House of Commons Amendments

House of Commons

Session 2007 - 08
Internet Publications
Other Bills before Parliament

Public Bill Committee: 5th June 2008
123

Human Fertilisation and Embryology Bill [Lords] continued

(a)
it is not reasonably possible for the person responsible

under the licence (“R”) to identify the person falling within

sub-paragraph (1)(b) (“P”), and
225
(b)
where any information that relates to P (without identifying

P or enabling P to be identified) is available to R, that

information does not suggest that P would have objected to

the use of P’s human cells to bring about the creation in

vitro of an embryo or human admixed embryo for use for
230
the purposes of the project.

      (3)
Condition B is that—

(a)
the person responsible under the licence (“R”) has taken all

reasonable steps to contact the person falling within sub-

paragraph (1)(b) (“P”) but has been unable to do so,
235
(b)
R does not have any reason to believe P to have died, and

(c)
the information relating to P that is available to R does not

suggest that P would have objected to the use of P’s human

cells to bring about the creation in vitro of an embryo or

human admixed embryo for use for the purposes of the
240
project.

      (4)
Condition C is that—

(a)
the person falling within sub-paragraph (1)(b) (“P”) has

died since P’s human cells were first stored,

(b)
the information relating to P that is available to the person
245
responsible under the licence (“R”) does not suggest that P

would have objected to the use of P’s human cells to bring

about the creation in vitro of an embryo or human admixed

embryo for use for the purposes of the project, and

(c)
a person who stood in a qualifying relationship to P
250
immediately before P died has given consent in writing to

the use of P’s human cells to bring about the creation in

vitro of an embryo or human admixed embryo for use for

the purposes of the project.

      (5)
The HTA consent provisions apply in relation to consent for the
255
purposes of sub-paragraph (4)(c) as they apply in relation to consent

for the purposes of section 3(6)(c) of the Human Tissue Act 2004;

and for the purposes of this sub-paragraph the HTA consent

provisions are to be treated as if they extended to Scotland.

      (6)
In sub-paragraph (5) “the HTA consent provisions” means
260
subsections (4), (5), (6), (7) and (8)(a) and (b) of section 27 of the

Human Tissue Act 2004.

      (7)
In this paragraph references to the person responsible under the

licence are to be read, in a case where an application for a licence is

being made, as references to the person who is to be the person
265
responsible.

      (8)
Paragraphs 1 to 4 of this Schedule do not apply in relation to a

consent given for the purposes of sub-paragraph (4)(c).”’.

Public Bill Committee: 5th June 2008
124

Human Fertilisation and Embryology Bill [Lords] continued

As Amendments to Dawn Primarolo’s proposed Amendment (No. 102):—

Dr Evan Harris

(a)

Line  206,  leave out ‘to a significant extent’.

Dr Evan Harris

(b)

Line  235,  leave out ‘have any reason to believe’ and insert ‘know’.

Mark Simmonds

Mr Andrew Lansley

7

Schedule  3,  page  66,  line  5,  at end add—

‘13A
After paragraph 15 (as inserted by paragraph 13 above) insert—

“Cases where consent not required for storage and research

15A
The human cells of a person (‘the donor’) may be used to bring

about the creation of an embryo or a human admixed embryo in

vitro; and any embryo or human admixed embryo so created may

be used or stored for the purposes of any project of research without

the donor’s consent if the following conditions are met:

(a)
Condition A is that the human cells are lawfully taken from

or provided by the donor;

(b)
Condition B is that the human cells were first stored or used

prior to the day on which Schedule 3 to the Human

Fertilisation and Embryology Act 2008 comes into force;

(c)
Condition C is that the human cells, embryos or human

admixed embryos are used in circumstances such that the

person carrying out the research (‘the researcher’) is not in

possession, and not likely to come into possession, of

information from which the donor can be identified;

(d)
Condition D is that it is not reasonably possible to contact

the donor to obtain their consent;

(e)
Condition E is that there are reasonable grounds for

believing that research of comparable effectiveness cannot

be carried out if the project of research for which the human

cells, embryos or human admixed embryos are stored or

used has to be confined to, or related only to, material in

relation to which there is an effective consent; and

(f)
Condition F is that it does not appear to the researcher that

the donor has indicated any objection to such use or storage

(as applicable).”.’.

Dawn Primarolo

103

Schedule  3,  page  66,  line  31,  at end insert—

    ‘(5)
References in this Schedule to parental responsibility are—

(a)
in relation to England and Wales, to be read in accordance with the

Children Act 1989,

(b)
in relation to Northern Ireland, to be read in accordance with the

Children (Northern Ireland) Order 1995, and

Public Bill Committee: 5th June 2008
125

Human Fertilisation and Embryology Bill [Lords] continued

(c)
in relation to Scotland, to be read as references to parental

responsibilities and parental rights within the meaning of the Children

(Scotland) Act 1995.

      (6)
References in this Schedule to capacity are, in relation to England and Wales,

to be read in accordance with the Mental Capacity Act 2005.

      (7)
References in this Schedule to the age of 18 years are, in relation to Scotland,

to be read as references to the age of 16 years.’.

Mark Simmonds

33

Schedule  4,  page  67,  line  8,  after ‘gametes’, insert ‘including the mitochondria,’.

Mark Simmonds

Mr Andrew Lansley

5

Clause  15,  page  11,  line  47,  leave out ‘ten’ and insert ‘seven’.

Mark Simmonds

34

Clause  15,  page  12,  line  3,  leave out ‘ten’ and insert ‘seven’.

Dawn Primarolo

41

Clause  16,  page  12,  line  14,  at end insert—

‘( )
in paragraph (c), after “application” insert “or a licence under paragraph

3 of that Schedule authorising activities in connection with the derivation

from embryos of stem cells that are intended for human application”, ’.

Dawn Primarolo

42

Clause  16,  page  12,  line  15,  after ‘(ca)’ insert ‘— (i)’.

Dawn Primarolo

43

Clause  16,  page  12,  line  16,  at end insert—

‘(ii)
after “that Schedule” insert “authorising activities otherwise than

in connection with the derivation from embryos of stem cells that

are intended for human application”, and’.

Public Bill Committee: 5th June 2008
126

Human Fertilisation and Embryology Bill [Lords] continued

Mark Simmonds

142

Clause  17,  page  12,  line  23,  at end insert—

‘(1A)
In subsection (1)(b) for “equipment is” substitute “equipment and premises are”’.

Mark Simmonds

143

Clause  18,  page  13,  line  29,  after ‘person’, insert ‘and is so qualified by training

and experience’.

Mark Simmonds

144

Clause  19,  page  15,  line  12,  leave out subsection (7).

Mark Simmonds

145

Clause  19,  page  15,  line  14,  at end insert—

‘(8)
Notification to the applicant of a decision whether to grant or refuse a licence

must be given within a specified time period to be determined by regulation.’.

Mark Simmonds

146

Clause  20,  page  15,  line  38,  at end insert—

‘(2A)
No more than four consecutive suspensions under subsection (1) can be granted,

totalling a maximum period of twelve months.’.

Mark Simmonds

147

Clause  20,  page  16,  line  4,  at end insert—

‘(6)
During a period of suspension all necessary, suitable and appropriate steps must

be taken by the Authority to ensure there is no damage to the cells, embryos and

gametes that were the responsibility of the licence holder or person responsible

when the licence was suspended.’.

Mark Simmonds

148

Clause  21,  page  17,  line  2,  leave out from ‘wholly’ to ‘and’ in line 3 and insert ‘of

persons who were not members of the initial grant, revocation or variation committee.’.

Public Bill Committee: 5th June 2008
127

Human Fertilisation and Embryology Bill [Lords] continued

Mark Simmonds

149

Clause  21,  page  17,  line  32,  at end insert ‘within 28 days of the appeals committee

meeting.’.

Dr Vincent Cable

Dr John Pugh

13

Clause  22,  page  18,  line  15,  at end insert—

‘(3A)
After subsection (4) insert—

“(4A)
In default of the exercise of the Authority of its power to make a direction

under this section, a judge of the High Court may give permission for

gametes stored under Schedule (3)(1)(2A) of this Act to be used within

the UK or exported and used outside the United Kingdom.”.’.

Mark Simmonds

Mr Andrew Lansley

6

Clause  24,  page  20,  line  10,  at end insert—

‘(5)
A relevant individual can also be an individual who has reached the age of 18

whose genetic parent was a relevant individual under subsection (4) but did not

themselves consult the register and is themselves deceased.’.

Mark Simmonds

35

Clause  24,  page  22,  line  17,  at end insert—

‘(c)
the donor has been given suitable opportunity to receive proper

counselling about the implications of such a request having been made.’.

Dawn Primarolo

44

Clause  24,  page  23,  line  7,  leave out ‘any of’.

Mark Simmonds

36

Clause  24,  page  23,  line  42,  at end insert—

‘(10)
In this section “reasonable period” means a period of no longer than 3 months’.

Mark Simmonds

38

Clause  25,  page  26,  line  4,  at end insert—

‘(za)
the disclosure is made—

Public Bill Committee: 5th June 2008
128

Human Fertilisation and Embryology Bill [Lords] continued

(i)
on clinical grounds, as part of the patient’s medical care, to a

practitioner who is bound by the ordinary duty of patient

confidentiality, or

(ii)
in order to ensure the safety of medical treatment which the

patient is to receive outside of licensed premises.’.

Dawn Primarolo

45

Clause  25,  page  26,  leave out lines 22 to 41 and insert—

‘(g)
the disclosure is made so that no individual can be identified from the

information,

(h)
the disclosure is of information other than identifying donor information

and is made with the consent required by section 33AB,’.

Dawn Primarolo

46

Clause  25,  page  26,  line  41,  at end insert—

‘(ja)
the disclosure—

(i)
is made 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 (“P”),

(ii)
is of information falling within section 31(2)(a) which could be

disclosed by virtue of paragraph (h) with P’s consent or could be

disclosed to P by virtue of subsection (10), and

(iii)
is made in circumstances where it is not reasonably practicable

to obtain P’s consent,’.

Dr Evan Harris

150

Clause  25,  page  27,  line  27,  at end insert—

‘(v)
the disclosure is made in order to ensure the safety of medical treatment

which the patient is to receive outside of licensed premises.’.

Dr Evan Harris

151

Clause  25,  page  27,  line  27,  at end insert—

‘(v)
the disclosure is made, on clinical grounds, as part of the patient’s

medical care, to a practitioner who is bound by the ordinary duty of

patient confidentiality.’.

Dawn Primarolo

47

Clause  25,  page  27,  leave out lines 38 to 50.

Dawn Primarolo

48

Clause  25,  page  28,  leave out lines 1 and 2.

Dawn Primarolo

49

Clause  25,  page  28,  line  7,  leave out from ‘of’ to ‘or’ in line 12 and insert

‘identifying donor information,’.

Public Bill Committee: 5th June 2008
129

Human Fertilisation and Embryology Bill [Lords] continued

Dawn Primarolo

50

Clause  25,  page  28,  leave out lines 18 to 30.

Dawn Primarolo

51

Clause  25,  page  28,  line  36,  leave out ‘treated together with another’ and insert

‘who is treated together with, or gives a notice under section 37 or 44 of the Human

Fertilisation and Embryology Act 2008 in respect of, another’.

Dawn Primarolo

52

Clause  25,  page  28,  leave out lines 39 and 40.

Dawn Primarolo

53

Clause  25,  page  28,  line  45,  at end insert—

‘( )
In this section “identifying donor information” means 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 consequence of which an identifiable

individual was, or may have been, born.’.

Dawn Primarolo

54

Clause  25,  page  28,  line  45,  at end insert—

‘33AB
   Consent required to authorise certain disclosures

(1)
This section has effect for the purposes of section 33A(2)(h).

(2)
Subject to subsection (5), the consent required by this section is the

consent of each individual who can be identified from the information.

(3)
Consent in respect of a person who has not attained the age of 18 years

(“C”) may be given—

(a)
by C, in a case where C is competent to deal with the issue of

consent, or

(b)
by a person having parental responsibility for C, in any other

case.

(4)
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 with the request.

(5)
In the case of information which shows that any identifiable individual

(“A”) was, or may have been, born in consequence of treatment services,

the consent required by this section does not include A’s consent if the

disclosure is necessarily incidental to the disclosure of information

falling within section 31(2)(a).

(6)
The reference in subsection (3) to parental responsibility is—

(a)
in relation to England and Wales, to be read in accordance with

the Children Act 1989;