PART 2LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION

Information and confidentiality13

1

It shall be a condition of every licence under Schedule 1 that all necessary arrangements are made to ensure that all information which is collected in pursuance of the licence or a third party agreement in relation to the licence—

a

is available for the purpose of tracing donations;

b

is kept up-to-date and corrected without delay where any discrepancy relating to such information is identified; and

c

is held securely and subject to safeguards against unauthorised additions, deletions, modifications or transfer of information.

2

Any information which is collected in pursuance of a licence under Schedule 1 or a third party agreement, and from which a donor (living or deceased) or recipient of tissue or cells may be identified, shall not be disclosed except where such disclosure—

a

is of information which has been rendered anonymous so that neither the donor nor recipient is identifiable,

b

is made in accordance with an order of a court,

c

is otherwise required by law,

d

is made to a person as a member or employee of the Authority,

e

is made to a person who is otherwise acting on behalf of the Authority in the exercise of its functions under these Regulations, including in particular its functions under Part 5 of these Regulations,

f

is made to a tissue establishment for the purpose of tracing a donation from donor to recipient or recipient to donor,

g

is made to a licence holder or a person to whom a licence applies for the purposes of his functions under the licence,

h

is made to a third party in relation to a licence for the purposes of his functions under a third party agreement,

i

is made pursuant to any consent to disclosure given by the person, being the donor or recipient of the tissue or cells, whose identity would be disclosed,

j

is necessary—

i

for any purpose preliminary to proceedings,

ii

for the purpose of, or in connection with, any proceedings,

iii

for the purpose of reporting a suspected offence,

iv

for the purpose of cooperating with a police investigation,

v

for the purpose of investigating a serious adverse event or serious adverse reaction,

k

is made by a licence holder or designated individual in accordance with directions given to that person by the Authority under section 23(1) or 24(1) of, or paragraph 2(4) of Schedule 3 to, the 2004 Act, as applied by regulation 8, or

l

is of information which has been lawfully made available to the public before the disclosure is made.

3

References to proceedings in paragraph (2)(j) include any formal procedure for dealing with a complaint.

4

Where a disclosure is made to a person pursuant to paragraph (2)(d) or (e), that person shall not further disclose the information received unless the disclosure—

a

is made in accordance with paragraph (2), or

b

is made by the Authority for the purpose of its obligations under regulations 17 and 20.