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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

(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.

(2) Where records which a person is so required to keep are stored in any electronic form, the power under sub-paragraph (1) includes power to require the records to be made available for inspection—

(a) in a visible and legible form, or

(b) in a form from which they can readily be produced in a visible and legible form.

(3) A duly authorised person may inspect and take copies of any records produced for inspection in pursuance of a requirement under this paragraph.

Entry and inspection of licensed premises

2

(1) A duly authorised person may at any reasonable time enter and inspect any premises in respect of which a licence is in force.

(2) The power in sub-paragraph (1) is exercisable for purposes of the Authority’s functions in relation to licences.

Entry and search in connection with suspected offence

3

(1) If a justice of the peace is satisfied on sworn information or, in Northern Ireland, on a complaint on oath that there are reasonable grounds for believing—

(a) that an offence under Part 1 or 2 or under the Human Transplantation (Wales) Act 2013 is being, or has been, committed on any premises, and

(b) that any of the conditions in sub-paragraph (2) is met in relation to the premises,

he may by signed warrant authorise a duly authorised person to enter the premises, if need be by force, and search them.

(2) The conditions referred to are—

(a) that entry to the premises has been, or is likely to be, refused and notice of the intention to apply for a warrant under this paragraph has been given to the occupier;

(b) that the premises are unoccupied;

(d) that an application for admission to the premises or the giving of notice of the intention to apply for a warrant under this paragraph would defeat the object of entry.

(3) A warrant under this paragraph shall continue in force until the end of the period of 31 days beginning with the day on which it is issued.

Execution of warrants

4

(1) Entry and search under a warrant under paragraph 3 is unlawful if any of sub-paragraphs (2) to (4) and (6) is not complied with.

(2) Entry and search shall be at a reasonable time unless the person executing the warrant thinks that the purpose of the search may be frustrated on an entry at a reasonable time.

(3) If the occupier of the premises to which the warrant relates is present when the person executing the warrant seeks to enter them, the person executing the warrant shall—

(a) produce the warrant to the occupier, and

(b) give him—

(i) a copy of the warrant, and

(ii) an appropriate statement.

(4) If the occupier of the premises to which the warrant relates is not present when the person executing the warrant seeks to enter them, but some other person is present who appears to the person executing the warrant to be in charge of the premises, the person executing the warrant shall—

(a) produce the warrant to that other person,

(b) give him—

(i) a copy of the warrant, and

(ii) an appropriate statement, and

(5) In sub-paragraphs (3)(b)(ii) and (4)(b)(ii), the references to an appropriate statement are to a statement in writing containing such information relating to the powers of the person executing the warrant and the rights and obligations of the person to whom the statement is given as may be prescribed by regulations made by the Secretary of State.

(6) If the premises to which the warrant relates are unoccupied, the person executing the warrant shall leave a copy of it in a prominent place on the premises.

(7) Where the premises in relation to which a warrant under paragraph 3 is executed are unoccupied or the occupier is temporarily absent, the person executing the warrant shall, when leaving the premises, leave them as effectively secured as he found them.

Seizure in the course of inspection or search

5

(1) A duly authorised person entering and inspecting premises under paragraph 2 may seize anything on the premises which he has reasonable grounds to believe may be required for purposes of the Authority’s functions relating to the grant, revocation, variation or suspension of licences.

(2) A duly authorised person entering and searching premises under a warrant under paragraph 3 may seize anything on the premises which he has reasonable grounds to believe may be required for the purpose of being used in evidence in any proceedings for an offence under Part 1 or 2 or under the Human Transplantation (Wales) Act 2013.

(3) Where a person has power under sub-paragraph (1) or (2) to seize anything, he may take such steps as appear to be necessary for preserving the thing or preventing interference with it.

(4) The power under sub-paragraph (1) or (2) includes power to retain anything seized in exercise of the power for so long as it may be required for the purpose for which it was seized.

(5) Where by virtue of sub-paragraph (1) or (2) a person seizes anything, he shall leave on the premises from which the thing was seized a statement giving particulars of what he has seized and stating that he has seized it.

Powers: supplementary

6

(1) Power under this Schedule to enter and inspect or search any premises includes power to take such other persons and equipment as the person exercising the power reasonably considers necessary.

(2) Power under this Schedule to inspect or search any premises includes, in particular—

(a) power to inspect any equipment found on the premises,

(b) power to inspect and take copies of any records found on the premises, and

(c) in the case of premises in respect of which a licence is in force, power to observe the carrying-on on the premises of the licensed activity.

(3) Any power under this Schedule to enter, inspect or search premises includes power to require any person to afford such facilities and assistance with respect to matters under that person’s control as are necessary to enable the power of entry, inspection or search to be exercised.

7

(1) A person’s right to exercise a power under this Schedule is subject to his producing evidence of his entitlement to exercise it, if required.

(2) As soon as reasonably practicable after having exercised a power under this Schedule to inspect or search premises, the duly authorised person shall—

(a) prepare a written report of the inspection or search, and

(b) if requested to do so by the appropriate person, give him a copy of the report.

(3) In sub-paragraph (2), the “appropriate person” means—

(a) in relation to premises in respect of which a licence is in force, the designated individual (as defined in section 41);

(b) in relation to any other premises, the occupier.

Enforcement

8

(1) A person commits an offence if—

(a) he fails without reasonable excuse to comply with a requirement under paragraph 1(1) or 6(3), or

(b) he intentionally obstructs the exercise of any right under this Schedule.

(2) A person guilty of an offence under this paragraph is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Interpretation

9

In this Schedule, “duly authorised person”, in the context of any provision, means a person authorised by the Authority to act for the purposes of that provision.

SCHEDULE 6

Wills Act 1837 (c. 26)

1

In section 1 of the Wills Act 1837, in the definition of “will”, after “child,” there is inserted “ and also to an appointment by will of a representative under section 4 of the Human Tissue Act 2004, ”.

Anatomy Act 1984 (c. 14)

2

In section 4 of the Anatomy Act 1984 (lawful examinations), in subsection (4) (which is expressed to be subject to subsections (5) to (8)), for “(5)” there is substituted “ (6) ”.

Coroners Act 1988 (c. 13)

3

(1) The Coroners Act 1988 is amended as follows.

(2) In section 19 (post-mortem examination without inquest), after subsection (1) (which confers power to direct a person to make a post-mortem examination) there is inserted—

(1A) No direction under subsection (1) above shall have effect to require a person to make a post-mortem examination if the making of the examination by him would contravene section 16(1) of the Human Tissue Act 2004 (under which a person may make a post-mortem examination only under the authority of a licence under that Act).

(3) In section 21 (which confers powers to direct a person to make a post-mortem examination in connection with an inquest), after subsection (4) there is inserted—

(4A) No direction under this section shall have effect to require a person to make a post-mortem examination if the making of the examination by him would contravene section 16(1) of the Human Tissue Act 2004 (under which a person may make a post-mortem examination only under the authority of a licence under that Act).

Human Organ Transplants Act 1989 (c. 31)

4

In section 1(1)(a) of the Human Organ Transplants Act 1989, for “Great Britain” there is substituted “ Scotland ”.

Criminal Justice and Police Act 2001 (c. 16)

5

(1) Part 2 of the Criminal Justice and Police Act 2001 (powers of seizure) is amended as follows.

(2) In section 57 (retention of seized items), in subsection (1) (provisions in relation to which the section has effect), at the end there is inserted—

(q) paragraph 5(4) of Schedule 5 to the Human Tissue Act 2004.

(3) In section 66 (interpretation of Part 2), in subsection (4) (references to a search to include references to activities authorised by virtue of specified powers), at the end there is inserted—

(n) paragraph 2 of Schedule 5 to the Human Tissue Act 2004 (entry and inspection of licensed premises).

(4) In Schedule 1 (powers of seizure), in Part 1 (powers to which section 50 of the Act applies), after paragraph 73D there is inserted—

(73E) Each of the powers of seizure conferred by the provisions of paragraph 5(1) (seizure of material relevant to licensing functions) and (2) (seizure of evidence of offences) of Schedule 5 to the Human Tissue Act 2004.

Enterprise Act 2002 (c. 40)

6

(1) Paragraph 3(1)(b), (2) and (3) of Schedule 2 shall be taken to be within the definition of “provision” in section 268 of the Enterprise Act 2002 (c. 40) (power to remove bankruptcy disqualifications under pre-8th November 2002 provisions or extend them to, or replace them with disqualifications of, persons subject to bankruptcy restrictions regimes).

(2) In its application by virtue of sub-paragraph (1), section 268 of the Enterprise Act 2002 (c. 40) shall have effect with the following modifications—

(a) subsections (5)(d), (6) to (8) and (15) (power to make application of disqualification provision subject to person’s discretion) are omitted, and

(b) for subsection (13) (order under section to be made by statutory instrument after parliamentary approval of a draft) there is substituted—

(13) An order under this section— (a) must be made by statutory instrument, and (b) shall be subject to annulment in pursuance of a resolution of either House of Parliament.

Asylum and Immigration (Treatment of Claimants, etc.) Act 2004

7

In section 4 of the Asylum and Immigration (Treatment of Claimants, etc. ) Act 2004 (trafficking people for exploitation), in subsection (4)(b), for “the Human Organ Transplants (Northern Ireland) Order 1989 ( S.I. 1989 / 2408 (N.I. 21))” there is substituted “ under section 32 or 33 of the Human Tissue Act 2004 ” .

SCHEDULE 7

Part 1 — Repeals

Part 2 — Revocations

Authorisation of activities for scheduled purposes

Remit

Preservation for transplantation

Membership

Disqualification

Tenure of office

Remuneration and pensions of members

Staff

Proceedings

Members' interests

Finance

Accounts and audit

Instruments

Status

Supplementary powers

Application of Statutory Instruments Act 1946

Public records

Investigation by Parliamentary Commissioner

House of Commons Disqualification

Northern Ireland Assembly Disqualification

Freedom of information

Power to grant licence

Characteristics of licence

Power to impose conditions

Pre-conditions to grant of licence

Power to revoke licence

Power to vary licence

Power to suspend licence

Procedure in relation to licensing decisions

Notification of licensing decisions

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

Applications under this Schedule

Introductory

Application to Scotland

Introductory

Purposes of general application

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

Purposes relating to existing holdings

Purposes relating to material from body of a living person

Purpose authorised under section 1

Power to amend paragraphs 5, 7 and 8

Inspection of statutory records

Entry and inspection of licensed premises

Entry and search in connection with suspected offence

Execution of warrants

Seizure in the course of inspection or search

Powers: supplementary

Enforcement

Interpretation

Wills Act 1837 (c. 26)

Anatomy Act 1984 (c. 14)

Coroners Act 1988 (c. 13)

Human Organ Transplants Act 1989 (c. 31)

Criminal Justice and Police Act 2001 (c. 16)

Enterprise Act 2002 (c. 40)

Asylum and Immigration (Treatment of Claimants, etc.) Act 2004

Editorial notes

[^c585160]: S. 58 partly in force; s. 58(3)-(7) in force at Royal Assent see s.60

[^key-e66f13427ecad38c68344eae740f4ad6]: S. 52 in force at 1.4.2005 for specified purposes by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-00f7e9f2c97091f4775e54e91bb254f3]: S. 54 in force at 1.4.2005 for specified purposes by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-0a3b7980c798a933cd59644b1c2411bf]: S. 27 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-4a8038df9bc7d9b43324064572013614]: S. 39 in force at 1.4.2005 for specified purposes by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-fa7bf8f8e6b94db458fd0a42143e704f]: S. 14 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-e0f75e3cbe8d95d24d73eb37d307102e]: S. 15 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-8cd52687c068fce61dca3c677b90331e]: S. 26 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-5a9046bf9c199d8bad142f2d9d47cdcd]: S. 41 in force at 1.4.2005 for specified purposes by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-4f53f50191f5edd0916604fa9ebdef6d]: S. 29 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-e9d0854d858415b39b1f6b55057ea347]: S. 36 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)

[^key-dbec0e9455ea08d8b5cfbd6fd0d77a58]: S. 40 in force at 1.4.2005 for specified purposes by S.I. 2005/919, art. 3, Sch. (with art. 2)

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Human Tissue Act 2004

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

6

7

8

9

Remuneration and pensions of members

10

Staff

11

Proceedings

12

13

Members' interests

14

Finance

15

Accounts and audit

16

Instruments

17

18

Status

19

Supplementary powers

20

21

Application of Statutory Instruments Act 1946