Health and Social Care Bill

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Dr. Fox: Can the Minister answer two questions? If the Government's view of the matter is so comprehensive, why was that not included in the national plan; and why were none of the groups mentioned by the Minister consulted about clause 59 before the Bill was published?

Mr. Denham: Several Government amendments reflect our discussions with interested groups. The clause was drafted partly in response to concerns raised within the medical profession, not least by the General Medical Council, which issued relevant professional guidance.

Dr. Fox rose—

Mr. Denham: I have been fairly generous and flexible about interventions during the Committee's sittings. I have noticed from Hansard that on occasion, because of the resulting swings in the debate, I have not said all that I had intended to put on record. While that may not always be a matter of great concern, as some of the issues that we have debated have been widely discussed outside the Committee, I am anxious that the record should include all the points that I consider important for the House to know about clause 59.

I shall give way again, but I hope that hon. Members will understand if I try to avoid bobbing up and down to take repeated interventions. I want to read my prepared text, because the matter that we are considering is of great public concern, and many allegations have been made in the media. It is important for issues to be put on the record and not inadvertently omitted because the debate swings from topic to topic.

Dr. Fox: I want to press the Minister. The debate has been about consultation. We asked two questions, and we have a right to be answered; but the Minister, with his usual mastery of language, managed to avoid them. We want to know why it was not in the national plan, and why there was no consultation before the legislation was published. It is not good enough for the Government to say that they will consult on some of their amendments. There should have been consultation before the Bill was published, which is why many of the groups involved feel aggrieved.

10.15 am

Mr. Denham: GMC guidance on timing was initially published in July, just before the NHS plan was finalised. The guidance to which we are attempting to respond will not be enforced until October 2001; it was issued in November 2000, well after the publication of the national plan.

We have sought to respond to the concerns expressed by the medical profession. Whether or not they were specifically dealt with in the NHS plan, the Government still need to address those issues in Committee. They cannot be put on one side for months or years, as though there was no external timetable. We have endeavoured to address the concerns of the professions, but we shall have to see as the discussion proceeds whether we have done so entirely. We are working with the professions to deal with their worries about the drafting of clause 59; and where appropriate we have tabled amendments.

Dr. Naysmith: I apologise for interrupting the Minister. Will he confirm that, immediately after the GMC's decision last July, the flow of information essential for cancer registries dried up and did not start again until that decision was put off for a further year? It is essential that information continues to be made available to cancer registries. It is suggested in some quarters that the provisions of clause 59 would make us the only country to impose such restrictions.

Mr. Denham: My hon. Friend is right. He has highlighted some of the conflicts that the Government have to deal with.

The Chairman: Order. That point is specifically covered in another group of amendments.

Mr. Denham: We are attempting to square a number of circles; every position that is taken seems reasonable, but they do not all fit neatly together.

Making the changes needed in the NHS will be a huge task. We will need to identify where information is used, when it is appropriate to rely on implied consent and what we need to do to be more confident that we have the informed consent of patients. In many circumstances, traditional practice will have to change, either to gain consent or to use anonymised information rather than confidential information about patients, because it has always been done that way. That will take time, and it will cause some disruption to NHS services, but the principle is right and we must take action to address it. However, we cannot afford a disruption to the flow of information, because the cost to individual patients and the public would be too high. We seek to address those matters in the Bill by allowing patient information to be passed on lawfully without consent in prescribed circumstances. However, those circumstances will be reviewed each year and, as soon as we can, we will take away that support.

We do not take that step lightly, but we believe that it is essential. The need for some such powers is widely recognised, including by the BMA and GMC. Others have positively lobbied us to take those powers. We recognise the concerns that have been expressed about the scope of the powers provided under the Bill. Indeed, the Govt amendments seek to address some of the concerns that have been expressed by the GMC, the BMA and others. We have built rigorous safeguards into the Bill, and I am sure we will discuss these in depth later.

I shall set out the safeguards that will be in place if the clause is accepted. First, the use of non-anonymised patient information must be approved by Parliament, and we have made that subject to the affirmative resolution procedure--hon. Members will recognise that Governments do not usually do that when making regulations. The regulations must be positively supported by both Houses of Parliament. The Data Protection Act 1998 continues to apply in full, and compliance with human rights requirements is also necessary. Nothing in the Bill overrides those provisions that are already law.

The use of information must be for a medical purpose. The power does not support wider Government use of patient information. It must be used to improve patient care, or its use must otherwise be in the public interest. It cannot be used to determine the care or treatment given to a particular individual. There is no power to interfere in normal clinician-patient relationships. Specific obligations of confidentiality will be placed on the recipients of the information. There cannot be a reasonably practical alternative way of achieving the medical purpose. The use of the power must be reviewed annually, and if a cost-effective alternative has been determined, it must be adopted. That is a powerful series of tests.

There have been a number of suggestions, in the Committee and outside, that we are taking powers without safeguards. The hon. Member for Sutton and Cheam (Mr. Burstow) spoke of the whim of the Secretary of State. I do not believe that the clause allows the Secretary of State to act on a whim. Later, we will be able to debate in detail the process that would follow the enacting of clause 59. In particular, we shall discuss the consultation process for determining what mechanisms are used to apply the tests, and those who would be involved. Let me be clear that that process will include patient organisations and professional organisations. They must be built into the process of exercising the powers in the Bill.

Mr. Burstow: On that point specifically, will the Minister give an undertaking to table an amendment at a later stage to include in the Bill a requirement for the organisations to which he has referred to be consulted?

Mr. Denham: It might be helpful to examine the conclusions of the Data Protection Commissioner, who has considered the Bill. In her comments on this part of the Bill, the commissioner states:

    ``The Commissioner welcomes the process of consultation envisaged by the Bill and believes that this will provide patients as well as interested parties such as herself to have input into any proposals.''

Our view of the clause, shared by the Data Protection Commissioner, is that as it stands, we will need to consider patients' interests in drafting these regulations. It is worth saying at this point that the commissioner, who was consulted at an early stage, states:

    ``While the Commissioner is naturally concerned about any processing of personal data without consent, as these proposals will clearly allow, on balance she believes that in this particular case the issue of safeguards has been addressed.''

We can return to that in more detail in later amendments. The Data Protection Commissioner has examined the drafting of the Bill and on balance believes that the issue of safeguards has been addressed. I hope that that brings some balance to our discussions this morning.

Mr. Burstow: I appreciate the Minister giving way, and it is helpful that he is placing so much information on the record. However, in the interests of balance, will he explain why it was that, although he consulted the Data Protection Registrar, he did not consult professional interest groups such as the GMC and the BMA? Those groups have legitimate interests and concerns and should have been consulted.

Mr. Denham: I do not have chapter and verse at hand, but the Data Protection Commissioner was consulted and involved in discussions in the early stages of the preparation of the Bill. I believe there to have been discussions with the General Medical Council and other interest groups about their concerns and their worries about abuse of patient confidentiality. The Government sought to take into account those concerns in the drafting of the legislation. I do not want to mislead people. That does not mean that every single line of every piece of legislation was a team effort, but in drawing up the legislation and instructing parliamentary counsel the Government have sought to reflect what we understood to be the concerns of those professional organisations.

On the amendments, subsections (1) and (2) give the Secretary of State a power to make regulations prohibiting or restricting the processing of patient information. That does not, as has been suggested, ban all disclosure or processing of information with the Secretary of State's consent. On the contrary: it allows for information to be disclosed and processed unless regulations have been made to the contrary. In simple terms, subject to other legislation such as the Data Protection Act, everything is permitted unless regulations have been made preventing it. Because of subsection (9), which applies to all regulations and not only those pertaining to the second part of the Bill, no regulations can be made until there has been consultation with bodies representing the interests of those affected.

As hon. Members have correctly surmised, the need for the clause became apparent as the result of a judicial review brought against the Department by a company called Source Informatics. Source was subsequently taken over by a company called IMS. In 1997, both Source and IMS, which at that time were competitors, began collecting information from GPs and pharmacies about doctors' prescribing habits in order to build up databases. The intention was —and I am using words that Source used in its evidence, so there is no dispute about this—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, was a breach of confidence. We sent a document to GPs and pharmacies warning of the legal risks and strongly discouraging disclosures on policy grounds. Source Informatics sought judicial review of that document. To cut a long story short, although the Department's case was initially upheld, the Court of Appeal decided that there was no breach of confidence or of the Data Protection Act.

Therefore, at present, anonymised information about a patient's health can be used for such commercial purposes and to put pressure on doctors to prescribe unnecessarily expensive medicines. Source Informatics envisaged that use of its database would result in improved efficiency for pharmaceutical companies. That is capable of interpretation. How much more efficient can a rep trying to sell medicines to a GP be if he knows that he or she already uses some of the company's products but in other therapeutic areas chooses cheaper, but equally effective, products? The type of targeting and the possible consequences are clear.

Of course, not all higher cost prescribing is bad prescribing. Of course, some doctors persist in using old-fashioned remedies when modern ones are far better. Of course, some doctors should perhaps be prescribing more of certain types of medicines. However, we are almost uniquely fortunate in this country in having comprehensive data about dispensed medicines. That information can be, and is, used by advisers employed by health authorities, primary care groups and trusts, and, increasingly, by GPs themselves to improve the quality of prescribing. Their advice is objective, impartial and in the combined interests of patients and the NHS. That cannot be the case for individual pharmaceutical companies or others with a commercial interest.

I have concentrated on prescribing information, because that is, as I said, the context in which the need for the power arose. However, similar considerations could apply in other areas where NHS expenditure is involved: for example, medical equipment. That is what this part of the clause is about. It is not about banning people from asking awkward or, indeed, perfectly sensible questions about the operation of the NHS, and it is certainly not about stopping independent assessment of the performance of the NHS. It is about preventing damage, especially financial damage, to the NHS through the use of information about patients.

We have listened to those who considered that the power as originally drafted was too widely drawn. Government amendment No. 334 restricts the regulation-making power so that regulations can only be made prohibiting or restricting the processing of patient information for commercial purposes. Government amendments Nos. 335 and 336 are consequential amendments. In particular, Government amendment No. 335 removes subsection (2)(a), which makes particular provision for restricting the use of anonymised patient information, so that it can be protected in similar ways to those by which identifiable information is protected under the Data Protection Act 1998. We have decided that we should regulate to restrict the processing of information for commercial purposes only, and regulations should be framed with that in mind. Government amendment No. 336 flows from the deletion of subsection (2)(a).

10.30 am

We considered various ways in which to amend the clause to reflect our intentions more precisely, and this seems to us to be the best fit. We are seeking powers to prevent the undesirable processing of information, and there will be a strong financial motivation to find a way round these restrictions. We had to strike a balance between allaying the fears of those concerned about the breadth of the powers as originally drafted, and reducing the risk of challenge to the use of the powers when it would be in the interests of the NHS to do so. We needed a form of words that was as clear as possible and that would allow little room for dispute about meaning. ``Commercial purposes'' is a phrase that appears in other legislation, such as the Town and Country Planning Act 1990 and various Finance Acts.

I accept that the power remains quite broad, but I have explained why too narrow a power would run the risk of not achieving its intended effect. We have no intention of preventing all commercial use of patient information. The amendment allows us to set out in regulations the commercial purposes that are affected. For example, we may want to prohibit the processing of certain patient information for the purpose of marketing goods and services to the NHS. It is difficult to envisage circumstances in which we would want to prohibit a company, such as a pharmacy, from using data from dispensed prescriptions for managing stock.

Amendment No. 319 would restrict or—if Government amendment No. 334 is accepted—further restrict the Secretary of State's powers under subsection (1) to make regulations prohibiting or restricting the processing of patient information. I have some sympathy with the sentiments underlying the amendment. I hope that that is apparent from what I have already said. The Government have no intention of introducing regulations that would run counter to the various worthy matters referred to in the amendments. Indeed, our intentions are, broadly speaking, quite the contrary. We want to be able, if necessary, to prevent patient information from being used in ways that would adversely affect the operation of the NHS in areas such as diagnosis, care and treatment.

I do not think that it would be right to include such detailed provisions in the Bill. I have some concerns about creating a lawyer's paradise. I fear that the amendment tabled by the right hon. Member for North-West Hampshire (Sir George Young) would do just that. When considering what amendments to table in response to the concerns that have been expressed about this part of the clause, I thought very carefully about the possibility of restricting the regulation-making powers to information that would be detrimental to the interests of the NHS or patients. I concluded that that would allow too much scope for legal argument.

I am happy to assure hon. Members that our intentions are wholly in line with the spirit of the right hon. Gentleman's amendment, but I cannot advise the Committee to accept it.

Amendment Nos. 286 and 228, taken together, would require, rather than permit, regulations to be made under subsection (1) prohibiting or restricting the processing of patient information, but would restrict this requirement to circumstances in which it was determined to be in the interests of patients. I am sympathetic to the proposition that regulations prohibiting or restricting the processing of information should be in the interests of patients, but I also think that the interests, including the financial interests, of the health service more generally need to be taken into account. It would not be right to require regulations to be made. We should regulate in this area only if and when it is necessary. We would prefer to proceed by discussion and agreement whenever possible.

The remaining Liberal Democrat amendments would, when taken together, entirely change the character of subsection (2). As it stands, and will stand if Government amendments are accepted, this subsection makes specific provision for regulations such as may be necessary to achieve the purposes that I outlined earlier: that is, to prevent damage, in particular financial damage, to the NHS through the use of information about patients. These amendments would change the purpose of the subsection completely. They would require regulations to be made ``in the public interest'', prohibiting the processing of such patient information as the regulations may prescribe from being processed without the patient's knowledge and consent. The provisions relating to terms of employment and other arrangements made by health service bodies and the provisions relating to offences and enforcement would relate to that—or at least, I suspect that is the intention, although they could still be used for other purposes. These amendments take us into areas relating to consent that we shall be debating at length a little later.

Amendment No. 231 would remove subsection (2)(b), which relates to the imposition of conditions on the disclosure or processing of information. The Consumers Association is concerned that the subsection will allow the processing of information from which a patient could be identified—albeit subject to conditions. That is a further inroad into the protection of confidential patient information. It also thinks that the subsection is unnecessary in order to achieve our policy aims.

The subsection is necessary. We need to make it clear that there is a middle way between releasing information and not releasing it. For example, we may wish to release information for research purposes subject to the condition that it should not be used for certain commercial purposes. The focus of subsections (1) and (2) is not on the disclosure of information, but on the prohibition and restriction of disclosure or other processing of information. Our intentions are the opposite of what the Consumers Association fears. We do not intend to use the subsection to free up information from which patients could be identified. Indeed, a condition could be imposed to anonymise and to aggregate information to ensure that individuals could not be identified. Nothing in the clause allows us to override the Data Protection Act 1998.

Amendment No. 323—unlike the other amendments mentioned so far—is not concerned solely with the provisions of subsections (1) and (2). It would introduce a general requirement to undertake consultations and to publish a report on the consultations and the conclusions as to what regulations may be required—whether under subsections (1) or (3) of the clause. The amendment is unworkable and unnecessary. It is unworkable because it assumes that at any one time it is possible to make a judgment on what regulations are required. That is clearly not possible: circumstances change and the need to regulate or not changes with them.

The amendment is unnecessary because the clause already provides for consultation with bodies that represent the interests of those affected by any proposed regulations. Regulations can—and under some parts of the clause must be—debated by Parliament. Therefore, it will be necessary for the Secretary of State or Ministers to justify regulations either under the affirmative procedure or under the negative resolution procedure if they are prayed against.

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