- This
case is concerned with human leukocyte antigen typing, which is otherwise known
as tissue typing. It is a technique which enables an embryologist to ascertain
whether an embryo will produce a child whose tissue will match that of an existing
person. Such a match would enable that child to act as a donor for an older sibling
with a serious genetic disorder by the donation of stem cell material from the
umbilical cord. The issue is whether the Human Fertilisation and Embryology (HFEA)
has the power to permit tissue-typing in conjunction with pre-implantation genetic
diagnosis or PGD. This technique involves three stages: (1) an in vitro
embryo is permitted to develop to the 6-8 cell stage which occurs three days after
fertilisation; (2) one or two cells are removed from it by the process of embryo
biopsy; (3) genetic material from the extracted cells is then taken and analysed.
In this way it is possible to see whether the original embryo will develop into
a child with matching tissue. No one doubts that this technology is capable of
producing benefits –for example, to the family whose circumstances are in evidence
in this case, the child of whom suffers from beta thalassaemia major and whose
best hope for a normal and longer life would be the transfer of blood stem cells
from a matched sibling donor. On the other hand, nor does anyone doubt that such
procedures raise serious ethical issues.
- The
HFEA was established by section 5 of the Human Fertilisation and Embryology Act
1990 ("the Act"). By section 11(1) it is empowered to grant
"the
following and no other licences –
(a)
licences under paragraph 1 of Schedule 2…authorising activities in the course
of treatment services…."
"Treatment
services" are defined in section 2(1) as
"medical,
surgical or obstetric services provided to the public or a section of the public
for the purpose of assisting women to carry children."
Paragraph
1 of Schedule 2 provides:
"(1)
A licence under this paragraph may authorise any of the following in the course
of providing treatment services –
(a)
bringing about the creation of embryos in vitro,
(b)
keeping embryos,
(c)
using gametes,
(d)
practices designed to secure that embryos are in a suitable condition to be placed
in a woman or to determine whether embryos are suitable for that purpose.
(e)
placing any embryo in a woman….
(2)
Subject to the provisions of this Act, a licence under this paragraph may be granted
subject to such conditions as may be specified in the licence and may authorise
the performance of any of the activities referred to in sub-paragraph (1) above
in such manner as may be so specified.
(3)
A licence under this paragraph cannot authorise any activity unless it appears
to the Authority to be necessary or desirable for the purpose of providing treatment
services…."
I
shall have to refer to other aspects of the licensing system later. The other
side of the coin is what the Act prohibits. Section 3, which is headed "Prohibitions
in connection with embryos", provides:
"(1)
No person shall –
(a)
bring about the creation of an embryo, or
(b)
keep or use an embryo except in pursuance of a licence."
- On
13 December 2001 the HFEA issued a press release under the heading "HFEA
to allow tissue typing in conjunction with pre-implantation genetic diagnosis".
It described PGD and referred to tissue typing as "an additional step whereby
the embryo is simultaneously tested for its tissue compatibility with an affected
sibling". It added
"Before
this technique can be used in treatment, approval will be required from an HFEA
Licence Committee which will consider applications on a case-by-case basis. If
licences are issued, these will be subject to strict conditions."
- At
the time of the press release the HFEA had before it an application from a clinic
for a licence to perform PGD screening for beta thalassaemia and tissue typing
in relation to the family to whom I referred earlier. On 22 February 2002, the
Licence Committee granted the clinic a licence in relation to (amongst other things)
PGD pre-implantation genetic screening for aneuploidy, subject to many conditions,
including one forbidding the use of information derived from tests on an embryo
or any material removed from it to select embryos of a particular sex "for
social reasons".
- The
present application for judicial review is brought by Josephine Quintavalle on
behalf of Comment on Reproductive Ethics (CORE), a group whose purpose is "to
focus and facilitate debate on ethical issues arising from human reproduction
and, in particular, assisted reproduction". Its standing to bring the application
was questioned by the HFEA in its Acknowledgment of Service but no point has been
taken about it since Crane J granted permission to apply.
- In
a nutshell, the case for CORE is that (1) tissue typing is prohibited by section
3(1)(b) as it involves the use of an embryo but (2) it cannot be licensed under
Schedule 2 because it cannot be said to arise in the course of providing "treatment
services" or to be necessary or desirable for the purpose of providing "treatment
services". This is said to flow from the definition of "treatment services"
as services "for the purpose of assisting women to carry children" and
the fact that the purpose of tissue typing is not to assist a woman to carry a
child but to relieve the suffering of another child. The case for the HFEA at
the permission hearing was that tissue typing can be licensed on the basis that
it is necessary or desirable for the purpose of assisting women to carry children.
At the substantive hearing, that has now been relegated to an alternative submission.
Now the primary submission on behalf of the HFEA is that tissue typing does not
in itself require a licence because it is performed not on an embryo but on cells
extracted from an embryo. However, it can be regulated by the imposition of conditions
on a licence permitting PGD. In Supplementary Grounds of Opposition dated 31 July
2002 it was suggested that suitable conditions to be imposed on a licence might
include (a) that no material recovered from an embryo may be subjected to a test
which supplies genetic information about the embryo that is not listed in an annex
to the licence or specifically approved by a licence committee in any particular
case; and (b) that no embryo may be transferred to a woman where any material
removed from it has been subject to a test which supplies genetic information
about the embryo that is not listed in an annex or approved by a licence committee
in any particular case. These conditions are among those imposed in the licence
which was granted on 22 February 2002.
- The
task of the Court in this case is legal rather than ethical. That much is common
ground. The task is one of statutory interpretation. As such, it is unaffected
by the perceptions or changes in the perceptions of others as to what the law
is or ought to be. The importance and sensitivity of the subject is illustrated
by a passage in the report of the House of Commons Select Committee on Science
and Technology which was published on 18 July 2002. The Committee had received
evidence from Dame Ruth Deech, the then Chair of the HFEA. The report is critical
of the HFEA’s approach to tissue typing, saying that it "went beyond the
scope of its own public consultation". It seems, that Dame Ruth had expressed
the view that it was desirable for the HFEA to take such decisions because "this
protects Members of Parliament from direct involvement in that sort of thing".
The Committee replied (at para 26):
"Parliament
does not need protecting and democracy is not served by unelected quangos taking
decisions on behalf of Parliament."
I
include reference to this spat out of historical interest. I accept that it has
no bearing on the task of statutory interpretation. Before I turn to that task,
it is appropriate for me to recount a little more history.
- In
July 1982 the Committee of Inquiry into Human Fertilisation and Embryology was
established to examine the social, ethical and legal implications of recent and
potential developments in the field of human assisted reproduction. It was chaired
by Dame Mary (now Baroness) Warnock. It reported in June 1984. Following a period
of consultation, in November 1987 the Department of Health and Social Security
published a White Paper, Human Fertilisation and Embryology: A Framework for
Legislation. This led to the eventual enactment of the Act, the long title
to which describes it as an Act
"to
make provision in connection with human embryos and any subsequent development
of such embryos; to prohibit certain practices in connection with embryos and
genetics; to establish [the HFEA] "
Section
1(1)(a) provides that, except where otherwise stated, "embryo means a live
human embryo where fertilisation is complete".
- In
R (Quintavalle) v. Secretary of State for Health [2002] EWCA Civ
29 the primary issue was whether an organism created by cell nuclear replacement
came within the definition of an embryo in section 1(1). The Court of Appeal,
on the basis of a purposive construction, held that it did. Lord Phillips of Worth
Matravers MR described the policy of the Act as follows (paras. 36-38):
"The
Act brings the creation and use of embryos within a regulatory regime which very
severely restricts the right to indulge in those activities. The reasons for legislating
to impose these restrictions are not in doubt. They are essentially ethical…..
Broadly
speaking it can be said that the legislative policy was that it was essential
to bring the creation and use of embryos under strict regulatory control for ethical
reasons.
To
the question of whether it is necessary to bring embryos created by cell nuclear
replacement within the regulatory regime created by the Act in order to give effect
to the intention of Parliament, there can only be one answer. It is essential.
There is no factor that takes embryos created by cell nuclear replacement outside
the need, recognised by Parliament, to control the creation and use of human organisms."
I
am told that that case is the subject of an appeal to the House of Lords which
is to be heard ‘in about three months’ time. However, it is presently binding
on this Court and, in any event, I respectfully agree with it. I take the view
that, in relation to an area such as this, the purpose of the legislation must
play a very important part in its interpretation if that interpretation is open
to doubt.
- I
now turn to the issues of interpretation which arise. I gratefully adopt the two
headings used by Miss Rose in her Skeleton Argument.
(1)
Is tissue typing governed by the Act?
- The
first question is whether tissue typing involves the "use" of "an
embryo" within the meaning of section 3(1)(b). If it does not, then it falls
outside the prohibition and is lawful without the need for a licence. The case
for the HFEA is a simple one. It accepts that embryonic biopsy, involving the
extraction of one or two cells from an embryo, involves the use of an embryo.
However, once such cells have been removed from an embryo pursuant to a licence
for the purpose of PGD, the carrying out of further tests on them does not amount
to the use of an embryo.
- In
my judgment this interpretation of section 3(1)(b) is incorrect. Tissue typing
involves the use of an embryo for the following reasons. First, tissue
typing involves the testing of an embryonic cell – a term used by Miss Rose and
one consonant with the language of the HFEA press release which gave rise to these
proceedings:
"….an
additional step whereby the embryo is simultaneously tested for its tissue
compatibility with an affected sibling."
Secondly,
section 3 is headed "Prohibitions in connection with embryos". The words
"in connection with" militate against a narrow construction. Thirdly,
it is common ground that tissue typing has a potential for misuse. That is why
the HFEA would only countenance it – in the words of its Chief Executive – "in
very rare circumstances and under strict controls". Although the HFEA is
entrusted by the Act with the making of many difficult decisions, it acts within
ground rules set by the Act. I find it inconceivable that an Act which goes to
great lengths to provide for the statutory control of the persons by whom and
the places at which controversial activities are carried out and subject to inspection,
was intended by Parliament to leave an activity such as tissue typing outside
the direct control of the Act. It cannot have been the intention of Parliament
to draw a line between the extraction of embryonic cells, which in itself gives
rise to no real ethical problem, and the subsequent genetic testing of them, which
has the potential for misuse. The distinction is artificial, unattractive and
unnecessary, having regard to the policy of the Act as explained by the Master
of the Rolls.
- Fourthly,
when one considers the structure of the Act as a whole, it is plain to see that,
to the extent that it addressed the testing of embryonic material, it did so within
the context of the licensing system. Schedule 2, paragraph 1(1) provides that
a licence may authorise:
"any
of the following in the course of providing treatment services…..
"(d)
practices designed to secure that embryos are in a suitable condition to be placed
in a woman or to determine whether embryos are suitable for that purpose.
That
is a licence in relation to the "use" of an embryo within the meaning
of section 3(1)(b). The fact that the licences enabled by Schedule 2, paragraph
1(1), are limited to those there specified or "such other practices as may
be specified in, or determined in accordance with, regulations" (paragraph
1(1)(g)) suggests that anything not specified in paragraph 1(1) is unlawful unless
its licensing is permitted by some future regulation. Miss Rose submits that it
is inappropriate to use Schedule 2 as an aid to construe section 3(1) but these
two parts of the Act are the two sides of the prohibition/licence coin and, in
my judgment, it is appropriate and necessary to consider one by reference to the
other.
- For
all these reasons I am satisfied that tissue typing falls within the prohibition
of section 3.
(2)
Can tissue typing be authorised under the Act?
- Miss
Rose’s alternative submission is that, if tissue typing is an activity governed
by the Act, it can lawfully be authorised by the HFEA by way of a licence. The
case for the Claimant is that it cannot. Mr. Gordon QC submits that (1) the Act
provides an exhaustive list of activities which may be authorised by a licence;
(2) a licence under Schedule 2, paragraph 1, cannot authorise any activity "unless
it appears to the Authority to be necessary or desirable for the purpose of providing
treatment services (paragraph 1(3)); (3) "treatment services" are services
provided "for the purpose of assisting women to carry children (section 2(1));
(4) the purpose of tissue typing is not to assist women to carry children but
to ensure that a child born to the particular woman will have tissue – compatibility
with an affected sibling.
- There
can be no doubt that the Act provides an exhaustive list of activities which may
be licensed by the HFEA. This is made clear by the language of section 11(1) –
"may grant the following and no other licences". The dispute
in this case is whether the purpose of tissue typing is one of "assisting
women to have children". It is submitted on behalf of the HFEA that, at least
in the circumstances of the present case, it is. Miss Rose contends for a broad
construction of the Act in the following stages: (1) the definition of "treatment
services" in section 2(1) is intended to be a wide definition of the forms
of treatment falling within the Act and should be construed as being broadly synonymous
with "fertility treatment"; (2) paragraph 1(3) of Schedule 2 does no
more than to make it clear that the HFEA cannot authorise an activity under a
licence unless it considers such an activity to be at least desirable for the
overall purpose of providing fertility treatment; and (3) to assist a woman to
carry a child with a particular characteristic – whether it be freedom
from genetic disorder or tissue compatability with an affected sibling – is an
activity which is desirable for that permitted purpose. Miss Rose accepts with
equanimity that such a construction might open the door to the use of PGD for
what is sometimes called "social selection" – for example selection
based on sex. Her answer is that it is the job of the HFEA to determine what is
acceptable and what is not through the licensing system and the HEFA, as a mixed
body of clinicians, religious leaders, ethicists and others, can be trusted to
grapple with the difficult questions that will arise. She then seeks to turn Mr.
Gordon’s argument round by submitting that, if he is right, it is not only tissue
typing but PGD generally which would be unlawful. That is something which this
case does not require me to resolve.
- In
my judgment, the construction for which Miss Rose contends is not correct. When
"treatment services" have been defined with a high degree of specificity
by section 2(1), it is not appropriate to rewrite that definition as being "broadly
synonymous with fertility treatment". Moreover, section 2(1) expressly defines
"treatment services" by reference to a single purpose – that of "assisting
women to carry children". To take the example of the unfortunate family whose
problems have given rise to this case – it is not suggested that those problems
arise from an impaired ability to conceive or to carry a child through pregnancy
to full term and birth. The sole purpose of tissue typing is to ensure that any
such child would have tissue compatibility with its older sibling. I do not consider
that it can be said to be "necessary or desirable" for the purpose of
assisting a woman to carry a child. The carrying of such a child after implantation
would be wholly unaffected by the tissue typing. It seems to me that the language
of the Act does not bear the strain which would be necessary to read "with
particular characteristics" into the carrying of a child. Nor do I find it
appropriate to resort to the Warnock Report as an aid to construction. The Report
was indeed the catalyst for the Act and the HFEA but it did not anticipate the
detailed statutory structure which is highly specific and restrictive, as the
Master of the Rolls observed in the other Quintavalle case (above).
There is no reason to give the language of the Act anything other than its ordinary
meaning in the context of the purpose which was identified in that case.
- Miss
Rose’s final submission is that, as section 3 of the Human Rights Act 1998 requires
me to construe the 1990 Act compatibly with Convention rights so far as it is
possible to do so, the right of the parents to respect for their private and family
life (Article 8) and the right of life of their existing child (Article 2) compel
the construction for which she contends. I reject this submission because I find
no incompatibility between the proper construction (as I have held it to be) and
Convention rights. This case is in the form of a challenge to the HFEA on the
basis that it has exceeded the powers which Parliament conferred on it. Parliament
plainly enjoyed a margin of appreciation in that respect. It seems that the activity
which the HFEA seeks to licence is one which is unlawful in most, if not all,
Convention countries. In these circumstances it is difficult to see how the present
case exhibits breaches of Convention rights.
Conclusion
- If
follows from what I have said that this application for judicial review succeeds.
I shall hear counsel further on the form of relief, although if they are able
to agree it and other ancillary matters there will be no need for them to attend
when the judgment is handed down.
- I
wish to make it clear that I have great sympathy with the family whose tragic
circumstances may be said to have given rise to this case and I respect the sincerity
of the views of those who wish to help them. This is a difficult area of medical
science and ethics. On any reading of it, the legislation has been tightly drawn
so as to ensure that the ground rules within which the HFEA operates restrict
the potential for misuse of science and technology. The pace of development in
this area in the last decade shows the sense of that. It is pertinent to observe
that when the HFEA and the Human Genetics Commission carried out a consultative
process in 2001 it produced the recommendation that there were sufficient ethical
difficulties with tissue typing to need further discussion before its use was
considered.