Deregulation Bill

Baroness Hayter of Kentish Town Excerpts

Wednesday 4th March 2015 Lords Chamber

[Baroness Hayter of Kentish Town (Lab)]

My Lords, I rise briefly to support these amendments, to which I have added my name. As the Minister said, they rather improve the wording which was accepted in principle in my amendments on Report. They are important because they take forward the intention in the Legal Services Act to increase the availability of legal services. As the Minister said, the CLC—an approved regulator for reserved activities, probate and the administration of oaths—has now been accepted to be the regulator for a wider range of legal services. However, it became apparent a bit belatedly that the Act which created the CLC and set out its powers actually restricts it from the enlarged role which it, the Legal Services Board and the MoJ had envisaged. It was then found that the powers in the Legal Services Act were also not sufficient to make the changes. Without these amendments, the CLC would be able to regulate only conveyancers, which means that a lawyer would have first to train as a conveyancer before being regulated by the CLC for other activities.

The other changes which have been mentioned are to simplify appeals so that any appeals against the CLC’s appeals and discipline committee can be heard by the First-tier Tribunal rather than the High Court, and to allow the CLC itself to appeal against determinations. There is also a provision to allow the CLC to suspend the licences of practitioners to protect the public while they await the outcome of disciplinary actions.

As for the CLC’s own governing council, the current requirement is that the number of lay members must exceed the number of professional members by exactly one. That means that if one of the professional members leaves for any reason, the council cannot continue its work. The amendments would allow for the lay majority to be at least one, which will get over that hurdle. Finally, instead of putting the time that the CLC has to determine applications in statute, in future it will be in regulatory rules. These are sensible and welcome changes. I thank the Government for bringing them forward and their work on this excellent drafting.

Amendment 23 agreed.

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Moved by

[Baroness Hayter of Kentish Town]

28: Clause 103, page 81, line 41, at end insert—
“( ) This section does not apply to the following—
(a) Professional Standards Authority,(b) Human Fertilisation and Embryology Authority, and(c) 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.”

[Baroness Hayter of Kentish Town]

My Lords, with the leave of the House I will move Amendment 28, which was tabled by my noble friend Lord Hunt of Kings Heath. Our concern is about the impact of the economic growth clauses on these health regulatory bodies and the risk of a negative impact on their overriding responsibility to protect the public. On Report, the Minister denied that that would happen and stated that the economic growth duty would sit alongside the other factors that a regulator must consider. However, “sitting alongside” suggests that it has some—or even the same—weighting and therefore cannot be ignored. The Minister also quoted the draft guidance, but the guidance adds to our concern. It states:

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

The term “not automatically” implies that it is entirely possible that it will take precedence, and that must put the protection of the public at risk.

The two health regulators, the Professional Standards Authority and the Human Fertilisation and Embryology Authority, were debated on Report. They are the subject of Amendment 28. My noble friend Lord Hunt questioned whether the Professional Standards Authority is indeed a regulator, given that it oversees nine statutory regulators, including the GMC, but is not itself a regulator. We say that there is no need for it to be covered in the Bill. Can the Minister confirm that the Government do not consider that the PSA is covered by the economic growth clauses because it is not such a regulator?

The HFEA performs a crucial and difficult task. We worry that the economic growth duty could make its task even more challenging. On 24 February this House had an excellent debate on mitochondrial donation and agreed the regulations. However, we did so only on the basis that the HFEA’s regulatory processes were robust. The HFEA—which, as we know, is highly respected as a model for the regulation of fertility and embryology treatments and research—has acknowledged on its website that it is not an economic regulator. Perhaps the Minister will confirm that that is so. However, I hope he will go further and address our concern that any growth duty could impact on the HFEA’s ability to regulate effectively. There is no requirement in the HFE Act to consider growth, thus the new duty could upset the delicate balance on embryo research which has served this country well.

At the centre of the balance is a settlement between science and society which involves a clear set of rules that enable scientists and clinicians to experiment while maintaining public confidence. The existing regime has enabled growth. Surely it is no accident that the UK is the first country in the world to allow mitochondrial donation; it is a by-product of a thriving bioscience sector combined with intelligent regulation. Good rules, flexibly applied, can foster growth. Ironically, the growth duty could upset that balance and even hinder growth in the sector. It risks HFEA decisions being judicially reviewed. For example, those who are against embryo research might argue that the HFEA will favour research because of the growth duty and challenge it on that basis; science-based companies might argue that if it fails to consider growth, it will be failing the growth duty.

I have some questions for the Minister. Do the Government accept that our bioscience sector has thrived and that HFEA regulation has contributed to that success? If so, what is the point of making the growth duty apply to the HFEA? Can the HFEA decide to ignore the growth duty if it is inappropriate in particular cases, for example in respect of patient safety or for new treatments such as mitochondrial donation? Can the Minister assure the House that the HFEA will not be more likely to be judicially reviewed because of the growth duty? Will statutory guidance make this clear so that the HFEA can refer to such guidance if challenged in court? Will the Government commit to exempt the HFEA from the regulation?

Perhaps I may also mention the relationship between the economic growth duty and the EHRC, an issue that has featured not only in this Bill but in the Small Business, Enterprise and Employment Bill. The Minister will be aware of the argument that the EHRC enjoys an A status as a national human rights institution. It is therefore right that the Government should always be crystal clear that it is not appropriate to apply general regulations to the EHRC. The A status is awarded by the UN International Coordinating Committee, which regularly reviews the EHRC’s compliance with the Paris principles, which require the EHRC to be independent. We have to avoid the perception—or the reality—that there is interference in the commission’s ability to perform its functions, and ensure that it is always independent. If that independence were jeopardised, it would jeopardise the A status which is vital to the UK’s international standing.

Last night, in response to these sorts of arguments in this House, the Minister, the noble Baroness, Lady Neville-Rolfe, agreed to look again at provisions regarding the EHRC in the Small Business, Enterprise and Employment Bill. Will the Minister agree to do the same thing with these two regulators in this Bill? I beg to move.

[The Earl of Lindsay (Con)]

My Lords, I speak to the amendment moved by the noble Baroness, Lady Hayter, from my perspective as a member of advisory bodies that advised the previous Government on better regulation—the Better Regulation Commission and the Risk and Regulation Advisory Council. I am also a member of a body that advises this Government on regulation—the Better Regulation Strategy Group.

I say immediately that if the growth duty compelled either the PSA or the HFEA, or indeed any other regulator, to pursue growth at the expense of undermining the protection of sensitive sectors or sensitive activities, I would have sympathy with this amendment. However, that is not the case. The growth duty does not compel the HFEA or other regulators, as suggested in the amendment, to pursue growth at the expense of undermining protections in the area that they regulate. What it does do is require regulators to consider the economic impact and any unnecessary, disproportionate or excessive bureaucratic burden that they might be imposing on those whom they regulate when carrying out their regulatory processes, producing guidance and so forth.

From my experience of better regulation, better regulators and better enforcement of, or compliance with, regulation, I can see absolutely no reason why the HFEA cannot consider the burden it is imposing on the businesses and organisations it regulates while continuing to ensure that patient protection remains its primary objective.

The growth duty is not a duty to achieve or pursue economic growth. Therefore, it is not a duty that would require the HFEA to drive growth in the fertility sector, for instance. Nor does it dictate that a regulator must attach a particular weight to growth. Therefore, the HFEA, or any other regulator obliged to have regard to the business and bureaucratic experience of being regulated, may reasonably decide that it will attach little or no weight to business factors in relation to a particular decision and that it must attach more weight to its other duties. In the HFEA’s case, prominent among those other duties would be patient safety. Therefore, the growth duty will not undermine or override regulators’ primary responsibilities in delivering protection.

Applying the growth duty to the HFEA will not affect its robustness as a regulator, and it will not affect its ability to protect the public, which was one of the concerns expressed by the noble Baroness. In that sense, the title of the Bill is, I think, misleading, in that the growth duty is more about better regulation than deregulation. It does not loosen regulation; nor does it remove any regulatory duties or responsibilities. Rather, it enables their delivery and enforcement, when and where appropriate, to be more sensitive and more user-friendly.

Also of relevance to this amendment is the fact that the HFEA is already within the scope of another of the better enforcement programme measures—namely, the Regulators’ Code—as it was with its predecessor, the Regulators’ Compliance Code. The Regulators’ Code is a clearly defined, simple and principles-based framework of good practice for regulators in engaging with those whom they regulate. To my thinking, the HFEA would apply the growth duty in a way that complements the existing requirement to which it is already subject through the Regulators’ Code. More importantly, it would, and can, do so without compromising its rigour as a regulator.

I can understand why exceptions might be made in requiring regulators to adopt this duty where it is an irrelevance to the way they regulate or to the areas they regulate, but I cannot see any sense in exempting the HFEA from the growth duty.

[Lord Wallace of Saltaire]

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 reassure 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 its 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.

Finally, in addition to excluding the PSA and the HFEA from the scope of the growth duty, the amendment seeks to give the Secretary of State the power to list by order,

“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.

[Baroness Hayter of Kentish Town]

I thank the Minister for a very thoughtful response, and for all the work and meetings that have clearly taken place. I particularly welcome the fact, if I have his words right, that the Government do not propose to bring the PSA into scope.

Turning to the HFEA, funnily enough I agree with virtually everything that the noble Earl, Lord Lindsay, says, except that I do not agree that it is against the amendment in front of us. I think that he is arguing for better regulation and for not putting unnecessary burdens on those being regulated, be they hospitals or laboratories. All the talk about better regulation, not having undue costs and not throwing away bottles after 24 hours is, to me, better regulation and not the same as the growth duty. I think that we are not very far away from that.

I welcome very much the recognition by the Minister that the HFEA is not an economic regulator, his words that it will not be required to drive or pursue economic growth, his willingness to continue this discussion and to use new guidance to try to help avoid the risk of challenge, and his words that the HFEA will decide for itself not to afford that duty in certain cases. We are probably fairly close on this, and the discussions and the new guidance will be helpful. On that basis, I beg leave to withdraw the amendment.

Amendment 28 withdrawn.

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[Lord Wallace of Saltaire]

That the Bill do now pass.

[Baroness Hayter of Kentish Town]

My Lords, I use this opportunity for a brief moment to pay tribute to my noble friend Lord Stevenson, who, from our side, has guided and marshalled our many Front Bench colleagues, including my noble friends Lady Thornton, Lord Tunnicliffe and Lord McKenzie, through what has been called a “Christmas tree Bill”. Of course, we do not think it is quite such a Bill because it is not full of goodies, but I thank my noble friend Lord Stevenson and, I have to say, our brilliant legislative adviser, Muna Abbas; this was her first such Bill. We think that it has ended up a little better than it arrived.

I thank the Minister and his sometimes expanding, sometimes reducing ministerial team. I also thank the other members of the Bill team who have helped negotiate, redraft, debate and discuss throughout the process, including the setting up of a large number of bilateral meetings, some of which have dealt with some very complex issues. They now deserve a very good holiday, so I suggest that before too long we have a general election so that they may have one.

[Lord Stoneham of Droxford (LD)]

My Lords, on behalf of these Benches, I thank my noble friend Lord Wallace for seeing us through this Bill. When we started, we thought that this would be a complete nightmare, but his skill, perseverance and patience have helped that not to be so. I thank also the opposition Benches for their part in seeing this legislation through, and our colleagues in our own office, Giles Derrington and Elizabeth Plummer, who supported us through the business of this Bill.