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I will also speak to Amendments 46, 53, 57, 58 and 59. Amendments 58 and 59 are in the name of my noble friend Lord Taylor. Amendments 46, 53 and 57 are in the names of my noble friends Lord Greaves and Lord Taylor, which gives some indication of where we are coming from on those issues.
I agree totally and utterly with the noble Baroness, Lady Quin, about the strength of support on her own Benches for the national parks and the Broads authorities. That is true of all Benches throughout this House, and I reiterate it on behalf of the Government.
We had a good debate on this matter in Committee on a similar group of amendments, and on that occasion I explained the Government's thinking in placing these bodies in Schedules 3, 5 and 6. I shall make things absolutely clear on the scope of Schedule 3 for the noble Lord, Lord Judd, who seemed to imply that the provision could be used in a slightly wider way, with matters from other clauses. We do not think that Schedule 3 could be used to go wider than it is set out, and I hope that I shall be able to cover that matter in due course. We dealt with Amendments 3, 5 and 6, which stemmed from the consultation on the governance arrangements for those bodies, which honoured a commitment in the coalition agreement-our bible-and was run in close co-operation with the national parks and Broads authorities. We asked each authority to make recommendations following consultation on the changes needed for their governance arrangements. We were clear from the start that the objective was to improve the governance arrangements of those bodies and not to remove or replace them. For that reason, they do not appear in other schedules to the Bill-not in Schedules 1 or 2, for example. Our consultation began with these words:
"The Government wishes to retain an independent authority, as currently exists, for each of the National Parks and the Broads. It intends that these authorities should continue to be the local planning authority for their areas".
In Committee, your Lordships pressed me on the sort of steps we might want to take and on why those could not be achieved without this Bill, perhaps by using powers which already exist in the Environment
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It would not be appropriate for me to pre-empt or predict the announcement that we shall make after the May elections. However, purely by way of illustration, the House will see a number of the suggestions which national parks authorities have already made. The proposals are-dare I say it?-largely in the public domain, having featured in various board papers produced by the authorities, and elsewhere. They include, for example, the power to remove the requirement for the Secretary of State formally to appoint the members whom parish councils choose and the power to allow non-councillors to be eligible for the parish seats, or to limit the maximum time that all members may serve on a national parks authority. Any of those points, if accepted, could be delivered through Clause 3.
I appreciate that noble Lords might feel that there are other ways of dealing with these things but we think it would actually be easier and better, under the powers in the Bill, to deal with those matters in that way. I therefore hope that your Lordships will agree that it is premature to consider removing Schedule 3 at this stage and that it should continue to stand as part of the Bill. There is no sinister motive behind that; all we are proposing is a power to amend constitutions and all the usual checks and balances are available in the Bill. We want to look at what comes out of that consultation. I have given some hint of that in what has appeared in the public domain but the noble Lord, Lord Judd, will probably know even more-the noble Lord smiles-about what might come from it. I hope that he will accept that this should continue to be part of the Bill.
As I said, we are perfectly happy to remove the national parks and Broads authorities from Schedules 5 and 6, which is why we have tabled our amendments. However, it is quite right that they should remain part of Schedule 3 on the power to modify constitutions. With those assurances, I hope that the noble Lord, Lord Judd, will feel able to withdraw his amendment.
Lord Judd: My Lords, first, I thank the noble Lord for his response and for its friendly tones, which I appreciate and which have characterised the Government's approach to discussions on the future of the national parks. I want everybody to recognise that we know that and appreciate it greatly. We are all getting titbits of indications about what might be in the review and what its outcome might be. The noble Lord has given us a few sweeteners and I have certainly heard some reports and seen some assessments of what that exercise might have indicated, but in the assessments I have seen there is no indication whatever of any great demand for radical change-none at all. There are some very constructive observations but there seems to be no argument coming out for a radical change of arrangements.
I am sure that the Minister, who is a reasonable man, will agree that it is not really satisfactory to be considering giving those undefined and extensive powers to which the noble Lord, Lord Marlesford, referred so well before we have seen the outcome of the consultation. If that consultation was necessary, surely we should see its outcome before we decide whether we want to give Ministers certain powers to meet that situation. This is untidy and the noble Lord in his heart of hearts probably would agree with me that constitutionally it is not really acceptable. There are also-and my noble friend Lady Quin made the point very well-all sorts of provisions under existing legislation. It just is not clear what is going to be better about putting these new, very extensive, open, ill-defined powers into this Bill.
I want to thank all those who have participated in the debate. Absolutely everyone, without exception, has spoken with the authority of engagement and of years of experience in these matters. I take particular encouragement from the fact that the noble Lord, Lord Marlesford, spoke; he and I came into the House together 20 years ago. We have watched each other and been friends across the divide and on probably far more issues than not, I am sorry to say, we do not see eye to eye. However, on this issue-the importance of the parks and their qualitative dimension to society and the areas of outstanding natural beauty-we have always seen eye to eye and it was therefore good to hear him. I want to thank everyone, from the Cross Benches, the Liberal Party and my own Front Bench who have contributed.
I am in touch with a very wide cross-section of people who care about these issues deeply. I have the privilege of being president of the Friends of the Lake District which represents CPRE in Cumbria. I have the privilege of being a vice-president of the Campaign for National Parks and although that does not make me a trustee or an executive staff member of either
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Lord Whitty: My Lords, my comment this evening is basically: why is Passenger Focus still here in the Bill? As the noble Earl knows, Passenger Focus had the distinction of appearing in three schedules to start with, plus we had a generalised statement from BIS that it wished to bring all consumer bodies together as one body, probably Citizens Advice. Because the consultation on all that has been postponed, we do not yet know whether the Government are still so minded, although I suspect that the noble Earl's department has seen off that proposal for the moment, so we are discussing Passenger Focus as a separate entity. In default of having a sensible rationalisation of consumer bodies, it is important that Passenger Focus remains.
When we removed Passenger Focus from Schedule 5, I received some assurances on the subject from the noble Earl, but this amendment relates to constitutional change in the body. As we have just heard from the noble Lord, Lord Henley, a lot of things could be done under the heading of constitutional change, so I would like some assurance from the noble Earl that the worst fears are unfounded. It was said that Passenger Focus would be reduced to its core role. I expressed concern at the time that that might mean that it would no longer be able to criticise the general conduct of
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If the inclusion of Passenger Focus in this schedule is simply aimed at its governance, I would need reassurance that that would not remove the regional base of its governance and its wide remit to go into the affairs and performance of individual train and bus companies. I hope that I can receive those assurances tonight, in which case we can have a very short debate on this item and welcome the fact that Passenger Focus will be affected by this Bill only to a minimum degree. However, I need those assurances. I beg to move.
Lord Hunt of Kings Heath: My Lords, perhaps I may briefly support my noble friend in saying that I hope that the noble Earl will be able to give the assurance that he requires. The problem with Schedule 3 is that, on the face of it, it gives considerable power to Ministers to alter the constitutional arrangements of bodies and offices. I take that to mean that, if the Government were unhappy with the performance of the board of such an organisation, they could make drastic changes in its governance arrangements by bringing an order before Parliament. The problem is that that power could also be used to remove members of the board who may be causing some disagreeableness to the Government. That is a matter of concern. Clearly, if these public bodies are not able to exercise their functions in a robust and independent way, they are unlikely to do their job effectively. This relates to all the bodies listed but I think that the question that my noble friend has raised about Passenger Focus is a fair one to put to the noble Earl, Lord Attlee. I hope that, specifically in regard to this body, the noble Earl will say on the record from the Dispatch Box that the changes envisaged to governance et cetera will only be minor.
Earl Attlee: My Lords, this amendment would remove Passenger Focus from Schedule 3, preventing our current proposals to change the governance arrangements of the body. The noble Lord, Lord Whitty, asks why the body is still here in the Bill. He also mentioned other bodies, such as Citizens Advice. He will recognise that BIS is developing proposals for reforming the wider consumer landscape, but it is too soon to say how the reform of Passenger Focus will fit with that, as this is too long term.
The noble Lord expanded his point to Citizens Advice and trading standards organisations, if I may put it like that. We would not want to rule that out but the consideration of options is at too early a stage for any commitment to be given. As was made clear in Committee, the appearance of Passenger Focus in the Bill does not reflect the view that passengers' interests are unimportant. We are very clear that passengers are the only reason that we run a public transport system in the first place. In addition, we fully accept the need
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The noble Lord, Lord Hunt of Kings Heath, made the important point-if I might paraphrase him-that this is perhaps an opportunity to weaken the body in certain circumstances. The answer to that is simply no. We want to maintain an effective passenger advocate; that is the best way of ensuring that transport operators are held properly to account. The Government also value having a passenger advocate that has the confidence and expertise to be a critical friend to the Government and is prepared, where appropriate, to hold both the Government and transport operators to account. This is an opportunity to ensure that role is performed in a robust and cost-effective way.
A significant amount of work has already taken place to review the details of Passenger Focus's work for next year within a significantly reduced budget. As part of this process, it is right that we should look at areas such as the size and composition of the Passenger Focus board. The noble Lord, Lord Whitty, asked how we would achieve the reduction in budget. An obvious area for reduction is research. We do not expect research to end altogether, but it is right to be sure that the current range of research is genuinely justifiable. We need to consider whether operators should do more to canvass the views of their customers, rather than expect the Government to pay for research.
As referred to in Committee, Schedule 3 can be used to implement changes to the composition of the Passenger Focus board. Indeed, we understand that Passenger Focus has for some time been considering streamlining the board's operation. Although the details are still to be finalised, it makes sense that a scaling back of its activities should be accompanied by a smaller board that will also result in savings for the taxpayer. I understand that Passenger Focus is looking at reducing the size and cost of its board through a combination of measures, including not filling vacancies and changing the scale and scope of board meetings. The Government are working constructively with Passenger Focus to help it maintain its important functions within the constraints of a reduced budget.
We are also interested in exploring the continued funding of passenger representation in Scotland and Wales, where rail policy is largely a devolved matter. We are in contact with the devolved Administrations about how this may be taken forward. Some of Passenger Focus's other specific Scottish and Welsh passenger activity, such as the current passenger link work, is expected to be restructured in a similar way to that in England.
I hope the noble Lord is persuaded that there are good reasons to have the ability to change the governance arrangements for Passenger Focus and that he will therefore feel able to withdraw his amendment on that basis.
Lord Whitty: My Lords, I am grateful to the noble Earl, although some of his assurances were not quite as unequivocal as I would have liked. It is also clear that, as a result of the pressure on Passenger Focus's budget, the restriction of research and its refocusing, it will not be as powerful a body as the noble Earl suggests. Nevertheless, I am glad he said that the Government remain committed to having a passenger advocate and see it as a very important part of how we conduct and enforce our public transport policy. I am therefore prepared at this stage to accept his assurances and I thank him for them. I beg leave to withdraw the amendment.
Lord Whitty: My Lords, in moving Amendment 39 I wish to speak also to Amendment 54. Essentially, my question to the Minister is the same as it was in the previous debate: namely, why is Ofcom still included? When we started out on this Bill, almost all the
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Expenditure on Ofcom has already been reduced by the department and the reference in the previous stage to a saving of some £400,000 could be achieved administratively. It is also true that advisory committees to Ofcom can be changed without primary or secondary legislation. Indeed, it seems to me that Ofcom, presumably with the connivance of its parent department, has already removed by stealth the Communications Consumer Panel from effective operation without it being entirely clear where those functions for the protection of consumers in the communications business now lie. Therefore, it is unclear why the Government need additional powers to make savings and streamline Ofcom's operation.
As regards Ofcom's inclusion in Schedule 5, we know about the transfer into Ofcom of the Postcomm responsibilities but there is a suspicion that there may be some transfer out of it. Ofcom has responsibility for regulating a whole range of communications industries, many of which are deeply sensitive. I referred just now to its sponsor department but it is sometimes unclear to us who is the sponsor department for Ofcom because, on the media side at least, a significant proportion of Ofcom's activities now appear to be the responsibility of DCMS rather than BIS. I do not regard that as a particularly healthy move. However, either way, it raises a suspicion that some of its media responsibilities, such as media ownership, broadcasting content and the whole structure of regional broadcasting, may be in line for being curtailed or moved back to the department. It would be alarming if a transfer out involved any of those items.
There are also other responsibilities. Just to show that I am not being partisan, I had a substantial and ongoing row with the previous Government about their provisions in the Digital Economy Bill. Those provisions have been handed over to Ofcom to implement, which is finding some difficult in doing that. There may be some irritation in government about that. Therefore, a lot of Ofcom's responsibilities could be transferred out.
I should like an assurance that Ofcom's continued inclusion in Schedule 5 in particular does not mean a reduction in its scope, particularly as regards those responsibilities. Ofcom has, in general, been a pretty
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Lord Fowler: My Lords, I agree entirely with the noble Lord, Lord Whitty, that Ofcom is an extremely important body, and I hope that the Government accept that because, in the media area, a body such as Ofcom that is independent and seen to be independent and skilful is of the utmost importance. Certainly, as regards Schedule 3, I should like confirmation that it is not necessarily the case that the proposal means there will be a cut in Ofcom's budget, although the budget can be modified either way.
I say that because it is difficult these days to debate Ofcom without discussing the role of the BBC Trust, which was set up by the previous Labour Government. The previous Secretary of State rightly changed his view, decided that the trust was an unnecessary body and that the logical way to run the BBC would be for there to be one chairman, a board and the executive, rather than the current extraordinary position, which is unique in the western world, whereby there is at one level the executive and then, in a separate building, the trust, headed by the noble Lord, Lord Patten of Barnes-I am glad to say. However, the noble Lord is able to call himself the chairman of the BBC only as an honorary title. That is ridiculous. He should actually be the chairman of the BBC, and there should be one unitary authority. That is the logical way, and that is why 99.5 per cent of organisations in this country run themselves in that way.
The position that I reach from that is that the responsibilities that are now with the BBC Trust could easily be transferred to Ofcom. That is their logical place and everyone has argued for that. If that happened, one would find that the Lords Communications Committee-no longer under my chairmanship-would consider this matter further. If that is the position, there would clearly be adjustments to funding arrangements and the rest, as set out here. That does not necessarily mean that the funding would be reduced, but that the funding for Ofcom would have to increase.
I ask my noble friend Lady Rawlings-who, I am glad to see, is refreshing herself with water for her reply-whether she will confirm that that is the case. It would be a grave mistake for the Government to accept the argument put by people who have very vested interests that Ofcom is of no particular value and should be downgraded. Everything that has happened in the media world over the past six months confirms the view that the importance of Ofcom should be underlined. That is what I should like to hear from my noble friend now that she has refreshed herself.
Baroness Jones of Whitchurch: My Lords, I am grateful to my noble friend Lord Whitty for continuing to champion the organisations that stand out as protecting
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During the passage of the Bill there have been several attempts by Ministers to make reassuring noises about the importance of Ofcom and its central role in the future of media regulation. This may well be the case, but I share my noble friend's concern that the thrust of these changes, far from giving Ofcom greater responsibility, will limit its power to intervene in crucial issues such as media ownership and changes to public broadcasting. Power appears now to be increasingly centralised in the hands of the Secretary of State.
As is the case with many other organisations for which changes are sought in the Bill, one is left to wonder about the cost savings that might occur if the Minister's department is serious about taking on those functions. I concur with the questions of the noble Lord, Lord Fowler, about the proposed savings expected from Ofcom in this context. The Government have trumpeted the increased transparency that will occur, but it remains unclear how we will be able to scrutinise the major decisions that will be taken in the department on issues such as media control. When it comes to transparency, give me Ofcom any day.
My noble friend repeatedly emphasised, in previous debates and today, the special status of the economic regulators and the need to protect their independent function. Again, the Government took steps in the past to reassure the House on this matter. However, like other noble Lords today, I am left wondering why they felt that it was necessary to put the remaining changes to Ofcom in the Bill, and whether this still represents a shift in power and authority away from independent economic regulators and back to the centre. If this is the case, it is a backward step both for the consumer and for the wider public, as well as being a cause for celebration for would-be media barons. I remain unconvinced of the need to change Ofcom's role through the formal mechanism of the Bill, and very much look forward to hearing the Minister's justification of why it is necessary.
Baroness Rawlings: My Lords, I thank the noble Lord, Lord Whitty, for tabling these amendments and for giving the Government the opportunity to state clearly to your Lordships' House how they intend to use the powers in Clauses 4 and 5 to reform Ofcom. The noble Lord asked why Ofcom is included in Schedules 4 and 5 to the Bill. This is so that we can bring forward several small changes to some of its duties that will make certain that it will be able to fulfil its statutory duties as efficiently and effectively as possible.
The communications landscape has changed significantly over the past decade, since Ofcom was established by the Office of Communications Act 2002. It is sensible and timely that we now use this opportunity to make some changes. At a time when the public sector must become more efficient, it is right to amend or remove some of Ofcom's duties, which will result in a small reduction in its cost to the public purse. I confirm that Ofcom is comfortable with the proposed changes to its duties. In answer to the concerns raised
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I note, too, that the noble Lord is concerned that the Government may look to introducing additional changes in years to come using the Public Bodies Bill. I can reassure him that we have no plans to make any additional changes to Ofcom's duties other than the nine small changes that we propose to bring forward by order after the Public Bodies Bill receives Royal Assent.
Once those changes are complete, the Government will use powers set out in Amendment 60 to remove Ofcom from Schedules 4 and 5, thereby repealing the power of Ministers to make changes to Ofcom via secondary legislation. I can tell the noble Lord, Lord Whitty, that that makes certain that Ofcom will not be subject to the powers in the Bill in perpetuity. Like all bodies named in the Bill, Ofcom is included for a specific purpose. Once that purpose has been met, it will be removed from the relevant schedules.
Amendment 39 would prevent the Government making the proposed change to Ofcom's financial arrangements. Currently, satellite filings are paid from Ofcom's grant in aid to manage the radio spectrum in the UK. Allowing this change would bring the UK into line with many other countries which charge for this work and save taxpayers in the region of £400,000 per annum. That is not a huge sum, but it is a saving that can and will be delivered. I can answer my noble friend Lord Fowler, after my water refreshment, that Ofcom's inclusion in Schedule 4 is for this purpose and not about funding levels.
Amendment 54 would prevent changes being made to Ofcom's governance arrangements which are part of our commitment to deregulation. Our proposed changes will cut duplication, reduce the need to undertake unnecessary reviews, and allow Ofcom to make cost savings. They include the removal of the requirement for Ofcom to undertake reviews of media ownership and public service broadcasting arrangements every three and five years respectively. Instead they will be done at the request of the Secretary of State. That is more efficient and will ensure that the review process is dictated by a need, not an inflexible statutory timetable.
Another proposed change will remove Ofcom's duty to promote development opportunities for training and equality of opportunity. That should not be mistaken for the Government turning their back on the issue of diversity. It would simply bring Ofcom into line with regulators of other industries who do not generally have such requirements. This decision was made on the basis that the media sector is fortunate to have Skillset already to promote training issues. The removal of this duty on Ofcom will allow Skillset to continue to develop its work in this field. In light of those details and the assurances about the limits of the Government's plan for the reform of Ofcom, I hope that the noble Lord will feel able to withdraw his amendment.
Lord Whitty: My Lords, I thank the Minister for those assurances as they have taken us a little further than previously. I also thank the noble Lord, Lord Fowler, and my noble friend Lady Jones for their contributions.
I understand from the Minister that there are nine changes. I may not approve of all of them but she is probably right to say that they are relatively small changes. One which she cited was about having no regular reviews unless the Secretary of State says so. I would probably not approve on the specifics, but nevertheless I accept that they are relatively minor changes in the overall picture. The power that will come in with Amendment 60 will mean that Ofcom will be removed from the schedules, so it is an early sunset clause. In the light of that, and as we have received greater assurances than previously, I shall not press my amendment tonight.
Although the noble Lord, Lord Fowler, made some good points to start with-and I do not entirely disagree with him about the structure of the BBC-including this regulator in the list for some future secondary legislation is the not way to change the governing structure of the BBC. I am very glad that that is not one of the consequences of allowing this to stand. In the light of the noble Baroness's tight assurances-more than we have had for several other bodies-I beg leave to withdraw the amendment.
Lord Roberts of Llandudno: I thank very much those who have taken part in our debates over a number of days. We have at least impressed on the Chamber the value of the Welsh language and how much it has been a part of our culture and our very personality. I feel that S4C is stronger after our debates.
Lord Roberts of Llandudno: I am glad that those on the Front Bench agree. I would say that jaw, jaw is better than war, war. The discussions that we have had over many hours have resulted in concessions. I asked for eight assurances. I received seven. With that result from our discussions, I can claim a Liberal Democrat victory in this Bill; and I will.
Lord McNally: My Lords, the three amendments in this group are in the name of my noble friend Lord Taylor of Holbeach. The reason that I am moving them is twofold. First, I am the Minister responsible for the National Archives; secondly, I am badly in need of a victory today.
The amendments moving the Advisory Council on Public Records, the Public Record Office and the Keeper of the Public Records to Schedule 5 constitute a straightforward and, I hope, uncontroversial legal tidying-up exercise-although I worry that the noble Lord, Lord Warner, is still in his place. They have been agreed with and led by the current chief executive of the National Archives, who is also the Keeper of the Public Records. I reassure noble Lords that no functions currently performed by the National Archives or any of its component parts will be negatively affected. There is no impact on staff and no financial implications.
The rationale for the reforms is to place the National Archives, its chief executive and its advisory bodies on a statutory footing, enabling the Government legally to complete the changes that began with its establishment as an administrative entity in 2003. That involves transferring the statutory duties of some of the National Archives' component parts using Schedule 5, which grants powers to modify or transfer functions to reflect existing administrative arrangements. For example, the role of the Advisory Council on Public Records is to advise the Lord Chancellor on matters concerning public records and archives. Following the merger of the Public Record Office and the Historical Manuscripts Commission in 2003, their respective Advisory Councils on Public Records and Historical Manuscripts also came together to form the Advisory Council on National Records and Archives.
The separate legal functions of the Advisory Councils on Public Records and Archives have for the past seven years been administered by the Advisory Council on National Records and Archives. The chairman of the Advisory Council on Public Records, the Master of the Rolls, assumed the chairmanship of the new body upon its creation and continues to do so.
The council will therefore be included in Schedule 5 to enable it to be renamed the Advisory Council on National Records and Archives, assuming the functions of the existing, non-statutory, Advisory Council on National Records and Archives and the Advisory Council on Historical Manuscripts. This change will therefore formalise the current arrangements to form a single body, providing greater clarity and efficiency, with one body doing the work of three.
In the case of the Keeper of Public Records, the Lord Chancellor appoints the keeper to take charge, care for and preserve public records under his direction. The chief executive of the National Archives holds the statutory office of keeper, as well as the office of Historical Manuscripts Commissioner. By moving the keeper to Schedule 5 to the Bill, the Government will be able to consolidate these roles-and those of the Queen's Printer of Acts of Parliament and Controller of Her Majesty's Stationery Office-into one statutory office, the Keeper of the National Archives. This reform will clarify lines of accountability for the National Archives' various functions by putting in statute the responsibilities of a new keeper. The changes will not affect the way that functions are carried out, and there are no financial implications. It is important to emphasise again that these reforms have been agreed with, and led by, the current Keeper of Public Records.
The Public Record Office was created by the Public Record Office Act 1838 as the national archive for public records. In 2003, the Public Record Office merged with the Historical Manuscripts Commission to form an administrative entity, the National Archives. In 2006, the Office of Public Sector Information and HM Stationery Office were also merged with the National Archives. All four bodies continue to exercise their legal functions, but within a single administrative body- the National Archives-under a single chief executive. The Public Record Office is therefore a statutory component of the National Archives.
The Government are committed to preserving the legal functions performed by the Public Record Office, and it will therefore be moved to Schedule 5, allowing the National Archives to absorb its functions and those carried out by other, non-statutory component parts of the organisation. Clause 7(3) will permit any necessary changes to the Public Record Office's constitutional arrangements, in particular its renaming as the National Archives, and the expansion of its funding to cover its new functions. This will put the organisation on a clear legal footing, provide clarity to the public and finalise the merger process begun under the previous Administration.
These amendments will enable the Government to place the National Archives, its chief executive and one of its advisory councils on a much clearer statutory basis, strengthening-not weakening-the ability of these bodies to perform functions which the Government believe to be of immense cultural value. I hope, on that basis, that noble Lords will feel able to support these amendments.
Baroness Thornton: My Lords, we turn to Amendments 49 and 50 and the subject of the HFEA and the HTA somewhat late in the evening again. We have now had time to reflect on what the Minister said on 9 March, to read the letter to my noble friend Lord Warner, which the noble Lord thoughtfully copied to me and others, and to compare the two. In reading the debate on 9 March, I realised it had centred on the issues that arise out of the siting of the HFEA rather than on the proposals for the HTA, so I shall start by raising a few issues that are particularly pertinent to the HTA.
Since the previous debate, the Government have announced that the HTA has been appointed as the competent authority to regulate the quality and safety of organs under the EU organ donation directive. The HTA is now the competent authority for two EU directives. I would be grateful if the Minister will explain where this competence will sit under the various options he outlined in his letter to my noble friend Lord Warner. In addition, the HTA's responsibilities with respect to EU legislation extend across the UK, but the Care Quality Commission's remit extends to England only. The Minister can see where I am leading with this question because of the statutory implications that such a move might involve. For example, have the Government consulted the Welsh Administration about this matter or would they divide the legislation or extend the geographical remit of the CQC? Indeed, what if the Welsh said no to such matters regulated by the CQC?
We also need to look at the context in which these changes are being proposed. There are loopholes between coroners legislation, the Human Tissue Act and the Police and Criminal Justice Act which the HTA is addressing at the moment. I think it is right to be
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When the Minister answered this debate on 9 March, he took the trouble to explain in some detail the Government's thinking about the future of the HFEA and the HTA and spoke about the possible creation of a new health research agency, which I think largely met with a great deal of approval across the House, and I shall return to that matter in a moment. His letter to my noble friend explores the various options that the Government might take with the powers that the Bill will grant them. I know my noble friend Lord Warner will want to explore the contents of that letter, so I shall limit myself to two issues that are still outstanding and need to be addressed before Parliament grants such powers with regard to these two bodies.
The first is the nature of the pick-and-mix proposals for the future of the HFEA and HTA, which the Minister suggested in his reply to the House on 9 March and in his letter to my noble friend, because I do not think it is acceptable to ask for powers fundamentally to change these organisations and not to know at this stage how those changes might be achieved and what they will do. The Minister spoke about this being a road of travel. Roads of travel are fine when one is developing policy but they are more difficult when one is putting into legislation things which will have a direct effect-in this case, on these two organisations.
Secondly, I return to public confidence, which I raised in Committee. I have read the Minister's reply on the importance of keeping public confidence in the functions of the HFEA and the HTA. It centres around the fact that he is keen to assure the House that the legislation, and the ethics that underpin that legislation creating the HFEA and HTA would not be fundamentally changed. But I am puzzled: I do not see how, as regards the options outlined by the Minister-the orders that would need to be consulted on-he would intend to stop those ethical issues that lie at the heart of that legislation being discussed at length because of the public confidence that resides in them. When change is being proposed, that reassurance and the assurance that the new arrangements will do their job is obviously very important. Option papers do not usually provide the necessary assurance about people's jobs or functions and, in this case, about where the ethical issues that underpin that legislation would lie.
I feel that the Government have the opportunity to move forward with the creation of a new science body, and the future of the HFEA and the HTA, with a great deal of agreement across the House and with a great deal of good will to make that happen. I do not think that this Bill is the place to start that, which probably is the heart of the problem.
Lord Willis of Knaresborough: Before the noble Baroness leaves the issue of ethics, if the agency model is developed, which would have a separate ethics committee
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Baroness Thornton: The noble Lord, Lord Willis, makes the point extremely well and much more eloquently than I was able to. It underlines the point that I have been trying to make. Taking the powers to break up the HFEA and the HTA, as it were, is not the way to start that process. The noble Lord makes exactly the right point. The Minister should recognise that there is a great deal of good will to make this happen across the House but not starting here. I beg to move.
Baroness Warwick of Undercliffe: My Lords, I declare my interest as chair of the Human Tissue Authority. I and my authority remain concerned about the impact of the Bill on public and professional confidence in the safe and ethical use of human tissue, as has already been raised by my noble friend. My first question to the Minister is to seek reassurance that the HTA's functions will not be divided. A division of our functions into three or possibly four different parcels would, in my view, risk undermining the legislation that the HTA was set up to implement, increase the regulatory burden on the sectors we regulate and damage public confidence that has been so hard won.
We must not forget that the HTA was established as a result of scandals at Alder Hey and Bristol Royal Infirmary. Those events caused profound grief among affected families, outrage amongst the public and a crisis of confidence. Those events are still recent. The Human Tissue Act, which set up the HTA and was subject to more than 100 of hours of parliamentary scrutiny, was passed in 2004. The HTA began regulating as recently as 2006. In a relatively short period, it has successfully turned around that crisis of confidence. When people know there is effective regulation, they are more confident in donating their tissue for medical research, their organs for transplant and their bodies for medical education and training. Increased public confidence should mean more donation; more donation should increase professional confidence, thereby creating a virtuous circle beneficial for all. More lives are saved; more people are given back their quality of life; and there is more research and surgical skills training for the benefit of the public.
The Government's arm's-length bodies review sets out proposals for transferring the HTA's functions across three or four different organisations. I fear that separating the HTA's functions would risk undermining the progress that has been made in building public and professional confidence. Leading thinkers have voiced profound concerns about dismantling the HTA. Senior legal academics have said in the Sunday Times:
"The proposals to abolish the Human Tissue Authority-HTA and the divisions of its functions among larger, non-specialist regulators-risk confusion and error in the implementation of the Human Tissue Act 2004, which in turn will erode public confidence".
The Minister has said that the HTA's health-related functions should transfer to the Care Quality Commission. I am still not clear about the fate of the HTA's organ donation and research functions. The ALB review does not suggest a home for its organ donation approvals and suggests that its research functions should transfer to a single research regulator.
With regard to organs, the Human Tissue Act requires board approval of highly sensitive and ethically complex cases of organ donation from living people. If this were to be placed with the CQC, how would the Minister meet the statutory requirement that at least three authority board members who are specifically trained in this area review such cases?
With regard to research, the new regulator for health research will provide a potentially helpful way forward for streamlining medical research in the UK, simplifying life for researchers and increasing the quantity and quality of research. The Minister stated at Second Reading that the purpose of this Bill was to streamline the process of regulation and to reduce costs and bureaucracy. I do not see how the proposal to transfer the HTA's research functions to this new regulator would achieve simplification; nor do I believe the proposals would save money. The sectors that the HTA regulates are interrelated and interdependent, and although it regulates a separate research sector, the licensing framework also allows establishments in the post-mortem, patient treatment and anatomy sectors to store tissue for research as well as for other purposes.
I take the post-mortem sector as an example. The proposal would result in at least one-third of post-mortem establishments needing to be licensed by an additional regulator if they wished to store material for research. A similar proportion of establishments storing tissue for patient treatment would also need to be licensed by an additional regulator. The regulatory burden on an estimated 200 establishments would therefore increase, not decrease. So can the Minister explain what impact this proposal will have on the regulatory burden on these establishments? Can he explain who would be responsible for producing the statutory code of practice on consent and who would be responsible for ensuring consistently high standards if the HTA's functions were divided?
My noble friend Lady Thornton raised concerns about the ethical dimensions of the work being lost in the rush to amend the mechanical processes. I share these concerns. This is a complex ethical landscape. The HTA has the professional expertise to respond to emerging forms of communication such as Facebook and Twitter. These are now being used as conduits for patients looking for organ donors. We are launching consultation on this very issue in May, and this is a good example of how agile and sensitive the authority
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I apologise for raising so many issues at this late hour but there are many issues still to be resolved. In summing up, I say only that the reason the HTA was established has not gone away and there is still work to be done. My argument is not against the Government's intention to simplify the regulatory landscape; rather, I want to avoid putting at risk the substantial gains that the HTA has made by splitting its functions across a number of different organisations and losing the overall coherent approach which has been so successful in supporting public and professional confidence and ensuring that tissues and organs are used safely and ethically and with proper consent.
The fact that so many noble Lords wish to speak to the amendment at this hour indicates that this is an issue of significance to your Lordships' House. In Committee, my noble and learned friend Lord Mackay ended his remarks by saying that he had helped to give birth to the baby that was the Human Fertilisation and Embryology Authority but that perhaps it was now time to let the child move out, or words to that effect. Before a child moves out into the world, it is important that a responsible parent-and I think that the House should regard itself as a responsible parent-knows that it is safe to do so. However, the reality is that during the passage of the Bill, and in particular during the Committee stage and in the clarification given since then, many questions asked on behalf of the HFEA and the HTA, as the noble Baroness has just indicated, have not been answered. That is regrettable. I think that the House accepts that what the Government are trying to do has a great deal of merit; it is just that it requires organisations to be properly set up before the functions are transferred.
As I have said on two previous occasions, I am not against what the Government are ultimately trying to do. However, before we get rid of two organisations in which the public have great confidence and whose operation is tried and tested, we should be absolutely clear about what will happen to their functions. Although the Minister has made tremendous attempts to satisfy inquiries from noble Lords on all sides of the House, I think that his letter of 22 March to the noble Lord, Lord Warner, raises more issues than it resolves. I am sure that the noble Lord will go through that letter in great detail and therefore I do not intend to do so. However, some of the comments in it indicate that two
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As for the Care Quality Commission, it is itself an organisation in its infancy and learning how to do its business. Indeed, there are significant complaints about the Care Quality Commission. That is not an overarching criticism. It is inevitable that when a new organisation sets itself up, particularly one that inherited so many problems from its predecessors, there will be difficulties, yet here we are, saying that we will lump another major piece of work with it.
In Committee, the Minister made it clear that the existing personnel would be transferred en bloc into the new organisations, yet in the letter to the noble Lord, Lord Warner, there is no mention of key personnel being transferred into the Care Quality Commission. I understand that staff are seeking posts elsewhere. They will move out of the organisation. If we are not careful, there will be nothing to transfer and we will be looking for new personnel in these key posts. Will the Minister clarify that issue?
The new Medical Research Agency will not be set up until the latter part of this Parliament at the earliest. The Minister floated the idea that some of its functions could be transferred early using the Public Bodies Act-regulation and inspection of clinical services could go to the Care Quality Commission, for example. There is a further suggestion that all but the research functions of both the HTA and the HFEA could be transferred under the Public Bodies Act, as it will then be, with the final process completed following the setting up of the Medical Research Agency. Such hypothetical and confusing scenarios to break up two well-respected and well-worked regulators will do little for public confidence in either of these two areas. It will do little for clinician confidence and will certainly do nothing for research community confidence either. It is important that the agency is set up, properly staffed and has clear terms of reference agreed with both Houses of Parliament before we transfer these key functions to it.
One function that has been set out by the Academy of Medical Sciences, which is a clear pathway, is an ethical structure. We argued when we were looking at the draft Bill and your Lordships in this House argued during the passage of the Human Fertilisation and Embryology Act that we ought to have some form of parliamentary ethics committee. At least the Academy of Medical Sciences has said that there ought to be an overarching ethics committee to look at both areas. But if clinical ethics are not dealt with by that organisation, who will deal with them? Where within the Care Quality Commission are the sort of important ethical considerations that are necessary if we are to transfer all these functions to that body?
I can see the attraction of a method of transfer of functions to avoid primary legislation. I understand why the Minister would want to go down that road, particularly given the enormously strong public scrutiny over legislation concerning the Human Tissue Authority and embryology and stem cells over the past five years, but the idea that if the scrutiny is only in both Houses of Parliament it will be less severe does not hold up. There are 200 new MPs in the other place who were not party to any of this legislation when it went through. It is highly optimistic to believe that there will not be very detailed scrutiny of any new arrangements. I suggest to the Minister in all humility that he accepts the amendment before us tonight or makes some provision to satisfy our concerns. He should seek a comprehensive solution to the problem that the Government have created for themselves. I for one-and, I suspect, many of your Lordships-would agree that there is a way forward from this. The Medical Research Agency is a good idea. There is a possibility of transferring some of the functions to the Care Quality Commission, but it needs to be done en bloc, rather than piecemeal, so that there is a danger of undermining two excellent regulators, which have public confidence, the confidence of most clinicians and the confidence of the research community.
Baroness Deech: My Lords, I declare an interest as a former chair of the HFEA. My name is on this amendment, and I support every word of what previous speakers have said. Those who oppose this amendment consist largely of those who are impatient about the shackles that regulation imposes and wish to be free of them. They will not be if this government scheme goes ahead. As researchers and clinicians, they will have to deal with at least two departments or bodies in place of one, which can be guaranteed to be no quicker or cheaper.
Criticisms have been made of the style or overlap of inspections, but that is not the point. Those faults can be remedied. Inspection can be delegated or contracted out. What is at issue is the continued existence and symbolism of one integrated body-the HFEA and the HTA-representing lay and clinical interests, accountable to patients through consultations and to Parliament, speaking with one voice to government and to the world. The HFEA may be alone among the many bodies listed in this Bill that has an international significance and symbolism. Google it, and you will see twice as many thousands of references internationally as in the UK. It has achieved a presence in the world that has helped to give UK science a good reputation and has enabled this country to be the first legally to embrace embryo research for stem cells and as the object of study around the world. Other advanced countries have national ethics committees, such as the United States and France, or HFEA-type regulators, such as Canada, California and parts of Australia. They will be aghast that where the UK led the way it is now abandoning its respected structure.
Now we have to look at the unanswered questions-indeed, there are more unanswered questions at this stage of the Bill relating to these two bodies than there were a few months ago. Noble Lords have referred to them. There is a failure of governance in the plans put forward in the Bill. Plans is too positive a word for an
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As others have said, the future division of functions has not yet been settled, but we know that there is already a risk that the CQC will be overburdened. If there is an overlap between the CQC and the HFEA in licensing, the CQC should be relieved by dropping HFEA-type inspections. In the mean time, the welfare of patients and children will be at risk. It is not clear what functions will go to the CQC and we do not know where the all-important database will go. In a few years' time, children will be entitled to ask how about their parentage. Who will safeguard the answers? Who will enable researchers to carry out anonymised research from that database? The future governance and organisation of IVF and related matters has been cast into even greater doubt than before in this latest attempt to sort out the detail, which goes to show what a bad idea it was to unpick the HFEA in the first place.
If the Government will accept this amendment, however, the criteria that should inform the establishment and general shape of regulation will be met. That is: we must keep independence in this sensitive, ethical area. It must be free from government. As a freestanding organisation, the HFEA is much more accountable and transparent than the new proposals for structure would be. It has a global name, which has done this country nothing but good, and provides a one-stop fount for those who wish to know about IVF and research here or who seek guidance as patients. It commands public confidence. There can be no argument about saving costs and preserving efficiency except by leaving it alone.
To fail to accept this amendment means a loss of respect and trust in the UK IVF world, a failure to keep these issues at arm's length from government, more control over funding when it is taken up by the Government and, possibly, an end to hopes of parity
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Finally, in summary, the concern is that the starting point for changing these two bodies, the HFEA and the HTA, has been tackled upside down. If it is considered that there is a need for a different HFEA, the starting point should be to look at what, if anything, is wrong with it and what is the best way to overcome those problems rather than starting with a decision to abolish and split up its functions that has been reached not by an analysis of the HFEA but, quite simply, to meet a political target to reduce arm's-length bodies. We should not tie ourselves to an outcome before we undertake a review.
I believe that the fear of many professional bodies and patient groups is that by disassembling the HFEA, we could end up with something much worse. It would seem prudent to do the review and the consultations before we determine the outcome. There is no hurry; one can wait until the new, all-purpose medical regulatory authority is established, and then decide what to do. If not, there is great risk so I hope that the Government will accept this amendment and believe that they would be greatly relieved if they did.
Lord Warner: My Lords, I support this amendment. I am conscious that I must guard against triumphalism after the Youth Justice Board amendment earlier, but I raise that because there are some similarities, in that the Government could walk into the same situation. With the Youth Justice Board, we had a situation where a body was functioning perfectly well and the Government tried to change it before they knew or could explain what to put in its place to safeguard the development of youth justice and the future delivery of services. The Government are in danger of falling into exactly the same position with the HFEA and the HTA: two bodies functioning perfectly well, which have international reputations and which, certainly in the HTA's case, are of relatively recent origin in their passage through Parliament. It is far from clear what the Government will do for a new set of arrangements that go wider than those two bodies and embrace a new agency of health research.
I am grateful to the Minister for his letter of 22 March about the Government's ideas for taking forward the transfer of functions of the HFEA and the HTA using this Bill's powers. However, I am not at all sure that I am much clearer about how things will work out in practice because the Government seem to be saying in that letter that they have a lot of options for changing things but seem rather uncertain about which option to pursue. On the Minister's own admission the Government cannot say at this stage what approach they prefer to take on transferring functions. That is a fairly big lacuna in the Government's thinking. If they cannot say how they want to change these functions with some degree of clarity and when this new agency
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Part of the problem, it seems to me, is that the Government are very unclear on when they will actually set up the new research agency. The proposed agency commands a huge amount of support across this House and indeed in the world outside. Many of us have long wanted to see that kind of comprehensive, coherent health research agency in place, but it is not an easy job to do. It will be quite a complicated business setting that up. I do not know, and I am not sure that the Government know, when they will have this body up and working and where they will get the funding from. They will need to carry on running existing agencies at a time of some degree of financial restraint and set up a new body to take over those functions in an orderly way. In my time in the public sector I have rarely seen changes of that kind implemented without some extra costs. I have read the Chancellor's statement, in which we all live happily ever after on this particular issue. I would really like to know from the Minister whether the Department of Health has actually got the funding. Has it got a game plan for implementing this agency? When will it come on stream? We need to know that to make any sensible judgments about the transferring of functions.
The noble Lord, Lord Willis, has drawn attention to the complications around licensing in relation to clinical research and clinical practice in these areas. These are complex issues. If we do not know in detail when the agency will be operational and what functions it will have transferred to it, it seems a great leap of faith to put these two bodies in Schedule 5 with a strong commitment from the Government that they are going to act on Schedule 5 and make changes in the functioning of these bodies but without knowing precisely what those changes will actually mean.
I found the penultimate paragraph of the Minister's letter to me of 22 March particularly puzzling. He claims that the mechanism in this Bill reduces the risk of opening up the whole HFEA primary legislation for debate. Like other noble Lords, I view that with deep, deep scepticism. The idea that we can open up a debate about the functions of the HFEA being transferred from it to another body without opening up many of the public concerns around that body and similarly with the HTA seems to me, if I may put it as brutally as this, extremely naive. It is not going to happen. Once you start tinkering with these two bodies of great sensitivity, as I am well aware of from taking the HTA legislation through this House, you are actually opening Pandora's box. You cannot be sure what the outcome will be in terms of public concerns.
I think that we have to go a long way further down the track in understanding the Government's thinking and how this will all work with the establishment of the new health research agency. I do not believe that it is either smart politically or sensible managerially to be heading off in this direction without knowing where the finishing post is.
First, under one of the options under consideration, the extensive and complex HFEA database will be managed by the NHS body that is at present charged with collecting and analysing all health data. There seems to be some confusion among your Lordships about the exact name of this body; it seems to be complex and changing, but I think that the Minister knows what I am referring to. As he also knows, the remit of that body covers only England, whereas the HFEA is responsible for collecting and analysing data for the whole of the United Kingdom. Furthermore, that body does not collect data from private clinics, whereas the HFEA is responsible for collecting data about IVF and its associated techniques from both NHS and private clinics, of which there are, of course, a good many. Can the Minister explain how these incompatible remits can be reconciled? One body is concerned only with England, but the HFEA is concerned with the UK as a whole; one body is concerned only with NHS data, but the HFEA is concerned with both private and NHS clinics.
My second question is on research. The Government are, I know, very interested in the recommendations in the Rawlins report and have it in mind to bring forward a Bill with a view to centralising all licensing for medical research in the proposed medical research agency, to which a number of your Lordships have referred. There is no doubt that in principle this is a welcome step in the direction of cutting out duplication and time wasting for medical research. However, the Rawlins report did not specifically recommend that research that is at present licensed by the HFEA should be passed to the proposed body; in fact, it simply left that matter to ministerial decision. If the research function of the HFEA is transferred to the new body, research involving embryos will still, because of the HFE Act, need both separate licensing procedures and separate inspection. The law will demand that. This will involve setting up a panel and inspection teams with the necessary specialised scientific expertise and specialised legal advice. What possible savings or advantage can there be in doing this? It would require the re-creation of a mini HFEA within the new parent body.
My third question is on the role of the Care Quality Commission. By October of this year, the HFEA and the Care Quality Commission will already have co-located and will be sharing back-office staff. They are working on how they can share inspections. They are already in the process of saving the kind of money that the Government have in mind. Does the Minister not agree that legally transferring some of the functions of the HFEA to the Care Quality Commission will add to the cost, entail the long drawn-out process of consultation and legislation that he mentioned in his letter to us and result in the break-up and reformation of a specialist team, with all the consequent disruption as well as the expense?
Everybody knows that the Minister commands huge respect in this House, but the questions that I and others have posed cannot be answered at the moment
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The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): My Lords, I am grateful to noble Lords for providing us with a further opportunity to debate the future of these two bodies. As is clear, these amendments would have the effect of putting the Human Tissue Authority and the Human Fertilisation and Embryology Authority outside the scope of the Public Bodies Bill. The Government recognise that a number of your Lordships remain unconvinced of the merits of our plans to reform these arm's-length bodies. The concerns that various speakers have raised are ones that we have debated previously and are therefore familiar. I hope, nevertheless, that I can address them.
To begin, I strongly feel that we cannot continue with the parallel systems of regulation that are currently running. There must be some scope for rationalisation and relieving the overall burden on those regulated. However, in looking to achieve that, I fully recognise the need to retain regulatory rigour and expertise in the fields of embryology and human tissue. I therefore offer further reassurance on those issues that have proved of most concern: the retention of expertise, public consultation and the potential savings offered by our proposals.
First, expertise will not be lost. It is envisaged that the expertise invested in individuals will follow functions -for instance, through staff transfers and establishing expert reference groups. There will be a carefully managed transition between regulators, which will ensure that key skills and knowledge are passed on to receiving organisations.
Secondly, there will be extensive consultation later in the summer on where functions are best transferred and, subsequently, on the orders to effect the transfers. We envisage that our consultation will cover two main areas. It will set out our proposals for the transfer of the regulation of treatment and research, and set out the options and considerations for other functions where there may be several different possible destinations, such as those related to the collection and sharing of information or policy decision-making. Let me be clear that these functions, which are required under the Human Fertilisation and Embryology Act and the Human Tissue Act, will continue. A number of your Lordships have voiced the fear that, for instance, the HFEA's registers and databases will be dissipated or lost. That will not happen. The consultation document will set out a number of different options for how these functions might be delivered in the future, and we will listen to people's views about this. I can reassure the House that, in considering how to transfer functions, we will want to maintain the best aspects of the current regulatory system and avoid action that might undermine them.
Thirdly, I turn to financial savings. Together, the budgets for the HFEA and the HTA total £13.6 million. Through the streamlining of regulatory functions, we envisage scope for savings in three areas. The first will be in grant-in-aid for reduced overall running costs.
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"We pay over £100,000 per annum in fees to the HFEA. Since 80% of our work is NHS funded that means that over £80,000 of the money that the PCT pays for fertility treatments goes straight to the HFEA".
That is money which in large measure could be saved and used to deliver healthcare to patients. The department will undertake more detailed analysis of current costs and potential savings to inform an impact assessment which will be developed as part of the consultation process, so the whole set of equations will be transparent.
Lord Harries of Pentregarth: I thank the Minister for giving way. In relation to that last point, when the impact assessment is made will it be possible not only to assess the impact of what the Government are proposing but that of simply telling the existing bodies that they have to cut costs by a certain amount, so that the one can be weighed against the other?
Earl Howe: My Lords, I do not think that I am chancing my arm by saying that that is my understanding of what the impact assessment ought to look like in that a typical impact assessment will have within it several alternatives so that it is possible to compare different options. I would be happy to come back to the noble and right reverend Lord with a definite answer on that but my understanding from previous impact assessments is that that kind of benchmarking ought to be possible.
The noble Baroness, Lady Thornton, has previously raised her concerns about where the ethical framework for any new arrangements will sit. Ethical safeguards, for example concerning the embryos and gametes 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 continue to remain firmly in place and will underpin the regulation of treatment and research as currently, by whoever is responsible for regulating. Where there are specific ethical issues surrounding new treatments, the department will consider how best to commission expert advice on an individual basis, as is currently being done for mitochondrial transfer, for example.
A number of noble Lords have shown interest in and support for the Government's announcement last week, as part of the growth review, about streamlining research regulation and governance. The Government announced in the Plan for Growth on 23 March that they will create a health research regulatory agency to combine and streamline approvals for health research which are at present scattered across many organisations. As a first step, the Government will establish this year a special health authority with the National Research Ethics Service as its core. When established, the new agency will work closely with the Medicines and Healthcare Products Regulatory Agency to create a unified approval process and promote proportionate standards for compliance and inspection within a consistent national system of research governance.
This will reduce the regulatory burden on firms and improve the timeliness of decisions about clinical trials and hence the cost-effectiveness of their delivery in the UK, and has clear support from the Academy of Medical Sciences review of medical research regulation and governance.
In this context, it is important for me to remind the House of a key point. Here I refer particularly to the question posed by the noble and right reverend Lord, Lord Harries. The AMS report recognised at paragraph 9.5.1 that there are significant benefits in bringing all medical research regulation, including embryo research currently undertaken by the HFEA, within the remit of a single health research regulatory agency. Indeed, remarks made by Sir Michael Rawlins in the Guardian on 11 January firmly backed up that view. We agree with that proposition but again the consultation will invite views on it.
My noble friend Lord Willis expressed his fears about the Government adopting a piecemeal approach to reorganisation, as did some other noble Lords. I accept that our approach to the HFEA and the HTA may indeed seem rather complex. The powers of the Public Bodies Bill will enable us to transfer some of the functions of the HFEA and HTA to other bodies but they do not enable us to do everything that we have set out in the arm's-length body review. In order to abolish the HFEA and HTA, or to transfer their research-related functions to any new research agency, we will require powers under future primary legislation.
It might help if I provided a rough outline of how and when we could take this forward. We intend publicly to consult on proposals to transfer all the HFEA and HTA functions to other bodies in the late summer of this year. During 2012-13, under the provisions of the Bill, we will prepare draft orders for formal consultation dealing with the transfer of functions, other than research functions. If appropriate, we would then be able to lay the orders before Parliament. This process would enable noble Lords and other interested parties to see, comment on and debate the proposals, as they progress.
Without the inclusion of these bodies in Schedule 5, we would have to provide for the transfer of their functions entirely within future primary legislation. I simply say again, particularly to the noble Lord, Lord Warner, that not including these bodies would significantly increase the risk that the underlying ethical provisions of the Human Fertilisation and Embryology Act and the Human Tissue Act were reopened for debate.
Lord Willis of Knaresborough: Would it not be possible to include a new clause in the Health and Social Care Bill to set up the new medical research agency and leave to consultation and secondary legislation the details that would follow? That would at least give certainty to that organisation and, with a new Bill in the second part of the Parliament, put it into the parliamentary timetable much earlier than envisaged.
Earl Howe: In theory, my noble friend makes a constructive suggestion. We have considered that option and, I am afraid, rejected it on the grounds that the Health and Social Care Bill is big enough as it is, and
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As I made clear earlier, I confirm to my noble friend that the CQC will have staff transferred into it. The intention is that expertise in staff and advice will follow the functions. Unfortunately, we cannot be definite about exactly which functions will be transferred to the CQC or elsewhere until after the summer consultation. If, standing here, I were to say exactly how that would work, I would be pre-empting the results of that consultation. I agree on the desirability of having clarity and certainty, and our aim is that there should be more clarity and certainty for HFEA and HTA staff after the consultation.
The noble Baroness, Lady Warwick, asked a number of detailed questions about the effect of our proposals on bodies regulated by the HTA and the way that its functions are performed. The case that she put eloquently was an argument in favour of keeping the HTA's functions together. I understand her point of view; however, I reassure her that we will consult on the option of keeping the HTA's functions together. We will not consult simply on one model, let alone pre-empt the results of the consultation.
Earl Howe: The direction of travel for the HFEA is one that we have mapped out. I am not aware that we are considering consulting on keeping the HFEA together. If I am incorrect about that, I will write to the noble Baroness. I understand why she wishes to press me on the point. However, I have not heard this option put forward, and it was not contained in the arm's-length bodies review.
I can assure the noble Baroness that the consultation will give an opportunity to all those with an interest to express their views on where would be the best place to transfer the functions, and on the merits of keeping functions together where appropriate. I recognise that the expertise of the HTA, and the extent to which this will be carried forward, is a key issue. The consultation that we plan will, as I mentioned, give an opportunity for interested parties to express their views on the point.
The noble Baroness, Lady Thornton, asked who would take over the role of competent authority for the EU tissue and organ directives from the HTA. That role will be considered for transfer to other bodies, as with other functions. It involves regulating according to quality and safety standards. We will consult on the most appropriate body for those functions to be transferred to.
My noble friend Lord Willis made clear his view that we should not split research functions. I can tell him that we envisage that the health research agency will cover what is now covered by the approval of research licences. In the context of human embryo research, the legislative requirements that the research is necessary or desirable, and that the use of embryos is necessary, will remain firmly in place. If that consideration includes an assessment of the research technique proposed, it will remain so in future.
The noble Baroness, Lady Thornton, and the noble and right reverend Lord, Lord Harries, asked how we would deal with the devolved Administrations. The intention of the proposals is to reduce both the cost of regulation and the bureaucracy for regulated establishments. It is important that a workable solution is found for the devolved Administrations, while recognising that the subject matter of the legislation is reserved. The Human Fertilisation and Embryology Act extends to the whole of the UK, and the Human Tissue Act extends to England, Wales and Northern Ireland. We hope to agree a way forward with the devolved Administrations that avoids any unnecessary duplication of effort in order to keep costs and bureaucracy for regulated establishments to a minimum. We have had constructive discussions already at official level, and these will continue. The CQC is at present an England-only body. If reserved functions were transferred to the CQC, we would extend its territorial remit in respect of those functions alone.
I will return to where I began. It is surely right that the Government and Parliament should look for opportunities to streamline regulatory mechanisms, as long as this is done in a way that preserves the legal functions, and the ethical underpinning of those functions that Parliament has put in place. The Bill provides us with the means to do that in respect of the HFEA and the HTA. In view of the Government's broader concessions on the Bill, and our intentions to consult widely on the proposed transfers of functions and to protect existing ethical and legislative safeguards, I hope that noble Lords will not press their amendments.
Baroness Thornton: I thank the Minister for another detailed response. I also thank the noble Lord, Lord Willis, the noble Baroness, Lady Deech, the noble and right reverend Lord, Lord Harries, and my noble friends Lady Warwick and Lord Warner. I counted 17 to 20 questions that the Minister was asked. He gave us a great deal of information, some of which was useful and very interesting. However, I do not think that he answered all the questions.
The Minister raised the issue of us not being convinced. We are not being perversely unconvinced. The problem is that there are still too many unknowns about this part of the Bill. Extensive consultation in the summer, to which the noble Earl has referred on many occasions, is after the decision has been taken and after the powers have been taken.
For example, the Minister was pressed on the concern about registers and databases. His answer was that the decision would be part of the consultation, that they would not be dissipated and that there would be
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On the ethical issues that I raised, the Minister suggested that those would go with whoever it seemed appropriate to be the responsible body. Frankly, at this stage of the Bill, an answer that has "whoever" in it is not satisfactory. There is widespread agreement that the medical research agency proposals sound promising, but that simply underlines the point that we should not proceed with including these two bodies in the Bill at this point.
The Minister has said several times that it is a complex process. We agree, and indeed the noble Lord, Lord Willis, made an extremely good suggestion about one way to simplify the process by using forthcoming legislation. Having been the Minister responsible for several Bills that might have been called Christmas-tree Bills, I am not sure that he does not have a very good point.
That begs the question: what is the hurry? If streamlining can be achieved without powers being taken in this Bill, money can be saved-as several noble Lords have said-without taking such powers, and a much larger discussion will be taking place as we move forward. It seems to me that those points remain outstanding.
At this point in our consideration, I do not think that we have reached a satisfactory and conclusive point in our discussions about the HFEA and HTA. I hope that we can resolve and clarify the remaining and outstanding uncertainties on this issue before Third Reading, and I very much welcome the fact that the Minister has said that he will be responding to certain points. I am sure that he is prepared to continue those discussions and I hope that we can resolve them before Third Reading. Otherwise, I fear that we may have to return to this issue. I beg leave to withdraw the amendment.
Lord Taylor of Holbeach: My Lords, even at this late hour, it gives me great pleasure to introduce this group of amendments, each of which introduces important changes to the schedules. I hope that they will be welcomed on all sides of the House.
Amendment 60 would create a power for a Minister, when making an order under Clauses 1 to 5, to include a provision to remove the body or office subject to the order from the schedule or schedules in which the body was listed. The amendment ensures that, where a Minister has been able to implement the proposed reforms by virtue of an order under the Bill, that body can be removed from the relevant schedule and therefore be assured of its ongoing status.
Amendment 69C represents a solution-which, I am happy to state, has the support of the noble Lord, Lord Hunt of Kings Heath-to the question of so-called omnibus orders relating to more than one body and whether they should be permissible under the Bill. I made a commitment in Committee to consider the matter further and have done so. During our debates in Committee, I expressed my concern that any restriction on omnibus orders should not prevent Ministers from the sensible and reasonable combination of related changes in a single order. For example, I am sure that the House will understand that there is little to be gained from a separate consideration of 160 orders making identical changes to internal drainage boards.
On that basis, the Government propose instead to amend Clause 11 to require that, should Ministers consider it appropriate to bring forward an omnibus order under Clauses 1 to 5, they must explain in the Explanatory Memorandum their justification for the decision. It will therefore be for Parliament to judge whether the Minister's decision was appropriate. I consider that to be a sensible and proper solution.
I am delighted to have added my name to Amendment 72, in the name of the noble Lord, Lord Hunt of Kings Heath, the noble Baroness, Lady Royall of Blaisdon, and my noble friend Lord Norton of Louth. That amendment, much like the amendment in Committee which now forms Clause 16, represents the outcome of genuine engagement and compromise on all sides of the House. I pay tribute to noble Lords who have assisted in presenting it to the House this evening. Amendment 72 effectively sunsets the entries in the schedules by ensuring that an entry in the schedule automatically lapses five years after its commencement. The amendment therefore clarifies that the listing of a body in one of the schedules will not involve endless changes to that body's status but will be a vehicle for specific reforms which the Government expect to be carried out in a timely fashion. As I described the Government's thinking in Committee, the amendment will ensure that the powers in the Bill will remain on the statute book. That ensures that, following future reviews of public bodies, the Government will have the option of using primary legislation to repopulate the schedules as a means of making further reforms, subject to Parliament's consent.
For that reason, I am unable to support Amendment 72A in the name of my noble friend Lord Goodhart. That amendment would sunset the entire Bill, as well as the entries in the corresponding schedules, following the dissolution of this Parliament. To do so would be a mistake. It would leave the Government without a mechanism to take forward the outcomes of what I believe all sides of the House hope will be regular, systematic reviews of public bodies. Particularly given the work that this House has undertaken to craft a mechanism in the Bill which can command the confidence of Parliament and the public, it would be a retrograde step to ask future Parliaments to begin that process from scratch.
The Government's amendments in this group and Amendment 72 each significantly improve the mechanisms of the Bill and are the product of a process of engagement and deliberation that characterises this House at its
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Lord Goodhart: My Lords, I have again tabled an amendment that I tabled in Committee, and which is now Amendment 72A. As my noble friend Lord Taylor says, the amendment involves a sunset clause. We now have government Amendment 72, which is a sort of sunset clause-it gets the clause going halfway down, towards the shadow, but not quite going the whole way. In view, however, of Amendment 72 and its wide range of supporters, I will support on this occasion Amendment 72 rather than my own amendment. That does not mean that I think that Amendment 72 is better; it is certainly a step forward but I am not convinced that it is in fact better than a simple sunset clause would have been. The effect of Amendment 72 is that after five years the Act will in reality be dead, but somehow it will be brought back to life by new primary legislation. That seems rather a clumsy arrangement, but if others wish to try it, so be it, and, as I said, I will support it.
Baroness Royall of Blaisdon: My Lords, I am grateful to the Minister. We certainly support him in his Amendments 60 and 69C and we are especially grateful for the work that the Government have done on omnibus orders. We think that they have arrived at a sensible and proper solution, as the Minister said.
As for the sunset provision, when we first broached this subject in Committee, the Bill was a very bad one. That is why we wanted to sunset the whole Bill. Since then we have genuinely engaged with the Minister and reached a very good compromise. Since Committee the Bill-its content and its architecture-has been radically transformed. Although my noble friend Lord Hunt will seek further change to the Bill's architecture at our next sitting on Report, we are content that the sunsetting of the schedules is adequate. We believe it right and proper that at the beginning of every Parliament there is the potential to have what would in essence be a new Public Bodies Bill. However, we also believe that the architecture is such that it could be maintained while looking again at the schedules. By sunsetting the schedules, the bodies that are currently in the schedule will have the comfort of knowing that if nothing has happened to them within the four or five-year period, they will be free, as it were; and the bodies that are not included will know that they can continue to work efficiently and effectively without a medium-term sword of Damocles hanging over them. We are therefore very grateful to the Minister for the changes to which he has agreed, and we look forward to the adoption of the amendments in question.
Viscount Eccles: My Lords, the first three amendments in this group are very welcome. Going right the way back to Second Reading, I remember the suggestion that Schedule 7 be dropped from the Bill being made right at that time. The dropping of Schedule 7 makes the arrangements for sunsetting a great deal easier to agree than they would have been if that schedule had stayed in. These two amendments are rather a subtle way of agreeing to a sunseting procedure, but they are none the less very welcome. I also remember that at Second Reading there was a suggestion that if this was the way that we were going and Schedule 7 were dropped, perhaps we would need Public Bodies Bill (No. 2). I am sure that my noble friends on the Front Bench and, particularly, my noble friend Lord Taylor are very pleased that he has found a way of avoiding Public Bodies Bill (No. 2), and I think we should all be very grateful for that. Finally, we have made a long journey and a lot of progress, which is extremely welcome.
Lord Taylor of Holbeach: I thank noble Lords for the general welcome given to these amendments. I thank those on the opposition Benches for their positive engagement on finding these solutions. For that, I am extremely grateful. I thank my noble friend Lord Goodhart for the gracious way in which he bowed to the consensus building on Amendment 72 and my noble friend Lord Eccles for the recognition he gave to the difficulties this Bill faced and for his part in overcoming those difficulties.
A message was brought from the Commons that they concur with the resolution of this House of 23 March relating to a Joint Committee to consider the draft Defamation Bill presented to both Houses on 15 March and that they have made the following orders:
That the Committee shall have power- (i) to send for persons, papers and records; (ii) to sit notwithstanding any adjournment of the House; (iii) to report from time to time; (iv) to appoint specialist advisers; and (v) to adjourn from place to place within the United Kingdom.
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