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Lord Winston: I too am extremely nervous about the issues which the noble Earl, Lord Howe, and the noble Lord, Lord Walton, have already raised.

We must recognise that this Government have shown huge concern for research governance and for improving the quality of patient involvement in research. But I remain very worried that research may be threatened by this clause as it currently stands. I accept that there are precedents for information being given to the Secretary of State. I am reminded of the Abortion Act, for example, where information has been sent for the past 30 years to the Secretary of State, as far as I know without harm to patients. Indeed, that has happened with regard to the Human Fertilisation and Embryology Act 1990. Nevertheless, there is a great deal of strong feeling in the medical community at large and concern about this matter which I hope will be addressed by the Minister this evening.

Lord Hunt of Kings Heath: This has been an extremely interesting debate. It is clear from the different views expressed from all sides of the Committee that the issues which we are debating are not at all easy of resolution. I believe that the balanced approach which the Government have taken and which is embraced within this clause provides us with the best possible way of meeting some of the real concerns which exist.

I should say to the noble Earl, Lord Howe, that it is essential for this clause to be accepted and enacted into law.

Clause 67 has two parts. The first provides the Secretary of State with a power to restrict in limited circumstances how patient information may be used. The second part provides him with a power to require patient information to be used, again, in limited and, where the information is confidential to patients, tightly controlled circumstances.

The first group of amendments relates to both parts of Clause 67. It may be helpful to set out some of the background to the clause. I shall then turn to the government amendments in this group. I shall write to Members of the Committee on the specific points raised in their amendments, as, at this time of the night, it is important to focus on the key principles which we are debating.

Both parts of Clause 67 have their opponents. There has been much debate and concern expressed. That is entirely understandable. We are dealing with fundamental concerns and issues about commercial interest, privacy and patient confidentiality. But I believe that some of the concerns have been misplaced.

Perhaps I may first cover the second part of the clause because that is clearly very much of the public interest. Subsection (3) provides for the Secretary of

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State to make regulation to require the flow of information in prescribed circumstances. That will allow us to achieve two aims: first, that patients will receive more information about their own clinical care, delivering the commitment in the NHS Plan; and secondly, to safeguard the continued operation of essential services that currently rely on patient identifiable information.

That point is crucially important. Those services are already in existence, carrying out work that benefits us all. The clause does not signal any change at all in the Government's view on the importance of patient consent. That is key to today's debate and I should like to put the Government's position on the record at this stage.

Informed consent is crucial to the Government's view of how a modern NHS should work. We simply cannot move to a patient-centred service if patients are not informed and consenting participants in the services that they receive. We know only too well that that is not the way in which the NHS operates at the moment. Much of what the NHS does in the NHS relies on implied consent. In some cases, that is appropriate; for example, sharing information within a hospital to ensure that a patient receives appropriate care. But in other cases, the definition of implied consent is pushed much too far. We are determined to address that. It is not small task and the culture of the NHS will have to change radically as we move away from what I can only describe as comfortable habits into practice based on real consent.

The professions have recognised the need to change the way we approach consent. The GMC guidance issued last year made clear its view that informed consent is the only secure legal and ethical basis for disclosing patient confidential information. It, too, recognises the scale of the culture and systems change necessary to deliver it, and has signalled that it will not seek to enforce its guidance until October this year. The Information Commissioner has also drawn attention to the need to improve the way that the NHS seeks consent for the use of patient information. We have made a commitment to her that we shall do just that.

This is a huge task. We will need to identify where information is used, where it is appropriate to rely on implied consent and where we need to do more to feel confident that we have a patient's informed consent. In many circumstances, traditional practice will have to change, either to gain consent or to use anonymised information rather than using confidential information about patients because it has always been done that way.

That will take time, and there will be disruption to NHS services, but the principle is right and we must take action to address it. However, there are certain circumstances where we simply cannot afford a disruption to the flow of information. The cost to individual patients and the public would simply be too high. It is those areas that the Bill seeks to address by allowing patient information to be passed on lawfully without consent in prescribed circumstances.

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That is not a step we have taken lightly but one which we believe is essential. The key issue is how far we should go in deciding which information flows should fall within the ambit of these powers. The government proposal is to set out a clear, transparent process where decisions can be reached on the merits of each case, following consultation with those likely to be affected by the regulations laid under these powers. Rigorous safeguards on the use of these powers are built into the process and the Bill. The Information Commissioner has accepted that these safeguards will protect the interests of patients. While we do not feel that it is appropriate to put further safeguards on the face of the Bill, we have assembled a working group with patient and professional representation, including the GMC, the BMA, the Academy of Colleges and the Medical Research Council, to advise on the process by which the power in the second part of this clause should be used.

Perhaps I may say to the noble Baroness, Lady Cumberlege, and my noble friend Lady Gibson that I cannot believe that the instances they raise will be affected by the circumstances in the clause. The safeguards built into the clause are tightly drawn. Perhaps I may say to my noble friend Lady Massey that it is difficult to envisage circumstances where, for instance, the confidentiality owed to teenagers could justifiably be set aside. In any case, there are the tests contained in the Bill and the need for an affirmative resolution after full debate in both Houses. My noble friends Lord Turnberg and Lady Gibson detailed the impact on essential programmes if this clause were not to be adopted.

I turn to the first part of the clause. The need for this part of the clause became apparent as the result of a judicial review brought against the department by Source Informatics. In 1997 both Source and IMS, which at the time were competitors, began collecting information from GPs and pharmacies about doctors' prescribing in order to build up databases. The intention was, as Source Informatics said in its evidence, that the database would primarily be used by pharmaceutical companies to allow them to target more precisely promotions and communications regarding their products.

The department was concerned on two counts: first, that targeted marketing would increase the pressure on GPs to prescribe higher cost medicines unnecessarily; and, secondly, that passing on information about the medicines prescribed to a patient, even though the patient was not identified, would be a breach of confidence. We sent a document to GPs and pharmacies warning of the legal risks and strongly discouraging disclosure on policy grounds.

Although the department's case was initially upheld, the Court of Appeal decided that there was no breach of confidence or indeed breach of the Data Protection Act involved. As the noble Baroness, Lady Northover, commented, the court said that if the department continued to view such schemes as operating against the public interest, it must take further powers. The department did indeed remain

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concerned. We had discussions with ABPI and with IMS during which it was clear that, if necessary, we would legislate to prevent the sort of activity which caused us concern. We have been unable to enter into any kind of agreement with IMS and we decided that we should take powers in primary legislation.

We took the view that it was important that nothing should be done without proper consultation. We thought that it was particularly important that, while enabling the Government to deal with activities which were not in the interest of the NHS, we should not inadvertently restrict activities which were innocuous or indeed beneficial. We included in the Bill a broad enabling power to restrict the processisng of information about patients or derived from information about patients, but subject to the important safeguard that before any regulations were made the Secretary of State would have to consult bodies representing the interests of those affected.

I know that the breadth of powers of this clause has caused concern. At Committee stage in another place we responded to the concerns of those who thought that it might be used, for example, to prevent independent scrutiny of the NHS by restricting the power to the use of patient information for commercial purposes.

We have taken note of the concerns expressed by the Delegated Powers and Deregulation Committee. We have taken steps to address these concerns, guided by helpful suggestions from the Select Committee, by putting forward a number of government amendments to the clause. I say to the noble Baroness, Lady Cumberlege, that the second report of the committee on these matters makes it clear that it now welcomes the Government's response to the report and is content with their proposed approach, which fully meets the committee's recommendations.

The ABPI certainly remains unhappy. We believe that the power is a necessary one. We simply do not think it right that information which has been obtained in the course of the provision of NHS services should be used against the economic or financial interests of the NHS. Government Amendments Nos. 292, 293, 295 and 312 take into account the helpful suggestions from the Select Committee and address these concerns.

In conclusion, I believe that the approach taken in Clause 67 is a proper and sensitive one. It is essential in relation to the circumstances described by my noble friend Lord Turnberg and the noble Baroness, Lady Gibson, to secure patient interest in relation to the use of confidential information. I believe that it is absolutely essential that this clause is accepted.

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