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House of Lords

Wednesday, 12 June 2013.

3 pm

Prayers—read by the Lord Bishop of Chester.

British Board of Film Classification


3.07 pm

Asked by Lord Storey

To ask Her Majesty’s Government what plans they have to re-examine the status of those films, videos and DVDs currently exempt from classification by the British Board of Film Classification.

Lord Gardiner of Kimble: My Lords, under the Video Recordings Act 1984, videos on recordable media, such as DVDs, are classified by the British Board of Film Classification. However, to date many products about sports, music, religion and education have been exempt from this requirement. Following a public consultation, the Government announced last month that they will bring forward legislation to tighten up the exemptions and to ensure that, in future, any products in these genres will be classified if they contain material deemed to be unsuitable for younger children.

Lord Storey: My Lords, I thank the Minister for his reply. I am sure that he is not aware of Cannibal Corpse’s “Live Cannibalism” DVD being legally supplied to British children or, indeed, the double-disc set “His Name was Jason: Thirty Years of Friday the 13th”, so the change in the law for such content to be brought within the regulatory scope of the BBFC cannot come too soon.

I note that the Government’s announcement also mentioned another potential loophole in the current regime, that being online music videos. Does my noble friend believe that the music industry should consider following the example of the home entertainment industry by adopting BBFC classifications for online music videos?

Lord Gardiner of Kimble: My Lords, I think we are agreed that the number one priority in all we are seeking to do is to protect children. The Prime Minister and the Secretary of State have been rightly robust about this, as have many noble Lords. The Government are taking action to protect children from inappropriate content, and there are strong intentions in the online area as well because it is clearly the case that children are viewing content online. We are therefore going to do more in the area of online video labelling, and we are working with many organisations and parents to deal with music or anything that could be potentially harmful to younger children.

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Baroness Howe of Idlicote: My Lords, I congratulate the Minister on confirming that the Government have decided to act decisively to ensure that currently exempt material which is potentially harmful to children is brought within the regulatory ambit of the BBFC. I mention this because as long ago as 2009 I moved amendments in this House seeking to change the law in this area. How swiftly does the Minister think that this change to the current regime can be implemented? I know that it has the support of the BBFC and, most importantly, of the parents of vulnerable children.

Lord Gardiner of Kimble: My Lords, I know of the deep interest of the noble Baroness in content available online, which we need to deal with. So far as this matter is concerned, we are working carefully to ensure that the definitions dealing with violent sexual behaviour and swearing are worded so as to ensure that they identify all products that are unsuitable for younger children. The final version of the definitions will be written into the draft legislation that is to be issued for consultation soon. We want to get it right and we would very much welcome any comments. We will then need to notify the EU about the new regulations, following which there will be the secondary legislative process.

Lord Cormack: My Lords, does my noble friend agree that the greatest crime of the 21st century is the destruction of childhood innocence? The second greatest crime is preventing young people growing up normally and naturally. Will he be a little bit generous in his interpretation of the word “children” to make sure that we do not expose young men in puberty and girls of equivalent age to things which, frankly, they should never ever be able to see?

Lord Gardiner of Kimble: My Lords, I have sympathy with my noble friend. Childhood at whatever age is a very precious time of our lives and children should be able to enjoy it. It is important that the Government should work with parents because their first priority and responsibility is looking after their children. It is obvious that online content is troubling many parents, so that is why we are working to set up internet parental controls and are working with wi-fi providers on a number of issues. In that way, we can ensure that children do not see inappropriate content.

Lord Swinfen: My Lords, new products are being developed at an ever increasing rate. Will the Government ensure that the regulations are drafted in such a way that they can be easily and quickly updated to deal with new products coming on to the market and so safeguard our children?

Lord Gardiner of Kimble: My Lords, it is very much a feature of technology moving so fast that we also need to ensure that the checks and controls are appropriately calibrated so that whatever happens with technological advances children do not see inappropriate content, which is what we want to ensure.

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Lord Laming: My Lords, does the noble Lord agree that, so far as children and young people are concerned, this material represents for them the values of our society and therefore our society has a special responsibility to make sure that what is conveyed actually accords to our values and beliefs, especially about childhood?

Lord Gardiner of Kimble: The noble Lord again raises an important point. That is why, across the piece, the Government, industry and charity, through the UK Council for Child Internet Safety, are working so much together and why the Secretary of State is having a summit meeting on 18 June with the major internet service providers, mobile operators, search engines and social media companies to explore all that can be done to ensure that children remain safe.

The Earl of Glasgow: My Lords, is the Minister aware of the scheme practised quite a lot in Italy by which DVDs and controversial material of that sort are classified by the users themselves and the users’ classification then becomes legal?

Lord Gardiner of Kimble: I have been quite busy learning about what happens in the United Kingdom, so I was not aware of what might be happening in Italy. However, I think—and I am sure it is what my noble friend was alluding to—we need to make sure that whether it is by age verification or whatever that children remain secure.

Ofcom: Public Service Broadcasting


3.14 pm

Asked by Lord Clement-Jones

To ask Her Majesty’s Government when they expect to reach conclusions on changes to Ofcom’s statutory duties and functions with respect to public service broadcasting.

Lord Gardiner of Kimble: My Lords, the Government published a consultation on 23 April proposing reforms to Ofcom’s statutory duties and functions, including measures relevant to public service broadcasting. Following this consultation, which closes on 25 June, the Government intend to bring forward a public bodies order before the Summer Recess. That order will be debated in both Houses in the autumn and we expect it to be in force at the end of this year.

Lord Clement-Jones: My Lords, quality and diversity in our public service broadcasting are hugely important for our society. Rapid changes in technology and convergence between the internet and television could affect both considerably over time. The Government acknowledged this in their response to the recent Communications Committee report on convergence, yet now they propose to get rid of Ofcom’s obligations to review public service broadcasters on a regular five-year basis to save just £180,000. Is that not perverse?

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Lord Gardiner of Kimble: The intention is to provide more flexibility in the timing of when reviews of public service broadcasting are conducted. It is certainly not the intention to remove the obligation to conduct such reviews in future, but rather to ensure that when they happen they are relevant, timely and of the correct scope. Of course, I must not prejudge the consultation. There are some more weeks of it to go and comments would be most welcome.

Lord Puttnam: My Lords, does the Minister accept that, whereas the quality of regulation in this country over the past few years has been at times questionable, Ofcom is, in my experience, regarded internationally as the gold standard for regulation, particularly in the very complex media industry? Can he assure us that nothing will be done to diminish the quality of Ofcom or in any way reduce its powers?

Lord Gardiner of Kimble: I am most grateful to the noble Lord and am particularly conscious of his long-term interest in this, having been so much involved in the setting up of Ofcom. I assure him that Ofcom will be required to ensure that the quota requirements are met by the public service broadcasting sector, whether in news, current affairs, original productions, independent productions, outside-London productions or regional news. It must also publish data on compliance with the above quotas in an annual PSB report. The Government are working closely with Ofcom, which we want to continue to be a very successful organisation.

Lord Brooke of Sutton Mandeville: My Lords, I congratulate the Government, through my noble friend, on the fact that they launched this particular consultation on Shakespeare’s birthday.

Lord Gardiner of Kimble: We should all celebrate Shakespeare’s birthday. In the arts and culture debate tomorrow, I might mention something about our most famous poet. I want to emphasise that Ofcom has now been in existence for 10 years and it is appropriate, given the huge technological advances in this sector, that we should look at how we could do things better.

Lord Foulkes of Cumnock: Will the Minister take on special responsibility for drawing to the attention of Ofcom and all broadcasting organisations the importance of balance in their output in the run-up to the referendum on Scottish independence?

Lord Gardiner of Kimble: I hope the noble Lord knows my own preferences on the matter of the referendum. Of course, impartiality must be absolutely key to anything we do, whether it is a referendum or general elections. It is part of the essence of public service broadcasting.

Baroness Bonham-Carter of Yarnbury: My Lords, as we are talking about Ofcom’s duties, what plans do the Government have to act on the recommendations made by Ofcom about plurality in the media in a report published last year at the request of the Secretary of State?

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Lord Gardiner of Kimble: Certain Members of your Lordships’ House attended the QSD on 22 May when we discussed plurality. The Government are seeking views on this matter, which is complex. I think Lord Justice Leveson agreed with that. We are building on Ofcom’s advice and the recommendations of Lord Justice Leveson. The process will begin in September. I know that your Lordships’ Communications Committee is also working on these matters.

Baroness Jones of Whitchurch: My Lords, following my question on a possible communications Bill in the Queen’s Speech debate, I was surprised to receive a letter from the noble Earl, Lord Howe, which I am sure he cleared with the noble Lord’s department. In that letter, the noble Earl states that, for the most part, our regulatory framework is working well and that there simply is not a great clamour for wholesale reform. Given the growing demands for greater child protection, which we have talked about this afternoon, and for internet controls, decent broadband and media ownership controls, does this not represent a lack of courage on the part of the Government? They really should be legislating on a broader scale to firm up outside regulation and increase controls in these areas.

Lord Gardiner of Kimble: I would say to the noble Baroness that the work we are doing on Ofcom is designed to ensure that we do not do things that are unnecessary and inefficient. We should be enabling Ofcom to undertake its really important responsibilities. I refer to refinements because, having looked at the recommendations in the consultation, I think they give a more refreshing and up-to-date twist on what we wanted Ofcom to do when the noble Lord, Lord Puttnam, was so involved in its creation.

Lord Grocott: In the light of this Question and the wider debate about the Leveson inquiry, is it not worth reminding ourselves of the fact that in this country broadcasters work within a democratically established regulatory framework? This is in comparison with the press, which talks at great length about freedom of the press. Of course we need to respect this and it is very important, but the broadcasters’ regulatory framework thoroughly enables them to conduct investigative reporting and news and current affairs reporting to the highest standards. It is perfectly possible to have the highest quality of media output within a proper regulatory framework.

Lord Gardiner of Kimble: I would say to the noble Lord that I think we should have a free and a responsible press.

Russia: Non-Governmental Organisations


3.22 pm

Asked by Lord Judd

To ask Her Majesty’s Government what representations they have made to the Government of Russia about their policy toward non-governmental organisations.

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Lord Wallace of Saltaire: My Lords, the Government are concerned by pressures on NGOs across Russia, including the NGO “foreign agents” law. These concerns are outlined in the FCO’s Human Rights and Democracy report for this year. In recent months the Foreign Secretary, the Minister for Europe, and my noble friend the Minister of State for Justice have raised this subject with their Russian counterparts. Two days before the Prime Minister’s 10 May visit to Sochi, senior officials raised concerns about the treatment of civil society at the annual UK-Russia human rights dialogue, held in Moscow.

Lord Judd: Do the Minister and the Government agree that a vibrant civil society, participating in public debates and analysing policy on the basis of the experience of engaging in society are vital to a healthy democracy? How can the recent draconian action by the Russians, with more than 208 organisations now raided by government officials, possibly strengthen democracy and stability in Russia? How can this be reconciled with membership of the Council of Europe? What are the Government, together with European Union partners, doing, in the Ministers’ meeting at the Council of Europe, in bilateral meetings and on every possible occasion, to bring these truths home to the Russians?

Lord Wallace of Saltaire: My Lords, Russia is at present moving away from the principles of open society. That is deeply concerning to all of us. We continue to express our deep concerns about that, and our concern that this does not allow for the long-term stability of Russia itself, every time we meet our Russian counterparts.

Baroness Williams of Crosby: My Lords, while I agree strongly with some of the remarks made by my noble friend the Minister and the noble Lord, Lord Judd, at present the Council of Europe is very much engaged in close discussions with the Russian authorities and some questions are being raised about whether the draconian law will be carried out effectively or reconsidered. May I therefore suggest that the better approach at present is probably through the Council of Europe, of which Russia is a member, dedicated as it is to all the values and ideals of democracy, rather than an individual national protest by the United Kingdom when the President of Russia is just about to arrive here?

Lord Wallace of Saltaire: My Lords, the United Kingdom is, I think, the only EU member state that has a bilateral human rights dialogue with the Russians. We have had it for some years and we think it is valuable. The EU itself has collectively expressed its concerns at the current Russian situation. Our counterparts in the German and French Governments, whose German party political foundation offices and Alliance Française have been raided and inspected in Russia, have also expressed their concerns.

Lord Anderson of Swansea: My Lords, does the Minister agree that the current swathe of repression of non-governmental organisations is just one of a number of measures taken by the Russian Government as they move along the path of a quasi-tsarist autocracy?

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Have we specifically raised this matter in the Council of Europe with like-minded countries, as Russia is a member and has certain obligations under the Council of Europe agreement?

Lord Wallace of Saltaire: My Lords, we actively discuss with our partners in the European Union and the Council of Europe a whole range of concerns, including those about Russia. I think I am correct in saying that one in every four cases before the European Court of Human Rights at present concerns Russia.

Lord Triesman: My Lords, we share the anxieties that have been expressed. I was interested to hear the Minister mention in his very first response NGOs from outside Russia. What is the current status of the relationship between the Russian Government and the British Council, and is the British Council able to conduct its normal and completely proper work inside that country? If I may follow up a point made by the noble Baroness, Lady Williams, is there perhaps an opportunity for a side meeting at the G8 to underline this issue with the Russian President?

Lord Wallace of Saltaire: My Lords, the British Council was under considerable pressure some years ago. Indeed, my wife and I were in St Petersburg and visited Stephen Kinnock, who was then the head of the office there, the day after his office had been inspected by the authorities in a clear attempt to intimidate its activities. At present, however, the Alliance Française is being pursued, not the British Council. The British Council does its best to operate in rather difficult circumstances.



3.27 pm

Asked by Lord Lee of Trafford

To ask Her Majesty’s Government, in the light of the possible closure of Science Museum Group museums in the north of England, what assessment they have made of the economic, educational and cultural benefits of regional museums.

Lord Lee of Trafford: My Lords, I beg leave to ask the Question standing in my name on the Order Paper and in doing so declare interests as the chairman of the Association of Leading Visitor Attractions, of which the Science Museum Group is a member, and as a former chairman of MOSI, the Museum of Science & Industry in Manchester.

Lord Gardiner of Kimble: My Lords, our country has a diverse network of high-quality museums and galleries, both national and regional, which educate and delight local people and tourists alike. DCMS has overall responsibility for those in England. These museums have a strong identity within their local communities. They are often at the heart of their regions’ creative industries, provide an educational resource and contribute to their regions’ international reputation and economy.

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Lord Lee of Trafford: My Lords, given that the Government are committed to promoting tourism in the regions, but also to encouraging youngsters to follow careers in science and engineering, is it not incomprehensible that the Science Museum Group is faced with a possible further 10% funding cut, on top of the 25% cut, thus publicly having to state that it might have to close one of its three regional museums? The Manchester Museum of Science & Industry, or MOSI, attracts 700,000 visitors a year of all ages. They come to see the museum of the first industrial city, the first baby computer and the first passenger railway station in Manchester. Would it not be bordering on the criminal if there was any question of contraction or closure?

Lord Gardiner of Kimble: My Lords, I must first acknowledge my noble friend’s long-term commitment to the Museum of Science & Industry in Manchester and as a distinguished former chairman of it. Visits to the museum have continued to increase and have increased by 31% since its merger with the Science Museum Group in January last year. I have of course read the reports in the press speculating on the future of regional branches of the Science Museum Group. The spending review process for 2015-16 has not reached its completion. It would therefore be premature, indeed impossible, for a considered decision by the Science Museum Group to be made until after that process is complete.

Lord Faulkner of Worcester: My Lords, I declare an interest as a trustee of the Science Museum Group and as a former chairman, like the noble Lord, Lord Lee of Trafford, of the advisory board of MOSI in Manchester. The Minister is right to draw attention to the huge popularity of MOSI. It is a similar story at the other museums in the Science Museum Group. The total number of visitors now exceeds 5 million a year. However, is he aware—and I hope that he listens very carefully to the points made by his noble friend—that the group has had to accept funding cuts of 25%, as the noble Lord says, over the past four years? A further 10%, if that is contained in the spending review, may make it inevitable, although very undesirable, that one of the museums in the group may have to close. Can he use all his influence to make sure that that spending review does not contain a cut on that scale?

Lord Gardiner of Kimble: My Lords, I well understand the concern that has been expressed in the north, in particular in Yorkshire and in Manchester. Clearly, as I said, the spending review process has not been completed. I am absolutely sure that ministerial colleagues to whom I have spoken in the department are absolutely clear about the contribution that museums make to the tourism market. The DCMS museums are the first six of all visitor attractions in the country. There is a full understanding of the beneficial impact that museums make on our national life.

Lord Alton of Liverpool: My Lords, would it not be a good idea if the Minister were to add to the number of visitors to some of the northern museums so that he could see for himself the quality of the Merseyside

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Maritime Museum, the Museum of Liverpool, Tate Liverpool, the Imperial War Museum North and the Museum of Science & Industry—to which the noble Lord, Lord Lee, has quite rightly drawn our attention today—and recognise that they make a major contribution to the cultural and educational life of the north of England? They are an indispensable asset for children in our schools. If they were to be removed at a time when we are trying to promote science, it would be an incredibly retrograde and backward step. It would also further entrench the impression of the north-south divide.

Lord Gardiner of Kimble: We do not wish for one moment for there to be any sense of divide. As the noble Lord has quite rightly said, this Government and the previous Government have invested a considerable sum of money through the Renaissance programme in regional museums. Since 2011-12, £180 million has been invested by DCMS in the regional museums. As he rightly alluded to, this programme has driven up visitor numbers in regional museums so that last year there were 19.1 million visitors to regional museums. I am very much aware of the—I think that there are seven—Liverpool museums. I have visited some and it would be lovely in the summer if I could visit many more.

The Lord Bishop of Ripon and Leeds: My Lords, in view of the contribution of the National Media Museum in Bradford to West Yorkshire culture, can the Minister tell us how he and colleagues will take local views into account in making decisions? In particular, what can he do to avoid competition between the three museums allegedly under threat at the moment?

Lord Gardiner of Kimble: As I say, there is this speculation. The three museums—the National Railway Museum in York, the National Media Museum in Bradford and MOSI in Manchester—all have a distinct character and history. I will be taking back to colleagues the strong opinions of the right reverend Prelate and others about the importance of the museums in their localities.

Lord West of Spithead: My Lords, I declare an interest as a trustee of the Imperial War Museum. Does the Minister agree that the draconian cuts that are being imposed have put a huge problem in the face of all the museums? Given the Imperial War Museum’s scope of museums, there is no doubt that one has to look at what draws the most visitors. There is no doubt that a museum such as the Imperial War Museum North—which is an amazing facility opposite the BBC in Salford, and is a fantastic focus—has to be at threat. I would ask whether we are looking at the dreadful business of possibly charging people, because I cannot see how museums can go forward with cuts of this scale.

Lord Gardiner of Kimble: My Lords, the Government are absolutely clear in the grant-in-aid arrangements that the policy of free admission should continue. Having looked at the increase in visitor numbers, and at the number of children who are visiting museums, I think that free admission is an important feature of our national and regional museum life. I am very

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conscious of what the noble Lord said about the Imperial War Museum. With the commemoration of the First World War and the investment that is going into the Imperial War Museum, and certainly from the meetings that I have had with officials there, I know that a lot of very exciting work is going to unfold at the Imperial War Museum as well as at Duxford. There is important work for the Imperial War Museum to show.

Lord Shutt of Greetland: My Lords, the clue is in the titles—the National Media Museum, the National Railway Museum, the National Coal Mining Museum for England. I have had a look at the names of two dozen people who are trustees of the Science Museum Group or members of the Science Museum advisory board and—would you believe it?—22 of those 24 people are based either in London or in Cambridge.

Noble Lords: Oh!

Lord Shutt of Greetland: Does the Minister have any faith that this group of people will have balance when it comes to looking at those national museums that are based in the regions?

Noble Lords: Hear, hear!

Lord Gardiner of Kimble: I think that I might have an uphill task persuading your Lordships. It is important to say that under the National Heritage Act 1983 the appointment of trustees must have regard to their experience of the development of science and technology, in the case of MOSI, and to their knowledge of management, industrial relations and administration. Interestingly, the chairman of the Science Museum lives in West Yorkshire, and I am led to believe that half the representatives of the board of trustees live outside London. If they are all also living in Cambridge, I will have to look at that.

Children and Families Bill

First Reading

3.37 pm

The Bill was brought from the Commons, read a first time and ordered to be printed.

Humber Bridge Bill

Humber Bridge Bill

Second Reading

3.37 pm

Moved by The Chairman of Committees

That the Bill be read a second time.

The Chairman of Committees (Lord Sewel): My Lords, I beg to move that this Bill be now read a second time.

Bill read a second time.

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Constitution Committee

Membership Motion

3.38 pm

Moved by The Chairman of Committees

That Lord Lester of Herne Hill be appointed a member of the Select Committee in place of Lord Macdonald of River Glaven, resigned.

Motion agreed.

Refreshment Committee

Membership Motion

3.38 pm

Moved by The Chairman of Committees

That Lord Tunnicliffe be appointed a member of the Select Committee in place of Baroness Gale, resigned.

Motion agreed.

Marriage (Same Sex Couples) Bill

Order of Consideration Motion

3.39 pm

Moved by Baroness Stowell of Beeston

That it be an instruction to the Committee of the Whole House to which the Marriage (Same Sex Couples) Bill has been committed that they consider the bill in the following order:

Clauses 1 to 4, Schedule 1, Clauses 5 to 10, Schedule 2, Clause 11, Schedules 3 and 4, Clause 12, Schedule 5, Clause 13, Schedule 6, Clauses 14 and 15, Schedule 7, Clauses 16 to 19.

Motion agreed.

Health: Children's Heart Services


3.39 pm

The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): My Lords, with the leave of the House, I shall now repeat a Statement made earlier today in another place by my right honourable friend the Secretary of State for Health on the Safe and Sustainable review of children’s heart services. The Statement is as follows.

“With permission, Mr Speaker, I would like to make a Statement on the Safe and Sustainable review of children’s congenital heart services.

On average, around 3,700 heart procedures are carried out each year on children who have been diagnosed with congenital heart conditions. The mortality rates at Bristol Royal Infirmary, identified as far back as 1989, indicated that we are not as successful as we

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should be in such operations. The Safe and Sustainable review began in 2008 and set out to make sure that children’s heart services are the best they can be for all children across the country. Whatever the controversy about the location of such services, we all have a responsibility to ensure the best possible outcomes for children and their families, who must always come first in any decision about service provision.

Sir Ian Kennedy, in his Bristol inquiry report in 2001, recommended the concentration of medical and nursing expertise in a smaller number of centres. Subsequent working groups and reports have endorsed that recommendation, including the Royal College of Surgeons in 2007. The public consultation on the Safe and Sustainable review received over 75,000 responses. This was the largest review of its kind, conducted independently of government by the NHS.

In July 2012, the then Joint Committee of Primary Care Trusts—the JCPCT—on behalf of local NHS commissioners, decided that children’s heart surgery networks should be formally structured around specialist surgical centres in Bristol, Birmingham, Liverpool, Newcastle and Southampton, as well as Great Ormond Street and the Evelina Children’s Hospital in London. They recommended that services should no longer be provided in Leicester, Leeds, Oxford and the Royal Brompton and Harefield in London. Following the JCPCT’s announcement, three local health overview and scrutiny committees formally referred the JCPCT’s decision for me to review and I wrote to the Independent Reconfiguration Panel—the IRP—asking them to undertake a full review of the proposals.

On 30 April 2013 I received the report. I would like to thank the IRP for producing such a comprehensive review of such a challenging topic. It strongly agrees with the case for change, specifically that congenital cardiac surgery and interventional cardiology should only be provided by specialist teams large enough to sustain a comprehensive range of interventions, round-the-clock care, specialist training and research. I agree with their analysis.

However, the report also concludes that the outcome of the Safe and Sustainable review was based on a flawed analysis of the impact of incomplete proposals, and leaves too many questions about sustainability and implementation. This is clearly a serious criticism of the Safe and Sustainable process. I therefore accept their recommendation that the proposals cannot go ahead in their current form and am suspending the review today. NHS England will also seek to withdraw its appeal against the judicial review successfully achieved by Save Our Surgery in Leeds.

None the less, the IRP is clear that the clinical case for change remains, and its report is very helpful in setting out the way forward in terms of broadening the scope of the discussion, and looking in detail at the affordability and sustainability of the proposals. The IRP says—and I agree—that this is not a mandate for the status quo or for going back over all the ground already covered during the last five years. The case for change commands widespread support and understanding and we must continue to seek every opportunity to improve services for children.

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The recommendations in the report set out what the IRP considers needs to be done to bring about the desired improvements in services in a way that addresses gaps and weaknesses in the original proposals. Specifically, they include: better co-ordination with the review of adult heart surgery services; expanding the detailed work on the clinical model and associated service standards for the whole pathway of care, beyond surgery; services to be fully modelled and their affordability retested; NHS England to establish a systematic, transparent, authoritative and continuous stream of data and information about the performance of congenital heart services; NHS England and the relevant professional associations to put in place the means to continuously review the pattern of activity and optimise outcomes for the more rare, innovative and complex procedures; NHS England to reflect on the criticisms of the JCPCT’s assessment of quality and learn lessons to avoid similar situations in its future commissioning of specialist services; and NHS England to use the lessons from this review to create with its partners a more resource and time-effective process for achieving genuine involvement and engagement in its commissioning of specialist services.

NHS England now must move forward on the basis of these clear recommendations and the Leeds court judgment. I have therefore today written to NHS England, and the local overview and scrutiny committees that originally referred the JCPCT’s decision to me, to explain that the IRP’s report shows that the proposals of the Safe and Sustainable review clearly cannot go ahead in their current form. It is right to give all parties some time to reflect on the best way forward, now that the IRP report is in the public domain, so I have asked NHS England to report back to me by the end of July on how it intends to proceed. In the mean time, it is important to stress that I believe that care for children with congenital heart conditions is safe in the NHS, and that ensuring it continues to be will be the top priority for all involved in this process.

I know that many families have found the Safe and Sustainable review to be a traumatic experience. People are rightly proud of the hospitals and the staff that have saved, or tried their best to save, the lives of their children. However, there is overwhelming consensus that we cannot stick with the model of care that we have now. To do so would be a betrayal of the families who lost loved ones in Bristol and who want nothing more than for the NHS to learn the lessons from their personal tragedies. So it is right we continue with this process, but it is also essential that it is performed correctly so that any decisions, as difficult as they may ultimately be, carry the confidence of the public. I commend the report and this Statement to the House”.

My Lords, that concludes the Statement.

3.47 pm

Lord Hunt of Kings Heath: My Lords, I thank the noble Earl for repeating the Statement and for reminding the House of the events which led to the Safe and Sustainable review. Terrible failings in the care of very sick children at the Bristol Royal Infirmary in the 1980s and 1990s led Sir Ian Kennedy to call for expertise to be concentrated on fewer surgical sites, a call supported by more immediate, recent events, including the suspension

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of children’s heart surgery at the John Radcliffe Hospital in Oxford in 2010. Since Bristol, Sir Ian’s important conclusion has had the support of the health professions and all sides of the House.

As we digest what the noble Earl has said, two considerations must remain foremost in our minds. First, this issue continues to transcend party politics; and secondly, the complexity it presents should not derail us from our determination to deliver the safest possible care for children in the country. That said, changes of this magnitude must be able to command consensus and public confidence and that has not happened since the decision on site selection by the joint committee.

When it was published, while the Opposition supported the reduction in sites, we expressed concerns about the distribution of the seven sites, skewed towards the west of England and leaving a large swathe of eastern England, from Newcastle to London, without a centre. For a family living in Hull or Lincoln, the prospect of leaving home to travel hundreds of miles, with the cost of accommodation and time off work, added to their stress and anxiety. Therefore, it is not surprising that there has been such strength of feeling, particularly across Yorkshire, the Humber and east Midlands. While clinical safety must predominate, does the noble Earl agree that the NHS needs to give further consideration to public access and travel times when reconfiguring services? In this case, as the IRP points out, the joint committee considered access the least important factor. The IRP concluded, surely rightly, that the decision used a flawed and incomplete analysis of accessibility. Going forward, can the noble Earl tell me that his department will ensure that that is corrected and that access will be a significant factor in a future decision?

On the review itself, the noble Earl will know that one main concern has been that mortality data were not given enough weight. While decisions on this cannot be based on death rates alone, we agree with John Deanfield, the director of NICOR, who, in his letter to NHS England in April 2013, said:

“Mortality is only one measure of quality, but currently is the most robust available outcome”.

Will the noble Earl confirm that, in the further process of review announced today, these data will feature more prominently?

The main concern we have with the announcement that the Government have made today is the proposal to link the children’s review with the review of adult heart services and the implications that might have for the timetable. The Statement uses the words “better co-ordination”. I understand that about 30 centres are carrying out adult heart surgery. The seven selected centres for children will not be collocated with adult heart surgery. As the noble Earl knows, there are a number of specialist children’s sites. The link between the children’s sites and the adults’ sites is not at all clear. Is there a danger that, by linking the review with adult heart surgery, the Government risk a loss of focus and, indeed, more delay? By broadening it in this way, is there a danger that we will lose the consensus that has already been gained over the future of children’s heart surgery?

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The decision will clearly have implications for the timetable of the children’s review. It is noticeable that the Statement does not really contain a clear timetable. Can the noble Earl set out a more precise timetable for when the actual decision is going to be made?

I wonder whether the noble Earl has seen the response from the Royal College of Surgeons today. It expressed disappointment that the reform plans will be suspended, adding to what it describes as a long and exhaustive process. In its final comment, it urges NHS England to act swiftly and decisively, and says:

“Continued foot dragging will only delay the much needed reform that will ensure children will get the best treatment available”.

Can the noble Earl respond to that? He says that the review will be concluded by the autumn, but the question here is when decisions will be made and, even more importantly, when they will be implemented.

The Statement sets out a major role for NHS England going forward. Can I be assured that, in the process that NHS England takes forward, it will operate independently of interests linked to the selected sites? Does he agree that it is vital that we do not lose confidence in the process and damage confidence in all 10 existing services? I noted what he said in reassuring the House about safety. I welcome that, but is his department taking action to ensure that all existing units will not lose expertise in the intervening period? That will be a source of concern the longer the review takes and the longer the decision takes to make.

It is clearly important that public confidence in the process and the final decision is maintained but, balanced against that, unnecessary delay will not bring the best results for the children who most need our help. In that regard, I should like to ask him about the comments made by Sir David Nicholson, the chief executive of the NHS, at the annual meeting of the NHS Confederation last week. In an interesting speech, he said:

“We cannot let the tyranny of the electoral cycle stop us from making the real and fundamental changes that we need to make to the NHS”.

He went on to say:

“So what happened when we got a new government in is we wasted those two years where you can really make change happen. We spent our time talking about reorganisation and changes and all the rest of it and we didn’t talk about the really important changes that are required for the NHS”.

I am quoting that because the election is less than two years away. Can the noble Earl reassure me that the electoral cycle is not going to get in the way of coming to a sensible and speedy decision?

3.55 pm

Earl Howe: My Lords, I am grateful to the noble Lord, Lord Hunt, for his measured comments. I agree with many, if not most, of them. I certainly agree that party politics should play no part in this matter. That is one reason why in 2008 his Government decided that the Safe and Sustainable review should be a process set apart from the Department of Health and led by the NHS. We agree with that and still believe that it should be NHS-led. I also agree with what he said about the complexity of this issue being no excuse

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for not proceeding as fast as is safe and possible with a process designed to see a satisfactory resolution of this issue. That is certainly our view.

I also welcome what the noble Lord said about public confidence. It is clear that parts of the Safe and Sustainable process sadly did not command public confidence, not least in Leeds, but also in Leicester and other places. The noble Lord will no doubt have noticed, in the IRP’s press releases today, the emphasis on openness and transparency in the process going forward. NHS England has also made clear that whatever the process that it recommends going forward, it should involve the maximum amount of consultation with those concerned, not just the clinicians in the centres involved, who are of course very important, but also patients and their families.

The noble Lord referred to the need for greater consideration to be given to access and travel times. I noted an emphasis on that very point in recommendation 4 of the IRP’s report. They clearly matter to families, as was very much picked up by the IRP in its work engaging with stakeholders. In agreeing to address all the recommendations of the IRP report, which NHS England has done, it could not fail to address that part of the recommendation.

With regard to mortality data, I am sure that the noble Lord will understand that when we are dealing with a procedure as complicated and specialist as children’s congenital heart surgery, while transparency of data is certainly an objective, it is important that the data published are not open to misinterpretation. Mortality data are a problem that beset this kind of area because the numbers are small. They must also be presented in a way that is understandable to the public as well as to clinicians. For the most part, clinicians already have this data, but it is important going forward to ensure that when we publish data, there is genuine comparability between the various centres in terms of the outcomes denoted.

The noble Lord rightly said that, by introducing the dimension of adult cardiac surgery, the IRP had added greater complexity to the whole issue. There is no doubt that that is true. All I will say to him is that this was by far the longest and most complicated review that the IRP has undertaken in its 10-year history. It took evidence over 25 full days. That alone should indicate that the opinions that were tapped were very extensive. The IRP did not come up with this recommendation lightly. Although it adds complexity, it behoves NHS England to take that point extremely seriously.

As regards the timetable for the work going forward, my right honourable friend the Secretary of State has asked NHS England to provide him with an interim report by the end of July. NHS England’s press release states:

“We will take the time to listen before coming up with a new proposition, working with patients, clinicians and the providers of services. We intend to announce a new way forward in the autumn, with plans for implementation within 12 months”.

I believe that is an ambitious aim given the added complexity, but it indicates that NHS England is conscious of the need to make progress in this area as rapidly as possible. As soon as I have further information—no doubt at the end of July or shortly after—I will ensure that the House is made aware of it.

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I have seen the Royal College of Surgeons’ press release. It is impossible to disagree with it that this is a disappointing state of affairs. Everyone would like to see this issue resolved. Nevertheless, the points the college makes, which were reflected in the noble Lord’s points about the need for expedition in this area, are absolutely right. The noble Lord was also right to say that over the coming months we need to make sure that all the units, which do such a fantastic job in this very complex area of clinical delivery, are supported and feel that their work is appreciated. It is certainly important that we do not see a draining away of expertise. The clinicians in the various centres should now see this as an opportunity to present their case even more fully than they did before. I hope that they will welcome that opportunity.

As regards the tyranny of the electoral cycle, I hope that in my opening remarks I expressed my agreement that that should not play a part in this. In so far as we can divorce decisions of this clinical magnitude from politics, the better it will be. We should achieve that if this process is as consultative and open as possible, as everybody wishes it to be.

4.03 pm

Lord Warner: My Lords, I take us back to Sir Ian Kennedy’s review 12 years ago in which he made it crystal clear that unless we significantly reduced the number of these centres, children would continue to die unnecessarily. That was the brutal conclusion of the Bristol inquiry. Has anything come out of the IRP review that fundamentally changes the July 2012 decision of the Joint Committee of Primary Care Trusts that seven centres, with clinical networks built around them, was the right number? As I understand it, the argument is not necessarily that seven was the wrong number of centres, but that the wrong seven were chosen. Are we not now opening up the whole issue of the relationship with adult services, which will take us back to a situation where we start to review from the beginning the appropriateness of the particular centres? Do we not need to get back to where the JCPCT was when there was a good deal of consensus around the idea that seven was the right kind of number? The issue is really about east coast versus west coast, and the danger of this report, thorough though it may be, is that it will now reopen all the issues on which we had actually made a good deal of progress by 2012.

Earl Howe: That is indeed the core of the disappointment felt by the clinical community and noble Lords: that we are little further forward in terms of deciding exactly where these services should be delivered. The noble Lord is also right to say that support for a philosophy of improving children’s heart services by concentrating surgical expertise to provide round-the-clock cover and develop networks of care is as strong as ever. There is a rare consensus on the clinical case for improving services on the pathway of care for children. The IRP has said that its report is not a mandate for going back over the ground of the past five years; indeed, it commends a great deal of the work done by the JCPCT. The IRP says that that work should be built upon. The JCPCT should not necessarily feel bruised by this, although I am sure that it will feel

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thoroughly disappointed. However, its groundwork has been publicly appreciated, and it is now for NHS England to take that work forward as swiftly as it can.

Baroness Howarth of Breckland: My Lords, I speak as the patron of Little Hearts Matter, the organisation that represents a large number of families who have children with heart conditions, particularly hypoplastic left heart syndrome, which is extremely serious and needs highly skilled intervention. Who does the Minister think is most disappointed about the failure of the review? I probably meet more families and children than most of your Lordships—children who await open heart surgery or extremely complex technical interventions, and whose anxiety is huge; and parents who thought that they were going to have clear answers on where their children would receive treatment and on the quality of those interventions at the end of the safe and sustainable review. I ask the Minister to take back with him all those disappointments and to look not only at safety, which is key to the families. Many of them would travel to wherever you took them if they were sure that the operation would be successful. As a woman from Yorkshire and the east of England, I understand that gap, but what the families want most is quality of service.

As the noble Lord, Lord Warner, pointed out, there is also great disappointment about the link being made with adult services because of where those services are located. Despite the review, there is a lack of understanding of the needs of children. There are certainly transitional difficulties and I ask the Minister whether it is those issues or other issues that have led to children being considered alongside adults. Will he take away with him the disappointment felt by families who are waiting longer for interventions because this has caused delay?

Earl Howe: My Lords, I am accountable to this House for government policy, but it is important for the noble Baroness to understand that this has been an NHS-led review. Many of her questions are for NHS England now to address. Of course there will be huge disappointment and concern among the families of those who require surgery in this area. I want to emphasise that until a decision is reached, the centres now delivering children’s heart services will continue to do so and will be fully supported in doing so.

However, we cannot ignore a series of recommendations from the IRP that has roundly criticised the methodology of the JCPCT. It concluded that the JCPCT’s way forward was flawed because the analysis was insufficiently thorough. If our aim is to improve the quality of outcomes for these children, I do not believe that it is in anyone’s interests to try to say to ourselves that we can make do with a half-good set of solutions. I do not suggest that the noble Baroness is saying that; of course she is not. We need to be thorough about this without spending another 10 years over it. I hope that I have given the sense to the House that NHS England is determined to progress this rapidly but thoroughly and, above all, in a consultative way. The families will have a chance to have their say in that process.

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Lord Walton of Detchant: My Lords—

Baroness Northover: My Lords, I remind noble Lords that these should be brief interventions. We have only had two thus far and we are seven minutes in. I suggest we hear the Bishop, then from these Benches and we try to get around.

The Lord Bishop of Ripon and Leeds: My Lords, I am grateful to the Minister and I am also grateful to the Leeds group Save our Surgery for persisting with criticisms, at least some of which seem to have been justified, as they pursued this. I am particularly grateful for the affirmation that children and their families must always come first. Will the Minister also accept that nothing about us should be done without us? Therefore, will he ensure that families, local communities and, indeed, the case for keeping cardiac and other children’s services in our hospitals are heard, in addition to the clinical professionals?

Earl Howe: I can readily agree with the right reverend Prelate. I think it is illustrative of the IRP’s approach that in its press release it states:

“The critical factor to consider, in the Panel’s view, is that engagement of all interested parties is the key to achieving improvements for patients and families without unnecessary delay. There is now a real opportunity to involve patients, the public and other stakeholders in taking work forward as set out in the Panel’s recommendations”.

I endorse that view wholeheartedly, and it is a point that has been directly picked up by NHS England in its press release today.

Baroness Eaton: My Lords, will my noble friend give an assurance that when calculating where centres should be located, account is taken not just of population numbers, but of the make-up of that population? He will know, for example, that children of Asian descent have greater need for these services than other communities, making up 23% of cases at Leeds. Their faster growing population must be taken into account.

Earl Howe: I hope that my noble friend will be reassured by the IRP’s recognition that the location and geography of these centres and where they are in the country are material factors in this equation. At the same time, I think it would be wrong to give the impression that one can establish a centre of expertise of this kind in every city; that is clearly not realistic. Merely because there is a certain density of a population in a location does not mean to say that there can be a children’s heart centre very close to the centre of that population. This is a highly specialised service and we must recognise that the centres that will deliver it will be few in number. Nevertheless, I am sure that the message that my noble friend has given will not be lost on NHS England.

Baroness Jolly: My Lords, it is critical that however NHS England proceeds, it does it openly and transparently. I welcome the Minister’s comments on that. Will he also agree that meetings of any review body should be advertised, public and make all necessary papers available to the public?

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Earl Howe: I agree that transparency in the process is vital, and I have no doubt that NHS England, in saying what it has today about its general approach to this, will bear that very point in mind.

Lord Woolmer of Leeds: My Lords, does the noble Earl recognise that in Leeds there will be a great sense of justification regarding the criticisms of the process previously followed and a welcoming of the forensic critique by the latest panel of that process? While it is certainly important that collocation of services is not essential to the provision of children’s heart surgery, does the Minister agree that, where there is outstanding and deliberately engineered collocation of high quality, that is an important factor in the future location of children’s heart surgery?

Earl Howe: The noble Lord makes another very good point, and Recommendation 3 of the IRP report focuses on that very issue. It says:

“Before further considering options for change, the detailed work on the clinical model and associated service standards for the whole pathway of care must be completed to demonstrate the benefits for patients and how services will be delivered across each network”.

Therefore, that point has been explicitly recognised.

Lord Walton of Detchant: My Lords, the noble Earl has explained with his customary clarity the reasons for this further delay. However, surely he would agree that, in the ultimate, the decision that is eventually reached must be based on quality of service and quality of outcomes. This must surely be the guiding principle throughout. I fully appreciate the concerns expressed by the people surrounding the units that were originally marked for closure, but I have to express a personal avuncular interest in Freeman Hospital in Newcastle, which, according to all international comparisons, is producing results in paediatric and adult heart surgery that stand comparison with the best cardiac centres in the world. I know that this further delay is going to cause concern and further damage morale in that unit. I only hope that in the long term it does not have any effect on the efficiency of the service. Let us hope that this review is concluded as quickly as possible.

Earl Howe: My Lords, I pay tribute to the work done in Newcastle in this extremely complex area of surgery. The noble Lord knows that hospital better than anyone in this House, and I understand the disappointment felt in Newcastle about this decision. Nevertheless, I would slightly qualify the comment that he made at the beginning. Although I agree that the decision must depend on outcomes and the quality of care, it must also bear in mind the sustainability of the service into the future. While we can recognise good care when we see it now, we must be sure that the service is capable of being sustained on that level into the future.

Baroness Finlay of Llandaff: Is the Minister able to tell us how many vacancies currently exist among highly specialised staff in children’s heart units and what NHS England is doing to monitor vacancies?

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During a time of uncertainty, when staff do not know what their future will be, recruitment problems can arise, and where vacancies occur at a very senior, highly specialised level, that in itself can threaten the quality of the service and indeed jeopardise long-term sustainability.

Earl Howe: I do not in fact have any statistics on vacancies, although if I can acquire them I shall certainly pass them on to the noble Baroness. However, the central point that she makes is of course right, and the second recommendation made by the IRP relates to the need to have sufficient staff in place to deliver a safe service. It says that patients should receive this service,

“from teams with at least four full-time consultant congenital heart surgeons and appropriate numbers of other specialist staff to sustain a comprehensive range of interventions, round the clock care”,

and, interestingly,

“training and research”.

I think that that sends a signal that will resonate with many noble Lords in the context of debates that we have had in the past about centres of excellence in the NHS.

Care Bill [HL]

Bill Main Page1st Report from the Delegated Powers Committee

Committee (3rd Day)

Relevant document: 1st Report from the Delegated Powers Committee.

4.19 pm

Clause 97 : The HRA’s functions

Amendment 58A

Moved by Lord Collins of Highbury

58A: Clause 97, page 80, line 35, at end insert—

“( ) The HRA shall also have the function of encouraging the translation of research into innovative practice.”

Lord Collins of Highbury: My Lords, in Amendment 58A, in addition to conducting and promoting health and social care research, we are seeking to give the Health Research Authority the ability to encourage this research to be translated into innovative practice.

On Monday, in a debate on amendments to Health Education England, many noble Lords highlighted the need to place research at the centre of what the NHS does. Under the Health and Social Care Act, Labour fully supported placing duties on the Secretary of State, the National Commissioning Board and CCGs to promote research. Indeed, my noble friends Lady Thornton and Lord Hunt supported amendments to the Bill reinforcing the importance of research.

In Monday’s debate, my noble friend Lady Wheeler reminded us of the concerns and frustration at the often painfully slow, complex and bureaucratic process of getting innovation in care and treatment adopted in the NHS. I suspect that the noble Earl shares this concern as in the debate in this House last January he reminded us that it took an estimated 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice. On Monday, too, my noble friend Lord Turnberg referred to the vision for research in

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the NHS contained in the recent publication of the Association of Medical Research Charities. In this vision, every patient should be offered the opportunity to be involved in research; all staff should be made aware of the importance of research; and the NHS should conduct high quality research and adopt innovation in healthcare rapidly. The purpose of the amendment is to achieve a joined-up approach in reaching these objectives so that when research is commissioned these principles are absolutely borne in mind. I look forward to hearing the Minister’s response.

With regard to Clause 97 standing part of the Bill, I should like to refer the noble Earl to paragraph 8 of the first report this Session of the Delegated Powers and Regulatory Reform Committee. The committee expressed concern over the Secretary of State’s powers to amend the main functions of the Health Research Authority. If, as suggested, they were needed to meet the obligations of an EU directive, an appropriate amendment could be made by exercising powers under Section 2(2) of the European Communities Act 1972. If that is the case, perhaps the noble Earl could explain why the Secretary of State needs these extra powers.

It is a long time since I completed my British Government A-level. I recall how Henry VIII clauses can give powers to delegated legislation to amend or repeal Acts of Parliament. However, I did a little more recent research and found reference to the 1932 Committee on Ministers’ Powers. One quote from its report is particularly relevant. A member said that, whether good or bad, delegated legislation is inevitable. It is,

“a necessary evil, inevitable … But nevertheless a tendency to be watched with misgiving”.

I look forward to the noble Earl’s further explanation as to why the Department of Health believes that these powers are necessary.

Lord Walton of Detchant: My Lords, I rise briefly to express my strong support for Amendment 58A. I used to teach my medical students and my postgraduates by telling them that today’s discoveries in basic medical science bring about tomorrow’s practical developments in patient care. Surely this is what the amendment is about. If I were to be pedantic, I would prefer a change in the wording to:

“The HRA shall also have the function of,”


“the translation of research into innovative practice”.

That is preferable to simply “encouraging” it. Again, I am happy to support the amendment.

The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): My Lords, this amendment takes us to a subject that is dear to my heart—the translation of research—and I agree very much with the tenor of what the noble Lord, Lord Collins, had to say. The Committee will know that our vision is to improve the health and wealth of the nation through research. The Government are committed to cutting the bureaucracy involved in health and social care research. We want to speed up the initiation and delivery of research so that research findings can benefit people more quickly and improve the UK’s competitiveness in the life sciences. At the same time, research involves a

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degree of risk, and we need to balance a desire for expediency with appropriate safeguards to protect people who participate or who may participate in research.

Clause 97 sets out the Health Research Authority’s four main functions, which are described in more detail in Clauses 98 to 104. It also sets out the authority’s main objective in performing those functions. The Health Research Authority will have functions in four main areas. These will be, first, functions relating to the co-ordination and standardisation of practice relating to the regulation of health and social care research; secondly, functions relating to research ethics committees; thirdly, functions as a member of the UK Ethics Committee Authority; and, lastly, functions relating to approvals for the exceptional processing of confidential patient information. The Health Research Authority’s main objective in carrying out its functions will be to protect participants, potential participants and the general public by encouraging safe and ethical research, and to promote their interests by facilitating the conduct of such research. This objective has been deliberately framed in a way that ensures that the interests of participants and the public are put first.

As I have said, research sometimes involves a degree of risk, so regulation provides participants, potential participants and the public with assurance that there are appropriate safeguards in which they can be confident. The Health Research Authority will meet the first part of its objective through the regulatory functions that this Bill confers on it relating to the regulation of health research and social care research in order to protect the dignity, rights, safety and well-being of research participants. The second part of the Health Research Authority’s overarching objective is to promote the interests of participants, potential participants and the general public in health research and social care research. The Health Research Authority will promote these interests by facilitating high quality and ethical research. This includes co-operating with others to create a unified approval process for research and to promote consistent and proportionate standards for compliance and inspection. To meet its objective of protecting and promoting participants, potential participants and public interest in research, we would expect the HRA to engage patients and the public in its work. For example, Schedule 7 would give it the power to set up committees or sub-committees which may include people from outside the Health Research Authority.

I turn now to the specifics of Amendment 58A, which seeks to make encouraging the translation of research into innovative practice a function of the Health Research Authority. First, I should like to reassure the noble Lord, Lord Collins, and the Committee that we are fully committed to encouraging the translation of research into practice. The Health and Social Care Act 2012 recognises the need to promote research and the use of research evidence and has created unprecedented powers and duties at all levels to meet that need. When it was passing through your Lordships’ House, we debated the duties that the Act places on the Secretary of State. Noble Lords will remember that the Act places a duty on the Secretary of State to promote the use within the health service of evidence obtained from

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research when exercising his functions in relation to the health service. The 2012 Act also places equivalent duties on the NHS Commissioning Board, now known as NHS England, and clinical commissioning groups when they are exercising their functions under the 2012 Act.

4.30 pm

The National Institute for Health and Care Excellence has a key role here. Its guidance helps health and care professionals to deliver the best possible care based on the best available evidence. In addition, it hosts NICE Evidence Services, a web-based portal that provides fast access to authoritative health and social care evidence. It has more than 250,000 resources from many accredited sources including the Cochrane Library and the royal colleges.

It is important to look at the wider picture here. The National Institute for Health Research also plays a vital role in driving faster translation of basic science discoveries into tangible benefits for patients and the economy and developing and supporting the people who conduct and contribute to applied health research. The NIHR provides the support and facilities the NHS needs for first-class research by funding a range of infrastructure facilities. This includes providing £800 million over five years to fund 11 biomedical research centres and 20 biomedical research units that conduct and support translational research to transform scientific breakthroughs into life-saving treatments.

NHS England recently designated 15 new academic health science networks. Their core purpose is to transform the identification, adoption and spread of proven innovations and best practice throughout the NHS. These have the potential to transform health and healthcare by putting innovation at the heart of the NHS. This will improve patient outcomes as well as contribute to economic growth.

As I have said, we need to look at what is going on in the round rather than just focusing on the HRA. As the HRA’s role is primarily about facilitating the initiation of safe and ethical research, it is not our intention to give it a function of encouraging the translation of research into innovative practice.

I hope I have been able to reassure the noble Lord that, while I am in sympathy with the spirit of Amendment 58A, I do not think that this is an appropriate function to put in the Bill for the HRA. We can feel relaxed about not doing that because there are other mechanisms in place to encourage the translation of research into innovative practice.

The noble Lord asked me about the power to amend the list of the Health Research Authority’s main functions in Clause 97(1). This power will ensure that the list of the Health Research Authority’s main functions is kept up to date in the light of any changes to legislation. However, we have not yet responded to your Lordships’ Delegated Powers and Regulatory Reform Committee. We will be doing so shortly.

Secondary legislation is regarded by some as a necessary evil. It is an expedient deployed by all Governments. We are sensitive to the caution that surrounds it in this House and the other place. However, it does not give the Secretary of State any additional power to add functions, but only to make consequential

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changes to the list when functions are conferred on the Health Research Authority in ways other than by primary legislation; for example, by way of regulations. That is because such regulations would not themselves be able to effect a change to the list in this clause. The scope for using this power is fairly limited. I hope that explanation is helpful and that the noble Lord will feel able to withdraw his amendment.

Lord Collins of Highbury: I thank the Minister for that response. I agree with him that we have to see this in the round. We were trying to pick this up as an objective rather than as a specific function so that in its work the HRA could see the benefits of ensuring that research was implemented in a way so as to change practice. In relation to Clause 97 standing part of the Bill, I again hear what the Minister has said. I was rather hoping for a detailed reference to Henry VIII in his response but that was not forthcoming. We will need to watch this matter carefully. I look forward to seeing the Government’s response to the committee’s report. In the light of that, I beg leave to withdraw the amendment.

Amendment 58A withdrawn.

Clause 97 agreed.

Clause 98 : Co-ordinating and promoting regulatory practice etc.

Amendment 58B

Moved by Lord Hunt of Kings Heath

58B: Clause 98, page 81, line 25, at end insert—

“( ) the Medical Royal Colleges;”

Lord Hunt of Kings Heath: My Lords, Clause 98 concerns a duty of co-operation with the Health Research Authority. That is of course absolutely supported. My Amendments 58B and 58C would insert into the list of organisations,

“Medical Royal Colleges … the General Medical Council, the General Dental Council and the Nursing and Midwifery Council”.

I have no doubt that the noble Earl will warn me of the dangers of this, but in a sense his own department has provoked it by putting a list into the Bill. Inevitably, we looked at that and wondered why some organisations were missing. I realise that Clause 98(1)(i) allows flexibility by regulations to add to the list and I am sure that that flexibility is welcome, but we should get this right in the first place. I find it difficult to understand why, for instance, the medical royal colleges are not listed. They have a vital role to play in this area.

Similarly, I support the noble Baroness, Lady Emerton, in her Amendment 59. I am sure she will speak to that in a moment. If the Chief Medical Officer is named, why is the Chief Nursing Officer not? I know there has been concern over the years about the position of the Chief Nursing Officer. The last Government as well as this one have debated this issue. Given that we wish to see an extension of research into nursing and clinical areas because of the absolute importance of enhancing the quality of nursing, it is disappointing that the Chief Nursing Officer is not listed.

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I also support Amendment 61 from the noble Lord, Lord Willis, which takes the responsibility in Clause 98(7) of local authorities and NHS trusts to have regard to guidance from the HRA on good practice in research and extends it to other providers, including the private sector. These are important amendments as a whole. It is important that the Bill is informed and improved.

On my Amendment 61A, I am puzzled that in Clause 98(7) the requirement is only to have regard to HRA guidance. Surely that should be strengthened, as in my amendment, which says that guidance “must” be followed,

“unless there is good reason not to do so”.

I have taken advice on this matter. The noble Earl will know that there has been a problem over the years in getting approval for multicentre trial research. I understand that the research ethics committees have improved their performance in recent years, and that is to be welcomed, but we now apparently have the problem with some NHS trusts and foundation trusts. Of course, as this is the start of another Committee day, I ought to declare my interests as the chair of a foundation trust and as a consultant and trainer with Cumberlege Connections. It is disappointing if individual NHS organisations are holding up multicentre research, for all the reasons that we know about: UK plc and the need for us to ensure that there is greater investment in research in the UK. I want some assurance that if there is undue delay, the HRA will be able to intervene and ensure that NHS organisations get on with giving the necessary approval.

On Amendment 60A, health research capacity in the UK is of course one of our strongest assets. It includes pharmaceuticals and medical devices, and takes place in our medical schools and hospitals. World-class research is undertaken here, frequently with outstanding results, yet we consistently fail to exploit that research when it comes to its translation into practice. How many other countries have exploited research undertaken in this country? I very much welcome the establishment of academic health science networks, which are responsible for encouraging much closer links between research and health service practice.

However, there is much more to be done. I would like the HRA’s objectives to include encouraging innovation and practice. It is important that the HRA is in a position to advise the department on potential policies that might have an impact on the scale of research and development in the UK. One such example is the present intention to move away from the current pharmaceutical price regulation scheme method of reimbursing pharmaceuticals. I know that the Government are committed to the introduction of value-based pricing. I always try to tempt the noble Earl to debate in your Lordships’ House the introduction of value-based pricing, principally because very few people understand what it involves. Even having been the Minister who received the original report on it, I must say that I am still in the dark as to exactly how it will unfold.

My key question is this. I know that the PPRS approach is not perfect and that at regular intervals Governments negotiate it downwards, but it has always given flexibility to the industry to price new-licence medicines as it wishes within a profit cap. The advantage

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of that flexibility is that many new drugs are launched in the UK rather than in other countries. I would like to hear from the noble Earl that the introduction of value-based pricing will not have an impact on the willingness and ability of pharmaceutical companies to continue launching products in the UK. I believe there is a link between the launch of products and investment in R&D in this country.

I may strain the patience of the House, but while I am talking about pharmaceuticals it is tempting to ask the noble Earl about the implications for the cancer drug fund. He knows that the intention was for that fund to become obsolete with the introduction of value-based pricing. However, cancer charities that I have met believe that value-based pricing will apply primarily to new active substance licences from 2014, and will therefore have limited impact on treatments made available through the fund. Will the noble Earl comment, or perhaps write to me, with an assurance that, before firm proposals are made on this issue, full consideration will be given to the impact of value-based pricing on the cancer drug fund, its continuation or potential substitution? I beg to move.

4.45 pm

Lord Turnberg: My Lords, I strongly support my noble friend in Amendments 58B, 58C and 59. This clause is about taking note of the regulation and the regulation of research activities, but not of people who are engaged in research. It is important to involve those who regulate the professions—the General Medical Council, the General Dental Council, the Nursing and Midwifery Council—as well as the nurses. I agree entirely with the statement that the nurses should be included. In saying this I should also mention the pharmacists, who play an important part in research. I have been approached by those involved in pharmacy regulation to indicate that they also have an interest here.

I wish to speak particularly to Amendment 60, which is in my name, and to Amendments 61 and 62. On Amendment 60, I emphasise the important part played by the local R&D committees of NHS trusts, which the noble Lord, Lord Hunt, mentioned. We now have the Health Research Authority, which is doing a really remarkable job in speeding up the process for approval of research by bringing together the different research ethics committees and the special ethical approval for research, using data where patients are no longer able to give consent. It has developed a single portal of entry and a single application, which is having an enormously helpful effect, but there remains one major hurdle in the way of those trying to carry out multicentre clinical trials: the local R&D committees of NHS trusts. Some are good and speedy while others are slow and capricious, and the whole clinical trial is determined by the slowest and most capricious of those who have to give approval.

When the Academy of Medical Sciences reviewed research regulation, it identified the local R&D committees as the most difficult and time-consuming concerned, with delays of almost a year in too many instances, so in Amendment 60 we are trying to give the HRA the responsibility of rationalising and improving the approval

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processes in R&D committees. If it can get the approval of all trust R&D committees to rely on and accept a single robust assessment, covering all their various concerns, it will not only relieve them of that burden but give them the confidence that the review has been properly performed. It will also speed up the process for researchers. I hope that we can include this message in the Bill at a time when I know that the HRA itself is working hard to achieve it. The amendment is simply intended to offer it the support that it needs for its efforts.

Amendment 61, in the name of the noble Lord, Lord Willis, who unfortunately still cannot be with us, gets at the problem of ensuring that all providers of services for the NHS, including the private sector, should have the same responsibilities for research and innovation as the rest of the NHS. The HRA should have a role in ensuring that they do. It is important that their staff have opportunities to engage in research; certainly, they should be encouraged to introduce innovation into their practice.

Amendment 62 is also in the name of the noble Lord, Lord Willis. We welcome the explicit mention of the responsibilities of NHS trusts in the Bill. However, there is further need to ensure that trusts not only have regard to guidance issued by the HRA but actively comply with such guidance. I would welcome further clarification of how the requirement to have regard to such guidance will be ensured and how trusts’ compliance with such guidance might be strengthened.

Lord Walton of Detchant: My Lords, I was uncertain whether to speak on these amendments in the presence of two past presidents of medical royal colleges, the noble Lords, Lord Turnberg and Lord Patel. I feel unable to support Amendment 58B because the medical royal colleges are not regulatory bodies. They are essentially educational bodies. They play a role in producing and monitoring the standards of qualifying examinations for those seeking to be specialists, but they are essentially educational and do not have a regulatory role, although, of course, they play an important part in advising on a whole range of health service issues.

However, I believe it is right that Amendment 58C should be inserted, because the bodies mentioned are regulatory authorities. The General Medical Council, for instance, can play a crucial and important role in disciplining doctors who have been found guilty of fraud and misconduct in medical research. This is very relevant to the qualities and responsibilities of the HRA, and for that reason I believe it right for this amendment to be included in the Bill.

Baroness Emerton: I rise to speak to Amendment 59 which includes the Chief Nursing Officer in the list of those participating in the authority. I thank the noble Lord, Lord Hunt, for his words on this point. I have raised the issue of the importance of evidence-based practice and the need for us to be able to develop research within the nursing profession where, to date, it has not been at the forefront of progress. Having the Chief Nursing Officer taking part in the work of the research authority, although perhaps not in its detailed content, will assist in raising the profile of the importance of research. It may well be delegated from the CCGs

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to the health trusts, where we may see professors of research, which will then encourage research throughout. The nursing profession is the largest single workforce within the NHS. It is important that we promote the idea and development of research by having the Chief Nursing Officer in the list.

While on this subject, it is encouraging to see the list in the Bill. When the Health Bill was introduced, health education was not included and the membership of Health Education England was not clearly set out. Although it does not relate to research, I would like to mention the importance of having an executive nurse on the health education board, because there is an executive doctor, but not an executive nurse. Perhaps I can return to this when we come to Report.

Lord MacKenzie of Culkein: My Lords, I rise briefly to speak to Amendments 58C and 59. The noble Lord, Lord Hunt, and the noble Baroness, Lady Emerton, rightly referred to including nursing in the Bill.

As the noble Baroness, Lady Emerton, said, the practice of nursing these days is underpinned by research. Of necessity, nurses are involved in research, and it must be right to include the Nursing and Midwifery Council and the Chief Nursing Officer in the Bill.

In debates on the Bill, we have heard a number of times that it is all too easy to exclude nurses. Whatever body they should be represented on, they so often are not there. I can go back, probably the better part of 40 years, maybe more, to when I once had the temerity to ask my matron to raise something at the hospital management committee. She said to me, “I’m sorry, nurse, I can’t, because I only attend by invitation of the group secretary”.

There have probably been about 20 reorganisations—I forget how many—since those days. However, all too often the situation has not changed and nurses remain excluded. The reason for excluding them, very often, is that the legislation does not cover it and therefore it is not necessary for nurses to be included. We now have the opportunity. Let us have nursing in the Bill. If we are going to have lists, as the noble Lord, Lord Hunt, said, I want to see nurses in it. I hope that the Committee will support that.

Baroness Cumberlege: My Lords, I strongly support the amendment tabled by the noble Baroness, Lady Emerton, and am very interested in what the noble Lord, Lord MacKenzie, said. It seems that, over the years, nursing has been the poor relation when it comes to promoting the medical profession. Both are so important, and they have to work together. If the Francis report tells us anything, it is that we need to ensure that both are of a very high quality.

I asked the Royal College of Nursing today to give me some examples of research that nurses are doing. I will not try the patience of the Committee by going through them, but it gave me three extremely good examples which undoubtedly improve the quality of patients’ experiences and recovery rates. This work is going on, but it really should be of a higher profile. It should be applauded and used. I appreciate very much what the noble Lord, Lord Hunt, said about lists, which are a trap that I remember falling into on

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occasions when I was a Minister. I suspect that the noble Earl will tell us that we want to have it both ways: sometimes we want things in regulations because that is more flexible and at other times we want them in the Bill. This is something of a dilemma, but if the medical profession is in the Bill, nursing certainly should be as well.

I also strongly support Amendment 60, in the name of the noble Lord, Lord Turnberg. I was very interested to read about the delays that occur through not getting together all the different organisations that are going to be involved in a single trial. According to Kidney Research UK, the time taken in one trail to receive R&D permission varied from around five weeks to 29 weeks. A study of stroke survivors took between one week and 35 weeks to receive permission from the NHS trusts involved. The time taken between submission of site-specific information and NHS approval ranged from five weeks to 50 weeks for a multi-centre trial comparing two types of emergency intervention for ruptured aortic aneurysm. This is totally unacceptable. Those who are promoting the research, and are the leaders in it, must get so frustrated when the bureaucracy will not allow them to go ahead. We need good research. It makes a huge improvement to patients’ lives, especially, of course, when it is translated to the patient in the bed, as it were. Anything that we can do to speed this up and to put pressure on to ensure that the time lags are not as long as this would be very much welcomed.

Lord Patel: My Lords, I rise to support Amendments 59, 60, 61 and 62, to which I have put my name. It was very clever of the noble Lord, Lord Hunt of Kings Heath, to have an amendment about the medical royal colleges lead to a discussion on value-based pricing and the cancer drugs fund. I am tempted to have that debate because it may be much more interesting; it is an issue that we should debate at some stage. In responding to the previous amendment, the noble Earl highlighted the Government’s strong backing for life sciences. When we talk about value-based pricing, we must consider how we could reimburse cell-based therapy, which is not drug therapy, at what stage in the development of cell-based therapy reimbursement should kick in and what value would be put on different stages. That would be a good debate to have.

Moving on from that, I strongly support the amendment tabled by the noble Baroness, Lady Emerton, on the inclusion of the Chief Nursing Officer. I also support her in asking why Health Education England does not have a nurse education director. If the nursing workforce is the largest health workforce in the NHS and does not have a nurse education directive, something is missing and needs to be replaced.

5 pm

I absolutely support Amendment 60, in the name of the noble Lord, Lord Turnberg. I remember when I was responsible for the research ethics committee. When I took over I was told that there were 152 research ethics committees in England alone, when France, with the same population, had only 35. I asked why, and quickly found out about the problems referred to by the noble Baroness, Lady Cumberlege, and why the delays occurred. Now that we are to have a Health

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Research Authority, I cannot see why it cannot clear, ethically and every other way, a clinical trial as part of a multi-centred clinical trial. The local NHS trust will have only to make sure that its board and its patient liaison committee are aware that such a trial is taking place. Its ethics committee will not have to go through it, which will reduce the time considerably and might encourage more clinical trials—which we currently have lost—to take place in the United Kingdom.

I turn to Amendments 61 and 62, in the name of the noble Lord, Lord Willis of Knaresborough. He is now at home and recovering. He has been asked to rest for about a month or so, if his family can manage to keep him down, but he is well and his treatment is going well. His son sent me an e-mail about it; our good wishes are doing the trick. Amendment 61 merely says that those who deliver patient care for NHS patients should be treated in the same way as NHS trusts. That cannot be wrong. Surely there is an omission. Amendment 62, to which the noble Lord, Lord Turnberg, referred, replaces “have regard to” in the Bill with “comply with”. What does “have regard to” mean? Surely those bodies must have to comply with directions given by the HRA. I hope the noble Earl will respond to that.

Baroness Jolly: I will speak briefly in support of Amendments 59, 61 and 62. We have had this debate about lists—sometimes they are good, and sometimes not. There is no way of knowing when they are good and when they are not. However, I welcome the additions suggested in the amendments, in particular the amendment in the name of the noble Baroness, Lady Emerton, on the Chief Nursing Officer. That is absolutely critical. Everybody knows about doctors, but the amendment sends out the key message that nurses play a role in collecting an evidence base to improve care for patients. That is very important. I have seen some very nice research done by nurses, who work in the community, about care. That really makes a difference and, of course, it is then shared among their colleagues.

I will also speak briefly to Amendments 61 and 62, in the name of my noble friend Lord Willis. These are about the guidance that the HRA produces and who should pay heed to it. Here we have a mini-list, but the not-for-profit and private sectors were missing from it. Anybody who does work for the NHS should be included. The wording should be strengthened from “have regard” to “comply with”. It currently makes no sense whatever. I would be grateful if the Minister can confirm that.

Lord Turnberg: My Lords, I am sorry to rise again, but I have a very brief question. In a clause dealing with promoting regulatory practice, why is the Secretary of State No. 1?

Earl Howe: My Lords, a great many points have been raised in this debate, so I may take a little time to respond. I hope that the Committee will bear with me. Amendments 58B to 62 seek to give the Health Research Authority a stronger role in streamlining the management of research, particularly in the NHS. I am the first to recognise that delays in obtaining research approvals

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in the NHS remain a problem for many researchers and that there is an expectation that the Health Research Authority will help to improve this situation through its relationship with the NHS.

I also appreciate that noble Lords, particularly in relation to Amendments 61 and 62, seek reassurance that all providers of NHS services will be required to pay attention to the guidance that the authority is required to produce under Clause 98(6). This issue was highlighted by both the Academy of Medical Sciences and the Wellcome Trust during pre-legislative scrutiny of the Bill. The clauses in the Care Bill would give the Health Research Authority a unique, free-standing duty to promote the co-ordination and standardisation of practice in the UK relating to the regulation of health and social care research. At this point I reassure the noble Lord, Lord Turnberg, that the duty of co-ordination and standardisation necessarily involves co-ordinating and standardising the practice of NHS trust research and development committees.

In addition, the Health Research Authority will have a reciprocal duty to co-operate with other regulatory bodies or individuals that have statutory functions in the regulation of health and social care research. Statutory functions are an important point. I take this opportunity to address the three amendments listed here that are concerned with this duty. In doing so, it is important to explain why Clause 98(1) would place a duty of co-operation on the HRA and in particular the Chief Medical Officer of the Department of Health. The reason is that the Chief Medical Officer holds functions relating to research under the Abortion Regulations 1991. These require notice to be given to the Chief Medical Officer of any abortion and any information relevant to it.

The disclosure of such information is restricted, except in specific circumstances, which include disclosure for the purposes of scientific research. The Chief Medical Officer is responsible for determining whether disclosure can be made. It is because of the Chief Medical Officer’s functions in approving the disclosure of information about abortions for the purposes of scientific research that the authority, the Chief Medical Officer and the bodies and individuals listed must co-operate with one another with a view to standardising and co-ordinating practice relating to the regulation of health and social care research. Similarly, other bodies and individuals listed have functions relating to the regulation of health or social care research. So it links in those statutory functions.

I listened with great care and a great deal of understanding to the noble Lord, Lord MacKenzie, my noble friend Lady Cumberlege, the noble Baroness, Lady Emerton, and others on their wish to expand the duty of co-operation to include the Chief Nursing Officer. The Chief Nursing Officer is an NHS England role, while the Department of Health has a director of nursing. Neither of these posts has any statutory functions relating to the regulation of health or social care research. That is the key point. For this reason, Clause 98(1) does not create a duty of co-operation on the HRA either with the Chief Nursing Officer of NHS England or with the Department of Health’s

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director of nursing and the bodies and individuals listed in Clause 98(1). I hope that this explanation is helpful.

On Amendments 58B and 58C, the medical royal colleges, the General Medical Council, the General Dental Council and the Nursing and Midwifery Council do not have such statutory functions in this context either. The noble Lord, Lord Walton, made an important and powerful point about the GMC. However, the Health Research Authority would have powers, under paragraph 13 of Schedule 7, to work with the GMC and the other medical regulators to help and advise them in their work. That, I hope, will reassure the noble Lord that that aspect of the HRA’s work has not been forgotten about.

Amendment 60A would require the Health Research Authority to assess the impact of proposed changes to the system for setting pharmaceutical prices on health and social care research. I pay tribute to the noble Lord, Lord Hunt, for introducing this extremely interesting topic to our debates. I believe that this function is best undertaken by the National Institute for Health and Care Excellence rather than making it part of the authority’s role in promoting the co-ordination and standardisation of regulatory practice. As he will know, we have already announced that NICE will play a central role in the pharmacoeconomic evaluation of new medicines in the context of the framework for value-based pricing, once that is announced.

The noble Lord made a point about value-based pricing, in that it is important for the Government—I agree with him—to take account of the need to attract investment into this country. As set out in our plan for growth and our Strategy for UK Life Sciences, the Government are absolutely committed to ensuring that the UK continues to offer an environment that supports and encourages investment and innovation by the life sciences sector, and where the NHS is a world leader in clinical trials. However, there are some legitimate points of debate here about the impact of medicine prices on companies’ decisions on where to locate investments or conduct research. As highlighted in the 2007 NERA study, Key Factors in Attracting Internationally Mobile Investments by the Research-Based Pharmaceutical Industry, this is a global market. Companies locate where they can find the best science base at reasonable cost, taking into account other factors such as taxation, flexible labour markets and economic stability. It is not self-evident that the pricing of medicines drives decisions of this kind. It is an interesting debate to have, but perhaps it is one for another occasion.

The noble Lord also asked about the cancer drugs fund. It is very heartening that more than 30,000 patients in England have now benefited from that fund, which in total amounts to £650 million over three and a half years. We are committed to building on that success. In the context of developing new pricing arrangements for branded medicines, I can reassure the noble Lord by saying that we are exploring ways in which new patients can benefit from innovative cancer drugs at a cost that represents value to the NHS. NHS England is very much included in that discussion, and we well appreciate how important it is for patients.

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To meet the duty of co-operation in this whole area, the Health Research Authority will be required to take the lead in actively identifying ways in which to remove duplication, streamlining the regulation of health and social care research and seeking to ensure that regulation is proportionate. At this point, I reassure noble Lords that the authority must facilitate all types of high-quality ethical research, including research that is multidisciplinary in nature and research by multiprofessionals. In keeping under review matters relating to the regulation of health or social care research, the authority may provide advice to the Secretary of State and must do so on request. Such advice could include recommendations to improve the regulatory landscape for research.

The existing Health Research Authority, the Special Health Authority, has already begun an ambitious programme of work to speed up the research journey in the UK, including the creation of a unified approval process and consistent, proportionate standards for compliance and inspection. I hope that will be welcome news to the noble Lord, Lord Patel, in particular. In doing so, it is working closely with other bodies, including representation from the NHS, to identify and implement effective solutions to make it faster and easier to initiate research.

5.15 pm

Clause 98(6) requires the HRA to publish guidance setting out principles of good practice in the management and conduct of health and social care research, and any statutory requirements that people conducting such research are subject to. This guidance would replace current guidance issued by my department, the research governance framework.

Amendments 61, 61A and 62 are concerned with the bodies that this guidance will apply to and how it will relate to them. This guidance will be applicable to anyone managing or conducting health or social care research. The HRA will be the authoritative voice that brings together and disseminates what is good practice. Having heard that the main residual barrier to research in the health service is at the level of the trust, as I believe many noble Lords are well aware, we have sought to strengthen the status of the HRA’s guidance by requiring NHS trusts and NHS foundation trusts to have regard to it.

My noble friend Lady Jolly and the noble Lord, Lord Patel, questioned the strength of that provision. The duty to have regard to the guidance shows that the guidance must be given great weight; it is not mere advice that its addressees are free to follow or not as they choose. It means instead that, in this case, NHS trusts, NHS foundation trusts and local authorities that provide or arrange care will be under a duty to consider with great care the guidance published by the HRA and will be expected to follow it unless they have very clear and cogent reasons for not doing so. The legal meaning of “have regard to” has been interpreted in the courts to mean that such guidance must be followed by those to whom it is addressed unless there are clear and cogent reasons for them not doing so. In fact, providers, including private providers of NHS services, can be required to have regard to the guidance

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by placing conditions within their operating frameworks and contracts, for example. In the final analysis, this matter could also be subject to judicial review.

The noble Lords, Lord Hunt, Lord Turnberg and Lord Patel, spoke about multicentre research and the HRA’s role in that context. The Health Research Authority special health authority already has a programme of work to enable the implementation of a unified approval process, as I have mentioned. This programme includes a feasibility study with a number of pilots to test the effect of rationalising and combining elements of NHS study-wide review with elements of the research ethics committee review into a single HRA assessment. The findings are expected to identify and show how to realise potential to improve both study set-up times and the quality and consistency of review. We expect this work to continue.

The guidance is also extended, as I have mentioned, to local authorities. Given that the HRA’s remit will now also extend to social care research, the statutory duty to have regard to the authority’s guidance means that these bodies must consider the guidance with great care. It will be expected that they will follow such guidance, as I have explained. We are not seeking to establish the HRA as an inspectorate with enforcement powers. Such powers would be required if a statutory duty to follow guidance were to be imposed on private providers, because there would have to be an express enforcement mechanism, such as powers to apply a sanction, if these providers failed to have regard to the guidance.

The existing special health authority is demonstrating, I believe, another way of working. A great deal can be achieved by working and co-operating with others. It is collaborating with its stakeholder community, including the NHS, charities and the private sector. For instance, securing buy-in through early engagement was key to the successful adoption of the integrated research application system by all research approval bodies across the whole of the UK. We want the HRA to continue to put that spirit of co-operation into practice and to get support for the guidance that it will be required to produce.

Giving the HRA powers to take enforcement action would be counterproductive if it made it more difficult for the authority to take a collaborative approach to carrying out its work and fostering informed support among the range of stakeholders. However, a number of mechanisms may be used as a means to secure compliance with the research governance framework. I have already mentioned contracts. Funding for research may be conditional on ensuring compliance with the framework. Compliance with the current guidance has also been achieved through the system of care regulation, so there are various ways in which to achieve what the noble Lord, Lord Patel, and no doubt my noble friend Lady Jolly, wants to achieve.

The Care Quality Commission’s guidance about compliance lists applicable publications, including the research governance framework. The guidance about compliance states that providers should reflect the key expectations of listed publications for their service as they relate to the essential standards of safety and

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quality. There is no reason why these mechanisms could not continue to be used to achieve compliance by providers commissioned to deliver services for the NHS or local authorities.

I hope that I have provided reassurances on the issues raised by this group of amendments. With those reassurances, I hope that the noble Lord will feel able to withdraw the amendment.

Baroness Emerton: I return to Amendment 59 and thank the Minister for explaining that there is no statutory requirement in this regard relating to the Chief Nursing Officer or the director of nursing. In the light of the comments that have been made about research and nursing this afternoon, will the Minister look at how we can take forward nursing research? If the structure is wrong for NHS England and the director of nursing for public health, where can we fit in a statutory requirement for research to be included? We cannot go on without having a means of recognising the importance of evidence-based practice based on research.

Earl Howe: My Lords, I heard very clearly a strong message from noble Lords on that point. Indeed, I recognised the noble Baroness’s strength of feeling in our earlier debates on Health Education England. Having noted that strength of feeling, I would like to engage with noble Lords between now and Report to see what avenues we can pursue in this area. I cannot make a specific commitment now, but I am very happy to talk further about these issues.

Lord Turnberg: I bring the noble Earl back to Amendment 60 on the research and development committees of NHS trusts. He made some very reassuring comments about the work that is going on in the HRA to try to unify this area. One of the difficulties at the moment is that the foundation trusts are a law unto themselves to a large extent and jealously guard their independence. I wonder whether we need to strengthen the HRA’s arm by including something about this area in the Bill.

Earl Howe: I understand the issue that the noble Lord has raised. There are a number of ways of exercising leverage on foundation trusts, if I can put it in that rather impolite way. One of them relates to the funding from the National Institute for Health Research. The noble Lord may well be aware that as from 1 April that funding is conditional on the 70-day timeline for the recruitment of the first patient into a trial. If that timeline is not met, the funding does not follow. I can tell the noble Lord that that has concentrated minds rather effectively across the health service, including in foundation trusts, towards achieving a much more efficient and effective decision-making process.

I am aware that I did not answer a question from the noble Lord, Lord Patel, about rationalising the number of research ethics committees, which may well bear upon this issue in another sense. The HRA and its predecessor have made good progress in reducing the timelines for ethical approval, something that stakeholders have recognised. The current special health authority feasibility study is looking at how to address

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other delays whereby trust decisions can be made based on their capacity and capability to take part in research. This is ongoing work. I come back to my point about the core function of the HRA, which is, above anything else, to protect the interests of patients and the public. It might not be advisable to load on to it too many other roles that could detract from that core function.

Lord Hunt of Kings Heath: My Lords, I am grateful to the noble Earl for that comprehensive response. I cannot help thinking that in order to protect the patient and the public there must be recognition that high-quality research is one of the best ways to enhance the quality of patient care. I remain concerned that bodies in the NHS still do not understand the importance of getting their act together in research approval. That does not mean that they do not have to go through a thorough process, because there clearly has to be a rigorous process to protect the public. I would like to see stronger language in the Bill that essentially allows the HRA to intervene if undue delays take place. I hope that we can return to that on Report.

I am grateful for the noble Earl’s comments on value-based pricing. All I would say to him is that I have been disappointed that there has been a great lack of public debate on this matter. I know that the department is shortly to publish further work. It is essential that these ideas are tested, and I am concerned that this is going to be simply a matter of negotiation between his department and the industry without there being a wider discussion of the implications. I appeal to the noble Earl for some opportunity on that.

Finally, the Minister has made it clear that the list in the clause represents bodies concerned with regulation, and that is now well understood. I come back to the question raised by the noble Baroness, Lady Emerton: is there not a case for another clause stating that there is a general duty of co-operation? There is an argument that while, of course, you have your statutory regulators which need to co-ordinate their efforts, you also want a lot of organisations and people to be involved, including the Chief Nursing Officer and the Director of Nursing at the department. I put that forward as a suggestion and beg leave to withdraw the amendment.

Amendment 58B withdrawn.

Amendments 58C to 63 not moved.

Clause 98 agreed.

Clauses 99 and 100 agreed.

Schedule 8 agreed.

Clauses 101 to 104 agreed.

5.30 pm

Amendment 64

Moved by Lord Patel

64: After Clause 104, insert the following new Clause—

“Human Tissue and Embryo Authority

(1) There shall be a body corporate called the Human Tissue and Embryo Authority.

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(2) The Authority shall consist of—

(a) a chairman and deputy chairman, and

(b) such number of other members as the Secretary of State appoints.

(3) The Authority shall keep proper accounts and proper records in relation to the accounts and shall prepare for each accounting year a statement of accounts.

(4) The annual statement of accounts shall comply with any direction given by the Secretary of State, with the approval of the Treasury, as to the information to be contained in the statement, the way in which the information is to be presented or the methods and principles according to which the statement is to be prepared.

(5) Not later than five months after the end of an accounting year, the Authority shall send a copy of the statement of accounts for that year to the Secretary of State and to the Comptroller and Auditor General.

(6) The Comptroller and Auditor General shall examine, certify and report on every statement of accounts received by him under subsection (5) and shall lay a copy of the statement and of his report before each House of Parliament.

(7) The Secretary of State and the Comptroller and Auditor General may inspect any records relating to the accounts.

(8) In this section “accounting year” means the period beginning with the day when the Authority is established and ending with the following 31st March, or any later period of twelve months ending with the 31st March; and Schedule 1 to this Act (which deals with the membership of the Authority, etc) shall have effect.

(9) The Authority shall prepare—

(a) a report for the period beginning with the 1st August preceding the day when the Authority is established (or if that date is a 1st August, beginning with that date) and ending with the next 31st March, and

(b) a report for each succeeding period of 12 months ending with 31st March.

(10) The Authority shall send each report to the Secretary of State as soon as practicable after the end of the period for which it is prepared.

(11) A report prepared under subsection (9) for any period shall deal with the activities of the Authority in the period and the activities the Authority proposes to undertake in the succeeding period of twelve months.

(12) The Secretary of State shall lay before each House of Parliament a copy of every report received by him under subsection (10).

(13) The following provisions of the Human Fertilisation and Embryology Act 1990 are repealed—

(a) sections 5 to 10, and

(b) section 11(1)(a) and (aa).

(14) Save for the provision in subsection (13), references in the Human Fertilisation and Embryology Act 1990 to “the Authority” shall be taken to be references to the Human Tissue and Embryo Authority.

(15) The Care Quality Commission may grant the following licences—

(a) licences under paragraph 1 of Schedule 2 to the Human Fertilisation and Embryology Act 1990 authorising activities in the course of providing treatment services,

(b) licences under paragraph 1A of that Schedule authorising activities in the course of providing non-medical fertility services.

(16) Sections 12, 13 and 13A of, and paragraph 4 of Schedule 2 to, the Human Fertilisation and Embryology Act 1990 have effect in the case of all licences granted under subsection (15) as they would do for licences granted under that Act.

(17) Section 13 of the Human Tissue Act 2004 is repealed.

(18) Save for the provision in subsection (17), references in the Human Tissue Act 2004 to “the Authority” shall be taken to be references to the Human Tissue and Embryo Authority.

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(19) In Schedule 5 (power to modify or transfer functions) to the Public Bodies Act 2011 omit—

(a) the entry for the Human Fertilisation and Embryology Authority, and

(b) the entry for the Human Tissue Authority.”

Lord Patel: My Lords, I rise to speak to this amendment in the name of the noble Lord, Lord Willis of Knaresborough, with some trepidation. It is not because I do not strongly support his amendment, but because I hope that I can do justice to it with the kind of passion that he would have demonstrated when presenting the argument if he had been here. However, I have no doubt that while resting in his bed, he has probably turned on BBC Parliament and is watching to see that I do the task adequately.

I think the reason why the noble Lord, Lord Willis, has demonstrated such passion is because he recognises that there is a need to reduce bureaucracy. Too many regulatory bodies mean more bureaucracy. To give an example, we have the second-highest number of competent authorities in the EU. Joint highest are Poland, Romania and Italy. However, on top of that, we have more regulatory authorities—over a dozen—than any other EU country. I see noble Lords look rather surprised, but I believe that to be true.

One issue is reducing unnecessary regulatory bodies. Another issue is reducing bureaucracy. The third issue is reducing duplication. The Human Fertilisation and Embryology Authority’s key role is to improve clinical services related to patients with fertility problems. The key reason that the authority was set up, following the birth of Louise Brown, was to reduce public anxiety about in vitro fertilisation. No such public anxiety now exists related to in vitro fertilisation.

Further functions were added to that authority in terms of embryo research. There may still be a need for that, but a reducing one. To give an example, we have enough clinical grade embryonic stem cell lines to last us a century and supply the world. I think the derivation of more embryonic stem cell lines is probably unlikely, unless there is some kind of major breakthrough. Research on embryos and embryonic stem cell lines is also now slightly superseded by induced pluripotent cells, dendritic cells and adult cells. However, I agree that there might still be a need for some embryo research and that function needs to remain.

The duplication is likely because the CQC will have a licensing role for those trusts that provide clinical services in infertility. Of course, I accept that the majority of infertility services relating to in vitro fertilisation—and I have no doubt that the noble Lord, Lord Winston, who is listening to me carefully, will correct me wherever I go wrong—are in the independent sector. Unless that service is provided for an NHS patient, the CQC does not have a role, and there must be a way of overcoming that. If we do not overcome that, the services provided within the NHS will run the risk of duplication of effort by the Human Fertilisation and Embryology Authority and the CQC.

There is also a fourth argument, and that is the reduction of cost. The noble Lord, Lord Willis, wrote a letter to the Times asking why all these regulatory authorities have a whole army of communication officers. What do they communicate? Why do they need so

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many? The noble Lord referred to the cost, and there are also other back office costs that are increased unless we reduce the number of regulatory authorities. His proposal is that there should be a reduction and that a body called the Human Tissue and Embryo Authority should be established rather than the HTA and the HFEA. The noble Lord lists where the changes would be required in their functions and in subsection (15) sets out the role of the Care Quality Commission to streamline all these efforts and reduce costs.

It is interesting that initially, in an attempt to reduce the number of quangos, the Government in the Health and Social Care Act decided that the HFEA and the HTA, with other quangos, would be abolished. Now, with the high profile of patient safety, we wonder whether some of the others should have been abolished. If I remember correctly, we debated the HFEA and the HTA during the passage of the Health and Social Care Bill and, in fact, we had a Division on it.

However, the Government decided to go to consultation, and I understand that Justin McCracken has been commissioned to review the operating functions of the HFEA and the HTA to see how they might deliver greater efficiencies. I think that this amendment, in the name of the noble Lord, Lord Willis of Knaresborough, would deliver those efficiencies, and I should be interested to know whether the Minister agrees that this would be a better way forward in dealing with the Human Tissue Authority and the Human Fertilisation and Embryology Authority. I beg to move.

Lord Warner: My Lords, I rise because I gave an assurance to the noble Lord, Lord Willis, that I would speak on this amendment as I have form, as they say, in this area.

Ten or so years ago, when one person accused me of being rather like Vlad the Impaler and we were slaughtering, as well as merging, a number of quangos, two of the candidates for merger were the Human Tissue Authority and the HFEA. Much of the argument for doing that was very similar to the argument that the noble Lord, Lord Patel, has advanced, although I did not know as much then as I know now about the number of bodies that we had compared with other countries regulating in this area. However, I assure the Committee that we had a lot more in 2003-04. Therefore, there is a case for this merger, and it has been made.

By backing away from this merger in the face of the arguments that were put forward, I ceased to be Vlad the Impaler and became Warner the Wimp. To their credit, this Government decided to have another go, but they seemed to get themselves in roughly the same position as Warner the Wimp and withdrew. Really, they withdrew because at the end of the day the savings were—certainly so far as I was concerned—not significant compared with some of the other savings that could be made. However, we have grown to appreciate more the importance of health research and the role of the life sciences in our economy, and I think that there is still a case for going the extra mile, when you can, to streamline the regulatory system in this area.

I hope that the Government will look sympathetically on this amendment, even if they do not want to accept it in its present form. I hope that some of us speaking

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out on this in the review will give the Government some courage to be a bit braver than they were, and than I was, in the past. Therefore, I support the spirit and the ideas behind this amendment.

Lord Winston: My Lords, I fear that I have to support the noble Lord, Lord Patel, on this amendment, even though I do not think it goes far enough. In my view, the case for having a Human Fertilisation and Embryology Authority at all is now quite dubious. It is 20 years or more since this treatment was established. There is no longer public anxiety about it, as there was in 1990, when the Act was introduced. It is now a regular treatment. As long as this treatment is licensed in this way, it will look like a maverick treatment to people—something extra, outside the health service.

One issue is that, sadly, these treatments are affordable only in private practice. Of course, the health service has done a good deal towards trying to supply them, but as the noble Earl knows, there are many examples where people pay very large sums in the private sector for these treatments and they are not and cannot be regulated. If one was really going to be serious about regulating in vitro fertilisation, the first thing that would be needed to prevent couples being exploited would be to find a way to reduce the massive burden of cost, which is out of proportion to the actual expense of the treatment. That is really something that needs to be looked at.

Sadly, the HFEA has not performed particularly well in the areas of research. I would like to recount briefly as an example the last licensed inspection of my own laboratory where we conduct experiments on embryos where there is no possibility of those embryos being transferred to a human patient. They are of course effectively dying in culture. It is extraordinary how stringent the last inspection was with regard to the quality of our laboratory. Why our laboratory should be seen to be more up to a particular standard than others doing cell culture work was beyond my comprehension given the fact that these cells, under no circumstances, could be used for human treatment: they were simply to investigate a phenomenon.

I could not help wondering whether in fact that particular inspection committee was being vituperative, because it had heard me speak against the HFEA at a previous debate in the House of Lords. I have no idea about that. But certainly, given that the previous year we had had a gold standard approval for our methods, I have to say that the inspection process is a patchy one. The problem really is that, currently, the HFEA licenses treatments that are practically research procedures that have not been validated and which are being charged to patients.

There are many examples of anomalies that are worrying. The noble Earl may have seen this week a full-page advertisement for egg sharing at a London private clinic. Incidentally, that clinic has been run by a member of the HFEA. One cannot help but feel that this is a shocking conflict of interest given that egg sharing is somewhat difficult to justify in certain circumstances as poor women may be persuaded to give their eggs under situations that are perhaps not ideal for them. They may in fact end up with someone else getting treatment at their mental expense—not

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their physical expense because they get a free treatment—and then 20 years later finding a child they do not even know about trying to trace them because of the information shown on our birth certificates. That anomaly has never been worked out.

I am really very surprised, too, that no serious attempt has been made to bar clinics that seek to send patients overseas for treatments that are not allowed in this country. There are many examples where patients are sent for various treatments where they might receive more than two embryos at a treatment, which would be against the regulations in this country, but they can come back and give birth to their triplets on the National Health Service. Clearly, that is an anomaly.

While I have absolutely no axe to grind about good private practice, there is no question that sometimes there are issues where clinics advertise wares that are unjustified. That happened two weeks ago when a clinic announced that it now had a treatment that could improve the success rate threefold. Of course, if I as a medical practitioner said that to the press, I could be held in front of the General Medical Council for advertising. But a clinic can get away with that kind of approach if it is not actually being mentioned by a medical practitioner.

The real reason for wanting to see at least some slimming down—we may need to come back to this at the Report stage to see exactly what clauses would be eliminated; it is difficult to see the whole of this rather large amendment now—is that at some stage in the near future we should revisit the Act of Parliament to see what would be best for purpose. In the mean time, however, there is a great deal of force in agreeing to slim down the number of regulatory authorities. As everyone across the House knows, regenerative medicine is one of the great opportunities for British medicine. At the moment, one may have to apply to up to 10 different regulatory authorities to get full licensing for the sorts of procedures one might want to follow for research, particularly where animal research may have to be done in parallel. That seems to be a very inhibitory process and there is evidence that it is preventing many bright people going into this research. They need to launch their PhD projects in other ways as quickly as possible.

While the amendment of the noble Lord, Lord Patel, is not perfect, slimming it down like this is a good start and an opportunity. I am also delighted to hear that the noble Lord, Lord Willis, who would have moved this amendment with the noble Lord, Lord Patel, is on the mend. That is good news about an outstanding parliamentarian. If the amendment were to be pressed, I would wish to vote for it.

5.45 pm

Lord Walton of Detchant: My Lords, it pains me to oppose this amendment because the noble Lords, Lord Willis, Lord Patel and Lord Winston, are people for whom I have the highest possible regard. Each in their own way has made outstanding contributions to issues relating to medicine and science in your Lordships’ House. Almost invariably, we have found ourselves singing the same tune, if perhaps sometimes in slightly different keys. Having said that, however, I am opposed

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to the amendment because I thought that this battle had been won two years ago. Admittedly, when this Government came into office, they embarked on what they called the “bonfire of the quangos”. A huge number of quangos were abolished, but after careful consideration and an attempt to merge these two bodies, the decision was made that they should continue to function independently.

Let me give my reasons for taking this view. When I came to this House in 1989, my baptism of fire was the Human Fertilisation and Embryology Bill that later became an Act. It was based upon the Warnock report. The function of the Bill was to create a Human Fertilisation and Embryology Authority that would license bodies and scientists working on research into the human embryo up to 14 days after fertilisation with, first, the objective of improving the treatment of infertility and, secondly, of helping in the prevention of inherited diseases. The noble Lord, Lord Winston, and others were among those who were eventually extraordinarily successful in carrying out the procedure known as pre-implantation diagnosis in order to detect embryos which were likely to cause serious human diseases. That was a very important development.

Subsequently, several other amendments were introduced—and I was deeply involved in those debates in your Lordships’ House—so that the licence could allow people to embark on research with these objectives and to address the important and crucial issue of carrying out research into the treatment of human disease. That in turn led to the development of the mechanism for creating stem cells for the treatment of human disease. There has been a series of progressive amendments that have been fully debated in your Lordships’ House. Now we are faced with the very exciting prospect, following an extensive period of consultation, whereby embryos can be created by pronuclear transfer derived from women who are likely to pass on devastating mitochondrial genetic mutations to all of their children of both sexes. The consultation is now complete and we can look with hope towards the prospect of the regulations to allow those embryos to be implanted being introduced into your Lordships’ House. This is a crucial development. I agree entirely with certain things that the noble Lord, Lord Winston, has said—the Human Fertilisation and Embryology Authority has not functioned as effectively as it might. However, his criticisms were largely concerned not with the potential merger but with the actual performance of the body as an authority.

I was also heavily involved in the debates in your Lordships’ House on the formation of the Human Tissue Authority. This body arose as a result of the so-called Alder Hey scandal where a huge number of human brains and other organs were kept in the hospital without the permission of the families. Of course, it was not recognised in many debates at the time that certain members of the medical profession held a widespread, ill-founded belief that once permission was given by a family for a post mortem examination it was proper to retain organs. That belief was partly based on the fact that to establish a diagnosis after a post mortem examination it is essential that certain organs are fixed in formalin before they can be studied

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and before the diagnosis can be confirmed. This is crucial. As a result of the so-called Alder Hey scandal the Human Tissue Authority was established. It has the authority to license anatomy departments to handle human organs and pathology departments to study human samples, both full organs and biopsy specimens. It has the authority to license organs being used for transplantation purposes and many similar functions. These departments in universities and hospitals are licensed by the HTA.

The function of these two bodies is entirely different and I do not believe that it is sensible—even in the attempt to create another quango which brings together two quangos—to merge them. The new body would undoubtedly have to create two sub-committees, one to look at human fertilisation and embryology and another to look at the issues of human tissue and the retention of it. I therefore do not support this amendment.

Lord Patel: I disagree with my noble, respected and even revered friend Lord Walton of Detchant. He fundamentally fails to understand this amendment. It does not remove the research functions of the Human Fertilisation and Embryology Authority. I have spoken strongly in the past about embryo research, including cell nuclear transfer and mitochondrial research. It is the authority that has held up for so long the progress in mitochondrial research. We should have been doing something about it at least 18 months ago. This amendment does not remove that function, nor does it remove the functions of the Human Tissue Authority, but by amalgamating these functions we can better promote research. The authority and functions of the Human Fertilisation and Embryology Authority—and now we are entering into a science debate, which is not the purpose of the Bill—stop once it gives a licence to do specific research on an embryo. Once the embryonic stem cells are created it has no authority over how those cells are used. Once the cells are used to create a tissue for research it does not have any authority, but the Human Tissue Authority may do. By amalgamating the two you are co-ordinating this research function and maybe improving it. I hope that my noble and revered friend accepts that explanation.

The Lord Bishop of Chester: My Lords, having listened to these distinguished doctors taking different points of view on this subject, I fear that I might lower the tone of the debate. However, I think that my money is with the noble Lord, Lord Walton of Detchant. There is a world of difference morally between research carried out on tissue taken from a dead body and research taking place on living tissue which has the potential to be a human being in one way or another. People will argue about when life begins and those arguments can be very sensitive and very divisive. That is why there is separate legislation on research and on therapeutic techniques involving eggs fertilised outside the womb. Whether one likes it or not, if you put together the Human Tissue Authority and the HFEA you will create an impression that you are just dealing with dead matter or whatever, just a lump of cells. That is the impression that will certainly be given psychologically, even if in practice one could construct the unified authority in a way that had the two legs.

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It may well be that one needs to revisit this area. The noble Lord, Lord Winston, speaks with such authority that I am very reluctant to take a different view. However, he seemed almost to be arguing for greater regulation rather than no regulation. I would be very reluctant to see a free market in implanting more than two embryos into women in this country, for example. The 14-day rule, which may be an irritant to researchers, was fought over and discussed at great length. To those of us who have quite a few reservations in this area, that is at least a line in the sand. I think that this area needs to be considered on its own merits and, notwithstanding the arguments quite rightly put by the noble Lord, Lord Patel, I am with the noble Lord, Lord Walton.

Lord Patel: Stem cells are not dead cells: they are immortal cell lines, such as the HeLa cells on which scientists have been doing research for decades. These cells were taken in 1951 from a woman called Henrietta Lacks—that is why they are called HeLa cells—and they are still alive. Most cancer research is done, and many drugs produced, using HeLa cells. They are immortal, living cells.

The Lord Bishop of Chester: My Lords, as St Paul once said, I speak as a fool. However, is there not a difference between stem cells that are alive in that sense and a fertilised egg that is alive in a different sense?

Lord Walton of Detchant: I intended to say, but did not, that the two different bodies’ areas of authority collide when you deal with stem cells, because they are derived from embryo research but then become cells that are used for tissue research and transplantation and so on. That is where they collide. That does not necessarily mean that it is crucial to merge the two authorities.

Lord Warner: My Lords, at the risk of lowering the tone even further, perhaps I may just take us back and slightly challenge the noble Lord, Lord Walton, which I do not normally do. I also took the Human Tissue Act through this House. I am well seized of the circumstances that we faced then. At the time, I was bombarded by the research community with their concerns about setting up that body and whether it would be another obstacle to research. They recognised that this country had to do something in legislation in terms of the EU directive on human tissue. We were caught between a rock and a hard place. We had to do something about the EU directive; we had all the concerns about what had happened in Liverpool; but we were also conscious that we needed to ensure that we did not put another set of barriers in the way of medical research.

When we were considering the merger of the Human Tissue Authority and the HFEA we were very strongly of the view—which is very similar to what the noble Lord, Lord Patel, has said—that there was not a great deal of difference between the nature, if I may put it that way, of the matter being used for research under the aegis of those two regulatory bodies. In some cases, human tissues were themselves living cells being used for research, and we did not regard that as fundamentally a different type of matter from the one that is regulated for research purposes by the HFEA. I cannot even brag of an O-level in science—“Shame on you, Warner”,

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says Michael Gove. But in my lay view we had a situation where the advice we got from the scientists was that having two bodies was likely to be a greater impediment. There was a case on savings grounds—back-office services etc; the kind of issues that the noble Lord, Lord Willis, mentioned in his letter to the


—but there was also a science argument for putting the two bodies together.

6 pm

Baroness Thornton: My Lords, it is a great pleasure to be back on the Front Bench as part of my noble friend’s health team, even if it is for a short time. I join other noble Lords in sending best wishes to the noble Lord, Lord Willis, for a speedy recovery.

As noble Lords will know, I have been interested in the future of the HFEA and HTA both as a Minister and during the course, in the early days of this Government, of the slash and burn Public Bodies Act, which both these bodies survived. The idea of merging the HFEA and HTA is not new, as my noble friend Lord Warner said, and has been rejected on more than one occasion. I am puzzled by the noble Lord, Lord Patel, raising it now, especially in the middle of yet another review. What I waited to hear, particularly from noble Lords with scientific and research backgrounds, was what the public thought. The right reverend Prelate was right when he said that this is also about how people feel about these issues, not just how the great doctors and scientists think things should be done. In fact, that was how we started out with all these issues.

As my noble friend Lord Warner said, this was first raised by my Government. We proposed establishing a new arm’s-length body called RATE—the regulatory authority for tissue and embryos. According to my research, in 2007 the Government wisely decided not to proceed with that following criticism from a Joint Committee set up to scrutinise that draft Bill. The arguments advanced against RATE then were just as persuasive as they are today. Many of us have held that there is little overlap in the work of the two bodies and that the specialist expertise each provides should be maintained to ensure that regulation remains effective and public confidence is maintained. The discussion we have had so far today has not convinced me that this proposal is the best way forward at the moment. The independence of the HTA and HFEA is important for a number of reasons, not least because of the public confidence needed in both the areas they cover.

In 2010, the Government proposed as part of their bonfire of the quangos that the functions of the HFEA and the HTA should be transferred largely to the CQC. Noble Lords will remember the debate about that during the passage of the Public Bodies Act. Following an extensive public consultation, that proposal was also rejected by the Government in January this year. Once more, a clear majority of those who responded thought that the risks involved in such sensitive areas of medicine were just too great. Instead, the Government decided that an independent review of the way the HFEA and HTA carry out their functions should be undertaken by Justin McCracken. I understand that Mr McCracken’s review is complete and Ministers have yet to decide what to do. Perhaps we will have a sneak preview of that today.

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Is there new evidence that there is an advantage in merging these two distinct and expert organisations? As I said, they have different roles. According to the brief I was sent, there are fewer than 10 organisations jointly regulated by both organisations. As context, around 130 organisations are regulated by the HFEA and 800 by the HTA across diverse sectors. On these Benches we are nervous that the amendment tabled by the noble Lord, Lord Patel, to merge the boards of both these organisations risks losing specialist expertise held by the HTA and HFEA and the unique roles in law that their respective boards have.