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Mr. Denham: This debate has been slightly more temperate than the earlier one—[Interruption.] I shall give way to the hon. Member for Isle of Wight if he wants to lower the tone. The starting point of our discussions should be the consensus that exists in Committee about the fact that there are some undertakings for which informed consent cannot practically be obtained at present, but which are so important that they should be allowed to continue. Cancer registries are clearly among those. What we are really debating in relation to this group of amendments is whether the Government have taken the right approach to defining the scope of the provision, or whether it should be defined very narrowly in the way that is proposed in the Conservative amendment with a list of specified registries? I know that in practice the hon. Member for Woodspring does not mean to refer only to cancer registries, but whether we should take Conservative approach of having a specified list of activities, the slightly broader approach of the Liberal Democrats which would define a set of activities while not actually listing them, or the Government's approach. It is important for me to explain why, after a great deal of thought and consideration, we have taken the approach that we have to drafting clause 59. In so doing, it will be useful to set out the process that we intend to follow after the enactment of the clause so that hon. and right hon. Members can see how the whole system is designed to work. It is clear from the amendments and the debate that there are circumstances where it is justified to override the basic requirement that confidential patient information should be disclosed only on the basis of informed consent. It may be because the public interest requires it or, as with notifiable diseases, because of existing requirements in law. I believe we all agree that the exceptions from this requirement should be limited. I want to make it clear that the Government are not seeking a replacement for informed consent as the basis for the release of confidential patient information. The Government propose to set out a clear, transparent process whereby 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 the powers are built into the process and the Bill. I will mention some of those safeguards again. First, any regulations that would be subject to affirmative decision by both Houses of Parliament would need to pass two clear tests: first, that the regulations were in the interests of improving patient care or in the public interest; secondly, that it was not reasonably practical to meet the need for disclosure of patient confidential information in any other way. I shall set out the process in as much detail as I can. We would initially set up an advisory group to design and document the process of implementing clause 59(3). Patient organisations, the GMC, the BMA, the Academy of Colleges, the Data Protection Commissioner, research and public health communities and others would all be represented. That would enable us to work out in detail, through consultation, the mechanism for enacting clause 59(3). Clause 59 provides that the power may only be invoked for a medical purpose—either to improve the care and treatment of patients or in the public interest— where the purpose is not to determine the care and treatment given to specific individuals and where there is no reasonably practical alternative way of achieving the purpose. It will also be necessary to demonstrate that wherever the power is invoked to support a specific activity, the Data Protection Act 1998 and the Human Rights Act 1998 are complied with. Those requirements will necessarily form the backbone of any process of determining whether the power should be invoked, but they need to be fleshed out and added to, as the hon. Member for Sutton and Cheam said this morning. We want the advisory group to which I have referred to assist us in that process, but I am sure that it would need to look at a number of factors such as assessing the value and quality of the activity involved, the standards required, the fact that reasoned arguments by patient consent should not be sought, and the assessment of other practical or potential alternative ways of conducting the activity without access to confidential information, including an assessment of barriers and costs. We want to establish a position where applications to utilise clause 59(3) should use an agreed template to make sure that all aspects of the testing process are effectively addressed. We envisage that applications would need to be submitted to a central point, which is likely to be the information policy unit of the NHS Executive. Having set up the process, the next stage would be for applications to be considered by an expert committee, which would be relatively permanent. We are working out the detail of how it would operate. Clearly, it would require the participation of the groups to which I referred earlier, to ensure that the Secretary of State received expert advice before making regulations under the provisions of clause 59(3). In addition to dealing with what is explicit in the legislation and identifying the requirements that the Secretary of State must fulfil, the process must be backed up by advice to the Secretary of State. Mr. Burstow: New and helpful information is emerging, but will the Minister say more about the process? An expert group will undertake the evaluation and submit its opinions to the Secretary of State before he exercises the powers in the clause. Will there be a requirement for the Secretary of State to set out his reasons for setting aside the opinions of the expert group? Will there be any further transparency in the process, at the point at which it reaches the Secretary of State? If so, will that be in the Bill? Mr. Denham: Effectively, it is in the Bill, because any regulations will be subject to affirmative procedures of both Houses of Parliament. The regulations will not need to be prayed against. They will have to be tabled by the Secretary of State and debated in Committee, and potentially on the Floor of the House and in another place, and the regulations will have to be voted on before they can be put in place. The procedure is a powerful safeguard. It is relatively rare, and takes up precious parliamentary time. It means that there will be public scrutiny, and Ministers will have to justify the approach taken by the regulations, both in the House and in the other place. I am sure that as part of that process, the Secretary of State would want to make it clear how he had arrived at his conclusions. It is not just a matter of the Secretary of State publishing a piece of paper that explains his actions. He, or one of his Ministers, will have to come to the House to justify the position. That is a powerful safeguard. It means that the Secretary of State will have to be cautious about rejecting advice. There will be consultation on the regulations, as was said earlier. Our intention is that regulations will not be permanent. The clause places an obligation on the Secretary of State to review annually whether the case for them can still be made. The NHS's position is not static. We are constantly extending our investment in information technology, such as electronic patient records. All such devices make if far easier to anonymise patient information than it has been in the past. Even if the Secretary of State were justified in using the powers under clause 59(3) today, he might not be justified in doing so in one or two years' time. In future it might be possible to deal with the problem either on the basis of informed consent, or on that of anonymised data. We have sought to build a series of protections and hurdles into the Bill. Mr. Hammond: In his last remark the Minister clarified the point that I wanted him to clarify. I thought that he said that regulations made under clause 59 would be subject to the affirmative procedure, but in fact only those made under subsection (3) will be subject to that procedure. Mr. Denham: The hon. Gentleman is right. We had to get the balance right. It is right that the most serious test should apply to the most sensitive issue, which is that of the use of patient information without informed consent. It was clear to us that such a test should apply to this part of the Bill. The same issue does not arise in the case of anonymised patient information, where although the considerations are serious enough to warrant the use of the powers, it is essentially a matter of protecting the financial interests of the NHS.
11 amI hope that I have explained that the regulations are not intended to provide an easy way around the need to seek informed consent. They are safeguards to protect essential data flows as the NHS makes the transition to a service that operates on informed consent to the use of information. That is why subsection (6) requires the Secretary of State to review the regulations annually to determine whether they are still appropriate. If the regulations fail the tests set out in the review they will be revoked. We intend to make the outcome of the reviews public on an annual basis. Therefore, the regulations will have had to be approved by both Houses of Parliament under the affirmative procedure and the Secretary of State must review them after a year. He will have to make public whether he has decided that they should still apply or that they are no longer necessary and should therefore be revoked. As I mentioned earlier, the Data Protection Commissioner has, on balance, approved this approach to protecting patient interests. The amendment proposed by the hon. Member for Woodspring narrows the use of the power so that it can be used only to require patient information to be disclosed to cancer registries and to regulate how they might subsequently use the information. I accept that in the public debate around the clause the example of cancer registries has probably been the most widely quoted and discussed. The fact that cancer registries are important should not free them from the obligation to satisfy the tests set out in the Bill. In other words there is no reason to say that because it is a cancer registry we should not explore over time whether it can use anonymised information. Under the amendment, cancer registries would not be subject to that test, and that would not be right. All registries should have to undergo the test. The amendment is restricted to cancer registries, but other disease registries should also be included. The amendment tabled by the hon. Member for Sutton and Cheam suggests a slightly wider approach limiting the power to all disease registries. First, not all disease registries need to use patient-identifiable information. They too should be subjected to the testing process. If they do not need to use patient-identifiable information, they should not be permitted to do so. A greater difficulty is that the amendment would rule out the use of regulations to guarantee information flows to anything other than disease registries. That could rule out some vital projects. The Medical Research Council, in its sensible confidentiality guidance, cites research into possible links between parental mental illness and unexpected child deaths as an example of an area where consent may be unattainable. The Oxford register of attempted suicides is another example of a subject where consent may be difficult. It has proved to be a key piece of work in demonstrating the link between the open supply of paracetamol and successful overdoses. That led directly to restrictions on the amount of the drug that can be purchased at any time. I do not know whether those two examples would pass the test that we have set out in the clause. They would have to go through the proper process, but they demonstrate the difficulty of putting the sort of restrictions that the hon. Member for Sutton and Cheam seeks into the Bill. We wanted to put something specific into the Bill that would meet the present needs of the NHS without inadvertently excluding something that would turn out to be a great patient benefit. That is why we have cast the legislation more broadly than the amendment and have built in a series of quite tough safeguards concerning the use of the legislation in practice.
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