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The Human Tissue Act 2004

We recently dealt with a case where a hospital had performed histopathology tests on tissue from a deceased patient without the consent of the next of kin. The hospital refused to accept it had done anything wrong despite the fact that we pointed out that its conduct was unlawful pursuant to the Human Tissue Act 2004.

Following the organ retention scandals at The Royal Liverpool Children’s Hospital and The Bristol Royal Infirmary, there was profound public disquiet regarding issues of consent and organ and tissue use and storage, which had been brought under the spotlight. There were also concerns about the risk of‘DNA theft’ meaning that human tissue could be used to identify inherited genetic disorders of patients without their consent.

The Human Tissue Act 2004 came into force on 1 April 2006. It repealed the Human Tissue Act 1961, the Anatomy Act 1984 and the Human Organ Transplants Act 1989. The aim of the act is to make consent a fundamental principle underpinning the use and storage of human tissue. The process is overseen by the Human Tissue Authority (HTA), which regulates the removal, storage, use and disposal of human bodies, organs and tissue. Both the public and medical profession accepted a need to change the law but the draft of the act initially came under fire from scientists. The Welcome Trust and Cancer Research UK said the proposed changes went too far and would jeopardise medical teaching and research. Further debate led to the concerns of many scientists and doctors being assuaged although some still fear that the act imposes an excessive bureaucratic burden.

The act outlaws the following actions:-

= Removing, storing or using human tissue without consent.
= DNA ‘theft’ - taking and testing DNA without consent.
= Organ-trafficking.
= Storing tissue or organs for a purpose not stated.

Penalties range from a fine to three years imprisonment, or both. The HTA provides licences and inspections for the following practises:-

= Anatomical examinations.
= Post-mortem examinations.
= Removal of post-mortem material.
= Storage of post-mortem material.
= Storage of anatomical specimens.
= Storage of material from a living person.
= Public display of a body or material from a deceased person.

Licences have been required for the storage of human tissue and cells for therapeutic use from April 2006 and for other practices from September 2006. The HTA also regulates transplants, working with UK transplants. The act is an example of the increasing importance attached by both Parliament and the courts to the principle of consent. It is hoped that the act will improve public confidence so that people will be more willing to agree to the use of tissue and organs in research. There is a risk that this will be jeopardised if its provisions are overlooked or ignored.

For further enquiries please contact Graham Bell (view full profile) on 01892 701358 or email graham.bell@ts-p.co.uk.

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