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Evans v Amicus Healthcare Ltd & Ors (includes Summary of Judgment)

[2003] EWHC 2161 (Fam)

The Honourable Mr Justice Wall

Approved Judgment

- v -

Case No: FD02PO1431
NEUTRAL CITATION [2003] EWHC 2161 (Fam)
IN THE HIGH COURT OF JUSTICE
FAMILY DIVISION

Royal Courts of Justice

Strand, London, WC2A 2LL

Date: 1 October 2003

THE HONOURABLE MR JUSTICE WALL

BETWEEN :

NATALLIE EVANS

Claimant

- and –

-

AMICUS HEALTHCARE LTD (1)

HOWARD JOHNSTON (2)

ROYAL UNITED HOSPITAL BATH NHS TRUST (3)

THE SECRETARY OF STATE FOR HEALTH (4)

THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (5)

Defendants

AND BETWEEN: -

LORRAINE HADLEY

Claimant

- and –

-

MIDLAND FERTILITY SERVICES LTD (1)

WAYNE HADLEY (2)

THE SECRETARY OF STATE FOR HEALTH (3)

THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (4)

Defendants

REPRESENTATION

MR ROBIN TOLSON QC AND MS SUSAN FREEBORN (instructed by Messrs Withy King Solicitors for the Claimants)

DR KRISTINA STERN (instructed by Messrs Bevan Ashford Solicitors)

for Amicus Healthcare Ltd and the Royal United Hospital Bath NHS Trust and

(instructed by Young & Lee) for Midland Fertility Services Ltd.

MR KAMBIZ MORADIFAR AND MS VANESSA MCKINLAY (instructed by Messrs Davey Son & Jones Solicitors) for Mr Howard Johnston

MR STEFANO NUVOLONI (instructed by Messrs Baches Solicitors)

for Mr Wayne Hadley

MR JASON COPPEL (instructed by the Office of the Solicitor for the Dept of Health

for the Secretary of State for Health

MISS DINAH ROSE (instructed by Messrs Morgan Cole Solicitors)

for the Human Fertilisation and Embryology Authority

Hearing dates : 30 June – 4 July 2003

Approved Judgment

Mr Justice Wall :

Glossary and index

1.

Throughout this judgment, I propose to use the following abbreviations:

(1) “The Act” means the Human Fertilisation and Embryology Act 1990.

(2) “AID” means artificial insemination by donor

(3) “The Authority” means the Human Fertilisation and Embryology Authority.

(4) “The Clinic” in the case of Ms Evans and Mr. Johnston means Bath Assisted Conception Clinic and in the case of Mr and Mrs Hadley means Midland Fertility Services Limited. “The Clinics” means both.

(5) “The Convention” means the European Convention for the Protection of Human Rights and Fundamental Freedoms as incorporated into English law by the Human Rights Act 1998.

(6) HRA 1998” means the Human Rights Act 1998.

(7) “ICSI” means Intra Cytoplasmic Sperm Injection

(8) “IVF” means in vitro fertilisation

(9) PGD means Pre-Implantation Genetic Diagnosis

(10) “The Secretary of State” means the Secretary of State for Health

(11) “Warnock” means the Report of the Committee of Inquiry into Human Fertilisation and Embryology, chaired by Dame Mary Warnock DBE, July 1984: Cmnd 0314

(12) “The White Paper” means Human Fertilisation and Embryology: A Framework for Legislation: November 1987: HMSO Cm 259

2.

The arguments in these two case were detailed and ranged over a wide area. I was told that this was the first major example of litigation between parties to IVF treatment in the United Kingdom, and the first time that the consent provisions of the Act had been subject to a full-blown HRA 1998 challenge. Given the importance of the issues involved, therefore, I have decided to set out both the facts and the arguments addressed to me in some detail. The result is a judgment of greater length than I had anticipated, and no doubt longer than is strictly necessary for the resolution of the issues, on which I have formed clear views. In order to help those reading the judgment, or wishing to identify a particular issue, I have prepared the following index: -

Subject Matter

Paragraph numbers

Introduction: the cases in broad outline and as pleaded

3 to 15

The history of the Act

16 to 17

Statutory interpretation as applied to the Act

18 to 19

The relevant provisions of the Act

20 to 29

Schedule 3 to the Act

30 to 36

The two most important principles underlying the Act

37

The Facts in the case of Ms Evans and Mr. Johnston

38 to 43

The Events of 10 October 2001

44 to 56

My findings of fact in relation to the events of 10 October 2001

57 to 67

The consents which Ms Evans and Mr Johnston signed on 10 October 2001

68 to 83

Events after 10 October 2001

84 to 93

The facts in the Hadley case

94 to 103

The first point of law: Are the consents given in this case capable of operating so as to enable the clinics to treat Ms Evans and Mrs Hadley on their own?

The argument

104 to 131

Discussion and Analysis

132 to 149

The second point of law: Have the remaining embryos in Mrs. Hadley’s case been “used” in the provision of treatment services, so that Mr. Hadley’s consent to their use cannot be varied or withdrawn?

The argument

150 to 154

Discussion and analysis

155 to 165

The Claims under the Human Rights Act 1998

Introduction

166 to 173

Article 2: the Right to Life

174 to 179

Article 8: the Right to respect for private and family life

Is Article 8 engaged?

180 to 182

Is there an interference with the right to respect for private life in this case?

183 to 185

The evidence filed on behalf of the Secretary of State

186 to 188

The case for Ms Evans and Mrs Hadley under Article 8

189 to 228

The Argument for the Secretary of State

229 to 244

The case for Mr. Johnston and Mr Hadley under Article 8

245 to 247

Conclusions on Article 8

248 to 260

Article 12: The right to marry

261 to 265

Article 14: Prohibition of Discrimination

266 to 277

Conclusions under HRA 1998 and the Convention

278

Estoppel

Can an estoppel exist in the face of the Act?

279 to 297

The ingredients and parameters of promissory estoppel

298 to 304

Application of the principles of estoppel to the present case

305 to 311

Information from other jurisdictions

311 to 314

The result

315

Footnote

316 to 320

Summary of the judgment

Introduction: the cases in broad outline and as pleaded

3.

With some exceptions, these two cases raise the same issues, and have been heard together. The two claimants are Ms Natallie Evans and Mrs. Lorraine Hadley. Each underwent IVF treatment with a partner (respectively the second defendants in each of the actions, Mr. Howard Johnston and Mr. Wayne Hadley) from whom each subsequently separated, and with who neither has any continuing relationship. In each case there remain in existence embryos, currently frozen and in storage, created from the gametes of each claimant and her former partner. Each claimant now wishes to remove the embryos created with her gametes from storage in order to have them transferred into her with a view to becoming pregnant.

4.

As pleaded in the amended particulars of claim by Mr. Robin Tolson, QC and Miss Susan Freeborn, who appear for both claimants, the relief sought in Ms Evans’ case is as follows-

a. A declaration that (Mr. Johnston) has not and may not in the future vary or withdraw his consent given on 10th October 2001 to the storage or use of the embryos.

b. An injunction requiring Mr. Johnston to restore his consent to the storage and use of the embryos.

c. A declaration that the embryos may lawfully be stored until 9th October 2011 (the expiry of the 10 year storage period for which consent was originally given).

d. A declaration that the claimant may lawfully be treated with the embryos during the storage period.

e. If necessary, a declaration of incompatibility pursuant to section 4(4) of HRA 1998 to the effect that section 12 and paragraphs 6(3), 8(2) and 4(1) of Schedule 3 of the Act

(i) constitute an unnecessary interference with (Ms Evans’) right to respect for her private and / or family life under Article 8 of the Convention;

(ii) fail to secure (Ms Evans’) right to found a family under Article 12 of the Convention;

(iii) permit discrimination against (Ms Evans) as a result of her infertility and /or disability, contrary to Article 14;

(iv) Fail to accord the embryo with any protection for such rights under Articles 2 and 8 as its status may justify; further or alternatively fail to protect any proprietary / possessory interest (Ms Evans’) may enjoy in respect of the embryo pursuant to Article 1 of the First Protocol of the Convention.

f. Such interim orders preserving the embryos as may be necessary in the event that the clinic alters its present position where it has agreed to continue to store the embryos.

5.

The relief sought by Mrs. Hadley is the same, except that in her case there is no application for an injunction. In her case, however, because three of the embryos created from the gametes provided by herself and Mr. Hadley had, on a previous occasion, been unsuccessfully transferred into her (and thus used), it was argued that the remaining two embryos in storage had also been used. Accordingly, since paragraph 4(2)(a) of Schedule 3 to the Act prevents any withdrawal of consent to treatment once an embryo has been used in providing treatment services, it was argued that Mr. Hadley was prevented by the Act from withdrawing his consent. The argument was initially limited to Mrs. Hadley’s case, but in their closing submissions Mr. Tolson and Miss Freeborn sought to include Ms Evans within it. I will deal with the argument under the heading The Second Point of Law in paragraphs 150 to 165 below.

6.

Neither Mr. Johnston nor Mr. Hadley consents to the embryos being unfrozen in order for them to be transferred into the claimants. Both have withdrawn their consent to the continued storage of the embryos, and both wish the embryos to be allowed to perish. Both say, quite simply, that the Act gives them (and the claimants) an unequivocal and unconditional right to withdraw their consent to treatment and to continued storage of the embryos up until the moment the embryo is used. The stored embryos, they say, have not been “used”, since in the context of this case, “use” means the transfer of the embryo into a woman. In so far as Convention Rights under HRA 1998 are concerned, both men say they are either not engaged, or, if engaged, are not breached. Article 8 in particular, they say, gives each of the four adults the right to respect for their private lives, and the State’s “interference” under Article 8(2) with those rights, by allowing them to withdraw their consent and thus prevent the transfer of the embryos into the claimants is, they say, necessary to prevent a breach of their Article 8 rights, and thus both justified and proportionate.

7.

The clinics which treated the couples are parties to the proceedings, although, in the event, no relief was sought against them, and in each case the clinics took a neutral stance in relation to the relief sought by each claimant. I was, however, materially assisted by the evidence called on behalf of the clinics and by argument from Dr. Kristina Stern, who appeared on their behalf. I was particularly impressed by the evidence of Dr. Nicholas Sharp, consultant obstetrician and gynaecologist specialising in reproductive medicine at the Royal United Hospital Bath NHS Trust, who was responsible for Ms Evans’ treatment; and by the evidence of Dr. Gillian Lockwood, obstetrician / gynaecologist at the clinic attended by Mrs. Hadley. I also heard from Mrs. Pamela Spearman, a fertility sister at Ms Evans’ clinic, and from Ms Susan Lowbridge, a fertility nursing sister at the clinic attended by Mrs. Hadley. I was generally impressed by the overall quality of the care which each of the claimants had received; and it was in my judgment quite appropriate in each case for Mr. Tolson to preface his cross-examination of the clinics’ witnesses by stressing how grateful each of the claimants was for the treatment they had received.

8.

In addition, and because of the importance of the issues raised by the case, both the Authority itself and the Secretary of State were joined to the proceedings by order of Dame Elizabeth Butler-Sloss P made on 19 September 2002. I thus had the advantage of argument from counsel instructed on behalf of each. Both took a neutral stance on the facts, but each argued that the terms of the Act itself precluded the court granting the relief the claimants sought

9.

The first point taken by both the Secretary of State and the Authority was that the original consents which each couple gave to IVF treatment were no longer effective. Both couples had consented, exclusively, to being “treated together” with their respective partners. Given the fact that both couples had separated, the argument was that it was simply not open to the Clinics to treat the claimants by transferring the embryos into them.

10.

Secondly, and in the alternative, both the Secretary of State and the Authority submitted that the provisions of the Act were unambiguous and gave both Mr. Johnston and Mr. Hadley (as well as both claimants) an unqualified right to withdraw their consent to the continued storage and use of the embryos.

11.

Both the Secretary of State and the Authority argued further that, in so far as the claimants’ Convention rights were engaged, the terms of the Act do not breach them, with the result that no question of a declaration of incompatibility under section 4 of HRA 1998 arose.

12.

In the case of Ms Evans, a further point arose. She relied on representations which she says Mr. Johnston made to her prior to the initiation of the IVF treatment. She argued that these representations, on which she says she acted to her detriment, create an equitable estoppel sufficient to make it unconscionable for Mr. Johnston now to be permitted to withdraw his consent to the embryos being transferred into her.

13.

In the amended particulars of claim, the matter is pleaded in the following way: -

5. Before undergoing IVF treatment (Ms Evans), realising that the eggs to be harvested from her represented her last chance of bearing a child, discussed with (Mr. Johnston) what should happen if their relationship were to end. In particular, on a date presently unknown to (Ms Evans) she suggested to (Mr. Johnston) in the presence of a member of the nursing staff at the clinic known to (Ms Evans) only as “Pam” (Mrs. Spearman) that she should have some of her eggs frozen, as opposed to be fertilised so that if necessary they might later be fertilised by sperm from a donor other than (Mr. Johnston) and be available for her use.

6. By his words and actions (Mr. Johnston) gave (Ms Evans) to understand that any embryos created from his sperm would always be available for her to use and that there was no need to consider other options. Amongst other things, he told the claimant that he loved her, wanted to share his life with her, would never leave her and was anxious to be a father ((Ms Evans) gives the gist of the words used). The couple discussed the position generally and agreed that sperm from (Mr. Johnston) would be used to attempt to fertilise all the eggs which were harvested

7. When agreeing to fertilise all the eggs, (Mr. Johnston) knew that these eggs would represent (Ms Evans’) last chance to bear a child naturally. He knew, further, that (Ms Evans) would, but for his assurances, have sought advice about and investigated in discussions with the clinic the possibilities of ‘insuring’ against the breakdown of their relationship, whether by freezing unfertilised eggs (which Ms Evans understands to be a problematic procedure) or by storing eggs fertilised by a donor other than (Mr. Johnston).

14.

On this basis, the creation of a promissory estoppel is pleaded as follows:

34. If and to the extent that (Mr. Johnston) had a legal right, whether contractual or arising under the Act, to vary or withdraw his consent, then he represented by the words and conduct set out above that his consent would be irrevocable or that it would not be withdrawn in the present circumstances.

35. (Ms Evans) relied on the representation in deciding not to seek further advice on the storage of unfertilised eggs or embryos created using sperm from another donor. It is (Ms Evans’) case that in the absence of the assurances she received from (Mr. Johnston) she would have taken every opportunity to maximise her prospects of having children in the future including specifically the storage of unfertilised eggs or eggs fertilised by another donor or by investigating other treatments for her cancer than the removal of her ovaries.

36. In the circumstances, (Mr. Johnston) is estopped from relying on any legal right to vary or withdraw his consent.

15.

Mr. Johnston denies inducing the belief in Ms Evans that any embryos created from his sperm would always be available for her to use, and asserts that no estoppel arises on the facts. He also submits, however, that even on the case made by Ms Evans the elements necessary for an equitable estoppel do not arise. In this latter context, he adopts an argument put forward by the Secretary of State that an estoppel is inconsistent with and excluded by the policy considerations underlying the terms of the Act.

The history of the Act

16.

The background to the Act, and the manner in which the Act regulates certain forms of fertility treatment, including of course IVF, the storage of gametes, and the creation, storage and use of human embryos outside the body for treatment services or research, are all authoritatively set out in the speech of Lord Bingham of Cornhill in R (on the application of Quintavalle) v Secretary of State for Health[2003] 2 WLR 692, hereinafter called Quintavalle CNR (cell nuclear replacement) in order to distinguish it from a second case involving Mrs. Quintavalle, R (Quintavalle) v HFEA (Secretary of State for Health Intervening)[2003] 2 FLR 335 (which I shall call Quintavalle (tissue typing) and in which there is also a detailed discussion of Warnock, the White Paper, the proceedings in Parliament leading to the passing of the Act and of the Act itself: - see the judgment of Lord Phillips of Worth Maltravers MR, and in particular paragraphs 27 to 36 ([2003] 2 FLR 1335 at 345-348).

17.

It is, I think, helpful to repeat what Lord Bingham of Cornhill said both about the background to the Act, and the approach to its interpretation. At paragraphs 11 to 13 of his speech ([2003] 1 All ER 113 at 119h) he said this: -

[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 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 (Report of the Committee of Inquiry into Human Fertilisation and Embryology (Cmnd 9314) (the Warnock Report)). A White Paper was published in November 1987 Human Fertilisation and Embryology: A Framework for Legislation (Cm 259) when the Department of Health and Social Security recognised (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 [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.

Statutory interpretation as applied to the Act

18.

For present purposes, one paragraph from Lord Bingham’s speech in Quintavalle CNR on the subject of statutory interpretationwill, I think, suffice. In paragraph 8 at [2003] 1 All ER 113 at 118 he said: -

[8] The basic task of the court is to ascertain and give effect to the true meaning of what Parliament has said in the enactment to be construed. But that is not to say that attention should be confined and a literal interpretation given to the particular provisions which give rise to difficulty. Such an approach not only encourages immense prolixity in drafting, since the draftsman will feel obliged to provide expressly for every contingency which may possibly arise. It may also (under the banner of loyalty to the will of Parliament) lead to the frustration of that will, because undue concentration on the minutiae of the enactment may lead the court to neglect the purpose which Parliament intended to achieve when it enacted the statute. Every statute other than a pure consolidating statute is, after all, enacted to make some change, or address some problem, or remove some blemish, or effect some improvement in the national life. The court’s task, within the permissible bounds of interpretation, is to give effect to Parliament’s purpose. So the controversial provisions should be read in the context of the statute as a whole, and the statute as a whole should be read in the historical context of the situation which led to its enactment.

19.

The history of the legislation, and the policy issues to which the Act gives expression are of considerable importance. They come to the fore when considering whether or not there are any breaches of Ms Evans’ and Mrs. Hadley’s Convention rights, and in particular whether any interference with their private and family lives is justified under Article 8(2) of the Convention. I will therefore deal with questions of policy when considering the Convention aspects of the claims.

The relevant provisions of the Act

20.

Before turning to the facts, it is necessary to set out the provisions of the Act which are relevant to the two cases. I do so by reference to the helpful synopsis provided by Ms Dinah Rose, counsel for the Authority.

21.

The long title of the Act describes it as:

An Act to make provision in connection with human embryos and any subsequent development of such embryos; to prohibit certain practices in connection with embryos and gametes; to establish a Human Fertilisation and Embryology Authority; to make provision about the persons who in certain circumstances are to be treated in law as the parents of a child; and to amend the Surrogacy Arrangements Act 1985

22.

At paragraph 4 of his speech in Quintavalle CNR [2003] 2 WLR 692 at 696, Lord Bingham identifies the three levels of control which the Act imposes; namely (1) that contained within the Act itself; (2) that provided by the Secretary of State through regulations; and (3) that exercised by the Authority. The instant cases fall within the category (3). As Lord Bingham points out in the extract from his speech which I have cited at paragraph 17 above, the Act occupies a field of great ethical sensitivity and controversy, in which the science is rapidly advancing.

23.

Sections 1 and 2 of the Act define a number of the terms used in the Act. In particular:

(1) By section 1(1)(a), an embryo is defined as “a live human embryo where fertilisation is complete, and by section 1(1)(b) “references to an embryo include an egg in the process of fertilisation;

(2) Section 1(2) of the Act provides that in so far as it governs bringing about the creation of an embryo, the Act applies only to bringing about the creation of an embryo outside the human body

(3) By section 1(3), insofar as it governs the keeping or use of an embryo, the Act applies only to keeping or using an embryo outside the human body;

(4) By section 2(1), “treatment services” are defined 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”;

(5) By section 2(2), references in the Act to keeping, in relation to embryos or gametes, include keeping while preserved (whether by cryopreservation or in any other way). Embryos so kept are referred to in the Act as “stored”.

24.

Section 3 deals with activities governed by the Act. By section 3(1), no person shall bring about the creation of an embryo, or keep or use an embryo except in pursuance of a licence. The storage or use of an embryo can only take place lawfully in accordance with the requirements of the licence in question. The contravention of section 3(1) is an offence, pursuant to section 41(2)(a) of the Act: see R v HFEA ex parte Blood [1997] 2 WLR 806, at 814D – H.

25.

Sections 11 to 13 of the Act deal with the scope of licences granted by the Authority and licence conditions. The Authority is empowered by section 11(1) to grant only three licences. The first of these is a licence for treatment under paragraphs 1 and 2 of Schedule 2 and which authorises the following (amongst others) 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 ……

26.

The second type of licences provided for in paragraph 2 of Schedule 2 are those authorising the storage of gametes and embryos; and the third are those authorising activities for the purposes of research (ibid paragraph 3). In the instant case we are, of course, only concerned with the first two types of licence.

27.

By section 12(c) of the Act, it is a condition of every licence granted that the provisions of Schedule 3 to the Act shall be complied with. Before turning to Schedule 3, however, it is necessary to identify one of the mandatory, and in my judgment very important conditions of licences for treatment identified in section 13(5) of the Act namely the following:

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.

28.

The means whereby the statutory obligation contained in section 13(5) of the Act is implemented is the code of practice which the Authority is required to maintain by section 25(1) of the Act. Section 25(2) provides that the guidance given by the code shall include guidance for those providing treatment services about the matters contained within section 13(5)

29.

The current code of practice sets out in paragraphs 3.8 to 3.21 the approach which centres should adopt and the matters which should be taken into account. It is not necessary for the purposes of this judgment to reproduce these paragraphs. It is, I think, sufficient to say that they cover, comprehensively (and to a much greater extent than, for example, is contained in the so-called welfare check list in section 1(3) of the Children Act 1989) every possible aspect of the unborn child’s physical and emotional welfare in the context of being born as a result of IVF treatment, and every aspect of the capacity of those seeking the treatment to care for the child. It is an impressive document.

Schedule 3 to the Act

30.

Schedule 3 to the Act is at the heart of this case. It governs consents to the use of gametes or embryos. By paragraph 1, a consent under Schedule 3 must be given in writing, and an effective consent means a consent under Schedule 3 which has not been withdrawn.

31.

By paragraph 2 of Schedule 3, a consent to the use of any embryo must specify one or more of the following purposes:

(1)

“use in providing treatment services to the person giving consent, or that person and another specified person together”;

(2)

“use in providing treatment services to persons not including the person giving consent”;

(3)

“use for the purposes of any project of research.”

A consent may specify conditions subject to which the embryo may be so used.

32.

By paragraph 3, a consent to the storage of any gametes or embryo must specify the maximum period of storage (if less than the statutory maximum); and must state what is to happen to the gametes or embryo if the person giving the consent dies or is unable because of incapacity to vary the terms of the consent or revoke it. Such a consent may also specify conditions subject to which the gametes or embryo may remain in storage.

33.

Paragraph 3 in Schedule 3 deals with the procedure for giving consent. A person must be given a suitable opportunity to receive proper counselling about the implications of taking the proposed steps, and must be provided with such information as is proper, before giving consent under Schedule 3. In particular, by paragraph 3(2):

“Before a person gives consent under this Schedule, he must be informed of the effect of paragraph 4 below.”

34.

Paragraph 4, which is the critical paragraph provides:

“(1) The terms of any consent under this Schedule may from time to time be varied, and the consent may be withdrawn, by notice given by the person who gave the consent to the person keeping the gametes or embryo to which the consent is relevant.

(2) The terms of any consent to the use of any embryo cannot be varied, and such consent cannot be withdrawn, once the embryo has been used –

(a) in providing treatment services, or

(b) for the purposes of any project of research.”

35.

By paragraph 6(3) of Schedule 3, an embryo the creation of which was brought about in vitro must not be used for any purpose unless there is an effective consent by each person whose gametes were used to bring about the creation of the embryo to the use for that purpose of the embryo, and the embryo is used in accordance with those consents.

36.

By paragraph 8(2) of Schedule 3, an embryo the creation of which was brought about in vitro must not be kept in storage unless there is an effective consent, by each person whose gametes were used to bring about the creation of the embryo, to the storage of the embryo and the embryo is stored in accordance with those consents.

The two most important principles underlying the Act

37.

These are the relevant statutory provisions for my purposes. Before moving on, however, a reading of the Act and the Code of Practice seems to me amply to justify the submission made by Miss Rose that the two most important principles to be found in the Act are (1) the welfare of any children born by treatment under its provisions, and (2) the requirements of consent from those participating in the treatment. For these propositions she relied upon Leeds Teaching Hospital NHS Trust v A and others[2003] 1 FLR 412, per Dame Elizabeth Butler Sloss P at paragraph 20, approving and quoting a passage from the judgment of Hale LJ in U v Centre for Reproductive Medicine[2002] EWCA Civ 565, paragraph 24. The President said: -

The two most important principles to be found in the Act are the welfare of any children born by treatment under the provisions: see for instance section 13(5) and the requirements of consent (see Schedule 3(5), section 28(2) and the statutory consent forms, and Annex C to the Code of Practice. Hale LJ said in U v Centre for Reproductive Medicine:

The whole scheme of the 1990 Act lays great emphasis upon consent. The new scientific techniques which have developed since the birth of the first IVF baby in 1978 open up the possibility of creating human life in ways and circumstances quite different from anything experienced before then. These possibilities bring with them huge practical and ethical difficulties. These have to be balanced against the strength and depth of the feelings of people who desperately long for the children which only these techniques can give them, as well as the natural desire of clinicians and scientists to use their skills to fulfil those wishes. Parliament has devised a legislative scheme and a statutory authority for regulating assisted reproduction in a way which tries to strike a fair balance between the various interests and concerns. Centres, the HFEA and the courts have to respect that scheme, however great their sympathy for the plight of particular individuals caught up in it.”

The facts in the case of Ms Evans and Mr. Johnston

38.

Against that background, I now turn to examine the facts of the two cases. I am conscious that both have been heard in public, and that my judgment will be handed down in public. I will therefore provide only such details of both claimants’ medical conditions and histories as are necessary for the purposes of my decision. Furthermore, although I heard factual evidence about a number of aspects of the personal lives of Ms Evans and Mr. Johnston in particular, and formed my impression of them both on all the evidence I heard, I propose only to make findings of fact in relation to those issues which are strictly necessary for my decision.

39.

Ms Evans was born on 23 October 1971. She is thus now 31. Mr. Johnston was born on 2 November 1976, and is now 26. In October 2001, when the critical events with which I am concerned occurred, she was rising 30 and he was rising 25. Mr. Johnston has never been married.

40.

On 30 August 1995, when she was married to another man, Ms. Evans was referred by her general practitioner with her husband to the Clinic. At that point, she and her husband had been trying to achieve a pregnancy for two years without success. Ms Evans had an irregular menstrual cycle with borderline serum progesterone suggestive of defective ovulation. She was prescribed Clomid, a drug used to stimulate ovulation.

41.

I do not need to chronicle Ms Evans’ treatment thereafter, which is set out in the statement from Dr Sharp. According to his statement in the proceedings, he suggested IVF treatment to Ms Evans and her then husband on 2 July 1997. This did not occur due to the subsequent breakdown of her marriage, and the clinic did not see Ms Evans again until 12 July 2000, when she attended with Mr. Johnston. However, I accept Ms Evans’ evidence that she had always wanted to conceive a child, and was bitterly disappointed when all her attempts at doing so failed.

42.

Between July 2000 and March 2001, Ms Evans was again treated with clomid. She did not, however, become pregnant. In April 2001 she had a hysterosalpingogram, an examination of the uterus and fallopian tubes, which demonstrated that both fallopian tubes were clear. She was, however, recommended for a laparoscopy, which took place on 13 September 2001. That examination gave rise to concern over the condition of her ovaries, and on 27 September 2001, she underwent a laparatomy, or surgical incision into the peritoneal cavity. The findings were, in summary, of serious borderline tumours present in both ovaries.

43.

On 9 October 2001 there was a meeting of the doctors at the clinic, the conclusions of which were that Ms Evans would require an oophorectomy (the removal of her ovaries) but that because the ovarian tumours were growing slowly Ms Evans could have IVF and embryo freezing followed by a formal oophorectomy with what is described as a “staging procedure” as soon as convenient but not before the IVF services were content that they had retrieved the eggs they needed.

The events of 10 October 2001

44.

The news that she was going to need an oophorectomy was conveyed to Ms Evans on 10 October 2001 when she attended the clinic with Mr. Johnston. Since this was the day on which both Ms Evans and Mr. Johnson signed their consents to IVF treatment, and since what Mr. Johnson is alleged to have said to Ms Evans during a meeting with Mrs. Spearman forms the basis of the promissory estoppel upon which she seeks to rely, I need to look at the events of the day in some detail.

45.

I preface my description of what happened on 10 October 2001 by recording my sympathy for Ms Evans both in relation both to her medical condition and to the events of that day. Events moved very swiftly. It was within minutes of receiving the terrible news that she had a life threatening condition and would need the removal of her ovaries that she was discussing the details of IVF with Mrs. Spearman and Mr. Johnston. In her oral evidence to me, she described the meeting with Mrs. Spearman as like being in a room full of water. It felt, she said, as if everybody was under water and she could not hear what he or she were saying. It was a graphic description.

46.

In her statement made for the purposes of the proceedings on 29 October 2002, Ms Evans describes what happened on 10 October 2001 in the following terms: -

14. On 10 October 2001, Howard (Mr. Johnston) and I went to see Nick Johnson (a consultant in gynaecological oncology who had carried out the formal laparotomy and ovarian cystectomy with Mr. Jaaback on 27 September) at the RUH. He told me that I would need a laparotomy procedure to remove my ovaries and my fallopian tubes. It was a complete shock and I was devastated.

15. He told me that because I needed to have my ovaries and fallopian tubes removed I had to consider whether I wanted to try IVF now before it was too late. He took Howard and I over to see Mr. Nick Sharp at the clinic to discuss this.

16. Twenty minutes after being told that I had ovarian cancer, Howard and I were sitting down with Mr. Sharp who explained what our options were. He told us that we could have one cycle of IVF treatment to attempt to harvest some eggs. Howard and I agreed with Mr. Sharp that before I underwent surgery to have my ovaries and fallopian tubes removed I would have some eggs harvested, which Howard would then fertilise. The embryos that resulted could then be frozen for use after my surgery so we could still have a family……

18. We saw Mr. Sharp and then went into another room where we saw Pam Spearman, one of the nurses. We signed the consent forms that we were asked to sign and I was shown what I needed to do in terms of injections and using a nasal spray.

19. I would say that our whole visit to the clinic took no more than about an hour. I know that during this visit we discussed a lot of things about the IVF treatment and what it would involve. It was a bit overwhelming. I was very anxious about my cancer, the surgery I needed and the whole IVF process. It was difficult to take in everything that we were told, and I have no clear recollection of what was or was not discussed.

47.

Ms. Evans then identifies the consents which were signed, and in her statement that concludes her narration of the events of that day. The statement then continues as follows:

22. Howard and I then attended the clinic on a regular basis. I recall one specific occasion, prior to the eggs being harvested, when we were with Pam Spearman. I cannot be certain of the date. I believe it was while we were in the process of having treatment. I cannot remember how the conversation started, but I asked Pam whether we had to have all the eggs that were harvested fertilised and then frozen. I asked whether it was possible simply to have my eggs frozen. Pam replied that they did not carry out that procedure at the clinic and that if I wanted to have my eggs frozen prior to them being fertilised I would need to go to another IVF clinic.

23. At this point Howard told me not to be stupid and that there was no need for that. He told me that he loved me, that we would be getting married and having a family together. I said, “But what if we split up?” Howard told me that we were not going to and that I should not be such a negative person.

24. I suggested that perhaps we freeze some of the eggs and that if we were still together in a couple of years’ time and wanted to use them he would always fertilise them then. He told me again that we would not be splitting up, that our future was together and that he loved me. He told me that he loved me, that he wanted to have a family and that I was the woman he wanted to share his life with. He told me that he would never leave me, and that he wanted to be the father of my children. I told him that I loved him and trusted him.

25. Pam Spearman was present throughout this conversation. She said that we would need to really think about what we wanted and to make up our minds what we wanted to do. Howard continued to reassure me and in the end I simply accepted what he said and we just carried on. It was not mentioned again.

48.

It is now clear, and Ms Evans in her oral evidence accepted, that she is wrong in ascribing the conversation which she describes in paragraphs 22 to 25 of her statement to a date after 10 October 2001. The conversation, whatever its precise terms, took place on 10 October 2001.

49.

Mr. Johnston, in his statement for the proceedings dated 17 January 2003, deals with the meeting with Mrs Spearman on 10 October 2001 in the following way:

9. I recall that the claimant and I then attended a further consultation with Pamela Spearman. Mrs. Spearman explained, in further detail, IVF treatment. It had already been made clear to us that the Clinic would not be able to store any unfertilised eggs and that if this was to be considered, we would have to attend an alternative clinic.

10. Eventually, (Ms Evans) and I signed consent forms for the IVF treatment at the Clinic. The contents of the consent forms were explained to us. Indeed, we were taken through the consent forms on a paragraph by paragraph basis. It was obviously made clear to us that the consent of both myself and (Ms Evans) would be required before anything could be done. It was also explained to us that the continued storage of the embryos would be considered on an annual basis so as to ensure that both myself and (Ms Evans) wanted the storage to continue. In addition, it was clear that upon the termination of our relationship the storage and use of the embryos would need to be reviewed. It was therefore clear that we would still maintain freedom to choose either whether we wanted to start a family together or when we would start a family together. I suppose I was reassured by the fact that I would still maintain the same control regarding this decision as I would had these unfortunate events not occurred. Having said that, I would estimate that the entire consultation lasted approximately 90 minutes. This was from the diagnosis being given to (Ms Evans) and us embarking on a course of IVF treatment. As outlined above, the circumstances were far from ideal. (Ms Evans) and I certainly had no opportunity to discuss matters in details privately. In fact, the only time we had time to discuss matters alone was when we talked in whispers for about 60 seconds whilst staff went to obtain an IVF kit.

11. I obviously wanted to reassure (Ms Evans) during this difficult time. I was concerned for her welfare. I cannot recall providing her with any specific reassurances at this time. As outlined above, save for about 60 seconds or so, (Ms Evans) and I were not alone. However, it is highly likely that I would have been trying to reassure and support (Ms Evans). I could hardly have done anything else in the circumstances. Certainly, I did not enter into any form of legally binding agreement with (Ms Evans). I would have only provided (Ms Evans) with assurances, the nature of which are frequently given on a daily basis in any relationship. As far as I am concerned, both myself and (Ms Evans) were fully aware of the basis upon which the embryos would be stored and used, namely in accordance with the consent forms which were fully explained to us, and which were signed by both of us.

50.

Mrs. Spearman gives her account in her statement made on 29 October 2002. She first met Ms. Evans and Mr. Johnston on 10 October 2001. She states she has a clear recollection of them, not least because of the very tragic circumstances in which they found themselves attending the clinic. She says that in view of those circumstances, and the fact that she was seeing the couple immediately after their consultation with Mr. Sharp:

……. the couple required particularly careful and detailed information and support to ensure that they were in full possession of all the physical, emotional and legal elements of the IVF treatment in order to understand its full implications.

51.

Mrs. Spearman exhibits to her statement the checklist which she used to ensure that all the relevant points had been covered. In particular she states in paragraphs 13 that she sought confirmation that Ms Evans and Mr. Johnston had received the Clinic’s information pack, a copy of which she annexes to her statement. She says she checked carefully that the couple had read and understood a leaflet included in the pack entitled “IVF and ICSI Treatment”.

52.

Mrs. Spearman also states:

16. I made it clear to the couple that the Clinic would not take any action to dispose of the embryos in storage without contacting both parties. Likewise, I confirmed that nothing would be done with the embryos without the consent of both partners. I also explained that the Clinic would write to them on an annual basis to check that both partners still wanted their embryos to remain in storage.

17. Clause two of paragraph 4 (of the consent form) states that: “Upon the cessation of our domestic relationship by divorce or legal separation we understand that the storage and use of the embryos must be reviewed”. I explained to Ms Evans and Mr. Johnston that this applied equally to unmarried couples. I also explained that they should notify the clinic of any change or breakdown in their relationship.

18. I also elaborated upon what was meant by “reviewing” the storage and use of embryos. I explained that, in the event of the breakdown of their relationship, it would not be possible for them to attend with a new partner and expect the Clinic to treat them using the same embryos.

53.

Mrs. Spearman then describes the process of taking Ms. Evans and Mr. Johnston through the Authority’s forms. She then states:

23. I recall that Ms Evans seemed quite tense during our meeting and she was very naturally upset about the operation she was going to have. However, I had no concerns about her relationship with Mr. Johnston: they appeared to be very happy together and he came across as being very supportive of Ms. Evans. He did mention that his mother had expressed some concerns about him pursuing this course of treatment with Ms Evans, but Mr. Johnston himself seemed committed to his partner.

24. I do not recall Ms Evans asking me about alternative treatments available although I am aware that she has suggested she asked me about the possibility of oocyte freezing. The question of oocyte freezing is frequently raised by couples who, at initial consultation, may not be aware of or understand the difference between oocytes and embryos. Had such a query arisen regarding treatment, I would have referred the couple back to Mr. Sharp and the wider team for further discussion and consultation. This is because if oocyte freezing had been raised, it would have suggested to me that there was some doubt about them seeking treatment as a couple. This would have changed both my and the team’s perception of the suitability and appropriateness of IVF treatment for the couple since the welfare of any potential child or children from such treatment is always our paramount concern.

54.

Having had the opportunity to consider Mr. Johnston’s statement, Ms Evans saw no reason to disagree with him that information about the Clinic’s inability to store unfertilised eggs was provided on 10 October 2001 and not on any later date, as she had initially thought. Her recollection was that Mrs. Spearman took Mr. Johnson and herself through the forms very briefly, and that they had to be signed then and there.

55.

Ms Evans is also very clear that neither she nor Mr. Johnston had been sent a copy of the Clinic’s Information Pack, and that Mrs Spearman is simply wrong in paragraph 13 of her statement (see paragraph 51 above) when she says she sought confirmation that they had received it, and when she says she checked carefully to ensure that they had read the particular leaflet contained within it. Ms Evans says that the first time she saw this document was when it was annexed to Mrs. Spearman’s statement I accept her evidence on this point, which was supported by that of Mr. Johnston..

56.

Mrs. Spearman also filed a supplementary statement on 25 June 2003 which, for the most part maintains her original position. However, she accept that: -

9. With regard to egg freezing, it is possible that Ms Evans asked me whether or not the Clinic offered egg freezing as a service to patients. Many patients have read or heard about egg freezing, and many confuse embryos and eggs. It was relatively common for patients to ask about egg freezing and I would not have found such a query remarkable if it had come from Ms Evans. I would simply have explained that the Clinic did not offer it as a service to patients.

10. In contrast, if Ms Evans had indicated that she wished to pursue egg freezing as an option, this would have raised concerns about her and Mr. Johnston receiving treatment as a couple. I would therefore have referred them back to Mr. Sharp and am sure that I would recall such a conversation if it had occurred in the manner described by Ms. Evans.

My findings of fact in relation to the events of 10 October 2001

57.

I heard oral evidence from Ms Evans, Mr. Johnston and Mrs. Spearman. I also heard from Dr. Sharp, although he could give no direct evidence as to what was said at the meeting between Ms Evans, Mr. Johnston and Mrs. Spearman. I thought all three were trying their best to assist me. As I have already made clear, Ms Evans frankly told me that she felt numb with shock on 10 October 2001 when given the results of the laparotomy and on being told that she would have to have surgery to remove her ovaries. No doubt it was this which caused her to place the critical conversation on the wrong date.

58.

Ms Evans’ oral evidence to me was very much along the lines of her statement. She was being told that the only option was to fertilise her eggs with Mr. Johnston’s sperm. She therefore asked Mrs. Spearman about egg freezing. She was trying to safeguard having a child – this was the real issue; she was concerned that Mr. Johnston would leave her. She told me that Mrs. Spearman said words to the effect of “we don’t do egg freezing at this clinic – you will have to go to an alternative clinic”, and that it was at this point that Mr. Johnston told her not to be a negative person: they did not need to have egg freezing. She said he told her he was not going to leave her. She put all her trust in him. He was trying to reassure her and he was going to be the father of her children. Had he not given her those assurances she would have looked for alternative treatment – either a different clinic or donor sperm.

59.

When cross-examined by Mr. Moradifar for Mr. Johnston the areas of dispute between Ms Evans and Mr. Johnston seemed to diminish. Ms Evans accepted that Mr. Johnston was not telling her in terms that she could always use the embryos but seeking to reassure her that they were not going to split up. Equally, when Mrs. Spearman gave evidence, the slightly defensive dogmatism of her statements softened. She was clear that there had not been a discussion with her about freezing eggs, but she accepted that it had quite possibly arisen as a question which was not followed up. She would have told Ms Evans that it was something the clinic did not do, and that Ms Evans would have to discuss it with Mr. Sharp.

60.

Mr. Sharp, when he gave evidence, had no recollection of any discussions with him about egg freezing. However, he regarded single person egg freezing as very much in its infancy and far removed from standard medical practice. The Clinic did not have a licence for it, and as far as he was aware, there were no reported pregnancies in the UK resulting from it.

61.

Mr. Johnston’s evidence seemed to me to confirm the narrowing of the issue. It had been a very emotional meeting He had not given an unequivocal assurance about the embryos, but he had done his best to be supportive. In a skilful cross-examination by Mr. Robin Tolson QC for Ms Evans he said that he was very much in love with Ms Evans. It had not crossed his mind that they might want to go their separate ways, although he knew the relationship would have ended if he had told her that he was not going to give her the child she so desperately wanted. He could not remember what he had said but he accepted that she had said words to the effect of “what if we split up” and that he had replied “we are not going to split up”. He saw no reason at that point why they should.

62.

Although I have spent a great deal of time setting out the evidence, the result, having seen the three principal witnesses on this point in the witness box, is reasonably clear. Despite errors in her initial statement (notably, of course, the date of the conversation) and despite the fact that – as Dr. Stern for the Clinics pointed out – Ms Evans was at points unable to recall important aspects of her treatment - I am satisfied, on the balance of probabilities, that during the session with Mrs. Spearman Ms Evans did raise, as a general enquiry, the possibility of freezing her eggs as opposed to freezing fertilised embryos. I am satisfied that Mrs. Spearman told her simply and shortly that this was something which the Clinic did not do. I also find, on the balance of probabilities,that she added that if Ms Evans wished to pursue this aspect, she would have to go back to Mr Sharp.

63.

I am equally satisfied on the balance of probabilities that when Mrs. Spearman had answered the enquiry about freezing eggs, Mr. Johnston gave Ms Evans the assurances I have set out in paragraph 58. They were not going to split up. She did not need to go in for egg freezing. She should not be negative. He wanted to be the father of her children.

64.

I find further on the balance of probabilities that Mrs. Spearman did hear Mr. Johnston give these assurances, but that she did not absorb them. As time has passed, and Mrs. Spearman having seen many couples since, the assurances have become simply part of her perception of him as a reassuring and supportive presence.

65.

It is, I think, quite clear, and accepted by Ms Evans that Mr. Johnston did not give her any categorical assurance, in terms, that whatever happened between them she could use the embryos in order to become pregnant. That, however, she says is the irresistible inference from what he did say.

66.

I am equally clear that, at the time he gave Ms Evans the assurances I have identified, Mr. Johnston meant what he said. In other words, he gave the assurances in good faith. He was in love with Ms Evans: he intended at that time to stay with her indefinitely. Despite some reservations about it, he entered into the treatment process with Ms Evans on the basis that if it was successful he would be the father of the resulting child, and that he and Ms Evans would in due course marry.

67.

I shall need to discuss, later, whether the assurances which I have found Mr. Johnston gave Ms Evans are capable of providing the basis for a promissory estoppel. I shall also need to consider the extent to which it can properly be said that Ms Evans relied on them to her detriment.

The consents which Ms Evans and Mr Johnston signed on 10 October 2001

68.

The documents which both Ms Evans and Mr. Johnston signed on 10 October 2001 fall into two categories. The first comprises those provided by the Clinic: the second category comprises those provided by the Authority which the Clinic needed in order to observe the terms of its licence. Several of the forms (notably those not signed on 10 October 2001) deal with the release of information by and to the couple’s general practitioner. Nothing turns on these forms, and I will not reproduce them.

69.

The most important form for my purposes is that in which Ms Evans and Mr. Johnston give their consent to treatment involving egg retrieval and embryo replacement. It is in two parts. Part I, which is signed by Ms. Evans, reads as follows:

1. I consent to [delete / complete as applicable]

(i) be prepared for egg retrieval;

(ii) the removal of eggs from my ovaries with the aid of ultrasound;

(iii) the administration of any drugs and anaesthetics which may be found necessary in the course of the procedure(s)

(iv) the mixing of the following: [tick each column as required];

my egg(s) with the sperm of my partner/ husband (“husband” is deleted)

2. I understand that if the donor has given effective consent under (the Act), the donor will not be the legal parent of any resulting child.

3. I have discussed with Mr. Sharp / Pam Spearman the procedures outlined above. I have been given information orally and in writing about them.

4. I have been given a suitable opportunity to take part in counselling about the implications of the proposed treatment (using donated sperm or eggs, or any IVF treatment).

70.

I have set out Part I of the Clinic’s consent form in full, even though several parts of it are inapplicable (this was not, of course, an AID case). The relevance of this information, however, is that on the form itself, two columns are provided for the answer to question 1(iv) with three boxes in each column. Ms Evans has ticked the first box in each column. Thus her consent is to the mixing of her eggs with the sperm of her partner / husband. The second box in the left hand column is designated “eggs donated by” with a blank left for the name. The third box in the column is designated “an anonymous donor’s egg(s). The second box in the right hand column is designated “with sperm donated by” and a gap for the name. The third box in the right hand column is designated “with an anonymous donor’s sperm”.

71.

It is thus clear from Part I of the Clinic’s consent form that the treatment to which Ms Evans was giving her consent on this form was to the mixing of her eggs with Mr. Johnston’s sperm. She did not give her consent to the mixing of her eggs with the sperm of any other named person than Mr. Johnston, and she was not consenting to AID.

72.

Part II of the form is signed by both Ms Evans and Mr. Johnston. It deals with the creation of embryos, the transfer of embryos, the fertilisation of surplus eggs and the storage of excess embryos. The phrase on the form: “*We authorise / do not authorise the medical practitioner to store excess embryo(s)” is left untouched. The form does, however, contain the provision that if authorisation is given for the storage of excess embryo(s) such storage will cease upon the following occurring: -

(a) upon their joint request for their use in a future treatment cycle;

(b) upon jointly signed written request by them to discontinue storage;

(c) at the expiration of an agreed period of time but in any event no longer than ten years from the date of the commencement of storage.

73.

The form also provides that upon cessation of their domestic relationship by divorce or legal separation they understand that the storage and use of the embryos must be reviewed (see Mrs. Spearman’s statement as recorded at paragraph 52 above). There is provision for an annual review, a medical disclaimer and both agree they have discussed the procedures with Mr. Sharp and Mrs Spearman and have been given information orally and in writing about t hem.

74.

Mr. Johnston signed the clinic’s “Male Partner’s Acknowledgement This reads:

I am not married to Natallie Evans, but I acknowledge that she and I are being treated together, and that I will become the legal father of any resulting child.

75.

The next relevant form is the Authority’s Form for Consent to Storage and Use of Eggs and Embryos, which begins with the following warning in bold type:

N.B Do not sign this form unless you have received information about these matters and have been offered counselling. You may vary the terms of this consent or withdraw this consent at any time except in relation to eggs or embryos which have already been used.

76.

There follows a warning about the risks of storing eggs. This is in the following terms: -

Patients wishing to store their eggs should note that egg freezing and the use of frozen eggs in treatment are experimental techniques. Not all eggs will survive the freezing and thawing process, and sometimes no embryo will be created using frozen eggs. There have not yet been enough treatments to be able accurately to predict the chance of a baby being born using frozen eggs. You are strongly advised to read the HFEA information leaflet on egg freezing before giving your consent.

77.

The form is then divided into two parts: use and storage. Ms Evans was given three options in relation to the use of her eggs. They were (i) in her own treatment (ii) in treating others and (iii) in any project of research. The form is completed by ticking Yes and No boxes. Ms. Evans ticked the “Yes” box in relation to her own treatment and the “No” box in relation to treating others and research.

78.

The second question under use (as completed) reads as follows: -

(b) I hereby consent to my egg(s) being fertilised in vitro to develop embryo(s) and to the use of those embryo(s) for the following purposes: -

i In the treatment of myself Yes

in the treatment of myself with a named partner Yes

Full name of partner Howard Roy Johnston

ii in treating others No

iii in any project of research No

79.

As with the first question under “use”, the answers in relation to the questions (b)(i to iii) are given by ticking boxes marked YES and NO. Consistent with her answers to the first question, Ms Evans is, accordingly, consenting once again to IVF treatment with Mr. Johnston.

80.

In relation to storage, Ms Evans consented to the storage of her eggs for a maximum period of 10 years, and to the storage of embryos developed in vitro from her eggs for 10 years. If she died or became mentally incapacitated she elected that neither her eggs nor her embryos should be allowed to perish; that they should continue in storage for the purposes specified in the answers to questions relating to use and storage, but should not continue in storage for any other purposes.

81.

The Authority’s Form for Consent to Storage and Use of Sperm and Embryos signed by Mr. Johnston is structured identically to that signed by Ms Evans with, of course, the necessary substitution of “sperm” for eggs. The form has the same warning at the top in relation to the right to vary or withdraw consent. Mr. Johnston consented to the following: -

I hereby consent to the use of my sperm to fertilise egg(s) in vitro and to the use of embryo(s) developed from these egg(s) for the following purposes:

i. in the treatment of myself together with a named partner Yes

Full name of partner: Miss Natallie Evans

ii. In treating others No

iii. in any project of research No

82.

Mr. Johnston’s instructions in relation to storage and to what should happen in the event of his death or incapacity are identical to those of Ms Evans, save that he did not tick any other boxes relating to the eggs / embryos continuing in storage for any other purposes.

83.

Before leaving the forms, it is, I think, unfortunate that Part II of the Clinic’s consent to treatment form, which I have summarised at paragraph 72 and 73, does not fully reflect the terms of paragraphs 4(1) and 6 of Schedule 3 to the Act. In this context the word “review” seems to me ambiguous, and inconsistent with the accurate statement (which I have set out in paragraph 75) which heads up the Authority’s form of Consent to Storage and Use of Eggs and Embryos. No doubt this is something the Clinic may wish to consider further in the light of this judgment.

Events after 10 October 2001

84.

Ms Evans duly began the course of treatment, part of which involved the injection hormones. On 16 October 2001 Ms Evans and Mr. Johnston signed the “Welfare of the Child: Consent to Release of Information about Me” form consenting to their general practitioner, Dr. Slack, providing information about them to the Clinic. They declared that they had read and understood the contents of the Authority’s leaflet on the Welfare of the Child. On 17 October 2001 Dr. Slack completed the welfare of the child information and declaration for GPs declaring that she knew of no reason why treatment should not proceed.

85.

From the evidence both Ms Evans and Mr. Johnston gave, it was plainly a tense and difficult time. On the morning of 12 November 2001, the day they were to attend the clinic together for Ms Evans’ eggs to be harvested and fertilised, there was an argument between them. Ms Evans says Mr. Johnston told her he was not going through with the treatment. Mr. Johnston says that Ms Evans initially refused to have her last injection, and told him that the whole thing was a waste of time, although she changed her mind shortly afterwards.

86.

I am reluctant to make findings of fact except in relation to issues of direct relevance unless I need to, and I am conscious of the fact that during the hearing, I discouraged cross-examination on the personal aspects of the relationship between Ms Evans and Mr. Johnston. On this point, however, having heard both of them, I accept Mr. Johnston’s version of this argument. I do not think for a moment that Ms Evans meant it when she said that the whole thing was a waste of time. It is, however, an indication of the tension under which both she and Mr. Johnston were operating, and may have some relevance in relation to the issue of estoppel.

87.

In any event, however, later on 12 November 2001, Ms Evans and Mr. Johnston both attended the clinic. Eleven eggs were harvested and fertilised. From these, six embryos were created and on the following day these were duly placed in storage by the clinic. On 26 November 2001, Ms Evans underwent a successful bilateral oophorectomy for high-grade multiple tumours of borderline malignant potential. The positive news is that, although Ms Evans cannot now conceive a child spontaneously, the latest ultrasound scans were normal, and she has been given the “all clear”. Since the cancer did not spread to her uterus, it is the opinion of Professor Ledger, the independent expert brought in to advise pursuant to the order of the President of 19 September 2002 that Ms Evans should be able to carry a pregnancy normally, although if she is unable to use the six frozen embryos fertilised on 12 November 2001, there is no prospect of her bearing a child which is genetically hers.

88.

On 19 December 2001, Ms Evans was advised that she ought to wait for two years before an embryo transfer should be attempted, although it could be done earlier. However, on 27 May 2002 the relationship between Ms. Evans and Mr. Johnston came to an end. The causes of the breakdown of the relationship are irrelevant for my purposes.

89.

Ms Evans says that subsequent to their separation there was an agreement between them that she could use the embryos provided he was not named on the birth certificate as the father and would not be financially liable for any maintenance. Mr. Johnson denies that any such agreement was reached. The furthest it went, he said, was her suggestion that she should set up a meeting with a solicitor to enable an agreement to be discussed and drawn up. He accepts that he agreed to attend such a meeting to discuss the possibilities, but Ms Evans did not arrange it. She agreed that this was the case, and attributed her failure to progress the matter by the serious emotional effect which the breakdown of the relationship had on her.

90.

On this part of the case, having seen them both in the witness box, I prefer Mr. Johnston’s evidence, and I am quite satisfied that no such agreement was reached. But even if it had been it would not, in my judgment, have been effective to achieve the objective Ms Evans desired. I will return to this point later – see paragraph 253.

91.

On 4 July 2002 Mr. Johnston wrote to the clinic, informing it that his relationship with Ms Evans had come to an end, and explaining that as far as he was concerned the embryos could be destroyed. The clinic then advised Ms Evans that Mr. Johnston had withdrawn his consent to their further storage. On 11 September 2002 Ms Evans instituted proceedings, and at a directions hearing before the President on 19 September 2002 the clinic undertook not to make any arrangements for the embryos to perish or be otherwise altered or destroyed until agreement between the parties or the final determination of these proceedings.

92.

All I need to add in relation to this part of the case is that whilst it was unfortunate that on 10 October 2001 the meeting with Mrs. Spearman had to take place immediately after Ms. Evans had received the terrible news that she required radical surgery to remove her ovaries, and whilst Mrs. Spearman was, as I indicated in paragraph 59 somewhat defensive in her original statement, I accept Dr. Stern’s submission that no criticism of the clinic can be made either in relation to Ms Evans’ treatment or in relation to the information which was given to Ms Evans and Mr. Johnston on 10 October 2001. Ms. Evans does not seek to say – nor could she – that the consents she signed were invalid or that she did not know what she was signing.

93.

Mrs. Spearman, whom I thought a pleasant, decent professional, and one who no doubt has, over the years, fielded the distress of many an IVF patient, fell into the trap - no doubt triggered by the fact of litigation – of turning her description of what she usually did into a narrative of what she actually did - and did so with more certainty than was perhaps warranted. For example, I have already accepted Ms Evans’ and Mr. Johnston’s evidence that they were not sent an information pack prior to 10 October 2001. Mr. Sharp agreed that this sometimes happened. Mrs. Spearman should not have been so unequivocal about it.

The facts in the Hadley case

94.

These can be taken much more shortly. Mrs. Hadley was born on 31 December 1964. She is thus now 38. Mr. Hadley was born on 1 April 1971 and is now 32. They married on 2 June 1995. Mrs. Hadley has a daughter from a previous relationship who is now 18.

95.

In June 1999, following upon previous preliminary assessments and investigations of the couple at the Clinic, Mr. and Mrs. Hadley commenced IVF treatment. The consents which they signed in August 1999 in relation to both treatment and storage are in no material respects different from those signed by Ms Evans and Mr. Johnston.

96.

On 20 September 1999, 11 eggs were harvested from Mrs. Hadley. Of these, 10 were successfully fertilised, of which 7 had potential to develop. On 22 September 1999, three of seven embryos were transferred into Mrs. Hadley. Of the remainder, 2 were placed in storage and two did not develop.

97.

In May 2000, Mr and Mrs. Hadley separated. They were divorced on 3 December 2001. In the intervening period, there were discussions between them about Mrs. Hadley being able to have the remaining embryos transferred into her on the basis that a resulting pregnancy would have no financial or other consequences for Mr. Hadley. Mrs. Hadley’s case is that Mr. Hadley agreed to this. Mr. Hadley denies it. Mrs. Hadley then suggests that Mr. Hadley agreed she could use the embryos provided that Mr. Hadley was registered as a semen donor and thus avoided financial responsibility for any subsequently born child. Mr. Hadley’s case is that the agreement between them was that the embryos should be allowed to perish at the end of the storage period (five years in their case).

98.

As in the case of Ms Evans and Mr. Johnston, I am satisfied that no post separation agreement was reached between Mr. and Mrs. Hadley in relation to the two stored embryos; but as in the case of Ms Evans and Mr. Johnston, no such agreement would, in my judgment, have been binding.

99.

Mrs. Hadley says she contacted the clinic in 2002 in the light of the agreement which she says she had reached with Mr. Hadley, but that the clinic said that if she wanted to have the embryos transferred into her both Mr. Hadley and his new partner would need to come into the clinic for a meeting and to give their consent. Mrs. Hadley says that she was very unhappy about the prospect of having to sit down with Mr. Hadley’s new partner, who was pregnant by him, to ask for her permission to use the embryos. She therefore let matters lie.

100.

Mrs. Hadley says that later in 2002, Mr. Hadley told her he was no longer content that she should use the embryos. By this time his new partner had given birth to their child. The clinic then contacted Mrs. Hadley to tell her that it had no alternative but to allow the embryos to perish at the end of the five year period. However, in August 2002 Mrs. Hadley read about Ms Evans’ case in the newspaper. She contacted the newspaper, which ran a story about her on its front page. Mr. Hadley’s reaction, she says, was to contact the clinic and to inform them in writing that he wished the embryos destroyed. After taking legal advice, Mrs. Hadley instituted proceedings on 11 September 2002. Similar directions were given in her case as in the case of Ms Evans and Mr. Johnston.

101.

Mrs. Hadley’s position, as she readily recognises, has none of the poignancy of Ms. Evans’ case. Mrs. Hadley suffers from polycystic ovary syndrome, a condition which does not preclude normal conception. In addition, she has, of course, already given birth to a healthy child, who is now adult, and who attended the final day of the hearing.

102.

Mrs. Hadley’s position, set out in her statement and repeated several times in oral evidence before me was that she and Mr. Hadley had begun a process; they had created two lives - two embryos; and that the embryos should not be allowed to perish. She wanted the opportunity to complete that which she and her former husband had begun. Life had already been started, she said, and she wanted to finish the job.

103.

Mr. Hadley, in his oral evidence, made it clear that he wished to be a father to any child in the full sense. He said he already had three children: his current partner had a child by a previous relationship: he was step-father to Mrs. Hadley’s child, and he now had a child by his current partner. “If I have a child on this planet I would be a father to it” he said, in answer to Mr. Tolson in cross- examination, explaining why nothing would now suffice to make him change his mind in relation to the two remaining frozen embryos.

The first point of law: are the consents given in this case capable of operating to enable the clinics to treat Ms Evans and Mrs Hadley on their own?

The argument

104.

Both the Authority and the Secretary of State take the point that Mr Johnston and Mr Hadley each gave consent only to the use of embryos fertilised with his sperm for the treatment of himself, together with his named partner. As the consent forms make clear, each was given the opportunity, but specifically declined, to consent to such embryos being used in the treatment of any other person, including, for example, Ms Evans and Mrs Hadley being treated alone, or with a different partner.

105.

In these circumstances both the Authority and the Secretary of State argue that (irrespective of whether or not the original consents have been subsequently varied or withdrawn), Schedule 3, paragraph 6(3) of the 1990 Act prohibits the use of the embryos in either case for any purpose other than for the treatment of Mr Johnston or Mr Hadley together with their respective partners. Since both couples have separated, the consents are no longer effective. If either claimant approached either clinic on her own, there would be no operative consent upon which either clinic could treat her.

106.

For ease of reference, I will set out the terms of paragraph 6(3) of Schedule 3. It reads: -

(3) An embryo the creation of which was brought about in vitro must not be used for any purpose unless there is an effective consent by each person whose gametes were used to bring about the creation of the embryo to the use for that purpose and the embryo is used in accordance with those consents

107.

If the phrase “in the treatment of myself together with a named partner” (the form of each of the consents in this case) is to be decided as a simple issue of fact, it is difficult to see how, given the separation of the two couples, either Ms Evans or Mrs Hadley presenting on their own at the respective clinics for treatment by transfer into them of the stored embryos could constitute treatment together with their named partner.

108.

Ms Rose, for the Authority, accepted that the term “treatment together” is both used in a variety of contexts in the Act, and is not defined (see, for example, ss. 4(1)(b) and 28(3)(a)). She argued, however, that the various uses of the phrase in a single statute ought to be consistently interpreted, and that the interpretation to be given to the phrase in paragraph 6(3) of Schedule 3 was entirely consistent with that given to it the decided cases under section 28(3) of the Act, where the issue under consideration was that of the paternity of subsequently born children.

109.

It therefore becomes necessary to look at the cases in which the phrase “treatment together” has been considered by the courts. They are, in chronological sequence, Re B (Parentage)[1996] 2 FLR 15, a decision of Bracewell J; (Re B); U v W (Attorney General Intervening)[1997] 2 FLR 282, a decision of Wilson J (U v W); and Re R (A Child)[2003] 2 All ER 131, a decision of the Court of Appeal (Sir Andrew Morritt V-C, Hale and Dyson LJJ) in which the judgment of the Court was given by Hale LJ (Re R).

110.

In Re B, the couple separated between the man’s donation of sperm in July 1991 and insemination of the woman, which took place in December 1991, although the judge found that sexual intercourse took place between them as late as November 1991. The donation of sperm took place before (whilst the insemination took place after) the relevant provisions of the Act had come into force. There was therefore no statutory consent, and the case is complicated by consideration of the transitional provisions.

111.

In essence, however, what happened was that following the birth of twins in August 1992, of whom the man accepted that he was the biological father, the mother sought financial provision for the children. In the absence of an express consent to treatment, the transitional provisions of the Act provided that he would be deemed to have consented, and would be treated as the father of the twins if he and the mother were receiving treatment together, including AID, and the man had not subsequently withdrawn his deemed consent. Since there had been no such deemed withdrawal of consent, the critical question was whether or not the treatment had been received jointly.

112.

Inevitably, Re B turns very largely on its facts. Bracewell J comprehensively rejected the man’s assertions that the donation of sperm had been a casual favour and that there had been no joint enterprise to conceive a child. The man’s case before the judge, it must be said, appears singularly unmeritorious, given that following the birth of the twins he had in September 1992 made a statutory declaration that he was the children’s father, was named on their birth certificates as their father, and was continuing to have sexual intercourse with the woman up until a short time before insemination.

113.

An indication of the nature of Bracewell J’s findings is given by the following extract [1996] 2 FLR 15 at 20:

I find the respondent knew of the hospital consultations, that the information relayed by the applicant was a truthful account of their common intentions and attempts to conceive despite the geographical constraints occasioned by work commitments. The respondent knew what was involved and after some initial hesitation he consented to the giving of sperm as part of a joint enterprise and he made a journey involving an air flight in order to do so. His version that there was no sex after 1989, possibly not even a meeting in 1990, and then an agreement merely as a casual favour to give sperm in the summer of 1991, makes no sense at all and I reject it. I do not find he donated as though he was an anonymous donor doing a favour which could have no repercussions for him. On the contrary, he was playing his essential role in aiding the applicant to achieve what both had been trying for, namely a pregnancy.

114.

U v W is another case under section 28(3) of the Act, this time involving the use of donor sperm. The facts are unusual. The couple had undergone IVF treatment, unsuccessfully, in England. The man’s sperm was weak. They went to Rome, where a particular doctor had developed a particular technique for implanting embryos into the uterus with a laser. The couple wanted to use the man’s sperm, but when it came to the point of insertion, the doctor told them that he had fertilised 12 of the woman’s eggs but that only one of them had been fertilised with the man’s sperm. The couple were told that the chances of the single embryo developing successfully if implanted on its own were negligible. The couple asked for time to reflect overnight, and on the following morning agreed that the treatment should proceed using six of the embryos, one of which, of course, was from the man. The man signed a form acknowledging paternity of the unborn child. Insertion then occurred.

115.

The woman was subsequently told that the embryo which the man had fertilised had died. Three of the remaining embryos developed. However, the woman was advised that for the safety of the foetuses, the third embryo should be the subject of termination. This operation took place in England.

116.

The couple’s relationship did not survive the woman’s return to England. Following the birth of the twins, the mother sought financial provision for them. Two questions arose, the first of which was whether or not the couple had received treatment services together within section 23(3) of the Act.

117.

Wilson J found that they had. Having referred to Re B, the decision of the Court of Appeal in R v HFEA ex parte Blood [1997] 2 WLR 806, the decision of Johnson J in Re Q (Parental Order) [1996] 1 FLR 369 and the Authority’s Code of Practice, he stated ([1997] 2 FLR 282 at 294D-E: -

I have no doubt that there is a mental element inherent in the notion of ‘treatment . . . together’ and that, if the respondent had believed at all material times that the treatment which was being provided was treatment in which his sperm alone was to be used, Dr A’s treatment of the applicant with donor sperm would not have amounted to services provided for them together.

That hypothesis, however, does not fit the facts of this case.

118.

Having then analysed the facts, he continued [1996] 2 FLR 282 at 250B:

The test in s 28(3)(a) is not whether the man consented either to be deemed in law to be the father of the prospective child or to become legally responsible for him: it is whether the relevant treatment services were provided for the woman and him together. It stretches the requisite mental element in the man too far to require either form of such consent. In my view, what has to be demonstrated is that, in the provision of treatment services with donor sperm, the doctor was responding to a request for that form of treatment made by the woman and the man as a couple, notwithstanding the absence in the man of any physical role in such treatment.

119.

Re R was also a donor insemination case. The woman had signed a consent form for IVF treatment involving egg removal, donor insemination and embryo replacement. The man countersigned the consent form acknowledging that they were being treated together and that he would become the legal father of any resulting child, pursuant to section 28(3) of the Act. Initial treatment did not result in a successful pregnancy, and the couple then separated. The woman began a relationship with a new partner. She became pregnant as a result of further treatment, carried out without the first man’s knowledge, but about which he found out a few months later. After the birth of the child he applied for parental responsibility and contact orders under the Children Act 1989.

120.

Before the judge, both the Official Solicitor, who had been appointed to act for the child, and the woman conceded that the man was the child’s legal father. The judge ordered indirect contact and adjourned the application for parental responsibility generally. The man was refused permission to appeal against that decision, but on the hearing of the application for permission, the court expressed concern that jurisdiction had been assumed on the basis of a concession made without proper exploration of the facts.

121.

The man then sought to clarify the situation by reinstating his application for parental responsibility and asking for consideration of his status under section 28(3) as a preliminary issue. The judge granted the respondent a declaration of paternity. The mother appealed, contending that the embryos which had resulted in the successful pregnancy had not been placed in her ‘in the course of treatment services provided for her and a man together’ for the purposes of s 28(3) if at the time when they had been so placed the parties had separated and the respondent had taken no part in the treatment she had then received.

122.

That argument succeeded in the Court of Appeal. It rejected the judge’s analysis, which bears some resemblance to the argument advanced on this point by (Ms Evans) in the instant case. The judge had said:

I am satisfied that “a course of treatment” is for the purpose of s 28(3) that which is spelled out in the consent form of the mother which her partner joins in by acknowledging the legal consequences to him. It seems to me that if circumstances change not only can either party withdraw if they so choose but that under the current Code of Practice the hospital, if informed, should bring that course of treatment to an end. If however that is not done then in my judgment the original course of treatment continues as treatment services provided to both of them together and, if a child is conceived in the course of that, the man will be the father. (emphasis supplied)

123.

The Court of Appeal rejected that interpretation, which it regarded as an unwarranted gloss on the simple words of the Statute. In its view: -

Section 28(3) cannot mean that the man is to be treated as the legal father if at some time during the provision of treatment services for the woman they were provided for them together. Gametes and embryos can be stored for up to ten years or even longer in some circumstances. There must be a point when the question has to be judged. The simple answer is that the embryo must be placed in the mother at a time when treatment services are being provided for the woman and the man together.

124.

The Court likewise warned against treating Wilson J’s statement in U v V (which I have cited at paragraph 118 above and which it regarded as clearly correct as part of his explanation of the decision in his case) as laying down a test to be applied to all cases, since to do so would also be to add a gloss to the clear words of the section. The simple and correct approach was to rely on the clear words of the Act.

125.

In the light of these authorities, and in particular the approach of the Court of Appeal in Re R, Miss Rose puts forward a very simple argument. Neither Mr. Johnston nor Mr. Hadley has ever given consent to the treatment of Ms Evans or Mrs Hadley alone or with another partner. The embryos therefore cannot be used in circumstances in which both men are separated from their partners and are taking no part in any treatment services. Thus the embryos cannot be used to treat either woman within the terms of the original consents, regardless of whether such consents have been or can be varied or withdrawn. Effective consent must mean consent effective at the point at which the embryos are transferred into Ms. Evans and Mrs. Hadley. That consent cannot be effective if the couples are no longer being treated together.

126.

The Authority’s argument is supported on this point by the Secretary of State and by counsel for both Mr. Johnston and Mr. Hadley.

127.

In their initial skeleton argument, Mr. Tolson and Miss Freeborn sought to meet this point by submitting that the argument of the Authority and the Secretary of State gave an unwarranted meaning to the word “together”. The Act, they argued, did not require two persons presenting for treatment together to be a ‘couple’. There is merely the person giving consent and “another specified person” (Schedule 3, paragraph 1(2)(a)). It is the fact that the one consents which means that they are treated “together”.

128.

To test this submission, they posited the example of a person whose sole purpose is to provide a friend with sperm to fertilise her eggs. He attends the clinic, receives his medical treatment (the collection of his sperm and their use in fertilising the woman’s eggs) provides moral support during this phase and perhaps during a first cycle of treatment and then, as originally intended, plays no further part. It was submitted the clinic would not look to obtain a paragraph 2(1)(b) ‘donor’ consent to implantation and would not have to do so. The man’s continuing consent would constitute the only but vital element to create treatment together.

129.

Mr. Tolson and Miss Freeborn also submitted that if Mr Hadley had separated from Mrs Hadley but maintained his existing consent, the effect of the Authority’s argument would be that Mrs Hadley would not be able to use the embryos despite the continued existence of the original consent: they would not be treated together during implantation. Worse, she would not be able to obtain any necessary variation of the consent if the embryos had already been “used”, whether in a selection process or in, say, tissue typing.

130.

Mr Tolson and Miss Freeborn also submitted that a purposive construction of the relevant provisions produced a similar result. Necessarily, they argued, a withdrawal of consent will often attend a separation. As a consequence it was important to make the consent, not the physical separation, the decisive factor in determining whether or not two people were being treated together.

131.

In reply, Mr. Tolson and Miss Freeborn sought to argue that even a superficial reading of Re R demonstrated that there were material differences between section 28 and Schedule 3 and a potential need to interpret them differently, a point which the Court of Appeal did not have to decide: see Hale LJ at [2003] 2 All ER 131 at 138f. Schedule 3 provided a “brightline” non fact sensitive approach, designed to protect the treating clinic. Mr. Tolson and Miss Freeborn sought to argue that the danger of the Authority’s approach was that in every case the clinic would have to ask “are this couple together?” The test would be utterly fact specific, potentially requiring an investigation into the state of the relationship of every IVF couple, throughout treatment services.

Discussion and analysis

132.

I agree with Miss Rose that the various uses of the phrase “treatment / treated together” should be consistently interpreted within the same Statute, unless the Statute itself makes it clear that the phrase is to be interpreted differently in differing circumstances. Moreover, I have no difficulty in applying the straightforward interpretation of the phrase given by the Court of Appeal in Re R to the system of consents required pursuant to Schedule 3. In each case, it seems to me, it is a simple question of fact.

133.

In cases involving disputes as to paternity, where, by definition, embryos have been successfully transferred, the question is whether, at the moment the embryo was placed in the woman, treatment services were being provided for the woman and the man together. Where, as in the case of Ms Evans and Mr. Johnston, we are concerned with embryos which have been created and are now stored, the question is whether, if Ms Evans sought to have the embryos transferred to her, that would still constitute treatment together with Mr. Johnston.

134.

In my judgment, there can be only one answer to this proposition, and it is “no”. Ms Evans and Mr. Johnston were undoubtedly being treated together on 12 November 2001 when Ms Evans’ eggs were harvested and fertilised by Mr. Johnston’s sperm. In my judgment, they remained in treatment together, notwithstanding that nothing happened, until their relationship broke down. From that point onwards it seems to me impossible to say that the couple are being treated together, or that if Ms Evans went to the clinic and asked to have the embryos inserted into her, this would be treatment of the couple together.

135.

There are, of course, elements of artificiality about the argument because, in conventional terms, the only “treatment” undergone by Mr. Johnston was the provision of his sperm. Furthermore, in the instant case, it is very difficult to divorce the fact of separation from the accompanying fact that Mr. Johnston is no longer willing to give his consent to Ms Evans having the embryos transferred to her. If “treatment together” is an issue fact, the mental element identified by Wilson J in U v V cannot be ignored.

136.

However, in the same way as the cases under section 28(3) of the Act make the critical moment for treatment together the moment when the embryos are transferred into the woman, the terms of paragraph 6(3) of Schedule 3 are equally clear and have the same underlying purpose. The latter provide that an embryo must not be used for any purpose unless both gamete providers consent to the use of the embryo for that purpose and the embryo is used in accordance with those consents. Both the cases decided under section 28(3) and the terms of paragraph 6(3) to Schedule 3 have the same underlying reality.

137.

The purpose of the treatment is the creation of a pregnancy. That pregnancy begins when the embryos are successfully transferred and implanted. It is at that moment that one looks to see if the couple are being treated together for the purposes of section 28(3). In the instant case the only material difference is that the embryos in question have been frozen. The claimants now wish to have them unfrozen and transferred into them. The question is whether or not that process would constitute treatment together. In this analysis, I see no material difference in the approach to or use of the phrase “treatment together”. In both cases, it is an issue of fact.

138.

Furthermore, Miss Rose points out, the Act requires consideration to be given to the welfare of any unborn child, and that counselling should be offered to prospective parents. If the circumstances which were taken into account when the couple were together change dramatically, it would plainly better serve the purposes of the Act if the matter had to be reconsidered and fresh counselling offered before a further attempt at implantation was offered.

139.

I agree with that submission. It also seems to me that Miss Rose’s analysis generally not only fits the scheme of the Act, but also reflects the reality. As an ongoing series of events over time, treatment together must be something which can change and, in particular, come to an end in different ways. Thus, I have no doubt that on 22 September 1999, when three fertilised embryos were placed in Mrs. Hadley, that constituted treatment together within the terms of Mr. Hadley’s consent. They were together as a couple and were so treated. Even if they had separated after the transfer of the embryos into Mrs. Hadley and before the birth of the child. Mr. Hadley would have been the father of the child.

140.

However, the breakdown in the relationship between Mr. and Mrs. Hadley before the transfer of the remaining embryos followed by the couple’s physical separation and divorce means not only that they are no longer physically together, but that the treatment which they were receiving together has come to an end, and the consent which Mr Hadley gave to being treated together with Mrs. Hadley no longer applies.

141.

In my judgment, Mr. Tolson and Miss Freeborn’s argument falls into the trap identified by the Court of Appeal in Re R of providing a sophisticated gloss to essentially very simple words and an equally straightforward concept. It equally gives too little weight to the fact that treatment designed to enable a woman to give birth to a child can only be provided in accordance with the strict terms of a clinic’s licence, and requires the clinic to take account of the welfare of the unborn child. The need for the clinic to have an effective, continuing consent of both gamete providers pursuant to paragraph 6(3) of Schedule 3 at all times up to the transfer of the embryo into the woman is thus critical. It is not a matter of the clinic being protected by a bright line, non-fact sensitive approach. Without effective consents, the clinic cannot lawfully use the embryos.

142.

I am reinforced in this view by the evidence of the two doctors from the respective clinics, particularly that of Dr Lockwood, who had been treating Mrs. Hadley. Dr. Lockwood told me that what was required was, as she put it, “the ongoing valid consent of both parties”. In the instant case what she had was consent for treatment with a named partner. Treatment of Mrs. Hadley without Mr. Hadley’s effective, ongoing consent would render her in breach of her licence.

143.

When cross-examined by Mr. Tolson, Dr. Lockwood told me that this was the first case in her experience in which there had been resistance to ongoing treatment by one of the gamete contributors. She had experience of couples separating during the course of treatment, since treatment was stressful, and could both drive couples apart as well as bring them closer together. However, she only had one or two separations every year out of some 1500 treatments.

144.

Dr. Lockwood also told me that there was nothing to stop a separating couple reaching an amicable agreement about the woman having access to the embryos, although this would not relieve the clinic of its obligations to consider the unborn child and to offer counselling. Dr. Lockwood could not imagine a married couple wanting this. She would have very real concerns about asking a couple what would happen if they separated: if they wanted to discuss that option she would want to counsel them and they would have to come back for further discussion if separation occurred. In such a situation she would have to go to the Authority for guidance, as it would require a whole new process: it was not possible to build it in as a contingency.

145.

Relating her evidence specifically to the situation in the case of Mr and Mrs Hadley, Dr. Lockwood was clear that the situation now appertaining was not envisaged when the consents were given, and that she would not consider treatment of Mrs. Hadley alone to fall within the terms of the original consent. It was for these reasons that she considered the clinic would be in breach of its licence if it treated Mrs. Hadley in these circumstances.

146.

I accept the argument advanced by Mr. Tolson and Miss Freeborn that it would be open to a clinic to treat a separated couple where the man maintained his consent to treatment (and, presumably, his willingness to acknowledge paternity of any child born as a result of the treatment) although such a situation would be highly unusual, and I bear in mind the evidence of Dr. Lockwood on the point, set out above. To treat in those circumstances, however, the clinic, in my judgment, would not only have to be positively satisfied of the man’s continuing consent to the treatment, but would have to give particular attention to section 13(5). This, however, is not the situation with which I am faced.

147.

I also accept that, as a matter of reality, and as Mr. Tolson and Miss Freeborn submitted, separation and the withdrawal of consent to continuing treatment will usually go hand in hand. That is what has happened in the instant case. They are thus entitled to argue (because the point is being considered irrespective of whether or not the consents have in reality been withdrawn) that we are positing a consent which has not been withdrawn, and which therefore remains in existence. The point, however, remains whether or not the consent is still effective. This is, essentially, an issue of fact. The facts here are that both couples have separated, and no longer have any form of relationship with each other. In these circumstances, in my judgment, it cannot be said, as a matter of fact, that either couple in this case is still being treated together.

148.

The licensing provisions of the Act are very strict. As I have already stated, for there to be continuing “treatment together” in circumstances in which a couple have separated, the clinic, in my judgment, would need to be satisfied that the man’s consent remained effective. I accept that this places a burden on clinics, but it is one, in my judgment, which it is appropriate for them to bear. I did not get the impression that either Dr. Sharp or Dr. Lockwood thought such a burden inappropriate. Indeed, their evidence seemed to me to be entirely consistent with the argument being advanced by the Authority and the Secretary of State. The twin pillars of the Act are effective consent to treatment and the welfare of the unborn child. Schedule 3 is critical to the operation of the Act and the process of regulation. Mr. Tolson’s and Miss Freeborn’s interpretation of paragraph 6(3) of Schedule 3 to the Act would, I think, undermine its operation.

149.

I am very conscious of the dangers of importing an unnecessary gloss onto the simple terms of the Act. On the facts of this case, however, it is clear to me that there is no effective consent by Mr. Johnston and Mr. Hadley to the continuing treatment of either Ms Evans or Mrs. Hadley on their own. The only consent is for treatment together, and for the reasons I have attempted to give, I do not think either couple can now be said to being treated together. I am therefore satisfied that, on this point, the argument of the Authority and the Secretary of State is correct, and that the claim in each case falls at this hurdle.

The second point of law: have the remaining embryos in Mrs. Hadley’s case been “used” in the provision of treatment services, so that Mr. Hadley’s consent to their use cannot be varied or withdrawn?

The argument

150.

My decision on the first issue is, subject to arguments of incompatibility with and breaches of Convention Rights and HRA 1998, sufficient to dispose of the case. However, I am conscious that I may be wrong on the first point, and accordingly I propose to deal with each of the points of law argued, including the question of promissory estoppel.

151.

The argument on the second point arises from the terms of paragraphs 4(1) and (2) to Schedule 3 of the Act which, again for ease of reference, I will repeat: -

(1) The terms of any consent under this Schedule may from time to time be varied, and the consent may be withdrawn, by notice given by the person who gave the consent to the person keeping the gametes or embryo to which the consent is relevant.

(2) The terms of any consent to the use of any embryo cannot be varied, and such consent cannot be withdrawn, once the embryo has been used –

(a) in providing treatment services, or

(b) for the purposes of any project of research.

152.

Mr. Tolson and Miss Freeborn devoted a considerable proportion of their opening skeleton argument to this point, and conducted an extensive analysis of the Act in an attempt to demonstrate that the term “use” in the Act in relation to an embryo did not equate either with transfer of the embryo into the woman or with some act which changed the nature of the embryo. The essence of the argument, however, was that the stored embryos in Mrs. Hadley’s case were likely to have been the subject of a selection process by which they were rejected from the first attempt at implantation. It was on this selection process that counsel relied to establish the proposition that the stored embryos had been “use (d) in providing treatment services”.

153.

Initially, Mr. Tolson and Miss Freeborn restricted this argument to Mrs. Hadley’s case, on the grounds that in her case there had been a selection process which had resulted in the selection for transfer of three of the embryos, and the storage of the remaining two. However, in their closing position statement, they submitted that the argument applied to the cases of both claimants.

154.

For the Authority, Miss Rose did not submit that the “use” of an embryo necessarily equated with its transfer into a woman. However, she once again submitted that “use” of an embryo was a straightforward issue of fact. In the instant case, what had happened in the case of both women was that embryos had been created and then examined to ensure that they had fertilised. In Ms Evans’s case they had then been stored, and in Mrs. Hadley’s case, three had been selected and then used: the remainder had been stored. Creation, selection, freezing and storage were not use: they were acts which were preparatory to, and necessary for use. The stored embryos had accordingly not been used.

Discussion and analysis

155.

In my judgment Miss Rose’s argument on this point represents both a compelling and a common sense analysis, which clearly fits the structure and purpose of the Act. As Mr. Tolson and Miss Freeborn readily acknowledged, if they are right, every embryo which has been created, examined and then frozen will have been “used” with the result that paragraphs 4(1) and (2) of Schedule 3 would be redundant. It would simply not be possible for a gamete provider to withdraw consent. Such a construction runs so counter to the consent provisions of the Act that I would only be able to contemplate it if the statutory language drove me to it. For the reasons I have already given, it does not.

156.

The only case cited to me in which the question of the “use” of an embryo as anything other than placing the embryo is a woman was the decision of the Court of Appeal in Quintavalle (tissue typing) [2003] 2 FLR 335. This is an extremely important case, although it is on a quite different point from that with which I am concerned. The question in Quintavalle (tissue typing) was whether or not tissue typing of an embryo to exclude the hereditary disease beta thalassaemia major (the disease) came within the definition of treatment services in section 2(1) of the Act as being “for the purpose of assisting women to carry children”.

157.

The facts can be shortly summarised. Mr and Mrs. Hashmi had a child (Zain) with the disease. Mrs. Hashmi had a genetic predisposition to producing children with the disease. Mr. and Mrs. Hashmi wanted to have another child, but wanted also to be certain that not only did that child not carry the disease, but that the child would have tissue which matched Zain’s, thereby enabling Zain’s condition to be cured by a transplant of stem cells.

158.

As described by Lord Phillips of Worth Maltravers MR at [2003] 2 FLR 335, 337, this process involved the following stages: -

(i) the fertilisation in vitro of a number of eggs taken from Mrs Hashmi with sperm taken from her husband to form embryos;

(ii) the removal from the developing embryo of a single cell by a biopsy;

(ii) the examination of that cell using molecular genetics to see whether the embryo carried the beta thalassaemia disease. This process is commonly described as PGD

(iv) use simultaneously of the same process to identify whether the embryo had the same tissue type. Because this process involves examination of proteins known as human leukocyte antigens (HLA), the form of PGD is described as “HLA typing”. I shall refer to it by the more popular phrase of “tissue typing”.

(v) jettison of embryos found by this analysis to be either disease bearing or of a different HLA type to Zain and the implantation in the womb of Mrs. Hashmi of an embryo shown to be disease free and of the same HLA as Zain.

159.

The Authority granted a licence for the process described in the preceding paragraph. The lawfulness of the licence was then challenged by judicial review. Before the judge, the question identified in the final sentence of paragraph 156 was broken down into two parts, namely (1) did genetic analysis of a cell taken from an embryo involve the “use” of an embryo?: and (2) was genetic analysis for the purpose of tissue typing necessary or desirable for the purpose of providing treatment services?

160.

The first question arose because the Authority submitted before the judge that tissue typing did not require a licence since it was performed on a cell extracted from an embryo rather than the embryo itself. The Authority accepted that the removal from the developing embryo of a single cell by a biopsy (stage (ii) as set out at paragraph 158) was “use”, but submitted that testing the cell thereafter did not constitute such use. The case for the applicant before the judge was that tissue typing did constitute use of an embryo and therefore required a licence. The judge found against the Authority on this point.

161.

In the Court of Appeal the focus of the argument shifted. It became common ground that the removal from the developing embryo of a single cell by a biopsy constituted use of the embryo, and the Authority did not pursue its argument that tissue typing did not require a licence. The question became whether the process was treatment “for the purpose of assisting a woman to carry a child”. The Court of Appeal held that it was.

162.

In his judgment, Mance LJ (at [2003] 2 FLR 335 at 360, paragraphs 110-111) expressly distinguished between the biopsy and the subsequent examination of the embryonic cell material. He took the view that the judge had been wrong to hold the latter to be “use” of the embryo. However, what mattered was that the entire process required a licence, and the question was, accordingly, whether the process complied with the terms of the Act.

163.

The relevance of Quintavalle (tissue typing) for my purposes is that the Authority accepts that the “use” of an embryo is not limited to its transfer into a woman. Miss Rose did not resile from the Authority’s acceptance in Quintavalle (tissue typing) that the removal from the developing embryo of a single cell by biopsy constituted “use”. She maintained her position, however, that in the instant case there had been no such biopsy, and no “use” of the embryos. All that had happened in the cases of both Ms Evans and Mrs. Hadley was that the embryos had been created, examined and stored. Three of Mrs. Hadley’s embryos had been used (transferred into her) the remaining two had been examined and stored. The latter had not been used. On the same basis, none of Ms Evans’ embryos had been used.

164.

Consequent upon their extensive review of the legislation, Mr. Tolson and Miss Freeborn submitted that the concept of using embryos must be found in the other activities there listed, including Schedule 2, paragraph 1(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”. With respect, I do not think this advances the argument. Paragraph 1(d) of Schedule 2 is equally apt to describe the process of examination and selection prior to use. Indeed, in my judgment, this is what, in the context of this case, it is describing.

165.

In my judgment, this is a simple point, and another issue of fact. The language of the Act is clear, and in the context of this case, “use” can only mean the transfer into either claimant. In my judgment, therefore, none of the frozen embryos in this case has been “used in providing treatment services” within Schedule 3 paragraph 4(2) and there is no impediment to Mr. Johnston and Mr. Hadley withdrawing their consent on this ground.

The Claims under the Human Rights Act 1998

Introduction

166.

My conclusions so far mean that both claims must fail unless in some material respects the claimants’ rights under the Convention are engaged and breached or, in Ms Evans’ case that the doctrine of promissory estoppel prevents Mr. Johnston withdrawing his consent to treatment. I will deal with the arguments under the Convention first, as the existence or otherwise of breaches of Convention rights and the compliance or otherwise of the Act with the Convention may well be material factors in the estoppel argument.

167.

I regard this part of the case as being the most important, since, as my decisions on “use” and “treatment together” demonstrate, both the language and the purpose of the legislation itself seem to me very clear. The structure of regulation and licensing contained in the Act; the definition of treatment services and the clear terms of Schedule 3 relating to consent do not seem to me capable of more than one interpretation. The question therefore is whether they breach the claimants’ Convention rights.

168.

The proper approach to this question, as identified by Lord Steyn in R v A (No 2) [2001] 2 WLR 1546, 1560 is, firstly, to consider whether the legislation interferes with a Convention right: if it does, then it is at the stage of justification that legislative purpose or intent becomes relevant, and the principle of proportionality will be applied.

169.

The bulk of the argument under the Convention has, unsurprisingly, centred on Article 8, although the claimants assert that Articles 2, 12 (Ms Evans only) and 14 are also engaged. The argument on Article 8 ranged very widely, principally, I think, because Mr. Tolson and Miss Freeborn sought to set up a positive obligation on the State to allow Ms Evans to have the embryos created by her and Mr. Johnston released from storage and transferred into her. This led Mr. Coppel, for the Secretary of State to set out in considerable detail the law on positive and negative obligations, as well as providing, with the assistance of Mr. Webb (an official in the Department of Health whose evidence I record at paragraphs 186 to 188 below) a comprehensive rationale of the policy considerations underlying the Act. Inevitably, in dealing with these arguments I will be selective of the points which most impressed me. I will, however, need to set out the material in some detail.

170.

I am assuming for this part of the argument that the case is proceeding on the basis that the consents given by Mr. Johnston and Mr. Hadley have been withdrawn, not that the consents originally given no longer have any effect because neither couple is any longer being treated together.

171.

In their opening skeleton argument, Mr. Tolson and Miss Freeborn formulated the Human Rights issues in the following way:

1. Would it be unlawful in terms of the Convention for the Court to bar implantation and/or continued storage of the embryos?

2. If it would, does the Act require that the Court bar implantation and/or storage; or can the Act be read and given effect to in a way which is compatible with the Convention (HRA98, section 3(1) and 6(2))?

172.

Counsel went on to argue that if the Act could not be read as Convention compatible, a declaration of incompatibility should be made. For this purpose, the relevant provisions of the Act which they sought to have declared incompatible were: section 12(c) (the condition of any licence granted under the Act that Schedule 3 shall be complied with); and paragraphs 6(3) (no use of embryos without effective consent of both parties); 8(2) (consent by both parties to storage) and 4(1) (power to vary or withdraw terms of any consent) of Schedule 3.

173.

I propose to deal with the Articles of the Convention relied upon in numerical order

Article 2: the Right to Life

174.

I can, I think, deal with this submission quite shortly. The first nine words of Article 2 read: “Everyone’s right to life shall be protected by law”. Mr. Tolson and Miss Freeborn accepted that an embryo is not a human life. They submitted, however, that it has a sufficiently “special” status to attract what they describe as a “qualified” right to life. Two aspects of that limited, qualified right were (1) to continue in being whilst one or other of the gamete providers wished; and (2) to be available for implantation if its mother wished.

175.

Although the argument was developed with considerable ingenuity over several pages of Mr. Tolson and Miss Freeborn’s skeleton argument, I am quite unable to accept that Article 2 is engaged in this case. Counsel’s proper concession that an embryo is not a human life seems to me fatal to the engagement of Article 2. There is no direct authority on the point in relation to embryos, but there is abundant domestic authority, binding on me, that a fetus, at whatever stage of its development, has no existence independent of its mother. If a fetus has no right to life under Article 2, it is difficult to see how an embryo can have such a right.

176.

Two citations will suffice. In In re F (in utero)[1988] Fam. 122, a local authority tried to make a fetus a ward of court, in order to protect it against its mother’s damaging life-style. The attempt failed. Counsel for the local authority sought to rely on Article 2, although it was not of course at that point incorporated into English law. Balcombe LJ dealt with Article 2 in the following way (at [1988] Fam 122 at 142C-D:

(Counsel for the local authority) also sought to rely on article 2 (1) of the European Convention for the Protection of Human Rights and Fundamental Freedoms: "Everyone's right to life shall be protected by law". However, inPaton v United Kingdom(1980) 3 EHRR 408, on a complaint by the unsuccessful plaintiff inPaton v BPAS Trustees (above), the European Commission of Human Rights ruled (in para 8 of their decision at p 413) that on its true construction article 2 is apt only to apply to persons already born and cannot apply to a foetus. They continued (at p 415):

The `life' of the foetus is intimately connected with, and cannot be regarded in isolation from, the life of the pregnant woman. If article 2 were held to cover the foetus and its protection under this article were, in the absence of any express limitation, seen as absolute, an abortion would have to be considered as prohibited even where the continuance of the pregnancy would involve a serious risk to the life of the pregnant woman. This would mean that the `unborn life' of the foetus would be regarded as being of a higher value than the life of the pregnant woman. The `right to life' of a person already born would thus be considered as subject not only to the express limitations mentioned in para. 8 above but also to a further, implied, limitation."

Thus, far from assisting (counsel’s) submission, article 2 of the Convention, as interpreted by the European Commission, is in my judgment against him.

177.

Balcombe LJ added a warning, recently re-inforced by Butler-Sloss LJ (as she then was) in one of the cases dealing with the autonomy over her body of a woman in labour who refused a caesarean section. In Re MB (Medical Treatment) [1997] 2 FLR 426 at 444 she said: -

The law is, in our judgment, clear that a competent woman who has the capacity to decide may, for religious reasons, other reasons, or for no reasons at all, choose not to have medical intervention, even though, as we have already stated, the consequence may be the death or serious handicap of the child she bears or her own death… The foetus up to the moment of birth does not have any separate interests capable of being taken into account when a court has to consider an application for a declaration in respect of a caesarean section operation.”

We respectfully agree with Balcombe LJ in Re F (In Utero) who also considered the possibility of the Court being asked to order delivery of the baby by caesarean section. He said [1988] Fam 122, 144:

‘If Parliament were to think it appropriate that a pregnant woman should be subject to controls for the benefit of her unborn child, then doubtless it will stipulate the circumstances in which such controls may be applied and the safeguards appropriate for mother’s protection. In such a sensitive field, affecting as it does the liberty of the individual, it is not for the judiciary to extend the law’.

178.

A fetus, of course, exists only within the womb of its mother. She has autonomy over her body and over the fetus. An embryo created by IVF exists initially outside the womb, and so far as the Act governs the creation of an embryo, it applies only to embryos created outside the human body – see section 1(2). There is no property in an embryo, but in contrast to a fetus, both gamete donors have an interest in, and rights over, the embryos they have created. Those rights are governed by the Act. The embryo, however, cannot be considered a person, or to have a “qualified” right to life. The introduction of Article 2 into the argument is, in my judgment, an unhelpful diversion from the important issues raised in the case.

179.

I would not, however, want it to be thought by my rejection of the argument that Article 2 is engaged that I regard the fate of embryos created by IVF as an insignificant question. To the contrary, it is one of the most important questions posed by the Act. It is simply that Article 2 is the wrong medium to address it. Embryos created through IVF self-evidently contain life in an embryonic form. The questions are how those embryos should be treated; when and in what circumstances they can be stored; when for what purposes they can be used; and when they should be allowed to perish. The fact that they have no independent right to life does not either diminish the importance of these questions or mean that they are not fully addressed by the Act.

Article 8: The right to respect for private and family life

Is Article 8 engaged?

180.

The next Article upon which reliance is placed is Article 8. As is well known, this provides:

1. Everyone has the right to respect for his private and family life, his home and his correspondence.


2. There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or the economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of the rights and freedoms of others.

181.

The first question which arises on the facts is whether or not Article 8 is engaged at all. There is, in my judgment no “family” life engaged here. The four adults are living separate lives, and – for reasons which are, I hope clear from my discussion of Article 2 - an embryo is not a person or an individual with rights under the Convention.

182.

However, each of the four protagonists has a right to respect for his or her private life, and although the private and the family elements of life are conjoined in the Article, each, plainly, can reflect a distinct area of life. In my judgment, therefore, the wishes of Ms Evans and Mrs Hadley to continue with IVF treatment and to have the embryos released from storage and transferred into them engage their right to respect for their private lives under Article 8, which is also engaged by Mr. Johnson’s and Mr. Hadley’s opposition to that course.

Is there an interference with the right to respect for private life in this case?

183.

I do not regard this as an altogether straightforward question, but in the end I am persuaded that, having engaged in the consensual process of IVF treatment, including the consensual creation and storage of the embryos, it is open to Ms Evans and Mrs Hadley to argue that the provisions of Schedule 3 which permit their former partners to refuse to allow them access to the embryos for the purpose of transfer into them can properly be said to be an interference by the State with their right to respect for their private lives.

184.

Mr. Tolson and Miss Freeborn describe this as the “male veto”, which they argue is both unwarranted and disproportionate. It is, however, I think worth bearing in mind at the outset of the argument that the right to respect for private life applies equally to both Mr. Johnston and Mr Hadley. An unfettered right on the claimants’ part to have the embryos transferred into them would, by parity of reasoning, constitute an interference with respect of the men’s Article 8 rights, in the same way that any attempt on their part to insist that the claimants have the embryos transferred into them against their will would undoubtedly constitute an interference both with the claimants’ right to autonomy over their own bodies, and with respect for their private lives.

185.

As, following R v A, the issue of legislative policy is now raised, and as the question of the Act’s compliance with the Convention seems to me a matter of general public importance, I propose to approach it by setting out, firstly, a summary of the evidence filed by the Secretary of State on the issue; secondly by setting out in some detail the way in which the case was advanced for the claimants, and then by examining the arguments of the Secretary of State before turning to the defences of Mr. Johnston and Mr. Hadley.

The evidence filed on behalf of the Secretary of State

186.

Evidence on behalf of the Secretary of State was filed by Mr. Edward Webb, head of the section in the Department of Health that has responsibility for policy on assisted conception and embryology. Mr. Webb set out the legislative history of the Act in some detail, with particular reference to the White Paper and the Parliamentary progress of the Bill. He then identified a number of particular policy considerations underlying the consent regime contained in Schedule 3 to the Act. I summarise them as: -

(1) the female right of self-determination in relation to a pregnancy;

(2) the primacy of consent accorded in the modern age to the need for freely given and informed consent to medical interventions;

(3) the period over which IVF takes place;

(4) the special significance of parenthood;

(5) the interests of the child;

(6) equality of treatment between the parties;

(7) the promotion of the efficacy and use of IVF and related techniques; and

(8) clarity and certainty in the relations between partners..

187.

Having briefly discussed each of these policy issues, Mr. Webb adds:

Once it was decided in principle that it would be appropriate to legislate in this field, and to enshrine within legislation the principle of consent to treatment services, it was, in the Secretary of State’s view, entirely legitimate, and consistent with the underlying objective, to favour clear or “bright line” rules which serve to produce certainty in all cases, and do not depend upon the circumstances of individual cases. Therefore, it was considered appropriate to permit male partners to withdraw their consent to treatment services prior to the use of an embryo in all cases, rather than to make that permission dependent upon the facts of the individual case: the circumstances, financial and otherwise, of the male, and of his partner or ex-partner, whether she was already a mother, whether she would be able to have recourse to IVF in the future, etc. A fact-sensitive rule would, in this situation, give rise only to uncertainty and to litigation. The fact that the present cases are perhaps the first major example of litigation between parties to IVF treatment (in contrast to the US, where there are several examples) demonstrates the success of the Act in regulating this very sensitive area. The position of the claimants is undoubtedly deserving of sympathy, but the consequences of Schedule 3 in an individual case cannot, in the Secretary of State’s view, negate the legitimacy and the legality of the policy of adopting clear rules which can govern all cases.

188.

In construing the Act, I not only have regard, of course, to HRA 1998 section 3(1) which requires me, so far as it is possible to do so, to read and give effect to the Act in a way which is compatible with Convention rights; I also respectfully adopt the approach set out in paragraph 8 of the speech of Lord Bingham of Cornhill in Quintavalle CNR[2003] 2 All ER 113 at 118, which I have already set out at paragraph 18 above.

The case for Ms Evans and Mrs. Hadley under Article 8

189.

In relation to “interference”, Mr. Tolson and Miss Freeborn argued that the interference begins when the State permits treatment by the Clinics only on terms that a withdrawal of consent by the male partner in the future is conclusive and continues during any effective prohibition on treatment as a result of the terms of the licensing regime. In the alternative, they argued that until the point at which the partners withdraw consent, the State has permitted both claimants to develop their private and family lives as they, and their partners, saw fit. The State had licensed (and not banned) an assisted conception regime which met the claimants’ needs. Accordingly, there had been no interference. However, interference occurred when the State required the clinics not to treat on the withdrawal of consent by the male partners.

190.

Strict rules of interpretation applied to the phrase “necessary in a democratic society for the protection of…morals, or …the rights and freedoms of others.” The criteria must be understood in such a way that the language is not extended beyond its ordinary meaning. Furthermore, the phrase “necessary in a democratic society” meant that there had to be a “pressing social need” for the restriction in question; the restriction had to correspond to that need; as a response the restriction had to be proportionate (i.e. do no more than is necessary); and the reasons advanced by the State had to be relevant and sufficient. It was, moreover, for the State to establish the pressing social need and the proportionality of the response.

191.

Applying these principles, Mr. Tolson and Miss Freeborn summarised the argument by submitting that it was not necessary to impose a power of veto, applicable in all circumstances, over an embryo to the male gamete provider so as to prevent implantation. To do so excluded all consideration of the female’s interest and investment in the embryo, the interests of the embryo and the interests of what counsel described as the “pro-life” argument. Most importantly, they argued, it did not recognise the possibility of hard cases in an area in which there are bound to be such.

192.

So far as storage was concerned, there was no significant disadvantage to continuing storage whilst one of the gamete providers wished it and respect for the embryo and the gamete provider’s ‘investment’, wishes and feelings required it.

193.

Whilst inviting the court to note that there are a number of States which do not legislate at all in this area (which, it was submitted, should prompt a cautious approach to any plea by the United Kingdom to ‘necessity’), Mr. Tolson and Miss Freeborn accepted that in licensing human fertilisation and embryology there would be a generous margin of appreciation as to the means permitted to a State which seeks to balance public and private interests (and competing private interests) in this area by a legislative regime. They acknowledged that no one licensing scheme would be required by the European jurisprudence. What amounts to a “pressing social need” domestically was, within the margin of appreciation, for the State to judge – as was the choice of means to address that need.

194.

Consequently, the claimants could and did concede that it was legitimate for a State to conclude (as the United Kingdom had concluded) that there were necessary interferences in this general area. The first was that a State permitted assisted conception. Having taken that step, a State might legitimately conclude that a number of matters required restrictions: - for example, ensuring standards of treatment and record-keeping; limiting research; prohibiting cloning; and limiting the numbers of children born to any one gamete provider. The State might also choose to limit the ‘age’ of the embryo – both ‘fresh’ (in the United Kingdom by the 14 day primitive streak period) and ‘frozen’ (in the United Kingdom by the 10 year storage period). All these were areas in which the State might interfere.

195.

Narrowing the focus, Mr. Tolson and Miss Freeborn submitted that the State might legitimately identify a need to balance the freedom to procreate against the freedom not to procreate. For example, the State should no more require a male to provide sperm to father a child than it should require a female to provide the egg, or to become pregnant. The consent of the gamete provider must be required, no matter how deserving the partner.

196.

However, they submitted, the issue central to Ms Evans’ case had a still narrower compass. It did not concern the lawfulness of a licensing scheme in general; or even the lawfulness of requiring consent. It concerned the circumstances in which consent already given could be withdrawn to the use of embryos lawfully created for the purposes of having a child. It was in this context, and not in any wider area, that the necessity for a particular set of rules must be examined. Thus, it was submitted, respect for both (i) the couple’s private rights; and, (ii) the embryo, produce very different requirements once an embryo has been created.

197.

Mr. Tolson and Miss Freeborn argued that before reaching this area of ‘state interference’, a couple will have moved through many of the areas in which they acknowledged the state had a legitimate reason to balance public and private interests (and a wide margin of appreciation as to means) to an area which they described as “more personal” and in which they submitted there was a lesser public interest. They will have attended a state-licensed clinic which complies with treatment standards, they will have provided relevant consents and produced no more than the maximum number of embryos.

198.

What all couples will in fact have done is to take a personal decision to have their children in a particular way – a decision made all the more personal because it will have been forced upon them in what will always be difficult circumstances. Their personal circumstances will vary, as would (absent state control) the arrangements made between them as to precisely how (i.e. on what terms) they wished to be treated. Properly characterised, whilst there may be a public interest in balancing the private interests in the embryo, Mr. Tolson and Miss Freeborn submitted that there was no public interest as such in embryos created in these circumstances being permitted to perish.

199.

In whatever other areas there may be “huge practical and ethical difficulties” (see, for example, U v Centre for Reproductive Medicine at para 24) Mr. Tolson and Miss Freeborn submitted there were none here which required state interference to resolve in favour of a veto for the male gamete provider - recalling that it is not enough for the State to say that there is another point of view; it must demonstrate that its existing rules are necessary.

200.

Mr. Tolson and Miss Freeborn then addressed Mr Webb’s evidence. The first point was “the female right of self-determination in pregnancy”. They agreed that the biological and social reality which lies behind the science, or which the science attempts to mimic, was important as a guide to the nature of the public interest and any balance. However, it pointed, they argued, to a different conclusion. During sexual intercourse, the male will have a role in fertilising the egg (and a free choice as to whether to attempt to do so or not), and a role in raising any child born. But in between, the fate of the embryo lies with the female. Before IVF, no male had ever been able by lawful means to prevent a female from developing and in due course giving birth to her embryo if she wished to do so. In any event, the Act did not promote “the right of the male to withdraw consent…at the point of transfer” as Mr Webb claimed: moreover “use” of an embryo in providing treatment services could occur well before this point, as Quintavalle (tissue typing) demonstrated.

201.

As to the primacy of consent, Mr. Tolson and Miss Freeborn submitted that if the primacy of consent means anything it was that the parties should be free to consent on the terms that they wished, not those imposed upon them by the State. This was not a question of a consent to medical intervention: Mr Johnston had consented to all the treatment which he needed to receive and he had received that treatment.

202.

As to the length of time over which IVF treatment can be given, Mr. Tolson and Miss Freeborn accepted that because of this it was important for the law to offer the power to a male to change his mind. But it was important not to refuse him the power to do anything else. If a man wished to reassure a woman whom he loved that her embryos would always be available for her then why should he not be free to do so because of the “primacy of consent”? Mr. Webb argued that it would be undesirable and unfair to insist on holding a male to his consent. Mr. Tolson and Miss Freeborn submitted that fairness pointed in a quite different direction in Ms Evans’ case.

203.

As to the special significance of parenthood, Mr. Tolson and Miss Freeborn argued that it was a commonplace for a child to be born against its father’s wishes. As to the welfare of the child, the interests of any child to be born – or the interests of the embryo if any – pointed in only one direction - birth. Whilst it could be argued that a child may have a right not to be born (for example a severely congenitally disabled embryo) no such argument applied here. The State was permitted to interfere in situations which were “potentially damaging” for the living child only in strictly defined circumstances - see Part IV of the Children Act 1989. Was it to be suggested that the State has a policy to prevent a child being born because its father did not wish it where there is no suggestion that that child is likely to suffer (at least) significant harm?

204.

Mr. Tolson and Miss Freeborn submitted there was no legitimate public interest in whether a given male fathers a child or not, other than the public financial interest in who will provide for the child born. The power of the Clinic to consider the welfare of the child under section 13(5) of the Act (which counsel described as itself of dubious validity) is more than enough protection for that public interest which, in the modern United Kingdom ought in any event to count for little.

205.

As to equality of treatment between the parties, Mr. Tolson and Miss Freeborn submitted that it did not follow that because a woman could not be compelled to be impregnated with an embryo, a man should not be held to his consent to permit her to be impregnated. The more important argument, they submitted, was the following. A man should be free to withdraw his consent if he wished for the reasons advanced by Mr Webb. But if he, at least, can give an irrevocable consent he should be free to do so. It will always be apparent to the man that in doing so, there could be no quid pro quo from the woman because it will be impossible to require her to submit to the medical treatment necessary for implantation. There is a natural imbalance here which it would be artificial for the law to try to correct.

206.

As to clarity and certainty in relations between partners, Mr. Tolson and Miss Freeborn submitted that there was a great danger in “bright line” rules in the area of private and family life. It was an area in which individual circumstances will vary greatly and where any policy in the law should, at the very least, be capable of admitting of exceptions. In any event a number of points in particular should be made. First, a freedom to agree an irrevocable consent is clear and “bright line” enough. Secondly (to anticipate the argument on “storage”) a rule which provided that there should be continued storage of embryos already created with consent unless both gamete providers determined otherwise was every bit as “bright line” as the present law. Thirdly, however “bright line” a law may be, if it contravenes any individual’s human rights then it cannot be maintained. Fourthly, certainty did not make a bad law better.

207.

As a guide to how arbitrary the Schedule 3 requirement was, Mr. Tolson and Miss Freeborn submitted that it drew no relevant distinction between the sperm of a partner and the sperm of an anonymous donor. It permitted the sperm donor to act on a whim by withdrawing his consent before “use”, no matter what the circumstances of the woman whose eggs had been fertilised. It appeared to make no allowance for irrevocable consent even in this context. This was the case notwithstanding that, if the donor maintained his consent he was not as a matter of law the father of the child (section 28(6) of the Act).

208.

Counsel submitted that Ms Evans’ case was stark enough, but if the sperm used had been donor sperm the position would raise other different and in their own way starker points. Assuming that all young victims of ovarian or similar cancers would at least be offered the opportunity to store fertilised eggs, the present position on the consent of the male gamete provider left them very vulnerable indeed. Counsel submitted that it was a bad law which would permit a donor to deprive a young cancer victim from bearing a child from an embryo fertilised with his sperm when he might do so for no good reason, or no reason at all and perhaps years after he had made the donation (for which he might have been paid).

209.

There were, however, two more fundamental objections to the policy arguments advanced on behalf of the Secretary of State. First, assuming there was some merit in the policies identified, none addressed the question of proportionality. An interference, even on permitted grounds, must be proportionate in Article 8 terms. In present circumstances, counsel submitted this requires, at least, that cases such as Ms Evans are recognised. More may be required, but what proportionality outlawed was the absolute nature of the present structure in Schedule 3.

210.

To adopt the narrowest submission of all which would still permit Ms Evans to succeed, Mr. Tolson and Miss Freeborn argued that if the State adopted any policy making continuing consent necessary, it must also admit of exceptions in cases such as hers. Whilst certainty and clarity in public policy terms were acceptable in the area of issues where the State is legitimately involved, such policies must permit/include a consideration of the specific features of any given case so that it can be determined whether an exception should be made.

211.

Mr. Tolson and Miss Freeborn accepted that polices had been upheld where sufficient regard was paid to the individual facts of the case. They cited the challenge in R v Sec State for the Home Department ex p. Mellor[2001] 3 WLR 533. The prison service policy on not granting artificial insemination facilities to prisoners unless there were exceptional circumstances was upheld as each request was considered on its merits and a highly subjective assessment was undertaken.

212.

By contrast, they submitted that successful challenges had been made in respect of prison policies of separating mothers and babies in prison in R v Sec State for the Home Department ex p. CD[2003] EWHC 155 Admin and R v Sec State for the Home Department exp. P., Q. and Q.B.[2001] EWCA Civ1151. In the latter the Court of Appeal had emphasised at paragraph 78 that ECHR law required of a general rule that its application to a particular case must be considered to determine whether in that particular case the interference is proportionate to the particular legitimate aim being pursued.

213.

The same considerations, Mr. Tolson and Miss Freeborn submitted, had been applied in relation to the treatment of transsexuals in R v N.W. Lancashire HA. Ex parte. A [2000] 1WLR 977, where a policy was not enforceable which failed to take account of individual assessment with due recognition of exceptional circumstances capable of constituting an overriding clinical need. They also relied upon the successful challenge to policy re transsexuals in Christine Goodwin v U.K.(2002) 35 EHRR 447, where the Department of Social Security’s policy in relation to the marking of records and the issue of only one National Insurance number was held to be a breach of Article 8. Likewise, the issuing of certificates by the Secretary of State for the Home Department in relation to disclosure of information held by the Security Services was held in Baker v Secretary of State for the Home Department[2002] EWHC Admin 381 to be an interference with Article 8 that was too all encompassing to be proportionate.

214.

Mr. Tolson and Miss Freeborn also pointed out that the European Court of Human Rights was equally concerned to ensure that any policy applied to asylum seekers, for example, was applied with sufficient regard for the individual facts and not inflexibly: - see Jarbari v Turkey[2001] I.N.L.R. 136.

215.

Mr. Tolson and Miss Freeborn accordingly submitted that any policy in relation to assisted conception and consent must have the same regard for exceptional, individual circumstances to comply with the Convention as interwoven with domestic jurisprudence.

216.

The second objection to the argument advanced on behalf of the Secretary of State was that it did not address the wording or particular requirements of Article 8. The State must show necessity on the specific grounds set out in Article 8(2). In present circumstances the interference must be necessary for “…the protection of…morals or…the rights and freedoms of others.”.

217.

Mr. Tolson and Miss Freeborn argued that in the case of Ms Evans (and depending, of course, on the facts found by the Court) there was no protection for “morals” in denying her the chance of motherhood. Mr Johnston’s “freedom” not to procreate was so restricted by his decision to permit Ms Evans to use his sperm (and further by his reassurance in whatever terms it was given) that it would be offensive for the State to protect it. This was his (not the State’s or the public’s) freedom and he, effectively, chose to exercise it in a particular way. Furthermore, there was no pressing social need to prevent Ms Evans attempting to have a child. Just because there may be a pressing social need in other cases to prevent implantation without consent did not mean that Ms Evans’ human rights have not been infringed. Consequently, it was not necessary, counsel submitted, for the State to prevent the clinic treating Ms Evans by implanting the embryos.

218.

Mr. Tolson and Miss Freeborn acknowledged that in Mrs Hadley’s case there was much more of a balance to be made. The Court would recognise her lesser ‘interest’ and ‘investment’ in the embryos. There was no estoppel argument in her case. However, for so long as the Clinic is or may be willing to treat, then if the ‘veto’ is not a necessary State interference Mrs Hadley should be entitled to rely on the clinic’s discretion.

219.

As to the storage of the embryos, Mr. Tolson and Miss Freeborn submitted that the focus for ‘necessity’ was narrower still in this area and the issue very different from implantation. Embryos were on any view ‘special’ and deserved special protection under the law. That was the rationale of the Act. They are different from mere property. ‘Specialness’ alone would be a good reason not to give a veto over continued storage to one gamete provider alone. There were, however, other reasons. Mr. Johnston and Mr. Hadley had already changed their mind once. They may do so again. If the status quo is continued they would be able to do so. If the embryos have been permitted to perish, they will not.

220.

Mr. Tolson and Miss Freeborn submitted that none of Mr Webb’s comments concerning prejudice to the male gamete provider, or the welfare of the child to be born applied to this part of the argument. The embryos could continue in storage without affecting the position of the male gamete providers at all (provided the women agreed to pay the cost of storage). The emotions of the party against storage on contemplating the continued existence of the embryos, though valid, must be weighed against the emotions of the party who did not want to see the demise of the embryos. Permitting the embryos to perish was offensive to the claimants, as it would no doubt be offensive to the pro-life lobby.

221.

So far as the public interest in this area is concerned, Mr. Tolson and Miss Freeborn submitted there was a clear interest in the law being fair and being seen to be fair. It was submitted that in present circumstances fairness between the parties (ignoring the embryos for this purpose) pointed to Ms Evans being treated and to Mrs Hadley at least being able to secure the continued storage of her embryos. To risk a blunt submission, it was difficult to think of examples in domestic law in which the law permitted the destruction even of mere property on the whim of one of two co-owners. It would not do so in the case of a family pet.

222.

Accordingly, Mr. Tolson and Miss Freeborn submitted that the law should not grant a veto to the male gamete provider to prevent continued storage. However, the claimants did not have to put their case so high: the submission was simply that there is no necessity for such an interference in the claimants’ private lives.

223.

As to the history of the legislation, Mr. Tolson and Miss Freeborn submitted that the veto on continued storage was not suggested by Warnock nor the subsequent Green Paper, nor the White Paper. It simply appeared in the Bill. It also appeared to be contrary to the 8th principle set out in the Report of the Ad Hoc Committee of Experts on Progress in the Biomedical Sciences as relied on by Mr Webb: “the destination of embryos stored for the use of a couple for procreation but not used by them may be decided upon only with the consent of both members of the couple” [emphasis added]. In other words, absent agreement the status quo continued.

224.

The Defendants’ case, Mr. Tolson and Miss Freeborn argued, was that the regime “strikes a reasonable and proportionate balance between the interests of each of the parties to a disagreement as to the future of an embryo, and of any child who may be born as a result of the use of that embryo.” In short, the regime was said to be within the margin of appreciation. Counsel submitted that in fact the Schedule 3 scheme on consents was not a balance of the interests of the parties in the embryos at all. If the male gamete provider did not consent, there would be no treatment. As to the interests of the child who may be born, no child will ever be born.

225.

On positive obligations, the need for the State to take positive action in this area sprang from the concept of ‘effective’ respect for private and family life: see Marckx v Belgium(1979) 2 EHRR 330: “When the State determines in its domestic legal system the regime applicable to certain family ties such as those between an unmarried mother and her child it must act in a manner calculated to allow those concerned to lead a normal family life” (para 31). Reference was also made to Airey v Ireland(1979) 2 EHRR 305 at paragraphs 32 and 33.

226.

Here, counsel submitted, the State had implemented a licensing regime which restricted the freedom of medical professionals and individuals to treat and be treated. It did so in an area in which the principal effect will be upon private and family life. It was therefore incumbent upon the State in doing so to act in such a way that its restrictions – whatever they may be – continued to provide effective respect for that private and family life. There could be no effective respect unless (i) it was possible for Ms Evans to be implanted with her embryos in the circumstances in which she found herself; and/or (ii) both women could secure the continued storage of their embryos.

227.

As to implantation, Mr. Tolson and Miss Freeborn submitted that it was an essential feature of private and family life that personal circumstances may vary greatly. It was an area in which choice and freedom of action are to be maintained where possible, precisely because a dogmatic inflexible approach by the State may produce great hardship. Therefore, at the very least in Ms Evans’ case the policy of the law must admit of exceptions. If it did not, there was no effective respect for the difficult situations and hard cases which may arise.

228.

As to storage, the disadvantages of continued storage were so few and the arguments for respect of the embryo so great that it was submitted there could be no effective respect for private or family life in a system which permits unilateral decisions to permit to perish at all, still less unilateral decisions to permit to perish without regard to the circumstances.

The argument for the Secretary of State

229.

Mr. Coppel began by identifying the well-established distinction in the Strasbourg case-law between the negative obligations of the state not to take action which restricts Convention rights, and positive obligations, which may require the state to take positive action so as to promote Convention rights. He gave as examples Gaskin v UK(1990) 12 EHRR 36 and X and Y v The Netherlands(1986) 8 EHRR 235). He argued that the distinction between positive and negative obligations under Article 8 was important for two reasons. Firstly, positive obligations arose under Article 8(1), and if they had been breached, there was no question of justification under Article 8(2) although the factors enumerated in relation to justification under Article 8(2) would be relevant to the question of whether any positive obligations arise at all.

230.

Secondly, he argued, Contracting States were accorded a particularly broad margin of appreciation when assessing the extent to which Article 8 creates positive obligations on the state to take action. For this proposition he cited Abdulaziz, Cabales and Balkandali v UK(1985) 7 EHRR 471, at paragraph 67; andBotta v Italy(1998) 26 EHRR 241, at paragraph 34.

231.

Mr. Coppel argued that the issues raised by the Act were a classic example of an area of controversy where the courts would be reluctant to question the approach adopted by the legislature. Hence, in Quintavalle CNR, Lord Bingham of Cornhill had noted the strong views on both sides of the debate surrounding IVF and held that the merits of the approach adopted by Parliament in the Act were not a matter for the House of Lords in its judicial capacity: see paragraphs 12 and 13 of his speech, which I have set out at paragraph 17 above. Similarly, he argued, in R (Assisted Reproduction and Gynaecology Centre) v HFEA[2003] 1 FCR 266, a case in which both common law and Convention claims were made, the Court of Appeal was concerned only to ensure that the HFEA had made a rational decision and would not trespass any further into the merits of that decision (see, in particular, paragraph 65 of the judgment of the court).

232.

Mr. Coppel submitted that the position is no different under HRA 1998. He relied on the classic statement of principle regarding the discretionary area of judgment – the domestic equivalent of the margin of appreciation – in the speech of Lord Hope in R v DPP ex parte Kebilene[2000] 2 AC 326, 381C:

In this area difficult choices may have to be made by the executive or the legislature between the rights of the individual and the needs of society. In some circumstances it will be appropriate for the courts to recognise that there is an area of judgment within which the judiciary will defer, on democratic grounds, to the considered opinion of the elected body or person whose act or decision is said to be incompatible with the Convention. This point is well made at p. 74, para. 3.21 of Human Rights Law and Practice (1999), of which Lord Lester of Herne Hill and Mr. Pannick are the general editors, where the area in which these choices may arise is conveniently and appropriately described as the 'discretionary area of judgment'. It will be easier for such an area of judgment to be recognised where the Convention itself requires a balance to be struck, much less so where the right is stated in terms which are unqualified. It will be easier for it to be recognised where the issues involve questions of social or economic policy, much less so where the rights are of high constitutional importance or are of a kind where the courts are especially well placed to assess the need for protection.

233.

Mr. Coppel submitted that the Act in general, including the issue of consent under it and, in particular, the circumstances in which it may be withdrawn, was clearly within an area where the state will be accorded a broad discretion. There were, he argued, four reasons for this:

(1)

It is within the area of social policy (see also Greenfield v Irwin[2001] 1 WLR 1279, paragraph 36: where there is a wide margin of discretion for the state in the area of family life).

(2)

The issue of consent requires a balance to be struck between competing rights and interests (and see Chassagnou v France(1999) 29 EHRR 615, paragraphs 112-113, where the Strasbourg Court held that the margin of appreciation would be particularly broad where it was necessary to strike a balance between competing Convention rights – here the rights of the women and of their respective former partners).

(3)

A high degree of respect is to be accorded to the balance struck by the Act precisely because it is embodied in an Act of Parliament, passed by the democratic legislature (as compared with, say, an act of administrative discretion): see R v Lychniak[2002] 3 WLR 1842, at paragraph 14.

(4)

A further factor which militates in favour of a particularly broad margin of discretion in this case is that there is no European consensus in favour of the position advocated by the claimants (and therefore, it is more difficult for them to say that the approach of the Act is not “necessary”). Indeed, the position is to the contrary: to the extent that there is consensus, it is strongly against the idea that an embryo should be available for the use of a female participant in IVF treatment in circumstances where her former partner, whose gametes were used in the creation of the embryo, does not consent.. It is well-established that the Strasbourg Court will have regard to the existence or otherwise of a consensus amongst Contracting States when determining the breadth of the margin of appreciation in a particular case: see Rasmussen v Denmark(1984) 7 EHRR 371, paragraph 40; and Petrovic v Austria(1998) 33 EHRR 307, at paragraphs 38-43.

234.

The case for the Secretary of State, accordingly was that, given the broad margin of discretion which must be accorded in the present case, the State may legitimately say that if there are a range of reasonable views on a particular issue, it cannot be criticised for having opted for one reasonable view over another.

235.

Turning to the grounds of justification, Mr. Coppel submitted that there was no breach of positive obligations, alternatively that any breach of Article 8(1) was justified under Article 8(2), on the grounds of the policy objectives set out in the statement of Mr Webb which I have set out at paragraphs 186 to 188 above. Mr. Coppel argued that the overall beneficial effects of Schedule 3 to the Act were not outweighed by the particular facts of the claimants’ cases.

236.

Mr. Coppel addressed the arguments advanced on the claimants’ behalf by reference to the policy issues Mr. Webb had identified. Thus, he submitted, the female right of self-determination in pregnancy dictated that the point at which an embryo is implanted in a woman (which will be the point of “use” in the vast majority of cases) is, in practice, the last possible moment at which consent to transfer could be withdrawn. No later point could be chosen. The claimants, he noted, did not dispute that but argued that the same rule should be applied to a frozen embryo stored outside the womb. However, that argument did not address the fundamental point that a woman who becomes pregnant following IVF treatment is in the same position as a woman who becomes pregnant following sexual intercourse only once she is pregnant.

237.

Furthermore, Mr. Coppel argued, it was indisputable that prior to the point of transfer of an embryo consent may be withdrawn without the need for a distressing medical intervention. The claimants’ use in argument of the female personal pronoun (“her embryo”) was, he submitted, instructive, and ran contrary to the whole scheme of the Act, which gave gamete providers equal rights and did not treat an embryo as belonging to one party or the other.

238.

As to the primacy of consent, the approach of Schedule 3 was that participants in IVF treatment should be able to give and withhold consent to the greatest extent possible, having regard to the potentially very lengthy period of time over which treatment might run and the special significance of parenthood which was the intended result of the process. Schedule 3 recognised the reality that people’s situations can change over the course of a period of years, perhaps quite unexpectedly; and, in the Secretary of State’s view, it would be undesirable and unfair to hold people (both men and women, since the rules apply equally to both) to consents which they may have given several years earlier.

239.

As to the interests of any child who would be born as a result of IVF treatment, Mr. Coppel did not disagree with the proposition advanced by the claimants that it was commonplace for a child to be born against its father’s wishes. That, however, did not establish that it was impermissible to consider this to be undesirable state of affairs. Further, the Secretary of State simply did not agree with the claimants that the only public interest in whether or not a father consented to the birth of a child was a financial one; nor, patently, did Parliament.

240.

Mr. Coppel submitted that equality of treatment between the parties to IVF treatment was an important point. Nobody, he suggested would argue that a male progenitor should be able to compel the use of an embryo by transfer into an unwilling female, but the claimants were arguing for a position whereby transfer can be enforced against an unwilling male. The claimants’ argument that this was merely an imbalance which was created by nature which the law should not seek to correct did not meet the point. The law must strive to avoid sex discrimination in the enjoyment of Convention rights (Article 14 of the Convention) regardless of its underlying cause. The regime contended for by the Claimants, whereby a frozen embryo would be treated as belonging to a woman who would have the sole power to determine its future would, he submitted, amount to a very serious form of sex discrimination, which it would not be open to the Court to countenance as result of its own duties under HRA 1998 section 6(1).

241.

Mr. Coppel also relied on the promotion of clarity and certainty by putting in place a “bright line” rule governing the withdrawal of consent rather than a fact-sensitive rule. He accepted that this was not an argument for fixing the “point of no return” in any particular place, but rather for making it a firm line wherever it is fixed, and which did not depend upon the facts of individual cases. As already noted, it was fundamental to the intention of Parliament when passing the Act to instigate a system of firm and clear statutory regulation in preference to a “free for all” governed only by the common law and equitable rules. The instant cases were, he submitted, very good examples of the difficulties which could arise both for the parties to IVF treatment and for licence holders providing treatment, if the fate of frozen embryos had to be decided on grounds of fairness in the particular case. . The need for certainty in this particular context answered the submission made by the claimants that a policy is per se disproportionate if it does not admit of exceptions. Everything depended upon the context: there may be a very good reason in a particular case for a “bright line” rule.

242.

Thus, Mr. Coppel submitted, the need for certainty in the law was the main reason why the policy objectives identified by Mr Webb were not outweighed by the facts of these particular cases. In each case there was an unwilling male former partner who did not want the interference with his right to respect for private life which use of the embryos would entail. Moreover, the effect of Schedule 3 was not to deny parenthood to the claimants. In Ms Evans’ case, a prohibition on the use of the embryos deprived her of a less than 30% chance of conception, and a possibly lower chance of a live birth. However, she also had the possibility of becoming a parent in other ways, by conception using donor eggs, and / or by adoption. In Mrs. Hadley’s case, the claimant was already a parent, and had a far greater prospect of conceiving another child of her own through the use of other techniques not involving the disputed embryos.

243.

Mr. Coppel submitted that the same essential arguments applied to the question of continued storage of frozen embryos, which the claimants treated as a separate point. If the parties did not consent to continued storage of embryos created with their gametes, then, in the Secretary of State’s view, that should not be imposed upon them. There were considerable benefits for a non-consenting party in resolving the situation once and for all, by removing the embryos from storage. This would put an end to any lingering doubts as to their fate, and obviate the possibility of pressure to change his / her mind being brought to bear upon the non-consenting party during the remainder of the storage period (for example, as had occurred in this case, through the media).

244.

For all these reasons, the Secretary of State submitted, in summary, that the provisions of Schedule 3 were justified in the public interest and did not amount to an unlawful interference with the claimants’ Article 8 rights.

The case for Mr. Johnston and Mr. Hadley on Article 8

245.

Unsurprisingly, counsel for both Mr. Johnston and Mr. Hadley adopted the arguments of the Secretary of State. Each pointed out that the two men also had a right to respect for their private lives, and that if Ms Evans’ and Mrs Hadley’s rights were engaged, so were theirs. There needed, accordingly, to be a balance of the competing rights. The interference by the State in the rights of Ms Evans and Mrs. Hadley was, they submitted, justified on the basis that it sought to protect the rights and freedoms of the male gamete holders.

246.

Both took issue with Mr. Tolson’s and Miss Freeborn’s proposition that Schedule 3 of the Act breached Article 8 of the Convention by providing the male gamete providers with a veto against removal from storage and use of the embryos. The true position was that the Act was based on the fundamental policy of informed consent to treatment. It treated all four gamete providers equally, and provided each of them with a veto. All four had an equal right to withdraw from treatment at any point up to transfer / implantation.

247.

Neither Mr. Johnston nor Mr. Hadley wished to father a child by a partner with whom neither now had anything in common, and in circumstances in which neither could play a full or proper part in the life of the child. The withdrawal of their consent to treatment and / or the continued storage of the embryos was, accordingly, a reasonable exercise of their rights to respect for their private lives.

Conclusions on Article 8

248.

I am in no doubt that on this part of the case, I prefer the arguments of the Secretary of State and of Mr. Johnston and Mr. Hadley. I am satisfied the interference in the private lives of the parties contained in Schedule 3 of the Act is both necessary for the protection of the rights of all four gamete providers and proportionate.

249.

In my judgment, this is pre-eminently an area in which it is for Parliament to legislate, and in relation to which a generous margin of appreciation is appropriate. I am satisfied that a regime of treatment based on the twin pillars of consent and the interests of the unborn child is an entirely rational and appropriate foundation for the legislation, the more so when the Act itself is the product of a report of the quality of Warnock, followed by extensive consultation, a White Paper and careful Parliamentary scrutiny.

250.

It is, in my judgment, entirely appropriate for the State to require that couples embarking on IVF treatment are in agreement about the treatment, and that it should be possible for either party to withdraw from it at any time before the created embryos are “used” – which, on the facts of these cases I have found plainly means transferred into the female gamete provider.

251.

Consistent with the need for consent to treatment is, of course, the principle of equality between the gamete donors. Mr. Tolson and Miss Freeborn frequently referred to the “male veto”. In my judgment, as I pointed out in paragraph 184, that is an incomplete analysis. As Mr. Johnson and Mr. Hadley pointed out, each of the four parties has a veto. I have no doubt – indeed Mr. Tolson and Miss Freeborn accept - that were there a provision in the Act which permitted either of the men to insist that either of the women had the embryos transferred into them against their will, both Ms Evans and Mrs Hadley would regard that as a gross interference with their right to respect for their private lives, and that they would be correct to so to regard it. By like token, it seems to me that a regime which permitted the women to override the men’s withdrawal of consent (which is what the claimants seek) would be a clear interference with the men’s right to respect for their private lives.

252.

Mr. Tolson and Miss Freeborn are dismissive of section 13(5) of the Act. But the policy behind it is surely sound – or, to put the matter at its lowest, one which the State is entitled to promote. Since the object of consensual IVF treatment is to produce a child for a couple, it is in my judgment not unreasonable, where the couple has separated prior to the transfer of the embryos, for each to be able to say that they wish the treatment to be discontinued because any child born as a result of the treatment will not be brought up by the couple. To put the matter another way, it is not unreasonable for either Mr. Johnston or Mr. Hadley to say, given the break-up of their respective relationships, that they do not wish to be the father of a child by a woman with whom they no longer have anything in common; by whom they would not wish now to have a child; and in circumstances in which, once any such child was born, they would not be in a position to play a full or proper paternal role, whilst at the same time remaining financially liable to maintain the child.

253.

I note in passing that any agreement between separated spouses or former spouses who have a child that the non-resident or absent parent, will not be financially responsible for the child’s support is void under section 34 of the Matrimonial Causes Act 1973. I also agree with Mr. Coppel that it is not open to parents - whether married or not - to contract out of the Child Support Act 1991 (the 1991 Act). Mr. Johnston and Mr. Hadley would be the fathers of any children born consequent upon the transfer of embryos in this case, and under section 1(1) of the 1991 Act each would be responsible for maintaining his child. Were either of the claimants to be in receipt of benefit, the Secretary of State would be entitled to require her to authorise him to take action to recover child support maintenance from the child’s father – see section 6 of the 1991 Act – irrespective of any agreement between the parents. It is for these reasons that I stated in paragraphs 90 and 98 above that any agreement between the parties in this case would not be binding.

254.

In my judgment, in this sensitive area of the law, it is for Parliament to legislate. It is an area in which the courts have only a limited role to play. Parliament has chosen a carefully structured system of regulation, with clear rules based on mutual consent and the interests of the unborn child. The approach to statutory construction set out by Lord Bingham of Cornhill in Quintavalle CNR (set out at paragraph 18 above) and Lord Hope of Craighead in Hope in R v DPP ex parte Kebilene (set out in paragraph 232 above) applies. If any changes in the law are appropriate, it is for Parliament to make them.

255.

It follows, in my judgment, that the scheme chosen by Parliament is legitimate and does not breach any of the parties’ Convention rights. Consistent with the scheme, the consent provisions appropriately provide that if either of the parties wishes to terminate what has begun as consensual treatment prior to use of the embryo, he or she should be entitled to do so. In these circumstances it is, once again, entirely appropriate, in my judgment, that the licensing system created by Parliament should provide clear and non-fact specific rules for any clinic which the Authority licences, which stand to lose its licence if it breaches its terms.

256.

In this context, I do not derive any assistance from the authorities cited by Mr. Tolson and Miss Freeborn which I have identified in paragraphs 211 to 214. Whilst they address Article 8 in the context of the administration of policies adopted by the State, they do not address the fundamental issue raised in the two preceding paragraphs,

257.

This is not a case of IVF using donor sperm. The careful argument advanced by Mr. Tolson and Miss Freeborn, which I have endeavoured to set out in full, accepts that the State has the right to regulate fertility treatment and that a generous margin of appreciation must be given to the means permitted to the State in doing so. They do not challenge the lawfulness of a scheme of treatment which requires consent. Their argument, it seems to me, boils down to the proposition that it should be possible for the male gamete provider, if he wishes, to give an irrevocable consent to the use of the embryos created with his gametes, and that there is no legitimate public interest in permitting embryos created in these circumstances to be allowed to perish. For the policy reasons set out by Mr. Webb and elaborated by Mr. Coppel I am unable to accept this approach.

258.

I find myself also unable to accept the analogy with the threshold criteria under section 31 of the Children Act 1989, which is designed to protect a child from significant harm. That, in my judgment, is quite different from a gamete provider withdrawing his or her consent to the use of embryos created from those gametes. The question which counsel pose at the conclusion of paragraph 203 seems to me the wrong one. The correct question, in my view, is whether or not it is legitimate for the State to allow gamete providers to withdraw their consent to the use / continued storage of subsequently created embryos In a regime based on mutual consent and section 13(5) the answer to this question must be “yes”.

259.

In my judgment, therefore, the interference from the State identified in Article 8 is necessary for the protection of the freedom of others, and entirely proportionate to the policy objectives identified. There is, accordingly, no breach of Article 8 on the facts of this case.

260.

I recognise, of course, that from her perspective, and because the Act cannot admit of exceptions, Ms Evans is what her counsel described as a “hard” case. Ms Evans is the victim of her physical condition and has had the misfortunate to suffer relationship breakdowns both with her former husband and Mr. Johnston. She was also obliged to enter into IVF in dramatic and hurried circumstances. It has to be said, however, that nobody can legislate for relationship breakdown, only for its consequences. In the field of IVF treatment, as the quotation from Hale LJ’s judgment in U v Centre for Reproductive Medicine (set out at paragraph 37 above) makes clear, I cannot allow my sympathy for Ms Evans’ position to outweigh my respect for the scheme which Parliament has put in place.

Article 12: The right to marry

261.

Article 12 provides that: -

Men and women of marriageable age have the right to marry and to found a family, according to the national laws governing the exercise of this right.

262.

I can take this shortly. Mr. Tolson and Miss Freeborn accepted the proposition that any interference with private and family which is justified under Article 8(2) cannot at the same time constitute a violation of Article 12: - see the review of the European jurisprudence carried out by Lord Phillips of Worth Maltravers MR in R v Secretary of State for Home Department ex parte Mellor[2001] 2FLR 1156 at paragraphs 22 to 38 and the first conclusion derived from that jurisprudence namely that “the qualifications on the right to respect for family life that are recognised by Article 8(2) of the Convention apply equally to the Article 12 rights”.

263.

As their principal allegation was that Ms Evans’ Convention rights under Article 8 were breached by the denial of access to the embryos because of the provisions of Schedule 3 to the Act, Mr. Tolson and Miss Freeborn very properly accepted there was no separate argument under Article 12.

264.

The two rights identified in Article 12 are expressed conjunctively. However, even if I were able to read them disjunctively, as Mr. Tolson and Miss Freeborn invited me to, and assume that the right to found a family can exist independently of the right to marry (which is plainly not engaged) it does not seem to me that they benefit either claimant in the instant case. The right to found a family through IVF can only, put at its highest, amount to the right to have access to IVF treatment. Self-evidently, it cannot be a right to be treated successfully. Furthermore, it is a right which is qualified by availability, suitability for treatment and cost. Once it is clear, as in my judgment it is, that the consensual scheme for IVF treatment contained in the Act (and to which both claimants have had access) is lawful and does not breach Article 8 of the Convention, it must follow that there is no breach of Article 12.

265.

In these circumstances I need not deal with the arguments addressed to me on Goodwin v UK(2002) 35 EHRR 123, and Cossey v UK (1990) 13 EHRR 622. In my judgment, Article 12 is not engaged on the facts of this case; alternatively, it is not breached for the reasons which I have given in relation to Article 8.

Article 14: Prohibition of discrimination

266.

Article 14 provides:

The enjoyment of the rights and freedoms set forth in this Convention shall be secured without discrimination on any ground such as sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status.

267.

The discrimination alleged is not addressed to any disproportionate enjoyment by men (as against women) of their rights and freedoms set out in the Convention, but seeks to compare the position of the claimants with that of healthy women conceiving naturally who enjoy Convention rights which protect their embryos and themselves. The rights identified are those under Articles 3, 5, 8 and 12. These articles, Mr. Tolson and Miss Freeborn argue, serve to give healthy women effective control over their embryos, subject to the laws on abortion. I have, of course, already found that there is no breach of Articles 8 and 12.

268.

The claimants, counsel argue, have both undergone assisted conception procedures as a result of a disability relating to their health. Such disability, they argued, was a relevant status for the purposes of Article 14. If the claimants had not had the relevant disability, they would not have had the treatment.

269.

Mr. Tolson and Miss Freeborn argued that there are many similarities between women who conceive naturally and women who conceive artificially, in particular in this case through IVF. Both are attempting to have a child, both are having their eggs fertilised and so on. There are also differences. Moreover, these differences (the creation and existence of an embryo outside as opposed to inside the womb) justify differences in treatment in terms of Convention rights. A woman if only as a matter of practicality cannot have the same exclusive control over her embryos outside her body as inside her body.

270.

But, counsel argued, there is no justification for the particular difference in treatment of which complaint is made in this case, namely the conferring on the male partner of the power to withdraw consent to implantation after fertilisation. They submitted that this was not a proportionate response to the (real) differences between the naturally conceiving woman and the woman receiving IVF treatment, or to the differences between an embryo in the woman’s body and an embryo outside the body. Permitting a unilateral withdrawal of consent without regard to the circumstances not only failed to reflect nature and the ‘veto’ which the female has, but did not attempt to address any balance of interest in the embryos.

271.

Mr. Tolson and Miss Freeborn argued that all young victims of ovarian or similar cancers who can no longer conceive naturally are very vulnerable under the UK system as it is at present, and submitted that the present imbalance was a breach of their Article 14 rights.

272.

For the Secretary of State, Mr. Coppel identified the correct approach to Article 14 challenges as being that set out in paragraph 85 of the judgment of the Court of Appeal in R (Hooper) v Secretary of State for Work and Pensions[2002] EWCA Civ 813:

In the leading judgment in Michalak v London Borough of Wandsworth[2002] 4 All ER 1136, Brooke LJ recommended the following structured approach to consideration of an Article 14 claim. The court should ask, sequentially, four questions. If any one is answered in the negative it will normally follow that the claim is ill-founded. The questions are:

"(i) Do the facts fall within the ambit of one or more of the substantive Convention provisions (for the relevant Convention rights see Human Rights Act 1998, section 1(1))?

(ii) If so, was there different treatment as respects that right between the complainant on the one hand and other persons put forward for comparison ('the chosen comparators') on the other?

(iii) Were the chosen comparators in an analogous situation to the complainant's situation?

(iv) If so, did the difference in treatment have an objective and reasonable justification: in other words, did it pursue a legitimate aim and did the differential treatment bear a reasonable relationship of proportionality to the aim sought to be achieved?"

We agree with Brooke LJ that this structured approach is helpful.

273.

Mr. Coppel submitted that quite apart from the fact that the claim must fail at the stage of justification (stage iv) for essentially the same reasons as the claim under Article 8, there were also, as in the case of Article 12, threshold objections (at stages ii and iii) which operated to dispose of the claim before the stage of justification was reached.

274.

Mr. Coppel accepted that the facts of the claims fell within the ambit of Article 8. Problems, however, arose at stage (ii). The first difficulty with the claimants’ argument that “healthy women conceiving naturally.. [have].. effective control over their embryos, subject to the laws on abortion whereas disabled women who undergo assisted conception procedures do not” was that there is no relevant difference in treatment between women who become pregnant through sexual intercourse, and women who become pregnant following assisted conception procedures. Once pregnant - that is, once an embryo is implanted in the womb, all women have a right of self-determination, subject to the criminal law, no matter what techniques have been used in order to assist in conception.

275.

Mr. Coppel argued that the second difficulty at stage (ii) was that Schedule. 3 of the 1990 Act which contains the provisions about which the claimants complain, does not distinguish between women on the grounds of whether or not they are disabled. It distinguishes between men and women whose partners have changed their minds about undergoing IVF treatment based on whether or not that change occurred before or after the relevant use of an embryo. That, however was not the burden of the complaint under Article 14. The fact that a woman who is disabled may suffer adversely as a result of the provisions of the Act (and not all women undergoing IVF treatment are disabled – see, for example, Quintavalle (tissue typing)) did not mean that they have been discriminated against on grounds of their disability.

276.

As for stage (iii), Mr. Coppel argued that a woman whose gametes have been used in the creation of a frozen embryo and who hopes that it will be implanted in due course is simply not in the same position as a woman who has become pregnant through sexual intercourse. Quite simply, the latter is pregnant and the former is not. If the former becomes pregnant, she will be treated in exactly the same way.

277.

I accept the arguments advanced by the Secretary of State as set out above. In my judgment the claimants’ arguments on this point cannot stand in the light of my conclusions under Article 8. In my judgment the Act does not discriminate against women undergoing IVF treatment.

Conclusions under HRA 1998 and the Convention

278.

In my judgment, the Act breaches none of the claimants’ Convention Rights which are engaged. It follows that the Act is HRA 1998 compliant, and no question of a declaration under HRA 1998 section 4(2) arises.

Estoppel

Can an estoppel exist in the face of the Act?

279.

In my judgment, the estoppel argument faces a number of insuperable obstacles. The first is the point taken by the Secretary of State that, regardless of the facts underlying the plea of estoppel, and regardless of whether the usual requirements for a promissory estoppel are made out, the Act itself excludes the operation of any estoppel which would prevent Mr. Johnston from withdrawing his consent prior to the use of the embryos.

280.

Mr. Coppel submitted, firstly that promissory estoppel is dependent upon there being some pre-existing legal relationship between the party allegedly estopped, and the party for whose benefit the estoppel is said to operate. He submitted that the Act prevented any such relationship from arising. In particular, of course, there was no “property” in the embryos created and as Mr Webb explained, the Act embodied a conscious decision by Parliament to impose statutory regulation in this area, in preference to leaving matters to be determined by the terms of contracts between individuals – see section 29 of the Act.

281.

So far as the issue of consent was concerned, Mr. Coppel submitted that the legal framework superimposed by the Act posited a legal relationship between participants in IVF treatment and the licence holder providing treatment services to them (in addition to the contractual relationship which may exist between patients and clinic, depending upon whether treatment was private or NHS), and between the licence holder and the HFEA, rather than between the participants themselves.

282.

The correct analysis, accordingly, was not that Mr. Johnston had, under Schedule 3, a right as against Ms Evans to withdraw his consent to the use of the embryos. It was, rather, that the Clinic was only permitted to store and use the embryos if Mr. Johnston consented, which consent was contingent up until the point at which the embryos were used in the material sense. It should be noted, Mr. Coppel argued, that in this context consent must be given to the licence holder, and could only be withdrawn by notice to the licence holder, regardless of what had passed between the participants themselves. The scheme of the Act therefore removed one of the essential pre-requisites for promissory estoppel.

283.

Secondly, Mr. Coppel submitted that just as a contract which is contrary to public policy is void and/or unenforceable, so equity would not recognise an estoppel which would operate contrary to public policy as set out in a statute. The contradiction here was created by paragraph 4(1) of Schedule 3, which permitted consent to be withdrawn merely by giving notice to the person providing treatment services, regardless of anything which may have passed beforehand between male and female partners.

284.

Mr. Coppel accepted that that not every apparently contradictory statutory provision barred an estoppel, and relied on the proposition contained in the judgment of Beldam LJ in Yaxley v Gotts [2000] Ch 162 at 191:

The general principle that a party cannot rely on an estoppel in the face of a statute depends upon the nature of the enactment, the purpose of the provision and the social policy behind it.

285.

The relevant test, he submitted was formulated in Kok Hoong v Leong Cheong Kweng Mines[1964] AC 993, 1016, in the following terms namely:

Whether the law that confronts an estoppel can be seen to represent a social policy to which the court must give effect in the interests of the public

286.

The point, Mr. Coppel argued, was that the benefit of statutory provisions may be waived by an individual where they were intended by Parliament to operate solely for the benefit of that individual and others in his position, but not where there is any wider interest at stake. If there is a wider interest in upholding the statutory provisions, estoppel cannot operate. There was, he argued, as might perhaps be expected, a strong identity between this rule, and the rule which applied to the issue of whether a party may waive statutory rights by contract (as opposed to conduct). The question in that context is whether the right conferred is exclusively personal (in which case waiver will be permitted) or is designed to serve other, broader public purposes and so, compendiously, whether to permit a waiver would undermine or frustrate the purposes of the statute: see Johnson v Moreton[1980] AC 37, 51F, 58B-D, 68D.

287.

Mr. Coppel argued that the claimants were wrong to contend that the consent provisions of the Act were not underpinned by any public policy. In so arguing, they ignored the evidence of Mr Webb who identified a number of such policies. The most relevant in the present context was that of promoting clarity and certainty in relations between parties in this field: see paragraph 186 above. Against the background that IVF and other techniques were being practised in this country before the Act, the enactment of the Act constituted in itself a recognition that common law and equitable rules were inadequate to regulate this field.

288.

Furthermore, Mr. Coppel argued, paragraph 4 of Schedule 3 contained a clear or “bright line” rule to the effect that consent may be withdrawn up to the point of use, in contrast to a fact-sensitive rule which would give rise to uncertainty and litigation. Certainty was an important policy in the general public interest. The effect of the claimants’ estoppel argument would be to superimpose a fact-sensitive rule, the operation of which would depend upon the contents of unminuted discussions between participants in IVF treatment, occurring perhaps at a time of great stress, and upon the whole range of factors which affect whether the courts will recognise an “equity” (fairness, clean hands etc.).

289.

It was also important, Mr. Coppel submitted, to consider the position of licence holders, who faced revocation of their licence and possible criminal prosecution if embryos were used in circumstances where Schedule 3 had not been complied with. The bright line rule obviously enabled licence holders to be sure about what they could and could not do. If estoppel could operate so as to overlay the provisions of paragraph 4 of Schedule 3, licence holders would be placed in the invidious position of having to investigate and make findings of fact in relation to what was said between male and female partners, and whether it was equitable to permit consent to be withdrawn. The livelihood of those working on behalf of licence holders would be at risk if their judgment of the facts was found by the courts to have been incorrect.

290.

There were, in short, substantial reasons of social policy underpinning the provisions of Schedule 3 to the Act, which militated strongly against the operation of any estoppel in this case.

291.

Mr. Tolson and Miss Freeborn’s response to this argument was that there was no threat to the “bright line” policy. Schedule 3 created a regime, the core aim of which was to protect the clinics. It was accepted that an estoppel could not bind the clinic, but this did not affect the position as between the patients themselves. Estoppels were not therefore prevented by any form of policy considerations.

292.

There was, however, a second point. The clinics were protected from patient / clinic estoppels by the consent regime itself. Clinics obtained effective consent, relied on it and maintained it until written notice of withdrawal. They were not bound by any equities purely between third parties on the usual principles. Thus if the notice of withdrawal may be avoided as a result of undue influence, duress or estoppel between the gamete providers, that did not affect the clinics in any way. They could carry on regardless unless and until they received notice. At that point they did not have to do anything other than continue to store the embryos.

293.

The remedy sought in this case was an injunction requiring Mr. Johnson to maintain his consent and a declaration as to lawful treatment. The remedy affects the effective consent, and there could, Mr. Tolson and Miss Freeborn argued be no public policy bar to such a remedy.

294.

Once again, I find the argument of the Secretary of State on this point compelling. I am particularly impressed by the consequences of Mr. Tolson and Miss Freeborn’s argument for the clinics. Neither the gamete providers nor the clinics can opt out of the statutory scheme. The clinics depend both for their livelihoods and their reputations on strict compliance with the terms of the licences granted to them. The importance of fulfilling the terms of the licence was at the forefront of the evidence of both Dr. Sharp and Dr. Lockwood and, in my judgment, rightly so.

295.

Thus any agreement or understanding between those receiving IVF treatment must be unenforceable unless it complies fully with the scheme. The Act gives Mr. Johnston an unequivocal right to vary or withdraw his consent both to treatment and the storage of the embryos at any point prior to their use. That right must be seen in its context, namely the structure of the scheme of licensed treatment operated under the Act, and as part of the policy of mutual consent discussed earlier under Article 8 of the Convention. The Statutory scheme is clear and, as I have found, Convention compliant. It exists for the benefit of all gamete providers. In such circumstances it seems to me that Mr. Coppel must be right to submit that there is a wider interest in upholding the provisions of Schedule 3, and that they cannot be waived for the benefit of an individual. These include, of course, the welfare of the unborn child.

296.

To put the matter another way, Mr. Johnston cannot give an unequivocal consent to the use of the embryos irrespective of any change of circumstances. In the wider public interest of the proper operation of the scheme under the Act, Parliament does not permit him to give such a promise.

297.

I therefore agree with Mr. Coppel that the estoppel for which Ms Evans argues cannot take effect on the face of the Act, even if the representations made to Ms Evans were in explicit terms. However, in case I am wrong on that point, I propose to examine the question in the overall context of the law relating to promissory estoppel as I perceive it to be.

The ingredients and parameters of promissory estoppel

298.

One of the difficulties I have in this area is in defining the parameters of equitable or promissory estoppel, and distinguishing it (where it is necessary to do so) from proprietary and other forms of estoppel. Thus, for example, although the legal rights between the person making the representation and the person who acts on it frequently arise out of a contract between them, in some circumstances it does not seem to be fatal to the existence of an estoppel for there to be no legal relationship between representor and representee.

299.

Thus in Jennings v Rice and others[2003] 1FCR 501, a case of proprietary estoppel the claimant did odd jobs for the deceased, latterly without payment, provided her with personal care out of compassion for her, and stayed in her house overnight to provide her with security. She had also promised him that she would “see him right”. The judge decided that the claimant had believed he was going to receive all or part of the deceased’s property on her death; that he acted to his detriment in caring for her unpaid; and that it would be unconscionable for the deceased to go back on her assurances to him. The judge awarded him £200,000 out of a net estate of £1.285 million. The case in the Court of Appeal was concerned with the extent of the relief to which the claimant was entitled having established the estoppel. There was no appeal against the judge’s finding that the claimant had established a claim.

300.

Although the case is concerned with proprietary estoppel, it seems to me that the judgments are helpful in the instant case. The Court of Appeal was referred to an article by Dr. Simon Gardner (1999) 115 LQR 438 entitled “Remedial Discretion in Proprietary Estoppel”. In his judgment in the case, Robert Walker LJ (as he then was) said:


[43] It cannot be doubted that in this as in every other area of the law, the court must take a principled approach, and cannot exercise a completely unfettered discretion according to the individual judge’s notion of what is fair in any particular case. Dr Gardner’s fourth hypothesis (‘the approach is for the court to adopt whatever style and measure of relief it thinks fit, for whatever reason it thinks fit’) cannot be right……

[44] The need to search for the right principles cannot be avoided. But it is unlikely to be a short or simple search, because (as appears from both the English and the Australian authorities) proprietary estoppel can apply in a wide variety of factual situations, and any summary formula is likely to prove to be an over-simplification. The cases show a wide range of variation in both of the main elements, that is the quality of the assurances which give rise to the claimant’s expectations and the extent of the claimant’s detrimental reliance on the assurances. The doctrine applies only if these elements, in combination, make it unconscionable for the person giving the assurances (whom I will call the benefactor, although that may not always be an appropriate label) to go back on them.

301.

I find that an extremely helpful passage. It helps to explain why, when one looks back at the cases to which I was referred, it is not always possible to find a formula which fits the facts of this particular case. The first classic expression of the concept is in the speech of Lord Cairns LC in Thomas Hughes v The Directors & etc of the Metropolitan Railway Company (1877) 2 App. Cases 439 at 448. The question in that case was whether a lessor could obtain an order of ejectment against a lessee when work under a notice of repair to leasehold premises was suspended following the lessee instituting negotiations for the lessor to purchase the lessee’s interest in the premises. Lord Cairns, giving the leading speech said:

It was not argued at your Lordships' Bar, and it could not be argued, that there was any right of a Court of Equity, or any practice of a Court of Equity, to give relief in cases of this kind, by way of mercy, or by way merely of saving property from forfeiture, but it is the first principle upon which all Courts of Equity proceed, that if parties who have entered into definite and distinct terms involving certain legal results - certain penalties or legal forfeiture - afterwards by their own act or with their own consent enter upon a course of negotiation which has the effect of leading one of the parties to suppose that the strict rights arising under the contract will not be enforced, or will be kept in suspense, or held in abeyance, the person who otherwise might have enforced those rights will not be allowed to enforce them where it would be inequitable having regard to the dealings which have thus taken place between the parties.

302.

Following the decision of Denning J (as he then was) in Central London Property Trust Limited v High Trees House[1947] KB 130, Denning LJ (as he had by then become) articulated the concept in Coombe v Coombe[1951] 2 KB 215. In that case, a divorced wife relied on a promise by her former husband to pay her maintenance of £100 a year. He did not pay. She did not apply for maintenance in the divorce proceedings, but issued a writ several years later relying on her former husband’s promise to pay, and arguing (inter alia) that it would be inequitable for the court to relieve him of his obligations. Having referred to a series of cases in which promissory estoppel had arisen, Denning LJ said:

In none of these cases was the defendant sued on the promise, assurance, or assertion as a cause of action in itself. He was sued for some other cause, for example, a pension or a breach of contract, or possession, and the promise, assurance, or assertion only played a supplementary role, though, no doubt, an important one. That is, I think, its true function. It may be part of a cause of action, but not a cause of action in itself. The principle, as I understand it, is that where one party has, by his words or conduct, made to the other a promise or assurance which was intended to affect the legal relations between them and to be acted on accordingly, then, once the other party has taken him at his word and acted on it, the one who gave the promise or assurance cannot afterwards be allowed to revert to the previous legal relations as if no such promise or assurance had been made by him, but he must accept their legal relations subject to the qualification which he himself has so introduced, even though it is not supported in point of law by any consideration, but only by his word.

Seeing that the principle never stands alone as giving a cause of action in itself, it can never do away with the necessity of consideration when that is an essential part of the cause of action. The doctrine of consideration is too firmly fixed to be overthrown by a side-wind. Its ill effects have been largely mitigated of late, but it still remains a cardinal necessity of the formation of a contract, although not of its modification or discharge. I fear that it was my failure to make this clear in Central London Property Trust Ltd v High Trees House Ltd which misled Byrne J in the present case. He held that the wife could sue on the husband’s promise as a separate and independent cause of action by itself, although, as he held, there was no consideration for it. That is not correct. The wife can only enforce the promise if there was consideration for it. That is, therefore, the real question in the case: Was there sufficient consideration to support the promise?

303.

From these cases, a number of conditions appear to be necessary for the concept of promissory estoppel to operate. Firstly, there must be a legal relationship between the parties. Secondly, the estoppel is not, of itself, the cause of action, although it may be an element in it. Thirdly, there must be a clear and unequivocal promise or representation which is designed to affect the legal relationship between the parties. Fourthly, there must be reliance on that promise or representation by the other party and, fifthly, it must be unconscionable for the person making the representation to be allowed to resile from it.

304.

In the instant case, the first three elements identified in paragraph 303 are undoubtedly missing and the final two depend, essentially, on my findings of fact. That said, however, it does not seem to me that the absence of any one or more of these elements is necessarily fatal to an equitable estoppel. The essence of the doctrine, as Robert Walker LJ comments in Jennings v Rice [2003] 1 FCR at 518f is to do what it necessary to avoid an unconscionable result. However, it does seem to me that in the instant case, the three critical elements which must be present are (1) a clear representation by Mr. Johnston; (2) reliance on that representation by Ms Evans to her detriment, and (3) a finding that it would be unconscionable to allow Mr. Johnston to allow Mr. Johnston to go back on the representation.

Application of the principles of estoppel to the present case

305.

In my judgment the estoppel undoubtedly fails on the first and the third of the three essential ingredients I have identified in paragraph 304 There was, of course, no contractual, or other legal relationship between Ms. Evans and Mr. Johnston. However, for the reasons I have given I do not think this fatal to the argument. In Jennings v Rice there was no contractual or other legal relationship between the claimant and the deceased, and the claimant succeeded in establishing a proprietary estoppel.

306.

I do not, however, agree with Mr. Tolson and Miss Freeborn that the assurances Mr. Johnston gave Ms Evans amounted to a clear and unequivocal representation as to the use of the embryos and a promise that he would never withdraw his consent to their use. On 10 October 2001, Mr. Johnson was doing his best to reassure Ms Evans that he loved her and that he wanted to be the father of her children. He was giving what I have no doubt was a truthful expression of his feelings at the time. He was not – nor could he be- committing himself for all time. In the field of personal relationships endearments and reassurances of this kind are commonplace, but they do not – nor can they – have any permanent, legal effect. They certainly cannot bind Mr. Johnston in what were totally changed circumstances, namely his separation from Ms Evans.

307.

Equally, for the reasons I have set out when dealing with the claims under the Convention, I cannot take the view that it would be unconscionable to allow Mr. Johnston to go back on the assurances he gave. What he is now saying simply reflects the reality. He and Ms Evans have separated. He no longer loves her, and she no longer loves him. In these changed circumstances, he no longer wishes to have a child by her. Were it not for the existence of the embryos, Ms Evans would not choose to have a child by him.

308.

I find the question of Ms Evans’ reliance on the assurances difficult, although the point may be academic in the light of my other findings. Ms Evans had very little time. She was given the news on 10 October 2001.Harvesting of her eggs and fertilisation of them took place on 12 November 2001. Ms Evans underwent an oophorectomy on 26 November 2001. The reality was that egg freezing was not a option, nor, I think, was the use of donor sperm. The clinic would not undertake the former. I think it highly unlikely, in the light of the evidence of Dr. Sharp and Dr. Lockwood that Ms Evans would have found a clinic which undertook it, even if she had had more time, and been able to afford it. Furthermore, both egg freezing and AID would have opened up the question of the durability of her relationship with Mr. Johnston. The alternative clinic would have been bound to enquire into why Ms Evans wanted egg freezing or to use donor sperm; and, despite her personal circumstances, might have felt unable to provide either when Ms Evans had a partner who was capable of providing the gametes to fertilise her embryos.

309.

My acceptance of Mr. Johnston’s account of what occurred on 12 November 2001, combined with Ms Evans’ initial difficulty about remembering the date of the conversation with Mr. Johnston (she initially put it after 10 October 2001) make it difficult for me to find in terms that she relied on Mr. Johnston’s assurances to the extent that she now believes. She was naturally in a highly anxious state of mind. She was, I think, by undergoing IVF with Mr. Johnston taking the only realistic course which was open to her. She was, I think, both aware that it was the only course, and it was one she was content to adopt. No doubt Mr. Johnston’s assurances played a part in what she did, but I do not think they were critical. Had Mr. Johnston not given her the assurances I have found he did give her, I think she would have gone ahead with the treatment in any event. However, even if I am wrong about that, and even if an estoppel is capable of existing in the face of the Act, I do not, for the reasons I have given, think it would be unconscionable to allow Mr. Johnston to withdraw his consent. It is a right which the Statute gives him within the clear scheme operated by Parliament. It was the basis upon which he gave his consent on 10 October 2001. It is perfectly reasonable for him, in the changed circumstances which appertain, not to want to father a child by Ms Evans.

310.

In my judgment, therefore, there is no effective estoppel in this case. The reality, as I find it to be, is that both Ms Evans and Mr. Johnston embarked on the treatment in good faith on the basis that their relationship would endure. However, it did not. In the changed circumstances of separation, it would in my judgment be quite inequitable not to allow either party to change their mind and withdraw their consent to treatment.

Information from other jurisdictions

311.

I was provided with a great deal of information, including a substantial document which Mr. Webb had downloaded from the internet prepared by the Council of Europe and entitled Medically Assisted Procreation and the Protection of the Human Embryo Comparative Study on the Situation in 39 States. Mr. Tolson and Miss Freeborn were highly critical of the suggestion that this document should be adduced in evidence, and agreement was reached that it was to provide background information only. Apart from critical references to it in the claimants’ opening, nobody sought to rely on it and I did not take it into account in reaching any of my conclusions.

312.

As Mr. Tolson and Miss Freeborn readily and rightly acknowledged, the legitimate differences between practice in different jurisdictions inevitably meant that, in the absence of a powerful consensus elsewhere, the claimants’ arguments stood or fell on my construction of the Act and its compliance with Convention rights.

313.

I was shown four cases (one Israeli and three American) in which divorced couples had argued over the fate of frozen embryos created from their gametes. One was a decision of a specially convened sitting of 11 judges of the Israeli Supreme Court in the case of Nachmani decided in 1996. Unfortunately, the judgments are only, I was told, available in Hebrew, and the only discussion of the case in English is in the Texas International Journal for Winter 2000 in an article by one of the judges involved, Justice Dalia Dorner. The others were a decision of the Supreme Court of Tennessee at Knoxville called Davis v Davis and reported at 842 S.W.2d 588, 597 (Tenn 1992); Kass v Kass, a decision of the New York Supreme Court, reported at 273N.Y. S2d 250 (1988); and A.Z. v B.Z, a decision of the Supreme Judicial Court of Massachusetts decided in March 2000 and provided to me in the Massachusetts Lawyers Weekly.

314.

In a judgment which is already overlong, I do not think it would assist if I set out the facts of these four cases and attempted to analyse the judicial reasoning behind them. Indeed, I doubt whether it would be a permissible exercise in the circumstances of this case. My task has been to find facts, to analyse the Act and to decide whether its terms contravene the terms of the Convention. I have also had to examine the English doctrine of estoppel. None of the five cases identified in paragraph 314 was based on the construction of a statute, let alone a statute in the same terms as the Act. Accordingly, whilst I found the decisions interesting, they do not assist me one way or the other in deciding this case.

The result

315.

The claims of both Ms Evans and Mrs Hadley must be dismissed. No doubt counsel, to whom this judgment will be circulated in advance, will be able to draw up the appropriate form of order to enable the clinics to remove the embryos from storage and allow them to perish.

Footnote

316.

I cannot leave the case without adding two comments. The first is my appreciation for the manner in which the case was conducted in court by both the lawyers and the parties. The hearing was dignified and calm, despite the highly emotive nature of the issues. Each of the claimants and the male defendants gave evidence with dignity and courtesy. I was very impressed with the professionalism and the dedication of the two medical specialists from whom I heard. All the witnesses were of a high quality.

317.

The second is my wish to repeat my sympathy for all four of the main protagonists. All four struck me as perfectly decent people locked into a dispute not of their choosing but deriving from the incapacity of the two claimants to conceive a child. In human terms, the greatest sympathy must, of course, be extended to Ms Evans, who, as a result of this case, now lacks the capacity to give birth to a child which is genetically hers.

318.

The Family Division, unfortunately, is only too used to the fact that nature often makes most fecund those least able properly to exercise parental responsibility, whilst at the same time denying parenthood to those who would undertake it conscientiously.

319.

It would be easy to criticise men in the position of Mr Johnston and Mr. Hadley in this case. But such criticisms would, in my judgment, be facile and unfair. As I have found, a man in the position of these men is entitled to say that he does not want to become a father by a woman from whom he has separated, and with whom he no longer has anything in common apart from the frozen embryos created from their gametes. The Act places great emphasis on considerations relating to the position of the unborn child. As I make clear in the substance of the judgment, Mr. Johnston and Mr. Hadley would be the biological fathers of children for whom they would be financially responsible, but with whom they could not enjoy any form of natural paternal relationship.

320.

Furthermore, as Miss Rose pointed out, it is not difficult to reverse the dilemma. If a man has testicular cancer and his sperm, preserved prior to radical surgery which renders him permanently infertile, is used to create embryos with his partner; and if the couple have separated before the embryos are transferred into the woman, nobody would suggest that she could not withdraw her consent to treatment and refuse to have the embryos transferred into her. The statutory provisions, like Convention Rights, apply to men and to women equally.

321.

Summary of the judgment

Mr Justice Wall :

Evans v Amicus Healthcare Ltd and Johnston

Hadley v Midland Fertility Services Limited & Hadley,

The Secretary of State for Health and the Human Fertilisation and Embryology Authority being parties to both claims

Press release by Mr. Justice Wall

1 October 2003

The judgment which I am handing down in open court this morning is a public document. However, it is extremely long, and deals with some difficult points of law. Because of the media interest in these two cases, I am taking the unusual step of publishing a summary of my reasons for reaching my conclusion that the claims of both Ms. Evans and Mrs. Hadley must be dismissed. That summary accompanies this press release and may be read as part of my judgment.

Summary of the judgment of Mr. Justice Wall in the case of Evans v Amicus Healthcare Ltd and Johnston and Hadley v Midland Fertility Services Limited & Hadley, the Secretary of State for Health and the Human Fertilisation and Embryology Authority being parties to both claims

The issues in the case

1.

Ms Evans and Mrs. Hadley both underwent IVF (in vitro fertilisation) treatment with their then partners (Mr. Johnston and Mr. Hadley respectively). In each case, embryos created from the gametes (the eggs and sperm) of the couple have been frozen and are being stored by the clinics at which the couples were treated. Both couples have now separated permanently, and Mr. and Mrs. Hadley are divorced.

2.

Ms Evans and Mrs. Hadley now both wish to remove the embryos created from their gametes from storage and to have the embryos transferred into them with a view to becoming pregnant. The two men have withdrawn their consent both to the IVF treatment and to the continuing storage of the embryos. They wish the clinics to allow the embryos to perish.

3.

As the two cases raise essentially the same points, they have been heard together. Ms Evans and Mrs Hadley argue that the court has the power both to override the withdrawal of their former partners' consent and to permit them to use the embryos. I have come to the conclusion that the court does not have that power.

The legislation

4.

IVF treatment is governed by an Act of Parliament, the Human Fertilisation and Embryology Act 1990 (the Act). The Act created a statutory body, the Human Fertilisation and Embryology Authority (the Authority). One of the most important functions of the Authority is to regulate treatments permitted under the Act by means of licences granted by the Authority to clinics such as those involved in these cases. Both the treatments which the clinics can offer, and the terms on which they can offer them, are carefully regulated.

5What have been described as the two main principles to be found in the Act are (1) the welfare of any child who may be born as a result of the treatment (section 13(5) of the Act); and (2) the requirements of consent to treatment contained in Schedule 3. It is a condition of every licence granted under the Act that the terms of Schedule 3 are complied with.

5.

Under Schedule 3, the consents given by the couple to the use of the embryos created from their gametes must specify one of three purposes. In each of these two cases, Ms Evans and Mr. Johnston and Mr and Mrs Hadley specified that the embryos were to be used in providing treatment services for themselves and their partners "together".

6.

Paragraph 4 of Schedule 3 to the Act gives to each party to IVF treatment an unconditional right to vary or withdraw his or her consent to treatment and to the continued storage of any embryos at any time up to the point at which the embryos are "used" in the treatment. In the present cases, I am satisfied that means until the moment the embryos are transferred into the woman.

7.

Paragraph 6(3) of Schedule 3 provides that an embryo must not be used for any purpose unless there is an effective consent by each gamete provider to the use of that embryo for that purpose.

The reasons the claims fail

8.

In my judgment, the claims fail for five principal reasons, each of which I will identify and then explain.

The men's original consents to treatment are no longer effective (paragraphs 104 to 149 of the judgment)

9.

The consents to treatment given in both cases were for "treatment together" with the named partner, and for no other purpose. The couples are no longer together. They have no continuing relationship of any kind with each other. Thus if either Ms Evans or Mrs. Hadley went to the clinics on her own and asked for the embryos to be unfrozen and transferred into her, the clinics would be in breach of their licences if they treated either women. The consents to treatment given at the outset are no longer effective or valid.

The men have an unconditional statutory right to withdraw or vary consent

10.

The claims also failed for the simple reason that by withdrawing their consent both to the transfer of the embryos into the two women and to the continued storage of the embryos, Mr. Johnston and Mr. Hadley are lawfully exercising the clear and unconditional right which Parliament has given them to take that course

The embryos have not been used (judgment paragraphs 150 to 165)

11.

Ms Evans and Mrs. Hadley sought to override the men's statutory right to withdraw consent in a number of ways, none of which, in my judgment, is valid. They argued, firstly, that because Mrs. Hadley had undergone a previous, unsuccessful course of treatment, the embryos which were not inserted in her in that cycle had, nonetheless, been "used" within the meaning of paragraph 4 of Schedule 3, and accordingly that it was too late for Mr. Hadley to withdraw his consent. The argument was also applied to Ms Evans' case.

12.

I am unable to accept that argument. As I have already stated, in the context of this case, "use" in my judgment means the transfer of the embryos into the women. The creation, examination, selection and freezing of the embryos are all steps preparatory to use: they are not use. If "use" meant what Ms Evans and Mrs. Hadley suggested, all embryos created and selected for storage would have been used, and it would effectively be impossible for consent to treatment ever to be withdrawn.

The Act does not breach Convention Rights (judgment paragraphs 166 to 278)

13.

Ms Evans and Mrs. Hadley argued that Schedule 3 of the Act provided what they described as an unwarranted "male veto" to treatment, which infringed their rights under the European Convention on Human Rights (the Convention), now enacted into our law by the Human Rights Act 1998 (HRA 1998).

14.

In particular they argued that Schedule 3 to the Act was an unwarranted interference with their right to respect for private and family life under Article 8. They also argued that the Act breached Article 12 (the right to marry and to found a family); Article 14 (prohibition of discrimination) and Article 2 (the right to life). They sought to persuade me that the Act was incompatible with their Convention rights, and that I should make a declaration to that effect under Section 4 of HRA 1998.

15.

In my judgment, none of these claims has any foundation in law. Convention Rights are given to everyone. They are therefore also enjoyed by Mr. Johnston and Mr. Hadley. Article 8 provides that there can be no interference by the State in the exercise of a person's right to private and family life unless it is (1) in accordance with the law and (2) necessary in a democratic society for (amongst other things) "for the protection of the rights and freedoms of others".

16.

The Act is an embodiment of the will of Parliament and was enacted for legitimate purposes, one of which is the regulation of IVF treatment. Although passed well before the enactment of HRA 1998, there is nothing in the Act which in my judgment breaches Article 8. Schedule 3 does not provide a "male veto". What it does is to give to each of the parties in these proceedings an equal right to respect for their private lives, which each is entitled to exercise.

17.

The Act requires the process of IVF treatment for a couple to be consensual throughout, and gives each party the right to withdraw consent to treatment before the embryos are used. There are sound policy considerations behind Schedule 3, which are identified in the evidence provided by the Secretary of State and set out in paragraphs 186-7 of the judgment. The interference by the State, accordingly, seems to me both lawful and proportionate (judgment paragraphs 248-260).

18.

None of the other Articles of the Convention, in my judgment, applies. In English law a foetus does not have a right to life under Article 2 because it is not a person. It must follow that an embryo cannot have rights under Article 2 (judgment paragraphs 174 to 179)

19.

Counsel for Ms Evans and Mrs. Hadley accepted that, if Article 8 was not breached, there was no breach of Article 12. I am equally satisfied that the Act does not discriminate against women who are unable to conceive without undergoing IVF treatment, and that accordingly Article 14 does not apply (judgment paragraphs 266 to 277).

The concept of Promissory Estoppel does not apply (judgment paragraphs 279 to 311)

20.

In very simple terms the concept of promissory estoppel means that a person may in some circumstances be prevented (estopped) from relying on his strict legal rights if he has made a promise or representation that he will not do so and the person to whom he made that promise has acted on it, to his or her detriment.

21.

Ms Evans says that Mr. Johnston should be prevented from withdrawing his consent because of promises she says he made to her at the initial interview in the clinic the effect of which was that he would not withdraw his consent to treatment, and that he would allow her to use the embryos even if they split up. Ms Evans asserted that she acted on these assurances to her detriment, and in particular that it was for this reason that she did not pursue the idea of freezing some of her unfertilised eggs.

22.

I am quite satisfied that the concept of promissory estoppel cannot apply in this case. Firstly, for reasons I elaborate in the judgment (paragraphs 305-311) it fails on the facts. Mr. Johnston, I find, did not give any categorical assurance that Ms Evans could use the embryos whatever happened between them. But even if he had, the concept of promissory estoppel cannot apply in the face of clear provisions in an Act of Parliament which represent a social policy (the right to withdraw consent) to which the court must give effect in the interests of the scheme operated under the Act. To put the matter another way, Mr. Johnston could not promise to do what the law did not allow him to do.

23 Other factors necessary for the existence of a promissory estoppel, which I identify in the body of the judgment (paragraphs 298 to 311) are also missing.

General observations

23.

I have considerable sympathy for all four of the adults in the dilemma which they face in these two cases. Ms Evans' case is particularly poignant, and she is most deserving of sympathy, because she has had to have an operation for the removal of her ovaries immediately following the harvesting of her eggs, and the frozen embryos represent her only chance of giving birth to a child which is genetically hers. She was also faced with the dilemma of having to make decisions about IVF within minutes of hearing the devastating news that she required radical surgery.

24.

However, I cannot allow my sympathy for Ms Evans to take precedence over the clear terms of the Act. In so far as medical science can alleviate infertility, the message of this case has to be, firstly, that IVF is governed by the Act, and subject to its careful regulation; and secondly, that it requires the consent of both parties throughout. Couples who embark on IVF treatment under the Act must appreciate that until the fertilised embryo is used (in this case transferred into the woman) the ongoing consent of both parties to the treatment is required and that either can withdraw. Furthermore, if the relationship breaks down, the clinic may well not be able to continue to treat the woman because she and the man are no longer being treated together.

25.

It would be easy to criticise men in the position of Mr Johnston and Mr. Hadley in this case. But such criticisms would, in my judgment, be unfair. The Act entitles a man in the position of these men to say that he does not want to become the father of a child by a woman from whom he has separated, and with whom he now no longer has anything in common apart from the frozen embryos. In section 13(5)the Act places great emphasis on considerations relating to the position of the unborn child. Mr. Johnston and Mr. Hadley would be the biological fathers of children for whom they would be financially responsible, but with whom they could not enjoy any form of natural paternal relationship.

26.

Furthermore, it is not difficult to reverse the dilemma. A man has testicular cancer; his sperm is preserved prior to treatment and used to create embryos with his partner. The couple then separate before the embryos are transferred into the woman. Nobody would suggest that the woman could not withdraw her consent to treatment and refuse to have the embryos transferred into her. The statutory provisions, like Convention Rights, apply to both men and to women.

27.

Finally, this is an area where Parliament has legislated very clearly and fully, following an expert report (that of the Warnock Committee) a consultation process and a White Paper. If the law is to be changed in this area, it is in my view for Parliament to do so, not the judiciary.

Evans v Amicus Healthcare Ltd & Ors (includes Summary of Judgment)

[2003] EWHC 2161 (Fam)

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