- Mr
and Mrs Hashmi have five children. The fourth, a son Zain was born with a blood
disorder known as beta thalassaemia major. By the time that he was 2½ years old
this had reduced him to a parlous condition, requiring him to take a daily cocktail
of drugs and to submit to regular blood transfusions in hospital in order to remain
alive. His life expectancy is uncertain. Mrs Hashmi had been aware that she had
a genetic predisposition to producing children with this disorder and, when pregnant
with Zain had undergone prenatal testing to see whether, if she carried Zain to
term, he would be born with the disorder. The test failed to disclose that this
was indeed the position.
- Zain’s
condition might be cured by a transplant of stem cells from someone with matching
tissue. The stem cells could be supplied from blood taken from the umbilical cord
of a new born child, or from bone marrow. The most likely source of matching tissue
would be a sibling, for statistically Mrs Hashmi has one chance in four of producing
a child with matching tissue, although the odds are somewhat longer of producing
such a child who is not affected with beta thalassaemia major. None of Zain’s
three elder siblings have tissue that matches his.
- Mrs
Hashmi resolved to have another child, in the hope that it would have matching
tissue. She conceived, but prenatal testing showed that the child would have beta
thalassaemia major, so she underwent an abortion. She conceived again, and a healthy
son was born, but unfortunately his tissue did not match that of Zain.
- At
this point Mrs Hashmi met Dr Simon Fishel, the Managing and Scientific Director
of Centres for Assisted Reproduction Limited (‘CARE’). CARE is the largest single
provider of in vitro fertilisation (‘IVF’) services in the United Kingdom. It
provides these services at various locations both to NHS and private patients.
Dr Fishel told Mrs Hashmi of a procedure, at the cutting edge of technology, that
had been developed at the Reproductive Genetics Institute (‘RGI’) in Chicago in
the United States and which might provide the solution to her problem. In summary,
that procedure would include the following stages:
- The
fertilisation ‘in vitro’ (‘IVF’) of a number of eggs taken from Mrs Hashmi with
sperm taken from her husband to form embryos.
- The
removal from the developing embryo of a single cell by a biopsy.
- The
examination of that cell using molecular genetics to see whether the embryo carried
the beta thalassaemia disease. This process is commonly described as ‘Pre-implantation
Genetic Diagnosis [‘PGD’].
- Use
simultaneously of the same process to identify whether the embryo had the same
tissue type as Zain. Because this process involves examination of proteins known
as human leukocyte antigens (‘HLA’), this form of PGD is described as ‘HLA typing’.
I shall refer to it by the more popular phrase of ‘tissue typing’.
- Jettison
of embryos found by this analysis to be either disease bearing or of a different
HLA type to Zain and implantation in the womb of Mrs H of an embryo shown to be
disease free and of the same HLA as Zain.
- Mrs
Hashmi asked Dr Fishel whether it would be possible for her to be impregnated
in this country with an embryo created and selected in this way. IVF treatment
can only be carried out in this country under licence issued by the appellant
(‘HFEA’) pursuant to the Human Fertilisation and Embryology Act 1990 (‘the Act’).
For some years PGD screening against genetic disease had been carried out as part
of IVF treatment licensed by the HFEA. Tissue typing had never, however, been
carried out as part of such treatment and Dr Fishel considered that this procedure
required express authorisation under licence from HFEA. After careful consideration
of the implications, CARE applied to the HFEA for a ruling as to whether an IVF
clinic could properly apply for a licence to administer treatment including tissue
typing.
- The
HFEA announced their decision in a press release on 13 December 2001. They would
be prepared in principle to grant a licence for treatment that included tissue
typing, subject to a number of conditions. The HFEA decided that tissue typing
should only be permitted where PGD was already necessary to avoid the passing
on of a serious genetic disorder. They also decided that licences permitting PGD
in conjunction with tissue typing should only be granted on a case by case basis.
Such licences would only be granted subject to the following conditions:
a) The
condition of the affected child should be severe or life threatening, of a sufficient
seriousness to justify the use of PGD
b) The
embryos should themselves be at risk of the condition affecting the child
c) All
other possibilities of treatment and sources of tissue for the affected child
should have been explored
d) The
techniques should not be available where the intended recipient is a parent
e) The
intention should be to take only cord blood for the purposes of the treatment
f) Appropriate
counselling should be given to the parents
g) Families
should be encouraged to take part in follow-up studies
h) Embryos
should not be genetically modified to provide a tissue match
- In
accordance with this decision, on 22 February 2002, the HFEA granted a licence
to Park Hospital operated by CARE in Nottingham to carry out IVF treatment that
included PGD for ‘beta thalassaemia in conjunction with HLA typing for patients
known as Mr and Mrs H’.
- Mr
and Mrs Hashmi then made two attempts to produce a child by IVF treatment involving
PGD and tissue typing. In the first IVF was effected at Park Hospital. 15 embryos
were produced. The biopsied cells from those were then flown to RGI in Chicago
for genetic analysis, while the embryos were frozen awaiting the results. Only
one embryo proved to have an exact tissue match, but it carried the beta thalassaemia
disease. Mr and Mrs Hashmi travelled to RGI for the second attempt. 10 embryos
were produced. Two of these proved disease free and to have a tissue match with
Zain. One was implanted in Mrs Hashmi, but no pregnancy resulted.
Mr
and Mrs Hashmi were prevented from a further attempt by the judgment that is the
subject of this appeal.
The
science involved
- Dr
Fishel in his witness statement described how PGD in conjunction with tissue typing
is carried out by the RGI. There is no need to attempt to describe the entire
process; it suffices to identify the following two stages.
- About
3 days after in vitro fertilisation, when the embryo has sub-divided into 8 cells,
one of these cells is removed by a biopsy.
- The
genetic material in the cell is then tested with a genetic probe, the DNA sequence
of which has been so prepared as to identify whether there is a tissue match and
whether the embryonic tissue contains any form of thalassaemia disease.
The
Challenge
- The
Respondent, Josephine Quintavalle, acts on behalf of Comment on Reproductive Ethics
(‘CORE’). CORE is a group whose purpose is ‘to focus and facilitate debate on
ethical issues arising from human reproduction and, in particular, assisted reproduction’.
Absolute respect for the human embryo is a principal tenet of CORE. The respondent
sought and obtained permission to seek judicial review of the HFEA’s decision
announced on 13 December 2001. She challenged that decision on the ground that
the HFEA had no power to issue a licence that permitted the use of HLA typing
to select between healthy embryos. Her challenge succeeded. On 20 December 2002
Maurice Kay J. gave judgment in her favour, quashing the HFEA’s decision.
- Maurice
Kay J. gave permission to appeal against his judgment to this Court because of
the importance of the issue of whether tissue typing can lawfully be licensed
by the HFEA. The Secretary of State for Health was concerned that the judgment
has wider implications - in particular that it puts in doubt the legitimacy of
the beneficial practice of PGD screening for genetic diseases. Accordingly the
Secretary of State obtained permission to intervene to support the HFEA’s appeal.
The
Act
- The
1990 Act was passed "to make provision in connection with human embryos and
any subsequent development of such embryos; to prohibit certain practices in connection
with embryos and gametes; to establish a Human Fertilisation and Embryology Authority",
and for other purposes.
- The
following provisions of the Act are particularly material:
2. (1) In
this Act -
…
‘treatment
services’ means medical, surgical or obstetric services provided to the public
or a section of the public for the purpose of assisting women to carry children.
Activities
governed by the Act
3. Prohibitions
in connection with embryos
(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.
5. The
Human Fertilisation and Embryology Authority
(1) There
shall be a body corporate called the Human Fertilisation and Embryology Authority.
Scope
of licences
11. Licences
for treatment, storage and research
(1) The
Authority may grant the following and no other licences -
(a) licences
under paragraph 1 of Schedule 2 of this Act authorising activities in the course
of providing treatment services,
(b) licences
under that Schedule authorising the storage of gametes and embryos, and
(c) licences
under paragraph 3 of that Schedule authorising activities for the purposes of
a project of research."
Licence
conditions
12. General
conditions
The
following shall be conditions of every licence granted under this Act -
(a) that
the activities authorised by the licence shall be carried on only on the premises
to which the licence relates and under the supervision of the person responsible."
13. Conditions
of licences for treatment
(1) The
following shall be conditions of every licence under paragraph 1 of Schedule 2
to this Act.
….
(5) A
woman shall not be provided with treatment services unless account has been taken
of the welfare of any child who may be born as a result of the treatment (including
the need of that child for a father), and of any other child who may be affected
by the birth
SCHEDULE
2
ACTIVITIES
FOR WHICH LICENCES MAY BE GRANTED
Licences
for treatment
1. (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,
(f) mixing
sperm with the egg of a hamster, or other animal specified in directions, for
the purpose of testing the fertility or normality of the sperm, but only where
anything which forms is destroyed when the test is complete and, in any event,
not later than the two cell stage, and
(g) such
other practices as may be specified in, or determined in accordance with, regulations.
(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"
Licences
for research
3. (1) A
licence under this paragraph may authorise any of the following -
(a) bringing
about the creation of embryos in vitro, and
(b) keeping
or using embryos,
for
the purposes of a project of research specified in the licence.
(2) A
licence under this paragraph cannot authorise any activity unless it appears to
the Authority to be necessary or desirable for the purpose of -
(a) promoting
advances in the treatment of infertility,
(b) increasing
knowledge about the causes of congenital disease,
(c) increasing
knowledge about the causes of miscarriages,
(d) developing
more effective techniques of contraception,
or
(e) developing
methods for detecting the presence of gene or chromosome abnormalities in embryos
before implantation,
or
for such other purposes as may be specified in regulations.
(3) Purposes
may only be so specified with a view to the authorisation of projects of research
which increase knowledge about the creation and development of embryos, or about
disease or enable such knowledge to be applied.
….
(6) No
licence under this paragraph shall be granted unless the Authority is satisfied
that any proposed use of embryos is necessary for the purposes of the research.
General
4.
(1) A licence under this Schedule can only authorise activities to be carried
on on premises specified in the licence and under the supervision of an individual
designated in the licence.
(2) A
licence cannot -
(a) authorise
activities falling within both paragraph 1 and paragraph 3 above,
(b) apply
to more than one project of research,
(c) authorise
activities to be carried on under the supervision of more than one individual,
or
(d) apply
to premises in different places."
- For
present purposes it is important to note the following scheme of the Act. Section
3 prohibits the creation or use of an embryo except in pursuance of a licence.
Section 11 restricts the power of the Authority to grant licences by reference
to the provisions of Schedule 2. Schedule 2 sets out lists of activities which
may be authorised by a licence and makes provision for adding to these by regulations.
So far as treatment is concerned, the Authority is, however, subject to the overriding
restriction that it cannot authorise any activity unless it appears necessary
or desirable for the purpose of providing ‘treatment services’.
The
Issues before the Judge
- Before
Maurice Kay J two issues were canvassed:
- Does
genetic analysis of a cell taken from an embryo involve the ‘use of an embryo’?
- Is
genetic analysis for the purpose of tissue typing ‘necessary or desirable for
the purpose of providing treatment services’?
- The
first issue arose out of the submission on behalf of HFEA that tissue typing did
not require a licence because it was performed on a cell extracted from an embryo
rather than the embryo itself. HFEA accepted that the removal of the cell by a
biopsy constituted ‘use of an embryo’, but submitted that testing the cell thereafter
did not constitute such use. Mrs Quintavalle contended that tissue typing did
constitute ‘use of an embryo’ and, in consequence, could not be carried on without
a licence.
- The
second issue arose only if the HFEA failed on the first issue. In that event the
HFEA contended that they could lawfully licence such use in that tissue typing
was ‘desirable for the purpose of rendering treatment services’. The HFEA argued
that the relevant test was whether the activity under consideration was ‘at least
desirable for the overall purpose of providing fertility treatment’.
- Mrs
Quintavalle relied upon the definition of ‘treatment services’ and submitted that
it could not be said that tissue typing was for the purpose of those services.
The purpose of tissue typing was not to ‘assist women to carry children’ but to
ensure that a child born to a particular woman would have tissue that was compatible
with the tissue of a sibling.
The
Judgment of Maurice Kay J.
- The
Judge held against the HFEA on both issues. There were a number of reasons why
he held that tissue typing involved the use of an embryo, including the fact that
it was inconceivable that Parliament intended to leave an activity such as tissue
typing, which had potential for misuse, outside the control of the Act. As to
the second issue he observed that tissue typing of an embryo had no impact on
the ability of a woman to carry the embryo after implantation. In those circumstances
it could not be said that tissue typing was ‘necessary or desirable for the purpose
of assisting a woman to carry a child’.
The
issues before us
- Mr
Pannick QC, who appeared for HFEA, accepted that the first issue considered by
Maurice Kay J. did not go to the heart of the case. He recognised that the primary
object of carrying out a biopsy of each embryo was to carry out tissue typing
of the cell that was removed. It was common ground that the biopsy involved ‘using’
the embryo. If the tissue typing was not carried out ‘for the purpose of assisting
a woman to carry a child’, then the biopsy could not be said to be for that purpose
either. More broadly Mr and Mrs Hashmi’s case demonstrated the true nature of
treatment involving tissue typing. The primary object of the entire treatment,
comprehending creation of the embryo, biopsy for PGD and tissue typing, the analysis
of the cell removed by the biopsy and the implantation of the embryo, if it proved
to be free of disease and a tissue match for Zain, was to produce a child whose
umbilical cord would provide the stem cells which might save Zain’s life. The
vital question was whether this treatment was ‘for the purpose of assisting a
woman to carry a child’.
- Mr
Pannick submitted that the answer to this question was ‘yes’. He submitted that
the Judge had wrongly concluded that treatment services had to have as their sole
object the assistance of the physical process of producing a child. IVF coupled
with PGD was a practice aimed at enabling women to have children free of hereditary
diseases. Analysis of the Act, and of background material to which it was legitimate
to have resort, demonstrated that treatment services extended to embrace PGD designed
to prevent the implantation of embryos which would result in the birth of a children
carrying genetic defects. Such screening assisted a woman to carry a child because
it gave her the knowledge that the child would not be born handicapped. Without
such knowledge some women who carried genetic diseases would not be prepared to
have children. In the same way tissue typing would assist Mrs Hashmi to carry
a child, for her wish to do so was conditional upon knowing that the birth of
that child would be capable of saving the life and health of Zain.
- Mr
Pannick accepted that under this reasoning PGD with the object of ensuring that
a child had certain characteristics for purely social reasons might also be said
to be ‘for the purpose of assisting women to carry children’ but submitted that
it was for the Authority to control PGD to ensure that this was not used for purposes
which were ethically objectionable. That accorded with the scheme of the Act.
It was only practices that were unquestionably objectionable that were prohibited
by the legislation. PGD for the purpose of avoiding genetic defects was not objectionable
at all.
- Mr
Pannick accepted that it would not be enough for him to show that tissue typing
was a practice that assisted women to carry children. He had to show that a biopsy
with the object of tissue typing was one of the specific activities listed in
paragraph 1 (1) of Schedule 2. He submitted that it fell within:
(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
Suitability
could have regard to the desired characteristics of the child that would be produced
by the embryo.
- Mr
Dingemans QC, for Mrs Quintavalle, challenged these submissions. He did not abandon
the primary submission that ‘treatment services’ only extended to services designed
to assist women in overcoming problems in conceiving and carrying a child to term.
Most of his energies were, however, directed to an alternative argument. Even
if PGD for the purpose of screening out genetic defects fell within the definition
of ‘treatment services’, such a practice differed in principle from PGD screening
designed to reject healthy and viable embryos because they lacked some desired
characteristic. While the former might be said to assist a woman in carrying a
child the latter certainly could not.
Background
material
- Maurice
Kay J. did not consider it necessary to resort to background material when interpreting
the Act but before us both parties devoted much time to exploring the history
of the legislation. I have found this a helpful exercise because that history
bears closely on the issue of construction that we have to resolve. The House
of Lords in R (Quintavalle) v Secretary of State for Health [2003] UKHL
692; [2003] 2 WLR 692 recently considered another issue of construction of the
Act raised by Mrs Quintavalle and Lord Bingham of Cornhill gave the following
summary of the legislative history and purpose of the Act. This is a good starting
point.
"11. The
birth of the first child resulting from in vitro fertilisation in July 1978 prompted
much ethical and scientific debate which in turn led to the appointment in July
1982 of a Committee of Inquiry under the chairmanship of Dame Mary Warnock DBE
to
‘consider
recent and potential developments in medicine and science related to human fertilisation
and embryology; to consider what policies and safeguards should be applied, including
consideration of the social, ethical and legal implications of these developments;
and to make recommendations.’
The
Committee reported in July 1984 (Cmnd 9314). A White Paper, Human Fertilisation
and Embryology: A Framework for Legislation, was published in November 1987 (Cm
259) when the Department of Health and Social Security recognised, at para 6,
‘the particular difficulties of framing legislation on these sensitive issues
against a background of fast-moving medical and scientific development.’
12. There
is no doubting the sensitivity of the issues. There were those who considered
the creation of embryos, and thus of life, in vitro to be either sacrilegious
or ethically repugnant and wished to ban such activities altogether. There were
others who considered that these new techniques, by offering means of enabling
the infertile to have children and increasing knowledge of congenital disease,
had the potential to improve the human condition, and this view also did not lack
religious and moral arguments to support it. Nor can one doubt the difficulty
of legislating against a background of fast-moving medical and scientific development.
It is not often that Parliament has to frame legislation apt to apply to developments
at the advanced cutting edge of science.
13. The
solution recommended and embodied in the 1990 Act was not to ban all creation
and subsequent use of live human embryos produced in vitro but instead, and subject
to certain express prohibitions of which some have been noted above, to permit
such creation and use subject to specified conditions, restrictions and time limits
and subject to the regimes of control briefly described in paragraph 4 above.
The merits of this solution are not a matter for the House in its judicial capacity.
It is, however, plain that while Parliament outlawed certain grotesque possibilities
(such as placing a live animal embryo in a woman or a live human embryo in an
animal) it otherwise opted for a strict regime of control. No activity within
this field was left unregulated. There was to be no free for all."
- Neither
party now suggests that tissue typing is an activity that is left unregulated
by the Act. The issue is whether it is absolutely prohibited by the Act, whether
it is an activity that the Secretary of State could by regulation permit to be
licensed but has not yet done so, or whether it is a practice which can be licensed
because it falls within paragraph 1(1)(d) of Schedule 2. A more detailed analysis
of the background material is needed to assist in resolving this issue.
The
Warnock Report
- The
first eight chapters of the Warnock Report address techniques for the alleviation
of infertility. Chapter 9 is headed ‘The Wider Use of these Techniques’. This
addresses the problem of hereditary diseases. It contemplates the possibility
of avoiding transmission of a gender linked hereditary disease by PGD screening
for gender to avoid implantation of embryos with the vulnerable gender. It states:
We
see no reason why, if a method of selecting the sex of a child before fertilisation
is developed, this should not be offered to couples who have good medical reasons
for choosing the sex of their child.
The
Report goes on to consider the possibility of gender selection for purely social
reasons and concludes that it is not possible to make positive recommendations
on this issue other than that the acceptability of such a practice should be kept
under review.
- Chapter
12 of the Report is headed ‘Possible Future Developments in Research’. This opens
with the following comments:
"12.1 There
is a number of specific techniques and procedures involving the use of human embryos
which have caused much public anxiety. Many of these have not yet reached the
stage where they are practical possibilities. We believe that our recommendations
for the regulation of research will allay much of that anxiety, as it will be
the duty of the proposed licensing body (13.3) to keep these and other new techniques
under constant review; indeed, in some instances our proposals will preclude certain
developments altogether. It is important, however to consider whether further
restrictions are required, although it must be borne in mind that we cannot foresee
all possible developments."
- The
Chapter specifically considers the possibility of embryonic biopsy followed by
PGD in order to diagnose whether an embryo is genetically abnormal and concludes
that this is unlikely to become feasible for a considerable time.
- Chapter
13 of the Report recommends the establishment of a new statutory licensing authority
both to regulate those infertility services which should be subject to control
and to licence research involving the use of embryos in circumstances where this
is justified by the objectives of the research.
The
White Paper
- The
White Paper, produced after consultation on the Warnock Report, announced the
Government’s intention to create a Statutory Licensing Authority. As recommended
in the Warnock Report one function of this Authority would be to licence the provision
of ‘infertility services’. So far as research was concerned, however, the consultation
process had disclosed strongly conflicting views. The Government proposed to leave
it to Parliament to decide whether the Authority’s role should extend to licensing
embryo research, or whether such research should be absolutely prohibited.
- The
White Paper set out in an annex the arguments for and against permitting the licensing
of research. Arguments in favour included:
"49. It
is argued that the greatest potential benefits of research involving human embryos
lie in the prevention of congenital disorders. Studies of eggs, sperm and early
embryos may lead to ways of preventing some chromosomal abnormalities developing.
Also, in the future, those who support research envisage the development of techniques
including embryo biopsy which might allow the very early detection of embryos
which had single gene or chromosome defects which would result in seriously abnormal
babies. In the UK some 7,000 babies a year (about 1 per cent of all babies) are
born with an obvious single gene inherited defect. Pre-implantation ‘diagnosis’
could ultimately result in some fall in that number."
A
footnote explained:
"1. Male
infertility is the sole cause in about 30 per cent of cases of infertility and
it is a factor in some others.
2. The
technique of embryo biopsy could extend the use of IVF from treating infertile
couples to those at risk of passing on an hereditary handicap. It would involve
the removal and culture of one or two cells from an embryo still in vitro and
need not affect the subsequent development of the embryo. It could, however, give
the possibility in some instances of rejecting defective embryos in favour of
healthy ones and reducing the number of requests for abortion on grounds of fetal
abnormality. Attempts are also being made to develop non-invasive techniques for
detecting defective embryos."
- The
White Paper commented:
"29.
The key distinction in the debate surrounding embryo research appears to be between
the use of an embryo with the intention of achieving (with that embryo) a successful
pregnancy leading to a healthy baby; and its use for other reasons (eg improvement
of knowledge about disease). Those who are opposed to all research involving human
embryos argue that procedures which lead to the destruction of the embryo or which
make it unsuitable for transfer to a woman should not be permitted in any circumstances.
Procedures which do not damage the embryo, or which are actively beneficial to
it, do not give the same cause for concern even though such procedures may form
part of what some would regard as a programme of research (for example the observation
of embryos developing in different nutrient fluids prior to transfer to a woman.)
30. The
Government therefore proposes that the alternative draft clauses which will be
made available to Parliament should be along the following lines:
It
will be a criminal offence to carry out any procedures on a human embryo other
than those aimed at preparing the embryo for transfer to the uterus of a woman:
or those carried out to ascertain the suitability of that embryo for the intended
transfer.
Except
as part of a project specifically licensed by the SLA, it will be a criminal offence
to carry out any procedures on a human embryo other than those aimed at preparing
the embryo for transfer to the uterus of a woman or those carried out to ascertain
the suitability of that embryo for the intended transfer."
- The
latter is plainly the origin of the provision that ultimately became paragraph
1(1)(d) of Schedule 2. It is to be noted that ‘suitability’ is not defined, but
that procedures carried out to ascertain suitability for transfer were considered
to be appropriate for licensing, whether or not embryo research was prohibited.
Proceedings
in Parliament
- The
Bill that became the Act was introduced in the House of Lords on 22 November 1989.
As presaged in the White Paper there were alternative draft provisions, one which
permitted the licensing of research and one which prohibited this. On the second
reading on 7 December 1989 the clause permitting embryo research was carried by
154 votes. The second reading in the House of Commons took place on 2 April and
the third reading on 29 April 1990. Proposed amendments imposing a ban on embryo
research were heavily defeated. By the time of the third reading it was known
that Dr Robert Winston had successfully implanted female embryos after genetically
screening out male embryos which were, or might have been, affected with gender
linked genetic disorders.
-
In the course of debate on the third reading, Mr Kenneth Clarke, the Secretary
of State for Health, remarked:
Not
all reproductive technologies are aimed at helping infertile couples to have children.
Some are designed to help people to have healthy normal children by allowing a
range of congenital diseases and handicaps to be detected prenatally by pre-implantation
diagnosis. The possibility of preventing genetic disease is one of the reasons
most frequently cited in support of embryo research.
Mr
Clarke was then addressed by Mrs Ann Winterton, who was opposed to embryo research.
She was anxious to refute the suggestion that a ban on research would lead to
a ban on PGD screening for hereditary defects. She asked him to confirm that ‘Schedule
2 paragraph 1(d) would allow such pre-implantation screening for genetic handicaps
to continue even if today we voted for a ban on destructive embryo research’.
Mr Clarke confirmed that ‘that treatment, now that it is being developed, could
be continued if the amendments were agreed to’. Mrs Winterton later made the same
point again and it was subsequently repeated by others.
Discussion
- Maurice
Kay J did not find it appropriate to consider whether the Act permits PGD screening
for hereditary diseases. Mr Pannick’s argument founded on this question as a stepping
stone to the construction for which he contended. It seems to me not merely appropriate
but necessary to consider the implications of any suggested construction on the
position of screening for hereditary diseases. As I have shown, this practice
was an important feature of the context in which the Act was passed.
- Mr
Pannick submitted that paragraph 3(2)(b) of Schedule 2 was significant. This permits
the licensing of embryo research activities for the purpose of ‘developing methods
for detecting the presence of gene or chromosome abnormalities in embryos before
implantation’. Mr Pannick argued that it would be strange if Parliament approved
research to develop a method for achieving an objective which was prohibited elsewhere
in the Act. The clear inference of permitting such research was that Parliament
approved of PGD to avoid implantation of embryos carrying genetic defects. The
phrase ‘for the purpose of assisting women to carry children’ and of ‘suitable
for that purpose’ in Schedule 2 paragraph 1(1)(d) had to be read so as to embrace
that activity.
- I
found this argument persuasive. The Warnock Report recommended permitting the
licensing of existing techniques of infertility treatment. It went on to consider
wider uses of IVF to screen out hereditary diseases. It was in favour of gender
selection to screen out gender linked diseases, which was the only form of PGD
screening which seemed likely to prove feasible in the immediate future. It anticipated
the remote possibility of PGD involving single cell biopsy of the type with which
this appeal is concerned, and recommended permitting regulated research. The White
Paper left open the question of whether research under licence should be permitted.
The decision turned essentially on whether the potential benefits from research
outweighed the ethical objection to creating and then destroying human embryos.
Foremost in the potential benefits was the possibility of preventing the passing
on of hereditary diseases to children.
- Parliament
chose to permit the licensing of research. It makes little sense for Parliament,
at the same time, to prohibit reaping the benefit of that research, even under
licence.
- The
matter is, in my judgment, put beyond doubt by the statement made by the Secretary
of State in the course of Parliamentary debate. This is one of those rare cases
where, under the application of the principle in Pepper v Hart [1993] AC593,
it is legitimate to resort to such material. The Minister made an express statement
to Parliament upon the very issue of construction under consideration and it is
clear that the issue in question was of particular concern to Parliament.
- The
question remains whether the two vital phrases ‘for the purpose of assisting women
to carry children’ and ‘designed to secure that the embryo is suitable for the
purpose of being placed in a woman’ are appropriate to describe the object of
IVF treatment which is designed not to assist the processes of fertilisation and
gestation, but to ensure that the child which is produced by those processes is
healthy.
- My
initial reaction to the meaning of ‘for the purpose of assisting women to carry
children’ was the same as that of Maurice Kay J. The phrase naturally suggests
treatment designed to assist the physical processes from fertilisation to the
birth of a child. But if the impediment to bearing a child is concern that it
may be born with a hereditary defect, treatment which enables women to become
pregnant and to bear children in the confidence that they will not be suffering
from such defects can properly be described as ‘for the purpose of assisting women
to carry children’. I believe that it is appropriate to give it this meaning in
order sensibly to reconcile the provisions of the Act that deal with treatment
and those that deal with research. I also think that it is legitimate when deciding
to adopt this construction to have regard to the fact that the more narrow alternative
construction would render unlawful a practice which has been carried on for over
a decade and which is patently beneficial. It is also legitimate to have regard
to Mr Clarke’s statement to Parliament.
- What
of the actual process of biopsy and PGD - can that properly be said to be ‘designed
to secure that the embryo is suitable for the purpose of being placed in a woman’?
Here I agree with Mr Pannick that, once satisfied that the treatment as a whole
is for the purpose of enabling a woman to carry a child, no further problem arises.
The word ‘suitable’ takes its meaning from its context. Where the object of the
treatment is to enable a woman to bear a child confident that it will not carry
a hereditary defect, an embryo will only be suitable for the purpose of being
placed within her if it is free of that defect. PGD is thus designed to secure
that the embryo is suitable for this purpose. The reassurance which Mr Clark gave
to Parliament was not one which did violence to the language of paragraph 1(i)(d)
of Schedule 2.
- I
should add that Mr Dingemans suggested that it was possible to accommodate PGD
testing within the narrow construction of the Act reached by Maurice Kay J on
the basis that embryos with genetic defects are more prone to result in miscarriage.
Mr Eadie, for the Secretary of State, sought permission to adduce evidence from
a geneticist, Professor Alexander Raeburn, that shows that some hereditary diseases
do not affect the development of the embryo within the woman. If it mattered,
I would have had regard to this evidence, but there is ample other evidence which
shows that the primary concern about genetic defects was and is not that they
imperil the pregnancy but that they lead to the birth of children carrying the
defects.
Tissue
Typing
- I
said that Mr Pannick used the question of whether the Act permitted PGD screening
as a stepping stone to the construction of the Act for which he contended. It
remains to consider whether this stepping stone takes him safely to his destination.
‘Treatment
for the purpose of assisting women to bear children’
- The
discussion thus far had led me to the following conclusion. When concern as to
the characteristics of any child that she may bear may inhibit a woman from bearing
a child, IVF treatment coupled with PGD that will eliminate that concern can properly
be said to be ‘…for the purpose of assisting women to carry children’. When the
Act was passed women who had reason to fear that they would give birth to children
with genetic defects were probably the only section of the population for whom
it was envisaged that IVF treatment could be justified on this basis. No evidence
suggests that the wish of a woman to bear a child in order to provide a source
of stem cells for a sick or dying sibling was anticipated at that time. Such a
wish is now the reality, and the case of Mr and Mrs Hashmi is not unique.
- The
activities that the HFEA has licensed in the case of Mr and Mrs Hashmi, are the
same as those it has regularly licensed for the purpose of assisting women to
bear children free of hereditary diseases:
- creation
of embryos
- biopsies
of the embryos
- analysis
of the cells removed by biopsy by the use of a DNA probe in order to identify
those embryos likely to produce children with desired characteristics
- implantation
of those embryos
The
difference is as to the desired characteristics.
That
difference may be critical in determining whether or not the HFEA will decide
to licence the activities in question. I cannot see, however, that the difference
can be critical in determining whether or not the treatment, including the PGD,
is ‘for the purpose of enabling women to carry children’. My conclusion is that
whether the PGD has the purpose of producing a child free from genetic defects,
or of producing a child with stem cells matching a sick or dying sibling, the
IVF treatment that includes the PGD constitutes ‘treatment for the purpose of
assisting women to bear children’.
‘Designed
to secure that the embryo is suitable for the purpose of being placed in the woman’
- Just
as in the case of PGD screening for genetic defects, the meaning of ‘suitable’
falls to be determined having regard to its context. When the object of the treatment
is to enable a woman to bear a child with a tissue type that will enable stem
cells to be provided to a sick sibling, an embryo will only be suitable for the
purpose of being placed within her if it will lead to the birth of a child with
the tissue type in question. Accordingly I conclude that the HFEA was right to
decide that the Act authorised it to licence IVF treatment with PGD for the purpose
of tissue typing subject to such conditions as it considered appropriate.
Conclusion
- IVF
treatment can help women to bear children when they are unable to do so by the
normal process of fertilisation. Screening of embryos before implantation enables
a choice to be made as to the characteristics of the child to be born with the
assistance of the treatment. Whether and for what purposes such a choice should
be permitted raises difficult ethical questions. My conclusion is that Parliament
has placed that choice in the hands of the HFEA. For the reasons that I have given
I would allow this appeal.
Lord
Justice Schiemann
- The
advances of science have made possible in vitro fertilisation and the creation
of embryos outside the human body. Those embryos can be used for experimental
and other purposes. They can, even after use for experimental or other purposes,
be implanted inside a woman. All this, for which the Common Law made no special
provision, gave rise to a considerable amount of public anxiety. Some wished to
prevent the creation of such embryos in vitro. Others considered that the
benefits to be gained by such creation outweighed the disbenefits. By the Human
Fertilisation and Embryology Act 1990 Parliament decided in principle not to forbid
the creation of embryos in vitro and their subsequent use but to regulate
what could be done.
- The
Act provided for the setting up of the Human Fertilisation and Embryology Authority
with a general power to keep under review information about embryos and about
the provision of treatment services and activities governed by the Act. Part of
the regulatory mechanism established by the Act is the issue of licences by or
on behalf of the Authority.
- The
underlying task which faces the Court in the present case is one of construction
of this Act. It is clear from the Act that Parliament itself has regulated some
matters: other matters it has left to be regulated by the Authority. We have to
decide whether the issue of a licence to permit tissue typing in order to test
an embryo for tissue compatibility with a sibling affected by a particular disorder
is in principle open to the Authority. The Judge held it was not. For reasons
which I shall endeavour to set out I respectfully differ.
- The
structure of the Act is as follows.
Some
activities are forbidden outright
- Parliament
has made the decision that the activities enumerated in section 3(2) and (3) of
the Act are unacceptable in any circumstances.
- Section
3(2) provides:
"No
person shall place in a woman –
(a)
a live embryo other than a human embryo, or
(b)
any live gametes other than human gametes."
- Section
3(3) provides:
"A
licence cannot authorise –
(a)
keeping or using an embryo after the appearance of the primitive streak,
(b)
placing an embryo in any animal,
(c)
keeping or using an embryo in circumstances in which regulations forbid its keeping
or use, or
(d)
replacing a nucleus of a cell of an embryo with a nucleus taken from a cell of
any person, embryo or subsequent development of an embryo."
- Section
41(1) provides:
"A
person who -
(a)
contravenes section 3(2) … of this Act, or
(b)
does anything which by virtue of section 3(3) of this Act, cannot be authorised
by a licence
is
guilty of an offence and liable on conviction on indictment to imprisonment for
a term not exceeding ten years …"
Some
activities are forbidden unless done in pursuance of a licence
- Some
activities are forbidden unless done in pursuance of a licence or of a direction
given by the Authority – see s.3(1) and s. 23(3).
- Section
3(1) provides:
"No
person shall –
(a)
bring about the creation of an embryo, or
(b)
keep or use an embryo
except
in pursuance of a licence"
- A
person who contravenes s.3(1) is guilty of an offence carrying a lesser maximum
penalty of 2 years imprisonment – see s.41(2) and (4).
The
licensing regime
- Parliament
has imposed inhibitions on what a licence can authorise. The phraseology imposing
those inhibitions is sometimes in positive form.
- Thus
section 11 indicates that the only activities for which licenses may be granted
are – (a) activities in the course of providing treatment services, (b) storage
and (c) research. From that one can deduce that Parliament has decided that licences
may not be granted for other activities.
- The
phraseology is sometimes in negative form forbidding outright the licensing of
some types of activity. I have drawn attention to the outright prohibitions in
s. 3(3) on what can be authorised. But there are other inhibitions.
- Thus
Paragraph 1(4) provides that a licence can not authorise altering the genetic
structure of any cell while it forms part of an embryo. Schedule 2 paragraph 4(2)
sets out further inhibitions on what a licence can do.
- The
phraseology is sometimes in the form of forbidding an activity unless certain
preconditions are satisfied. One example of this legislative technique is provided
by Schedule 2 paragraph 1(3) which in my judgment is the crucial provision in
this appeal. It provides that:
"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 return to this paragraph later.
- There
seems to me no practical differences between inhibitions imposed in the negative
and those imposed in the positive form.
- One
should note that Parliament has not imposed any express obligation on the Authority
to grant a licence in any prescribed circumstances.
What
a licence can authorise
- By
contrast with the inhibitions as to what may be done and as to what may
be authorised by a licence, subparagraphs 1(1) and (2) of the Second Schedule
set out what may be authorised by a licence. A provision to which reference
has been made in the argument is the following:
"1(1)
A licence under this paragraph 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"
The
Decision under attack
- The
decision of the Authority which was quashed by the Judge was the decision in principle
to allow tissue typing to be used in conjunction with preimplantation genetic
diagnosis for serious genetic diseases. It was made clear by the press release
that, before this technique could be used in treatment, approval would be required
from an HFEA Licence Committee which would consider applications on a case-by-case
basis and that licences would be subject to strict conditions. A licence has indeed
been issued designed to assist Mr and Mrs Hashmi to have a further child which
will not suffer from the genetic disease from which Zain suffers and whose tissue
is compatible with his. The validity of that licence is, however, not directly
in issue before us.
- The
whole process envisaged by the Authority was
- the
removal of a cell from an embryo created by in vitro fertilisation,
-
the testing of that cell to see both
- whether
the embryo carries a genetic disorder and
- whether
the embryo enjoys tissue compatibility with a sibling affected with that disorder,
- where
it was established that the embryo both did not carry the genetic disorder and
enjoyed tissue compatibility, the implantation of the embryo in the mother of
the affected sibling.
- Hereafter
I shall refer to this whole process as the Process in Issue.
Analysis
: Schedule 2 subparagraphs 1(3)
- It
is convenient at this point to set the relevant subparagraph again
"1(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."
- The
crucial question for the Court is whether the Process in Issue could lawfully
appear to the Authority as being necessary or desirable for providing treatment
services.
- The
definition of treatment services appears in section 2(1). This provides:
"In
this Act –
‘treatment
services’ means medical, surgical or obstetric services provided to the public
or a section of the public for the purposes of assisting women to carry children."
- Incorporating
that definition into paragraph 1(3) of the second schedule leads to the following
result -
"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 medical,
surgical or obstetric services provided to the public or a section of the public
for the purpose of assisting women to carry children."
- All
parties, faced with this inelegant amalgam, have proceeded on the basis that the
issues before us can be resolved more easily by simply ignoring the words which
I have placed in italics. I agree that this seems the most sensible approach.
The primary question can thus be phrased thus: Can the Process in Issue lawfully
appear to the Authority as necessary or desirable for the purpose of assisting
a woman to carry a child?
Some
background considerations
- It
is clear that Parliament decided to permit the creation in vitro and subsequent
use of embryos in some circumstances for some purposes. There is therefore not
the absolute ban on this type of activity, which undoubtedly some would have wished.
There is, however, an absolute ban on certain segments of this type of activity
which are absolutely prohibited as being ethically objectionable in all circumstances
and thus within what it is convenient to call a Prohibited Area.
- The
dispute between the parties has centred on whether the Process in Issue falls
within the Prohibited Area or within the area which is to be regulated by the
Authority.
- The
ethical concerns which underlie this legislation are concerns about (a) the creation
of embryos and (b) the use of embryos. Four separate matters fall for consideration:-
- the
creation of the embryos,
- their
use in the course of carrying out the biopsies and also (so it is argued) the
testing procedures in relation to the extracted cell,
- the
implantation of an embryo after tests have revealed that it does not suffer from
a genetic defect and its tissue is compatible with that of a sibling, and
- allowing
embryos which did not suffer from a genetic defect to perish because their tissue
is not so compatible.
- It
is a commonplace practice in one IVF cycle to create several embryos. One is then
implanted. The others are stored ready for implantation in a later cycle if a
further attempt to achieve pregnancy is needed. If however a pregnancy results
and there is no wish for a further pregnancy, the other embryos are allowed to
perish. This is so even though there is no reason to suspect any abnormalities
in them. Paragraphs 44-48 of the White Paper make clear that the Government did
not regard this as always unacceptable. Section 17 of the Act seeks to ensure
that proper arrangements are made for the disposal of embryos that have been allowed
to perish.
- It
seems to me that the creation of embryos with the knowledge that some perfectly
healthy embryos will deliberately be allowed to perish was not regarded by Parliament
as always unacceptable. The contrary has not been argued.
- Further,
it seems to me that the use of an embryo by implantation after tests have
revealed that it does not suffer from a genetic defect was not regarded by Parliament
as always unacceptable in itself. Again, the contrary has not been argued.
- Allowing
embryos which do not suffer from a genetic defect to perish was also
not regarded by Parliament as always unacceptable. Again the contrary has not
been argued.
- The
submissions have concentrated on the concern identified in paragraph 79(ii). This
relates to two matters. It has not been argued before us that the use of an
embryo by carrying out of a biopsy to extract one cell was itself regarded
by Parliament as always unacceptable. The evidence is that this process need not
harm the embryo from which the cell has been extracted.
- There
is in my judgment no indication in the Act that the carrying out of tests on
cells extracted from an embryo was regarded by Parliament as unacceptable
as such. Again the contrary has not been argued although I think that Mr Dingemans
wished to leave the point open.
- It
is clear that amongst the purposes for which embryos are permitted to be used
are projects of research specified in the licence: Schedule 2 paragraph 3(1).
Amongst those purposes can be developing methods for detecting the presence of
gene or chromosome abnormalities in embryos before implantation, increasing knowledge
about the causes of congenital disease and other serious disease and enabling
such knowledge to be applied in developing treatments for serious disease: see
Schedule 2 paragraph 3(2) and The Human Fertilisation and Embryology (Research
Purposes) Regulations 2001. These are all matters which Parliament has permitted
the Authority to sanction.
Conclusion
- The
analysis undertaken in the preceding paragraphs indicates that Parliament was
not opposed in principle to doing to an embryo any of the things which are likely
to happen to it if the decision of the Authority is implemented. On the other
hand Parliament did not sanction a free for all. No part of the Process in Issue
(with the possible exception of carrying out tests on the extracted cells) can
lawfully be done without a licence granted by an Authority specially set up by
Parliament to supervise developments in this field. The phraseology of paragraph
1(3) immediately points to the Authority as the primary decision taker.
- One
of the tasks of that Authority was to determine whether the Process in Issue appeared
to it to be necessary or desirable for the purposes of assisting a woman to carry
a child. That involved the Authority in determining whether the Process in Issue
would assist a woman to carry a child and, if so, whether it was necessary or
desirable for that purpose.
- In
my judgment it was lawfully open to the Authority to come to the conclusion that
the Process in Issue would assist some women, who would otherwise refrain from
conception or abort either spontaneously or deliberately, to carry a child.
- Further
in my judgment it was lawfully open to the Authority to come to the conclusion
that the Process in Issue was necessary or desirable for that purpose.
- I
therefore consider that the Authority’s decision in principle does not infringe
Paragraph 1(3) of the Second Schedule.
- It
remains to consider whether the sanctioning of the Process in Issue is inhibited
by Paragraph 1(1)(d) of the Schedule.
- Since
the Process in Issue does not offend against subparagraph 1(3) it follows that
it will be done for the purpose of assisting a woman to carry a child. If that
be so, it will also be done ‘in the course of providing treatment services’ and
thus fall within the opening words of paragraph 1(1).
- It
does not appear to me that the separation out of various activities in the latter
part of paragraph 1(1) presents any further difficulties if I am right in my conclusions
so far.
- The
creation of the embryo in vitro is expressly listed. So is the placing
of an embryo in the woman.
- Once
one accepts, as I do, that the Process in Issue can in some circumstances lawfully
be regarded by the Authority as desirable for the purpose of assisting a woman
to carry a child, then this implies in my judgment that the concept of suitability
in paragraph 1(1)(d) is wide enough to embrace ensuring that the embryo does not
suffer from a genetic defect and tissue incompatibility. I therefore consider
that the remaining proposed activities fall comfortably within the phrase "practices
designed to determine whether embryos are suitable" for the purpose of implantation.
- For
these reasons I would allow this appeal.
- I
point out in conclusion that Parliament did not impose upon the Authority any
express obligation to sanction the grant of licences even if what was proposed
was indubitably necessary for the purpose of assisting a woman to carry a child.
That seems to me to dispose of much of the force of the argument that if what
has been sanctioned in principle here and licensed in one case is lawful, then
licensing activities for the purpose of social selection is an unavoidable consequence.
If the decision of the Authority is upheld in the present case it does not mean
that parents have a right to in vitro fertilisation for social selection purposes.
Lord
Justice Mance
Introduction
- The
facts of this case excite great sympathy. But the issue is one of law. It involves
the construction of the Human Fertilisation and Embryology Act 1990, in the context
of scientific developments which go beyond any specifically envisaged at the time
of the Act. Mr and Mrs Hashmi presently have five children, one of whom, Zain,
suffers from a potentially fatal blood disorder, beta thalassaemia, so that he
produces no or inadequate red blood cells. His condition fluctuates, sometime
giving great cause for concern, but giving him, even at the best of times, a quality
of life which is described as "extremely miserable" in relation to the
other children. His future is uncertain. He may live to his 30s or even early
40s on evolving medication and frequent blood transfusions; he could become allergic
to medication, which could itself be life-threatening; and he might at any time
develop fairly rapid organ failure. All this could be cured by a successful stem
cell transplant from a matched donor, after which Zain could achieve a relatively
normal life.
- A
matching donor may sometimes be found in the form of an existing relative willing
to assist, or in a donor bank. Failing success in one of these ways, Dr Fishel,
the Hashmi’s clinical embryologist, explains that consultants commonly suggest
the delivery of a sibling matching the sick child. Following the birth of such
a sibling, stem cell blood can be recovered from the umbilical cord and donated
to the sick child. This procedure does not in any way invade the new child’s body.
Mrs Hashmi has tried to give birth to a matching sibling on two occasions. This
has led to one pregnancy being terminated because of the presence of beta thalassaemia
and to the birth of the Hashmi’s son, Haris, who is not however a tissue match
for Zain.
- Against
that background Care at the Park Hospital, Nottingham ("the Care Clinic")
applied to the Human Fertilisation and Embryo Authority ("HFEA") on
27th September 2001 for a licence to perform a Preimplantation Genetic
Diagnosis ("PGD"), including thereby screening for beta thalassaemia
and tissue (or Human Leukocyte Antijen) typing for Mr and Mrs Hashmi. The term
PGD is in the previous sentence used in a wide sense to include tissue typing.
The documents before us show that the term is sometimes used in a narrower sense
to cover simply testing for genetic defects. The proposal was for embryos created
by in vitro fertilisation ("IVF") to be biopsied and for the
biopsied material to be transported to Chicago for screening and tissue typing.
In November 2001 a committee of the HFEA and (as it had become) the Human Genetics
Commission had approved such screening "where there is a significant risk
of a serious genetic disorder being present in the embryo", but had "agreed
that there were sufficient ethical difficulties" with tissue typing "that
it should be subject to further discussion before its use was considered".
Despite this, the HFEA received favourable advice from its ethics committee on
22nd November 2001 on the proposal relating to Mr and Mrs Hashmi. After
discussing this, the HFEA at its meeting on 29th November 2001 concluded
that, in circumstances where there would have in any event to be a biopsy to screen
for beta thalassaemia, the HFEA might in very rare circumstances and under strict
controls, permit further testing of cells derived from the embryo, including in
particular tissue typing. That decision was announced by press release dated 13th
December 2001. The present proceedings were brought by Josephine Quintavalle on
behalf of Comment on Reproductive Ethics ("Core") on 5th
March 2003, seeking an order quashing the HFEA’s decision and declaring that a
licence granted by the HFEA cannot authorise practices designed to test an embryo
for tissue-compatibility with an affected sibling.
- After
consideration by the HFEA the Care Clinic’s application led to the grant of a
licence on 22nd February 2003 for various listed activities to be carried
out under the supervision of Mr Simon Thornton, including IVF, PGD and Preimplantation
Genetic Screening for Aneuploidy.
- The
licence is subject to extensive conditions, set out in Annex A, which in turn
refers to Annexes B, C and D. In particular, section (5)a) of Annex A provides
that, with respect to any PGD programme, it is a condition "that PGD may
only be carried out for those disorders specifically listed in the PGD licences
Annex C to the licence". Annex C provides for "Sexing for X-linked diagnosis"
in respect of haemophilia, Duchenne muscular dystrophy and Linz syndrome, for
"Specific diagnosis" in respect of cystic fibrosis, beta thalassaemia,
sickle cell anaemia and chromosomal translocation and for the following "Special
Category":
"ß-thalassaemia
in conjunction with HLA typing for patients known as Mr and Mrs H".
- All
these tests appear in Annex C under the general heading of PGD. Screening for
genetic defects and tissue typing both involve a detailed genetic analysis using
the same cells taken from an embryo by biopsy. But genetic screening for abnormalities
such as beta thalassaemia can be undertaken without at the same time undertaking
tissue typing.
- A
note to Annex C refers back to Annex A, sections 4 and 5 for additional conditions
relating to PGD. Section 4 makes it a condition with respect to any programme
involving blastomere/polar body biopsy
"b)
that no embryo or material removed from it may be subjected to a test which supplies
genetic information about the embryo that is not listed in an annex to this licence
or specifically approved by a licence committee in any particular case.
c)
that no embryo may be transferred to a woman where that embryo, or any material
removed from it or from the gametes that produced it, has been subject to a test,
which supplies genetic information about the embryo, that is not specifically
listed in an Annex to this licence or not specifically approved by a licence committee
in any particular case.
d)
that centres should not use any information derived from tests on an embryo, or
any material removed from it or from the gametes that produced it, to select embryos
of a particular sex for social reasons."
- The
licence is capable on its face of covering any number of treatments, save for
its (unprecedented) inclusion, in Annex C, of the "Specific Category"
referring to Mr and Mrs Hashmi. Two unsuccessful IVF procedures had been undertaken
by the time the present case brought by Mrs Quintavalle came before Maurice Kay
J for hearing. On 20th December 2002 he gave judgment quashing the
decision in principle announced by the HFEA on 13th December 2001.
The present appeal is brought by the HFEA with the support of the Secretary of
State. The arguments have developed before us along rather different lines to
those raised before the Judge.
The
Human Fertilisation and Embryology Act 1990
- I
need not repeat the statutory scheme, which has been set out by the Master of
the Rolls. The relevant starting point consists in the prohibitions under s.3(1)
on bringing about the creation of an embryo (defined in s.1(2) as meaning creation
outside the human body) or use of an embryo, except in pursuance of a licence.
A licence can only authorise activities "in the course of", and which
appear to the HFEA to be necessary or desirable "for the purpose of",
providing treatment services": see s.11 and Schedule 2 paras. 1(1) and (3).
Treatment services are defined by s.2(2) 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". Treatment services extend beyond the
activities for which any licence would be required. There are of course many medical,
surgical and obstetric services (including advice, medicine and hospital facilities)
"for the purpose of enabling women to carry children" which do not involve
the creation outside the human body, or the keeping or use, of an embryo.
- The
House of Lords in R (Quintavalle) v. Secretary of State for Health [2003]
UKHL 692; 2 WLR 692 has recently considered the statutory scheme. Lord Bingham
(with whose speech Lords Steyn, Hoffmann and Scott all agreed) identified the
Act as imposing three levels of control:
"The
highest is that contained in the Act itself. As is apparent, for example from
section 3(2) and (3), the Act prohibits certain activities absolutely, a prohibition
fortified by a potential penalty of up to ten years' imprisonment (section 41(1)).
The next level of control is provided by the Secretary of State, who is empowered
to make regulations for certain purposes subject (so far as relevant here) to
an affirmative resolution of both Houses of Parliament (section 45(1), (4)). Pursuant
to section 3(3)(c) the Secretary of State may make regulations prohibiting the
keeping or use of an embryo in specified circumstances. The third level of control
is that exercised by the Authority. Section 3(1) prohibits the creation, keeping
or use of an embryo except in pursuance of a licence, and the Act contains very
detailed provisions governing the grant, revocation and suspension of licences
and the conditions to which they may be subject: see, among other references,
sections 11-22 of and Schedule 2 to the Act. A power is also conferred on the
Authority to give binding directions: sections 23-24."
- The
House of Lords had, as we have, to grapple with at first sight contrasting rules
that a statute always bears the meaning that it had when Parliament passed it
and that a statute is always speaking, and with the difficulty that arises in
deciding whether a modern invention or activity falls within statutory language
used at a time when it did not exist. The House approved Lord Wilberforce’s description
(in Royal College of Nursing of the United Kingdom v Department of Health and
Social Security [1981] AC 800, 822) of the court’s role in this situation:
"In
interpreting an Act of Parliament it is proper, and indeed necessary, to have
regard to the state of affairs existing, and known by Parliament to be existing,
at the time. It is a fair presumption that Parliament's policy or intention is
directed to that state of affairs. Leaving aside cases of omission by inadvertence,
this being not such a case, when a new state of affairs, or a fresh set of facts
bearing on policy, comes into existence, the courts have to consider whether they
fall within the Parliamentary intention. They may be held to do so, if they fall
within the same genus of facts as those to which the expressed policy has been
formulated. They may also be held to do so if there can be detected a clear purpose
in the legislation which can only be fulfilled if the extension is made. How liberally
these principles may be applied must depend upon the nature of the enactment,
and the strictness or otherwise of the words in which it has been expressed. The
courts should be less willing to extend expressed meanings if it is clear that
the Act in question was designed to be restrictive or circumscribed in its operation
rather than liberal or permissive. They will be much less willing to do so where
the subject matter is different in kind or dimension from that for which the legislation
was passed. In any event there is one course which the courts cannot take, under
the law of this country; they cannot fill gaps; they cannot by asking the question
'What would Parliament have done in this current case - not being one in contemplation
- if the facts had been before it?' attempt themselves to supply the answer, if
the answer is not to be found in the terms of the Act itself."
Tissue
typing as use of an embryo
- The
prohibition in s.3 on creation or use without a licence relates to any "embryo".
Under s.1(1), except where otherwise stated, embryo means "a live human embryo
where fertilisation is complete", but also includes "an egg in the process
of fertilisation". The Judge concluded that tissue typing itself involved
use of an embryo. The most substantial reasons the Judge gave were that Parliament
could not have intended to leave an activity such as tissue typing outside the
direct control of the Act, and that Schedule 2 para.1(1)(d) covers practices designed
to secure the suitable condition, or to determine the suitability, of embryos
to be placed in a woman. The Judge’s view would have significant practical consequences.
Under s.12(a) (though subject to the possibility of directions under s.24, subss.(3)
and (4) in particular) a licence must provide that the activities which it authorises
shall be carried on only on the premises to which the licence relates and under
the supervision of the person responsible, i.e. here at the Care Clinic under
Mr Thornton’s supervision. On the Judge’s view, the transporting of embryonic
cell material to a laboratory outside the Care Clinic (e.g to Chicago, as in this
case) would, at least in the absence of any relevant qualifying directions, be
impermissible.
- I
do not consider that the Judge’s view was correct. An embryo is distinct from
embryonic cell material, which is extracted from an embryo leaving the embryo
free to continue to develop. S.3A(1) with its distinction between an embryo and
female cells taken or derived from an embryo also confirms this. The points made
by the Judge overlook the fact that the creation outside the human body, biopsying
and implantation of an embryo all fall within s.3. They can all only take place
under a licence, which may impose strict conditions regarding the nature of any
testing permissible in respect of any embryonic cell material removed from such
an embryo. Clause (d) also controls the purpose for which any such biopsy must
take place, a point to which I will return. The fact that some practices
(e.g a biopsy) designed to secure the suitable condition, or determine the suitability,
of embryos to be placed in a woman involve use of an embryo does not mean that
all practices for such a purpose involve "use" of the embryo,
or therefore require to be licensed as activities under paragraph 1(1) of Schedule
2. The language of the HFEA’s press notice and licence are open to the forensic
comment that at points they equate embryonic cells with an embryo from which they
have been removed, and treat PGN (including here both screening and tissue typing)
as activities themselves requiring to be licensed. But these documents cannot
construe for us the true scope of the legislative provisions.
Creation
and biopsying of an embryo for the purpose of any form of PGD
- The
central issues are thus whether the activities of bringing about the creation
by IVF of an embryo and, particularly, its biopsying are activities capable of
being licensed, when the purpose is to test embryonic cells removed from the embryo
by PGD, including tissue typing, and only to place the embryo in the relevant
woman if the embryo is both free from genetic disorder and has tissue compatible
with an existing sibling.
- These
issues turn, firstly, upon the definition of "treatment services" in
s.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".
Licences may (as stated in paragraph 107) only be granted authorising activities
which satisfy the two initial criteria, that they are "in the course of",
and appear to the HFEA to be necessary or desirable "for the purpose of",
providing treatment services (s.11 and Schedule 2 paras. 1(1) and (3)).
- Treatment
services are already defined by s.2(1) to include a required purpose (that "of
assisting women to carry children"). Schedule 2 para. 1(3), in providing
that any activity must appear to the HFEA necessary or desirable for the purpose
of services for that purpose, is to say the least inelegant. There is a duplication
of "purposes" if the full definition is read into para. 1(3). It does
not make sense to consider whether an activity (consisting for example of "placing
an embryo in a woman") is necessary or desirable for the purpose of providing
medical services for the purpose of assisting women to carry children. The intention
must be that the activity should appear to the HFEA to be necessary or desirable
for the simple purpose of assisting women to carry children. The true function
of Schedule 2 para. 1(3) is to establish the standard by which the HFEA must form
its judgment as to whether an activity should be licensed.
- Provided
an activity meets the two initial criteria, and in the absence of any regulation
under Schedule 2 para.1(1)(g), it must also fall within one of the particular
heads of Schedule 2 para.1(1). The most relevant one is (d) – "practices
designed ….. to determine whether embryos are suitable for that purpose [viz "to
be placed in a woman"]. Part of clause (d) was relied on in the Claim Form,
but it was not relied on as a bar to the HFEA’s objection by the Judge, or it
seems raised as such in argument before him. There was no respondent’s notice
seeking to raise it before us. Nevertheless, it was referred to before us and
is important to consider. Curiously, the only relevant argument raised in the
Claim Form related to the initial words of clause (d) "in a suitable condition
to be placed in a woman". The Claim Form submitted, firstly and correctly,
that these words focus on condition; secondly, that they are only concerned with
"those characteristics of the embryo which in objective terms render
it unsuitable to be placed in any woman"; and thirdly that any contrary
interpretation would permit the HFEA to license selection for characteristics
such as sex, intelligence or hair colour. The first submission ignores the critical
later words: "practices designed ….. to determine whether embryos are suitable
for that purpose". These words go on any view wider than the condition of
the embryo, to allow some consideration of its inherent characteristics or qualities.
I return to the second submission in paragraph 127 and to the third in paragraph
145.
The
permissibility of screening out genetic defects?
- The
Judge said that the case did not require him to resolve whether not only tissue
typing, but also PGD, in the limited sense of screening to avoid use of any embryo
showing genetic defects, was unlawful. But, in deciding in Mrs Quintavelle’s favour,
he interpreted "treatment services" in a way which, the HFEA submits,
could present obstacles to screening of embryos for genetic defects, as well as
to the taking of decisions not to implant particular embryos based on the results
of such screening. The Judge associated the concept of "assisting women to
carry children" with problems arising from "an impaired ability to conceive
or to carry a child through pregnancy to full term and birth", and observed
that the carrying of a child would be "wholly unaffected by the tissue typing".
By focusing on the single question whether the woman could conceive and carry
a child to full term and birth, the Judge on one view eliminated the possibility
of any test the main purpose or effect of which could be said to determine whether
the child would, after its birth, be healthy or suffer from, or be the carrier
of, some abnormality, as well as the possibility of deciding against the implantation
of a particular embryo because of any abnormality detected that would affect the
viability of the embryo while being carried.
- It
is doubtful whether so limited an interpretation was advanced to the Judge. The
skeleton argument lodged on Mrs Quintavelle’s behalf in the Administrative Court
contains these passages:
"15.
… (c) Parliament was aware of the possibility of genetic testing by embryonic
biopsy and, in the light of that knowledge, provided that a licence could authorise
"practices designed to …. determine whether embryos are suitable" to
be placed in a woman: see Sch. 2, para. 1(1)(d).
…..
(e)
But there are some activities which Parliament placed beyond the reach of regulations.
…. [Sch. 2 para. 1(3)] ensures that any such [genetic] testing must be carried
out for the purpose of assisting women to carry children (e.g. by screening out
embryos with a genetic defect) and not for any other purpose – for example,
to allow parents to choose a male or female child or (to take another more extreme
example) to choose a baby with a preferred eye or hair colour."
- Those
passages regarding Parliament’s knowledge and intentions are amply born out by
the information regarding research which took place and came to Parliament’s attention
during the Parliamentary process as well as by the debate recorded in Hansard,
to which the Master of the Rolls has referred. Before us, Mr Dingemans QC for
Mrs Quintavelle sought to reconcile the Judge’s words with the general permissibility
of genetic testing. He submitted that the Judge’s formulation would not restrict
genetic testing to screen out abnormalities, because abnormal genetic conditions
involve a greater risk of problems in carriage and birth, even though this risk
may not materialise in any particular case. He drew attention, as the only relevant
evidence, to a passage in the witness statement of Dr Fishel, to the effect that
most chromosomal abnormalities "are not compatible with normal foetal development".
On that basis, he submitted (in the words of his skeleton argument) that "If
it is right that most defects cause an embryo to be non-viable, the dire consequences
predicted by the [HFEA] do not follow". The Secretary of State sought to
put before us fresh evidence from Professor Raeburn, at which it was agreed that
we could look provisionally (or de bene esse). It was that chromosomal
abnormalities are likely significantly to impair the viability of an embryo, whereas
the majority of conditions caused by single gene abnormalities (which we were
told include beta thalassaemia) do not affect the viability of an embryo, but
almost always have a major postnatal impact.
- Had
Professor Raeburn’s evidence appeared critical to this appeal, I would have been
reluctant, in view of the importance of the issue, to proceed without it and without
admitting in reply any further evidence that the respondent might have been able
to adduce. But we know, as Dr Fishel’s statement tells us, that some abnormalities
are compatible with normal foetal development. One has also to ask whether Parliament
can have intended to limit the assistance given to women to carry children to
treatment for infertility, including treatment to determine the viability of an
embryo for implantation, carriage to and birth at term; or whether Parliament
must be taken to have had a broader concern for the health of the child after
birth and future generations. Children with inherited genetic problems are of
course loved and receive exceptional care from their families, as in the case
of Zain. That does not however bear directly on the question whether it is open
to a family to choose that the potential mother in the family should not conceive
a child who may suffer disability, pain and perhaps an early death or who as a
carrier may expose his or her own children to the same fate.
- The
legislation contains a number of indications telling against any limitation of
focus to mere viability. First, Parliament resolved the choice left to it as a
result of the White Paper of November 1987 ("Human Fertilisation and Embryology:
A Framework for Legislation, para. 30) in favour of permitting research under
licence on embryos. It therefore included s.11(1)(c) and Schedule 2 para.3. Under
Schedule 2 para.3 such licences may authorise creation and use of embryos "for
the purpose of ….. (e) developing methods for detecting the presence of gene or
chromosome abnormalities in embryos before implantation" or for other purposes
which might be specified in regulations "with a view to the authorisation
of projects of research which increase knowledge about the creation and development
of embryos, or about disease, or enable such knowledge to be applied". Regulations
permitting licences for the purposes of increasing knowledge about the development
of embryos and about serious disease and of enabling any such knowledge to be
applied in developing treatments for serious disease have now been made (the Human
Fertilisation and Embryology (Research Purposes) Regulations 2001, SI 188). While
it is theoretically possible that Parliament intended to permit research into
methods of detecting abnormalities, or into applications of knowledge acquired
about disease, which it would be impermissible to licence for practical use unless
the Act was amended, it seems improbable that it was contemplated that research,
a particularly contentious matter, should be permissible into methods and applications
the use of which in practice Parliament had decided to exclude.
- Second,
under Schedule 2 para.1(1)(f) licences may be granted authorising the mixing of
sperm "for the purpose of testing the fertility or normality of the sperm".
- Third,
there is some support in s.13(5) for a conclusion that Parliament cannot have
limited its sights to matters going to the viability of an embryo for the purpose
of being implanted, carried to term and born as a child. It is true that s.13(5)
is a condition which must be included in every licence under Schedule 2 para.1
(and is included in the licence relating to Mr and Mrs Hashmi), and that its role
is to require the treating body, here the Care Clinic, to take account of the
welfare of every child who may be born as a result of the treatment and of any
other child who may be affected by the birth. This is a requirement that must
not only apply before, but continue throughout the administration of treatment
services. On the respondent’s case it is not a requirement which the clinic can
fulfil in one most effective way, by screening to avoid the implantation of an
embryo which has or may have a genetic abnormality which would affect the child
after birth (and, potentially, also affect siblings, in cases where the birth
of such a child might impose heavy stress on the family generally). In short,
s.13(5) points towards a wider concern for the future child and siblings, which
is better served if the legislation is read as permitting such screening.
- Fourth,
I note that "treatment services" are defined as "medical, surgical
and obstetric services provided to the public or a section of the public".
Although their purpose must be to assist women to carry children, they are not
services provided exclusively to women. The potential father is someone to whom
such services may be being provided, and whose natural concerns about future health
and welfare would be expected to be relevant (cf also s.28). This too tends to
point against any conclusion that the legislation focuses solely on the woman’s
narrow physical ability to become pregnant and give birth.
- I
turn to the Warnock report, which inspired much of the subsequent Act. The Judge
did not consider it appropriate to have regard to this report, but the relevance
of it and the subsequent White Paper as background, and of the mischiefs intended
to be addressed as indicated by these documents, is confirmed by the House of
Lords’ reasoning in the first Quintavalle case. The Warnock committee took
a positive view towards the wider use of techniques (then in their infancy) as
a facility or service available in cases other than infertility (Chap. 9). Chap.
9.2 dealt with the transmission of hereditary disease "which may be severely
handicapping to the next generation, either because the individual has the condition
or is a carrier". The committee also identified among these techniques sex
selection for "couples who have good medical reasons for choosing the sex
of their child" (Chap. 9.11), while observing that, "if an efficient
and easy method of ensuring the conception of a child of a particular sex became
available, it is likely that some couples would wish to make use of it for purely
social reasons", which could affect not only the individual family and the
children involved, but society as a whole (Chap. 9.11). While "dubious"
about the use of sex selection techniques on a wide scale, the committee did not
find it possible to make any positive recommendations. It considered that the
whole question of the acceptability of sex selection should be kept under review,
and referred in this context to Chapter 13, where it recommended the establishing
of an authority such as the HFEA.
- The
White Paper focuses on the issue of research, on which the government proposed
to leave Parliament with a choice. But it contemplated expressly (in paragraphs
29-30) that embryos could under the proposed legislation be screened by PGD, so
as to achieve "successful pregnancy leading to a healthy baby", that
embryos would only be implanted "if suitable", and that they would be
allowed "to perish where they were not to be transferred (eg because an abnormality
had been detected)". As I shall demonstrate in more detail (in paragraphs
135-139 below), the White Paper does not suggest that any different approach than
that adopted in the Warnock report was being taken to the particular wider techniques
on which the Warnock report had commented in its Chapter 9.
- I
am in these circumstances left in no real doubt that the concept of "medical,
surgical or obstetric services …. for the purpose of assisting women to carry
children" was intended to embrace not merely services to assist women physically
to carry to term and give birth, but also services to assist them to give birth
to children who would be normal and healthy during their lives and would in turn
be able to have normal and healthy children. I have equally little difficulty
in concluding that the words "practices designed ….. to determine whether
embryos are suitable for that purpose [namely to be placed in a woman]" in
Schedule 2 para.1(1)(d) were intended to embrace PGD in the form of screening
to avoid the use of any embryo with an abnormality which might affect the viability
of the embryo if implanted or which might affect any resulting child either during
that child’s own life or any future generation because the child would be a carrier.
"Suitable" is explained in Longman’s Dictionary of the English Language
as "meeting the requirements of a use, purpose, or situation". But here
the statute only identifies the next step or immediate purpose, leaving it to
those interpreting it to ascertain from its background and other terms the more
distant purposes and wider context that may admissibly be taken into account when
judging suitability.
- The
initial words of para.1(1)(d) - "Practices designed to secure that embryos
are in a suitable condition to be placed in a woman" – focus on the need
to protect the embryo’s condition, by for example keeping and treating it in an
appropriate way. The second half of para.1(1)(d) deals in a more general way with
the "suitability" of the embryo to be placed in "a woman".
The abstract and impersonal way in which this is expressed is explicable because
the paragraph is dealing with practices that may and will usually be authorised
by a licence granted to a clinic in general terms for classes of activity in relation
to women who have not yet been ascertained. It does not follow from this formulation
that the suitability of an embryo for implantation is to be assessed objectively
without reference to the particular woman in whom it is to be placed. That would
make no sense. The compatibility of the particular embryo with the particular
mother must, at least, be a fundamental consideration.
- I
add this consideration. To see the legislation as interested only in women’s ability
successfully to experience the physical process of pregnancy and birth would seem
to me to invert the significance of the human wish to reproduce. Just as "placing
an embryo in a woman" is only a first step towards a successful pregnancy,
so pregnancy and the experience of birth are steps towards an expanded family
life, not an end in themselves.
The
permissibility of tissue typing?
- This
brings me to the more difficult question whether the concepts of "treatment
services" and "practices suitable ….. to determine whether embryos are
suitable" to be placed in a woman cover the present case. Mr Eadie for the
Secretary of State submitted that this question does not arise in circumstances
like those of Mr and Mrs Hashmi, with which the HFEA’s decision announced on 13th
December 2001 was also concerned. A biopsy is necessary in any event for the legitimate
purpose of testing embryonic cells to screen out beta thalassaemia. Taking the
opportunity to test the same cells to check for tissue compatibility with an affected
sibling would not itself constitute an activity requiring a licence and would
not affect the legitimacy of the licensed activity of taking a biopsy to screen
out beta thalassaemia. In Mr Eadie’s skeleton argument, this argument was put
on the basis that the HFEA was only prepared to permit tissue typing tests "where
the genetic test (the dominant and necessary purpose of the biopsy) is to take
place".
- Mr
Pannick (while not adopting Mr Eadie’s present argument in other respects) did
submit that there was no evidence that Mr and Mrs Hashmi would not want another
child in any event (provided only that the child was free of an abnormality such
as beta thalassaemia). If necessary, I would infer that Mr and Mrs Hashmi would,
in their whole family’s interests, decide against having another child unless
they could be confident of realising their hopes to improve the whole family’s
life by curing Zain. But, whether this is so or not, the present proceedings relate
to a decision by the HFEA announced in December 2001 which was directed to circumstances
where both screening out of a genetic defect and tissue typing were (and in the
case of Mr and Mrs Hashmi are) important purposes of an intended biopsy. If one
looks at the actual licence granted to the Care Clinic in respect of Mr and Mrs
Hashmi, this also confirms that, whatever other longer term decision might or
might not be taken, the biopsy envisaged by the HFEA’s decision and the Care Clinic
licence had a dual purpose, which was to authorise both PGD to screen out abnormalities
and tissue typing. Indeed, Mrs Hashmi in her powerful oral plea before
us underlined her family’s desire to save Zain, while stressing the protection
that any new child brought into the family home would enjoy.
- Where
a biopsy has two basic purposes of this kind, I do not, as presently advised,
think that a licence can be given for it, if one of those purposes falls outside
those permitted under s.2(1) and Schedule 2 para.1(1)(d).
Mr Pannick was therefore right in my view to accept that in such circumstances
the appellant has to establish that each of these purposes can properly be regarded
as being "for the purpose of assisting women to carry children" and
as falling within the concept of "practices ….. designed to determine whether
embryos are suitable" to be placed in a woman. The former phrase is the primary
control, which only Parliament can relax. The latter concept would be capable
of expansion within the limits of the former phrase, by the Secretary of State
making regulations under Schedule 2 para.1(1)(g) and s.45(1) of the Act.
- It
follows from paragraphs 129 to 131 that whether a biopsy for the purpose of tissue
typing is capable of being licensed cannot depend upon whether or not a
biopsy is also intended for the purpose of PGD screening for genetic abnormalities.
The HFEA by its decision announced in December 2001 and by its licence to the
Care Clinic restricted tissue typing to cases where a biopsy was anyway necessary
to screen out genetic abnormalities. But that was a restriction introduced not
because the HFEA regarded the Act as requiring it to limit any licence in this
way, but because the HFEA, exercising its judgment, considered that the invasive
procedure of a biopsy should only be undertaken on an embryo if it was necessary
in the first instance from the point of view of the embryo, in other words to
confirm the embryo’s genetic normality. If a biopsy was necessary in any event
on that ground, then there was no objection to allowing it for the further purpose
of tissue testing.
- For
reasons that I have already considered in relation to PGD screening to exclude
abnormalities, the assistance to women to carry children which the Act contemplates
is not limited to assistance in the narrow physical operation of becoming pregnant
and giving birth. It extends to assistance in ensuring that any child born will
so far as possible be free of genetic defects and not be a carrier of some hereditary
problem which could affect a future generation. Considerations relating to the
future well-being of yet-to-be-born children will weigh heavily with any prospective
parents. So too will any effect that a new child would be likely to have on an
existing sibling. Families which cannot, for financial reasons or because of the
needs of an existing sibling, accommodate another child, may take steps to avoid
having one. Families may equally have another child with the idea in mind that
he or she will be company for an existing child. Such considerations may no doubt
also play a significant role in the clinical judgment, about the welfare of any
child who may be born and of any other child who may be affected by the birth,
which is contemplated by s.13(5) of the Act. Whilst that subsection probably had
primarily in mind consideration of any adverse effects on the welfare of the future
or any existing child, the language does not exclude positive effects. The relevant
considerations may indeed point in opposite directions. For example, it might
be to the benefit of an existing child to have a companion, but there might be
a countervailing risk to the welfare of the new child in the form of some hereditary
disability.
- It
is, however, at the core of the respondent’s case that the services which may
be provided do not extend to assisting women to carry children selected for particular
characteristics unrelated to any abnormality. Screening out genetic abnormalities
is one thing. Screening out certain normal characteristics is another. The crucial
distinction has been put as being between "screening out abnormalities"
and "screening in preferences". That distinction raises a spectre of
eugenics and "designer babies". But it is a crude over-simplification
to view this case as being about "preferences". The word suggests personal
indulgence or predilection and the luxury of a real choice. But there is no element
of whim in the circumstances that the HFEA had it in mind to licence in December
2001, and Mr and Mrs Hashmi are not seeking to indulge themselves. The case is
about a family’s reaction, understandable in the light of current scientific possibilities,
to a cruel fate which one of its members is suffering and will continue to suffer,
without a successful stem cell transplant. Ethical concerns that a child to be
born might be used as a vehicle, or would not be valued and loved were, for good
reason in the circumstances as they appear, not at the forefront of any submissions
made to us in the present case. Other concerns, for example regarding any increase
in the numbers of embryos that might be discarded, were raised. But I do not regard
any of them as in any way decisive, or as having any relevance approaching that
which attaches to the Warnock report and White Paper, which evidence the immediate
background to the legislation and the aspects of IVF which were being addressed.
On the HFEA’s and the Secretary of State’s case, such ethical concerns as may
be raised by the presently proposed procedures fall appropriately to be addressed
by the HFEA and the Care Clinic in the exercise of their respective functions.
- Returning
to the discussion in the Warnock report, Chap.9.11, on sex selection (see paragraph
124 above), the present circumstances lie conceptually between the two poles of
"good medical reasons" for tests, by which the Warnock committee was
referring simply to medical reasons affecting children yet to be born, and testing
for "purely social reasons" which the Warnock committee said would "obviously
affect the individual family and the children involved, and would also have implications
for society as a whole". However they lie far closer in spirit in my view
to the former pole that to the latter. There are here good medical reasons for
screening any embryo, although they do not relate to any future child’s health.
The concerns to which the HFEA’s decision and the licence for Mr and Mrs Hashmi
are directed are anything but "purely social", relating as they do to
the health of a sibling and the well-being of the whole family. What matters in
any event is that the Warnock committee proposed in Chap.9.11 of its report to
leave even the general question of the acceptability of sex selection to the authority
which it recommended should be established.
- Mr
Dingemans submitted that the Warnock committee had elsewhere made clear that the
legislation should prohibit absolutely any development such as the presently proposed
tissue typing. He referred to Chap.12.16. The committee in Chap.12 anticipated
the future development of various techniques (among them in Chap.12.11 cloning
by embryo-splitting, in Chap.12.12-13 embryonic biopsy to identify any abnormality
and in Chap.12.14 nucleus substitution). In Chap.12.15, it anticipated a possible
further technique to identify and replace a defective gene. Then, in Chap.12.16,
the committee said this:
"Public
anxiety about these techniques centres, not so much on their possible therapeutic
use, but on the idea of the deliberate creation of human beings with specific
characteristics. This has overtones of selective breeding. We regard such techniques
as purely speculative but believe that any developments in these fields are precluded
by the controls we have already recommended. …."
It
added:
"We
would go further. We recommend that the proposed licensing body promulgates guidance
on what types of research, apart from those prohibited by law, would be unlikely
to be considered ethically acceptable in any circumstances and therefore would
not be licensed. We envisage this guidance being reviewed from time to time to
take account of both changes in scientific knowledge and changes in public attitudes."
- When
speaking of "such techniques" as purely speculative, it is not clear
that the Warnock committee had in mind all the possible future techniques previously
discussed, or whether it was referring to techniques with "overtones of selective
breeding". But, assuming that it was speaking of all the possible future
techniques, its reference to "the controls we have already recommended"
did not contemplate that all such techniques would be absolutely prohibited under
the legislation. The "controls" in question were to consist of a combination
of absolute prohibitions (see e.g. Chap.12.8 and 9) and the performance by the
proposed licensing body of its function. See also Chap.12.1, where the committee
said that:
"We
believe that our recommendations for the regulation of research will allay much
of that anxiety, as it will be the duty of the proposed licensing body (13.3)
to keep these and other new techniques under constant review; indeed, in some
instances our proposals will preclude certain developments altogether."
- In
these circumstances, I see no inconsistency between Chaps.9.11 and 12.16 of the
Warnock report.
- One
of the potential future techniques to which the Warnock report referred without
recommending any absolute prohibition was embryo-splitting (Chap.12.11). Lord
Bingham noted this as a point of some relevance when he concluded in Quintavalle
(at p.701F-G) that the Act permitted the licensing of cloning by cell nuclear
replacement ("CNR"), involving implanting a replacement nucleus in an
unfertilised egg, as distinct from replacing the nucleus of an already fertilised
embryo. The White Paper did, however, go further than the Warnock report in two
other areas – by recommending absolute prohibitions of nucleus substitution and
of techniques aimed at modifying the genetic constitution of an embryo. Lord Bingham
inferred in Quintavalle that s.3(3)(d) of the Act was enacted to give effect
to this White Paper recommendation. It is in my opinion of considerable relevance
to this appeal that neither Warnock nor the White Paper recommended any absolute
prohibition in relation to embryonic testing or in relation to sex selection for
reasons unrelated to the child- to-be-born’s medical condition.
- Mr
Pannick also pointed out that the effect of s.4(1)(b) (which contains a limited
extension of protection beyond embryos to sperm) is to enable use in the course
of providing treatment services (as defined in s.2(1)) to prospective parents
together of sperm sorted to select sex. That is not to say that the same approach
governs sex selection in relation to embryos. It clearly does not. Embryos enjoy
on any view a higher level of protection, and, when their use is permissible at
all, it is only under the control of the HFEA. But it is at least clear that there
is no absolute bar on sex selection in all circumstances.
- The
Act was framed at a time when PGD to screen out disabilities was understood as
a possibility, and was (as I have concluded) contemplated in certain of its provisions.
In contrast, tissue typing and other techniques to screen out certain normal characteristics
were only speculative possibilities at the time of the Act. That the distinction
between these procedures may itself be debatable, as Mr Pannick exemplified by
taking the instances of dyslexia and deafness, does not really help, since problems
of scope on any view arise. But it can be said that the concept of "services
…. for the purpose of assisting women to carry children" seems on its face
wide enough to embrace some forms of activity in relation to healthy embryos,
e.g. testing to ensure that the right sperm and egg had been used, although the
considerations here differ from those presently under consideration.
- More
importantly, once it is recognised that the concept of "services …. for the
purpose of assisting women to carry children" extends beyond purely physical
problems affecting the viability of the embryo during pregnancy and birth, and
allows the screening of embryos for genetic abnormalities, it becomes clear that
such services may have regard to prospective parents’ and society’s concern for
others and for the future. The concept is in other words to be read in a general,
rather than a restrictive sense. If that is so, I see no basis for drawing a line
which excludes the services envisaged by the decision announced on 13th
December 2001. The assistance to carry a child provided can be viewed either as
assistance to have a child whose addition to the family could, without any invasion
of tissue, bring very special benefits for a sibling and for the family as a whole
and who would be expected to be valued correspondingly, or more narrowly as assistance
to the parents in giving them crucial information to decide whether the potential
mother should go ahead to have an embryo placed in her. In whichever way the assistance
is viewed, I regard it as coming within the statutory concept of "services
….. for the purpose of assisting women to carry children".
- Where
Parliament intended to put absolute limits in the fields of potential scientific
development identified by the Warnock report and White Paper, it did so expressly,
as in s.3(2) and (3). Notably it did not include any absolute prohibition in the
area of sex selection for "social purposes". The inference is that even
this was left to be regulated by the licensing authority with the assistance of
clinics (on which licences must under the Act impose conditions extending well
beyond the purely medical or surgical to matters of general welfare). The present
circumstances involve a form of selection which is much less obviously problematic
than, and very far removed from, selection for social purposes. But, as I have
stressed, what matters is that the HFEA’s judgment of the desirability of the
proposed treatment services has not, as such, been challenged, if it lay within
its powers to make it at all. I would therefore hold that it was, in circumstances
such as those faced by the Hashmis, open to the HFEA under the Act to conclude
that a biopsy for the purpose of selecting an embryo with tissue compatible with
that of a very sick child was an activity necessary or desirable for the purpose
of treatment services as defined.
- Viewing
the issue in terms of the guidance provided by Lord Wilberforce’s formulation
(paragraph 109), a biopsy for the purpose of tissue typing is, in the wider sense,
a form of PGD. Its direct purpose is to establish the embryo’s genetic makeup
and in that light to decide whether or not it should be implanted. The differences
between the testing of embryonic cells for abnormality and for tissue typing lies
in the precise aspects of the genetic makeup tested and in the factors taken into
account when deciding whether to implant. In the one case, it may be said, the
procedures are with a view to ensuring the health of the child to be or of future
generations, while in the other they are to promote the health of a sibling and
the general welfare of the existing family. The taxonomy of statutory provisions
may offer no easy answer (cf the difference of judicial opinion in Royal College
of Nursing itself), but I would regard these as differences falling in Lord
Wilberforce’s terms within the same genus (even if not the same species) of facts
as those to which the expressed statutory policy has been formulated. Indeed,
I would go further for reasons which I have already indicated. The background
(in the form of the Warnock report and White Paper) supports the view that Parliament
envisaged the possibility or likelihood of future developments (even though it
could not know precisely what they would be) and positively intended to bring
all such procedures within the sphere of the HFEA, with the exception of those
specifically prohibited.
- It
remains to consider Schedule 2 para.1(1)(d). I have rejected the suggestion that
this clause is only concerned with characteristics which in objective terms render
an embryo unsuitable to be placed in any woman (paragraph 127 above). The
compatibility of the particular embryo with the particular woman is fundamental.
Clause (d) also enables a clinic and parents to consider before implantation not
merely whether the embryo can viably be implanted and carried to term, but also
whether the future child will himself or herself be healthy or a carrier of an
hereditary disease which may affect future generations (paragraphs 126 to 128).
I have further concluded that a biopsy for the purpose of tissue typing and of
enabling a choice to be made regarding implantation based on the compatibility
of the embryo’s tissue with that of a sibling is capable of constituting a service
for the purpose of assisting woman to carry children (paragraph 142). But is suitability
for placement in a woman, in contrast to treatment services, to be judged only
by considering whether the embryo is viable and capable of leading to a healthy
child who will not be a carrier of an hereditary disease? If it is, there is still
the possibility of the Secretary of State widening the ambit of licensable activities
by regulation under Schedule 2 para.1(1)(g). Nevertheless, I consider it improbable
that this was a distinction or a limitation that Parliament intended at this point
to introduce by the bare requirement that a licensed practice should be designed
to determine whether an embryo was suitable to be implanted. As I have observed,
that requirement leaves open the more distant purposes and wider context by reference
to which suitability may be judged (paragraph 126). Having concluded that the
concept of treatment services embraces the situation addressed by the HFEA’s decision
announced on 13th December 2001, it is natural also to regard the concept
of suitability as apt to do so. Tissue typing is aimed at providing assistance
matching the felt and perceived needs of the family as a whole and the parents
and siblings in particular. The HFEA must already bear their interests in mind
when determining whether to issue any licence. The HFEA, when granting any licence,
may, in the exercise of its powers under s.11 and Schedule 2 para.1(1) and (2),
limit in such way as it considers appropriate the practices which it licenses
or the purposes for which they may be undertaken – as it in fact did (see paragraph
105 above). Clinics are bound to have regard to the interests of siblings as well
as those of any child-to-be-born under s.13(5) when providing any treatment services;
and their performance of that role is likely to be assisted by information obtained
from tissue typing. I conclude that the suitability of the embryo to be placed
in a (particular) woman may be considered in the context of objectively established
aims and perceived needs relating to the child-to-be-born’s parents and to an
affected sibling, of the kind that the HFEA had in mind in reaching its decision
announced on 13 December 2001 and in later granting the Care Clinic’s licence.
Conclusion
- I
would for these reasons hold that the appeal succeeds. I would accordingly set
aside the order whereby the Judge quashed the HFEA’s decision in principle announced
on 13 December 2001 to allow tissue typing to test an embryo for tissue compatibility
with an affected sibling.