The Human Tissue Act 2004 applied to transplantation and research 23 April 2012 Victoria Marshment

Regulatory vs. legal framework ‘Regulate’ To control or direct according to rules Rules = regulatory framework Regulatory framework = the law + policy The law = Human Tissue Act 2004

HTA vs. the HT Act The HTA Set up, and its remit defined, by the Act The HTA does not ‘own’ the Act Legislation is controlled by Parliament Statutory terms, some with fixed definitions

The Act and licence requirements A number of consent and licensing exceptions Storage licence exception for research approved by a ‘recognised’ REC No exception from the requirement for premises to be licensed where removal of tissue from the deceased for research takes place Even if there is REC approval The Act does not permit a roving or regional licence – licences are tied to named premises

Options and progress DH not keen to change the legislation Asked us to find a non-legislative solution Discussions with transplant professionals, NHSBT, NRES, BTS, UKDEC and DH about various options A number of letters sent to DH on this issue Swiftest and simplest - extend existing licences Extending licences might not be straightforward HTA is developing and will implement a new licence in May

Summary of key points Licence needed for removal of research material from the deceased (the law) Licence extension might not be ideal New removal licence might be preferred Once legal requirements are met, challenges for transplant researchers to work with NHS organisations to implement best arrangements

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