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Mr. Denham: This is an important debate on an important matter. It is a shame that, so far, it has not lived up to the importance of the subject.

I think that the characterisation of the clause that has been advanced is not justified by what is in the Bill or by the Government's intentions. As I hope to make clear, the debate has not assessed properly the debate outside the House about the use of patient information. Contributors to that debate have said that the Bill should not contain the proposals that it does contain, or that the proposals should be different, or that they should not be introduced now, and so on.

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As I said in Committee, the Government are starting from a position in which the use of non-anonymised patient information in the NHS is widespread, and has been so for years. The problem that we must tackle is to establish the principle of informed consent on the use of patient information from a starting point that has not made the use of informed consent the principle by which the NHS is guided.

The Government's task with this clause is to find the best way to move as quickly as possible to deal with a problem that was never tackled by the previous Government. They tolerated it, and never criticised its existence, but everyone accepts that the situation is different now. I do not entirely blame the previous Government, because there has been a sea change in attitudes towards the handling of patient information, both among the public and members of the medical profession. I could criticise the previous Government for many things, but it would not be fair to judge Ministers of 10 or 15 years ago by the standards of today. The standards applicable to a lot of the issues to do with patient consent were different then.

I have described the Government's task with the clause. It had to be accomplished at a time when we were not entirely in control of the time scale. That is why the hon. Member for Isle of Wight (Dr. Brand) was wrong to say that we should have waited.

As everyone knows, the General Medical Council, exercising its responsibilities as a professional self- regulatory body, last summer issued guidance that had an immediate impact on the collection of data by cancer registries. As I said in Standing Committee, it issued

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further guidance in November in response to the ensuing debate. That guidance appeared after the publication of the NHS plan, and said that the professional obligation would not be asserted until October 2001.

If the Government had not taken the earliest possible opportunity, represented by this Bill, to put a proper statutory framework around the use of patient information, I have every reason to believe that the GMC would have felt under a professional obligation to carry through its advice. That would have had an immediate impact on the operation of cancer registries and other activities. The Government are therefore not in control of the time scale, which is why I believe that we are right to go ahead with the proposal and why it would have been wrong to wait.

The hon. Member for Isle of Wight referred to work in the Department on the use of patient information. That work is part of a different exercise looking at all the changes that need to be made across the NHS to put our use of information on a satisfactory basis. We will not have the results until later this year, but it is right for us to get right the statutory framework contained in the Bill.

Dr. Fox: I understand that the Minister is genuine in what he says about what the Government's wish for the Bill, but why has the clause drawn so much criticism from such a wide range of bodies? They cannot all have misinterpreted what the clause is capable of, so surely this is a fault in the drafting. It is not the intention of the Government but the use to which the provisions could be put that has caused such widespread anxiety among the many groups mentioned in the debate.

Mr. Denham: There is disagreement outside the House, as well as in it, about the relevant issues. For example, Professor Martin Vessey of the department of public health at Oxford university wrote to me about the work that he carried out with Dr.--now Sir--Richard Doll in the 1960s investigating the links between leg vein thrombosis, pulmonary embolism and women who had been using oral contraceptives. He wrote about the necessity of using patient data at the time.

I have received a letter from Leslie Davis of the National Perinatal Epidemiology Unit, in which he states:

We have received correspondence from Dr. Monica Roche and Professor David Foreman of the United Kingdom Association of Cancer Registries. The letter states:

The attached briefing note goes on to explain why the approach adopted in the Bill is necessary. Sir Richard Doll from the clinical trials service unit and the epidemiological studies unit at the university of Oxford has written to state:

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I could continue with examples from other correspondence, but the point is not simply that the correspondence illustrates that there is a debate in the medical profession about how to approach this matter. I do not think that there is a debate about informed patient consent, but there is a debate about how we move from where we are, and the practices that have been developed over many years, and reach a better system in the future.

I chose the correspondence that I did because, with the exception of the cancer registries, they referred to activities that fall outside the definition of cancer registries. I gave other examples in Standing Committee. That is why I believe that the approach adopted in the Bill, which has many built-in safeguards, is better than attempting to list or predict in a narrow way in the Bill all the acceptable uses of information.

Dr. Brand: The Minister has used very valid examples, and they all involve bits of research where problems can be overcome by anonymising the clinical data. That is why it is so relevant to say that the outcome of his own working party's research on confidentiality and the processing of clinical data should be available before we decide about what should be the proper legislative proposals that the Minister needs. If the Minister would accept amendment No. 15 or new clause 1, his anxieties over cancer registries would be overcome and he would have time to reflect on whether he needs to take powers that are as wide as those contained in the Bill. We have no doubts about the Minister's intent, but we have great worries about what is in a Bill that does not mention patient confidentiality anywhere.

Mr. Denham: I think that the hon. Gentleman has simply--and inadvertently, I am sure--not really looked at the Bill and the safeguards that it contains. He asserts that all the examples that I gave involved work that could be undertaken with anonymised patient data. I do not have confidence that the hon. Gentleman is right about all the research that I mentioned, or about other legitimate, important and pressing research that might be undertaken.

I hope that, in the not too distant future, the NHS IT systems will be fully in place, so enabling electronic patient records to be kept and anonymised patient data to be used routinely. However, I am not sure that we have reached that point yet. That is why the Bill contains two important safeguards that have been included from the outset.

First, the Bill limits the use of the powers to medical purposes where there is a benefit to patient care and public health. Secondly, it limits their use to circumstances in which there is no reasonably practical alternative. The latter is not a once-and-for-all test, and does not mean that once a particular activity slips past the test it is there for ever and a day, because the Secretary of State is required by the Bill to review each set of regulations every year.

Therefore, any activity will have to pass the "practical alternative" test and, as I explained in Standing Committee, it must be looked at by an advisory group. That group will involve organisations such as the GMC, the BMA, research councils, patients' organisations and

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others. If they advise the Secretary of State that there is no reasonably practical alternative, the Secretary of State then has to make regulations. He then has to consult on the regulations.

That is not an end to the matter because those regulations have to come before Parliament, not, as is so often the case, through the negative resolution procedure, but under the affirmative resolution, which requires a positive vote by both Houses of Parliament. Even if that is achieved, the following year and every year after that, the Secretary of State has to satisfy himself, no doubt by taking advice, that the conditions that led him to believe that anonymised data should not be used no longer apply.

That is a pretty robust set of safeguards, but the hon. Member for Woodspring (Dr. Fox) painted a picture of the Secretary of State getting out of bed one morning and making up his mind on this matter, as if that were an end to it. That is so far from the truth that it is outrageous. Such caricatures are one of the reasons for the amount of concern about the Bill.

On the second issue, which was raised by several hon. Members, including the right hon. Member for North-West Hampshire (Sir G. Young), I suspect that there is simply a difference of opinion in the House, as there was in Committee. We were concerned about the activities of a company called Source Informatics. We believed that its processing of anonymised patient information led, or was likely to lead, to a targeted marketing effort that was not beneficial to the NHS, so we sought to restrict its activities. We lost that case in court on the basis that there had been no breach of confidence, and we are not attempting to overturn that judgment in the Bill. However, we are, as the judge invited us to do, taking the necessary powers to restrict such activity in future.

It is clearly ridiculous to suggest that this Government, who have published more information about the NHS than any previous Government, are engaged in an exercise to suppress information or criticism. I accept that the hon. Member for Woodspring thinks that in the distant future he might be Secretary of State and that he would use the legislation differently. He invited me to use the precautionary principle to deny him that power. However, it is necessary to take action to protect the interests of the NHS, and with the amendments that were made in Committee, the Bill is a proportionate response to that need.

Since the debate in Committee, the Association of Medical Research Charities has written to us to say:

That is what I believe we are doing.

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