The Human Tissue (Scotland) Act 2006 (Maintenance of Records and Supply of Information Regarding the Removal and Use of Body Parts) Regulations 2006

Explanatory Note

(This note is not part of the Regulations)

These Regulations replace the Human Organ Transplants (Supply of Information) Regulations 1989, made under section 3(1) of the Human Organ Transplants Act 1989 (that Act is repealed by the Human Tissue (Scotland) Act 2006 (“the 2006 Act”) (section 61 and the Schedule)). They come into force on 1st September 2006, being the date on which the 2006 Act comes into force (by S.S.I. 2006/251). They make provision for–

• the maintenance of records regarding the removal of parts from human bodies for transplantation and the use or retention, for any other purpose referred to in section 3(1) of the 2006 Act, of parts removed from bodies of deceased or living persons;

• the provision of information as may be so specified with respect to the removal of parts from human bodies for transplantation, the use or retention for that purpose of parts removed or the use or retention for any other purpose referred to in section 3(1) of the 2006 Act of parts removed from bodies of deceased or living persons.

Regulation 2 places a requirement on registered medical practitioners who remove a body part for transplantation to compile and maintain records. Records, in the case of a living donor, are to be maintained for 6 years from the date of removal or 3 years from the date of the donor’s death (even although the donor dies after the expiry of that six year period), whichever is the longer. In the case of a cadaveric donation, records are to be maintained for 6 years from the date of removal of the body part in question.

Regulation 3 places a requirement on certain specified persons who have received a body part which is to be used or retained for a relevant section 3(1) purpose (defined in regulation 1(2) as being any purpose other than transplantation referred to in section 3(1) of the 2006 Act), namely research, education, training or audit. Identical record keeping requirements are imposed on those persons as on registered medical practitioners under regulation 2 in terms of periods for keeping of records.

Regulation 4 places a requirement on a registered medical practitioner who has removed a body part for transplantation to supply the information specified in Schedule 1 to the Regulations to NHSBT and to either the relevant Special Health Board or the Health Board for the area in which the removal was carried out. The specified information to be supplied is information about the removal and information about the body part and the donor.

Regulation 5 places a similar requirement on a registered medical practitioner to supply information as that under regulation 4, but in this case the requirement is on a registered medical practitioner who receives a body part for transplantation. The information to be supplied is specified in Parts 1 to 3 of Schedule 2 to the Regulations, being information about receipt, the body part and the transplant.

Regulation 6 places a requirement on other specified persons who receive a body part which is to be used or retained for a relevant section 3(1) purpose, again research, education, training or audit. Paragraph (1) requires any of the persons specified in paragraph (3) to supply the specified information to NHSBT. Paragraph (2) places an additional requirement on the manager of any establishment which is not a hospital, to supply the information to the local Health Board in addition. The information to be supplied is specified in Parts 1, 2 and 4 of Schedule 2, being information about receipt, the body part and the research, education, training or audit in question.