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1.46 pm

The Parliamentary Under-Secretary of State for Health (Mr. Tom Sackville): I am grateful to the hon. Member for Islington, North (Mr. Corbyn) for bringing the issue to the attention of the House. I want to express my deepest sympathy to the women who have suffered side effects as a result of radiotherapy for breast cancer. I know that they can endure severe, debilitating pain and even bone fractures, as the hon. Gentleman said. In some cases, the injury to the arm is such that the women cannot continue their careers or undertake ordinary daily tasks without help. We must aim at discovering the reason for those strong reactions to treatment that, for most women, is effective and has few long-term side effects.

Radiotherapy dose and treatment techniques are determined by the clinician in charge. However, all patients have a right to consent to or reject treatment, and all are entitled to a clear explanation of any treatment proposed--including of any risks and alternatives. All treatments carry some risk, and patients must be allowed to decide whether they wish to continue with the treatment proposed. That important principle has been highlighted in the patients charter and it is departmental policy.

Any health professional will take any steps possible to avoid adverse effects, and significant cases are published so that all doctors may learn lessons from them. It is important to define factors that cause adverse effects in particular patients so that they may be avoided. It is possible that, in future, research will allow a patient's sensitivity to radiation to be assessed before treatment, to allow the treatment to be individually tailored. Unfortunately, adverse effects from radiotherapy are frequently incurable because the effect on the tissue cannot be reversed by surgery. The effects of radiotherapy are drastic because that is the nature of the treatment: it is designed to kill tumour cells and in doing so will kill a proportion of normal cells as well.

As the hon. Gentleman knows, representatives from RAGE Breast, the organisation representing many of the women suffering severe side effects, met Lady Cumberlege and the Department's chief medical officer last year to discuss the concerns of their members. Following the meeting, discussions took place between the Department of Health, the Royal College of Radiologists and RAGE at which it was agreed that the royal college would undertake a confidential clinical review of consenting RAGE members, funded by the Department of Health.

The aim of the review was to discover what common factors in treatment may have lead to these women suffering such effects. It is a relatively homogenous group and we hope that the audit will yield useful information about common factors in treatment that might have led to the adverse effects. Armed with this information, we can then assess the need for further studies.

Two hundred and forty-nine patients--all of whom are now members of RAGE--treated at 15 centres in the 14 years between 1980 and 1993 were invited to

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participate; 126 consented to do so. A conservative estimate of the total number of patients receiving radiotherapy for breast cancer at these centres over the same period is 65,000. The clinical review has now been completed and the report will be published on 6 December. Following that, each participating RAGE member will receive a personalised assessment of his or her case.

At the behest of the Department of Health, the Royal College of Radiologists has developed guidelines for the care of women who have suffered tissue damage following radiotherapy for breast cancer. They were sent to the NHS in October this year. Additionally, the Department has funded the production of factsheets--prepared by the cancer charity BACUP and other charities--for women about to undergo radiotherapy, and for women experiencing short and long-term effects following it.

As for quality assurance systems, the ionising radiation regulations are intended to prevent unnecessary or excessive exposures to medical radiation. The Secretary of State's inspectorate investigates cases of suspected breach. There are four inspectors who are Department of Health officials. The introduction of dose-reducing strategies continues and is part of a thrust to reduce radiation doses to as low as reasonably practicable in order to achieve the required diagnostic or therapeutic purpose.

Guidance notes for the protection of persons against ionising radiations arising from medical or dental use were issued in 1988. In July 1991, guidance was issued to health authorities on quality assurance in radiotherapy. It sets out 18 requirements to be satisfied to ensure that quality is maintained. The guidance has been considered in two sites--the Bristol oncology centre and the Christie hospital in Manchester. Both centres completed their assessments, and their findings were disseminated by way of a document called "Quality Assurance in Radiotherapy", which I launched at a conference in May last year. The document will act as a quality assurance model for the wider NHS; it will be for each radiotherapy department to produce a quality manual showing how the requirements of the guidance are to be met and detailing procedures in the department.

I fully realise that many of the women suffering side effects would wish to have their injuries recognised and consideration given to their claims for compensation, commensurate with their injuries. It is important to be clear about how such claims are pursued. First, we believe it right that people harmed in the course of clinical treatment should be able to seek compensation through the usual legal process. But that does require them to demonstrate not only that they have been harmed but that there has been negligence, and that the negligence caused the harm. When negligence cannot be shown, there is no case in law for compensation.

From time to time it has been suggested that this is not right, and there have often been calls for the introduction of a system of no-fault compensation. Hon. Members will recall that this issue has been considered in the House before, most recently on Second Reading of the National Health Service (Compensation) Bill on 1 February 1991. On that occasion, as on every other when the issue has been raised, the House concurred with the view that a no-fault compensation scheme would not be helpful.

Perhaps I should remind the House of the reasons for that conclusion. We are sensitive to the fact that some of the victims of medical accidents oppose no-fault

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compensation on the ground that it would make it less likely that plaintiffs' non-financial concerns would be addressed. Many plaintiffs argue that their motivation for pursuing a claim is not to secure money but to obtain an explanation and an apology and to ensure that what happened to them does not subsequently happen to others. Thus a system designed mainly to deal quickly with the financial aspects of medical accidents, without regard to fault, would deflect attention from plaintiffs' most important concerns.

Another issue is accountability. Our legal system holds all individuals accountable for their actions, which arguably has a deterrent effect on malpractice. No-fault compensation could remove or weaken it.

We must also be mindful of the possible cost implications of a no-fault compensation scheme. Costs falling on the NHS could increase greatly. For instance, a scheme in New Zealand which covers accidents generally is thought to cost at least 1.5 per cent. of its gross national product. Given that we spend about 6 per cent. of our GDP on health, hon. Members can imagine the possible impact on our health budget.

Proponents of no-fault compensation have yet to show why compensation in health care should be regarded as essentially different from negligence and compensation in other walks of life, where claims are resolved through the usual legal process.

Finally--

Mrs. Maria Fyfe (Glasgow, Maryhill): I am sorry that the Minister seems to be approaching the end of his speech because I had hoped to hear a quick word about the sums devoted to research into breast cancer, and the efforts to detect it in women under the age of 50. He probably knows that current mammography methods are not suitable for women under 50, who are clearly an important group.

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The Minister has expressed his worries about NHS budgets. Clearly, if enough money were spent on research in the first place, fewer women would suffer from breast cancer.

Finally, it would seem from the Minister's argument that only women with money in the bank will be able to claim compensation at all.

Mr. Sackville: Although I have outlined some of the reasons why no-fault compensation has been thought inappropriate, we have recently accepted that a system should be tried for mediation in such cases. The Minister of State recently agreed to set up pilot mediation schemes that may make it easier to reach agreement. We have no wish gratuitously to defend certain cases or to cause any unnecessary delays.

The Calman review was set up precisely to ensure that best examples of cancer treatment in this country should be disseminated throughout the system. In particular, we should ensure that more patients see specialists and that those with rare or difficult-to-treat cancers do not always end up in local cancer departments. They should be referred to tertiary specialist cancer centres, possibly on a regional basis, so that people with the qualifications to treat cancer can diagnose and treat the more difficult cases referred to them.

Following the general agreement that we need to take such steps to improve cancer care, I hope to see more widespread best practice. I offer the House a commitment today on behalf of the NHS: we will do everything possible to ensure that accidents of this sort are avoided in the future.

It being Two o'clock, the motion for the Adjournment of the House lapsed, without Question put.

Sitting suspended, pursuant to Standing Order No. 10 (Wednesday sittings), till half-past Two o'clock.


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