. I should point out that the Government commit also to lay the draft guidance and the draft order, listing the functions to which the duty will apply, before Parliament at the same time for informed debate. Both these, as noble Lords are aware, will be subject to the affirmative resolution in both Houses. There will be continuing engagement with stakeholders to help regulators consider how the duty can be applied, which we hope will help regulators to decide what weight, if any, they should apportion to the growth duty when considering it alongside their protection duties.
Since the Report stage debate, BIS officials have met with the HFEA and the Department of Health to discuss how the growth duty might apply to their specific regulatory role. I am grateful to my noble friend Lord Howe for his commitment that the two departments should continue working together and with the HFEA to address any concerns on specific issues as we move forward. I know that some strong concerns were raised on Report about the HFEA’s role in regulating some of the extremely high fees being charged by some fertility clinics. The noble Lord, Lord Winston, talked of a lady, approaching her forties, who went to a clinic in London and was quoted the extremely large sum of £11,000 for three months of fertility treatment.
Having explored the powers that the HFEA has as a non-economic regulator, we found that it has no power to regulate the prices charged in IVF clinics. I understand that the HFEA does want to do more. It has recently decided to provide patients with a feedback mechanism on its website where patients can say whether the costs they actually paid were as originally advertised. I know from discussions with the HFEA that it recognises that costs are a key concern for many patients. However, at present it can only act within its powers. I want to assure the noble Lords, Lord Hunt and Lord Winston, and noble Lords here today, that the Government will work with the Department of Health to explore further the matters raised.
As I said, officials from BIS and the Department of Health have met with the HFEA to consider their statutory regulatory functions which are taken from the Human Fertilisation and Embryology Acts 1990 and 2008, and other legislation. It is the Government’s view that the HFEA could have regard to growth when exercising these regulatory functions in a way that would not weaken its regulatory role. It could apply to the HFEA in its general course of operation, such as licensing, inspections or the information that centres are required to provide for them. For example, in the HFEA’s overall licensing and inspection of clinics, if it decided to implement a new licensing process, the growth duty requires a consideration of the importance of exercising such regulatory functions in a way which ensures that regulatory action is taken only when it is needed and that any action taken is proportionate. This would encourage the HFEA to consider the impact that this change may have on those it regulates.
The HFEA, as an expert in its respective and expanding field, will decide what weight, if any, to afford growth as part of its decision-making process in each case. In some circumstances it may be appropriate that the HFEA, in making a particular decision, has regard to growth, but makes a reasonable decision not to give it any weight in its decision-making. For example, while exercising its licensing and inspection functions the HFEA may find that a clinic’s ability to provide a safe service was in question. The clinic may have breached the Human Fertilisation and Embryology Act 1990, its licence conditions or the HFEA’s code of practice to the extent that it is at risk of the suspension of its licence or even having its licence revoked. In this circumstance, where patient safety is clearly an issue, the HFEA may, in considering the facts before it and weighing up its various statutory duties, make a reasonable decision not to apportion any weight to growth in considering whether to continue to license or close the clinic.
It may also be helpful to draw on an example from the pharmaceutical sector to further illustrate the type of mischief that the growth duty seeks to resolve. A pharmaceutical business used an alcohol spray product in bottles which had certification to say it was safe to use for three months. However, the inspector told the business that once opened, it must throw out bottles after 24 hours. Despite the business pointing out the certificate and the three-month agreed safe lifespan, the inspector refused to read the material and imposed the requirement that the company throw out the spray every 24 hours. This clearly placed an unnecessary financial burden on the business, due to the cost of the product. It could no longer afford to use the product or manufacture a particular pharmaceutical product. The growth duty would have required the inspector to have regard to the economic impact of its decision on the business. It would also have ensured that regulatory action was taken only when needed and that the action taken was proportionate. In neither of those cases would the issue of safety have been jeopardised in any way.
The Government are committed to creating a positive business environment right across the economy and applying a growth duty to regulators across a broad range of sectors that will contribute to this. It is, thus, the Government’s view that the HFEA should continue to be included within the scope of the growth duty. I hope that I have clarified the scope and intent of the duty and provided the necessary reassurances on this front.
“any persons exercising a regulatory function with respect to health and care service”,
and in that order to exclude them from the scope of the growth duty.
The Department of Health feels that excluding health regulators from the growth duty would be at odds with other departments and inconsistent with the Government’s intent. I hope that I have provided the assurances that the Opposition and others were looking for in this complex area, and I hope that that will enable the noble Baroness to withdraw the amendment.