|
| |
|
(e) | arrange for samples of the DNA of such persons to be analysed |
| |
| |
(f) | make such arrangements as it thinks fit for the disclosure of |
| |
information on the register between persons who appear to the |
| |
Authority to be genetically related, and |
| 5 |
(g) | impose such conditions as it thinks fit to prevent a person (“A”) |
| |
from disclosing information to a person to whom A is |
| |
genetically related (“B”) where that information would identify |
| |
any person who is genetically related to both A and B. |
| |
(3) | The Authority may make arrangements with any person by whom a |
| 10 |
voluntary contact register is kept before the commencement of this |
| |
section for the supply by that person to the Authority of the |
| |
information contained in the register maintained by that person. |
| |
31ZG | Financial assistance for person setting up or keeping voluntary contact |
| |
| 15 |
(1) | The Authority may, instead of keeping a voluntary contact register, |
| |
give financial assistance to any person who sets up or keeps a voluntary |
| |
| |
(2) | Financial assistance under subsection (1) may be given in any form, and |
| |
in particular, may be given by way of— |
| 20 |
| |
| |
| |
(d) | incurring expenditure for the person assisted. |
| |
(3) | Financial assistance under subsection (1) may be given on such terms |
| 25 |
and conditions as the Authority considers appropriate. |
| |
(4) | A person receiving assistance under subsection (1) must comply with |
| |
the terms and conditions on which it is given, and compliance may be |
| |
enforced by the Authority.” |
| |
25 | Restrictions on disclosure of information |
| 30 |
For section 33 of the 1990 Act (restrictions on disclosure of information) |
| |
| |
“33A | Disclosure of information |
| |
(1) | No person shall disclose any information falling within section 31(2) |
| |
which the person obtained (whether before or after the coming into |
| 35 |
force of section 24 of the Human Fertilisation and Embryology Act |
| |
2008) in the person’s capacity as— |
| |
(a) | a member or employee of the Authority, |
| |
(b) | any person exercising functions of the Authority by virtue of |
| |
section 8B or 8C of this Act (including a person exercising such |
| 40 |
functions by virtue of either of those sections as a member of |
| |
staff or as an employee), |
| |
(c) | any person engaged by the Authority to provide services to the |
| |
| |
(d) | any person employed by, or engaged to provide services to, a |
| 45 |
person mentioned in paragraph (c), |
| |
|
| |
|
| |
|
(e) | a person to whom a licence applies, |
| |
(f) | a person to whom a third party agreement applies, or |
| |
(g) | a person to whom directions have been given. |
| |
(2) | Subsection (1) does not apply where— |
| |
(a) | the disclosure is made to a person as a member or employee of |
| 5 |
the Authority or as a person exercising functions of the |
| |
Authority as mentioned in subsection (1)(b), |
| |
(b) | the disclosure is made to or by a person falling within |
| |
subsection (1)(c) for the purpose of the provision of services |
| |
which that person is engaged to provide to the Authority, |
| 10 |
(c) | the disclosure is made by a person mentioned in subsection |
| |
(1)(d) for the purpose of enabling a person falling within |
| |
subsection (1)(c) to provide services which that person is |
| |
engaged to provide to the Authority, |
| |
(d) | the disclosure is made to a person to whom a licence applies for |
| 15 |
the purpose of that person’s functions as such, |
| |
(e) | the disclosure is made to a person to whom a third party |
| |
agreement applies for the purpose of that person’s functions |
| |
| |
(f) | the disclosure is made in pursuance of directions given by |
| 20 |
| |
(g) | the disclosure is made so that no individual to whom the |
| |
information relates can be identified, |
| |
(h) | the disclosure is of information falling within section 31(2)(a) |
| |
and is made with the consent required by subsection (4), |
| 25 |
(i) | the disclosure is of information falling within any of paragraphs |
| |
(b) to (e) of subsection (2) of section 31 and is made— |
| |
(i) | with the consent of the individual to whom it relates, |
| |
| |
(ii) | with the consent of any other individual who may be |
| 30 |
identified from that information, |
| |
(j) | the disclosure is of information which shows that an individual |
| |
who has attained the age of 18 is a relevant individual and is |
| |
| |
(i) | with the consent of that individual, |
| 35 |
(ii) | in a case where the disclosure of that information would |
| |
also disclose any information falling within section |
| |
31(2)(a), with the consent required by subsection (4), |
| |
| |
(iii) | with the consent of any other individual who may be |
| 40 |
identified from that information, |
| |
(k) | the disclosure is of information which has been lawfully made |
| |
available to the public before the disclosure is made, |
| |
(l) | the disclosure is made in accordance with sections 31ZA to |
| |
| 45 |
(m) | the disclosure is required or authorised to be made— |
| |
(i) | under regulations made under section 33C, or |
| |
(ii) | in relation to any time before the coming into force of the |
| |
first regulations under that section, under regulations |
| |
made under section 251 of the National Health Service |
| 50 |
| |
|
| |
|
| |
|
(n) | the disclosure is made by a person acting in the capacity |
| |
mentioned in subsection (1)(a) or (b) for the purpose of carrying |
| |
out the Authority’s duties under section 8A, |
| |
(o) | the disclosure is made by a person acting in the capacity |
| |
mentioned in subsection (1)(a) or (b) in pursuance of an order of |
| 5 |
a court under section 34 or 35, |
| |
(p) | the disclosure is made by a person acting in the capacity |
| |
mentioned in subsection (1)(a) or (b) to the Registrar General in |
| |
pursuance of a request under section 32, |
| |
(q) | the disclosure is made by a person acting in the capacity |
| 10 |
mentioned in subsection (1)(a) or (b) to any body or person |
| |
discharging a regulatory function for the purpose of assisting |
| |
that body or person to carry out that function, |
| |
(r) | the disclosure is made for the purpose of establishing in any |
| |
proceedings relating to an application for an order under |
| 15 |
subsection (1) of section 54 of the Human Fertilisation and |
| |
Embryology Act 2008 whether the condition specified in |
| |
paragraph (a) or (b) of that subsection is met, |
| |
(s) | the disclosure is made under section 3 of the Access to Health |
| |
| 20 |
(t) | the disclosure is made under Article 5 of the Access to Health |
| |
Records (Northern Ireland) Order 1993, or |
| |
(u) | the disclosure is made necessarily for— |
| |
(i) | the purpose of the investigation of any offence (or |
| |
| 25 |
(ii) | any purpose preliminary to proceedings, or for the |
| |
purposes of, or in connection with, any proceedings. |
| |
(3) | Subsection (1) does not apply to the disclosure of information in so far |
| |
| |
(a) | the information identifies a person who, but for sections 27 to 29 |
| 30 |
of this Act or sections 33 to 47 of the Human Fertilisation and |
| |
Embryology Act 2008, would or might be a parent of a person |
| |
who instituted proceedings under section 1A of the Congenital |
| |
Disabilities (Civil Liability) Act 1976, and |
| |
(b) | the disclosure is made for the purpose of defending such |
| 35 |
proceedings, or instituting connected proceedings for |
| |
compensation against that parent. |
| |
(4) | For the purpose of subsection (2)(h) and (j)(ii), the consent required by |
| |
| |
(a) | where any person is identifiable from the information, the |
| 40 |
consent of that person, or |
| |
(b) | where treatment services were provided to two persons |
| |
together and both persons are identifiable, if disclosure is made |
| |
for the purpose of disclosing information about the provision of |
| |
treatment services to one of them, the consent of that person. |
| 45 |
(5) | For the purposes of subsection (2)(h), (i) and (j), consent to disclosure |
| |
given at the request of another shall be disregarded unless, before it is |
| |
given, the person requesting it takes reasonable steps to explain to the |
| |
individual from whom it is requested the implications of compliance |
| |
| 50 |
|
| |
|
| |
|
(6) | Information falling within section 31(2) cannot be disclosed by virtue of |
| |
subsection (2)(h), (i) or (j) to a person who has not attained the age of 18. |
| |
(7) | Paragraph (u) of subsection (2), so far as relating to disclosure for the |
| |
purpose of the investigation of an offence or suspected offence, or for |
| |
any purpose preliminary to, or in connection with proceedings, does |
| 5 |
| |
(a) | to disclosure of information enabling a person to be identified |
| |
as a person whose gametes were used in accordance with |
| |
consent given under paragraph 5 of Schedule 3 for the purposes |
| |
of treatment services or non-medical fertility services, in |
| 10 |
consequence of which an identifiable individual was, or may |
| |
| |
(b) | to disclosure, in circumstances in which subsection (1) of section |
| |
34 of this Act applies, of information relevant to the |
| |
determination of the question mentioned in that subsection, |
| 15 |
made by any person acting in a capacity mentioned in any of |
| |
paragraphs (c) to (g) of subsection (1). |
| |
(8) | In the case of information which relates to the provision of treatment |
| |
services for any identifiable individual, subsection (1) does not apply to |
| |
disclosure in an emergency, that is to say, disclosure made— |
| 20 |
(a) | by a person who is satisfied that it is necessary to make the |
| |
disclosure to avert an imminent danger to the health of an |
| |
individual with whose consent the information could be |
| |
disclosed under subsection (2)(h), and |
| |
(b) | in circumstances where it is not reasonably practicable to obtain |
| 25 |
that individual’s consent. |
| |
(9) | In the case of information which shows that any identifiable individual |
| |
was, or may have been, born in consequence of treatment services, |
| |
subsection (1) does not apply to any disclosure which is necessarily |
| |
incidental to disclosure under subsection (2)(h) or (8). |
| 30 |
(10) | Subsection (1) does not apply to the disclosure to any individual of |
| |
| |
(a) | falls within subsection (2) of section 31 of this Act by virtue of |
| |
any of paragraphs (a) to (e) of that subsection, and |
| |
(b) | relates only to that individual or, in the case of an individual |
| 35 |
treated together with another, only to that individual and that |
| |
| |
| |
(a) | in paragraph (j) “relevant individual” has the same meaning as |
| |
| 40 |
(b) | in paragraph (q) “regulatory function” has the same meaning as |
| |
in section 32 of the Legislative and Regulatory Reform Act 2006, |
| |
| |
(c) | in paragraph (u) references to “proceedings” include any formal |
| |
procedure for dealing with a complaint. |
| 45 |
33B | Power to provide for additional exceptions from section 33A(1) |
| |
(1) | Regulations may provide for additional exceptions from section |
| |
| |
|
| |
|
| |
|
(2) | No exception may be made under this section for— |
| |
(a) | disclosure of a kind mentioned in paragraph (a) or (b) of |
| |
subsection (7) of section 33A, or |
| |
(b) | disclosure in circumstances in which section 32 of this Act |
| |
applies of information having the tendency mentioned in |
| 5 |
subsection (2) of that section, made by any person acting in a |
| |
capacity mentioned in any of paragraphs (c) to (g) of subsection |
| |
| |
33C | Disclosure for the purposes of medical or other research |
| |
| 10 |
(a) | make such provision for and in connection with requiring or |
| |
regulating the processing of protected information for the |
| |
purposes of medical research as the Secretary of State considers |
| |
is necessary or expedient in the public interest or in the interests |
| |
of improving patient care, and |
| 15 |
(b) | make such provision for and in connection with requiring or |
| |
regulating the processing of protected information for the |
| |
purposes of any other research as the Secretary of State |
| |
considers is necessary or expedient in the public interest. |
| |
(2) | Regulations under subsection (1) may, in particular, make provision— |
| 20 |
(a) | for requiring or authorising the disclosure or other processing |
| |
of protected information to or by persons of any prescribed |
| |
description subject to compliance with any prescribed |
| |
conditions (including conditions requiring prescribed |
| |
undertakings to be obtained from such persons as to the |
| 25 |
processing of such information), |
| |
(b) | for securing that, where prescribed protected information is |
| |
processed by a person in accordance with the regulations, |
| |
anything done by that person in so processing the information |
| |
must be taken to be lawfully done despite any obligation of |
| 30 |
confidence owed by the person in respect of it, |
| |
(c) | for requiring fees of a prescribed amount to be paid to the |
| |
Authority in prescribed circumstances by persons in relation to |
| |
the disclosure to those persons of protected information under |
| |
| 35 |
(d) | for the establishment of one or more bodies to exercise |
| |
prescribed functions in relation to the processing of protected |
| |
information under those regulations, |
| |
(e) | as to the membership and proceedings of any such body, and |
| |
(f) | as to the payment of remuneration and allowances to any |
| 40 |
member of any such body and the reimbursement of expenses. |
| |
(3) | Where regulations under subsection (1) require or regulate the |
| |
processing of protected information for the purposes of medical |
| |
research, such regulations may enable any approval given under |
| |
regulations made under section 251 of the National Health Service Act |
| 45 |
2006 (control of patient information) to have effect for the purposes of |
| |
the regulations under subsection (1) in their application to England and |
| |
| |
(4) | Subsections (1) to (3) are subject to subsections (5) to (8). |
| |
|
| |
|
| |
|
(5) | Regulations under subsection (1) may not make any provision |
| |
requiring or authorising the disclosure or other processing, for any |
| |
purpose, of protected information, where that information is |
| |
information from which an individual may be identified, if it would be |
| |
reasonably practicable to achieve that purpose otherwise than pursuant |
| 5 |
to such regulations, having regard to the cost of and technology |
| |
available for achieving that purpose. |
| |
(6) | Regulations under this section may not make provision for or in |
| |
connection with the processing of protected information in a manner |
| |
inconsistent with any provision made by or under the Data Protection |
| 10 |
| |
(7) | Subsection (6) does not affect the operation of provisions made under |
| |
| |
(8) | Before making any regulations under this section the Secretary of State |
| |
shall consult such bodies appearing to the Secretary of State to |
| 15 |
represent the interests of those likely to be affected by the regulations |
| |
as the Secretary of State considers appropriate. |
| |
| |
“prescribed” means prescribed by regulations made by virtue of |
| |
| 20 |
“processing”, in relation to information, means the use, disclosure, |
| |
or obtaining of the information or the doing of such other things |
| |
in relation to it as may be prescribed for the purposes of this |
| |
| |
“protected information” means information falling within section |
| 25 |
| |
| |
26 | Mitochondrial donation |
| |
After section 35 of the 1990 Act insert— |
| |
| 30 |
35A | Mitochondrial donation |
| |
(1) | Regulations may provide for any of the relevant provisions to have |
| |
effect subject to specified modifications in relation to cases where— |
| |
(a) | an egg which is a permitted egg for the purposes of section 3(2) |
| |
by virtue of regulations made under section 3ZA(5), or |
| 35 |
(b) | an embryo which is a permitted embryo for those purposes by |
| |
virtue of such regulations, |
| |
| has been created from material provided by two women. |
| |
(2) | In this section “the relevant provisions” means— |
| |
(a) | the following provisions of this Act— |
| 40 |
(i) | section 13(6C) (information whose provision to |
| |
prospective parents is required by licence condition), |
| |
(ii) | section 31 (register of information), |
| |
(iii) | sections 31ZA to 31ZE (provision of information), and |
| |
|
| |
|
| |
|
(iv) | Schedule 3 (consents to use or storage of gametes, |
| |
embryos or human admixed embryos etc.), and |
| |
(b) | section 54 of the Human Fertilisation and Embryology Act 2008 |
| |
| |
| 5 |
| |
After section 35A of the 1990 Act (as inserted by section 26 above) insert— |
| |
| |
| |
(1) | The Authority may charge a fee in respect of any of the following— |
| 10 |
(a) | an application for a licence, |
| |
(b) | the grant or renewal of a licence, |
| |
(c) | an application for the revocation or variation of a licence, or |
| |
(d) | the exercise by the Authority of any other function conferred on |
| |
it by or under this Act or by or under any other enactment— |
| 15 |
(i) | in relation to a licence, |
| |
(ii) | in relation to premises which are or have been premises |
| |
to which a licence relates, |
| |
(iii) | in relation to premises which are or have been relevant |
| |
third party premises in relation to a licence, or |
| 20 |
(iv) | in relation to premises which, if an application is |
| |
granted, will be premises to which a licence relates or |
| |
relevant third party premises. |
| |
(2) | The amount of any fee charged by virtue of subsection (1) is to be fixed |
| |
in accordance with a scheme made by the Authority with the approval |
| 25 |
of the Secretary of State and the Treasury. |
| |
(3) | In fixing the amount of any fee to be charged by virtue of that |
| |
subsection, the Authority may have regard to the costs incurred by it— |
| |
(a) | in exercising the functions conferred on it by or under this Act |
| |
(apart from sections 31ZA to 31ZG and 33C), and |
| 30 |
(b) | in exercising any other function conferred on it by or under any |
| |
| |
(4) | The Authority may also charge such fee as it thinks fit in respect of any |
| |
| |
(a) | the giving of notice under section 31ZA(1) or 31ZB(1), or |
| 35 |
(b) | the provision of information under section 31ZA, 31ZB or 31ZE. |
| |
(5) | In fixing the amount of any fee to be charged by virtue of subsection (4) |
| |
the Authority may have regard to the costs incurred by it in exercising |
| |
the function to which the fee relates. |
| |
(6) | When exercising its power to charge fees under section 8(2), 31ZF(2)(d) |
| 40 |
or this section, the Authority may fix different fees for different |
| |
| |
|
| |
|