Care Bill [HL]

Lord Owen Excerpts

Wednesday 7th May 2014 Lords Chamber

There must be a sustained programme with the support of the medical profession and all other clinical professions. The public has great trust in clinical professions, but not in managers of health—and nor, dare I say it, in politicians. Assuming that the points above are addressed and the pilot projects are successful, I hope that we can then move on to how we can progress this further. In this respect, can the Minister make a commitment that no changes to the law will be made to provide for the access of commissioners to this kind of data without further consultation and parliamentary scrutiny? Can he also say something about how the data will be handled in a secure way?

[Lord Owen (Ind SD)]

My Lords, I speak to my Amendment 45E. A recent comment article in the Lancet starts off with the words:

“Trust in the protection of confidential patient data in England seems to be at an all-time low given recent breaches in releases of patient data and the finding that hospital data have been sold to companies with insufficient oversight”.

There is no question or doubt that the research base in this country—particularly the base in pharmaceuticals and medical bioscience—is now at a very high level. Of course, it is because of this that there is a very strong debate over whether AstraZeneca should be taken over by the very large American pharmaceutical company Pfizer.

However, we also have to recognise in this debate that without confidence and the free exchange of information in this world of science data, research will be very badly damaged. Already we know that very serious members of the medical profession want to institute not the present opt-out system but an opt-in system. Most of us know that that will make great inroads into the effectiveness of our data. There are also some GPs who, because of their concerns, now actively encourage patients to use their right to opt out. This is therefore very urgent, and I welcome that the Government, in recognition of the crisis of confidence, have instituted a six-month pause. I understand that the pause has now been extended and that there is no artificial deadline.

In that context, there is another root cause for concern. We have been making data available to the pharmaceutical industry and other areas of commercial science for some time. Perhaps I should declare an interest. For 16 years—I am now off the board—I was on the board of Abbott Laboratories in Chicago, one of the very big American healthcare companies. However, well before that I was a neuroscientist at St Thomas’s Hospital and worked in the early 1960s with ICI, using its remarkable pharmaceutical research product, beta-blocker drugs—one of the great discoveries which led to James Black winning a Nobel Prize. I therefore have no need to assure noble Lords of my belief that a thriving commercial sector in pharmaceutical and other research is an important addition to the research that goes on in universities and hospitals up and down the country.

However, it is a fact that when you embark on a new extension of data being available to commercial operations outside the public sector, people demand and expect much higher safeguards. Before moving my own amendment and shoring it up, I looked very carefully at whether it was possible to get agreement on a mechanism to keep data in the public sector unless commercial organisations have expressed consent. That was seen by many people as blocking commercial activity, and it was not possible to reach agreement on it. That makes it even more important that we should have a statutory form of oversight.

The amendment I placed on the Order Paper proposes a new clause that would place on a statutory footing the current non-statutory Independent Information Governance Oversight Panel, which was set up by the Secretary of State. The present chairman, Fiona Caldicott, has the support of many people in this area, both in this House and outside. However, its present non-statutory terms of reference need to be given the authority of a statutory imposition. The new clause would also require persons and bodies across the health and social care system to have regard to its advice. It defines the relevant information; I strongly agree with the two previous amendments tabled by the noble Lords, Lord Turnberg and Lord Hunt. It is absolutely necessary to make it crystal clear what “promotion” means. It has different meanings in many different contexts—some perfectly acceptable and some borderline objectionable. There are other detailed aspects of the amendment, but it is pretty clear in its intent.

The medical profession is not the only body that ought to be considered in this. The Royal Statistical Society has made it clear that oversight and public trust in enforcement could improve the situation. It says that a new statutory body is likely to be needed to fulfil this role. Statisticians are as worried about the loss of confidence that is developing over medical data as anyone in the medical profession—they are the actual people who handle this.

I am pleased, indeed proud, that the amendment is supported by the Wellcome Trust. There is no better trust in the world than the Wellcome Trust. It is also supported by the charities that are associated with medical research, which also know the importance of the Wellcome Trust’s money and expertise. I have talked to the Minister about this and I will leave my comments for when I formally press the amendment, as I do not want to traduce what he is going to say to the House. He explained his position with his usual courtesy, but I remain of the view that, if we are to hold, restore and, in the future, enlarge public confidence—because I believe a greater exchange of information has huge potential—we have to listen to these concerns.

Whether we like it or not, people expect answerability, not just from NHS England, which is a quango, but also from the Secretary of State. Parliament has a role in this, and the issue is every bit as sensitive as some of the others that we brought under statutory oversight, such as embryology, the whole question of DNA and research into all these areas. We thought that they were so sensitive that Parliament should have a say, at least, and should know whether Ministers are taking actions that have qualifications, or even objections, from a statutory body so that we can make a determination. It is in that spirit that I will later seek to press the amendment.

[Lord Ribeiro (Con)]

My Lords, when many members of the public, and patients in particular, feel that their data may be mis-sold to insurance companies or other bodies that may use them either to increase premiums or for their own personal benefit, then we have a problem. Earlier this afternoon we had assurances from the Minister that that would not be the case. This must be information that is used for non-commercial purposes, which has been made very clear. It is important, too, to remember that patients can opt out. I have heard these expressions about the difficulties that they may have with GPs who might prevent their doing so, but they have a choice. They may well opt out. I believe that if we go ahead with care.data and provide the information as needed, many patients, in time, will see the benefits of this and will choose to opt back in.

We have also talked about the need, again, to have anonymised data and to prevent it going anywhere other than the non-commercial areas. Patients also have a right to decide what to do with their data; it is enshrined in the NHS constitution that they have rights on the disclosure of their personal data. I personally feel that all patients should have their own information—they should have their own notes. They should have a memory stick with their records and have ownership of their records. They can then determine, in the circumstances, where that information goes.

Many people are horrified by the idea of patients having their own records. I had experience of this in 1973, when I was a surgeon working in Ghana. Patients would come with their own notes, moth-eaten and dog-eared. The reason was very simple: if their notes were in the hospital, a certain bribe had to be paid before those notes could be released. Patients have always been suspicious about what happens to their notes. Give them to them—that is what I would say.

The proposal from the noble Lord, Lord Owen, for yet another layer of scrutiny above what is being proposed, is something that we should consider very carefully. He referred to the fact that it would be for the Secretary of State and NHS England to make those decisions. However, noble Lords will recall that when we debated this matter not that long ago, the noble Lord, Lord Willis, and others put forward a proposal for the Health Research Authority. If this Bill goes through, the Health Research Authority will have the authority to decide how information is disclosed. Therefore, I speak very strongly in support of the care.data programme. It is important for patients to be reassured and that point has been well made from all sides of the House. They clearly have to have that reassurance. However, I see no need for an extra layer or an oversight panel. That would provide just one more barrier for researchers to climb.

--- Later in debate ---

Moved by

[Lord Owen]

As an amendment to the Motion that this House do agree with the Commons in their Amendment 45, at end insert “and do propose Amendment 45F as a consequential amendment”.

45F: After Clause 118, insert the following new Clause—
“The Oversight Panel
(1) There shall be a body corporate to be known as the Independent Information Governance Oversight Panel for Health and Social Care (referred to in this section as “the Oversight Panel”).
(2) The main duty of the Oversight Panel shall be to provide independent advice on all matters relating to the processing of relevant information in relation to health and adult social care.
(3) In exercising its main duty, the Oversight Panel shall—
(a) provide advice and make recommendations and proposals on such processing to the Secretary of State, and report annually; and
(b) provide advice on such processing to any other person in relation to health and adult social care.
(4) Any person or body who is advised by the Oversight Panel pursuant to this section shall have regard to that advice.
(5) The Secretary of State and the Board (“NHS England”) when making directions under section 254(1), and regulations under section 267, must seek and have regard to the advice of the Oversight Panel.
(6) The Secretary of State or, as the case may be, NHS England must lay before Parliament a response to the advice given by the Oversight Panel under subsection (5).
(7) The Secretary of State may by regulations make provision about the Oversight Panel relating, in particular, to appointment of the chair and other members, terms of appointment, establishment and membership of committees or sub-committees, its proceedings and payment of remuneration, allowances and expenses.
(8) The Health and Social Care Information Centre (Establishment of Information Systems for NHS Services: Collection and Analysis of Primary Care Data) Directions 2013 and The Health and Social Care Information Centre (Establishment of Information Systems for NHS Services: Data Services for Commissioners) Directions 2013 are revoked.”

[Lord Owen]

My Lords, for those who have not been in the debate I will try to deal with the specific responses from the different speakers. First, perhaps I may deal with the response from the noble Lord, Lord Lester. I agree very much with what he said. I believe that the European Court of Human Rights and the human rights legislation, coupled with the privacy Act, do enough to safeguard confidentiality and privacy. With respect, however, that is not what this amendment is essentially about. This amendment is essentially about how you release those documents, what the procedures and mechanisms are, and what the criteria are for release. That is what is so very sensitive at the moment. That is why we need the reassurance of outside scrutiny not only over NHS England, which is effectively a quango, but also over a matter as sensitive as the regulations that might come from the Secretary of State.

In his speech, the noble Earl, Lord Erroll, reminded us of the complexity of this issue. In fact, the issue is geared into a lot of the technology and science of how one collects this information. As for the noble Baroness, Lady Campbell, she warned us seriously about what is likely to come out of Europe, which could have profound aspects. I believe that legislation is coming. However, the key issue is what the noble Earl, Lord Howe, said in his speech. With his characteristic courtesy, he had already given me an indication of how he was likely to reply. Those who were present earlier will remember that I did not try to summarise his views; I thought it was more important that the House should listen to them. I listened as carefully as I could, and I do not want to be churlish about this—what he said was important and will give some comfort to people outside. He said that he was sympathetic to the desire to put an oversight panel on a statutory basis and I very much welcome that. He also referred to how Dame Fiona Caldicott was uniquely well placed to be the chairman of this body and, by implication, a new statutory body. I think that all the contributions from both sides have agreed on that issue.

The noble Earl said that there may well be merit in establishing the existing panel and went on to say that in his conversations with Dame Fiona, she said that she would look first at the question of statutory underpinning and then at it in terms of the relationship. The problem, as I explained to the noble Earl this morning, is that I should like to have a letter from the Secretary of State committing himself to that. Those of us who have been in government know that the time of the legislative committee is very much fought over: everybody wants to legislate but time is short. An unequivocal commitment to legislate would be necessary for me to withdraw this amendment, but, with respect, we did not get one. We got a lot of sympathy, and I hope and believe that legislation will come. I even hoped that the noble Earl would say, “The Government will be neutral. We are not taking a position. Let it go to the Commons and let’s see what the Commons view is”. I think that that would be helpful and would give him more time to build a consensus around the pattern and form of legislation.

If the House does not mind, I would like to ask for its agreement to this amendment—in the spirit that I believe that it would do a lot to ease the current suspicion and distrust over the whole issue of medical data, patient data and hospital data. I say to those who did not hear the speeches that no one in this entire debate has questioned the absolute importance of these data: they could be crucial for this country’s future in the biological sciences and in pharmaceutical research. If the issue is handled properly and with confidence, I believe that we can ensure that the number of those opting out—which is a natural right—will be very small. As long as the number of those opting out remains small then the data will be statistically significant and extremely important. The danger is that the number of those opting out could become quite substantial. I hope and pray that that does not happen. In our vote tonight, we will at least be showing those who are concerned that we believe that there should be a statutory underpinning. I beg to move.