The Human Tissue Act received Royal Assent in November 2004, and was fully enacted on September 1st 2006. Whilst its main focus is to redress the inadequacy on the law on tissue retention the inclusion of the “DNA theft” clause in the Act (section 45) has implications for good practice in relation to paternity testing.

What does the Human Tissue Act do? The Act regulates the removal, storage and use of human tissue. This is referred to in the Act as "relevant material" and is defined as material which has come from a human body and consists of, or includes, human cells.

The Act lists the purposes for which consent is required. The consent required under the Act is called 'appropriate consent', which broadly means consent from the appropriate person, as identified in the Act. Penalties of up to three years imprisonment or a fine, or both, are provided in the Act as a deterrent to failing to obtain or to misusing consent.

The Act established the Human Tissue Authority to advise on and oversee compliance with the Act. The Authority will issue good practice guidance in statutory codes of practice.

The Human Tissue Act and DNA Testing The Act makes it an offence to have human tissue, which includes hair, nail and gametes in this context, with the intention of its DNA being analysed without the consent of the individual from whom the tissue came, or of those close to them if they have died. This provision applies UK-wide. Penalties for not obtaining consent are provided.

Section 45 of the Act has a particular relevance to paternity testing given that it covers the non-consensual analysis of DNA. It stipulates that "A person commits an offence if he has any bodily material intending":-

• that any human DNA in the material be analysed without qualifying consent, and
• that the results of the analysis be used otherwise than for an excepted purpose,

A person guilty of an offence under this section:-

• is liable on summary conviction to a fine not exceeding the statutory maximum;
• is liable on conviction on indictment:- to imprisonment for a term not exceeding 3 years, or to a fine, or to both.

Guidance and Codes of Practice One of the HTA’s statutory functions is to issue codes of practice. The first six codes have been published and the first covers the central issue of consent. The giving of consent is seen as a positive act. The absence of refusal is not evidence of consent.

The section on consent and the use of DNA is the one area of the Code of Practice that specifically refers to paternity testing, rather than considering it as part of the whole. It states that “As the issue of paternity testing is a sensitive one, further guidance has been published by the Department of Health in this area.” This further guidance is the DH’s voluntary Code of Practice and Guidance on Genetic Paternity Testing in the UK, first published in 2001 and which is currently under review.

The Department of Health have stated that new Paternity Testing code will have to be consistent with the HT Act and with other legislation relating to Court-directed services and advertising. They envisage that the new code will go beyond the Human Tissue Act and the Codes to give more detail, and best practice guidance, that is tailored to paternity testing. Industry consultation on the new DH code will commence in November 2006.