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Baroness Gibson of Market Rasen: I do not have the expertise of some Members of the Committee who have spoken in the debate. However, I want to put forward the concerns that have been presented to me. At this point, I declare my interest as a former health and safety commissioner. The Health and Safety Executive has presented to me its concerns in the event that the clause is removed from the Bill.

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In my work as a health and safety commissioner I tried to ensure that, when studies of workers' health were carried out, the proposed research was explained in detail to workers' representatives and their approval obtained for such studies. However, I recognise that in some situations informed consent cannot be obtained and that the importance of the consent principle in such cases may be outweighed by the public good.

Many occupational research studies do not involve direct contact with the subjects. Instead, they carry out long-term follow-up of the health of groups of workers through death records and cancer records collected routinely by the Office for National Statistics and the NHS. In such studies, it is impracticable for the HSE to contact all former workers in order to obtain their consent. However, for the results to be valid, they must be included.

Perhaps I may give a few examples of research which is necessary in order to gain knowledge to protect the health of workers and the public, and which is either impossible or impracticable if informed consent is mandatory. I shall start with the subject of asbestos, which has formed an extremely important part of the HSE's work over recent years. Going back over almost 30 years, the HSE has the details of 80,000 workers who have been affected by asbestosis. It is impossible to contact so many people in order to explain the purpose of the research study. Even if it were possible, the restriction of the study to those who write back giving their consent will probably so bias the results as to make them invalid.

Other studies of occupational health risks in which it has not been possible to obtain consent include the Health and Safety Executive's study of causes of death and cancer in the semi-conductor industry, where the workforce has serious concerns about possible health risks. The HSE has the full support and agreement of the workforce representatives, but contacting former workers is impracticable.

Similar studies have shown that workers have been exposed to vinyl chloride monomer--an industrial chemical, widely used in making plastics, that may cause cancer--and many other hazardous chemicals. Some years ago the HSE undertook a large study--noble Lords may have read it--of childhood cancers in the area of the Sellafield nuclear plant. That study would not have been undertaken if consent had been required from all the subjects or their parents to access their medical information.

It is not only the HSE that has been in touch with me. Members of the Committee have said that a number of organisations oppose Clause 67. The Association of Medical Research Charities, which consists of more than 100 charities and which includes some prominent cancer charities, including the Breakthrough Breast Cancer, the Breast Cancer Campaign, Action Cancer and Cancer Research Campaign, is totally in favour of Clause 67 and is most concerned that it may be tampered with or removed from the Bill. I shall quote what it said in this context. It said:

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    "Clause 67 will allow the use of some data for public benefit in restricted circumstances and under strict control. Without legislation, some types of research will no longer be possible ... Applications for approval for the use of data about patients will be examined by an expert committee set up by the Secretary of State and be subject to a period of public consultation. If accepted they would then require affirmative resolution in both Houses of Parliament. Only research for which it has not been possible to ensure complete anonymity or for which it has proved impossible or completely impracticable to obtain patients' informed consent will be considered for approval ... AMRC believes that fully informed consent by patients is essential for research that directly involves them. Even where research is done some time later on data or specimens obtained from named patients, consent should be sought. But sometimes this is not possible, for example, in retrospective studies, where patients have died or are no longer traceable ... It is in circumstances such as these, where it is impossible or impracticable to obtain consent, that permission could be sought under this Clause".

Those people do not write lightly and they are of importance. I understand the reasoning that motivates those who oppose the clause or contend parts of it, but my experience of HSE research makes it clear that such opposition is somewhat misguided and could cause profound harm to research.

12.45 a.m.

Lord Rea: Although my amendment, Amendment No. 302A, relates to Clause 67(3), I begin by discussing subsections (1) and (2). I support the spirit of the Government's general intention in this regard. The pharmaceutical industry says that use of "anonymised" prescribing data can, among other things, result in cheaper prescribing. As a former general practitioner, I can think of no case in which a pharmaceutical company, other than a generic company, came to me with a preparation that was cheaper. The argument could be that the more expensive and more effective drugs that companies were selling me saved money overall by reducing hospital admissions, referrals, investigations and so on. However, it is not for the pharmaceutical industry to tell us about that; that is for independent, university or research charities to consider. Work by the pharmaceutical industry is, I am afraid, almost certain to represent its side of the case.

Amendment No. 302A includes the words, "valued consent". That is an extremely important concept which should be added to the Bill. It would allow such highly important consent to be overridden only when it was "not reasonably practicable" to obtain it. My noble friend Lord Turnberg and other Members of the Committee described cases in which it was not possible to find patients because they had gone abroad or died. Patients might refuse to co-operate in a case in which it was absolutely essential for the research to go on because the disease being studied was so important.

I hope that the Minister will consider the amendment. The Secretary of State can currently override such considerations as he considers necessary or expedient. That gives him far too much leeway. I want that decision to be removed from the Secretary of State even further than the amendment proposes. It should be removed to a statutory independent body or commission whose nature should be specified in the

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Bill. I refer to an independent commission such as that in Denmark, which meets that very purpose. That provision could be specified in subsection (9). I should like the body to be more tightly defined than it is in subsection (9) which refers to,


    "such bodies appearing to him"--

the Secretary of State--


    "to represent the interests of those likely to be affected"--

patients, I presume. That gives the Secretary of State too much leeway. The membership of such a body should be written into the Bill, and it should consist of a lay or non-scientific majority, so that patients can have confidence and trust in it, as in the Danish model. It impressed the Science and Technology Sub-Committee, which has been examining the handling of human genetic databases. I hope that my noble friend will consider my amendment sympathetically.

Baroness Masham of Ilton: I shall say only a few words. It seems from the amount of information that has been circulated that there is great concern about Clause 67. It remains unacceptable and there is a strong feeling that lack of clarity underlines the importance of ensuring that adequate safeguards over the sweeping powers awarded to the Secretary of State should be on the face of the Bill. There should be nothing to discourage research into complicated diseases or the development of useful drugs, which patients need, as long as it is anonymised information.

I mention a few conditions, such as motor neurone disease, Parkinson's disease, multiple sclerosis, diabetes, HIV/AIDS, CJD, epilepsy and MRSA. The list could go for a long time. We need effective drugs.

With disasters such as happened at Alder Hey, we need to be sensitive towards patients and their relatives. Whenever possible, patients or their next of kin should be asked permission. Confidentiality is of utmost importance when clinical research is being undertaken. What is wrong with making anonymised information available for research if it will help patients in the long run? The development of drugs takes a long time and is expensive.

If we do not ensure that the clause is acceptable to all who are interested in it, we shall be criticised. The country looks to us to improve legislation and the clause needs to be improved.

Baroness Massey of Darwen: Perhaps I may comment briefly on the issue of confidentiality. It is important. I am sorry that we are having to debate such important issues at this time of night. In discussing confidentiality, I want to comment specifically on the doctor-patient relationship in the case of young people. The Minister knows of my concerns in this matter, and I am grateful to him for responding sympathetically. I want to register my concerns about young people and confidentiality.

If there is any doubt in young people's minds that confidentiality will be breached, they will not seek help and advice. Messages about confidentiality--or lack of it--may be interpreted as being threatening to individual rights. That is particularly true in the area

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of reproductive health, for example. We have good evidence that if young people are worried about confidentiality, they will not trust professionals and will be afraid to seek advice and help. Teenage pregnancy rates, for example, may rise. I seek reassurance from the Minister that those concerns will be addressed in this clause.


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