Deregulation Bill

Earl of Lindsay Excerpts

Wednesday 4th March 2015 Lords Chamber

[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 The Minister also quoted the draft guidance, but the guidance adds to our concern.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.