Clause 10 : Consultation
Moved by Lord Hunt of Kings Heath
1: Clause 10, page 5, line 34, at end insert-
"( ) Where the Minister considers that the changes proposed do not warrant a full public consultation under subsection (1)(g), the Minister must publish a copy of the proposal on the website of the relevant Government department or make it otherwise publicly accessible."
My Lords, the Bill's return after a period of some weeks is welcome. In this amendment I return to the issue of public consultation, a matter that we have debated on a number of occasions. Given the enormous powers that the Bill will give to Ministers-powers embracing the abolition, merger, finance and governance of a considerable number of public bodies-it seems only right that when changes are made to any of the orders listed in the Bill, the public should have a say.
The House did not agree to my amendment to ensure that whenever a Minister proposes to make an order under Clauses 1 to 6, the public should always be consulted. However, the noble Lord, Lord Taylor, was rather more sympathetic to a further amendment to which I spoke, which would have ensured that when a Minister considers that proposed changes do not warrant a full public consultation, the Minister must at least publish a copy of the proposal on the website of the relevant government department or make it otherwise available. The noble Lord kindly said that he understood the arguments that had been put forward and that where consultation does not take place, a proposal will at least be put on the website. He said that he would consider the issue between Report and Third Reading, and I should be grateful for, and am hopeful of, a positive response from him.
My next amendment, Amendment 6, relates to regional development agencies and the need for consultation on their proposed abolition. I will not reopen the whole question of whether or not it is wise to abolish regional development agencies, but I must say that the longer the economy flatlines, as it is, the more convinced I am that it is a very big mistake to remove a regional strategic body for economic development. I want to raise the issue of consultation, specifically the consultation that will need to follow the Government's proposals to abolish regional development agencies.
One problem with the Bill is that the Government have failed to engage in any pre-legislative consultation on these matters. One example of that is the remarkable decision to fire-sale the assets of RDAs. That has been the subject of a number of comments. I find it extraordinary that instead of the RDAs being allowed to pass on assets under deferred payment schemes to, for instance, local authorities, they are being forced down the route of selling off assets at the worst possible time. There is real concern here that if those assets are sold in the current economic climate, their values will not be at current market levels, to the detriment of the local economy and future work of both local authorities and local enterprise partnerships, which are to take the place of RDAs.
I come to the specific issue of consultation. The noble Lord will know that this matter was raised by the House Of Commons Public Administration Committee in its report. It refers to the evidence given by the Minister, who had been asked what consultation had taken place in advance of deciding to abolish bodies listed in the Bill. The report states that the Minister responded that,
"the level of consultation would have been 'very varied [...] in some cases, will have been quite extensive; in other cases, will have been very little'".
He also said:
"These are essentially decisions in principle; these are decisions made where departments will know, or should know and I'm sure do, in a great deal of detail what those bodies do, what their functions are and how they are carried out".
The committee reports that it reached the view from these comments that the Minister had assumed that the nature of the decision was such that consultation was unnecessary. As the Commons Select Committee stated, that assessment is wrong. It concluded:
"The Government did not consult properly on these proposals. When undertaking such a fundamental review of the machinery of government it is desirable and sensible to do so. We welcome the fact the Government is now taking steps to rectify this, but question how useful consultation can be, given that decisions on the future of many bodies have already been taken. Having agreed to amend the Bill"- as the Government did, and it has now been so amended-
"to allow for more consultation we expect these consultations to have real effect on the outcome of the review; even if this means reversing decisions that have already been made. We expect the Government to give us such an assurance in its response to this Report".
In their response to the report published in March, Command Paper 8044, the Government state:
"The Government has always been committed to ensuring appropriate consultation and external input in relation to its proposals. There is a substantial role for consultation to play, and a strong impact to be made on the delivery of these decisions".
I should therefore like the Minister to confirm that, so far as it affects the bodies listed in the Bill but specifically RDAs, there will indeed be proper consultation, the consultation will be duly considered and, in the light of that consultation, the Government will, if appropriate, reverse their decision. My amendment is intended to ensure, if the Government decide to bring forward any orders that would embrace RDAs, the explanatory document that has to be brought forward in conjunction with the order will make it clear that a proper consultation was undertaken, including a summary of the representations received in respect of the principle of abolition. That would ensure a proper and genuine consultation process. I hope that the noble Lord will be able to be positive on both amendments. I beg to move.
My Lords, I have added my name to Amendment 1. As the noble Lord, Lord Hunt of Kings Heath, said, at Report your Lordships rejected an amendment in the name of the noble Lord which would have required public consultation in all cases covered by Clause 10. Your Lordships rejected the amendment because the Minister argued that it cannot be appropriate and proportionate for a full public consultation to be undertaken on the implementation of all exercises of power under the Bill, however limited they may be. However, he also said:
"The Government support the principle behind this amendment, which is to ensure that the public are given an opportunity to make their views heard on the reform of public bodies.-[Hansard, 4/4/11; col. 1555.]
Amendment 1 would achieve that objective. It would ensure that the public were able to inform themselves of all proposals for change and were able to contribute to the debate if they wished. The amendment would therefore promote accountability, and it would do so at no cost or inconvenience to the Government.
The Minister may say that the amendment is unnecessary as this is so obviously sensible as a practice that the Government would do it in any event. However, a ministerial assurance given, I accept, in good faith cannot bind Ministers in this or any future Government. Even after the very welcome amendments that have been made to the legislation in this House, the Bill will still confer very extensive powers on Ministers over public bodies, and it is therefore important to make clear in the Bill the essential obligation contained in this amendment.
My Lords, I thank the noble Lords, Lord Hunt of Kings Heath and Lord Pannick, for bringing back these issues because it gives me the opportunity to clarify the Government's position. As they say, Amendments 1 and 6 revisit the issue of consultation and so I shall respond to them together.
Amendment 1, to which the noble Lords, Lord Hunt of Kings Heath and Lord Pannick, have spoken, would require Ministers to publish the proposed reform on their department's website or to otherwise make it publicly available in the event that a full public consultation was not to be undertaken. This is a helpful amendment and one that speaks to an important principle, so I thank noble Lords for bringing it back at Third Reading.
I said on Report that I thought that this was something that the Government could consider, and I can assure your Lordships' House that we have done so. Supportive as we are of the objective behind this amendment, on balance, we do not believe that such a requirement is appropriate on the face of the Bill. We are debating ostensibly an issue of guidance and best practice, not imposing a legal requirement. For that reason I am able to support the purpose of the amendment but not its inclusion in the Bill. Given that I believe that this is an issue of guidance, I am happy to give a very specific assurance that the guidance for use by officials on making orders under the Public Bodies Bill, to be published by the Cabinet Office, will include a specific reference that departments ought to consider the most appropriate way of making a proposal publicly available.
The Government are committed to increasing transparency and accountability across the public sector. I do not believe that I can honestly stand here and say that I oppose the purpose of the amendment and still be true to that overall objective. I fear that our only point of divergence is on how to ensure that this purpose is reflected in the best way possible when Ministers are developing proposals and drafting orders. It is the Government's clear judgment that a more practical and proportionate way of achieving the noble Lord's objective is to capture this issue in the guidance which will be used by departments when bringing forward orders. On Report, the noble Lord, Lord Hunt, described my pledge to take this back to my colleagues in government as "handsome". I hope that he will not consider this an ugly conclusion by the Government. I can assure him that the principle of making proposals publicly available is one on which all sides of the House agree.
I should like to make one further observation on the noble Lord's amendment. I agree that, in 2011, a website represents a very sensible vehicle for making proposals publicly available; indeed, I should expect departments seriously to consider whether website publication is not appropriate for publicising their proposals. However, my crystal ball will not tell me whether this will be the case for ever. Technology moves on. The statutory framework for consultation on this legislation is set out in Clause 10, and it is intended to be a stable and firm statutory requirement for reforms long into the future. It is guidance, not the statue book, that can be readily updated to reflect whatever is most appropriate at given times. That provides further weight to the argument that, however sensible this amendment might seem, it is not an appropriate addition to the Bill.
I am disappointed that I cannot be more supportive of the noble Lord's amendment. I know that it is a sincere attempt to improve the Bill and to help the Government deliver a comprehensive and watertight piece of legislation. However, the vote on Report made it clear that consultation must not always be full public consultation and that a Minister must ultimately be responsible and indeed accountable to Parliament for deciding how to undertake proportionate and meaningful consultation. It is therefore not appropriate to seek to alter this legal framework through the noble Lord's amendment.
I shall now turn to Amendment 6 in the name of the noble Baroness, Lady Royall, and the noble Lord, Lord Hunt of Kings Heath. This proposed amendment to Schedule 1 in practice concerns the issues of consultation and subsequent procedure, set out in Clauses 10 and 11, and how they might apply to the closure of the regional development agencies. I shall start by once again taking the opportunity to pay tribute to the work of the RDAs. I also acknowledge that the noble Lords have a strong regard for the work that the RDAs did and would prefer them to continue.
We have had very thorough debates in the House, in Committee and on Report, on the RDAs. The noble Lord, Lord Hunt, referred to these debates. I have explained that the Government's strong preference is to abolish the RDAs, and I have set out the reasons behind this, including why the current arrangements are no longer sustainable. The coalition agreement, the June 2010 Budget Statement and the local growth White Paper are equally clear about the Government's proposal to abolish the RDAs. The Government continue actively to engage with RDAs and interested parties on how closure is to be achieved. Individual RDAs have been in touch with their stakeholders, for example about their asset plans. The consultation and engagement are taking place irrespective of the requirements in the Bill.
I have listened to the arguments for the reform of public bodies to be an open process. Clauses 10 and 11 underline the Government's desire for this to be the case. Clause 10 requires a Minister to consult on a proposal to which an order made using the Bill would give effect. The amendment proposes that in the case of RDAs, the explanatory document that accompanies an order should include, first, the question that was asked about the principle of abolishing RDAs, and, secondly, a summary of the representations received on that question.
The requirements of Clause 10 on a Minister to consult when making an order covered by the Bill are clear. The requirements applied to the RDAs would oblige the Government to ask about the principle of abolition. Similarly, Clause 11(2)(d) requires that any explanatory document should include a summary of representations received in consultation. Therefore, I do not believe that the amendments in this group would provide any additional information for Parliament. Instead, they would unnecessarily complicate the drafting of the Bill. I hope that, in the light of the clarification that I have given with regard to the existing requirements-
My Lords, does the Minister recall that on Report, I asked about the consultation process for RDAs in the light of a letter that the Minister had written to my noble friend Lady Royall, in which he stated that consultation effectively would take place after the passage of the legislation? I asked on that occasion whether in those circumstances the consultation that took place with individual RDAs would be on the basis that each case would be considered on its merits, or whether in effect it was all or nothing in terms of abolition. Will there be an individual consultation in respect of each RDA, with the possibility of a different conclusion in respect of one RDA as opposed to another, or is it to be abolition tout court?
The consultation will be based on the statutory instruments that will be tabled in connection with each RDA. Therefore, there will indeed be consultation, and an opportunity for each regional development agency to have input on its future. The regions of the country, if they feel particularly motivated, will be able to discuss the reasons why they believe no change should be made to their status.
It is the nature of consultation that the Government are open to persuasion: that is the purpose of a consultative exercise. The policy decision has been made. It is the resolve of the Government to implement the policy. None the less, there will be a consultative process, at which there will be an opportunity to argue the opposite case.
I hope that, in the light of the clarification that I have given on the requirements of Clauses 10 and 11, the noble Baroness and the noble Lord will not press their amendments. I also hope that, given my assurances on guidance and the problems with adding Amendment 1 to the Bill, the noble Lord will withdraw his amendment.
I am grateful to the Minister for his response. I shall take Amendment 6 first. My noble friend Lord Beecham surely put his finger on it, and it really takes us back to the comments made in the House of Commons Public Administration Committee, which made it clear that, having agreed through this Bill to have proper consultation, that consultation must be done properly. That must mean that the Government have to consider on their merits the responses received. Let me take the West Midlands as an example. There is almost uniform opposition and hostility to the abolition of Advantage West Midlands. There is also a dawning recognition that the local enterprise partnerships which are to be put in its place simply do not have the wherewithal or coverage of the region to do the job that the RDA is proposing. So the question arises of whether the Government, having considered the results of the consultation, will in all fairness give due consideration to those comments before coming to a decision. That is a very important matter.
I was disappointed with the Minister's response to Amendment 1. All noble Lords know that the heart of the noble Lord, Lord Taylor, is in the right place when it comes to this amendment. It is disappointing that his department has not been able to respond in the same way. I fully accept that your Lordships' House did not agree to my amendment to make public consultation apply in all cases. However, this amendment modestly suggests that when, in appropriate cases, a Minister decides that public consultation is not necessary, there should be at the very least a reference to it on the department's website. With the best will in the world, I have not heard any convincing argument as to why that cannot be in the Bill. I do not see why it should be left to guidance which can be changed at any point. Moreover, in referring to that guidance, the Minister carefully used the words "ought to". He did not say that departments "must".
This is a matter of principle. I accept that this House decided that there will be circumstances in which it will be appropriate for a Minister not to seek public consultation. In the interests of good governance, however, surely there should be a record, and a reference should be made to it at least on the department's website. I think that this is a matter of principle and I wish to test the opinion of the House.
Moved by Baroness Royall of Blaisdon
2: After Clause 11, insert the following new Clause-
"Time limit on scheduled bodies
Any entry in Schedules 1 to 5 ceases to have effect at the end of the period of five years beginning with the day on which it came into force (without affecting any order already made by virtue of that entry)."
My Lords, in moving Amendment 2, which will put a time limit on the bodies mentioned in Schedules 1 to 5, I will not rehearse the well honed arguments which have been put forward many times about the importance of sunsetting. Suffice it to say that the sunsetting of the schedules is one of the fundamental and welcome changes which have been made to this Bill. I am very grateful to the Minister for putting his name to this amendment, which appears for a second time because, I have to confess, I failed to move it on Report. I beg to move.
My Lords, I am delighted to have added my name to Amendment 2, which is also tabled in the names of the noble Baroness, the noble Lord, Lord Hunt of Kings Heath, and my noble friend Lord Norton of Louth. As the noble Baroness has said, perhaps she failed to move the amendment on Report, but then so did I. I think we were all caught up in the heat of the moment after a Division, so I am pleased that we have an opportunity to bring it back again. It is the outcome of a constructive engagement across the House and I thank noble Lords for their input into the process and for retabling the amendment to ensure that it becomes part of the Bill.
Grouped with Amendment 2 are three government amendments to clauses relating Welsh Ministers. They are essentially minor and technical in nature and have been requested by the Welsh Assembly Government. Amendment 3 clarifies that Clause 13(6) refers to internal drainage boards which have responsibility for geographic areas partially but not wholly within Wales. National boundaries do not necessarily follow catchment areas. Amendment 4 is a drafting amendment to ensure that the procedure for transfer schemes made by Welsh Ministers under Clause 23 applies to transfer schemes set up in connection with orders made under Clause 13. Amendment 10 alters the Long Title to reflect the fact that the Bill as amended on Report grants powers to Welsh Ministers in Clause 13 in relation to a number of other bodies and offices in addition to those powers that already exist in relation to environmental bodies specified in, and by virtue of, Clause 12. These amendments rightly clarify the Government's intentions for the use of powers in the Bill and I trust that they will be welcomed by the House.
Amendment 2 agreed.
Clause 13 : Powers relating to other bodies
Moved by Lord Taylor of Holbeach
3: Clause 13, page 8, line 27, after "board" insert "for an area"
Amendment 3 agreed.
Clause 24 : Transfer schemes: procedure
Moved by Lord Taylor of Holbeach
4: Clause 24, page 14, line 35, after "12" insert "or 13"
Amendment 4 agreed.
Clause 25 : Transfer schemes: taxation
Moved by Lord Whitty
5: Clause 25, page 15, line 28, at end insert-
"( ) In relation to a transfer to another public body or to any other body of functions, duties or powers under section 1 or 5, or to a merger (where such transfers are involved), under section 2, the Transfer of Undertakings (Protection of Employment) Regulations 2006 (S.I. 2006/246) shall apply to a transfer which relates to rights or liabilities under a contract of employment whether or not the transfer would, apart from this subsection, be a relevant transfer for the purposes of those regulations.
( ) In the case of an employee of a body whose functions, duties or powers are transferred or merged under section 1, 2 or 5-
(a) a period of employment with the transferor is to be treated as a period of employment with the recipient organisation;
(b) the transfer to the recipient organisation is not to be treated as a break in service."
This amendment deals with the way in which the employees of the organisations covered by this Bill are dealt with. On one level, I apologise to the Minister for bringing the issue back because we debated it in Committee. Subsequently, I had a meeting with him and he sent me a useful letter. His goodwill in this respect is appreciated. However, I do not think that the situation is as clear as it should be, and I certainly do not apologise to the House or to the Government as a whole for bringing back an issue which is important to what are still several thousand public sector employees in those organisations which remain in the Bill.
One has to accept that some of the anxieties and suspicions relate not so much to the Bill as to the perceived general attitude of some members of the Government towards public service workers as a whole. Many employees of the organisations concerned have huge expertise and have been there for many years. They have done a very effective job on behalf of the population as a whole in those areas of public responsibility.
I appreciate that the Government have reached a conclusion that some of these bodies are no longer necessary. They have also reached a conclusion that some of their functions, powers and responsibilities are best carried out elsewhere, either in central government, the private sector, the third sector or in other public bodies. That has left huge uncertainty among employees. The Minister's assurances have gone some way towards clarifying the position, but not entirely. The Minister's position seems effectively to be that where there is a transfer, TUPE will apply, except where there is a public function exemption, in which case the Cabinet Office guidance-the COSoP, as it is termed-will apply, which will give rights and responsibilities equivalent to TUPE. If there are any doubts, what is now Clause 23(6)(f) will apply and Ministers will be able to clarify the situation when the regulations regarding individual organisations come into play.
On the face of it, that is a relatively watertight position and, generally speaking, the principles of TUPE will apply where there is a transfer. I do not apologise for reverting to the organisation of which I was chair until Christmas and which is still in the Bill. For reasons best known to the Government it is listed under Schedule 1, for abolition, whereas BIS's policy as far as I understand it is to transfer the powers rather than to abolish them. They will be transferred in the main to Citizens Advice, which is a private sector body. If that is the case, it is not clear which powers, functions and responsibilities are being transferred or whether all of them will be, and whether they will all be transferred in the same direction-it is clear that they will not, because Citizens Advice Scotland and the Consumer Council for Northern Ireland will have some, other bodies will undertake others and others will lapse. That is not an unusual situation with the various bodies still stipulated in the Bill; indeed, we have just had a debate focusing largely on the RDAs, some of whose functions will in effect transfer to local partnerships, local government and elsewhere. Uncertainty is therefore quite widespread until the consultative process leading to the regulations makes the situation clearer.
In his letter to me, the Minister has said:
"In any transfer scheme relating to an order made under the Bill, a person will need to ... determine a 'relevant transfer', as defined by TUPE, is taking place. This will sometimes not be the case, for example where the new organisation will be carrying out a function or activity which is different in nature from the old, or where the exception in TUPE"- which relates to public functions-
"applies. In the first case, it would not be appropriate to apply TUPE. The reality is that a 'transfer' is not actually taking place-employees' roles are not going to be continued. Accordingly, the situation should be dealt with by their current employer terminating their contracts by reason of redundancy and meeting his liabilities as regards compensation".
That is quite logical, but, regrettably, it is not what the guidance on TUPE from BIS actually says at present. It effectively says that the responsibility for determining which measures will be regarded as transferred rests not with the existing employer but with the transferee employer-so not the transferor employer.
That has caused some confusion in the past, as is did when Consumer Focus was first set up because it did not seem to be the logical way of approaching things. It made the Minister's words seem more logical in many respects. But they are at odds with what tribunals have been interpreting under the 2006 regulations and what, in slightly obtuse form, the rather lengthy guidance issued by BIS states very heavily: it places responsibility on the transfer organisation. That is one example of the lack of clarity and we need greater certainty on the record.
Relatively few bodies involved in this Bill are designated for merger, but when there is a merger, everything goes into the merged body, whether or not that merged body will have the responsibility for doing everything that the previous organisation was going to do. In which case, the exemption does not apply, but on the Minister's interpretation TUPE does not apply either.
I am well aware that there is a general view in Whitehall, following the Cabinet Office's guidance and so forth, that says to staff, trade unions and Back-Benchers like myself, "Don't worry about it you lot. It will all become clear. The Government are committed to applying the TUPE principles". It is also true that in certain situations, where the function is not continuing, it may be in the interests of individuals for TUPE not to apply. But we still need clarification as to what is a relevant transfer.
In the case of my old organisation, it is not clear what is being transferred. It is not clear to whom and it is not clear whether some functions will not be transferred and whether TUPE or COSoP will be applied. In that respect and in relation to many of the other bodies, we anticipate a consultative document fairly soon. However, I understand that the consultative document on consumer structures that was expected to be issued in March has been significantly delayed and the final outcome of that is again not clear, so the whole process has been put back. I would like the Minister today to clarify the situation. I accept his goodwill in this matter and I assure him that I will not press the issue to a vote, but I would like on the record at this last stage an indication of where the Government stand.
It is not all that easy to rely as a safety net on what is now Clause 23(6)(f), which states that a transfer scheme may,
"if the TUPE regulations do not apply in relation to the transfer, make provision which is the same or similar".
The clause says "may" and it is sensible in the drafting to say "may" because there are a lot of other subsections to which "may" clearly applies, but it would be helpful if the Minister would say that as far as that subsection is concerned, the transfer scheme would make provision for the equivalence of TUPE to apply in those circumstances.
I am asking the Minister to say what he has already attempted to convince me of, although I do not think we are yet there: that in all situations where there is a transfer or merger, individuals will be subject to either TUPE or the public sector equivalent. The default position should be that TUPE or COSoP applies and that in that sense the Government accept their responsibility to all employees of the quangos that remain subject to the Bill and to the obligations that they have in terms of individual and collective procedures under TUPE regulations.
If the Minister can use words to that effect, I will not press him further today and he will go some way to reassure several thousand rather anxious public sector employees, many of whom the Government will continue to need to rely on, albeit possibly in a different guise. I beg to move.
My Lords, I rise to support my noble friend on this amendment and thank him very much for introducing it. As he rightly says, there is a great deal of uncertainty among public sector workers at the moment. Of course, there is a bit of a campaign about the public sector, as far as I can see, on the part of certain sections of the press, designed to give the impression that public sector workers are so much better off than people in the private sector. If you look at it very carefully, that really is not the case. On the other hand, it all adds to the sense of insecurity that many public sector workers feel. Therefore, it is essential that there should be something in this Bill that makes it clear that when people are transferred they have the protection afforded by the TUPE regulations.
Not to give that sort of protection would be to give the public sector workers, who provide the services that we all rely on, the sense that they are disposable. Our workers are not disposable and must be protected in the way suggested in the TUPE regulations. I therefore hope that the Government this time round feel that they have to support this amendment and that it eventually appears on the face of the Bill.
My Lords, I am grateful for the opportunity of coming back on the amendment proposed by the noble Lord, Lord Whitty. I am sorry if my prose failed to clarify the situation as well as it might, and I hope that my words and the speech prepared for me provide the clarification that the noble Lord seeks. He used the phrase, "words to that effect". Let us hope that these words that I am about to deliver are to good effect.
The amendment gives me, as the Minister taking this Bill through the House, an opportunity to say that the Government recognise the valuable contribution made by their staff. We want to be, and feel that we are, a good employer, and staff in public bodies are important for good governance. We are keen to support all those affected by change and are committed to TUPE and COSOP as they currently apply. The noble Lord, Lord Whitty, agreed that extending TUPE is not necessarily the best option for all staff, which is what makes this particular matter more complex than it might otherwise be.
The amendment would require that TUPE regulations must apply to any transfer of functions or activities that take place as a result of an order made under the Public Bodies Bill. As I did in Committee, I would like to inform the House why the Government believe that existing protection for staff is sufficient and why it would be inappropriate to accept the suggested amendment.
The purpose of TUPE and the European law that underpins it is to protect staff in circumstances where the business that they work for or services to which they are assigned are to be carried out by a different organisation. TUPE ensures that the staff retain their jobs and conditions with new employers stepping into the shoes of the old. When a change falls within the TUPE definition of "relevant transfer", TUPE will apply and the staff will be protected. The definition is broad and many changes brought about by the Bill will be covered. However, there may be circumstances where it is uncertain whether TUPE applies or is excluded.
Clause 23 gives the Government the power to provide protection to staff in circumstances where TUPE is not engaged. This is underpinned by the Cabinet Office statement of practice on staff transfers-referred to as COSOP-which provides that, even where TUPE does not apply to public sector transfers, organisations will be expected to apply TUPE's principles as a matter of policy. I assure the noble Lord that the Government remain committed to COSOP. In practice, such transfers are effected through legislation which closely follows the provisions in TUPE, including the continuity provisions.
Legislative transfer schemes which are used to effect transfers in non-TUPE situations do not always apply TUPE to the letter. For example, some schemes permit greater flexibility in relation to post-transfer contractual variations. This can assist the process of harmonising disparate reward packages, thus reducing the risk of unlawful discrimination, particularly on equal pay claims, and avoiding unnecessary barriers to reform. Where the change does not fall within the definition of "relevant transfer" because the new organisation will be carrying out a function or activity which differs in nature from the old, it would not be appropriate to grant TUPE protection; the reality there is that there is no transfer of employees' functions-the staff are redundant and should be dismissed and paid the compensation to which they are entitled. I assure your Lordships that, if there is legal uncertainty on whether a function is to be continued, Clause 23 gives scope for TUPE protection to be provided.
It would be inappropriate to accept the amendment because, in the Government's view, the blanket application of TUPE to all those transfers which are effected pursuant to the Bill is not appropriate and could lead to inefficiencies and unintended consequences. The Bill provides a framework for a wide variety of reforms to public bodies. Given this, it is crucial that those involved in transfers taking place under the Bill retain the flexibility to respond to each situation according to the facts. It is necessary to form a judgment in each case about whether the particular facts fall within the TUPE definition of "relevant transfer" and, if not, whether a transfer scheme which follows TUPE principles is appropriate. Staff could otherwise be compelled to move and, perhaps, relocate-even where their work is not going to be continued-and all those involved in the transfer could find themselves subject to restrictions which are not helpful nor apposite to the situation.
I appreciate the contribution made by the noble Baroness, Lady Turner of Camden, and I thank the noble Lord, Lord Whitty, for again bringing this to the attention of the House. I assure them both that I am quite happy to write to them again and will keep them posted on developments under the legislation, if they wish. In respect of Cabinet Office advice in this area, I am perfectly happy to keep all noble Lords informed on this matter. However, in the light of the assurances that I have given, I hope that the noble Lord will feel able to withdraw his amendment.
My Lords, I, too, thank my noble friend Lady Turner for her points underlining the issue of uncertainty that surrounds so many employees in these organisations and beyond at the moment. I am also grateful to the Minister for stating pretty clearly the Government's commitment to the TUPE principles and to continuing to apply COSOP where that is the relevant coverage. I was slightly more dubious about the last two or three paragraphs. There is a slightly schizophrenic nature to the Minister's response. I do not know whether two people drafted his speech for him, as he carefully said at the beginning. On the one hand, there is that very clear commitment, which I appreciate. It is an important message for the Government to get out there. There were then references to flexibility in situations which hitherto may well have been regarded as transfers. I accept that some fine-tuning of TUPE is necessary and helpful, provided that that is done individually or collectively with the employees concerned.
The situation where neither TUPE nor COSOP applies probably requires one-off handling. However, if the principle is that the main principles of TUPE will be held to apply unless there is a good reason why they should not, I would rather have heard a speech from the Minister in those terms-that the default position is that TUPE should apply. However, clearly I am not going to get a lot more from the Government on this one; I think that I have done quite well over the previous stages of the Bill. I suspect that there will be some work for our learned friends in some of these areas, and I hope that the good will extended by the Minister at the beginning of his speech and the commitment to the TUPE principles that he reflected here will in practice be reflected in the proposals for the individual organisations and the approach that the individual departments take when we are drawing up the regulations to implement these parts of the Bill.
I thank the Minister. I am not entirely satisfied, and I suspect that some people outside will not be either, but I will not press this today. I beg leave to withdraw the amendment.
Amendment 5 withdrawn.
Schedule 1 : Power to abolish: bodies and offices
Moved by Lord Hunt of Kings Heath
6: Schedule 1, page 19, line 36, at end insert-
"4 The explanatory document required under section 11(2) in respect of the regional development agencies must include-
(a) the wording of the question that was asked about the principle of abolishing regional development agencies;
(b) a summary of representations received in respect of the principle of abolishing regional development agencies."
My Lords, we have already debated my Amendment 6, which would ensure that when the consultation takes place on the abolition of regional development agencies, there has to be a proper consultation. It is an important point of principle and I beg to move.
Schedule 5 : Power to modify or transfer functions: bodies and offices
Moved by Baroness Deech
7: Schedule 5, page 22, line 11, at end insert-
"2 An order may not be made in respect of the Human Fertilisation and Embryology Authority or the Human Tissue Authority unless an independent assessment indicates that making such an order under section 5(1) would increase the cost-effectiveness of the functions exercised by that Authority."
My Lords, in a nutshell what I and others are calling for is that the HFEA and the HTA should remain untouched until a new research regulatory body is in place with its own statute ready to receive those functions, and that in the mean time there should be a wholly independent external review of the HFEA.
The HFEA is like no other quango. Its work touches deeply on the intimate lives of the one in six couples who cannot conceive naturally, the health of babies, scientific research, cures for diseases now and in the future, the profits of scientific companies, and public morality. It is unique, has an international reputation and was a British first. I am seeking to preserve it from being shattered and to prevent lasting damage being caused to that area.
The HFEA and the Human Tissue Authority, to which similar considerations apply, are both listed in Schedule 5 as bodies that may have their functions transferred or modified under Clause 5. In Committee and at Report, amendments were tabled to remove the HFEA and the HCA from that schedule but, for various reasons, the proposal was not voted on but withdrawn to give the Government a further chance to reflect on the damage that it seems to us will be done, which we were convinced would persuade the Government to change their minds. This did not occur. Indeed, it seems that the Government are developing policy in this area as they go along. I sometimes suspect that behind closed doors there would be relief if the amendments being looked at by the House today were to succeed.
The first two amendments in the group are set down in my name and those of the noble Baroness, Lady Warwick, the noble Lord, Lord Walton, and the noble and right reverend Lord, Lord Harries, who cannot be in his place today because he has an unbreakable prior commitment but is giving his full support. The amendments seek to rectify an omission-the need for an independent review-and to prove a point that change in the organisations will be for the worse.
We have the support of the key organisations in this field-the Association of Clinical Embryologists, the British Fertility Society, the British Infertility Counselling Association, the BMA, the RCN, the RCOG and the Infertility Network UK. They do not consider that the HFEA should remain in the Bill because there has been no full and impartial public review of the risks and benefits of the new proposals, including the financial costs of all the options. However, as I have said, the removal of the two bodies from the schedule is not now a possibility. There is agreement that there are some elements of its remit that the HFEA could do better. Therefore, there should be an independent external review of the HFEA, with the aim of reducing bureaucracy, increasing accountability and saving money-albeit that the cost to the public purse is only £2 million and can be reduced. Even those who are most critical of the HFEA cannot oppose these two amendments, which call for just such a review.
The consultation proposed by the Government is not at all the same. No doubt the HFEA's working practices could be streamlined with other regulators. Efficiencies could be found in the back offices and research regulation could be improved. However, there was no need to include the HTA and the HFEA in this Bill. No matter how irritating the HFEA may have been found to be by clinicians, they must surely welcome a review, for if they accept the Government's way forward the irritations will no doubt increase and there will be no improvement of those functions.
I wish to say a few words about the third amendment, Amendment 9. Just shifting the HFEA into the Care Quality Commission will not achieve money savings or efficiency. The shift will not meet the objections of the professionals to some of the ways in which the HFEA works. I am saying: do not take it apart but make it better, with an impartial review by, for example, the King's Fund, the Nuffield Foundation or the Wellcome Trust. Indeed, the proposed overarching regulatory body could work with the HFEA to achieve the aims desired by the Government. By splitting away the research functions of the HFEA as the Government propose, there is the risk of creating additional bureaucracy and increasing, rather than diminishing, the burden of regulation. The HFEA and HTA functions will be transferred to the Care Quality Commission, and research will go to a new body that has not yet been created. There is to be consultation about that reallocation of functions, even about the database-perhaps the most important feature to be concerned with in dismembering the HFEA-but in the mean time, the shadow of destruction hangs over the HFEA. That will affect staff morale and retention, and the confidence of scientists and clinicians, who rely on it for legitimacy and guidance, not to mention international respectability.
I submit that the CQC does not have the experience or expertise in the complex areas governed by the HFEA and the HTA, and there is the danger of losing the corporate knowledge developed over the past 20 years, along with the relationship built up between the HFEA and the clinics. There is no practical benefit in abolishing the HFEA and handing its responsibilities over to the Care Quality Commission. More members of staff will have to be recruited and trained to replace the existing ones. Rearrangement of all external relations will have to be accomplished. The efficiency and cost-effectiveness of that has not been tested. Nobody can understand why that is being done, when other countries such as Canada are trying to emulate what has been done so successfully here over the years to regulate infertility practice and embryology while staying ahead of the field in maintaining safety and patient confidence.
If ever there was a time to protect consumers in this field, it is now. Patients are used to having a single port of call for information and complaints. To disband the HFEA and the HTA sends the message that the Government do not trust the way that tissue, infertility and embryology is handled in this country. It is a message that will go right around the world.
I fear that there will be fragmentation in an illogical way. The latest government proposal is that the licensing of embryo research, the release of identifying treatment data to researchers where it is not practicable to obtain consent, and the provision of guidance to researchers will be hived off to a new research regulatory body. Those things are in fact inseparable from the maintenance of the database, which is of enormous significance in itself, and advice to patients, all of which is HFEA-based now. There is no definite timetable for the establishment of a new, overarching research regulatory body, on which the architecture depends. It depends on new primary legislation, likely to be after 2012. In the mean time, it is proposed that there be an interim special health authority in 2011-12 to bridge the gap until the hoped-for primary legislation in the second Session of this Parliament. It will need more funding from the Department of Health budget.
If noble Lords think that that is incomprehensible and confusing, they are right. The cost of a bridging research agency will no doubt far outweigh any savings-not that we have been told what they might be-that could be envisaged in the transfer of HFEA and HTA functions. That is why the third amendment has been tabled. Our preference, of course, is that your Lordships should vote for the first amendment, which calls for a review, but even so, if there is to be transfer, the Government's intentions have not yet been made plain in detail. Why is a bridging authority necessary? How much will it cost? How can an interim body deal effectively and authoritatively with ethical questions-those specific to the sensitive functions of the two existing bodies? That is why the third amendment is here, for it covers newly revealed policies not hitherto debated or explained in sufficient detail. Can the Minister guarantee that the HFEA and the HTA will remain untouched until legislation is in place and all is set to receive their functions into a new body? Of course we do not know what the other place will do in this area.
Some have said that IVF is routine and does not need special attention. That is not the Government's view, for they rightly propose to stick to the primary legislation. The Human Fertilisation and Embryology Acts will stay in place; they will not go. The demands that they place on laboratories and clinicians will stay, every word of them. Nor do the public think that IVF is routine. Their emotions and intelligence are engaged by every new development-for example, as recently reported, in treating mitochondrial disease, set out in some of the tabloids as having three mothers; in screening embryos; and in protecting the patents on stem cell work. All those who hope for cures for terrible diseases are involved in this debate. The uniting of eggs and sperm, and the resultant possibilities, can never be routine unless one is very hard-boiled. This is what commentators have said. The Guardian said:
The New Statesman said:
"The regulation of fertility and embryology ... will now be hidden within the remit of the Care Quality Commission ... There will be repercussions ... Without a distinct, visible body to oversee reproductive ethics, scientists in the field stand to lose public trust".
I should have said that I declare an interest, in that I was chairman of the HFEA years ago, and my heart is engaged in this topic for the sake of the patients and because of the whole enormously enriching field that was opened up to me and to many others. I urge your Lordships to do the right thing-to call for a review before committing this pointless transfer, which will save no money and damage British interests. I beg to move.
My Lords, I added my name to the first two of these amendments for a variety of reasons. Four or five years ago in a debate on the National Health Service in your Lordships' House, I remarked that I had identified more than 40 organisations that had the right to inspect, assess and consider health service activities, and I defined those organisations as constituting an intolerable "quangocracy". I believed that I was the first to create that neologism but since then others have claimed authorship. However, when I heard of the Government's intention to embark upon a bonfire of the quangos, the two quangos that I would never have contemplated being the first to go on the bonfire were the Human Fertilisation and Embryology Authority and the Human Tissue Authority. In my opinion, each of them has fulfilled and continues to fulfil a vital function-vital for suffering humanity and vital for the pursuit of medical research-and I believe that the Government's current proposals are likely to be damaging to both bodies and their functions.
Why do I say that? Perhaps I may go back. The Human Fertilisation and Embryology Authority was established by the Human Fertilisation and Embryology Bill based on a splendid report prepared under the chairmanship of my noble friend Lady Warnock. From the moment the authority was established, it required that any individuals wishing to work with human embryos up to 14 days after fertilisation would have to have a licence from the authority. In the first instance, that licence helped greatly to improve the treatment of infertility.
However, as time went by, the Act was amended and we went on to develop the pre-implantation diagnosis of genetic disease, allowing individuals carrying harmful genes which would produce in their offspring very harmful diseases to be studied so as to prevent diseases such as cystic fibrosis and Duchenne muscular dystrophy. Later still, amendments to the Act led to many other crucial developments. Further regulations made it possible to use spare embryonic material in in vitro fertilisation programmes to generate stem cells for the treatment of human disease, and that is slowly but surely becoming a reality. As my noble friend Lady Deech said, only recently the HFEA established an expert committee to examine the results of some highly fundamental world-leading research, carried out in my former university of Newcastle upon Tyne, using the technique of pro-nuclear transfer for the prevention of mitochondrial disease. I as a neurologist have seen and tried to help and treat patients with devastating mitochondrial diseases. This is a massive development which is likely to be of enormous value to humanity.
I agree that it is possible to consider the transfer of these research functions to other organisations but let me make one or two important points relating to that proposal. The Care Quality Commission has recently merged the Healthcare Commission, the Mental Health Commission and the social care commission. It has taken on a massive regulatory task. I cannot conceive of any mechanism by which that organisation, constituted as it is, could possibly fulfil the functions of the HFEA without creating within itself expert committees with the right kind of background and expertise to be able to assess the importance of the functions that it will be absorbing from the HFEA. If that is the case, why abolish the HFEA or merge it into a body that is certainly not constituted to carry out those particular functions?
Let me turn for a moment to the Human Tissue Authority. The Alder Hey scandal was a failing on the part of members of my profession. Everyone in the profession knows that when a post-mortem is carried out inspections of the organs that one sees at that examination cannot, except in most unusual circumstances, give you the full diagnostic picture or the information necessary to prove the cause of death, or give evidence that is likely to help in future research. To obtain that information it is necessary to remove the organs and to fix them in formalin. After they have been fixed you then take sections that are examined under the microscope which give you diagnostic information. Regrettably many pathologists took the view that when permission for a post-mortem was given, that gave them authority to retain the organs and they did not regularly seek permission to retain them. Now, of course, the Human Tissue Act makes it absolutely clear that the retention of organs after a post-mortem for examination and diagnostic purposes absolutely requires the permission of the next of kin of the individual who is undergoing a post-mortem examination.
Quite apart from that the HTA has major responsibilities on issues such as the transplantation of human organs. There are many sensitive issues, such as whether someone donating an organ should be in any way compensated, whether it is appropriate that it should come from blood relations or whether well-meaning individuals not related to the individual should be allowed to give an organ for transplant. These and many other issues fall to the remit of the HTA. I recall very well when we considered the Human Tissue Act in your Lordships' House and in Grand Committee-it took hours and hours of consultation. The Bill as it came to us from the Commons contained several major defects. Those major defects would have hamstrung diagnostic purposes and been immensely damaging to the future of medical research-not least the constraints on the use of archive material which had been removed from patients years before and which were vital for research purposes.
Happily we were able to introduce some major amendments in your Lordships' House to improve the Human Tissue Act and to establish the Human Tissue Authority. I remember very well, as I am sure will the noble Lord, Lord Jenkin, that several people in the research community and in the royal colleges said, "Thank God for the House of Lords". That Act was improved and the Human Tissue Authority was given the appropriate regulations to enable it to fulfil its function.
If the process that the Government intend goes ahead, and if these bodies are merged with the Care Quality Commission, who will be responsible for licensing? Will they carry out inspections and have the authority, under the Human Fertilisation and Embryology Act, to withdraw recognition from people who are not fulfilling the terms of their licence?
I have heard a suggestion that the research functions of these bodies might be transferred to a future health research agency. I am immensely supportive of the splendid report produced by a committee chaired by Sir Michael Rawlins for the Academy of Medical Sciences on the future regulation of research. The main purpose of the report is to clarify and make easier many of the constraints that have been imposed on multicentre research projects; it is to make medical research easier to regulate and conduct. To convey to that body, if it is eventually established, the responsibilities for research held by these two organisations, will not be its primary function, although of course the Government have not yet legislated-and may not for some time, until the next Session of Parliament-to establish the health research agency. In the mean time, it is crucial that the HFEA and the HTA-which are not perfect; they each have problems, which can readily be resolved without legislation-should be allowed to continue with their functions, because the proposals that the Government have put forward will be inestimably damaging to the future of embryo research and research in a variety of medical fields. I warmly support the first two amendments in the group.
My Lords, I, too, support the amendments of the noble Baroness. My interest is that I appointed her as chairman of the Human Fertilisation and Embryology Authority all those years ago. One of the first Bills for which I had responsibility in Parliament when I was Minister for Health was the Human Fertilisation and Embryology Act, following the very distinguished report of the noble Baroness, Lady Warnock. I have also served on the Medical Research Council.
The noble and right reverend Lord, Lord Harries, said that umpteen days had been spent debating the Bill. I like that term, and it is absolutely accurate. I, too, when I was a Minister in another place said, "Thank God for the House of Lords", because, whenever a particularly difficult and emotional issue arose, I knew that words of wisdom could be consulted in the House of Lords. They were a very good touchstone for me when I took on the task.
If ever there was emotion between scientists, clinicians, social scientists, theologians and patient groups, it was then. The fact that it has now become a relatively quiet issue does not mean that it does not have the potential to become once again extremely noisy. It speaks for the hugely effective way in which the HFEA has gone about its work, and the confidence that it has built not only in the United Kingdom among all parties but, as has rightly been said, around the world. If clinicians are irritated by the HFEA from time to time, that makes me even more convinced that there must be something good about it, because there is a distinction between the mind of the scientist and pioneering doctor, and the ethical balance of those calling for slightly more caution, control and constraint. When the area is that of the creation of life outside the body, it is a moral issue: we should never forget that.
The Minister, who is sympathetic, thoughtful and kind, and who listens endlessly to requests from Members of this House, has already been extremely accommodating. He has agreed to coherence and transparency; he has agreed that he will not rewrite the ethical standards; and he has agreed that most of the functions should be kept together. Nevertheless, the Care Quality Commission has a huge agenda of work, as was rightly said by the noble Lord, and most of its activities are of a different nature from those of the Human Fertilisation and Embryology Authority, so can the Minister give us further assurances and find a way to meet the objectives of the noble Baroness's amendments?
Amendment 9, which is about the establishment of the health research regulatory agency, is even more important to me because it seems to be a prerequisite for the changes taking place. Of course we all believe in what we have now learnt to call a bonfire of the quangocracies. The easiest thing for any junior Minister to do is to make their name by setting up a quango; it is much harder to make your name by shutting down a few quangos, and we know it needs to happen. However, like other noble Lords, I urge the Minister to think very carefully before he puts the HFEA and the HTA at the top of his list.
My Lords, I shall speak to all three amendments in this group. I declare my interest as chair of the Human Tissue Authority, whose work is so much affected by this Bill. At the start of the passage of the Bill, there was much confusion over its purpose and the future direction of travel for many of those arm's-length bodies listed in it. Much progress has been made during the passage of the Bill. The Government have given due attention to concerns raised, thought through the potential outcomes and clarified many issues for all of us. I want to thank the Minister, the noble Earl, Lord Howe, for the attention he has paid to our specific areas of interest: the HFEA and the HTA. I particularly welcome his statement in the letter he sent to my noble friend Lady Thornton in which he recognised the need for our preferred option, which is to keep the functions of the HFEA and the HTA together, and gave a commitment to discuss directly with the HTA any potential movement of our research-related functions to another organisation.
I believe we are nearly there, but I feel that these amendments are necessary and will act as a safety framework for the Bill as it enters the other place and then goes onwards for external consultation. We are seeking a set of reassurances and safeguards from the Minister to ensure that the hard work everybody has done to shape this Bill will not be lost further down the road.
The noble Baroness, Lady Deech, and the noble Lord, Lord Walton of Detchant, have already set out the main arguments in favour of the amendments. I support them and shall not reiterate them. The amendments suggest measures by which the Government could assess the cost-effectiveness of the proposed moves, and I urge the Minister to consider utilising them. In his letter to my noble friend Lady Thornton, the Minister addresses the need for an impact assessment, but he proposes only a partial assessment. I believe that a full and thorough assessment is needed in order to give a true picture of cost-effectiveness. We are all looking for ways in which to reduce costs and bureaucracy and therefore see an increase in cost-effectiveness as the gold standard we should aim for in the public services we provide. If a saving is made in one area only to increase costs in another, that would be unacceptable. It is for this reason that I urge the Government to conduct a full impact assessment, not a partial one.
The HTA is already recognised as an efficient regulator with a clear focus on improving value for money. We are a lean organisation costing only £1 million in government grant in aid and we will reduce that by 14 per cent in cash terms this year. We have reduced our licence fees across all sectors this year, including a 30 per cent reduction in the research sector. I have already raised and evidenced my concerns that any proposals to transfer the HTA's research functions would not achieve either simplification or financial savings. Indeed, we estimate that it would impose additional regulatory and financial burdens on around 200 establishments across various sectors. So I suspect it will not surprise your Lordships to know that I am concerned to ensure that cost-effectiveness is real and not just perceived as an outcome of this assessment.
I now turn to the amendment that deals with setting up the new independent health research agency. As I mentioned, I seek reassurance from the Minister in a set of safeguards. The Government have set out a draft transfer timetable, and have made clear their intention to cause the least amount of disruption to all involved by enacting all transfers of the HTA and HFEA functions at the same time. None of this can happen until the health research agency has a legal basis in its own right and it has been decided whether any HTA functions should transfer to it. Will the Minister therefore outline a more specific timetable for its establishment, and reaffirm his commitment to hold off transfers until then?
In addition, the amendment would require that a separate ethics committee be established within the new agency to undertake the ethical considerations of any functions that are transferred. This would be paramount in ensuring that we do not lose public and professional confidence through this period of change and that we continue to ensure that tissues and organs are used safely and ethically and with proper consent. Finally, therefore, is the Minister minded to establish such a committee and so accept this amendment in full?
My Lords, I support both this amendment and the two related amendments that follow it. They would guarantee in one way or another that the enormously valuable work of precisely the present ethics committee of the two bodies is continued. I speak in general, so far as a Bishop can ever speak, for the Christian churches and for other faith communities for whom the human embryo and human tissue have moral significance. That is not to say that the present ethics committee is in the pocket, so to speak, of the Bishops or of any faith community leaders. It is not, and the range of views and commitments of its members is and should be wide. However, it would be a serious mistake not to have an ethics committee or expert body specifically to weigh the moral as well as the medico-scientific questions that are involved in this very proper research, not least into the tragedy of infertility.
Also of great significance for me is the serious support of the relevant professional bodies, so I urge the Government to consider these amendments very favourably.
My Lords, I declare an interest because my wife is a pathologist who works in the National Health Service. She does no forensic work. Nevertheless, I declare that interest appropriately.
A number of noble Lords have mentioned the importance of the role of the House of Lords in considering such difficult and complex matters. We had plenty of evidence of that even before the Bill came to your Lordships' House, at least in debate on these two issues. Indeed, we had a very fruitful debate on
I listened very carefully to what the noble Baroness, Lady Deech, said, and I do not disagree with any of it. She put forward her case clearly, but she focused in particular on the HFEA. A whole set of very important issues are involved there, and I hope that my noble friend the Minister may be able to give some kind of comfort to her and her colleagues, because I have a lot of sympathy for her case, as I do for much of what the noble Lord, Lord Walton, said. However, one of the difficulties has been that although there is clearly a need for legislation and for a body that undertakes these matters-the operation of the HTA in Scotland has been rather better than it has in England-it is important to draw to the attention of your Lordships' House that the impact of the way in which the legislation has been interpreted and conducted by the HTA has not inspired confidence, particularly among pathologists. I heard what my noble friend said about that proving what a good thing it is, but that does not show a very nuanced understanding of what is going on.
One of the problems, which the noble Lord, Lord Walton, and other medical noble Lords will know very well, concerns the final diagnostic tool, the post-mortem. We all have our thoughts about diagnosis from a clinical point of view but in the end you will get a definitive answer from the pathologist after a full post-mortem and all the investigations. When I was training, the Government's ambition was that 10 per cent of all non-forensic cases would have post-mortems conducted. Why? It was in order that there would be a proper audit of clinical diagnosis. Is that the case? On the contrary, it has gone completely in the opposite direction. There are whole departments now where month after month scarcely a post-mortem takes place. We are now coming to the point where many members of the Royal College of Pathologists feel completely deskilled in the process of conducting post-mortems because there has been a feeling of a hostile environment in the conduct of post-mortems. We have to recognise this.
I shall quote from a letter written in February by the president of the Royal College of Pathologists to the right honourable Andy Burnham, the Minister. It is an eight-page letter from which noble Lords will be relieved to know I will quote only a short amount. The letter states:
"The Royal College of Pathologists does not contest the need for legislation on the uses of human tissues that led to the Human Tissue Act 2004-though we do continue to protest, with others, that aspects of that legislation are not working as intended and that the parallel Scottish legislation is much more sensible. Nor do we deny the need for a regulatory body such as the Human Tissue Authority. But it seems obvious that the HTA and the profession need to work together with mutual respect, and that at present neither group is displaying that respect. The recent actions of the HTA have considerably exacerbated an existing problem. Since the events"- he refers to earlier events to which he has referred in the letter-
"pathologists will inevitably perceive the Human Tissue Authority as an aggressive regulator, all too ready to wield the force of the criminal law even when, it transpires, a crime has not been committed"- thus wielding the law against medical practitioners. The letter continues:
"Changes in the attitudes of pathologists cannot be expected to occur without very visible and major changes in the Human Tissue Authority".
The letter goes on to list a page of suggested changes.
That is not to say that there should not be some kind of authority or legislation. But it is important to put on record in your Lordships' House that everything had not been going smoothly and suddenly the Government have come in to knock over something that was working perfectly well. As I say, I exclude the HFEA from that discussion. That is not the issue for me.
Having said all that, and giving that as a backdrop to my sense that it would be easier if the HTA and HFEA were not in the same amendments because they involve different issues, I have considerable sympathy with the intentions behind these amendments. They are thoughtful and are an attempt not to knock the whole applecart over. They try to ensure that the transitional arrangements, and where we come to at the end of the journey, are building and capitalising on all the very good things that have happened and that none of that is lost. In that regard, I hope my noble friend may have some comfort for those who have put their names to these amendments and that they will find some satisfaction.
My Lords, I wonder whether I might start by expressing my warm thanks to my noble friend Lady Bottomley for intervening in this debate. I had been dithering about whether to do so because for reasons I cannot understand my Front Bench regard me as a bit of a troublemaker on this Bill. Since no one could possibly accuse my noble friend Lady Bottomley of being a troublemaker, she has leant me a cloak of respectability, which I now put on. I agree very much with what she said. I should perhaps declare an historic interest as chair of a hospital trust that did transplants at the time that the Alder Hey events came to light and was, therefore, much interested in the introduction and passage, and the subsequent success, of the Human Tissue Act. So I have some longstanding interest in this.
But even without that, there is a concern that what we may be doing here is upsetting arrangements that appear to have worked pretty well without being at all clear about what we are going to put in their place. My noble friend also referred to her concern, as I have done on an earlier occasion, about whether the Care Quality Commission, which already has more on its plate than it can deal with, can take on any more until it has settled down to what it is seeking to do at the moment. Given the eloquence of the speeches made, particularly those of the noble Baronesses, Lady Deech and Lady Warwick, the noble Lord, Lord Walton, and others, I hope that my noble friend the Minister will give these amendments very careful consideration indeed.
I hope your Lordships will not think that I am indulging myself if I take this opportunity to express my gratitude for the kind words said at the last knockings of the Report stage about my absence at the time through ill health. My particular thanks go to the noble Lords, Lord Pannick and Lord Whitty, for picking up a couple of my amendments, even though they did not get what I would regard as perfect answers. I am also grateful for the very warm words of the shadow Leader of the House, the noble Baroness, Lady Royall, who I am sorry not to see in her place. She was kinder about me that I ever thought I would deserve, and as a result probably caused more upset on these Benches. It would be tempting as a counterpoint to say that my noble friend Lord Taylor of Holbeach saw me here last week and his first words were, "Should you really be here? Wouldn't you be better off at home?". But that would be very unfair because he has been genuine solicitous of my welfare and has actually offered to release me from slavery even when he thinks I would not cause trouble. I am very grateful to him.
I have already indicated to my noble friend Lord Howe that I have some sympathy with these amendments and that I shall listen carefully to what he says if he does not want to accept them. I want simply to tell him that what he says will have to be good.
I rise to speak specifically in support of Amendment 9, to which I have added my name. However, I want first to record my thanks to the noble Earl, Lord Howe, on the Front Bench for the very courteous way in which he has tried to respond to these issues throughout the passage of the Bill. The reality is that we should not be at this particular juncture now. If we had had proper consultation before these proposals came to light, we would have been able to argue the issues out sensibly and carefully. I recall the way the last Government treated the draft tissue and embryo Bill. They created a committee of both Houses that looked carefully at the issues and prepared a report. It was accepted by them and actually changed the legislation that was going through the House. With hindsight, we can always do things differently, as we learnt last Thursday.
I think that Amendment 9 is crucial. The Academy of Medical Sciences made a proposal to create a health research agency that was not just supported by the medical and research professions, but by all the political aspects of all the parties in both Houses of Parliament. It is rare for that to occur. I have argued with the Minister that the real crux of this Bill is not knowing what you are actually going to move to. I think that the concerns about the CQC are a little unfair. The reality of the situation is that the CQC already regulates and inspects a significant number of premises and establishments that deal with the use of embryos, embryo research and the clinical application of techniques using embryos. There is already significant duplication, so to argue that a new body would either increase or decrease duplication would depend on how you finally decide which functions will go to which organisation.
Health research is also crucial. The report of the noble Baroness, Lady Warnock, has rightly been mentioned often today. She established firmly back in the 1980s the fundamental issue of the special nature of the embryo, particularly when dealing with research. The noble Baroness, Lady Deech, is absolutely right that the founding of the HFEA has enabled research using the embryo, particularly when we started to look at stem cells and admixed hybrid embryos, to go through. That is because there has been a regulatory authority for which there has been public as well as clinical and academic support. We throw that away at our peril.
I put it to the Minister in Committee that we could not move to an interim authority for health regulatory research and believe that we could maintain continuity and credibility within the research communities both here and abroad. Unless we establish the health research agency, we will lose ground. It is too important an area for us simply to say, "Well, we'll wait and see'. In his incredibly helpful letter to the noble Baroness, Lady Thornton, the Minister referred to setting up an interim authority. However, in Committee, I proposed to my noble friend that a new clause be inserted in the Health and Social Care Bill to set up the paving legislation for the new regulatory research agency. My noble friend makes it clear in his letter to the noble Baroness that that Bill is now on hold for a while for a variety of reasons. Surely this is an excellent opportunity for the draftsmen to put into that Bill a clause which enables the agency to be set up. At one fell swoop, an early place in the legislative timetable-literally within the next six months could be given to an agency that all of us agree needs to be in place. Amendment 9 offers the Minister the opportunity to respond positively today and we could go ahead with those proposals.
The second part of Amendment 9 deals with the incredibly important business of an ethics committee. Many people who are not involved in the ethical consideration of these issues believe that this is somehow a sop or an add-on. It is not; it is fundamental to maintaining confidence in the research frameworks and the regulatory authorities. I hope that when my noble friend the Minister responds to the amendment he will give us clear direction on how the new agency will have an ethics organisation which meets the aspirations not only of this House but of the research and clinical communities.
One of the greatest ethical issues involved in this treatment is its lack of accessibility. It is a highly privileged treatment, because it is mostly in the private sector. It is true that the NHS provides some, but many health authorities have based their fees to some extent on the private sector. Therefore, the hard-pressed PCTs have not been able to offer as many treatments as many people recommend.
When I left practice running a large IVF clinic some five or six years ago, we were charging very much less than is currently charged by clinics. We were still able to turn more than £1 million a year over to research and provide the Hammersmith Hospital with a great deal of surplus income, which was then used to treat other patients.
One of the key issues with which the HFEA has not dealt is the high cost of IVF treatment. In my view, it is a scandal. There are clinics that treat patients for around £3,400 a cycle. It is only when you look at their websites that you see that they are charging up to £1,100 to £3,200 for drugs that should be obtained on contracts at around £500 to £700 per cycle. Embryo freezing will be increasingly required if we are to limit the number of pregnancies that result in multiple births by transferring just one embryo each time. One clinic in London charges £915 for embryo freezing. That is for a mechanised treatment that is extremely easy to do in the laboratory. If that were not enough, the storage fees are £325 a year. Given that liquid nitrogen, which is what the embryos are stored in, costs a few pence a litre, that seems somewhat excessive, even allowing for the costs of regulation. I am afraid that the HFEA has shown itself to be completely unable to deal with this issue at all. This privileged treatment is a shocking issue.
Secondly, one thing that the HFEA claims to be doing is giving accurate information to patients. This morning, I trawled a few IVF clinic websites. A prominent clinic in London-which I can name but will not-argues on the front page of its website a 69 per cent IVF success rate. That figure is repeated twice on the website. It is only when you delve into the small print that you realise that it is nowhere near that. That is the cumulative success rate over several cycles of treatment. Another clinic argues that it has a 30 per cent success rate in women over 40 or 42. That is a biological impossibility given that the implantation rate alone of a patient under 40 is something around 18 per cent per embryo-at best 25 per cent. What the site does not say is that this is for pregnancy but not delivery of a live baby. It does not take into account the vast number of miscarriages that presumably these patients are going through. This kind of misinformation occurs again and again.
The Bridge fertility clinic offers a 71 per cent pregnancy rate per blastocyst treatment and 67 per cent success rate for pre-implantation genetic diagnosis. As someone who has been intimately involved with pregenetic screening of this kind, I find those figures, frankly, quite incredible. Perhaps they depend on very few patients being treated and a good deal of luck. But that is highly misleading. These treatments have not been validated by the HFEA. Presumably, that is why it has allowed advertising to continue.
Then we come to the ways of promoting treatments that are not acceptable in this country. There are several clinics in London alone that offer their services in, for example, Mauritius-that is one of the Harley Street clinics-the USA, India and Spain. There they can display all sorts of unvalidated success rates on their websites and in addition can offer treatments that are not acceptable in the United Kingdom, such as multiple embryo transfer. Why has the HFEA not withdrawn the licences of those clinics? Why has it not argued that this is dishonest and dangerous?
Then, of course, we have the question of the database, which has been referred to already. The database ought to be very valuable but, sadly, in practice it is useless because we cannot follow up patients in the long term. That is a very serious issue. As the Minister knows, epigenetic issues-early experiences in development from fertilisation onwards-may have a profound effect on our health when we become adults. IVF in this country is not followed up in this way, so we have no way of knowing whether some of the treatments or exposures of the human embryo may be more likely to cause damage at a later date.
Then we have the question of another issue, which the HFEA seems to have been totally powerless to deal with. That is the issue of treatments without any evidence base that they work. Let us take the example of immune therapy, which is charged at anything from £1,000 to £3,000 a time, in addition to the already high fees of IVF. Where is the evidence that immune therapy actually improves the success rate of pregnancies? I do not know of that evidence-and, indeed, the treatment may even be damaging or harmful to the patient's residual immune system.
Then we have preimplantation genetic testing, which is testing of embryos genetically when IVF has previously failed. I accept that preimplantation genetic diagnosis works, as the noble Lord, Lord Walton, has said, and it is a valuable technique in a few patients. However, there is actually no evidence base showing that preimplantation genetic testing in people who do not have a genetic defect, as widely used by many clinics, provides a helpful and improved chance of a pregnancy afterwards. The control trials and the control evidence are not there, and this treatment-if it is done at all-should be done on a research basis. However, the HFEA has failed to licence it on that basis. The same applies to the treatment of assisted hatching. These are not small treatments; preimplantation genetic testing is charged in one clinic at £2,690 in addition to the £3,000 or so charged for the IVF and the £800 to £1,000 for the drugs that the patient pays for. At this stage, patients who are desperate will do anything to ignore the avarice of the people who might be treating them. This is a massive issue, as it is with another treatment, widely offered, of assisted hatching, in which a little piece of damage is done to the zona pellucida around the embryo or egg in the hope that it might improve the pregnancy rate. Over many years it has not been shown to be really effective, but it is still widely sold without any proper regulation.
We have heard from a number of speakers in this debate that the HFEA is the envy of the world. If it is the envy of the world, why has no other jurisdiction accepted this method of regulation? It is not used in Singapore, the USA, France, Israel or Australia, the countries that are most successful at reproductive treatments. I am not suggesting for a moment that we should not have a proper culture of regulation or a proper ethical standard in how we deliver medicine, but the current workings of the Act of Parliament are now not suitable for the original purpose. We have outgrown it. With the burgeoning private practice that has occurred with this treatment as a result of the failure to fund it in the health service, we have an increasing problem, which is very far-reaching.
It is true that there are virtually no good academic units in the United Kingdom that really produce cutting-edge research in the field of reproductive biology where it applies to humans. That was not true 30 or 40 years ago, when we led the world, in places like Cambridge, London, Edinburgh and many other centres in Scotland. Now we cannot find people to appoint to chairs in reproductive medicine. The chair at Hammersmith was left vacant for three years after my retirement, and eventually they decided not to seek anyone to fill it, because they could not find somebody who was a suitable academic because people are being attracted to the highly lucrative business that IVF provides. In my view, this is a very serious problem.
One of the most respected academics in this field is Professor Alison Murdoch, in Newcastle, who has pointed out something really quite interesting. I take her view very seriously as I believe that hers is an example of a really well-run, ethical practice. She points out that regulation of in vitro fertilisation is now far greater than regulation of, for example, abortion. That does not seem to make sense. I listened very carefully to the right reverend prelate the Bishop of Guildford. However, does he really believe that the protection of the embryo is more important than the protection of the foetus or the protection of research on the newborn child, the patient who is pregnant or the elderly patient who may be about to die from various diseases? Surely the notion of centralising our research under one body makes good sense, because we can then have a rational basis for important ethical decisions. I shall listen with great intent to how the Minister responds to this debate. However, I am not convinced that even if we vote for this amendment, it would be a good idea to vote for the preservation of the HFEA as it stands.
My Lords, I shall be brief as we have been debating this for a long time. I spoke to this issue in Committee and, apart from the noble Lord, Lord Winston, and the noble and learned Lord, Lord Mackay of Clashfern, who is not in his seat, I was the only one to argue against preserving the HFEA's current status and role, particularly on the clinical side.
I start by agreeing with the noble Lord, Lord Willis of Knaresborough, about the medical research authority. I totally agree with him that the Academy of Medical Sciences report has been widely accepted and backs the establishment of such an authority. It will also have an ethics committee because, according to the report, it will take over the national ethics service, which is currently run separately. It will therefore have an ethical body to assess the ethical issues related to all medical research. There cannot be any doubt about that. Last time, the noble and learned Lord, Lord Mackay of Clashfern, asked-and I have his permission to repeat the question-whether, in the interim, the Minister will find a way of establishing such an authority before the legislation is put in place.
I turn to the HFEA and its other role. Yes, it is true that we should all feel a glow when we mention the HFEA. When it was established, soon after the birth of Louise Brown, a voluntary licensing authority established by the Royal College of Obstetricians and Gynaecologists and the Medical Research Council had been operating for two years. Its creation gave both clinicians and the public the confidence that the newspaper headlines of the time-that monsters would be created in Petri dishes-would not be realised. It is true that in its formative years the HFEA did a fantastic and useful job in establishing and licensing premises for delivering good care to those requiring IVF treatment. Yet the world has moved on. More than 1 million children the world over have been born following IVF treatment.
There is no reason to think that the clinical care provided for patients requiring infertility treatment, including IVF, is any different, or should be any different, from the care provided for children with cardiac anomalies. Both treatments are properly regulated by the CQC and the professional organisations. We hear of units being shut down because of poor outcomes; so let us consider the recent performance of the HFEA. How should we measure it? We should measure it against the success rate for IVF. As the noble Lord, Lord Winston, mentioned, apart from spurious claims there is no evidence that our outcome for patients requiring IVF treatment is any better than anywhere else in the world; in fact, it is poorer than in some other countries. Measured against promoting better outcomes for the patients, the HFEA has not delivered.
I agree with the noble Baroness, Lady Bottomley, that clinicians would complain if threatened, but these clinicians are not complaining because they are threatened-they are complaining because they think that they could do better if they were not so harshly regulated by an authority that looks at more and more ways of regulating. It has become a legend in its own mind. It makes the delivery of clinical care more difficult and, therefore, the outcome for patients poorer.
The noble Lord, Lord Winston, was right to mention the promotion of research. One of the objectives in setting up the authority was to promote research to improve the outcomes of patients with infertility. In fact, it blocked the use of valuable data. The noble Lord mentioned the example of using epigenetic factors-environmental, dietary and other factors-that would affect the health of the babies born. There has been an ideal opportunity to do so over the past 20 years, but we failed to.
Let us be quite clear: the glow that we feel about the HFEA may be slightly tarnished. We have to ask which of the functions we need to retain. I seek an assurance from the Minister that the medical research authority will be set up soon, and that it will take over all the research functions of the HFEA. Let us have a debate about whether the HFEA delivers now when it comes to improving care and outcomes for the patients. That, I think, is when we will find that it is currently found wanting.
My Lords, I thank the noble Baroness, Lady Deech, my noble friend Lady Warwick and other noble Lords for their determination to have the future work of the HFEA and the HTA clarified during the course of the Bill. I join others in thanking the Minister for his patience and accessibility in discussing the different aspects of the issue.
We have had another excellent debate that has illustrated why it was necessary to bring the issue back to the Floor of the House for further discussion. The House needs to heed the voices raised across the House-as well as the pleas contained in the letters that we have received from some of the parents of Alder Hey children, the letter in the Times this morning signed by a galaxy of medical experts and the briefing from the BMA on behalf of several organisations-as a sign of increasing concern.
Since Report, the Minister has kindly written to me explaining further the Government's proposals for the HFEA and the HTA and the staged break-up that seems to be the Government's preferred option at the moment. In brief, the break-up involves HFEA and HTA functions being transferred to the CQC except for research-related functions, which will be transferred to the health research regulatory agency, presumably covering what have been broadly referred to as the ethical issues. To facilitate this, as the noble Baroness, Lady Deech, explained, a special health authority will be created in 2011-12 and there will be primary legislation to establish the agency proper in the second Session of this Parliament. Presumably, the ethical issues will therefore be dealt with by the interim body in that process. Notwithstanding the proposals of the noble Lord, Lord Willis, regarding the Health and Social Care Bill when-indeed, if-it reaches us, it is clear that there will be primary legislation to establish the new research body.
I am further grateful to the Minister for his explanatory letter because it served to strengthen my view that these bodies should never have been in the Bill in the first place. It also illustrated for me the question that I want to put to him: why go through such disruption, risk, lack of stability, potential loss of expertise and expense for the next two years prior to the introduction of primary legislation to establish the new health research agency, which will address all of these issues? Why not agree the amendment that establishes an independent assessment of the work of both bodies? That could feed into the pre-legislative process and consultation, which will include all the questions that need to be asked, leading to primary legislation in about two years' time. If the Government go down the route that the Minister is proposing, they intend to launch a consultation this summer, as outlined in the Minister's letter to me, and then presumably will break up the agencies at some point towards the end of this year and the beginning of next. That means that at the beginning of 2012 the agencies would be broken up and then, by the end of 2012, we would start the pre-legislative programme to set up the new research agency.
That is why we on these Benches will be supporting all these amendments. It is not that either the HTA or the HFEA should be preserved for ever; indeed, it is clear that my noble friend Lord Winston and the noble Lord, Lord Patel, have grave problems with the HFEA. I make the point to the noble Lords, which I have also done outside the Chamber, that that is not the point of the Bill. Passing the amendments would actually be more likely to address their concerns than would leaving the situation as it is. In other words, there is no guarantee that their concerns about the HFEA, which I am sure are legitimate, would be addressed if we left the Bill as it is without the reassurances.
The one thing that we know is that there is going to be a health research agency. It is an idea of merit. It is also a proposal that is ideally suited to the expertise and inclination of this House; the Select Committee, the pre-legislative scrutiny, the draft Bill and, if I may say, the skills that the Minister brought to bear when he helped to create both these agencies make this the place where that process should start. I am certain that that would ensure a good outcome.
The amendments are different from the simple deletion amendments that we tabled in Committee and on Report, particularly the third amendment, because it accepts the principle that the Minister may transfer or modify the functions under Clause 5 in respect of these bodies but would require the Minister to have first established the Government's new regulatory body with a separate ethics committee. It would ensure that there were no gaps between what is happening now with the current bodies and the Government's intended independent regulatory body in future, a point that many noble Lords have made. However, it would not preclude an examination and independent assessment of the work of both these bodies. It would ensure that the critically important ethical functions performed by these bodies were recognised and catered for, which, in a way, is where we came in at the first stage of the Bill.
My Lords, I thank noble Lords who have moved or spoken to these amendments. I recognise and understand the sentiments underlying them. I do not in the least wish to argue against or downplay the importance of cost effectiveness in any legislative changes that we propose, or of ensuring that the right successor arrangements are in place for discharging the relevant functions of the HFEA and HTA. I therefore hope that what I am about to say will satisfy noble Lords that in most key respects I am in the same place as they are regarding the points at issue.
Since our debate on Report I have written to the noble Baroness, Lady Thornton, to set out my reflections on the points that she and others have made. There were common themes: a desire for greater clarity on where the Government intend to transfer the functions of the HFEA and HTA to; concern that the dispersal of functions across a range of bodies would risk fragmenting regulation; and concern over loss of expertise. I have considered these concerns carefully. As I have made clear, we intend to consult in the late summer on the options as to where certain functions would be most appropriately transferred. That remains our aim. However, having taken into account the strength of feeling about keeping functions together, we now intend to proceed on the basis that our preferred option is for all HFEA and HTA functions to be transferred to the Care Quality Commission, except for certain research-related functions that will transfer to the proposed health research regulatory agency. We shall therefore consult on this basis but, at the same time, remain open to receiving views on the way forward from all stakeholders through the consultation process. I hope noble Lords will agree that this preferred option will address concerns about the potential impact of fragmentation.
The noble Baroness, Lady Deech, expressed the fear that the Government's proposals would lead to a vacuum as regards the ethical focus of these bodies-in the decision-making process for research and treatment involving embryos in particular. Let me explain what we intend. Ethical safeguards-for example, the type of embryo and gamete that can be used in treatment, the need to consider the welfare of the child, and the need for consent in respect of human tissue-are clearly enshrined in legislation in accordance with the wishes of Parliament. These safeguards will remain firmly in place.
In keeping an integrated approach to HFEA functions, the CQC would be the focal point for ethical considerations of treatment licensing that arise from the Human Fertilisation and Embryology Act. There is no reason whatever to suppose that it is not up to fulfilling that role. I say to my noble friend Lord Newton that my department's officials have had discussions with the CQC senior managers about the proposed transfer of functions. The CQC is confident that these can be taken on effectively. The health research agency will provide a focal point for the ethical consideration of research using embryos. It will draw on expert advice, as the HFEA does now. The aim is to simplify and rationalise the ethical approvals process for all kinds of research. Far from the ethical focus for each type of activity being lost, it will be actively preserved.
My noble friend Lord Willis suggested that we might use the Health and Social Care Bill, now in another place, as the vehicle for the proposed changes, rather than this Bill. I recognise the force of his proposal. He will know why we have chosen not to go down that road. We do not want to add to what is already a substantial Bill. It is important, too, that the Government retain momentum for their planned changes across the ALB sector. The ALB review process has already garnered significant rationalisation across the health sector and we do not want that rolled back. By keeping the HTA and the HFEA within the Public Bodies Bill, we can deal discretely with complex issues and undertake detailed consultation and impact assessments in a timely and considered way. We also, as I have indicated on several earlier occasions, wish to avoid reopening the Human Tissue Act and the Human Fertilisation and Embryology Act, which command widespread agreement. Our desire to maintain momentum is why we plan to establish a special health authority to continue and strengthen the work of the National Research Ethics Service and to be a starting point for the simplification of research approval processes. That special health authority would be the platform on which we would build the fully fledged research regulator.
Does the Minister not understand the incredulity of many of us? This is a Bill that deals with getting rid of quangos, yet the Minister's solution is to set up a quango to create time in order to set up a bona fide agency. Surely the Minister sees that by simply delaying the whole process until the agency is in place, everything can be transferred either to the CQC or to the new agency, all at once, without an interim body.
I ask my noble friend to wait a few minutes; I hope I will tell him something that he will welcome.
I turn to the amendments. On Amendments 7 and 8 the issue is not so much the end point that they seek to achieve as the practical implications that they would carry if they were accepted. Let me set out what we plan to do. There will be a full public consultation on our proposals this summer. Alongside that, we will publish an impact assessment, which will include a view about the cost-effectiveness of options for transferring functions. I assure the House that the key comparison for the purposes of the assessment will be between our preferred option and the organisations' own plans for rationalisation. I hope noble Lords will endorse the idea of a formal impact assessment as the vehicle for doing this. It is a process that, until now, has been accepted by Parliament for general legislative and policy changes. There does not seem to be any obvious reason why that should not be an appropriate way to proceed in this case.
In addition, as I have said previously, there will be a further consultation on the proposed regulations in due course before these are laid. Taken together, these three safeguards should be sufficient to meet the aspirations of noble Lords for achieving a robust evaluation. The approach that we propose on consultation and impact assessment will, I suggest, produce a result that is thorough, transparent, balanced and, therefore, fit for purpose. The amendments, taken literally, would have us go further by suggesting a formal process of independent assessment of cost-effectiveness. This would be neither necessary nor desirable. With the best will in the world, any such assessment would be costly to the public purse, highly subjective-as any assessment of cost-effectiveness is bound to be-and very difficult to measure definitively. Practically, it would get us no further forward than a standard impact assessment. In any issue of this kind, we need to take care that legislation does not set conditions that are impossible to meet. That is why I hope the assurances that I have given will be enough to persuade the noble Baroness not to press these amendments.
In turning to Amendment 9, I will address the question posed by my noble friend Lord Willis. The amendment seeks to ensure that no HFEA or HTA functions would be transferred using the powers in this Bill until the health research regulatory agency has been established. I fully appreciate the reasoning behind this. It very much accords with the Government's wish to avoid a piecemeal approach to the transfer of functions. In my letter of
"in principle our preference would be to consult on the draft secondary legislation during 2012 and to commence it after the primary legislation is place that will give the health research regulatory agency the necessary legal basis. In that way, transfer could take place as a single and clear exercise, and in a co-ordinated and least disruptive way".
In the light of this amendment and the points made today in support of it, I am prepared to go further and give a firm commitment that, subject to the will and views of Parliament, the Government will proceed on the basis of transferring functions from the HFEA and HTA only once the research regulatory agency is established in legislation. I hope that this commitment will satisfy the House. There are problems with including the amendment in the Bill from a legal perspective. It is difficult to envisage how, within this Bill, we could describe with the necessary level of legal certainty the new research body that would need to be established. The detail of what a new regulator will look like and the functions it should hold is a matter for Parliament to debate and determine as and when the relevant legislation comes before it. To make provision for a future body in this Bill risks both describing it in a way that is not accurate, thus making the power to transfer functions redundant, and attempting to limit the discretion of Parliament in relation to future legislation.
The amendment also seeks to provide in this Bill that the research agency,
"must have a separate ethics committee to undertake ... ethical consideration functions" transferred to it from the HFEA and HTA. I fully appreciate the need for assurance that the research regulatory agency will have access to the relevant expertise to deal with the licensing of embryo research and any research-related functions that may transfer to it from the HTA. Therefore, I repeat the assurance that we have consistently given that expertise will follow function, and that we expect that the research agency will have access to expert peer reviewers and others in the relevant fields that are currently available to the HFEA and HTA. However, I suggest that the level of detail on matters such as expert committees is again more appropriate for consideration by Parliament in relation to any legislation that will seek to establish the research regulatory agency rather than attempting to include it prematurely in this Bill.
Although, for the reasons I have given, I cannot accept the amendment, as I indicated at the beginning of my remarks, I would like to believe that noble Lords who have spoken will not now be too far removed from the Government's own position on these matters. In view of our developed approach to the transfer of functions and our clear intention to consult on our proposals in an open and transparent way, I hope that the noble Baroness will feel able to withdraw the amendment.
I thank the Minister and all noble Lords who have spoken. However, I particularly thank the Minister who has, as others have said, been very attentive throughout the passage of the Bill to the concerns of those involved in this field. I know that he has the best interests of the HFEA, the HTA, and all the people involved in them, at heart. When the Minister says that he gives a firm commitment, the whole House believes him and relies on his word.
The noble Lords, Lord Alderdice and Lord Winston, pointed to problems: in one case in the HTA; in the other in the HFEA. However, those points, and the points made by the noble Lord, Lord Patel, are irrelevant as, whatever problems there are with the HFEA and the HTA will not be solved by moving them lock, stock and barrel to another agency, because, as we all know, the human fertilisation and embryology Acts will remain. I say to the noble Lord, Lord Winston, that there is nothing that the agencies can do about costs. They are not able to fix costs. We all wish that the NHS would take on IVF; that would provide a solution to all our problems. However, no one can seriously imagine that if regulation were transferred to another government department, charges would somehow mysteriously come down, the patients would be charged less and nobody would make a profit. Indeed, the stories that the noble Lord, Lord Winston, shared with the House show precisely why regulation is necessary. If the doctors are all competing and jostling for pole position, this again confirms the need for regulation by a body other than a purely medical one.
It is also the case that the law is involved. I am sorry to say this about my fellow lawyers, but there are many things that the HFEA and the HTA cannot do, or cannot do more vigorously, because of the way in which the Human Rights Act came in on top of the existing human fertilisation law and shifted it much more towards the individual, the requirements of the Competition Commission and the requirements of the Data Protection Act, which make it very hard to carry out the research that we wish could be undertaken. If ever there was a case for calling for an external independent review, which is what at least one of these amendments calls for, the noble Lord, Lord Winston, has made the case because all those points can be looked at by an external impartial review, which is what we are calling for.
Although there is no time to go into this, other countries do have regulation such as is carried out here. Israel has a system for considering cases on a one-by-one basis. Canada is emulating us. Surely we do not want to be like the USA where recently a woman gave birth to octuplets. Noble Lords who have a spare moment can go online and look up Cryobank and see sperm for sale. Usually the students involved are called Randy and have a PhD from Berkeley or Stanford and sell their sperm online. We do not want to go down the unregulated route followed by the USA. I know from my involvement with the HFEA that we were bombarded all the time with concerns from the public. Many noble Lords will recall that when the HFE Act was revised in 2008, members of the public lined the streets across the road and waved banners that depicted their fear about hybrid embryos as they showed embryos that were half man and half horse because they did not understand the subject yet it meant an awful lot to them. Therefore, it is very important that regulation is put in place. I should not say that the issue was more important than abortion or neonatal care, but all these areas have their own special regulations and laws taking care of them, as this area should do. The points made by the noble Lords, Lord Alderdice, Lord Winston and Lord Patel, perfectly make the case for an independent review.
The noble Earl, Lord Howe, to whom I am extremely grateful, seems to have given a firm commitment that there will be only one transfer, if it ever happens, of the functions of the HTA and the HFEA-one jump straight into new bodies that will have been firmly established by legislation. That is very satisfactory and I am grateful to those who have listened to that case. I know it is difficult, but they have listened and we should be appreciative of that.
That leaves just one area of disagreement-the nature of the review. I do not wish to sound sceptical, but government reviews and consultations often start from a particular point of view and present rather limited options, and in the end the Government may well do what they wish anyway. I believe that given the range of problems that have been revealed, not just when I was addressing your Lordships' House but by expert speakers on the Floor, there is a strong case for a wholesale review by an external learned body before the HFEA and the HTA take the irreversible move into the new bodies, when they are established.
Therefore, the points that lie behind certainly Amendments 7 and 8 have not been met and I wish to test the opinion of the House on Amendment 7.
My Lords, I beg to move that this Bill do now pass. In doing so, I crave the indulgence of the House to say a few words. Today is
I say a word of thanks to Members of this House for that role. In particular, I thank those on the opposition Front Bench for the constructive way in which we have been able to talk about the Bill from the beginning. They had firm ideas of what they wanted to happen to the Bill; we had ours; but the discussions were always friendly and open. I am very grateful to them. I am very grateful to all Peers who have attended our meetings: those from the Cross Benches, in particular, for their construction of ideas and resolution of some of the impasses which looked difficult to overcome; and to coalition Peers for their support and input. Right to the end, we have been discussing these matters, and the House has been divided on them, but there has been a real sense of partnership on the Bill. That has been particularly true of my Front Bench colleagues who have shared the passage of the Bill with me and have taken particular amendments. I have been reluctant to comment on individual involvement, but I feel that I should thank my noble friend Lady Rawlings, who is my Whip on the Bill and who has been with me more or less throughout its passage.
I conclude by thanking the Bill team, because they have had to work particularly hard not just within the Cabinet Office, which originated the Bill, but across all government departments, because every government department has been engaged in the Bill. I thank them for the way in which we have enjoyed working on the Bill together. They now go to see it through another place, and their job continues. I also mention the Bill team manager, as was, Louise Parry, who during the Easter Recess had a baby daughter. Cecilia is perhaps the most visible token of the Bill's passage through this House, and we are delighted for both of them. They are both very well and I thank Louise for her support to me and to her colleagues during the passage of the Bill.
My Lords, I must say that when we completed the passage of the Marine and Coastal Access Bill, which also took about six months, I never thought that I would be facing the noble Lord, Lord Taylor, on another Bill which took so long. I echo his comments: I think that the Bill is much changed; it has benefited from scrutiny in your Lordships' House. I am sure that the whole House would wish to thank the noble Lord, Lord Taylor, for his stewardship of the Bill. He has shown great skill and sensitivity to the issues that have been raised. All of us are grateful for the manner in which he has met us to discuss the issues, but his responses in your Lordships' Chamber have also been in a flavour of seeking a way through. We are very grateful to him.
There has been a cast of thousands on either side of the opposition and government Front Benches. I, too, very much thank my colleagues for their help. I echo the noble Lord's words of thanks to the Bill team. We are very grateful to them for the help that they have given us over the months. I, too, congratulate the Bill team manager on the birth of her daughter during Easter.
The Bill goes to the other place much enhanced. Because of the sunset clause, although the Bill will deal with a number of public bodies, when that is done, there will be a mechanism for looking at public bodies in future in a way that noble Lords find a very satisfactory outcome.
My Lords, before the Bill passes, perhaps I may add a caveat to some of the comments that have been made. I immediately recognise that the noble Lord, Lord Taylor, and the government Front Bench have made concessions on a number of aspects of the Bill, and people in the Forest of Dean and elsewhere will no doubt be very happy with what has happened. However, the noble Lord will not be surprised that my reservation concerns the fact that the uncertainties about the future of the Welsh television channel S4C have still not been resolved. There had been a hope of amendments being tabled at Third Reading. I understand the reasons why that was not allowed, although I recall the noble Lord, Lord Roberts of Llandudno, saying on
I do not want to go over old ground and I certainly accept that the Government have moved on a couple of points but, if the consultation with the National Assembly had taken place, it would have been very much more satisfactory from the outset. However, with the announcement today of a new chair for S4C-Huw Jones, whom we wish well-we would have hoped to see a line being drawn under many of these matters so that S4C could move forward with confidence. When the Bill goes to another place, three aspects will need to be resolved. The first is the constitutional position of S4C, the second is the safeguarding of S4C's funding and the third is its right to make managerial decisions without people from the BBC sitting in on them.
On Wednesday, a report on this matter will be published by a Select Committee of another place and it will contain remarkable cross-party agreement on the unsatisfactory nature of this Bill. Therefore, I very much hope that, when the Bill goes to another place, the aspects that have not been addressed in your Lordships' House will be addressed and we will have the same satisfaction regarding S4C as noble Lords have indicated they have with regard to other aspects of the Bill.
My Lords, before my noble friend makes what I know will be succinct and relevant remarks, as his remarks always are, perhaps I may remind the House of the guidance that Third Reading is not an opportunity for debate and that comments should be extremely brief.
I am tempted to sit down in view of that rebuke but I shall not do so. I only wanted to say, in a modest kind of way, that I know I have been a lot of trouble to my noble friends. I know that my noble friend Lord Taylor of Holbeach has been incredibly patient and understanding with me and I say to the Chief Whip that I really did not want to do anything more than be nice to him. Is that allowed? He has done a great job in helping us as a House to do our job, and he has produced the near-miracle-I speak in the presence of a number of ministerial colleagues-of bringing about a Bill that leaves the House shorter than it entered. Can anyone think of a government Bill that went anywhere and ended up shorter when it finished than when it began? That is a near-miracle. My noble friend has brought it limping into port with its superstructure destroyed and most of its cargo dumped, but at least he has got it there. He has contributed to the worst defeat of Henry VIII at the hands of the barons in 500 years, but unfortunately I do not think that it is yet the Waterloo. Henry is regrouping in Whitehall, hoping to find some mercenaries and commoners to come to his aid, and your Lordships may yet have more work to do. Meanwhile, my noble friend and many of his colleagues have done a fantastic job for us with patience, courtesy and understanding, as well as, I think, working behind the scenes to good effect, and I add my thanks to those of others.
Bill passed and sent to the Commons.