Question proposed, That the clause stand part of the Bill.

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,  and in the synthesis of new treatments and better care, cannot be overstated. In research terms, more information about how people with certain conditions react to treatments can led to better research being undertaken, which uses resources more efficiently and improves a patient’s quality of life.

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:

“One of people’s commonest concerns about their medical records is that they’ll be used for commercial purposes, or mean they are discriminated against by insurers or in the workplace.

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:

“You may be able to identify people if you had a lot of data. It depends on how people will use the data once they have it. But I think it is a small, theoretical risk”.

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

“how people will use the data once they have it.”

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.

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  of how health data are used in that way. The ultimate consequence would be the exacerbation of health inequalities in a two-tier health service.

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.

I want to say a few words in support of the shadow Minister and my hon. Friend the Member for Oldham East and Saddleworth.

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  different team, admittedly—gave the Committee cast iron guarantees that what I have described would not happen, and that all the data would be made anonymous. It is a matter of concern that that will not happen with the provisions we are considering.

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.

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?

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.

Debbie Abrahams rose—

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.

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.

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.

The point is about accountability, it is not about safeguarding. Will he address the point made by my hon. Friend the Member for Oldham East and Saddleworth about accountability?

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  research. Those safeguards should be even stronger when it comes to ethical research and clinical trials. Safeguards around the HRA are very strong, as strong as they would have been and were under the previous Government’s legislation.

I am intrigued. Can the Minister give an example—there may be one; this is a genuine question—of where there has been political interference in medical research programmes?

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.

The answer is no.

I gave the example of the Mid Staffordshire crisis, where political interference affected patients.

Order. I think it is better to use examples that are related to commissioning approval or non-approval, giving ethics approval or in relation to research.

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.

I suggest a scenario in which patient data are sold to an insurer and through that a patient is denied insurance. Who would be held to account?

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  that were put in place by the previous Government. I think they are very robust. We are strengthening those rules by making sure that the system is even more independent and is protected from any potential political interference.

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.

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.

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.

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.

The safeguards to protect patient data are just as robust as they ever were. The hon. Gentleman cannot, as he said, give an example of the safeguards  not working so far. [ Interruption. ] He has just said that, so I am using his own argument against him. The safeguards will be just as robust as they ever were. That is clear and he has accepted 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.

Question put and agreed to.

Clause 115 accordingly ordered to stand part of the Bill..

Clauses 116 and 117 ordered to stand part of the Bill.