The UK Human Tissue Act 2004,1
designed to regulate all activity involving human tissue, organs, or bodies, was introduced in the House of Commons in December 2003, received Royal Assent on 15 November 2004,2
and has been partially implemented by Commencement Orders from April 2005. The new act, which repeals and replaces the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989, has its origins in events of serious public concern, namely the retained organs scandals at Bristol Royal Infirmary3
and the Royal Liverpool Childrens' Hospital.4
The act is correspondingly dominated by regulation of postmortem examinations and retention of human tissue, with consistent emphasis on the need for fully informed consent. Compliance with these requirements is now mandatory with the threat of up to three years' imprisonment and/or fines for any deviation.
The impact of the original proposals within the bill on research and the clinical practice of pathology have been carefully considered and documented,5
with subsequent amendments to ameliorate professional concerns.6
The act, however, also carries significant implications for medical practice in areas where donor recruitment for transplantation can take place, and representations on these aspects during readings of the bill7
have produced neither clarification, justification, nor amendment within the final legislation.
Section 43 will make it lawful for hospital authorities “to take steps for the purpose of preserving the part for use for transplantation and to retain the body for that purpose”. The original explanatory notes for the bill8
while it proceeded through parliament implied that such action, prior to consent to transplantation being sought, was then lawful, clause 44 as section 43 then was, merely serving to consolidate this point. The basis of such an assertion is unclear, but this stance was reiterated by the minister of state before the standing committee, who declared such interventions: “lawful because there is no law against it. ... Just as embalming is lawful, so is cold perfusion.”7
In section 27 of the act, “Provision with respect to consent”, subparagraph 8 states: ”a person's relationship shall be left out of account if—(c) having regard to the activity in relation to which consent is sought, it is not reasonably practicable to communicate with him within the time available if consent in relation to the activity is to be acted on”. Regardless of the lack of important detail as to which interventions will be accommodated under the above sections, the incompatibility of these declarations with the fundamental principle underpinning the new regulations, that of proper consent, is not addressed, despite interim unequivocal central directives of such a requirement in these fields.9
Before the second reading of the bill in parliament on 15 January 2004 there was extensive lobbying by the British Medical Association (BMA) for the bill to go beyond the above “preservation” techniques and base the actual procurement of organs on ”presumed consent” (BMA press release, 8 January 2004). This cause was also championed by individual pressure groups (Today,
Radio 4, BBC December 2004) supported by certain MPs during that second reading,10
and was the subject of a subsequent private member's bill endorsed by the BMA.11
Despite the stance of the minister of state that ”presumed consent” would not be introduced, it is apparent from the above components of the act that “presumption” to some degree is now lawful.
The entire legislation is inevitably a complex balance between respect for the individual and broader societal benefit, further complicated by an acceptance that the process of consent cannot be rigidly standardised for every scenario and individual. It is reasonable to ask, however, whether the approach taken toward organ procurement in favouring third party benefit and exempting any requirement for informed consent, deviates significantly from other aspects controlled under the act. If this process fulfils the criteria for ”presumed consent” the further step from preservation techniques to actual procurement arguably becomes less of an insurmountable hurdle, and it is therefore reasonable to ask whether the persistent call to change the basis of organ procurement toward presumed consent is ethically defensible. The other facet of the legislation worthy of scrutiny relates to the already problematic scenarios in which donor recruitment would take place and lack of specificity as to the manoeuvres which would be accommodated under “preserving the part for use for transplantation”.