CONSENT AND STEM CELL USE
4.35 The creation, use and storage of human admixed
and other embryos for the purpose of a research project requires
the effective consent of the donor of the cell or nucleus.[195]
A number of scientists and research professionals have expressed
their concern that the proposals in the Bill could stifle developing
stem cell research. Their concerns focus on two issues: (a) the
retrospective effect of the provisions on consent where cells
or tissues have already been collected and where no explicit and
specific consent exists and they are anonymised or donors are
untraceable and (b) the inability of parents to consent on behalf
of children to the use of their cells. For example, in a letter
to The Times, dated 21 January 2008, the group explained:
We fully agree that in the future such consent should
be a requirement and that it would be wrong to use previously
donated cells if there were good reason to believe that the donor
would have specifically objected to their use in embryonic stem
cell research. However, many existing cell and tissue samples
and cell lines were donated, for any research purpose, by patients
(now untraceable) with particular diseases before this sort of
research was imagined).[196]
4.36 A separate issue arose in respect of research
on childhood diseases and consent:
The Bill does not currently make any provision for
parents or guardians to consent on behalf of their children. This
has the regrettable side effect that it will in future be impossible
to carry out embryo research using cells for sufferers of serious
or life threatening diseases that exclusively affect and usually
kill children
This removes a vital route to increasing our
understanding of the development and causes of these terrible
diseases.[197]
4.37 The Government resisted these arguments on the
basis that a stringent consent based regime would be necessary
to meet the requirements of the Human Rights Act and Convention
rights.[198] The Government
has made a commitment to reconsider the provisions on consent
and are expected to bring forward two sets of amendments for this
purpose in the House of Commons. The Government considers that
amendments to provide exceptions to the rule on consent must be
accompanied by appropriate safeguards to meet the right to respect
for private life as guaranteed by Article 8 ECHR.
4.38 The Government has correctly identified that
the use of genetic material to create an embryo without consent
will engage the right to private life, as protected by Article
8 ECHR. The Minister explains that new evidence has persuaded
the Government that limited exceptions to the requirement for
express consent may be justified, if accompanied by appropriate
safeguards. These safeguards have not yet been identified.[199]
We accept that in principle,
the requirement for consent to the use of genetic material for
these purposes is not absolute and that in some limited circumstances
proceeding without consent may be justified. We
note any human admixed embryo or any other embryo created for
the purposes of research must generally be destroyed after 14
days.[200] We consider
that the right to respect for private life is engaged when dealing
with individual genetic material. The Government relies on the
right of autonomy and the fact that the European Court of Human
Rights have recognised that Article 8 ECHR incorporates the right
to respect for decisions about whether or not to "become
a parent".[201]
While this case law is relevant, we do not consider that a direct
analogy can be drawn between parenthood without consent, and the
use of genetic material to create an embryo for the purposes of
research, subject to a short time frame and subject to regulation
by the HFEA.
4.39 Any amendments
proposed by the Government and containing safeguards for the protection
of human rights should be published at an early stage to allow
for effective scrutiny.
4.40 In debate, the Government
has explained that the provisions in the Bill which relate to
consent are necessary to meet the right to respect for private
life, as guaranteed by Article 8 ECHR.[202]
This issue was not considered in the original Explanatory Notes
accompanying the Bill. We accept that the Government may not have
anticipated any objection to these provisions. Although new Explanatory
Notes have been produced to accompany the Bill on its passage
from the House of Lords to the House of Commons, neither of these
issues has been addressed. In order to find a full explanation
of the Government's analysis of compatibility with Convention
rights, we have had to follow the debates, and then obtain a letter
from the Minister sent to members of the House of Lords and deposited
in the House of Lords Library. Where
the Government provides a further explanation of its views on
the human rights compatibility of provisions in a Bill, it would
assist effective scrutiny if this explanation were included in
the Explanatory Notes which accompany the Bill when it passes
from the first to second House.
ARTIFICIAL GAMETES, RESEARCH AND
FERTILITY TREATMENT
4.41 Members of the scientific community have raised
significant concerns about the potential for the Bill to stifle
emerging research on the development and use of artificial gametes.
Broadly speaking, this research involves the creation of sperm
and embryos. The Bill currently provides that although artificial
gametes may be created for the purposes of research, they cannot
be produced for the purposes of fertility treatments. Amendments
were proposed in the House of Lords which would widen these provisions,
for example, by introducing a regulatory power to extend licensing
powers to use for treatment. The Government resisted a number
of these amendments by reference to human rights arguments. For
example, at Third Reading, resisting an amendment which would
extend to treatment only provided to a man and a woman, the Minister
explained:
The Government's concern relates to Article 14 of
the ECHR in conjunction with Article 8 on the right to privacy.
The Government are concerned about whether the technique is available
for same-sex couples or whether they will be treated differently.
If they are treated differently, the Government's view is that
this must be justified to comply with Article 14 ECHR. Techniques
for same-sex couples may be a lot further off or unsafe at this
moment, and different treatment may be justified, but we are exploring
these issues and will consider them further in the Commons.[203]
4.42 There is no right to fertility treatment using
existing technology, let alone any potential forms of treatment
which may be developed in the future. However, should treatment
be available, any distinctions in relation to access must be justified.
We welcome the Government's commitment to look again at these
amendments on this basis.[204]
151 Joint Committee on the Human Tissues and Embryos
(Draft) Bill, Session 2006-07, Report on the Human Tissues
and Embryos (Draft) Bill, HL Paper 169-I/HC 630-I. Back
152
Bill 70 EN, paras 260 - 263. Back
153
See Paton v United Kingdom (1980) 3 EHRR 408, in which
the applicant unsuccessfully challenged the Abortion Act 1964
on the basis that permitting an abortion to proceed without his
consent as the father would be in breach of the rights of the
foetus under Article 2 ECHR and his right to private and family
life as protected by Article 8 ECHR. See also Vo v. France,
App. No 53924/00, Judgment of 8 July 2004, in which the applicant
unsuccessfully claimed that it was in breach of the right to life
enjoyed by the foetus for French law to fail to require the doctor
who had negligently caused her to have a miscarriage to be prosecuted
for unintentional homicide. Back
154
Evans v. the United Kingdom, Judgment of 7 March 2006,
App. No. 6339/05. In this case, the Grand Chamber rejected the
applicant's claim that it was in breach of her rights under Articles
8 and 12 to require her former partner's consent to the use of
embryos which they had created and frozen after her treatment
for cancer left her infertile; See also Dickson v United Kingdom,
App No 44362/04, Judgment 4 December 2007. In this case, the Grand
Chamber decided that a blanket policy which barred access to artificial
insemination for prisoners, other than in very limited exceptional
circumstances, was disproportionate and in breach of the applicants'
right to respect for private life as protected by Article 8 ECHR. Back
155
Part 2. Back
156
Appendix 8. Back
157
Appendix 9 Back
158
Human Fertilisation and Embryology Act 1990, Section 31. Back
159
See for example, Gaskin v. UK (1989) 12 EHRR 36. In this
case the applicant successfully argued that a failure to provide
for independent adjudication on whether individuals should lawfully
be permitted to withhold their consent to his accessing files
held on his early years foster care was in breach of his right
to respect for private life under Article 8 ECHR. The Court concluded
that the applicant had a vital interest in receiving information
necessary to understand his childhood and early development. Back
160
Odievre v France, App. No 42326/98, Judgment 13 February
2003, paras 44 - 49. This case concerned French legislation
which allowed women who gave birth and surrendered their child
for adoption to do so anonymously. The applicant alleged that
it would breach her right to private life if the identity of her
genetic mother could be concealed subject to her consent to disclosure.
The Court considered that French legislation which would allow
a woman to waive anonymity in certain circumstances and to consent
to identifying information being presented would strike a fair
balance between the rights of the genetic mother, the applicant
and the wider interests of society. In this case, there was no
violation of Article 8 ECHR in the decision to allow identifying
information to be withheld. Back
161
Rose v Secretary of State for Health [2002] EWHC 1593 (Admin). Back
162
Article 7. Back
163
"Gillick competence" refers to guidelines approved by
a majority of the House of Lords in Gillick v West Norfolk
and Wisbech Area Health Authority (1986) 1 AC 112. Under this
test, a doctor may give advice and treatment to a child under
the age of sixteen in confidence and without the consent of the
child's parents if that child has sufficient maturity and intelligence
to understand the nature and implications of the proposed treatment
and provided that certain other conditions are satisfied. Back
164
Appendix 9, paras 9 - 11. Back
165
Reynolds v Secretary of State for Work and Pensions [2006]
1 AC 173, paras 85 - 91. In this case, the House of Lords decided
that it was not in breach of the right to the peaceful enjoyment
of possessions (Article 1, Protocol 1), taken together with Article
14 to discriminate between those under 25 and those over 25 when
setting rates for income support. Back
166
Human Fertilisation and Embryology Act 1990, Section 13(5). Back
167
Clause 14(2)(b). Back
168
House of Commons Science and Technology Committee, Fifth Report,
Session 2004-05, Human Reproductive Technologies and the Law,
HC 7-I, para 101. Back
169
See for example: HL Deb, 28 January 2008, Cols 449 - 450. Back
170
See for example, Fretté v France (2004) 38 EHRR
21, para 32. In addition, the Equality Act (Sexual Orientation)
Regulations 2007 (SI 2007/1263) provide that goods and services,
including healthcare, must be provided without discrimination
on the grounds of discrimination. If access to fertility treatment
by same sex couples was restricted as a result of the requirement
to consider "the need for a father", that action could
be considered unlawful, either as direct or indirect discrimination. Back
171
Sahin v Germany, App. No 30943/96, Judgment, 8 July 2003.
Back
172
Clause 23 (2); HL Deb, 21 January 2008, Col 55; HL Deb 28 January
2008, Cols 449 - 450. Back
173
Clause 8. Back
174
Clause 9. Back
175
EN, para 155; Appendix 9. Back
176
See for example, HL Deb, 28 January 2008, Cols 456 - 463. Back
177
Clause 25, new Section 33C. Back
178
Fourteenth Report of Session 2007-08, Data Protection
and Human Rights, HL Paper 72/HC 132, paras 15 - 21. Back
179
Appendix 9, para 22. Back
180
Fourteenth Report, Session 2007-08, Data Protection
and Human Rights, HL Paper 72, HC 132, paras 15 - 21. Back
181
See also Third Report, Session 2006-07, Legislative Scrutiny:
Second Progress Report, HL Paper 39, HC 287, para 3.11 - 3.16. Back
182
Appendix 9. Back
183
Appendix 9, para 39. Back
184
Clause 8, new Section 8C. Back
185
YL v Birmingham City Council & Ors, (2008) 1 AC 95. Back
186
For a fuller explanation of the Committee's view on the meaning
of public authority for the purposes of the Human Rights Act,
see Eighth Report, Session 2007-08, Legislative Scrutiny: Health
and Social Care Bill, HL Paper 46, HC 303, paras 1.6 - 1.24. Back
187
Appendix 9, para 57. Back
188
For a fuller explanation of the Committee's concerns about the
protection of human rights in contracted out services, see Seventh
Report, Session 2003-04, The Meaning of Public Authority under
the Human Rights Act, HL Paper 39, HC 382, paras 75 - 88.
See also Ninth Report, Session, The Meaning of Public Authority
under the Human Rights Act, HL Paper 77, HC 410. Back
189
Joint Committee on the Human Tissues and Embryos (Draft) Bill,
Session 2006-07, Report on the Human Tissues and Embryos (Draft)
Bill, HL Paper 169-I, HC 630-I, paras 267 - 276. Back
190
HL Deb, 28 January 2008, Cols 502 - 512. Back
191
HL Deb, 28 January 2008, Col. 502. Back
192
See for example, HL Deb, 28 January 2008, Col. 510. Back
193
Appendix 9, paras 45 - 49. See also, for example, HL Deb, 28 January
2008, Col. 509 - 510. Back
194
Appendix 9, paras 41 - 44. Back
195
Schedule 3. The terms of consent are detailed under the Bill and
must be express and specific in relation to the scope of the consent.
Any consent must be in writing and consent to use of any human
admixed embryo must specify the use for the purposes of a project
of research and may also specify conditions for which a human
admixed embryo may be used. Back
196
The Times, Stem cell research is vital and can save lives,
21 January 2008. Back
197
HL Deb, 4 February 2008, Col. 896 (Lord Walton of Detchant). Back
198
Letter from Lord Darzi of Denham to all peers who spoke during
debate on the Human Fertilisation and Embryology Bill dated 31
January 2008. Copies available from the House of Lords Library. Back
199
Letter from Lord Darzi of Denham to all peers who spoke during
debate on the Human Fertilisation and Embryology Bill dated 31
January 2008. Copies available from the House of Lords Library. Back
200
The Human Fertilisation and Embryology Act 1990 provides that
no license can authorise the keeping or use of an embryo after
the appearance of the primitive streak, which is assumed to have
taken place 14 days after its creation, not counting any time
the embryo spends in storage. The Bill will make similar provision
for human admixed embryos. Back
201
Evans v United Kingdom, App No 6339/05, Judgment 10 April
2007 (GC). Back
202
Schedule 3. Back
203
HL Deb, 4 February 2008, Col. 852. Back
204
Letter from Lord Darzi of Denham to all peers who spoke during
debate on the Human Fertilisation and Embryology Bill dated 31
January 2008. Copies available from the House of Lords Library. Back