The UK government's Human Tissue Bill will benefit nobody.
The UK Human Tissue Bill, which had its second reading in the House of Commons on 15 January 2003, will, according to the Department of Health, ‘establish a regulatory system to give confidence to patients, families, doctors and researchers’ (1). How? By threatening doctors who remove organs from dead bodies without the prior consent of the deceased person or their next of kin with unlimited fines and up to three years in prison. A Human Tissue Authority will be set up to inspect premises and ensure that strict codes of conduct are being observed.
These moves to tighten the regulation of how human tissue and organs can be used sit uneasily with the growing problem of organ shortages. The organisation UK Transplant warns that the number of people waiting for an organ transplant in the UK has increased by almost a third in the past 10 years. There are currently over 7,000 patients who need a transplant to save or greatly improve their lives (2).
Many of those who have praised the bill on the whole are raising concerns about its impact on the availability of human tissue and organs for transplants, research and education purposes. Liberal Democrat MP Evan Harris is tabling an amendment – with wide support from the medical establishment – calling for an ‘opt out’ policy for organ donation. This form of ‘presumed consent’ would assume that everyone is a willing donor unless they have explicitly registered their refusal. Dr Michael Wilks, chairman of the British Medical Association (BMA) Ethics Committee, stated: ‘There is a great deal that the BMA welcomes and supports in this bill. However, we believe the government is wasting an opportunity here by not including provision for presumed consent for organ donation in the proposed legislation.’ (3)
The BMA argues that instead of being asked to consent to donation, family members would be informed that their relative had not opted out of donation. Unless they objected – either because they knew their relative would not want to donate their organs or because it would cause the family major distress – the donation would proceed (4).
The government has rejected these proposals, with health minister Rosie Winterton firmly stating that consent will remain the cornerstone of the Human Tissue Bill (5). Indeed, the Human Tissue Bill is built on the notion that the Alder Hey and Bristol Royal Infirmary scandals, in which organs were taken from the bodies of dead children without their parents’ consent, were the consequence of doctors’ arrogance and unaccountability, and their failure to take sufficient account of the feelings and wishes of relatives who had lost loved ones.
The UK government’s response to these scandals has been to try to hold doctors to account for every move they make it: forcing them to seek explicit consent for every bit of tissue retained after a medical procedure or autopsy. The assumption is that unless all the checks and balances are in place, doctors may get up to something untoward.
Given this rather cynical premise of the Human Tissue Bill, it is curious that most of its critics preface their comments with the disclaimer that the aim of the bill is to be welcomed – before going on to argue the case for implied consent. For example, Britain’s biggest biomedical research charity, The Wellcome Trust, warns that research into life-threatening diseases could be outlawed under proposed legislation. The Trust’s director, Dr Mark Walport, said that ‘the proposed legislation has admirable aims’. Yet he went on to raise some fundamental concerns: ‘[The] aim of preventing a repeat of the Alder Hey and Bristol tragedies could have unintended consequences by preventing some types of life-saving research. The bill is a confusing mix of contradictions and ambiguities which could result in an unworkable, bureaucratic system that stifles legitimate research.’ (5)
Cancer Research UK, while also welcoming the government’s intention to provide a consistent legal framework for the use of human tissues and organs, believes that key details have not been properly worked through and could cause unintended harm (4). The charity warns that donations to Cancer Research UK’s tumour banks have dropped since the Alder Hey and Bristol inquiries, ‘as public suspicion has combined with the nervousness of doctors uncertain of their legal position’ (6).
What none of the bill’s critics seems to appreciate is that the problem with the Human Tissue Bill does not lie in its specific proposals. The problem is the assumptions upon which the entire bill is based. This is the assumption that Cancer Research UK hints at, in its reference to ‘public suspicion’ and ‘the nervousness of doctors’.
This bill is premised on the idea that doctors cannot be trusted and need further regulation. Implied consent can only work if there is a relationship of trust between the doctor and the patient. But, as Dr Michael Fitzpatrick has outlined on spiked, that trust has been steadily corroded by an increasingly comprehensive official framework of bureaucratic regulation of medical practice: with ‘a flurry of documents indicating the direction of measures for tougher action against rogue or “underperforming” doctors, and for closer regulation of the medical profession as a whole’ (see After Bristol: the humbling of the medical profession, by Dr Michael Fitzpatrick).
This increased regulation may give the ‘appearance of a radical, modernising government courageously imposing change on a reactionary medical profession’, Fitzpatrick has warned; but there is ‘a serious danger that it will degrade the profession as a whole and do further damage to the relationship between doctor and patient’.
Tackling the problem of trust between people and the medical profession requires, not yet more laws, but an attempt to engage with and challenge public attitudes. In the past, relatives gave agreement for post-mortems and transplants on the general understanding that this would be beneficial for other patients, medical research and teaching purposes. They would see themselves as having a common purpose with the medical establishment: to aid the development of medical science. Yet when the public are encouraged to view the medical establishment with suspicion and to presume that their motives for retaining organs and human tissue are suspect, no amount of legal acrobatics in relation to the wording of the notion of ‘consent’ will solve the problem.
There is no easy answer to the problem we are now faced with. But one thing we can be sure of is that the bluntness of the law will make matters worse.
(1) Government rules out presumed consent, Department of Health, 14 January 2004
(2) Need for organ transplants increasing, UK Transplant, 3 December 2003
(3) BMA pushes for ‘presumed consent’ in human tissue bill, British Medical Association, 14 January 2004
(4) BMA pushes for ‘presumed consent’ in human tissue bill, British Medical Association, 14 January 2004
(5) Medical research under threat from new bill, Wellcome Trust, 14 January 2004
(6) Call for clarity on Human Tissue Bill Release, Cancer Research UK, 14 January 2004
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