Source: http://www.legislation.gov.uk/cy/ukpga/2004/30/schedules
Timestamp: 2019-10-17 14:33:56
Document Index: 60868871

Matched Legal Cases: ['art. 3', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 1', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 3', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art 2', 'art. 3', 'art. 2', 'art 2', 'art. 3', 'art. 2', 'art 6', 'art. 3', 'art. 2', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art. 4', 'art. 2', 'art. 2', 'art. 3', 'art. 2', 'art. 4', 'art. 3', 'art 1', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art 2', 'art. 2', 'art. 3', 'art. 3', 'art. 4', 'art. 1', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art 1', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art 1', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art. 3', 'art. 2', 'art 2', 'art 2', 'art 1', 'art. 2', 'art. 2', 'art. 3', 'art. 3', 'art. 3', 'art. 2', 'art. 2', 'art. 3', 'art 1', 'art. 2', 'art. 3', 'art 2', 'art. 2', 'art. 3']

Newidiadau dros amser i: Human Tissue Act 2004 (Atodlenni yn unig)
s. 1(1A) inserted by 2013 anaw 5 s. 16(2)(a)
s. 1(2) words substituted by 2009 c. 25 Sch. 21 para. 48
s. 1(10)(c) words substituted by 2019 c. 7 s. 2(3)
s. 1(12)(a) modified by S.I. 2002/618, reg. 4T(1) (as inserted) by S.I. 2019/791 reg. 3(7)
s. 3(6)(c) words inserted by 2019 c. 7 s. 1(3)
s. 5(3) words substituted by 2009 c. 25 Sch. 21 para. 49(2)
s. 5(4)(a)(i) words substituted by 2009 c. 25 Sch. 21 para. 49(3)
s. 46 omitted by S.I. 2019/481 reg. 2(2)
s. 52(3) word inserted by 2019 c. 7 s. 2(5)
s. 52(3) words omitted by S.I. 2019/481 reg. 2(3)(a)
s. 52(4) word inserted by 2019 c. 7 s. 2(6)
s. 52(4) words substituted by S.I. 2019/481 reg. 2(3)(b)
s. 52(8) words omitted by S.I. 2019/481 reg. 2(3)(c)
s. 52(10) words inserted by 2019 c. 7 s. 2(7)
s. 52(10) words omitted by S.I. 2019/481 reg. 2(3)(c)
Sch. 6 para. 3 repealed by 2009 c. 25 Sch. 23 Pt. 1
1Anatomical examination.
2Determining the cause of death.
3Establishing after a person’s death the efficacy of any drug or other treatment administered to him.
4Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person (including a future person).
5Public display.
6Research in connection with disorders, or the functioning, of the human body.
7Transplantation.
9Education or training relating to human health.
10Performance assessment.
11Public health monitoring.
12Quality assurance.
SCHEDULE 2E+W+N.I.The human tissue authority
F11(1)The Authority shall consist of—E+W+N.I.
(b)such number of other members appointed by the Secretary of State as the Secretary of State thinks fit,
(c)a member appointed by the [F2Welsh Ministers], and
(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.
[F1(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. ]
F1Sch. 2 para. 1(3) inserted (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3), 25(6)
F2Words in Sch. 2 para. 1(1)(c) substituted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(11)(a), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)
I13Sch. 2 para. 1 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
I14Sch. 2 para. 2 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
(a)he is the subject of a bankruptcy restrictions order [F3or 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],
F3Words in Sch. 2 para. 3(1)(a) substituted (1.10.2012) by The Tribunals, Courts and Enforcement Act 2007 (Consequential Amendments) Order 2012 (S.I. 2012/2404), art. 1, Sch. 2 para. 51 (with arts. 5, 6)
I15Sch. 2 para. 3 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
4Subject 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.
I16Sch. 2 para. 4 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
I17Sch. 2 para. 5 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
6Previous service as chairman or other member of the Authority does not affect a person’s eligibility for appointment to either office.
I18Sch. 2 para. 6 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
7A 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.
I19Sch. 2 para. 7 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
I20Sch. 2 para. 8 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
9A 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.
I21Sch. 2 para. 9 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
[F49AThe appointing authority may suspend a person from office as chairman or other member of the Authority if it appears to the appointing authority that one of the conditions in paragraph 9 is or may be satisfied in relation to the person.
F4Sch. 2 paras. 9A-9C inserted (19.1.2010) by Health Act 2009 (c. 21), s. 40(1), Sch. 3 para. 7 (with Sch. 3 para. 19); S.I. 2010/30, art. 2(d)
9B(1)This paragraph applies where the appointing authority decides to suspend a person under paragraph 9A.E+W+N.I.
9C(1)This paragraph applies where a person is suspended from office as chairman under paragraph 9A.E+W+N.I.
(8)The Secretary of State may remove a person from office as interim chairman if he is satisfied that it would be in the best interests of the Authority for another member to be the interim chairman.]
Remuneration and pensions of membersE+W+N.I.
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.E+W+N.I.
(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.
I22Sch. 2 para. 10 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
11The Authority may appoint such staff as it considers appropriate, on such terms and conditions as it may determine.
I23Sch. 2 para. 11 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
ProceedingsE+W+N.I.
12Subject to any provision of this Act, the Authority may regulate its own procedure (including quorum).
I24Sch. 2 para. 12 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
13The 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 [F5Welsh 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
(c)the composition for the time being of the membership of the Authority.
F5Words in Sch. 2 para. 13(a)(ii) substituted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(11)(b), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)
I25Sch. 2 para. 13 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Members' interestsE+W+N.I.
14(1)The Authority shall establish and maintain a system for the declaration and registration of private interests of its members.E+W+N.I.
(2)The Authority shall publish entries recorded in the register of members' interests.
I26Sch. 2 para. 14 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
FinanceE+W+N.I.
15The 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.
I27Sch. 2 para. 15 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Accounts and auditE+W+N.I.
(b)the [F6Welsh Ministers],
[F7(5A)The Welsh Ministers shall lay before the National Assembly for Wales each statement of accounts received by them under sub-paragraph (4).]
F6Words in Sch. 2 para. 16(4)(b) substituted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(11)(c), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)
F7Sch. 2 para. 16(5A) inserted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(11)(d), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)
I28Sch. 2 para. 16 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
InstrumentsE+W+N.I.
17The 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.
I29Sch. 2 para. 17 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
18A document purporting—
(a)to be duly executed under the seal of the Authority, or
shall be received in evidence and be taken, without further proof, to be so executed or signed unless the contrary is shown.
I30Sch. 2 para. 18 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
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.E+W+N.I.
(2)The property of the Authority is not to be regarded as property of, or property held on behalf of, the Crown.
I31Sch. 2 para. 19 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Supplementary powersE+W+N.I.
20The 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.
I32Sch. 2 para. 20 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
21The 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
(c)to a committee consisting of persons each of whom is—
(i)a member of the Authority, or
(ii)a member of the staff of the Authority.
I33Sch. 2 para. 21 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Application of Statutory Instruments Act 1946E+W+N.I.
I34Sch. 2 para. 22 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Public recordsE+W+N.I.
23In 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. ”
I35Sch. 2 para. 23 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Investigation by Parliamentary CommissionerE+W+N.I.
24In 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. ”
I36Sch. 2 para. 24 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
House of Commons DisqualificationE+W+N.I.
25In 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. ”
I37Sch. 2 para. 25 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Northern Ireland Assembly DisqualificationE+W+N.I.
26In 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. ”
I38Sch. 2 para. 26 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Freedom of informationE+W+N.I.
27In 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. ”
I39Sch. 2 para. 27 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
SCHEDULE 3E+W+N.I.Licences for the purposes of section 16
Power to grant licenceE+W+N.I.
1The Authority may on application grant a licence for the purposes of section 16.
I40Sch. 3 para. 1 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I41Sch. 3 para. 1 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I42Sch. 3 para. 1 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I43Sch. 3 para. 1 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I44Sch. 3 para. 1 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Characteristics of licenceE+W+N.I.
2(1)A licence shall not authorise the carrying-on of more than one activity to which section 16 applies.E+W+N.I.
(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,
(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.
C1Sch. 3 para. 2(4)(c)-(f) applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3)8(2)(e)(6)(7) (with reg. 2(3))
C2Sch. 3 para. 2(4)(c)-(f) applied (with modifications) (12.7.2012 for specified purposes, 27.8.2012 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3), 6
C3Sch. 3 para. 2(4)(c)-(f) amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4
C4Sch. 3 para. 2(5) applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3), 8(2)(e)(6)(7) (with reg. 2(3))
C5Sch. 3 para. 2(5) applied (with modifications) (12.7.2012 for specified purposes, 27.8.2012 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3), 6
C6Sch. 3 para. 2(5) amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4
I45Sch. 3 para. 2 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I46Sch. 3 para. 2 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I47Sch. 3 para. 2 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I48Sch. 3 para. 2 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I49Sch. 3 para. 2 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
3(1)This paragraph applies to a licence authorising the storage of anatomical specimens.E+W+N.I.
I50Sch. 3 para. 3 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I51Sch. 3 para. 3 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I52Sch. 3 para. 3 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I53Sch. 3 para. 3 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I54Sch. 3 para. 3 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
4(1)This paragraph applies to a licence authorising the activity mentioned in section 16(2)(e).E+W+N.I.
(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—
(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—
(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.
I55Sch. 3 para. 4 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I56Sch. 3 para. 4 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I57Sch. 3 para. 4 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I58Sch. 3 para. 4 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I59Sch. 3 para. 4 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Power to impose conditionsE+W+N.I.
C7Sch. 3 para. 5 applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), regs. 1(2)(3), 8(2)(e)(6)(7) (with reg. 2(3))
C8Sch. 3 para. 5 applied (with modifications) (12.7.2012 for specified purposes, 27.8.2012 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 6 (as amended (14.7.2014) by S.I. 2014/1459, reg. 4)
C9Sch. 3 para. 5 amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4
I60Sch. 3 para. 5 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I61Sch. 3 para. 5 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I62Sch. 3 para. 5 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I63Sch. 3 para. 5 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I64Sch. 3 para. 5 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Pre-conditions to grant of licenceE+W+N.I.
6(1)The Authority may not grant a licence in pursuance of an application unless the following requirements are met.E+W+N.I.
(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—
(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.
I65Sch. 3 para. 6 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I66Sch. 3 para. 6 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I67Sch. 3 para. 6 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I68Sch. 3 para. 6 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I69Sch. 3 para. 6 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Power to revoke licenceE+W+N.I.
7(1)The Authority may revoke a licence on application by—E+W+N.I.
(b)the designated individual.
(2)The Authority may revoke a licence otherwise than on an application under sub-paragraph (1) if—
(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,
(c)it ceases to be satisfied that the premises specified in the licence are suitable for the licensed activity,
(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, F8...
(g)it is satisfied that there has been any other material change of circumstances since the licence was granted [F9or
(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].
[F10(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.]
F8Word in Sch. 3 para. 7(2)(f) omitted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by virtue of The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), reg. 1(2)(3), 9(4)(a)
F9Sch. 3 para. 7(2)(h) and word inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), reg. 1(2)(3), 9(4)(b)
F10Sch. 3 para. 7(3) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), reg. 1(2)(3), 9(5)
C10Sch. 3 paras. 7-11 applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3), 8(2)(e)(6)(7) (with reg. 2(3))
C11Sch. 3 paras. 7-11 applied (with modifications) (12.7.2012 for specified purposes, 27.8.2012 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3), 6
C12Sch. 3 paras. 7-11 amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4
I70Sch. 3 para. 7 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I71Sch. 3 para. 7 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I72Sch. 3 para. 7 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I73Sch. 3 para. 7 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I74Sch. 3 para. 7 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Power to vary licenceE+W+N.I.
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—E+W+N.I.
(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.
(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—
(6)The powers conferred by this paragraph do not extend to the conditions required by paragraphs 2(4), 3 and 4.
I75Sch. 3 para. 8 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I76Sch. 3 para. 8 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I77Sch. 3 para. 8 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I78Sch. 3 para. 8 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I79Sch. 3 para. 8 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Power to suspend licenceE+W+N.I.
9(1)Where the Authority—E+W+N.I.
(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—
(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.
I80Sch. 3 para. 9 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I81Sch. 3 para. 9 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I82Sch. 3 para. 9 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I83Sch. 3 para. 9 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I84Sch. 3 para. 9 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Procedure in relation to licensing decisionsE+W+N.I.
10(1)Before making a decision—E+W+N.I.
(b)to grant an application for a licence subject to a condition under paragraph 5,
(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—
(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—
(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.
I85Sch. 3 para. 10 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I86Sch. 3 para. 10 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I87Sch. 3 para. 10 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I88Sch. 3 para. 10 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I89Sch. 3 para. 10 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Notification of licensing decisionsE+W+N.I.
11(1)In the case of a decision to grant a licence, the Authority shall give notice of the decision to—E+W+N.I.
(b)the person who is to be 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—
(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).
I90Sch. 3 para. 11 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I91Sch. 3 para. 11 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I92Sch. 3 para. 11 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I93Sch. 3 para. 11 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I94Sch. 3 para. 11 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Permission for the purposes of the licence condition required by paragraph 3(2)E+W+N.I.
I95Sch. 3 para. 12 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I96Sch. 3 para. 12 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I97Sch. 3 para. 12 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I98Sch. 3 para. 12 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)
I99Sch. 3 para. 12 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Applications under this ScheduleE+W+N.I.
13F11F12(1)The Authority may by regulations make provision about applications under this Schedule[F11[F12, Schedule 1 to the 2007 Regulations and Schedule 1 to the 2012 Regulations] and may, in particular, make provision about—E+W+N.I.
(a)the form and content of such an application,
(b)the information to be supplied with such an application, and
(c)procedure in relation to the determination of such an application.
(2)An application under this Schedule shall be accompanied by such fee (if any) as the Authority may determine.]
F11Words in Sch. 3 para. 13(1) inserted (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3)33
F12 Words in Sch. 3 para. 13(1) substituted (12.7.2012 for specified purposes, otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501) , regs. 1(2)(3), 25(7)
C13 Sch. 3 para. 13 applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523) , regs. 1(2)(3), 8(2)(e)(6)(7) (with reg. 2(3))
C14 Sch. 3 para. 13 applied (with modifications) (12.7.2012 for specified purposes. otherwise 27.8.2012) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), regs. 1(2)(3), 6 (as amended (14.7.2014) by S.I. 2014/1459, art. 4)
C15Sch. 3 para. 13 amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4
I100 Sch. 3 para. 13 in force at 20.10.2005 for specified purposes by S.I. 2005/2792 , art. 2(2)(j)
I101 Sch. 3 para. 13 in force at 1.3.2006 for specified purposes by S.I. 2006/404 , art. 2(3) (4) , Sch. (with arts. 4-6 )
I102 Sch. 3 para. 13 in force at 7.4.2006 for specified purposes by S.I. 2006/404 , art. 3(3) , Sch. (with arts. 4-6 )
I103 Sch. 3 para. 13 in force at 31.7.2006 for specified purposes by S.I. 2006/1997 , art. 2 , Sch. (with art. 4 )
I104 Sch. 3 para. 13 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997 , art. 3(2) (with arts. 4 , 7 , 8 )
SCHEDULE 4U.K.Section 45: supplementary
Part 1 U.K.Qualifying consent
I105Sch. 4 para. 1 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I106Sch. 4 para. 1 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Qualifying consentU.K.
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.U.K.
(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—
I107Sch. 4 para. 2 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I108Sch. 4 para. 2 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I109Sch. 4 para. 3 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I110Sch. 4 para. 3 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Part 2 U.K.Use for an excepted purpose
4This Part of this Schedule makes provision for the interpretation of “use for an excepted purpose” in section 45(1)(a)(ii).
I111Sch. 4 para. 4 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I112Sch. 4 para. 4 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Purposes of general applicationU.K.
5(1)Use of the results of an analysis of DNA for any of the following purposes is use for an excepted purpose—U.K.
(a)the medical diagnosis or treatment of the person whose body manufactured the DNA;
(b)purposes of functions of a coroner;
(c)purposes of functions of a procurator fiscal in connection with the investigation of deaths;
(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—
(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
F13(c)constitutes one or more [F13service offences within the meaning of the Armed Forces Act 2006.]
(5)Sub-paragraph (1)(g) shall not be taken to confer any power to make orders or give directions.
F13Words in Sch. 4 para. 5(4)(c) substituted (28.3.2009 for specified purposes, 31.10.2009 in so far as not already in force) by Armed Forces Act 2006 (c. 52), s. 383(2), Sch. 16 para. 242; S.I. 2009/812, art. 3(a)(b) (with transitional provisions in S.I. 2009/1059); S.I. 2009/1167, art. 4
C16Sch. 4 para. 5(4)(c) modified (24.4.2009 for specified purposes, 31.10.2009 in so far as not already in force) by The Armed Forces Act 2006 (Transitional Provisions etc) Order 2009 (S.I. 2009/1059), art. 1(3), Sch. 1 para. 55
I113Sch. 4 para. 5 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I114Sch. 4 para. 5 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Purpose of research in connection with disorders, or functioning, of the human bodyU.K.
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).U.K.
(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.
I115Sch. 4 para. 6 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I116Sch. 4 para. 6 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Purposes relating to existing holdingsU.K.
7Use 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;
(c)education or training relating to human health;
(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.
I117Sch. 4 para. 7 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I118Sch. 4 para. 7 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Purposes relating to material from body of a living personU.K.
8Use 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—
(b)education or training relating to human health;
(c)performance assessment;
(d)public health monitoring;
(e)quality assurance.
I119Sch. 4 para. 8 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I120Sch. 4 para. 8 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
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—U.K.
(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.
(a)that bodily material has come from the body of a living person,
(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
(ii)that a decision of the donor to refuse consent to the use of the material for that purpose is in force, or
it may direct that this paragraph apply to the material for the benefit of the other person.
(3)If the Authority is satisfied—
(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”),
(e)that the donor has been given notice of the application for the exercise of the power conferred by this sub-paragraph,
(4)If the Court of Session is satisfied—
(iii)that the donor is an incapable adult within the meaning of the Adults with Incapacity (Scotland) Act 2000 (asp 4),
(5)If the Court of Session is satisfied—
(iii)that the donor is an incapable adult within the meaning of the Adults with Incapacity (Scotland) Act 2000, and
I121Sch. 4 para. 9 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I122Sch. 4 para. 9 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
10Use 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.
I123Sch. 4 para. 10 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I124Sch. 4 para. 10 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I125Sch. 4 para. 11 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I126Sch. 4 para. 11 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Purposes relating to DNA of adults who lack capacity to consentU.K.
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—U.K.
(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.
I127Sch. 4 para. 12 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I128Sch. 4 para. 12 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Power to amend paragraphs 5, 7 and 8U.K.
13The 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.
I129Sch. 4 para. 13 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I130Sch. 4 para. 13 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I131Sch. 5 para. 1 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I132Sch. 5 para. 1 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I133Sch. 5 para. 1 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I134Sch. 5 para. 1 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I135Sch. 5 para. 2 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I136Sch. 5 para. 2 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I137Sch. 5 para. 2 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I138Sch. 5 para. 2 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
(a)that an offence under Part 1 or 2 [F14 or under the Human Transplantation (Wales) Act 2013] is being, or has been, committed on any premises, and
F14Words in Sch. 5 para. 3(1)(a) inserted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(12)(a), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)
I139Sch. 5 para. 3 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I140Sch. 5 para. 3 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I141Sch. 5 para. 3 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I142Sch. 5 para. 3 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I143Sch. 5 para. 4 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I144Sch. 5 para. 4 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I145Sch. 5 para. 4 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I146Sch. 5 para. 4 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
(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 [F15or under the Human Transplantation (Wales) Act 2013].
F15Words in Sch. 5 para. 5(2) inserted (E.W.) (1.12.2015) by Human Transplantation (Wales) Act 2013 (anaw 5), ss. 16(12)(b), 21(1) (with s. 14); S.I. 2015/1679, art. 3(e)
I147Sch. 5 para. 5 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I148Sch. 5 para. 5 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I149Sch. 5 para. 5 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I150Sch. 5 para. 5 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I151Sch. 5 para. 6 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I152Sch. 5 para. 6 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I153Sch. 5 para. 6 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I154Sch. 5 para. 6 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I155Sch. 5 para. 7 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I156Sch. 5 para. 7 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I157Sch. 5 para. 7 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I158Sch. 5 para. 7 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I159Sch. 5 para. 8 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I160Sch. 5 para. 8 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I161Sch. 5 para. 8 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I162Sch. 5 para. 8 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I163Sch. 5 para. 9 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I164Sch. 5 para. 9 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I165Sch. 5 para. 9 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I166Sch. 5 para. 9 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
SCHEDULE 6U.K.Consequential amendments
Wills Act 1837 (c. 26)E+W+N.I.
1In 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, ”.
I167Sch. 6 para. 1 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I168Sch. 6 para. 1 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Anatomy Act 1984 (c. 14)S
2In 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) ”.
I169Sch. 6 para. 2 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I170Sch. 6 para. 2 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
I171Sch. 6 para. 3 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I172Sch. 6 para. 3 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Human Organ Transplants Act 1989 (c. 31)S
4In section 1(1)(a) of the Human Organ Transplants Act 1989, for “Great Britain” there is substituted “ Scotland ”.
I173Sch. 6 para. 4 in force at 20.10.2005 by S.I. 2005/2792, art. 2(2)(h)
Criminal Justice and Police Act 2001 (c. 16)E+W+N.I.
5(1)Part 2 of the Criminal Justice and Police Act 2001 (powers of seizure) is amended as follows.E+W+N.I.
(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—
“Human Tissue Act 2004 (c. 00)
73EEach 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.”
I174Sch. 6 para. 5 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)
I175Sch. 6 para. 5 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)
I176Sch. 6 para. 5 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)
I177Sch. 6 para. 5 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Enterprise Act 2002 (c. 40)E+W+N.I.
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).E+W+N.I.
(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—
I178Sch. 6 para. 6 in force at 1.4.2005 by S.I. 2005/919, art. 3, Sch. (with art. 2)
Asylum and Immigration (Treatment of Claimants, etc.) Act 2004E+W+N.I.
7[F16 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 ” . ]
F16Sch. 6 para. 7 repealed (N.I.) (26.4.2013) by Criminal Justice Act (Northern Ireland) 2013 (c. 7), s. 15(1), Sch. 4 Pt. 2
I179Sch. 6 para. 7 in force at 20.10.2005 by S.I. 2005/2792, art. 2(2)(i) (with art. 3(1)(a))
Part 1U.K.Repeals
I180Sch. 7 Pt. 1 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(f)(j)
I181Sch. 7 Pt. 1 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Human Tissue Act (Northern Ireland) 1962 (c. 19 (N.I.)) The whole Act.
Anatomy Act 1984 (c. 14) The whole Act.
National Health Service and Community Care Act 1990 (c. 19) In Schedule 9, paragraph 7.
Human Fertilisation and Embryology Act 1990 (c. 37) In Schedule 4, paragraphs 8 and 9.
Health Authorities Act 1995 (c. 17) In Schedule 1, paragraph 92.
Part 2 U.K.Revocations
I182Sch. 7 Pt. 2 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(g)
I183Sch. 7 Pt. 2 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)
Corneal Tissue (Northern Ireland) Order 1988 (S.I. 1988/1844 (N.I. 14)) The whole Order.
Human Organ Transplants (Northern Ireland) Order 1989 (S.I. 1989/2408 (N.I. 21)) The whole Order.
Health and Personal Social Services (Northern Ireland) Order 1991 (S.I. 1991/194 (N.I. 1)) In Part II of Schedule 5, the entry relating to the Human Tissue Act (Northern Ireland) 1962.
Anatomy (Northern Ireland) Order 1992 (S.I. 1992/1718 (N.I. 11)) The whole Order.