Legalize / United Kingdom / Public General Act

Human Tissue Act 2004

Type Public General Act

Publication 2004-11-15

Last updated 2024-09-09

State In force

Department Statute Law Database

Source legislation.gov.uk

articles Not indexed

Reform history JSON API

(1) The Authority shall prepare—

(a) a report for the first twelve months of its existence, and

(b) a report for each succeeding period of twelve months.

(2) A report under this section shall deal with the activities of the Authority in the period to which the report relates.

(3) The Authority shall send each report under this section—

(a) to the Secretary of State,

(b) to the Welsh Ministers, and

as soon as practicable after the end of the period to which the report relates.

(4) The Secretary of State shall lay a copy of each report received by him under this section before each House of Parliament.

(5) The relevant Northern Ireland department shall lay a copy of each report received by it under this section before the Northern Ireland Assembly.

(5A) The Welsh Ministers shall lay a copy of each report received by them under this section before the National Assembly for Wales.

Directions

37

(1) The Authority may give directions for any purpose for which directions may be given under this Part.

(2) Any power under this Part to give directions includes power to vary or revoke directions given in previous exercise of the power.

(3) Any power under this Part to give directions is exercisable by instrument in writing.

(4) Directions under this Part to a particular person shall be given by serving notice of the directions on the person.

(5) Directions under this Part in respect of any licence (including one which has ceased to have effect) may be given—

(a) by serving notice of the directions on the person who is (or was immediately before the cessation) the designated individual or holder of the licence, or

(b) if it appears to the Authority that it is not practicable to give notice in that way, by publishing the directions in such way as, in its opinion, is likely to bring them to the attention of the persons to whom they are applicable.

(6) Directions under this Part which appear to the Authority to be general directions may be given by publishing them as mentioned in subsection (5)(b).

(7) This section does not apply to directions under Schedule 2.

Duties in relation to carrying out functions

38

(1) The Authority must carry out its functions effectively, efficiently and economically.

(2) In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).

Exceptions

Criminal justice purposes

39

(1) Subject to subsection (2), nothing in section 14(1) or 16(2) applies to anything done for purposes related to—

(a) the prevention or detection of crime, or

(b) the conduct of a prosecution.

(2) Subsection (1) does not except from section 14(1) or 16(2) the carrying-out of a post-mortem examination for purposes of functions of a coroner.

(3) The reference in subsection (2) to the carrying-out of a post-mortem examination does not include the removal of relevant material from the body of a deceased person, or from a part of the body of a deceased person, at the first place where the body or part is situated to be attended by a constable.

(4) For the purposes of subsection (1)(a), detecting crime shall be taken to include—

(a) establishing by whom, for what purpose, by what means and generally in what circumstances any crime was committed, and

(b) the apprehension of the person by whom any crime was committed;

and the reference in subsection (1)(a) to the detection of crime includes any detection outside the United Kingdom of any crime or suspected crime.

(5) In subsection (1)(b), the reference to a prosecution includes a prosecution brought in respect of any crime in a country or territory outside the United Kingdom.

(6) In this section, references to crime include a reference to any conduct which—

(a) constitutes one or more criminal offences (whether under the law of a part of the United Kingdom or of a country or territory outside the United Kingdom),

(b) is, or corresponds to, any conduct which, if it all took place in any one part of the United Kingdom, would constitute one or more criminal offences, or

Religious relics

40

(1) This section applies—

(a) to the use of—

(i) the body of a deceased person, or

(ii) relevant material which has come from a human body,

for the purpose of public display at a place of public religious worship or at a place associated with such a place, and

(b) to the storage of—

(i) the body of a deceased person, or

(ii) relevant material which has come from a human body,

for use for the purpose mentioned in paragraph (a).

(2) An activity to which this section applies is excluded from sections 14(1) and 16(2) if there is a connection between—

(a) the body or material to which the activity relates, and

(b) the religious worship which takes place at the place of public religious worship concerned.

(3) For the purposes of this section, a place is associated with a place of public religious worship if it is used for purposes associated with the religious worship which takes place there.

Supplementary

Interpretation of Part 2

41

(1) In this Part—

“the 2007 Regulations ” means the Human Tissue (Quality and Safety for Human Application) Regulations 2007;

“the 2012 Regulations ” means the Quality and Safety of Organs Intended for Transplantation Regulations 2012;

“anatomical specimen” means—the body of a deceased person to be used for the purpose of anatomical examination, orthe body of a deceased person in the course of being used for the purpose of anatomical examination (including separated parts of such a body);

“appeals committee” has the meaning given by section 20(2);

“designated individual”, in relation to a licence, means the individual designated in the licence as the person under whose supervision the licensed activity is authorised to be carried on;

“export” means export from England, Wales or Northern Ireland to a place outside England, Wales and Northern Ireland;

“import” means import into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland;

“scheduled purpose” means a purpose specified in Schedule 1.

(2) In this Part, references to the carrying-out of an anatomical examination are to the carrying-out of a macroscopic examination by dissection for anatomical purposes of the body of a deceased person, and, where parts of the body of a deceased person are separated in the course of such an examination, include the carrying-out of a macroscopic examination by dissection of the parts for those purposes.

(3) In this Part, references to a person to whom a licence applies are to a person to whom the authority conferred by the licence extends (as provided by section 17).

Part 3 — Miscellaneous and general

Miscellaneous

Power of Human Tissue Authority to assist other public authorities

42

(1) The Authority may if it thinks it appropriate to do so provide assistance to any other public authority in the United Kingdom for the purpose of the exercise by that authority of its functions.

(2) Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.

Preservation for transplantation

43

(1) Where part of a body lying in a hospital, nursing home or other institution is or may be suitable for use for transplantation, it shall be lawful for the person having the control and management of the institution—

(a) to take steps for the purpose of preserving the part for use for transplantation, and

(b) to retain the body for that purpose.

(2) Authority under subsection (1)(a) shall only extend—

(a) to the taking of the minimum steps necessary for the purpose mentioned in that provision, and

(b) to the use of the least invasive procedure.

(3) Authority under subsection (1) ceases to apply once it has been established that consent making removal of the part for transplantation lawful has not been, and will not be, given.

(4) Authority under subsection (1) shall extend to any person authorised to act under the authority by—

(a) the person on whom the authority is conferred by that subsection, or

(b) a person authorised under this subsection to act under the authority.

(5) An activity done with authority under subsection (1) shall be treated—

(a) for the purposes of Part 1, as not being an activity to which section 1(1) applies;

(b) for the purposes of Part 2, as not being an activity to which section 16 applies.

(6) In this section, “body” means the body of a deceased person.

(7) This section does not apply in relation to a part of a body lying in an institution in Wales.

(For provision in these circumstances see section 13 of the Human Transplantation (Wales) Act 2013).

Surplus tissue

44

(1) It shall be lawful for material to which subsection (2) or (3) applies to be dealt with as waste.

(2) This subsection applies to any material which consists of or includes human cells and which has come from a person’s body in the course of his—

(a) receiving medical treatment,

(b) undergoing diagnostic testing, or

(3) This subsection applies to any relevant material which—

(a) has come from a human body, and

(b) ceases to be used, or stored for use, for a purpose specified in Schedule 1.

(4) This section shall not be read as making unlawful anything which is lawful apart from this section.

Non-consensual analysis of DNA

45

(1) A person commits an offence if—

(a) he has any bodily material intending—

(i) that any human DNA in the material be analysed without qualifying consent, and

(ii) that the results of the analysis be used otherwise than for an excepted purpose,

(b) the material is not of a kind excepted under subsection (2), and

(2) Bodily material is excepted if —

(a) it is material which has come from the body of a person who died before the day on which this section comes into force and at least one hundred years have elapsed since the date of the person’s death,

(b) it is an existing holding and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified, or

(3) A person guilty of an offence under this section—

(a) is liable on summary conviction to a fine not exceeding the statutory maximum;

(b) is liable on conviction on indictment—

(i) to imprisonment for a term not exceeding 3 years, or

(ii) to a fine, or

(iii) to both.

(4) Schedule 4 (which makes provision for the interpretation of “qualifying consent” and “use for an excepted purpose” in subsection (1)(a)) has effect.

(5) In this section (and Schedule 4)—

“bodily material” means material which—has come from a human body, andconsists of or includes human cells;

“existing holding” means bodily material held immediately before the day on which this section comes into force.

Power to give effect to Community obligations

46

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Power to de-accession human remains

47

(1) This section applies to the following bodies—

The Board of Trustees of the Armouries

The Trustees of the British Museum

The Trustees of the Imperial War Museum

The Board of Governors of the Museum of London

The Trustees of the National Maritime Museum

The Board of Trustees of the National Museums and Galleries on Merseyside

The Trustees of the Natural History Museum

The Board of Trustees of the Science Museum

The Board of Trustees of the Victoria and Albert Museum.

(2) Any body to which this section applies may transfer from their collection any human remains which they reasonably believe to be remains of a person who died less than one thousand years before the day on which this section comes into force if it appears to them to be appropriate to do so for any reason, whether or not relating to their other functions.

(3) If, in relation to any human remains in their collection, it appears to a body to which this section applies—

(a) that the human remains are mixed or bound up with something other than human remains, and

(b) that it is undesirable, or impracticable, to separate them,

the power conferred by subsection (2) includes power to transfer the thing with which the human remains are mixed or bound up.

(4) The power conferred by subsection (2) does not affect any trust or condition subject to which a body to which this section applies holds anything in relation to which the power is exercisable.

(5) The power conferred by subsection (2) is an additional power.

General

Powers of inspection, entry, search and seizure

48

Schedule 5 (which makes provision about powers of inspection, entry, search and seizure for the purposes of this Act) has effect.

Offences by bodies corporate

49

(1) Where an offence under this Act is committed by a body corporate and is proved to have been committed with the consent or connivance of or to be attributable to any neglect on the part of—

(a) any director, manager, secretary or other similar officer of the body corporate, or

(b) any person who was purporting to act in any such capacity,

he (as well as the body corporate) commits the offence and shall be liable to be proceeded against and punished accordingly.

(2) Where the affairs of a body corporate are managed by its members, subsection (1) applies in relation to the acts and defaults of a member in connection with his functions of management as if he were a director of the body corporate.

(3) Where an offence under this Act is committed by a Scottish partnership and is proved to have been committed with the consent or connivance of a partner, or to be attributable to any neglect on the part of a partner, he (as well as the partnership) commits the offence and shall be liable to be proceeded against and punished accordingly.

(4) In subsection (3), “partner” includes a person purporting to act as a partner.

Prosecutions

50

No proceedings for an offence under section 5, 32 or 33 shall be instituted—

(a) in England and Wales, except by or with the consent of the Director of Public Prosecutions;

(b) in Northern Ireland, except by or with the consent of the Director of Public Prosecutions for Northern Ireland.

Offences: Northern Ireland

51

(1) This Act has effect in relation to Northern Ireland with the modifications specified in subsections (2) and (3).

(2) In sections 32(5)(a) and 33(6)(a), for “51 weeks” there is substituted “ 6 months ”.

(3) In section 32(4)(a)(i), for “12 months” there is substituted “ 6 months ”.

Orders and regulations

52

(1) Any power to make orders or regulations under this Act includes power—

(a) to make different provision for different cases, and

(b) to make incidental, supplementary, consequential or transitional provision or savings.

(2) Any power to make orders or regulations under this Act is exercisable by statutory instrument.

(3) A statutory instrument containing an order or regulations under this Act, except sections 1(11), 3(9), 6, 6(1), 7(4), 10(9), 14(4), 16(5), 27(9), 33(3) and (7) ... and 54(10) and paragraphs 6(2), 12(2) and 13 of Schedule 4, made by the Secretary of State shall be subject to annulment in pursuance of a resolution of either House of Parliament.

(4) No order under section 1(11), 10(9), 14(4), 27(9) or 54(10) or paragraph 13 of Schedule 4, and no regulations under section 3(9), 6, 7(4), 16(5) or 33(3) or (7) or paragraph 6(2) or 12(2) of Schedule 4, shall be made unless a draft of the statutory instrument containing it, or them, has been laid before and approved by a resolution of each House of Parliament.

(4A) No order under section 27(10) may be made by the Welsh Ministers unless a draft of the instrument has been laid before, and approved by a resolution of, the National Assembly for Wales.

(4B) No regulations may be made under section 3(9A) unless a draft of the regulations has been laid before, and approved by a resolution of, the Northern Ireland Assembly.

(4C) The power of the Department of Health in Northern Ireland to make regulations under section 3(9A) is exercisable by statutory rule for the purposes of the Statutory Rules (Northern Ireland) Order 1979 and subsection (2) does not apply to that power.

(5) Subsections (1) and (2) do not apply to any power of a court.

(6) Subsections (1) to (3) do not apply to orders under section 58 or 60.

(7) The power under section 14(4) or 16(5)—

(a) so far as relating to museums in Wales, may only be exercised with the consent of the Welsh Ministers, and

(b) so far as relating to museums in Northern Ireland, may only be exercised with the consent of the Department of Culture, Arts and Leisure.

(8) The Secretary of State shall consult the Welsh Ministers and the relevant Northern Ireland department before acting under any of the following provisions—

section 1(9)(a) and (11);

section 4(10)(b);

section 6 section 6(1);

section 7(4);

section 8(4)(d);

section 10(9);

section 14(4);

section 16(3) and (5);

section 27(9);

section 33(3) and (7);

section 34(1);

section 54(10);

paragraphs 6(2), 10(b), 12(2) and 13 of Schedule 4;

paragraph 4(5) of Schedule 5.

(9) Before acting—

(a) under section 54(10) in order to amend section 54(9) so far as having effect for the purposes of Schedule 4, or

(b) under paragraph 6(2), 10(b), 12(2) or 13 of Schedule 4,

the Secretary of State shall also consult the Scottish Ministers.

(10) Before acting under any of the following provisions, the Secretary of State shall also consult such other persons as he considers appropriate—

section 1(11);

section 3(9);

section 6 section 6(1);

section 7(4);

section 10(9);

section 14(4);

section 16(5);

section 27(9);

section 33(3) and (7);

section 54(10);

paragraphs 6(2), 12(2) and 13 of Schedule 4.

(11) Before acting under section 3(9A), the Department of Health in Northern Ireland must consult such persons as it considers appropriate.

“Relevant material”

53

(1) In this Act, “relevant material” means material, other than gametes, which consists of or includes human cells.

(2) In this Act, references to relevant material from a human body do not include—

(a) embryos outside the human body, or

(b) hair and nail from the body of a living person.

General interpretation

54

(1) In this Act—

“adult” means a person who has attained the age of 18 years;

“anatomical examination” means macroscopic examination by dissection for anatomical purposes;

“anatomical purposes” means purposes of teaching or studying, or researching into, the gross structure of the human body;

“the Authority” has the meaning given by section 13(1);

“child”, except in the context of qualifying relationships, means a person who has not attained the age of 18 years;

“licence” means a licence under paragraph 1 of Schedule 3;

“licensed activity”, in relation to a licence, means the activity which the licence authorises to be carried on;

“parental responsibility”—in relation to England and Wales, has the same meaning as in the Children Act 1989 (c. 41), andin relation to Northern Ireland, has the same meaning as in the Children (Northern Ireland) Order 1995 (S.I. 1995/755 (N.I. 2));

“relevant Northern Ireland department” means the Department of Health, Social Services and Public Safety.

(2) In this Act—

(a) references to material from the body of a living person are to material from the body of a person alive at the point of separation, and

(b) references to material from the body of a deceased person are to material from the body of a person not alive at the point of separation.

(3) In this Act, references to transplantation are to transplantation to a human body and include transfusion.

(4) In this Act, references to decent disposal include, in relation to disposal of material which has come from a human body, disposal as waste.

(5) In this Act, references to public display, in relation to the body of a deceased person, do not include—

(a) display for the purpose of enabling people to pay their final respects to the deceased, or

(b) display which is incidental to the deceased’s funeral.

(6) In this Act “embryo” and “gametes” have the same meaning as they have by virtue of section 1(1), (4) and (6) of the Human Fertilisation and Embryology Act 1990 in the other provisions of that Act (apart from section 4A).

(7) For the purposes of this Act, material shall not be regarded as from a human body if it is created outside the human body.

(8) For the purposes of this Act, except section 49, a person is another’s partner if the two of them (whether of different sexes or the same sex) live as partners in an enduring family relationship.

(9) The following are qualifying relationships for the purposes of this Act, spousecivil partner,, partner, parent, child, brother, sister, grandparent, grandchild, child of a brother or sister, stepfather, stepmother, half-brother, half-sister and friend of long standing.

(10) The Secretary of State may by order amend subsection (9).

Financial provisions

55

There shall be paid out of money provided by Parliament—

(a) any expenditure incurred by the Secretary of State in consequence of this Act, and

(b) any increase attributable to this Act in the sums payable out of money so provided under any other enactment.

Consequential amendments

56

Schedule 6 (consequential amendments) has effect.

Repeals and revocations

57

The enactments and instruments specified in Schedule 7 are hereby repealed or revoked to the extent specified.

Transition

58

(1) In relation to an offence committed before 2 May 2022, the reference in section 32(4)(a)(i) to 12 months the general limit in a magistrates’ court is to be read as a reference to 6 months.

(2) In relation to an offence committed before the commencement of section 281(5) of the Criminal Justice Act 2003, the reference in each of sections 32(5)(a) and 33(6)(a) to 51 weeks is to be read as a reference to 6 months.

(3) The Secretary of State may by order made by statutory instrument make in connection with the coming into force of any provision of this Act such transitional provision or savings as he considers necessary or expedient.

(4) The power under subsection (3) includes power to make different provision for different cases.

(5) Before making provision under subsection (3) in connection with the coming into force in England and Wales of any provision of this Act, except section 47, the Secretary of State shall consult the Welsh Ministers.

(6) Before making provision under subsection (3) in connection with the coming into force in Northern Ireland of any provision of this Act, except section 47, the Secretary of State shall consult the relevant Northern Ireland department.

(7) Before making provision under subsection (3) in connection with the coming into force in Scotland of any provision of this Act, except section 47, the Secretary of State shall consult the Scottish Ministers.

Extent

59

(1) Subject to the following provisions, this Act extends to England and Wales and Northern Ireland only.

(2) Sections 58(1), (2) and (5) and 60(3) extend to England and Wales only.

(3) Sections 51(1) to (3), 58(6) and 60(4) extend to Northern Ireland only.

(4) The following provisions also extend to Scotland—

(za) section 13,

(a) sections 45(1) to (3) and (5) and 47,

(b) section 49 so far as having effect for the purposes of section 45,

(c) section 52 so far as relating to orders under section 54(10) or paragraph 13 of Schedule 4 or regulations under paragraph 6(2) or 12(2) of that Schedule,

(d) section 54(2)(a), (3), (8) and (9) so far as having effect for the purposes of Schedule 4,

(e) section 54(6) and (7) so far as having effect for the purposes of section 45 or Schedule 4,

(f) sections 54(10) and 58(3) and (4), this section and sections 60(1) and (2) and 61,

(fa) Schedule 2,and

(g) Schedule 4, except paragraphs 3 and 9(2) to (5), and section 45(4) so far as relating thereto.

(5) The following provisions extend to Scotland only—

(a) sections 58(7) and 60(5),

(b) paragraphs 3 and 9(4) and (5) of Schedule 4, and section 45(4) so far as relating thereto, and

(6) Subject to subsection (5), any amendment made by this Act has the same extent as the enactment to which it relates.

(7) Subject to subsection (8), any repeal or revocation made by this Act has the same extent as the enactment or instrument to which it relates.

(8) Except as provided by subsection (9), the repeals of the following do not extend to Scotland—

(a) the Human Tissue Act 1961 (c. 54),

(b) the Anatomy Act 1984 (c. 14),

(d) the Human Organ Transplants Act 1989 (c. 31).

(9) The repeals of the following provisions do extend to Scotland—

(a) in section 1(4A)(b) of the Human Tissue Act 1961, the words “, Primary Care Trust”;

(b) in section 1(10) of that Act—

(i) paragraph (a) of the definition of “health authority”,

(ii) in the definition of “NHS trust”, the words “the National Health Service and Community Care Act 1990 or”, and

(iii) the words after the definition of that expression;

(d) in the Human Organ Transplants Act 1989—

(i) in section 1, the words “in Great Britain”, in the first and third places where they occur,

(ii) in sections 2 and 3, the words “in Great Britain”, in each place, and

(iii) sections 5 and 6.

Commencement

60

(1) The following provisions shall come into force on the day on which this Act is passed—

this section, and

sections 58(3) to (7), 59 and 61.

(2) The remaining provisions of this Act shall come into force on such day as the Secretary of State may appoint by order made by statutory instrument, and different days may be so appointed for different purposes.

(3) Before exercising the power under subsection (2) in relation to the coming into force in England and Wales of any provision of this Act, except section 47, the Secretary of State shall consult the Welsh Ministers.

(4) Before exercising the power under subsection (2) in relation to the coming into force in Northern Ireland of any provision of this Act, except section 47, the Secretary of State shall consult the relevant Northern Ireland department.

(5) Before exercising the power under subsection (2) in relation to the coming into force in Scotland of any provision of this Act, except section 47, the Secretary of State shall consult the Scottish Ministers.

(6) No day may be appointed under subsection (2) for the coming into force of section 5 or 8 which is earlier than the end of the period of three months beginning with the day on which the Authority first issues a code of practice dealing with the matters mentioned in section 26(2)(h) and (i).

(7) If the Authority first issues a code of practice dealing with one of the matters mentioned in subsection (6) before it first issues a code of practice dealing with the other, that subsection shall have effect as if the three month period were one beginning with the later of—

(a) the day on which the Authority first issues a code of practice dealing with the matter mentioned in section 26(2)(h), and

(b) the day on which the Authority first issues a code of practice dealing with the matter mentioned in section 26(2)(i).

Short title

61

This Act may be cited as the Human Tissue Act 2004.

SCHEDULE 1

1

Anatomical examination.

2

Determining the cause of death.

3

Establishing after a person’s death the efficacy of any drug or other treatment administered to him.

4

Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).

5

Public display.

6

Research in connection with disorders, or the functioning, of the human body.

7

Transplantation.

8

Clinical audit.

9

Education or training relating to human health.

10

Performance assessment.

11

Public health monitoring.

12

Quality assurance.

SCHEDULE 2

Membership

1

(1) The Authority shall consist of—

(a) a chairman appointed by the Secretary of State,

(b) such number of other members appointed by the Secretary of State as the Secretary of State thinks fit,

(d) a member appointed by the relevant Northern Ireland department.

(2) The Secretary of State shall exercise his power to appoint members of the Authority to secure that at all times not less than half of the members are persons who do not have, and have not had, a professional interest in any of the kinds of activity within the remit of the Authority.

(3) The Scottish Ministers may nominate a person who is a member of the Authority to make representations about the carrying out of its functions in Scotland.

Disqualification

2

A person is disqualified for being appointed as chairman of the Authority if he has, or has had, a professional interest in any of the kinds of activity within the remit of the Authority.

3

(1) A person is disqualified for being appointed as chairman or other member of the Authority if—

(a) he is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order, or a debt relief restrictions order or interim debt relief restrictions order under Schedule 4ZB of the Insolvency Act 1986,

(b) a bankruptcy order has been made against him by a court in Northern Ireland, his estate has been sequestrated by a court in Scotland or, under the law of Northern Ireland or Scotland, he has made a composition or arrangement with, or granted a trust deed for, his creditors, or

(c) in the last five years he has been convicted in the United Kingdom, the Channel Islands or the Isle of Man of an offence and has had a qualifying sentence passed on him.

(2) Where a person is disqualified under sub-paragraph (1)(b) because a bankruptcy order has been made against him or his estate has been sequestrated, the disqualification shall cease—

(a) on his obtaining a discharge, or

(b) if the bankruptcy order is annulled or the sequestration of his estate is recalled or reduced, on the date of that event.

(3) Where a person is disqualified under sub-paragraph (1)(b) because of his having made a composition or arrangement with, or granted a trust deed for, his creditors, the disqualification shall cease—

(a) at the end of the period of five years beginning with the date on which the terms of the deed of composition or arrangement or trust deed are fulfilled, or

(b) if, before then, he pays his debts in full, on the date on which the payment is completed.

(4) For the purposes of sub-paragraph (1)(c), the date of conviction shall be taken to be the ordinary date on which the period allowed for making an appeal or application expires or, if an appeal or application is made, the date on which the appeal or application is finally disposed of or abandoned or fails by reason of its non-prosecution.

(5) In sub-paragraph (1)(c), the reference to a qualifying sentence is to a sentence of imprisonment for a period of not less than three months (whether suspended or not) without the option of a fine.

Tenure of office

4

Subject to the following provisions of this Schedule, the chairman and other members of the Authority shall hold and vacate office in accordance with the terms of their respective appointments.

5

(1) The terms of appointment of the chairman and other members of the Authority shall be such as the Secretary of State may determine, subject to sub-paragraph (2).

(2) Appointment as chairman or other member shall be for a term not exceeding three years.

6

Previous service as chairman or other member of the Authority does not affect a person’s eligibility for appointment to either office.

7

A person holding office as chairman or other member of the Authority may resign that office by giving notice in writing to the person who appointed him.

8

A person holding office as chairman or other member of the Authority shall cease to hold that office if he ceases to be qualified for appointment to it.

9

A person may be removed from office as chairman or other member of the Authority by the person who appointed him if that person is satisfied that he—

(a) has been absent from meetings of the Authority for six consecutive months, or longer, without the permission of the Authority, or

(b) is unable or unfit to carry out his functions as chairman or other member.

Remuneration and pensions of members

10

(1) The Authority may pay to the chairman or any of the other members of the Authority such remuneration as the Secretary of State may determine.

(2) The Authority may pay, or make provision for paying, to or in respect of the chairman or any of the other members of the Authority such pensions, allowances, fees, expenses or gratuities as the Secretary of State may determine.

(3) The Authority may make a payment to a person who ceases to hold office as chairman or other member of the Authority otherwise than on the expiry of his term of office if it appears to the Secretary of State that there are special circumstances which make it right for that person to receive compensation.

(4) A payment under sub-paragraph (3) shall be of such amount as the Secretary of State may determine.

Staff

11

The Authority may appoint such staff as it considers appropriate, on such terms and conditions as it may determine.

Proceedings

12

Subject to any provision of this Act, the Authority may regulate its own procedure (including quorum).

13

The validity of any proceedings of the Authority shall not be affected by—

(a) any vacancy in the office of—

(i) chairman,

(ii) member appointed by the Welsh Ministers, or

(iii) member appointed by the relevant Northern Ireland department,

(b) any defect in a person’s appointment as chairman or other member, or

Members' interests

14

(1) The Authority shall establish and maintain a system for the declaration and registration of private interests of its members.

(2) The Authority shall publish entries recorded in the register of members' interests.

Finance

15

The Secretary of State may out of money provided by Parliament make payments to the Authority of such amounts, at such times and on such conditions (if any) as he considers appropriate.

Accounts and audit

16

(1) The Authority shall keep proper accounts and proper records in relation to its accounts.

(2) The Authority shall prepare a statement of accounts in respect of each of its financial years.

(3) Any such statement of accounts must comply with any directions given by the Secretary of State with the approval of the Treasury as to—

(a) the information to be contained in it,

(b) the manner in which that information is to be presented, and

(4) The Authority shall send a copy of each statement of accounts required by sub-paragraph (2) to—

(a) the Secretary of State,

(b) the Welsh Ministers,

(d) the Comptroller and Auditor General,

before the end of such period after the end of the financial year to which the statement relates as the Secretary of State may specify by notice given to the Authority.

(5) The relevant Northern Ireland department shall lay before the Northern Ireland Assembly each statement of accounts received by it under sub-paragraph (4).

(5A) The Welsh Ministers shall lay before the National Assembly for Wales each statement of accounts received by them under sub-paragraph (4).

(6) The Comptroller and Auditor General shall—

(a) examine, certify and report on each statement of accounts received by him under sub-paragraph (4), and

(b) lay a copy of each such statement of accounts, and of his report on it, before each House of Parliament.

(7) The power under sub-paragraph (3) to give directions includes power to vary or revoke directions given in previous exercise of the power.

(8) In this paragraph, “financial year” means—

(a) the period beginning with the date on which the Authority is established and ending with the next 31st March, and

(b) each successive period of 12 months ending with 31st March.

Instruments

17

The application of the seal of the Authority shall be authenticated by the signature of any member of the Authority or of any other person who has been authorised for the purpose by the Authority, whether generally or specially.

18

A document purporting—

(a) to be duly executed under the seal of the Authority, or

(b) to be signed on its behalf,

shall be received in evidence and be taken, without further proof, to be so executed or signed unless the contrary is shown.

Status

19

(1) The Authority is not to be regarded as the servant or agent of the Crown, or as enjoying any status, privilege or immunity of the Crown.

(2) The property of the Authority is not to be regarded as property of, or property held on behalf of, the Crown.

Supplementary powers

20

The Authority may do anything which is calculated to facilitate, or is conducive or incidental to, the carrying-out of its functions, but may not borrow money.

21

The Authority may delegate any of its functions (to such extent as it may determine)—

(a) to any member of the Authority,

(b) to any member of the staff of the Authority, or

(i) a member of the Authority, or

(ii) a member of the staff of the Authority.

Application of Statutory Instruments Act 1946

22

The Statutory Instruments Act 1946 (c. 36) shall apply to any power to make orders or regulations conferred by an Act on the Authority as if the Authority were a Minister of the Crown.

Public records

23

In Schedule 1 to the Public Records Act 1958 (c. 51) (definition of public records), in Part 2 of the Table at the end of paragraph 3 the following entry is inserted at the appropriate place— “ Human Tissue Authority. ”

Investigation by Parliamentary Commissioner

24

In Schedule 2 to the Parliamentary Commissioner Act 1967 (c. 13) (departments and authorities subject to investigation), the following entry is inserted at the appropriate place— “ Human Tissue Authority. ”

House of Commons Disqualification

25

In Part 2 of Schedule 1 to the House of Commons Disqualification Act 1975 (c. 24) (bodies of which all members are disqualified), the following entry is inserted at the appropriate place— “ The Human Tissue Authority. ”

Northern Ireland Assembly Disqualification

26

In Part 2 of Schedule 1 to the Northern Ireland Assembly Disqualification Act 1975 (c. 25) (bodies of which all members are disqualified), the following entry is inserted at the appropriate place— “ The Human Tissue Authority. ”

Freedom of information

27

In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (c. 36) (public authorities), the following entry is inserted at the appropriate place— “ The Human Tissue Authority. ”

SCHEDULE 3

Power to grant licence

1

The Authority may on application grant a licence for the purposes of section 16.

Characteristics of licence

2

(1) A licence shall not authorise the carrying-on of more than one activity to which section 16 applies.

(2) A licence shall—

(a) specify the premises where the licensed activity is authorised to be carried on, and

(b) designate an individual as the person under whose supervision the licensed activity is authorised to be carried on.

(3) A licence shall not authorise the licensed activity to be carried on—

(a) on premises at different places, or

(b) under the supervision of more than one individual.

(4) It shall be a condition of a licence—

(a) that the licensed activity shall be carried on only on the premises specified in the licence;

(b) that the licensed activity shall be carried on only under the supervision of the individual designated in the licence as the person under whose supervision it is authorised to be carried on;

(c) that such information about such matters relating to the carrying-on of the licensed activity as may be specified in directions shall be recorded in such form as may be so specified;

(d) that any record made for the purposes of the condition in paragraph (c) shall be kept until the end of such period as may be specified in directions;

(e) that there shall be provided to such person and at such intervals as may be specified in directions—

(i) such copies of, or extracts from, any record to which the condition in paragraph (d) relates, and

(ii) such other information,

as may be so specified;

(f) that there shall be paid to the Authority at such times as may be specified in directions sums of such amount as may be so specified in respect of its costs in connection with superintending compliance with the terms of licences.

(5) Directions for the purposes of sub-paragraph (4) may be given in relation to licences generally, licences of a particular description or a particular licence.

3

(1) This paragraph applies to a licence authorising the storage of anatomical specimens.

(2) It shall be a condition of a licence to which this paragraph applies that storage at the premises specified in the licence of the body of a deceased person for use for the purpose of anatomical examination shall not begin before that body’s storage there for use for that purpose has been authorised in writing by—

(a) the designated individual, or

(b) an individual who has the Authority’s permission to give such authorisation (see paragraph 12).

(3) It shall be a condition of a licence to which this paragraph applies that any anatomical specimen which is stored at the premises specified in the licence shall be released from storage at the premises only into the possession of a person who is authorised in writing by the designated individual to have the specimen in his possession.

(4) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give authority for the purposes of the condition in sub-paragraph (3) only if he is satisfied—

(a) that the person to whom authority is given is a suitable person to have the specimen in his possession, and

(b) that that person intends to use the specimen only for the purpose of education, training or research.

(5) It shall be a condition of a licence to which this paragraph applies that any authority given for the purposes of the condition in sub-paragraph (3) shall specify—

(a) the person to whom the authority is given,

(b) the specimen to which the authority relates,

(d) the duration of the authority.

(6) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give such notice of any authorisation for the purposes of the condition in sub-paragraph (3) as may be specified in directions.

(7) It shall be a condition of a licence to which this paragraph applies that such information about authorisations for the purposes of the condition in sub-paragraph (3) as may be specified in directions shall be recorded in such form as may be so specified.

4

(1) This paragraph applies to a licence authorising the activity mentioned in section 16(2)(e).

(2) It shall be a condition of a licence to which this paragraph applies that any former anatomical specimen which is stored at the premises specified in the licence shall be released from storage at the premises only into the possession of a person who is authorised in writing by the designated individual to have the specimen in his possession.

(3) The condition in sub-paragraph (2) does not apply to the release from storage of a specimen for the purpose of its decent disposal.

(4) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give authority for the purposes of the condition in sub-paragraph (2) only if he is satisfied—

(a) that the person to whom authority is given is a suitable person to have the specimen in his possession, and

(b) that that person intends to use the specimen only for the purpose of education, training or research.

(5) It shall be a condition of a licence to which this paragraph applies that any authority given for the purposes of the condition in sub-paragraph (2) shall specify—

(a) the person to whom the authority is given,

(b) the specimen to which the authority relates,

(d) the duration of the authority.

(6) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give such notice of any authorisation for the purposes of the condition in sub-paragraph (2) as may be specified in directions.

(7) It shall be a condition of a licence to which this paragraph applies that such information about authorisations for the purposes of the condition in sub-paragraph (2) as may be specified in directions shall be recorded in such form as may be so specified.

Power to impose conditions

5

The Authority may grant a licence subject to such further conditions as it thinks fit.

Pre-conditions to grant of licence

6

(1) The Authority may not grant a licence in pursuance of an application unless the following requirements are met.

(2) The proposed designated individual must—

(a) be the applicant for the licence, or

(b) consent to the application for the licence.

(3) The Authority must be satisfied that the proposed designated individual—

(a) is a suitable person to supervise the activity to be authorised by the licence, and

(b) will perform the duty under section 18.

(4) Where the applicant for the licence is not the proposed designated individual, the Authority must be satisfied that the applicant is a suitable person to be the holder of the licence.

(5) The Authority must be satisfied that the premises in respect of which the licence is to be granted are suitable for the activity to be authorised by the licence.

(6) A copy of the conditions to be imposed by the licence must have been shown to, and acknowledged in writing by—

(a) the applicant for the licence, and

(b) where different, the proposed designated individual.

(7) In this paragraph, references to the proposed designated individual are to the individual whom the application proposes the licence designate as the person under whose supervision the activity to be authorised by the licence is to be carried on.

Power to revoke licence

7

(1) The Authority may revoke a licence on application by—

(a) the holder of the licence, or

(b) the designated individual.

(2) The Authority may revoke a licence otherwise than on an application under sub-paragraph (1) if—

(a) it is satisfied that any information given for the purposes of the application for the licence was in any material respect false or misleading,

(b) it is satisfied that the designated individual has failed to discharge, or is unable because of incapacity to discharge, the duty under section 18,

(d) it ceases to be satisfied that the person to whom the licence is granted is a suitable person to be the holder of the licence,

(e) it ceases to be satisfied that the designated individual is a suitable person to supervise the licensed activity,

(f) the designated individual dies, ...

(g) it is satisfied that there has been any other material change of circumstances since the licence was granted or

(h) it is not satisfied that any third country premises are suitable for carrying out activities in a manner which secures that tissues or cells imported from a third country by an importing licence holder meet standards of quality and safety equivalent to those laid down in the 2007 Regulations.

(3) For the purposes of sub-paragraph (2)(h), “importing licence holder”, “third country” and “third country premises” have the same meaning as in the 2007 Regulations.

Power to vary licence

8

(1) The Authority may on application by the holder of a licence vary the licence so as to substitute another individual for the designated individual if—

(a) the application is made with the consent of the other individual, and

(b) the authority is satisfied that the other individual is a suitable person to supervise the licensed activity.

(2) The Authority may vary a licence on application by—

(a) the holder of the licence, or

(b) the designated individual.

(3) The Authority may vary a licence without an application under sub-paragraph (2) if it has power to revoke the licence under paragraph 7(2).

(4) The powers under sub-paragraphs (2) and (3) do not extend to making the kind of variation mentioned in sub-paragraph (1).

(5) The Authority may vary a licence without an application under sub-paragraph (2) by—

(a) removing or varying a condition of the licence, or

(b) adding a condition to the licence.

(6) The powers conferred by this paragraph do not extend to the conditions required by paragraphs 2(4), 3 and 4.

Power to suspend licence

9

(1) Where the Authority—

(a) has reasonable grounds to suspect that there are grounds for revoking a licence, and

(b) is of the opinion that the licence should immediately be suspended,

it may by notice suspend the licence for such period not exceeding three months as may be specified in the notice.

(2) The Authority may continue suspension under sub-paragraph (1) by giving a further notice under that sub-paragraph.

(3) Notice under sub-paragraph (1) shall be given to the designated individual or, where the designated individual has died or appears to the Authority to be unable because of incapacity to discharge the duty under section 18—

(a) to the holder of the licence, or

(b) to some other person to whom the licence applies.

(4) Subject to sub-paragraph (5), a licence shall be of no effect while a notice under sub-paragraph (1) is in force.

(5) An application may be made under paragraph 7(1) or 8(1) or (2) notwithstanding the fact that a notice under sub-paragraph (1) is in force.

Procedure in relation to licensing decisions

10

(1) Before making a decision—

(a) to refuse an application for the grant, revocation or variation of a licence, or

(b) to grant an application for a licence subject to a condition under paragraph 5,

the Authority shall give the applicant notice of the proposed decision and of the reasons for it.

(2) Before making a decision under paragraph 7(2) or 8(3) or (5), the Authority shall give notice of the proposed decision and of the reasons for it to—

(a) the holder of the licence, and

(b) where different, the designated individual.

(3) A person to whom notice under sub-paragraph (1) or (2) is given has the right to require the Authority to give him an opportunity to make representations of one of the following kinds about the proposed decision, namely—

(a) oral representations by him, or a person acting on his behalf;

(b) written representations by him.

(4) The right under sub-paragraph (3) is exercisable by giving the Authority notice of exercise of the right before the end of the period of 28 days beginning with the day on which the notice under sub-paragraph (1) or (2) was given.

(5) The Authority may by regulations make such additional provision about procedure in relation to the carrying-out of functions under this Schedule as it thinks fit.

Notification of licensing decisions

11

(1) In the case of a decision to grant a licence, the Authority shall give notice of the decision to—

(a) the applicant, and

(b) the person who is to be the designated individual.

(2) In the case of a decision to revoke a licence, the Authority shall give notice of the decision to—

(a) the holder of the licence, and

(b) the designated individual.

(3) In the case of a decision to vary a licence on an application under paragraph 8(1), the Authority shall give notice of the decision to—

(a) the holder of the licence, and

(b) the person who is to be the designated individual.

(4) In the case of any other decision to vary a licence, the Authority shall give notice of the decision to—

(a) the holder of the licence, and

(b) the designated individual.

(5) In the case of a decision to refuse an application for the grant, revocation or variation of a licence, the Authority shall give notice of the decision to the applicant.

(6) Subject to sub-paragraph (7), a notice under sub-paragraph (2), (4) or (5) shall include a statement of the reasons for the decision.

(7) In the case of a notice under sub-paragraph (2) or (4), the notice is not required to include a statement of the reasons for the decision if the decision is made on an application under paragraph 7(1) or 8(2).

Permission for the purposes of the licence condition required by paragraph 3(2)

12

(1) This paragraph applies to a licence authorising the storage of anatomical specimens.

(2) The reference to the Authority’s permission in the condition of the licence required by paragraph 3(2) (“the authorisation condition”) is to—

(a) permission granted by the Authority on an application made, in conjunction with the application for the licence, by—

(i) the applicant for the licence, or

(ii) the person who, within the meaning of paragraph 6, is the proposed designated individual, or

(b) permission granted by the Authority on application by—

(i) the holder of the licence, or

(ii) the designated individual.

(3) The Authority may grant permission to an individual for the purposes of the authorisation condition only if it is satisfied that the individual is a suitable person to give authorisation under that condition.

(4) The Authority may revoke permission granted to an individual for the purposes of the authorisation condition—

(a) on application by the individual, the designated individual or the holder of the licence, or

(b) if it ceases to be satisfied that the individual is a suitable person to give authorisation under that condition.

(5) Before refusing an application for the grant or revocation of permission, the Authority shall give the applicant notice of the proposed refusal and of the reasons for it.

(6) Before revoking permission under sub-paragraph (4)(b), the Authority shall give notice of the proposed revocation and of the reasons for it—

(a) to the individual concerned, and

(b) to the designated individual and, where different, the holder of the licence.

(7) Paragraph 10(3) and (4) shall apply in relation to notice under sub-paragraph (5) or (6) as to notice under paragraph 10(1).

(8) In the case of a decision to refuse an application for the grant or revocation of permission, the Authority shall give notice of the decision to the applicant.

(9) In the case of a decision to grant or revoke permission, the Authority shall give notice of the decision—

(a) to the individual concerned, and

(b) to the designated individual and, where different, the holder of the licence.

(10) Notice under sub-paragraph (8), and notice under sub-paragraph (9) of revocation under sub-paragraph (4)(b), shall include a statement of the reasons for the refusal or revocation.

(11) Where the Authority—

(a) has reasonable grounds to suspect that there are grounds for revoking permission granted to an individual for the purposes of the authorisation condition, and

(b) is of the opinion that the permission should immediately be suspended,

it may by notice suspend the permission for such period not exceeding three months as may be specified in the notice.

(12) The Authority may continue suspension under sub-paragraph (11) by giving a further notice under that sub-paragraph.

(13) Notice under sub-paragraph (11) shall be given to—

(a) the individual concerned, and

(b) the designated individual and, where different, the holder of the licence.

Applications under this Schedule

13

(1) The Authority may by regulations make provision about applications under this Schedule, Schedule 1 to the 2007 Regulations and Schedule 1 to the 2012 Regulations and may, in particular, make provision about—

(a) the form and content of such an application,

(b) the information to be supplied with such an application, and

(2) An application under this Schedule shall be accompanied by such fee (if any) as the Authority may determine.

SCHEDULE 4

Introductory

1

This Part of this Schedule makes provision for the interpretation of “qualifying consent” in section 45(1)(a)(i).

2

(1) In relation to analysis of DNA manufactured by the body of a person who is alive, “qualifying consent” means his consent, except where sub-paragraph (2) applies.

(2) Where—

(a) the person is a child,

(b) neither a decision of his to consent, nor a decision of his not to consent, is in force, and

(c) either he is not competent to deal with the issue of consent or, though he is competent to deal with that issue, he fails to do so,

“qualifying consent” means the consent of a person who has parental responsibility for him.

(3) In relation to analysis of DNA manufactured by the body of a person who has died an adult, “qualifying consent” means—

(a) if a decision of his to consent, or a decision of his not to consent, was in force immediately before he died, his consent;

(b) if paragraph (a) does not apply, the consent of a person who stood in a qualifying relationship to him immediately before he died.

(4) In relation to analysis of DNA manufactured by the body of a person who has died a child, “qualifying consent” means—

(a) if a decision of his to consent, or a decision of his not to consent, was in force immediately before he died, his consent;

(b) if paragraph (a) does not apply—

(i) the consent of a person who had parental responsibility for him immediately before he died, or

(ii) where no person had parental responsibility for him immediately before he died, the consent of a person who stood in a qualifying relationship to him at that time.

Application to Scotland

3

(1) In its application to Scotland, paragraph 2 has effect with the following amendments.

(2) In sub-paragraphs (2) and (4)(b)(i) and (ii), for parental responsibility for there is substituted “ parental responsibilities in relation to ”.

(3) At the end there is inserted—

(5) In this paragraph— adult means a person who has attained the age of 16 years; child means a person who has not attained the age of 16 years; parental responsibilities has the meaning given by section 1(3) of the Children (Scotland) Act 1995 (c. 36).

Part 2 — Use for an excepted purpose

Introductory

4

This Part of this Schedule makes provision for the interpretation of “use for an excepted purpose” in section 45(1)(a)(ii).

Purposes of general application

5

(1) Use of the results of an analysis of DNA for any of the following purposes is use for an excepted purpose—

(a) the medical diagnosis or treatment of the person whose body manufactured the DNA;

(b) purposes of functions of a coroner;

(d) the prevention or detection of crime;

(e) the conduct of a prosecution;

(f) purposes of national security;

(g) implementing an order or direction of a court or tribunal, including one outside the United Kingdom.

(2) For the purposes of sub-paragraph (1)(d), detecting crime shall be taken to include—

(a) establishing by whom, for what purpose, by what means and generally in what circumstances any crime was committed, and

(b) the apprehension of the person by whom any crime was committed;

and the reference in sub-paragraph (1)(d) to the detection of crime includes any detection outside the United Kingdom of any crime or suspected crime.

(3) In sub-paragraph (1)(e), the reference to a prosecution includes a prosecution brought in respect of a crime in a country or territory outside the United Kingdom.

(4) In this paragraph, a reference to a crime includes a reference to any conduct which—

(a) constitutes one or more criminal offences (whether under the law of a part of the United Kingdom or a country or territory outside the United Kingdom),

(b) is, or corresponds to, conduct which, if it all took place in any one part of the United Kingdom, would constitute one or more criminal offences, or

(5) Sub-paragraph (1)(g) shall not be taken to confer any power to make orders or give directions.

Purpose of research in connection with disorders, or functioning, of the human body

6

(1) Use of the results of an analysis of DNA for the purpose of research in connection with disorders, or the functioning, of the human body is use for an excepted purpose if the bodily material concerned is the subject of an order under sub-paragraph (2).

(2) The Secretary of State may by regulations specify circumstances in which the High Court or the Court of Session may order that this paragraph apply to bodily material.

Purposes relating to existing holdings

7

Use of the results of an analysis of DNA for any of the following purposes is use for an excepted purpose if the bodily material concerned is an existing holding—

(a) clinical audit;

(b) determining the cause of death;

(d) establishing after a person’s death the efficacy of any drug or other treatment administered to him;

(e) obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person);

(f) performance assessment;

(g) public health monitoring;

(h) quality assurance;

(i) research in connection with disorders, or the functioning, of the human body;

(j) transplantation.

Purposes relating to material from body of a living person

8

Use of the results of an analysis of DNA for any of the following purposes is use for an excepted purpose if the bodily material concerned is from the body of a living person—

(a) clinical audit;

(b) education or training relating to human health;

(d) public health monitoring;

(e) quality assurance.

9

(1) Use of the results of an analysis of DNA for the purpose of obtaining scientific or medical information about the person whose body manufactured the DNA is use for an excepted purpose if—

(a) the bodily material concerned is the subject of a direction under sub-paragraph (2) or (3) or an order under sub-paragraph (4) or (5), and

(b) the information may be relevant to the person for whose benefit the direction is given or order is made.

(2) If the Authority is satisfied—

(a) that bodily material has come from the body of a living person,

(b) that it is not reasonably possible to trace the person from whose body the material has come (“the donor”),

(c) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the donor, and

(d) that there is no reason to believe—

(i) that the donor has died,

(ii) that a decision of the donor to refuse consent to the use of the material for that purpose is in force, or

(iii) that the donor lacks capacity to consent to the use of the material for that purpose,

it may direct that this paragraph apply to the material for the benefit of the other person.

(3) If the Authority is satisfied—

(a) that bodily material has come from the body of a living person,

(b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come (“the donor”),

(c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,

(d) that there is no reason to believe—

(i) that the donor has died,

(ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or

(iii) that the donor lacks capacity to consent to the use of the material for that purpose, and

(e) that the donor has been given notice of the application for the exercise of the power conferred by this sub-paragraph,

it may direct that this paragraph apply to the material for the benefit of the other person.

(4) If the Court of Session is satisfied—

(a) that bodily material has come from the body of a living person,

(b) that it is not reasonably possible to trace the person from whose body the material has come (“the donor”),

(c) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the donor, and

(d) that there is no reason to believe—

(i) that the donor has died,

(ii) that a decision of the donor to refuse consent to the use of the material for that purpose is in force, or

(iii) that the donor is an incapable adult within the meaning of the Adults with Incapacity (Scotland) Act 2000 (asp 4),

it may order that this paragraph apply to the material for the benefit of the other person.

(5) If the Court of Session is satisfied—

(a) that bodily material has come from the body of a living person,

(b) that it is desirable in the interests of another person (including a future person) that DNA in the material be analysed for the purpose of obtaining scientific or medical information about the person from whose body the material has come (“the donor”),

(c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,

(d) that there is no reason to believe—

(i) that the donor has died,

(ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or

(iii) that the donor is an incapable adult within the meaning of the Adults with Incapacity (Scotland) Act 2000, and

(e) that the donor has been given notice of the application for the exercise of the power conferred by this sub-paragraph,

it may order that this paragraph apply to the material for the benefit of the other person.

10

Use of the results of an analysis of DNA for the purpose of research in connection with disorders, or the functioning, of the human body is use for an excepted purpose if—

(a) the bodily material concerned is from the body of a living person,

(b) the research is ethically approved in accordance with regulations made by the Secretary of State, and

(c) the analysis is to be carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified.

Purpose authorised under section 1

11

Use of the results of an analysis of DNA for a purpose specified in paragraph 7 is use for an excepted purpose if the use in England and Wales, or Northern Ireland, for that purpose of the bodily material concerned is authorised by section 1(1) or (10)(c).

12

(1) Use of the results of an analysis of DNA for a purpose specified under sub-paragraph (2) is use for an excepted purpose if—

(a) the DNA has been manufactured by the body of a person who—

(i) has attained the age of 18 years and, under the law of England and Wales or Northern Ireland, lacks capacity to consent to analysis of the DNA, or

(ii) under the law of Scotland, is an adult with incapacity within the meaning of the Adults with Incapacity (Scotland) Act 2000 (asp 4), and

(b) neither a decision of his to consent to analysis of the DNA for that purpose, nor a decision of his not to consent to analysis of it for that purpose, is in force.

(2) The Secretary of State may by regulations specify for the purposes of this paragraph purposes for which DNA may be analysed.

Power to amend paragraphs 5, 7 and 8

13

The Secretary of State may by order amend paragraph 5, 7 or 8 for the purpose of—

(a) varying or omitting any of the purposes specified in that paragraph, or

(b) adding to the purposes so specified.

SCHEDULE 5

Inspection of statutory records

1

(1) A duly authorised person may require a person to produce for inspection any records which he is required to keep by, or by virtue of, this Act.

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.

Human Tissue Act 2004

Directions

37

Duties in relation to carrying out functions

38

Exceptions

Criminal justice purposes

39

Religious relics

40

Supplementary

Interpretation of Part 2

41

Part 3 — Miscellaneous and general

Miscellaneous

Power of Human Tissue Authority to assist other public authorities

42

Preservation for transplantation

43

Surplus tissue

44

Non-consensual analysis of DNA

45

Power to give effect to Community obligations

46

Power to de-accession human remains

47

General

Powers of inspection, entry, search and seizure

48

Offences by bodies corporate

49

Prosecutions

50

Offences: Northern Ireland

51

Orders and regulations

52

“Relevant material”

53

General interpretation

54

Financial provisions

55

Consequential amendments

56

Repeals and revocations

57

Transition

58

Extent

59

Commencement

60

Short title

61

SCHEDULE 1

Part 1 — Purposes requiring consent: general

1

2

3

4

5

6

7

Part 2 — Purposes requiring consent: deceased persons

8

9

10

11

12

SCHEDULE 2

Membership

1

Disqualification

2

3

Tenure of office

4

5