Care Bill [Lords]
The Committee consisted of the following Members:
Kate Emms, Committee Clerk
† attended the Committee
‘() the Chief Nursing Officer of the Department of Health,’.
‘(j) the Chief Nursing Officer of the Department of Health;
(k) the Medicines and Healthcare Products Regulatory Authority.’.
Paul Burstow: As was said at the beginning of the previous sitting, we are very nearly there. I did not see a man on the way here with a sign saying, “The end is nigh”, but none the less it feels like we are pretty much at the end of the road in this wonderful process. I look forward to the two days of Report, the next stage of the Bill.
The amendment is short but, as I hope the Minister will agree, perfectly formed. Its intention is to correct a defect that I think must have resulted purely from an oversight. Clause 109, which outlines the co-ordination and promotion of regulatory practice with regard to the Health Research Authority, lists numerous individuals or organisations that should be part of the consideration of how the HRA operates. Subsection (1) contains a long list that includes, quite rightly, the Secretary of State, those responsible for licensing medicines, the Health and Social Care Information Centre, the chief medical officer and several other bodies.
One problem with comprehensive lists is that later they can be interpreted as excluding rather than including, so I wanted to ensure that we did not erroneously exclude the voice of a rather important profession in such matters: the Department’s chief nursing officer, who seems to me to have some interest in supporting the Health Research Authority in the discharge of its responsibilities, ensuring that the nursing profession plays its part in promoting access to and awareness of trials, and supporting patients and families in decisions that are sometimes difficult and complex. I therefore tabled the amendment to ensure that the central and fundamental role of nursing is reflected properly. I hope that the Minister can give us some reassurance that its omission was an oversight that the Government are keen to correct. I look forward to his response.
The Chair: It has been the practice so far in our discussion of the Bill to debate amendments and therefore not clause stand part. My intention with this group is to continue on that basis, so if people want to speak more widely about the clause and not just about the narrow amendments, they are free to do so.
When I was travelling in on the tube this morning, I did not see, “The end of the world is nigh”, but I did notice a Cancer Research UK advert proclaiming, “Three times more people than are in this carriage are saved by research each day”. It struck a chord with me about the importance of these discussions. Getting the regulation right for how we undertake medical research is critical, not only because that research saves and improves lives but because the UK is a world-leading centre for research, and we have world class universities in life science and medical research. The purpose of setting up the Health Research Authority was to facilitate safe and ethical research and, by working with relevant partners, help create an environment in which applying to do research is simpler and people get quicker decisions. That will be an important part of getting the regulatory regime right. Will the Minister therefore confirm that, as the HRA becomes an arm’s length organisation, the anticipated triennial review will take place so that its achievements so far can be noted, lessons can be learnt and improvements considered?
I have the great fortune of being a member of the Science and Technology Committee, which undertook an inquiry into medical research and clinical trials. In that, we noted the significant positive steps that the Government had taken to build trust among the public about the safety of participation in clinical trials and how well received the HRA has been so far. I want clarity on whether the HRA’s important work, such as its 2013 “OK to ask” campaign, which encouraged people to participate in clinical trials by raising awareness, will be part of its new regulatory regime as proposed in the Bill, so that protection of those participating in clinical trials and promotion of participation is there in equal measure.
The UK Clinical Trials, which the Government introduced, is great: it helps more people understand how they can participate in research and enables more research to be carried out. In the Minister’s summing up, will he confirm that the HRA will have, as its key role, not only protecting people, but promoting participation in medical research so that the UK’s world-leading academics can continue to pioneer new treatments? That work is not just a benefit to our constituents; it contributes a great deal to growth in the economy, which the Government see as being science and technology based.
Mr Jamie Reed (Copeland) (Lab): I almost regret mentioning the gentleman with the sandwich board that said, “The end is nigh,” not least because I forgot to mention which constituency he represented—I am sure that it was a marginal seat.
I thank the right hon. Member for Sutton and Cheam for tabling his amendment and starting the debate on this group of amendments. He has demonstrated a
I share the right hon. Gentleman’s concern about omissions from the list in the subsection and he made a good point about the nature of a comprehensive list. Amendment 169 deals with two omissions: the chief nursing officer and the Medicines and Healthcare products Regulatory Authority. I thank the Royal College of Nursing for its help and advice on the first part of the amendment. It believes that the omission of the chief nursing officer is an oversight that must be rectified. It stated:
“The nursing profession has a fundamentally important contribution to make in health and social care research, recognised by the UK Clinical Research Collaboration...and National Institute for Health Research”.
“The paucity of evidence of what works in care and caring practices could be a factor in identifying what constitutes good levels of care. In times of austerity when resources are limited it is more important than ever to ensure that care and caring practices are both compassionate and effective.”
“Research is essential to develop the knowledge base to underpin nursing practice and ensure that the deployment and interventions of the largest health care workforce are both efficient and effective.”
As the right hon. Gentleman has set out, there is simply no justification for the omission of chief nursing officer from the list. I hope that the Minister will agree with the arguments and accept the amendment. If not, I hope he will explain why.
Our amendment goes further: we want to see the Medicines and Healthcare products Regulatory Authority included in the list. I understand that the licensing authority is referred to in the list, but, under the Medicines Act 1968, the function is conferred on a group of Ministers to act as the licensing authority, so there is legislative reasoning for the inclusion of the MHRA. With the functions of the clause to promote co-operation and research and the regulation of research, it is essential that the body responsible for regulating medicines in the UK is included.
The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring that they work and are acceptably safe. Underpinning all its work lie robust and fact-based judgments to ensure that the benefits justify the risks. That is the blurb from the MHRA website. It clearly has a role to play in the standardisation of research practices. Can the Minister outline the role he expects the MHRA to play in relation to the functions of the HRA in subsection (1)? The benefits of involving the regulator of medicines and medical devices in the research and the development of medicines and medical devices is surely apparent to all. The MHRA expertise on the efficacy and safety of products cannot be surpassed, and it must have a part to play in this area.
One of the key objectives for the MHRA is to support research and ensure, through the application of better regulation principles, that regulation does not stifle innovation. As such, its place in the process becomes even clearer. Subsection (l)(i) gives the Secretary of State power to introduce regulations that would give direction for other groups to be included in the list, with which the HRA must co-operate. Can the Minister give assurances that both the chief nursing officer and the MHRA will be included when the regulations are introduced, and can he assure the Committee that that will be done sooner rather than later? If he can give those assurances, there will be no need for me to test the will of the Committee.
The Parliamentary Under-Secretary of State for Health (Dr Daniel Poulter): I am pleased to confirm to the Committee that the consensual nature of our proceedings will continue in our discussions on the clause. We have had speeches from Government and Opposition Members highlighting the importance of facilitating research and ensuring, as my hon. Friend the Member for Truro and Falmouth said, that the UK can be proud of our international standing as a centre of international research and a centre of excellence for that research. The clauses on the role and function of the HRA are about facilitating and supporting the development of UK plc as an international centre for research. They are also about strengthening the ethical criteria for research and streamlining the process to make it easier for clinicians, researchers, patients and the public to understand how ethical approvals are given in medical research.
My hon. Friend the Member for Truro and Falmouth asked whether the Government will carry out a review of the HRA and its functions. The answer is yes, absolutely; I can confirm that. It will be undertaken, as appropriate, after the HRA’s creation as a non-departmental public body once the Bill is enacted.
I hope that I can also reassure my right hon. Friend the Member for Sutton and Cheam. The move to establishing the HRA’s functions in statute will pave the way to cementing Britain’s place in the world as a leader in international research. Amendments 91 and 169 directly concern the HRA’s role and functions and the people who have a duty to co-operate with that body. Specifically, the amendments deal with the bodies that are required directly to co-operate with each other in respect of functions related to health and care research, with a view to co-ordination and standardising regulated practice, under clause 109(1).
It is worth reflecting on the fact that the HRA is already making excellent progress as a special health authority in co-operating with other bodies to create a unified approval process for research and promote consistent, proportionate standards for compliance and inspection. Sir John Tooke, of the Academy of Medical Sciences, gave evidence to the Joint Committee that scrutinised the draft Bill, which was chaired by my right hon. Friend, saying:
“In terms of successes in its early days, we welcome the relationships that have been forged with the MHRA and devolved administrations. Those are very important if this is going to act as a coherent body. We also welcome the broader stakeholder engagement because we will only resolve these issues if we involve all the parties that are involved in the process. The creation of the Collaboration and Development Steering Group is a very important step in that regard.”
Both amendments would add the chief nursing officer of the Department of Health to the list of persons and bodies under duties of co-operation in clause 109(1). Amendment 169 would also add the Medicines and Healthcare products Regulatory Agency to the list of bodies.
We all recognise the valuable contribution that nursing research can make to improving health. It may be useful if I outline some of the valuable contributions from work that is going on, which I am sure will reassure Committee members. Through the National Institute for Health Research’s policy research programme, the Department supports several projects on nursing care, led by or involving nurses. Research funded by the NIHR is typically multidisciplinary and often involves a range of health care professionals. The NIHR supports a range of other research on nursing and care. Committee members will be reassured to know that clinical research nurses comprise the largest research group involved in delivering clinical research in our NHS. There are more than 3,000 nurses in the NIHR clinical research networks. Two nurses have been given the senior investigator award, which is that body’s most prestigious award. One of those, Professor Nicky Cullum, from Manchester university, was made a dame for services to nursing in the Queen’s birthday honours list last year.
The integrated clinical academic training programme for nurses, midwives and allied health professionals and the NIHR fellowship programme support 100 annual training places on clinical academic training masters programmes for nurses and allied health professionals, 18 clinical doctorate research fellows and clinical lecturers, who are nurses, and 10 NIHR doctoral fellows, who are nurses.
The amendments would add the chief nursing officer of the Department to the list of persons and bodies that must co-operate with one another. However, the Department does not have a chief nursing officer, so the amendments as drafted would not work. The Department has a director of nursing. The chief nursing officer is based in NHS England, as my right hon. Friend will remember from piloting the Health and Social Care Act 2012.
Clause 109(1) lists the persons or bodies with whom the HRA must co-operate in exercising its functions: the Secretary of State, the licensing authority for the purposes of the Medicines Act 1968, to which I will
Unlike the Department’s chief medical officer, neither NHS England’s chief nursing officer nor the Department’s director of nursing have statutory functions relating to regulation of research. It may be useful if I explained why the chief medical officer has such a statutory function. This is not about creating arbitrary distinctions between doctors and nurses and different parts of the medical profession; we value multidisciplinary research and nurses are leading the way in much of the work being done by the NIHR. The CMO’s function in this regard relates to previous statutes.
The post is listed because it holds specific statutory functions related to the research under the Abortion Regulations 1991. The regulations require notice to be given to the Chief Medical Officer of any abortion and any information relevant to it. Disclosure of such information is restricted, apart from 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.
I have sympathy with the amendment and I hope I have assured hon. Members with what I have said that, in delivering its functions, the existing Health Research Authority is working, and the new authority will work, with a wide range of bodies with an interest in health and social care research. Subsection (3) gives the authority a freestanding duty to promote the co-ordination and standardisation of practice relating to the regulation of research. In meeting this duty the authority will work with bodies and persons with an interest in multidisciplinary research, including those with an interest in the contribution of the nursing profession and NHS providers, in addition to those persons listed with specific statutory functions.
The existing special health authority employs a number of people with a nursing background, including the head of the National Research Ethics Service, who has previously held a number of clinical nursing posts. Around three quarters of research ethics committees have at least one nurse member and as we are expecting a smooth transition from the special health authority to the non-departmental public body when the Bill is passed, the new body will have similar nurse representation. I am sure my right hon. Friend will agree that that is very strong nurse representation.
More broadly, I reassure hon. Members that the main objective of the Health Research Authority requires the authority to facilitate the conduct of safe, ethical research in performing its functions. It will, of course, do this in the multidisciplinary way we have been discussing today. In meeting this objective, the authority must facilitate all types of high quality, ethical research, including research that is multidisciplinary in nature. In the explanatory notes we now explicitly state that the definitions of health research and social care research are not restricted to any particular professional group—so, for example, they would include nurse-led research.
Turning to the amendment which would add the Medicines and Healthcare products Regulatory Agency, the MHRA, to the list in subsection (1), I am pleased to reassure the hon. Member for Copeland that there is already a duty of co-operation with the agency. As an agency of the Department of Health, the MHRA is not established in statute, which is why it is not listed by name in the clause. However, it does have statutory functions relating to the regulation of health research, as it is the licensing authority for the purposes of the Medicines Act 1968. It is, therefore, the body listed in subsection (1)(b). The MHRA is responsible for regulating all medicines and medical devices in the UK.
It might be worth highlighting an example of the MHRA’s statutory functions under the Medicines for Human Use (Clinical Trials) Regulations 2004, which implement EU Clinical Trials Directive 2001/20/EC. Clinical trials of medicinal products in human subjects require authorisation by the competent authority, which is the MHRA in the UK. The MHRA therefore assesses applications from sponsors to conduct clinical trials of medicinal products. The HRA, which would become a member of the UK Ethics Committee Authority under the Bill, provides for the ethics of clinical trials of medicinal products to be assessed. So both the HRA and the licensing authority, which is the MHRA under the Bill, have relevant statutory functions relating to the regulation of research. That is an example, also, of the streamlining of research that we have been describing throughout our discussions this morning.
Subsection (1)(b) already creates a reciprocal duty of co-operation between the MHRA, the HRA and the other bodies listed in this section, by virtue of the fact, as we have discussed, that the MHRA is the licensing authority for the purposes of the Medicines Act 1968. I hope that I have explained why neither the NHS England’s chief nursing officer nor the Department of Health’s director of nursing are specifically mentioned in subsection (1), and that hon. Members are reassured that the Health Research Authority will have an interest in multidisciplinary research by virtue of its main objective. I also hope that hon. Members are reassured that subsection (1)(b) would already create a reciprocal duty of co-operation between the HRA, the MHRA and the other bodies listed. With these explanations and reassurances, I hope that hon. Members will not feel the need to press their amendments.
Paul Burstow: I am grateful to the Minister for the reassuring way he has set out the conduct that he expects the Health Research Authority to adopt. I am now clear why this clause may not be the most appropriate place to put a technically deficient amendment. None the less, I hope that the Minister will ensure that the Health Research Authority engages further with the RCN, which is clearly sufficiently concerned about this matter to raise it in briefings to members of the Committee and sought the tabling of this amendment. I hope that the Minister’s words will also reassure the RCN and on that basis I beg to ask leave to withdraw the amendment.
Paul Burstow: I want briefly to raise a question and make a request. I have been working with the Teenage Cancer Trust for some time looking at some issues that arose from the tragic case of a young lady called Chloe Binner, who died from an aggressive form of cancer. She was unable to get on to clinical trials, because of age bars that were built into those trials. A lot of interesting progress has been made in this country around the question of approval of research, which is the subject of clause 111.
However, we still feel that not enough progress is being made to ensure that enough teenagers are getting into research trials. We feel that the way in which trials are designed is based on the mechanism of action rather than the chronological age of the patient to determine whether they are in or out of the trial. A change in approach would give much heart to many parents and teenagers who currently find themselves shut out of trials. It could also help to expand the number of trials taking place.
My request is therefore to ask the Minister if he will consider meeting me and the organisations to discuss how this clause and others relating to the Health Research Authority can be used to help effect an acceleration of access to these trials for teenagers.
Dr Poulter: My right hon. Friend makes a very important point. We need to have the right health research in place, particularly in important periods of transition in a child’s life. More broadly, I hope I can reassure my right hon. Friend and, of course, I will be pleased to meet him. He has a keen constituency interest in his local hospital, the Royal Marsden, and has been a great supporter of it. Of course, when it comes to children, additional safeguards may have to be put in place. However, the general spirit of the clauses is about promoting much more streamlined processes of health research for children and adults. I hope that that provides some reassurance, but I would be delighted to meet him and representatives from his constituency or whoever else he chooses to bring to the meeting.
Mr Reed: I rise to make some brief but pertinent points about the impact of the provisions in clause 115. First, let me be clear that, in principle, the Opposition support the proper utilisation of anonymous patient data. The importance of such data in medical research,
We should all strive towards those ends, and I am sure that we are doing so, but they do not justify any means. It is acceptable to use patient data only in a proper manner. Patient data are rightly private, and they must continue to be so. The Minister must explain how he intends to ensure that adequate safeguards are in place to protect patients and their data. Phil Booth, the co-ordinator of the patient group medConfidential, has said of the clause:
Rather than prevent this, the care data scheme is deliberately designed so that ‘pseudonymised’ data—information that can be re-identified by anyone who already holds information about you—can be passed on to ‘customers’ of the information centre, with no independent scrutiny and without even notifying patients. It’s a disaster just waiting to happen.”
Will the Minister respond to the points raised by Mr Booth? The explicit removal of the Secretary of State’s power to scrutinise applications for patient data takes away a significant protection. That decision will be taken instead by the Health Research Authority. Given that the authority will be a under a statutory duty to consult a wide range of professional bodies, however, it will logically have an in-built bias towards releasing such information.
Mr Booth also touches on the idea of pseudonymised data—patient data that are redacted, but only partially. They would still contain an individual’s date of birth, ethnicity, gender and postcode, all of which are remarkably personal to a patient. I think it is evident to the Committee that it would be relatively easy to identify somebody using that information. Mr Booth highlighted the fact that the data are not anonymous and have not been redacted fully, and as such could lead to discrimination by insurers or in the workplace. That is unacceptable, and nobody wants to see that happen. I hope that the Minister will address those points.
I would also like the Minister to respond to a quote that The Guardian attributed to Mark Davies, the public assurance director at the Health and Social Care Information Centre, which is the body that will hold patients’ data. He said:
How can it be right for the Government to absolve themselves of the responsibility of safeguarding patient data when those data can be used to identify someone? Mr Davies said that the risk depends on
Do the Government retain any responsibility for ensuring that the data are used in a proper manner, or can buyers use the data in any way that they see fit once they have purchased them? If it is the former, I would like the Minister to outline what the safeguards are, and if the latter, I would like him to justify the freedom that the clause will grant to companies.
I said I would be brief, so I turn to my final point on the matter, namely the patient whose personal data are up for grabs. Will the Minister explain why there is no mechanism for notifying a patient when their data have been purchased? I also want to address the issue of opting out of the data-sharing system altogether. I understand the benefits of wider participation, but patients must be given the chance to opt out of the scheme. Yet we understand that the Government are penalising those GPs who have patients who opt out. That is leading to reports that GPs are making it more difficult for patients to choose to withdraw from the scheme. That is unacceptable and cannot be justified.
Finally, the Government’s public awareness campaign has left a lot to be desired and I have a number of questions on that. Under the previous Government, issues of patient data were subjected to a wide public awareness campaign. Personalised letters, which—as we know from our day jobs—people are likely to read, were sent to everyone in the country and a six-month public awareness campaign was undertaken. We have not seen anything on the same scale for what amounts to such a big change. Will the Minister explain why not?
The Government’s actions have amounted to the distribution of an information leaflet that could be mistaken for junk mail and not be read. Given that the same leaflet has been sent out, can the Minister tell us how his Department has quantified the delivery rate? Does the Department know how many households have definitely received the leaflet? Can anyone be sure? If everyone has received the leaflet, how many have actually read it? How is that measured?
Patient privacy must be respected at all times and I do hope that the Minister can explain what safeguards he has put in place to ensure that any patient information is completely anonymous and that companies who access this information cannot use it to identify patients.
Debbie Abrahams (Oldham East and Saddleworth) (Lab): I endorse the points made by my hon. Friend the Member for Copeland. We can all share the objective of having a more streamlined research process. However, removing the safeguard of the Secretary of State from the process is a serious matter. We must ensure that the unintended consequences of such a move are properly debated and considered. I would like to see the clause deleted from the Bill.
Data confidentiality is a major public concern that has understandably increased with the recent health reforms, particularly the centralisation of many aspects of the reformed NHS and Department of Health. There has been an increase in the number of quangos and unelected bodies, including NHS England, Health Education England and now the HRA. It is wrong to hand over ultimate control of such sensitive issues as patient data to an unelected quango.
I do favour a streamlined process for supporting research. As a former public health director of research, I know it is important to do that. However, I am concerned about unintended consequences. As my hon. Friend mentioned, we have seen an increased privatisation of certain health services and increased concern about how the data might be used by private health insurers and others. We need to consider the matter fully and recognise the experience of the Americanised system
My hon. Friend also mentioned the national opt-out process. I am grateful to the Minister for some of his written answers to my questions on the matter. I hope he will answer in detail my hon. Friend’s inquiry about how it is being monitored. There is a concern that there is no national process. I have a question about whether one can opt out over the phone. The process seems very ad hoc. My household certainly has not received any information about the system. If I now ask the Minister if I can opt out of the process, will that be acceptable? We need to be clear about the opportunities for patients to ensure the safety of their information.
There is agreement about the need for research and there has been excellent news this week. I am always sceptical about reports in the Daily Express but tremendous strides are being made, with the potential for a cure for type 1 and type 2 diabetes, and today there is news about a breakthrough in treating peanut allergy. Those are important steps forward, and no one in the Opposition denies the need for proper research in a proper framework. However, many members of the public share the concern that there will be no way for them to work out who has access to some of the more sensitive information about them—their medical records. Nor will they know what use the data are put to.
My understanding, although perhaps the Minister will correct me if I am mistaken, is that the extracted information will contain NHS numbers, date of birth, post code and details of ethnicity and gender. Many people, including me, would have little concern about truly anonymous data being shared with organisations such as university research departments, but far fewer would be comfortable with the idea that insurers and drug companies would be able to apply to the Health and Social Care Information Centre to get access to such sensitive information.
Firms will have to pay to extract the information, and some of the personal identifiers will be removed—but not enough to make it completely anonymous. That is a matter of concern to many, including, I assume, some hon. Members on the other side of the Committee. There is a risk that patients could be re-identified because insurers, pharmaceutical companies and other health sector companies have their own medical databases, which could be matched against the records in question.
If the information is used for commercial purposes, that could lead to insurers discriminating against customers, or pharmaceutical companies marketing their own products at people they know suffer from a condition. Furthermore, it cannot be guaranteed that such sensitive information would be secure in the hands of private companies. It could be targeted by hackers or be leaked for commercial gain. Many people would not want to share such information with pharmaceutical companies and insurers. It seems contentious that the Government should legislate to do that on the public’s behalf.
I served on the Committee on the Health and Social Care Act 2012, and I remember the big debate about setting up the arrangements under that Act. Ministers—a
Dr Poulter: It is important to make it clear at the outset that we are talking about the Health Research Authority and not care.data. The Opposition have in discussion perhaps inadvertently conflated the issue with ethical research and relevant committee functions. I shall give a little reassurance on some of the care.data information, but will not be drawn into wider discussion, which might be out of order. I am sure that there will be more general opportunities to discuss the issue in the House, which would be a more appropriate place.
There are strict rules about what information the Health and Social Care Information Centre can release to the NHS and outside organisations. Anonymised information does not identify individuals or small numbers of patients with rare characteristics or diseases. Potentially identifiable patient information, which is information about individual patients, but does not contain any identifiers, is never published.
There are strict controls about the release of potentially identifiable information; for example, that type of information would only ever be released to approved organisations for approved purposes, and there must be a legal contract in place, with penalties for any misuse of information. There are very strict criteria in place. People, as we know, can opt out from that care.data scheme and it is not to be conflated with this clause that we are discussing about the HRA. I will give way once because I do not wish to try your patience, Mr Bayley, by deviating from discussions about this Bill.
Debbie Abrahams: I do not think that this is deviating from the Bill. Will the Minister confirm that this is transferring responsibility for safeguarding confidentiality of patient data from the Secretary of State for Health, an elected representative, to a health research authority, a non-elected quango?
Dr Poulter: I will come on to talk specifically about the HRA clause now, which may be useful, but it is important to point out that in this debate there has been considerable conflation of the care.data discussion, which is completely separate to this debate and the one that we are having about the Health Research Authority. It is worth talking first of all about the role of research. In all aspects of health care, research is perhaps the area with the most stringent and strictest criteria about protecting patients’ interests. That is undoubtedly the case. We also recognise that sometimes there are variable practices across different health care and NHS organisations that seek to engage in research. This Bill is about drawing that together by streamlining the processes but protecting those existing ethical safeguards that are in place for patient confidentiality.
Dr Poulter: I will address the hon. Lady’s point in one moment. I will not let her try the patience of the Committee by trying to deviate discussions to the care.data discussion, which are not directly relevant to this clause.
Research has a vital role in improving both the health and wealth of our nation and there are occasions when medical research requires the use of identifiable patient information and when it is not practical to obtain consent, but that happens only in very rare circumstances. For example, the research study may require access to identifiable patient data to allow linkages between different data sets where the cohort is too large for consent; this would require time-limited access to identifiable information where gaining the consent of a large retrospective cohort would not be feasible and would more require more identifiable data that would be necessary for linkages.
The Health Service (Control of Patient Information) Regulations 2002, which continue to have effect under section 251 of the NHS Act 2006, make provision for approval to set aside the common law duty of confidentiality to omit disclosure of confidential information for medical research purposes, where it is not possible to use anonymous information and where seeking consent is not practical. There are strong safeguards put in place by the previous Government—and these are the previous Government’s safeguards to protect patient information from being passed on. I will give way one more time.
Debbie Abrahams: The Minister still has not answered my question. This clause is about transferring the responsibility for safeguarding confidentiality of patient data from the Secretary of State, an elected Member of this House, to an unelected quango, the Health Research Authority.
Dr Poulter: I will come on to that point. I fail to see where the Secretary of State being involved in the process offers any necessary additional safeguards to the process. The process and ethics of medical research, and the ethics committees that have been set up, have rigorous safeguards in place. We have a similar process in place, for example, in the Human Fertilisation and Embryology Authority. There are very rigorous safeguards in place to protect patient confidentiality, to make sure that not only is confidentiality protected but that research is facilitated in the right way and patients are protected. Similar processes exist in many other areas of health care, but if hon. Members think that it is right that politicians should be safeguarding ethics and rights in health care, they should think again.
Dr Poulter: The Secretary of State has direct responsibility for special health authorities and ultimate responsibility for all arm’s length bodies of the NHS in some way, shape or form, depending on whether it is through the accountability framework of NHS England, or HEE. It is about that day-to-day ability to interfere in the process—it is important that we see less political interference, and we see that in the clauses on the CQC. We believe that, as far as possible, these processes should be independent from political interference. We need to facilitate good research and make sure that we have strong safeguards to protect the public in place, as we always have in
Dr Poulter: When we talk about political interference in the health service, we know from evidence that has been given that, in cases such as the Mid Staffordshire crisis, there was political involvement in decisions to release health care information which was not for the benefit of the health service. Particularly with issues to do with patient confidentiality, the Secretary of State of course has oversight of the health service, but the day-to-day decision making should be removed from the political process. In practical reality, that is what happens.
Dr Poulter: I made the point already that the system as set up by the previous Government, with the involvement of the Secretary of State in overseeing the system and the research process generally, works very well. This further crystallises the independence of the HRA as a non-departmental body and is welcomed by the research sector. That is a good thing as it will broaden the independence of that group. Be it in the HRA or the CQC, we do not want day-to-day political interference, or the potential for that interference in the health service. That has been to the detriment of the health service with the CQC in the past. There is, of course, the potential for that to happen elsewhere and that would not be good. The Opposition have consistently raised concerns about patient-identifiable data, but can they give me an example today of a patient who has had his confidentiality directly breached through the research processes that they put in place and whose independence we are strengthening in the Bill? I challenge them to do that because I think the answer will be no. I am also happy if they want to raise examples with me in writing.
Dr Poulter: Again, the hon. Lady tries to conflate this with broader issues to do with research data. This is to do with the ethical approval of research, which is governed by very strict criteria put in place by the previous Government. If she has concerns, she should perhaps raise them with former Ministers who put those criteria in the legislation. I do not have concerns about the rules
Clause 115 makes a number of consequential amendments to these regulations to transfer the Secretary of State’s power to approve the processing of confidential patient information for medical research purposes to the HRA, which is best placed to protect and promote the interests of patients and the public. No substantive changes are being made at all to the safeguards around the processing of confidential patient information, and the amendments ensure that the HRA cannot give approval for processing of confidential patient information unless a research ethics committee has approved the medical research concerned.
Sarah Newton: I want to draw the Committee’s attention to the excellent work that the Science and Technology Committee did on this, which I referred to earlier. It has four Labour members, including a Labour chair, and warmly welcomed the HRA and the Government’s approach to the regulation of research in these proposals.
Dr Poulter: That is an important point. Rather than trying to throw up political smoke about the issues, that Committee took a consistent view, looked at the good legislation passed by the previous Government to protect the public and patient confidentiality, and recognised the importance of a more streamlined process for the transfer of information, and for medical ethics and research.
That is exactly what the relevant clauses do. They were broadly welcomed in pre-legislative scrutiny by my right hon. Friend the Member for Sutton and Cheam and his Committee, and in the House of Lords, with the scrutiny of many medical and research experts. They were also broadly given a strong welcome by the Science and Technology Committee, as my hon. Friend the Member for Truro and Falmouth mentioned.
The clauses are good and I make no apology for removing the potential for political interference from the process. We already have a robust way of protecting patient confidentiality with the current medical research ethics system and the Health Research Authority, and the Opposition were unable to give one example of data being used inappropriately against the wishes of the patient or against the contract. It is a false debate and a straw man, and it has the potential to put short-term politics in the way of doing the right thing and making the HRA’s role more independent.
Grahame M. Morris: Does the Minister not see the danger? It is all very well waving the blue duster and talking about political interference, but he has pointed out the law of unintended consequences before. The present system works very well, but data have gone missing on occasion. I can think of several occasions that have caused considerable embarrassment. Patient data are highly sensitive, and there would be commercial advantage for drug companies and others in acquiring it.
We have experienced the potential for political involvement in decisions; we saw it with the Care Quality Commission under the previous Government in the Mid Staffordshire crisis, when advice was not taken and concerns about health care failures were not raised. We do not want political interference in decisions about the health service or research decisions. We accept the strong and rigid safeguards laid down by the previous Government to protect patients and research.
The main issue is making sure that we have an independent system with robust, strong safeguards for patients and to protect the public, and the clauses provide that. Nothing would be added by a direct mention of the Secretary of State in the clause. If things go wrong with the health service he has an overall duty to step in if required; but because safeguards have worked so far, there is no need to do that. The clauses are good, and they will protect and enhance research.
‘(A1) In section 65H of the National Health Service Act 2006 (Chapter 5A of Part 2: consultation requirements), in subsection (7) after “Secretary of State;”, insert—
“(c) any overview and scrutiny committees in whose area the affected trusts have hospitals, establishments or facilities; and”
(A2) In section 65H of that Act (consultation requirements), in subsection (8) leave out
“(a) an overview and scrutiny committee of any authority to which section 244 applies;”.’.
‘(A3) In section 65H of that Act (consultation requirements), at the end of subsection (4) insert—
( ) The Trust Special Administrator must hold at least one meeting with overview and scrutiny committees in whose area the affected trusts have hospitals, establishments or facilities.”.’.
‘(A4) In section 65KB of the National Health Service Act 2006 (Secretary of State’s response to regulator’s decision), after paragraph (1)(b), insert—
“(ba) that in the discharge of its functions the trust special administrator has reasonably sought and considered responses from any affected trusts, staff of any affected trusts and such persons as the trust special administrator may recognise as representing staff of any affected trust, and any person to which an affected trust provides goods or services under this Act that would be affected by the action recommended in the draft report.”.’.
Paul Burstow: We move on to another subject that, I am sure, will not prove controversial. I say that with a sense of irony as I suspect it will be exactly the opposite. The trust special administrator regime has been controversial since it was first proposed in the Health Act 2009. It is an area where we come into direct conflict between the legitimate interests of the general public to be fully involved in decisions that shape and affect their health care, and the scenario in which, as a very last resort, actions are needed to protect the public’s interest by maintaining a continuity of service for an organisation that is financially unable to operate. That is what the clause seeks to develop further—because the clause is not the beginning of this story of trust special administration and its power to intervene in the event of an organisation’s being under severe financial pressure and in sustained financial difficulty. It is a consequence of the recognition by successive Governments that there needed to be a mechanism in place.
The clause amends the trust special administrator regime that was set out in the previous Government’s 2009 Act. The aim was good. As I said, it was to protect the public’s interest through maintaining continuity of health services. The trust special administrator regime was there for rare cases, and Ministers in the previous Government emphasised that it was to deal with rare and unusual circumstances. I hope that the Minister will confirm today that that remains the underlying policy intention. It concerns those organisations—the NHS trusts and foundations trusts—that find themselves at financial breaking point. It is, by definition—at least, I hope it will continue to be by definition—very much a last resort after all other steps have been taken. The amendments explore what that might mean in practice.
The 2009 Act sets out the process for appointing administrators and how they do their job. It has been a given now for some years. The Act was designed to ensure that speed would be of the essence when making recommendations to secure health care for local people. However, it had a flaw, which was dramatically exposed in the court case regarding the role of the special administrator in Lewisham.
The way in which the trust special administrator regime was set up in the 2009 Act took an entirely institutional view. It looked at individual trusts as though they were islands, but we all know that a local hospital is part of a complex web of relationships and services. It is an interdependent organisation. It does not stand on its own, and sometimes financial difficulties are not caused by its actions, but by those of others in the local health economy. As the Government make progress on their agenda for integration, those interdependencies will become even more profound and important. If we see the emergence of integrated care organisations, that will be even more profound in terms of understanding those interdependencies. That is recognised in the clause, but the Government amendments take it further, and that is welcome.
The Government amendments—I look forward to the Minister’s setting this out in more detail—would ensure that the administrator, once appointed, had to engage with and consult affected areas and trusts. That picks up the point that trusts are not islands, but interdependent. It is right to ensure that those who could be affected by the administrator’s recommendations
Amendments 151 and 153 ask the Government to remove the Secretary of State’s discretion and make it a requirement that overview and scrutiny committees, like other health organisations in the area, are consulted and engaged with during the work of the special trust administrator.
I also hope that the Minister will say more about the obligations that apply to the special trust administrator on public engagement and involvement. The quality of the engagement at this last resort stage is very important in trying, to some extent, to mitigate the sense of alienation that the public will have about a process that they feel is taking power away from them. It is very important that that is clear and I hope the Minister will say something about that.
Secondly, in the Health and Social Care Act 2012, we debated at length whether there should be a duty on the Secretary of State to respect the autonomy of NHS organisations. The 2012 Act requires the Secretary of State to have regard to his obligation to step back and allow organisations in the NHS empowered to do certain things, to do so unmolested by him on a day-to-day basis. That is a good idea, which needs to be thought through in the context of trust special administration. Will the Minister say how the Secretary of State, in taking a recommendation to start a trust special administration process, takes into account his duty on autonomy under section 5 of the 2012 Act?
Amendment 170 relates to some comments made by the NHS Confederation and the Foundation Trust Network. They are calling on the Department and, I suspect, by extension NHS England, to have a clearer strategy for stepping in ahead of the need to trigger the unsustainable provider regime—the missing piece of this puzzle. Surely that involves making sure that, to avoid the need to trigger a trust special administration regime, there is good quality engagement with all the stakeholders—all those in the local community who have an interest in the future of health care for their area. That is not simply a box-ticking exercise or about paying lip service.
When we look at research on public engagement on commissioning and reconfiguration decisions, there are few examples of world class change management in the NHS. The example that is often cited is stroke care changes in London, but when one looks for other examples, they are few and far between. The NHS does not do this very well very often. Stroke care is an example where it did it very well. It brought stakeholders with it and explained why the changes were necessary, and that went through remarkably peaceably, considering the level of change that was taking place.
Debbie Abrahams: I do not want to test the Committee’s patience, but could that be something to do with the National Institute for Health and Clinical Excellence intervention committee not meeting for three years, so that there has not been the opportunity to look at evidence-based policy, and the fact that so little research money has been spent on health systems approaches?
Paul Burstow: That may or may not be part of it, but there is also a flaw in the way in which we train those who manage and lead our NHS organisations. We do not train for patient involvement and engagement. It is learnt on the job and sometimes bad habits are transferred from one organisation to another as a consequence. That has to change and I hope it is one of the things that Health Education England can address. It seems to be a very important key that can unlock much better dialogue between the public and the NHS about how their NHS is organised. That will be necessary, because we will see change in our health services. If we are to dissolve boundaries between organisations and integrate health and social care, it will require changes.
Some of those changes need good, world class change management to help people through them and help them see the benefits that can make a difference to them and their families. That is why I also hope that the Minister will respond to amendment 170. It simply says, on behalf of the Foundation Trust Network, that, when the Secretary of State receives the report from the TSA, he should demonstrate that he is satisfied that the requisite amount of consultation has taken place and that the views of those affected have been sought and considered.
Will the Minister confirm that, as under the previous Government, the powers are a last resort? Will he spell out the obligations for public engagement and consultation? Triggering those powers would surely be an admission not just of the financial failure of an individual organisation, but of the wider system, if the situation had been spotted but the necessary action had not been taken. That would be a failure for all in the system. Surely prevention is better than having to sort out these things in a rush. That is why engaging the public meaningfully from the outset, not simply as lip service, is key to securing consent to change.
I hope that my amendments prompt a debate on those points, and that the Minister can at least accept that overview and scrutiny committees should be able to bring their expertise into the process, ensuring better outcomes.
The Chair: I have been asked for a stand part debate on the clause. I am inclined to grant that as long as people in their stand part speeches raise matters that have not been previously covered on the amendments. They will have to make that case when they speak. It therefore makes sense to invite the Minister to speak about his amendments. Then we will have a wider debate, if the Committee desires, on the amendments, reach a decision on them and move on to stand part.
Dr Poulter: I fully agree with the sentiments and points made by my right hon. Friend the Member for Sutton and Cheam. The TSA process is one of last resort that also needs to respond and recognise—and will recognise as a result of Government amendments—that
Amendment 135 is a minor and technical amendment that would ensure that the provision in clause 118 to extend commissioner sign-off for the recommendations of a trust special administrator at a foundation trust to include commissioners of other affected trusts can be commenced following Royal Assent.
Amendment 136 would further improve the changes we are making to strengthen the regime under clause 118. It relates to the administrator’s statutory consultation on the draft recommendations to secure sustainable services in a local health system. I remind the Committee that Lord Darzi told the House of Lords during the Committee stage of the 2009 Act that the regime was intended to ensure that the
“final decision on the future of services is informed by an independent process involving evidence-based judgments, underpinned by accountability to the public and patients”.—[Official Report, House of Lords, 5 March 2009; Vol. 708, c. GC336.]
The amendment would ensure that decisions about affected trusts were soundly based. It would require an administrator at an NHS trust or foundation trust to consult other NHS provider trusts, their staff and commissioners who may be affected by the draft recommendations. The amendment would complement the extended scope of an administrator under clause 118. Amendments 137 and 138 are technical and consequential on amendment 136.
Representations made to the Government have shown a clear expectation that an express wider power for an administrator should be matched by an express wider consultation requirement. We are therefore responding positively to a strong view from key stakeholders who represent NHS providers—some of those stakeholders were outlined in my right hon. Friend’s speech—who believe it is logical and necessary to widen the scope of a TSA remit. The amendment is a proportionate extension of the current consultation requirements. It would ensure that an administrator’s final recommendations are formed by a full evidence base and deep understanding of the issues facing the entire local health system and local health economy. It would help the administrator to recommend the right long-term solution.
Amendments 151 and 153 would require a TSA, during the consultation, to receive a written response and to hold at least one meeting with any overview and scrutiny committee in whose area any provider trust affected by the administrator’s proposals has hospitals, establishments or facilities. I agree entirely with the principle that a TSA should consult relevant overview and scrutiny committees. I am sympathetic to the desire for such requirements, but we believe that it is important not to have an entirely prescriptive process in statute about whom an administrator must consult, beyond certain legal minimum requirements. It is right that current minimum legal requirements for consultation include consulting the public.
The National Health Service Act 2006 already allows anyone with an interest to provide views on the administrator’s proposals and for the administrator to hold at least one meeting to seek responses from anyone who wishes to attend. The legislation does not confine or constrain that requirement for public consultation. Equally, it is right that minimum consultation requirements include staff of the failing trust and its commissioners. Our amendments to extend the minimum requirements to other provider trusts, their staff and commissioners are, in our view, important in complementing the extended scope of an administrator’s remit. I believe that my right hon. Friend the Member for Sutton and Cheam strongly supported that point in his remarks. Beyond minimum legal requirements and the ability of the Secretary of State and Monitor to direct an administrator to whom else they should consult, statutory guidance from the Secretary of State and Monitor is clear that administrators must be able to use their judgement in choosing who else to consult to ensure meaningful and effective engagement. In practice, it is hard to conceive of an administrator not wanting to engage with the local authority, given the importance of developing the best possible proposals.
“legal requirements are a minimum and it is expected that Trust Special Administrators will use their judgement in choosing to consult other organisations or persons…Trust Special Adminstrators must exercise discretion about who they should consult to ensure there is…effective engagement during…consultation on their draft report.”
An annex to the guidance suggests that relevant overview and scrutiny committees, including joint overview and scrutiny committees, are among the organisations and individuals an administrator might wish to consult. Paragraph 84 of the statutory guidance issued by Monitor to foundation trusts is almost identical.
I hope that my right hon. Friend finds my remarks somewhat reassuring. I would like to reassure him further by saying that we will look again at the issue and our statutory guidance, to convey in clear terms the importance of local authority involvement in any special administration process. We will ask Monitor to do likewise with its statutory guidance for administrators at foundation trusts. I further reassure him that I am sympathetic to the arguments he made about overview and scrutiny committees. We will reflect on what has been said here today, in advance of Report.
Grahame M. Morris: The Minister is keen on examples, so will be reflect on what happened at Lewisham? He talks about altering the statutory guidance— he refers to paragraph 53. If there had been one meeting of the overview and scrutiny committee, even involving neighbouring authorities, does he think that would have been enough to assuage public concern and win back public trust?
Dr Poulter: In discussing the amendments, I will not discuss issues of the past. The Bill is not retrospective, but prospective. It will ensure that we improve the trust special administration regime, which the previous Government established in 2009, and make it more fit for purpose. Our amendments would provide for a broader duty of consultation, with broader duties for
Liz Kendall (Leicester West) (Lab): Is the Minister aware that Andy McKeon, the new chief executive of the Nuffield Trust, says that the Minister’s amendments inviting the public to give their views are not enough? He says that, even with the changes that the Government propose, the time scales are far too curtailed and the standard rules on consultation should apply. I am sure that the Minister knows that Mr McKeon and the Nuffield Trust are pro-changes to hospital services where they can be shown to work, but they are very clear that full public consultation must take place, if a trust that is not failing gets drawn into the process of reconfiguration. That is what Mr McKeon says; what is the Minister’s response?
Dr Poulter: The hon. Lady says that there is a very tightly curtailed timetable. We have actually extended the consultation time for the TSA process under clause 118. I do not want to return to the debates that we had on clauses 82 and 83 about single failure regime, but I am sure the hon. Lady recognises that, when we are dealing with quality failure of trusts, it is important that action is taken quickly to protect patients and the public.
It is not acceptable to put more delays in the system. We are increasing the amount of consultation in this process by a number of weeks, but the process in its entirety can take between six and eight months to go through. That is a fairly lengthy process and a lot of consideration is done. I am sure that the hon. Lady would not want to endanger patients’ and the public’s lives by extending it further. That is the risk if we make these processes too lengthy.
Liz Kendall: If a trust is not failing, but has been brought in to look at how the whole health economy is dealt with, why should there not be the same standard process and standard length of time for a consultation?
Dr Poulter: The previous Government set out a strong and robust process in the 2009 Act. Our amendments extend the timetable for the TSA process and the consultation to affected trusts and commissioners. We are already consulting the public. There is a very robust system in place that was envisaged originally by the right hon. Member for Leigh (Andy Burnham), so I am surprised that the hon. Lady is taking exception to the process. We recognise that there were deficiencies in the 2009 legislation. That is why we have extended the scope for consultation to additional providers, to other affected providers and to additional commissioners. We have also made sure that there is proper engagement with the public and we are looking at the issues that my right hon. Friend the Member for Sutton and Cheam raised about the wider health and social care economies, on which health overview and scrutiny committees had a very strong view.
Liz Kendall: Will the Minister confirm that the same standard period of consultation does not apply to a trust that has been brought into the reconfiguration and has not been failing? What is the justification for less
The Chair: Order. The hon. Lady is not listening to responses. It is possible for her to make a speech about the Minister’s amendments or, indeed, those of the right hon. Member for Sutton and Cheam, later in proceedings.
Dr Poulter: The hon. Lady is misinterpreting my points—I am sure not wilfully—and has perhaps inadvertently misled herself in her interventions. It is clear that there is a process for when a serious failure of sustainability of the trust or a quality failure occurs. That is an important step that we included through triggering the TSA regime in clauses that we discussed earlier. It is important that that process is dealt with relatively rapidly. Even so, we are extending the process for broad consultation. However, the first step when there are concerns about quality in a trust—when the CQC issues a warning notice or raises concerns—is the one taken by this and the previous Government: for discussions to take place with local commissioners about the quality of services at that trust. That is the first step in dealing with concerns about quality in a trust. There is also strong oversight from Monitor and the Trust Development Authority to intervene and exercise their powers where appropriate when a trust has sustainability or financial problems.
Those are the first steps that will need to be taken. Part of the process, for example through the special measures criteria now being used, is about involving other trusts in the health care economy in helping facilitate solutions where appropriate. That happens every day, right here, right now. It is happening on the back of the Keogh review, thanks to what we have done on putting special measures in place for trusts. There is a comprehensive process that works well and takes into account the broader health economy. Sometimes, when things get to that extreme stage and other mechanisms have been exhausted, it is important that there is a TSA process, and that has broad consultation built into it.
Liz Kendall: I will try once more. I am sure that the Minister is not wilfully misinterpreting my question. I am referring to a trust that has not failed on quality or finances, but has been brought into a process being used to deal with another trust that has failed on quality or finances. Why should the trust that has not failed be subject to less consultation than the standard public consultation process for those trusts that have?
Similarly, on the financial sustainability of trusts, we would expect commissioners, the TDA and Monitor where appropriate to work with the trust in question and more broadly across the health care economy. Those changes are at the heart of the Secretary of State’s approach to putting trusts in special measures. That is pairing trusts together where there are concerns and problems and taking that broader look at the health care economy. Implicitly, other health care trusts and providers are involved, as are other commissioners, in dealing with solutions at an early stage.
Then, if necessary, in extreme circumstances due to quality failure or other issues around financial sustainability, the TSA process is triggered. At that point there is a process for consultation again across the broader health economy, and that is relatively lengthy. The TSA will take that broad look across the health economy in accordance with our amendments. That is a robust process. However, when the TSA is triggered because things are so serious, we will get to a conclusion; if there are issues of patient care at stake, they will be dealt with quickly.
Grahame M. Morris: The Minister is generous in giving way. Will he respond to a point arising from one of his remarks? He said the TSA would be an infrequent and rare occurrence. Are not 30% of non-foundation trusts and about 11% of foundation trusts forecasting that they will run a deficit for this financial year? This is a major change that may be very important if more and more trusts are forecasting deficits.
Dr Poulter: The hon. Gentleman may remember that the last time that trusts got into major deficit was when the hon. Member for Leicester West was a special adviser in the Department. [ Interruption. ] There is no point chuntering from a sedentary position. We are not in a position at the moment whereby we have changed in any way what the previous Government envisaged. The TSA process is a last resort, and because patients’ lives may be at risk, it cannot be an open-ended, incredibly lengthy process.
Even so, we have a robust process in place for broad consultation as part of the TSA regime. We have slightly extended the process of consultation to ensure that the views of other commissioners and providers are taken fully into account. For those reasons, we have made sure that we are putting a strengthened regime in place. It is about protecting people’s lives when there is a quality failure. I am sure the hon. Member for Easington would not want that to be an open-ended ticket; it needs to be resolved quickly.