A promise worth more than money

The Alder Hey victims' parents want compensation. But they also want a law to ensure that nothing like this happens again.
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The new all-encompassing legislation promised by the Government to prevent future Alder Hey scandals will have to take account of increasingly sophisticated research techniques which can turn body parts into the raw material for very valuable treatments.

The new all-encompassing legislation promised by the Government to prevent future Alder Hey scandals will have to take account of increasingly sophisticated research techniques which can turn body parts into the raw material for very valuable treatments.

The Chief Medical Officer Professor Liam Donaldson has recommended amending existing legislation quickly to make it clear that parental consent must be sought for the retention of organs from their children and to introduce sanctions for non-compliance. But he then wants the Government to carry out a more fundamental review of the law, to produce new legislation which will encompass the taking, storage, use and disposal of human tissue and organs from the living and the dead, backed up by an independent system of regulatory control.

For Professor Andrew Grubb, professor of medical law at Cardiff Law School, such all encompassing legislation should consider the rights of individuals when their body parts prove vital in developing profitable treatments, raising legal issues of title, commerce and intellectual property rights. "I am sure that we should have legislation to outlaw the sale of tissue and organs for research purposes. It is already illegal for transplantation purposes. But I doubt if the Government will be able to deal in any comprehensive way with the commercial exploitation of tissue, because there are too many vested interests to solve this problem easily or quickly."

Faced with widespread revulsion at the scale of organ retention, both at Alder Hey and at hospitals around the country, the Chief Medical Officer Professor Liam Donaldson proposed 17 recommendations intended to balance parents' demands with the need for medical research. While existing legislation was "unclear, ambiguous and ageing", he said society's difficulty in addressing the issue of death meant that "silence, embarrassment and half-truths have substituted for openness, provision of information, sensitivity and dialogue".

He recommended as an "immediate measure" amending the Human Tissue Act 1961, which regulates the removal of body parts "for therapeutic purposes or for the purposes of medical education or research" and allows hospitals to authorise the removal and use of body parts if it believes the deceased or any surviving relative would not object. The amendments would make it clear that, where the patient was under 16, parental consent was required and that there should be penalties for non-compliance, though the recommendation does not spell out whether these should be criminal or civil.

He also called for an early change in the Coroners' Rules 1984 to make it clear that pathologists had no independent right to retain human material once the coroners' post-mortem, for which consent is not required, is concluded, except with the authority of the coroner or with the consent of parents. At the same time, a code of practice should to be introduced as soon as possible, setting out what information should be given to parents, backed up by a standardised consent form. Ian Cohen, head of clinical negligence with Liverpool solicitors Goodmans, represents the Pity II Alder Hey parents' action group. He said the debate about the balance between individual rights and medical needs involved not just the Department of Health but the Home Office, responsible for coroners, the Department of Education, responsible for universities doing medical research, and pharmaceutical companies.

"The recent developments in genetics, for instance, are just the tip of the iceberg. Medical research has the potential to create treatments worth vast sums of money, but that must be balanced by proper protection for patients," he said.

His firm was last week appointed lead solicitors in a group action for damages against the Royal Liverpool Children's NHS Trust, responsible for Alder Hey, for the extreme stress caused by the organ retention and the handling of the scandal. The Regional NHS executive and/or Liverpool University may also be potential defendants.

Daniel Marks, medical negligence expert with London solicitors Finers Stephens Innocent, estimated that awards for trauma caused by the hospital's negligence would be between £10,000 and £20,000. However, Mr Cohen said parents had made it clear compensation was not a priority. What they wanted was the truth about what had gone on, and about what would be done to stop it happening again - "but so many people suffered such increased anger and stress over the way the hospital behaved after the discoveries were made in September 1999, that a lot were pushed down the route of taking civil action". He hoped that the Government, which would fund any claims against the hospital and come to a common agreement to compensate families.

Laurence Vick of Exeter law firm Michelmores is joint lead solicitor for the Bristol Heart Children Action Group's 300 families. He has been asked by 30 families to investigate possible compensation claims based on the hospital's unauthorised retention of childrens' organs and interference with the families' right to possession of their children's body and organs for burial, as well as psychological trauma. "However, litigation for the families is very much secondary to making sure the Government takes steps to ensure this never happens again," Vick said.

The Alder Hey parents also want to see those responsible held accountable. Merseyside police are looking into the scandal and the Alder Hey report has been sent to the Director of Public Prosecutions. Mr Cohen said that, while there were no penalties in the Human Tissue Act, there was "a degree of precedent" in the 1973 case of the Crown v Lennox-Wright involving the taking of human tissue by an unqualified person. "It was deemed that breaching or disobeying a statute in itself constitutes an offence and the conviction was allowed. It is not a quantum leap to a qualified person removing tissue in breach of the Act. Several parents have approached us to look at private prosecutions in the event the DPP doesn't take any action." He said parents wanted any sanctions to be criminal. "A fine is not good enough."

Professor Grubb also called for criminal sanctions, such as those in the Anatomy Act 1984. He believed one of the best models for new legislation would be the statutory requirements for consent under the Human Fertilisation and Embryology Act 1990.

The next stage would be an elaborate licensing and accreditation system for practitioners and institutions, so that they are controlled by a central authority. This could be achieved by setting up a statutory body like the Human Fertilisation and Embryology Authority or within a department, such as the Department of Health.

Organ donation is another issue. John Harris, Sir David Alliance professor of bioethics at Manchester University, fears the emphasis on informed consent runs counter to proposals to introduce an opting-out system, whereby organ donation would be automatic unless a person opted out. "Many thousands of lives are lost each year because of insufficient donor organs. There is no excuse for not establishing an opting-out system. Failing to do so would be to murder thousands of citizens each year, because there won't be enough donor organs."

But Mr Cohen warned: "Parents are not looking to stifle medical research or organ donation. But the Human Tissue Act provided for opting out rather than opting in, and that was abused. Consent must be positively sought and positively given - that is the only safeguard."