HC Deb 25 November 1998 vol 321 cc183-8 1.30 pm
Mr. Mark Oaten (Winchester)

I am grateful for the opportunity to highlight the plight of five families who have lost a family member from Creutzfeldt-Jakob disease as a result of human growth hormone treatment. Their position has been made worse by the fact that to date they have not been entitled to any compensation because a judicial ruling in 1996 stated that damages could be paid only to victims who started the treatment, or had the majority of it, after July 1977.

The issue concerns hon. Members on both sides of the House, particularly those who have witnessed the trauma experienced by the families involved. My constituents, Mavis and Tony Lay, lost their 22-year-old daughter Alison to that terrible disease in 1985. Alison was a clever, bubbly girl who was adored by many people. She was the first person in Britain to die from CJD. Her parents' anguish has been made worse by their continuing fight for compensation from the Department of Health.

Let me set out the necessary background details to the case. Between 1959 and 1985, nearly 2,000 children were given human growth hormone derived from donated glands. The Medical Research Council ran the programme as a clinical trial until 1977, when the Department of Health assumed full control.

Although the programme proved successful and was in great demand, not just in Britain but throughout the world, a number of concerns among leading scientists raised the likelihood of a link with CJD. During clinical trials, Dr. Alan Dickinson of the Agricultural Research Council, a veterinary scientist who was working on scrapie, alerted officials at the Medical Research Council to the risk of CJD being transmitted through human growth hormone. He consequently made four suggestions on how to improve the safety of the hormone. Two were never acted on, the third was only partially implemented and the fourth was not put into force until 1980—three years after the Department of Health started running the treatment. The Medical Research Council appointed two virologists as consultants, but that was not until the medical trials had been completed.

The programme also failed to fall within the regulatory framework of the Therapeutic Substances Act 1956 or the Medicines Act 1968, so the hormone escaped any regulation in terms of its safety or purity. It comes as no surprise, therefore, that one senior Government scientist recorded that the laboratories where the hormone was prepared were "wholly inadequate and inappropriate". They were consequently shut down just one year into the Department of Health programme, after failing inspection. The full growth hormone programme ended in 1985 following the death of my former constituent, Alison Lay, from CJD, and similar deaths in the United States.

When the families concerned took their case to trial, the High Court ruled in July 1996 that the Medical Research Council and the Department of Health were negligent in not acting on the scientists' concerns, which probably would have resulted in the suspension of the treatment from July 1977. The judge, Mr. Justice Morland, stated that, if consultants had been properly alerted, new patients would not have been started on the programme. However, he went on to say that those who were already receiving treatment would legitimately have been continued on the programme. The ruling meant that only families of patients who started treatment after July 1977 would be entitled to compensation. As a result, several families were not entitled to compensation and were devastated.

My constituent, Alison Lay, began her treatment in 1972 and her family have had to endure prolonged distress as a consequence of the ruling. Their trauma has been worsened by the refusal of Mr. Justice Morland to go beyond his original ruling.

This afternoon, I would like to put to the Minister a number of compelling reasons for reviewing the matter and compensating the five families.

The fundamental argument is simple. It points to a lack of consistency in the CJD litigation and the unfairness of the matter. It cannot be right that some people who died of CJD from contaminated growth hormone have been treated differently from the rest of the group. Although I understand and do not dispute Mr. Justice Morland's decision to institute a cut-off date, the fact that five families remain unentitled to compensation seems to be unjust and unfair.

It is also clear that, because only five cases are outstanding, there will not be any further claims of this precise nature and that, by changing their stance, the Government would not be opening the floodgates to many appeals.

Mrs. Teresa Gorman Billericay)

The hon. Gentleman is referring to human growth hormone, yet he is talking about CJD being linked to cattle and sheep. Is he talking about CJD in general or about people who had been given human growth hormone which is extracted from human pineal glands?

Mr. Oaten

I apologise if I have not made it clear that I am referring to CJD caused by the use of human growth hormones in treating other humans.

In view of the limited number of outstanding cases, the Government should be persuaded on compassionate grounds that some form of compensation should be awarded at limited cost to the Department of Health.

There is an additional issue that makes a compelling case for compensation to the five families. In June this year, six individuals won compensation of between £3,500 and £300,000 due to having suffered from psychiatric illness because of "rational fears" of contracting CJD. One wonders why the principle of extended compassion cannot be stretched just a little further to encompass the five cases that I have outlined.

Let me remind the Government of their stance on the issue in opposition, when they pressed strongly for compensation for CJD victims. For example, the then shadow Health Secretary, now the Secretary of State for Education and Employment, stated: Ministers should establish an inquiry in the UK as a matter of urgency and examine ways in which a compensation scheme might be set up. There is certainly no doubt about the Government's recent commitment to try to settle many outstanding compensation issues.

Perhaps the Government should follow the examples of Australia and France, where all CJD claimants have been compensated without having to establish liability. Is there not a similarity between the case of the haemophiliac victims who became infected with HIV through contaminated factor 8 blood products? In that case, the Department established a no-fault compensation scheme. Is that not a practical example of how the remaining five CJD cases should be handled?

It may be that the Minister will take the same view as the former Under-Secretary of State for Health, the hon. Member for Orpington (Mr. Horam), who stated last year in an oral reply that no further compensation should be given over and above Mr. Justice Morland's ruling because it must be the first and overriding responsibility of the Department of Health to concentrate on preventing ill health and curing it when it occurs, not on compensating those who have contracted that terrible problem."—[Official Report, 18 February 1997; Vol. 290, c. 730.] Although I do not dispute the main responsibility of the Department of Health, there is a moral case for compensating the five families. I ask the Minister to remember the human suffering and injustice that have taken place and to try to resolve the issue speedily by compensating the five families. The numbers are small, and the cost to the Department of Health is not significant. Is it not time to end their distress? As my constituent, Mavis Lay, stated: we have had enough torment over the last 14 years.

1.39 pm
The Minister for Public Health (Ms Tessa Jowell)

I pay tribute to the hon. Member for Winchester (Mr. Oaten) for raising the issue and to Alison Lay's parents, who have been tireless campaigners since her death.

Let me recap the history of the tragedy. The human growth hormone treatment programme ran from 1959 to 1985 and just under 2,000 children were treated in the United Kingdom during that period. It is a real tragedy that, as a result of the programme, there have been 27 deaths in the United Kingdom from Creutzfeldt-Jakob disease, which, as we all now know, is a dreadful disease with awful consequences. The use of human growth hormone ended in 1985 when the link with CJD was established.

Children with growth deficiency may suffer permanent short stature, disability or even, in some cases, death. Most children are diagnosed as having a growth deficiency by a paediatrician in a specialist child growth clinic. The growth hormone that has been used since 1985 is manufactured genetically and is regarded as safe.

As we now know, CJD was transmitted through the human growth hormone that was used in the human growth hormone treatment programme. The administration of that programme by the Department of Health and Social Security, as it was then, was the subject of a comprehensive and open hearing in the High Court before Mr. Justice Morland, as the hon. Member for Winchester said.

The main court hearing ran from April 1996 to July 1996. During the hearing, the judge conducted a thorough examination of a great deal of documentary evidence on the conduct of the programme, and heard evidence from witnesses, including some of the most eminent experts in the field.

The Department co-operated as far as possible in the full production of all the documents and witnesses that could help the court to understand and unravel the circumstances surrounding the administration of the treatment—everything that was relevant and could be traced was produced.

Mr. Justice Morland found that the Department had been negligent in the administration of some aspects of the programme, and patients whose treatment commenced after 1 July 1977 and who had been treated with growth hormone prepared according to the Wilhelmi or Hartree Wilhelmi method were successful in their action. He ruled that, on that date, action should have been taken to withdraw the HGH treatment or clinicians should have been warned that CJD could be transmitted. The date was set as the benchmark for compensation. The Department of Health, but not the Medical Research Council, was ruled to have been negligent.

Representatives of a number of patients who had died of CJD and whose treatment had straddled 1 July 1977 appealed against the finding—their appeal was heard in November 1997. The Court of Appeal referred the case back to Mr. Justice Morland to clarify some aspects of his original finding.

A further hearing took place during April this year. Mr. Justice Morland reviewed his earlier judgment and upheld the appeal of those patients who were treated with Wilhelmi or Hartree Wilhelmi hormone and who had received at least half their treatment with that preparation after 1 July 1977. Fourteen patients are involved, and we are working with the legal representatives of their estates to finalise any compensation that is payable.

The Department has accepted all those findings in full. We have sought at all times to co-operate fully with the courts and to comply as quickly as possible with their judgments. I have also accepted that any patient whose treatment with human growth hormone meets the criteria set by the court and who contracts CJD will receive compensation in terms similar to those reached for the plaintiffs who took part in the court action. Sadly, we have already had to pay interim compensation to four patients in that situation, and we will continue to make payments in any further cases that may arise.

I am also aware of the very real worries of all those treated with human growth hormone who are well at present but could contract CJD. I am sorry that their lives should be blighted by the knowledge that they risk contracting the disease. We all wish that they were not in that position—obviously, we all hope that the worst will never happen.

Some of the human growth hormone patients took legal action against the Department, claiming damages for the psychological harm and distress that they had suffered. I have met a number of those patients and those associated with their cases.

The case was heard, again by Mr. Justice Morland, during April and May 1998—the judgment was given in June 1998. As a result of the earlier negligence finding against the Department, the judge found that human growth hormone patients would be entitled to compensation if their treatment was completed after 1 July 1977, they received Wilhelmi or Hartree Wilhelmi hormone and they were suffering from a recognised psychiatric illness as a result of knowing that they were at risk of CJD. Again, we have accepted that finding and have agreed and paid compensation in 29 cases. A number of further claims are being investigated.

I know that many hon. Members have been concerned about the implications of that judgment, but we must recognise that all medical treatments, particularly new treatments, carry some risk. We intend to minimise that risk. Earlier this year, we announced proposals on some of the ways in which we will review our procedures and practices and issue guidance on the safest, most effective and most appropriate management of clinical practice.

Under those proposals, which were announced in July 1998 in the document "A First Class Service", the new national institute for clinical excellence will draw on expertise developed across a wide range of national and regional bodies to produce guidance and ensure that treatments are provided on the basis of safety, quality and efficacy.

I am aware of the calls for a general no-fault compensation scheme. I understand the motivation for those calls—many of which are from those who, as a result of the courts' decisions, will not receive compensation—and have given the question much thought.

The Government's policy—like that of the previous Government—is that compensation will be paid only when negligence has been proved. We believe that paying compensation on a no-fault basis would be enormously complicated, would not necessarily solve the problems that are being encountered, would be expensive and would have ramifications beyond the health service.

We believe that compensation should be paid only when a duty of care is owed, when a negligent act has been committed and when harm has been caused by that negligence. It is clearly better for the national health service that money is spent on direct patient care, rather than on the inordinate costs incurred in fighting compensation claims. Hon. Members will want to know that we are continuing to fund the counselling service for patients who were treated with human growth hormone and their families.

Mr. Alan Duncan (Rutland and Melton):

I congratulate the hon. Member for Winchester (Mr. Oaten) on his contribution, in which he made some very serious points. However, the CJD argument has moved on. We are talking about compensation for the use of growth hormone, but what if blood products and medical instruments are found to carry similar risks? The Minister has a duty of care, so will she give a pledge to compensate those who may suffer from her negligence, and that of the Department, in not making clear today the risks of CJD infection from such sources?

Ms Jowell

The Government are absolutely committed to publishing information and evidence on the risks from CJD and on other public health hazards. We will seek the best scientific evidence, which we will publish and act on. Our framework for determining compensation remains that, where negligence is proved by the courts, compensation will be paid.

Mr. Paul Flynn (Newport, West)

Many hon. Members have constituents who are in this distressing situation. Does my right hon. Friend think that the Government—by relying today on a legalistic argument for what is a limited claim for a tiny number of people—will appear to people outside to be taking a heartless attitude?

Ms Jowell

I very much hope that the Department's approach—which extends beyond this specific issue, and is a matter of general principle—will be seen as fair, not heartless. In everything that we have done in representing the Department's position and recognising the heartbreak suffered by the families, we have sought to establish a balance between what is fair and reasonable and not exposing the Department or the national health service to completely unfettered claims which have not been founded on clear evidence of negligence. We believe that the establishment of negligence in the courts is the fairest way of determining compensation. Once the judgment has been made, we have proceeded as quickly as possible to ensure that compensation is, in practice, paid to the families concerned.

I wish to remind the hon. Member for Winchester of the continuing support available to families provided by a unit under the leadership of Professor Michael Preece which is located at the Institute of Child Health in London. It was established in 1992 and does valuable work in supporting patients who have CJD, as well as those who are treated with the growth hormone but who are well at present. The unit is available to provide advice for clinicians and other health or social services staff who may have contact with human growth hormone patients, as well as to mobilise local health and social services to help human growth hormone patients, especially if CJD is suspected.

I fully understand the real concerns expressed by the hon. Member for Winchester. I am as anxious as the other hon. Members who have spoken in the debate to see what lessons can be learned from the tragic circumstances surrounding this treatment programme, to bring the matter to a swift and just conclusion and to ensure that we increase the chances of such mistakes and such dreadful tragedies never happening again.

It being before 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.