The Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020
| Jurisdiction | UK Non-devolved |
| Citation | SI 2020/521 |
| Year | 2020 |
2020 No. 521
Human Tissue, England
The Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020
Made 19th May 2020
Coming into force 20th May 2020
The Secretary of State makes the following Regulations in exercise of the powers conferred by sections 3(9) and 52(1) of the Human Tissue Act 20041.
In accordance with section 52(10)2of that Act, the Secretary of State has consulted such persons as the Secretary of State considers appropriate.
In accordance with section 52(4) of that Act, a draft of this instrument was laid before Parliament and approved by a resolution of each House of Parliament.
Citation, commencement, extent and application
1.—(1) These Regulations may be cited as the Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020 and come into force on 20th May 2020.
(2) These Regulations extend to England and Wales only.
(3) These Regulations apply in relation to activities done in England for the purpose of transplantation3.
Relevant material that is not permitted material
2.—(1) Paragraphs (2) to (5) specify types of relevant material4for the purposes of the definition of “permitted material” in section 3(9) (“appropriate consent”: adults) of the Human Tissue Act 2004.
(2) Subject to paragraphs (3) and (4), the whole or any part of the following is specified—
(a)
(a) arm;
(b)
(b) brain;
(c)
(c) face;
(d)
(d) finger;
(e)
(e) foot;
(f)
(f) forearm;
(g)
(g) hand;
(h)
(h) leg;
(i)
(i) lower leg;
(j)
(j) mouth;
(k)
(k) nose;
(l)
(l) spinal cord;
(m)
(m) thigh;
(n)
(n) toe;
(o)
(o) trachea;
(p)
(p) upper arm;
(q)
(q) cervix;
(r)
(r) clitoris;
(s)
(s) embryo (inside the body)5;
(t)
(t) fallopian tube;
(u)
(u) foetus;
(v)
(v) labia;
(w)
(w) ovary;
(x)
(x) penis;
(y)
(y) perineum;
(z)
(z) placenta;
(aa)
(aa) prostate;
(bb)
(bb) testicle;
(cc)
(cc) umbilical cord;
(dd)
(dd) uterus;
(ee)
(ee) vagina;
(ff)
(ff) vulva.
(3) The following is not specified in so far as it is disaggregated from any of the relevant material specified in sub-paragraphs (a) to (p) of paragraph (2)—
(a)
(a) artery;
(b)
(b) bone;
(c)
(c) muscle;
(d)
(d) nervous tissue;
(e)
(e) skin;
(f)
(f) tendon.
(4) The whole or part of the trachea is not specified in so far as it is attached to a lung.
(5) The following types of cells are specified only in so far as all or part of the cells is for use in, or as, an advanced therapy medicinal product—
(a)
(a) limbal stem cells;
(b)
(b) liver cells;
(c)
(c) lung epithelial cells;
(d)
(d) pancreatic cells;
(e)
(e) renal epithelial cells.
(6) In this regulation, “advanced therapy medicinal product” has the same meaning as in the Human Medicines Regulations 20126.
Helen Whately
Minister of State,
Department of Health and Social Care
19th May 2020
EXPLANATORY NOTE
(This note is not part of the Regulations)
These Regulations are made under the Human Tissue Act 2004 (c.30)(“the 2004 Act”). Section 3 of the 2004 Act makes provision for the interpretation of “appropriate consent”. This term is used in section 1 in relation to an activity involving the body, or material from the body, of a person who is an adult or has died an adult.
Section 3(6) provides that, in relation to certain activities done in England, in certain circumstances, appropriate consent means deemed consent. Certain of those activities involve the removal, storage or use, for the purpose of transplantation, of “permitted material”. Section 3(9) defines...
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