Public Bodies Bill [HL]

Lord Mackay of Clashfern Excerpts

Wednesday 9th March 2011 Lords Chamber

[Lord Mackay of Clashfern]

My Lords, I declare an interest as an honorary fellow of the Royal College of Obstetricians and Gynaecologists and as the person who had the privilege of introducing to this House the Bill that ultimately became the Act which has been referred to more than once. As a parent of such a body, it would be strange if I wanted to see it dissolved altogether. On the other hand, a parent who is interested in his child is glad to see him or her develop and possibly make unions with others who seem to be suitable for them. I had the honour of serving on the Joint Committee looking at the recent Bill in this area under the distinguished chairmanship of the noble Lord, Lord Willis of Knaresborough. I strongly supported the decision taken by that committee to recommend against the proposed union between the Human Fertilisation and Embryology Authority and the Human Tissue Authority. I think I am right in saying that the noble Lord, Lord Willis, may have done a slight injustice to the noble Lord, Lord Warner, because I think the noble Lord, Lord Warner, said that he had recommended against it to the Minister. I do not know whether the Minister accepted it immediately, but eventually it was accepted by the corresponding Minister.

The matters that were the subject of the Bill which I had the privilege of introducing are certainly among the most important areas of modern scientific and medical work. But science and medicine have moved on very fast and far since that Bill was introduced and the developments dealt with in the most recent Act show that. That Act moves out of pure human embryology to the transition towards hybrids and, at the extreme end, towards the animal end of embryology. It shows that science has developed in such a way that the distinct field carved out in the original Bill has been altered by progress, if you like to think of it in that way, and I hope that that is what it is. There is a great deal to be said for the view that modern scientific and medical research is very difficult to split up. The embryo is important, but there are other important aspects of that research. I can therefore see a very strong argument for having a research body which has overall responsibility in this area.

There are of course other functions in HFEA which are important, particularly the control of IVF. When the body was originally set up, the practice of IVF was exceptional and a complete novelty, but a lot of water has gone under the bridge since then and it has become much more of a standard clinical procedure. It is true that developments have taken place there, but they have taken place also in other branches of medicine. It is not only embryology or IVF that have moved forward; fortunately, a great number of developments have taken place in the practice and application of medicine and surgery. It strikes me as extremely logical to have a body that would have overall responsibility for that.

If that be right, there is a good deal to be said for the view that the time has come to review the position in regard to the two health bodies that we are discussing and see whether a more integrated approach to research on the one hand and clinical practice on the other could be furthered by having bodies responsible for the whole of the first and the whole of the second. I agree that a good deal of detail needs to be filled in, but I remind myself that we are not deciding today whether this should happen. We are talking about a power for a Minister to decide what to do in the light of the further consultation provided for in the amendments moved by the Government since the Bill has been in Committee. It is a valuable opportunity for these matters to be considered. I can understand a lot of what has been said on the other side of this argument, but I should like to see retained in the Bill the power to deal with these issues in a way that reflects the developments that have taken place in the research and practice of medicine since the original Act came into force.

[Lord Winston]

My Lords, my noble friend Lord Warner has declared support for the Minister sitting on the Front Bench; I suspect that I might in the next few minutes give him even greater support.

We have to understand that research in these areas has now gone way beyond embryology. There was a time when people were very concerned about the status of the embryo, when embryo research was relatively novel. I should like to correct a remark made by the noble Lord, Lord Walton, who very kindly referred to work on pre-implantation diagnosis. That work produced pregnancies before the establishment of the Human Fertilisation and Embryology Authority, and people like me were greatly exercised to establish regulation. In spite of what has been said in this Chamber, we were very much in favour of regulation. Since there was no government regulation, we started a voluntary licensing authority which became a model in time—obviously, a very imperfect model—for the body set up under the splendid Bill introduced by the noble and learned Lord, Lord Mackay of Clashfern.

Stem cell biology covers every aspect of human disease, from cancer to brain research, from human consciousness to the replacement of organs and transplantation, and a whole range of other areas. It is really—forgive the pun—inconceivable that this could be dealt with by the Human Fertilisation and Embryology Authority properly under its present form or any future form. I would argue that with the advent of epigenetics, the recognition that now the environment in which cells are placed in culture and elsewhere is such a universal issue in medicine there has to be a much more global look at this kind of research. I feel that there is a strong case for suggesting that we have to accept that research ethics are universal and that they tend to have the same sorts of problems, whether it is patient consent, the end or beginning of life, or a whole range of other issues. In fact, the end and beginning of life have some very similar moral issues which need to be debated by ethics committees. The noble and learned Lord was right to point out that trying to look at these issues in a new form would be absolutely apposite. I for one am certainly not in favour of a free-for-all. I am not quite certain who in the medical profession is. I do not think that that is true.

The regulation of clinical treatment has been in many examples woefully inadequate. The noble and learned Baroness, Lady Butler-Sloss, pointed out that while she was sitting on the Bench she had the most terrible case of a woman who had the wrong embryo transferred. That was done, of course, under the auspices of the Human Fertilisation and Embryology Authority. No regulatory authority, no matter how perfect or how good, can regulate against every human error. We should have a set of principles in laboratories which keep those mistakes to a minimum, and the regulation of medical practice must also enforce that.

I do not think that there is any evidence from what has happened that the HFEA has done a particularly good job or a particularly bad job. In some areas it has not been very powerful. For example, many things are forbidden under regulation in this country. Patients actively seek fertility tourism in other countries where they can get, for example, donor eggs and perhaps come back pregnant. Very often clinics in this country, although it may be against regulations, refer these patients outside. Of course the HFEA, not unreasonably, is powerless to deal with that sort of problem.

It is also true that the fees charged to patients are often extremely exploitative. I have no doubt that we will come back to this when we come to the pending health Bill, because this is a much bigger issue in terms of how we finance the health service. At the moment, IVF, whether it is done in the private sector or in my view in the National Health Service, is charged on the basis not of what it costs but rather of what the market will bear. That is a very big issue which we will need to discuss, because I suspect that that may apply to a lot of medical practice. It is an issue to which I am sure this House will want to return. Costing the procedure is very important.

Someone mentioned follow-up: one sad thing about the opportunity in 1990 was that we did not—even though we had records of IVF pregnancies, and IVF successes and failures—make any attempt to follow up babies after this procedure for the long term. There have been many reasons why that was difficult, such as data protection. But this lost opportunity means that some of the procedures often in routine use may have unforeseen consequences in children when they are adults. We now know from David Barker’s work, for example, that babies who are born underweight and premature are much more likely at the age of 50 or 60, as the Minister knows, to suffer from heart disease, stroke, hypertension and possibly osteoporosis as well as diabetes and one or two other diseases as well. Of course, we may see more diseases which are likely to be epigenetic due to those early influences.

I have to say that, although it is claimed that the HFEA gives out information to patients, six years after I retired from clinical practice running a very large IVF service, I am bombarded daily with e-mails—I have had several today—from patients who want information about IVF and do not feel that they are getting the information they should from the statutory authority. That remains a problem.

The clinical regulation of non-evidence-based practices has been poor. For example, there is no evidence that the preimplantation and genetic screening of embryos designed “to improve pregnancy rate” works. Yet several clinics charge large fees for doing this under regulation even though there is not a base for justifying its use. That also applies to costly immune therapy, which is highly controversial. Again, this is used in women who sometimes fail to get pregnant, under licence from the HFEA. This is an example of how in fact regulation is really quite limited in clinical practice.

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[Lord Newton of Braintree]

Perhaps I may just indicate briefly that, although I said slightly flippantly that I had not had a chance to look at all the other amendments, I had a glance through them. I had some of the same reservations about the amendment in the name of the noble Lord, Lord Goodhart, as the noble Lord, Lord Hunt of Kings Heath, has just adumbrated. The two that I found myself most drawn to were that you cannot have an omnibus order but must deal with things one by one, which seems well worth considering, and this business about hybridity. If there was manifestly something that picked out an individual interest and treated it differently from other interests—if I might do my non-lawyer’s translation of the hybridity problem—that would be a real question to be considered in certain circumstances. I hope that my noble friend will at least be able to reflect on these points.

[Lord Mackay of Clashfern]

On the amendment in the name of the noble Lord, Lord Goodhart, as the noble Lord, Lord Hunt, said, there is a question of a chilling factor in relation to bodies or organisations once they are named in a Bill. There is something to be said for having a closure in respect of bodies named now but also, if we get the Bill through in a satisfactory way, for it being a model for future reviews of these public bodies. One difficulty has been to provide a definition of what is meant by a public body. If the Bill passes into law as a sound piece of review legislation then, after, for example, the end of this Parliament and the beginning of the next one, there is a good deal to be said for the next Government coming forward with a list of bodies that would be suggested as amendments to this Bill, which would then possibly be subject to review under the powers that we have stipulated in the Bill.

[Lord Taylor of Holbeach]

I do not suppose that the Committee would have chosen to debate this important group of amendments at this time of night. I do not really want to rush but I am mindful of the time. It is interesting that the amendments contain the workplace of me and the Bill team. This is certainly an area in which we are and have been much engaged. I hope that all noble Lords will understand that it is rarely possible to deliver everything. There are some areas where the Government have to draw a line but there are others—I think that I can indicate these in the debate this evening—where further consideration is justified and where I would hope to come back with amendments before Report, after discussions with noble Lords. I say that by way of preface.

The whole group of amendments relates to the procedures that Ministers must follow. These issues have had substantial discussion in Committee. I thank noble Lords across the Committee for their contributions. As I seek to respond to each amendment, I ask noble Lords to contextualise the debate against the changes that we have already announced in the Bill, notably the removal of Schedule 7 and our ongoing commitment to work with noble Lords on a variety of related issues.

I begin with Amendment 106A in the name of my noble friend Lord Newton of Braintree. This amendment would add the objectives of,

“fairness, openness, transparency and justice”,

to the list to which the Minister must have regard when considering making an order under Sections 1 to 6. I thank him for his amendment and reassure the Committee that these objectives underpin the Government’s rationale for reforming public bodies and, of course, the Government’s programme as a whole. It is good that my noble friend carries the coalition agreement in his inside pocket, close to his heart. I am reassured by that and always value his contributions, even when they are not necessarily supportive of everything that I am seeking to do with this Bill. The only points where I fear we disagree concern whether this amendment would work in practice and whether such wording is necessary on the face of the Bill. The Government believe that such a requirement in legislative terms would be ambiguous and could, as drafted, be quite difficult to measure or assess. However, it is an area in Clause 8 that we have committed to look at.

Amendment 114A returns us to the question of consultation, which was originally debated on our first day in Committee on this Bill. It would amend government Amendment 114 by introducing a specific requirement to consult the public before laying an order using the main powers in the Bill. The Government have accepted the principle that Ministers should be required to consult on their proposals to reform public bodies before using these powers. The Government also accept that in some cases it is completely appropriate to consult the public in relation to such proposals. For example, I can confirm to the Committee that the Department for Business, Innovation and Skills intends to consult this year on its proposed changes to competition bodies. We discussed that earlier this evening. It will be a public consultation. The Government Equalities Office will soon publish its consultation document on reform of the Equality and Human Rights Commission. Later this year, Defra will issue a public consultation on its plans to replace British Waterways with a charitable body.

However, I take issue with the amendment in the name of the noble Lord, Lord Hunt, as it would apply without due regard to proportionality to any proposed reform. Such an approach runs contrary not only to the policy of this Government but also to the existing code of practice on consultation, which was issued in June 2008 by the Government of whom the noble Lord, Lord Hunt, was a part. The introduction to the code of practice is clear:

“Ministers retain their existing discretion not to conduct formal consultation exercises under the terms of the Code. At times, a formal, written, public consultation will not be the most effective or proportionate way of seeking input from interested parties”.

I do not quote from this document to seek to absolve Ministers of responsibility. Subsection (1)(b) in Amendment 114 specifically requires a Minister to consult persons whom he or she considers,

“to be representative of interests substantially affected by the proposal”.

This provision clearly could include the public. The Minister must therefore expect to be held accountable for his or her decisions in relation to this provision. However, the proper requirement that Ministers should consider whether to consult the public does not lead to the conclusion that it will prove necessary or proportionate in all cases. For example, is it proportionate to require a full public consultation on the statutory abolition of Food From Britain, a body that, to all intents, has been defunct since 2009, or on the proposal to use Schedule 2 to merge the Pensions Ombudsman with the ombudsman for the board of the Pension Protection Fund? These two bodies already share services to a great extent and those functions will not change.

As with other cases in the Bill where the public will rightfully expect to be consulted, undoubtedly they will, but the Bill as drafted allows for that possibility and the Government accept their responsibility to ensure that that occurs when necessary. By contrast, the amendment proposed by the noble Lord, Lord Hunt, will remove the ability of Ministers to conduct a more targeted consultation when that is appropriate. While I have sympathy with the sentiment behind Amendment 114A, the Government do not believe that the public will welcome a proposal that would add unnecessary bureaucracy to the order-making process and with it, in effect, the process of reform.

The question of proportionality is also pertinent to Amendments 118A and 118B in the name of the noble Lord, Lord Hunt, which concern the parliamentary procedure that should apply to orders made under this Bill. In responding to these amendments, I should clarify for your Lordships’ House that we have substituted government Amendment 118 with a new version that makes it explicit that the enhanced procedure can be activated by a recommendation of a committee of either House. This clarification responds to paragraph 24(a) of the sixth report of the Delegated Powers Committee—that is, the committee’s second report on this Bill. I am happy to clarify the Government’s intentions in response.

Amendment 118A seeks to make it explicit that a Minister wishing to make an order following a period of consultation must lay before Parliament a draft order and explanatory document. I agree with the spirit of the noble Lord’s amendment, but I do not consider it necessary. While the current drafting of subsection (1) in government Amendment 118 states that a Minister,

“may lay … a draft order, and … an explanatory document”,

it would in practice not be possible to make an order without following this procedure. Our current drafting simply reflects the fact that, following a period of consultation under Amendment 114, the Minister is not obliged to proceed with the proposal.

Amendment 118B would introduce a wholly new parliamentary procedure for these orders, giving a committee of either House the opportunity not only to reject but also to amend an order, or to recommend that the proposals be taken forward only through primary legislation. As I argued when we debated this issue on the first day in Committee, the Government cannot support that proposal for a number of reasons. First, I maintain my position that the noble Lord’s amendment goes beyond the scope of the Bill in seeking to effect a fundamental shift in how this House deals with secondary legislation. Secondly, I do not accept that the powers of the Bill, especially in the light of the removal of Schedule 7 and the additional safeguards that the Government are now proposing, justify the use of such a restrictive parliamentary procedure. It is now the case that no body can be subject to the powers of the Bill unless Parliament has consented through primary legislation to its inclusion in the Bill’s schedules. The waiting room of Schedule 7 has gone. Therefore, the scope of the powers in this Bill has been significantly narrowed. On this basis, to continue to suggest that the Bill requires a more restrictive scrutiny procedure than, for example, the Legislative and Regulatory Reform Act appears a disproportionate response, particularly in the light of the additional safeguards that we have introduced and continued to work towards and the fact that the proposed procedure would apply to each and every order made under this Bill.

I do not intend to quote a list of examples of such reforms. Suffice it to say that I do not consider that the opposition amendment represents a proportionate procedure for an order to abolish a body that is already defunct. Our approach, by contrast, gives Parliament the flexibility to select and enhance procedure while maintaining for the Government the reasonable ability to act to implement their programme. It is for this reason that I cannot accept Amendment 118B or Amendment 117.

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[Lord Mackay of Clashfern]

I have been privileged to put my name to the amendment and of course I support it wholeheartedly. It makes clear the legal framework within which the ministerial powers under the Bill may be exercised. I thank my right honourable friend Francis Maude for seeing me on this matter and I assure the noble Baroness, Lady Royall, that the consultation right across Whitehall was necessary. That is perhaps one of the reasons why we were not quite as early with this as some of us might have liked. I thank members of the Bill team very much for the patience that they exhibited in listening to me preaching to them about this, in a manner to which your Lordships are accustomed.

[Lord Hunt of Kings Heath]

My Lords, I say to the noble Lord, Lord Lester, that if he continues to table amendments of this quality he will be very welcome to move them after midnight, day after day. I, too, thank him, as this is an important amendment. It provides considerable reassurance to noble Lords about how the Bill will operate when enacted. I am grateful to him; it goes right back to that first vote on day one in Committee, which seems a little time ago. I also thank the noble and learned Lord, Lord Mackay, for his great assistance, and the Bill team and the Minister. This is a very positive outcome.