Society of Apothecaries | 7 March 2015

Ethico-Legal Aspects of Reproductive & Genetic Technologies

James Lawford Davies

© LAWFORD DAVIES DENOON LTD 2011

Overview

• • • • Introductory comments UK Policy Development The Human Fertilisation and Embryology Act and the HFEA • • • • • • Specific areas: Consent and autonomy Property rights, control and disposal Pre-implantation Genetics Research The Welfare of the Child A Right to a Child?

Apothecaries' Hall - 7 March 2015

Approaches to Regulation in IVF

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Approaches to regulation

1.

2.

3.

4.

• • Prohibitions or restrictions: Germany’s 1990 Embryo Protection Act and Stem Cell Act of 2002 (as amended in 2008) Italy’s Law 40/2004 • • Regulation or licensing: Victoria’s Infertility Treatment Act 1995 (Australia) UK’s Human Fertilisation and Embryology Act 1990 (as amended) • Guidance or self-regulation: China’s 2003 joint MoH and MoST Ethical Guiding Principles for hES cell research No regulation Apothecaries' Hall - 7 March 2015

Controls and limitations

.

Prohibition .

Unregulated

Prohibitions of certain procedures Licence conditions Restrictions on research purposes Requirements re source material Restrictions on funding Limitations on duration of research Governance frameworks Ethics review

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Common rationales

• • • Public health and safety Welfare of the child and family considerations • • • The status of the human embryo Regulation stems partly from consensus that embryos have special status No consensus as to how that status defined or protected Inevitable compromise - unless research prohibited Apothecaries' Hall - 7 March 2015

UK Policy Development

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UK policy development

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UK policy development

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UK policy today

• • • • • • 1990 Act (as amended by 2008 Act): Protects patients Allays public concerns Protects researchers Provides an environment within which scientific innovation and progress may flourish • • • • But requires: Adaptability Proportionate implementation Objective and impartial regulator Expertise and efficiency Apothecaries' Hall - 7 March 2015

The Human Fertilisation and Embryology Act and the HFEA

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Legislation: 1990 Act

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Legislation: 1990 Act

• • • • Created the Human Fertilisation and Embryology Authority (HFEA) Defined meaning of ‘mother’ and ‘father’ for various family models Set out unique confidentiality and data protection principles Provided a detailed consent framework Apothecaries' Hall - 7 March 2015

Legislation: 1990 Act

• • • • • • • Defined licensable activities: Creation and use of human embryos Storage of gametes and embryos

in vitro

Storage and use of donated gametes and embryos Use of human embryos in research up to 14 days These activities require a licence from HFEA Unlicensed treatment is a criminal offence Apothecaries' Hall - 7 March 2015

Legislation: 2008 Act

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Legislation: 2008 Act

• • • • • • • Key developments: Ensuring different categories of embryo fall within scope of regulation Ban on social sex-selection Retention of ‘ welfare of the child ’ father ’ but removal of ‘ need for a Recognition of same-sex couples as legal parents of donor conceived children Amending restrictions on use of HFEA data Formal regulation of PGD and ‘ saviour siblings ’ Admixed embryos Apothecaries' Hall - 7 March 2015

Overview of UK & EU Regulation

Procurement Analysis

EU 2004/23/EC Human Tissue and Cells Directive EU 2006/17/EC Implementing 2004/23/EC UK Human Tissue Act 2004

Proof of Product and Process

UK Human Fertilisation and Embryology Act 1990 and Regulations OECD Principles of Good Laboratory Practice (GLP) UK SI 3106 1999 GLP Regulations

Product Manufacturing Pre-clinical Trials Clinical Trials Launch

EU 2003/94/EC GMP for Medicinal Products EU 2001/20/EC Clinical Trials Directive EU 2001/28/EC GCP for Medicinal Products UK SI 1031 2004 Medicines for Human Use Clinical trials Regulations EU 2001/83/EC Medicinal Products for human use (includes 2003/63/EC, 2004/27/EC and Advanced Therapy Regulation)

Post-launch

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• • •

HFEA

Human Fertilisation and Embryology Authority 14 Members, including Chair Large Executive arm under a Chief Executive with various Directors

“The Human Fertilisation and Embryology Authority is the UK's independent regulator overseeing the use of gametes and embryos in fertility treatment and research.

The HFEA licenses fertility clinics and centres carrying out in vitro fertilisation (IVF), other assisted conception procedures and human embryo research.”

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HFEA: Principle Functions

• • • • • Licence treatment services, the storage of gametes and embryos, and research on embryos Monitor and inspect premises and activities carried out under statutory licence Submit an annual report to the Secretary of State Maintain a Code of Practice for activities carried out under a licence Keep a register of information about licensed treatment services Apothecaries' Hall - 7 March 2015

HFEA: General Functions

• • • Keep under review information about embryos and activities governed by the 1990 Act Publicise the services it provides or which are provided under a licence Provide advice and information to licensed centres, patients and donors • Also competent authority for EU Tissues and Cells Directive (EUTCD) Apothecaries' Hall - 7 March 2015

HFEA: Licensing

• • • • • • Routine licence decisions made by ‘Executive Licensing Panel’ Complex, novel or controversial issues referred to a Licence Committee Statutory appeals procedure 116 centres currently hold HFEA treatment licences Also transport and satellite clinics 21 Research licences Apothecaries' Hall - 7 March 2015

HFEA: Licensing

• • • • Person Responsible:

The person under whose supervision the activities authorised by the licence are carried out (see section 17 in particular)

Holder of the Licence (formerly Nominal Licensee):

The ‘person’ who holds the licence

Either may apply to revoke Either may be catalyst for revocation Apothecaries' Hall - 7 March 2015

HFEA: Sanctions

Licence committees may vary or revoke a licence where: • information given in a licence application is false/misleading • premises no longer suitable • material change in circumstances since grant • Person Responsible failed to discharge duties under s.17

Licence committees may revoke where: • character of Person Responsible or Nominal Licensee unsatisfactory for supervising licensed activities • Person Responsible convicted of an offence under the 1990 Act • Person Responsible dies Apothecaries' Hall - 7 March 2015

HFEA: Sanctions

• • • • Criminal offences include: Bringing about the creation of, storing or using an embryo except in pursuance of a licence Storing any gametes except in pursuance of a licence Using donated gametes except in pursuance of a licence Disclosing confidential information to a third party Powers to enter and search premises, and seize evidence where offence suspected Apothecaries' Hall - 7 March 2015

HFEA: Sanctions

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HFEA: Sanctions

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HFEA: Sanctions

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HFEA: Sanctions - ARGC (2)

• • • •

Timeline

: 3 January 2007: HFEA told by police - no offence 5 January 2007: McNab records interview for BBC Panorama 10 January 2007: Licence Committee representations hearing • • • • • 15 January 2007: c.11am – McNab attends court to apply for warrant to raid ARGC and RGI c.2pm – warrant executed by 6 HFEA Executives, 2 Healthcare Commission staff and 5 police officers 2.05pm – press conference announced 3.30pm – McNab gives unprecedented press conference at HFEA 9pm – BBC Panorama programme broadcast Apothecaries' Hall - 7 March 2015

HFEA: Sanction - ARGC (3)

• • • Immediately thereafter: • Police investigation Not resolved until 2009 • • • GMC HFEA sought and encouraged patients to complain to GMC Matters related to Panorama not pursued, and GMC found no evidence to support – but not until 6 May 2009 HFEA referred two other patient complaints to GMC, eventually thrown out half way through in October 2008, but after months of work, cost, and adverse publicity • • Licensing HFEA sought to have licence for ARGC revoked and refused to grant licence for ARGC Continued to maintain this position until 2010 Apothecaries' Hall - 7 March 2015

HFEA: Sanctions - ARGC (4)

• • • • • • Reputational: HFEA briefed against ARGC and in support of their actions Withdrew ARGC’s statistics from website Published minutes of licence committee proceedings ‘Driving Improvement’ Report targeted ARGC • • • Litigation: Issued proceedings for judicial review in relation to decision to obtain and execute warrant on 15 January 2007 Two further judicial reviews regarding withdrawal of statistics and appearance of bias of Appeal Committee Libel claims against HFEA and BBC Apothecaries' Hall - 7 March 2015

Consent and Autonomy

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Consent (1)

1.

2.

3.

4.

5.

• • Before giving consent, patient must be given: Suitable opportunity to receive counselling “ Such relevant information as is proper ” Consent must be signed and in writing • • Consent to use of an embryo must: Specify purpose for which it can be used May specify conditions upon use • • Consent to storage must Specify maximum storage period State what is to happen in event of death or incapacity • Consent may be varied or withdrawn - but not after use in treatment, training or research One year cooling-off period Apothecaries' Hall - 7 March 2015

Consent (2)

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Consent (3)

“It follows that Mr. Blood's sperm should not in fact have been preserved and stored. Technically therefore an offence was committed by the licence holder as a result of the storage under section 41(2)(b) of the Act of 1990 by the licensee. There is however no question of any prosecution being brought in the circumstances of this case and no possible criticism can be made of the fact that storage has taken place because Professor Cooke of the I.R.T. was acting throughout in close consultation with the authority in a perfectly bona fide manner, in an unexplored legal situation where humanity dictated that the sperm was taken and preserved first, and the legal argument followed. From now on, however, the position will be different as these proceedings will clarify the legal position.”

(Lord Woolf in R v Blood, 1997) Apothecaries' Hall - 7 March 2015

Consent (4)

Apothecaries' Hall - 7 March 2015

Consent (5)

Evans v Amicus Healthcare Ltd & Ors (Court of Appeal, 2003): • • • •

Article 8 ECHR (the right to respect for private and family life)

Both men and women entitled to respect for private lives Appropriate for state to require that it be possible for either party to withdraw their consent Reversal of roles would clearly be breach Not open to parents to contract out of Child Support Act 1991 Apothecaries' Hall - 7 March 2015

Consent (6)

Contrast with… 1.

• • • Nachmani v Nachmani (1995): No statute or precedent applied - principles of justice and morality Only chance for Ruthi to have her own genetic child Harm of denying her that chance of parenthood was greater than harm to Danni 1.

Contradictory US case law Apothecaries' Hall - 7 March 2015

Consent (7)

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Consent (8)

“I am satisfied from the written evidence produced on behalf of Mrs Warren and her own oral evidence that had he have known fully of his options and the requirements Mr Brewer would have consented to his sperm being stored for a period in excess of 10 years, up to a maximum of 55 years, and would have obtained the necessary medical opinion required under the 2009 Regulations. I am satisfied it was his wish that Mrs Warren should have the opportunity to have the use of his sperm after his death in order to have his child or children if she so wanted, and he would have done everything required of him to achieve this.”

(Mrs Justice Hogg, 31 January 2014) Apothecaries' Hall - 7 March 2015

Storage without consent

• • • • • Storage without consent lawful if: 16+ Lacks capacity Likely to regain capacity Fertility likely to be impaired In ‘best interests’ Apothecaries' Hall - 7 March 2015

Consent

• • • • • Raises numerous challenges for clinics: Patients’ competence to consent and their understanding of complex, voluminous forms and information Patients’ understanding of the consequences of consent The internal consistency of consents Ensuring that consent has not been varied or withdrawn Acting in accordance with consent Apothecaries' Hall - 7 March 2015

Property Rights, Control and Disposal

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Property Interests and Control (1)

• Are embryos and gametes capable of being property?

• • • No property rights in human beings • • • Assumption of rights usually punishable by criminal law: Kidnap Trafficking Slavery Property interests body

may

attach to material derived from a living Apothecaries' Hall - 7 March 2015

Property Interests and Control (2)

• • • • • Moore v Regents of the University of California (1990) In 1976 John Moore consented to splenectomy at UCLA Extensive research conducted on T-lymphocyte cells and cell line derived In 1983, Moore asked to sign consent form for research • In 1984, Regents granted patent for cell line derived from Moore’s cells Estimated commercial value of US$3billion over a six-year period Moore sued for conversion and breach of duty Apothecaries' Hall - 7 March 2015

Property Interests and Control (3)

• • Moore (contd): • Californian Supreme Court held: Rejected Moore’s claim that he remained owner of cells after removal • • Policy concerns about impact on medical research To impose liability for conversion would impose a duty on all scientists to investigate consensual pedigree of every sample • Agreed there had been a breach of duty in relation to consent Contrast with… Apothecaries' Hall - 7 March 2015

Property Interests and Control (4)

• • • • Hecht v Superior Court of Los Angeles County (1993) Deceased stored sperm prior to suicide Bequeathed samples to partner in his will Children from previous relationship disputed validity of will and whether sperm capable of disposition • • Court of Appeals held: Sufficient decision-making authority about use of sperm for it to amount to his ‘property’ Distinguished Moore - no expectation that he could continue to exercise control over his spleen after removal Apothecaries' Hall - 7 March 2015

Property Interests and Control (5)

• • • Yearworth v North Bristol NHS Trust (2009) Six men lost sperm samples following mechanical fault Claim for damages for ‘personal injury’ unsuccessful, but… • • Court of Appeal recognised property interests in samples: Regulatory framework gave men negative control They alone generated it with sole intention that it be available for their later use in treatment • • Developments in medical science require review of how law deals with parts of living bodies They had ‘ownership’ of samples they produced and could claim in bailment Apothecaries' Hall - 7 March 2015

Property Interests and Control (6)

Questions arising from Yearworth: 1.

• Purpose for which gametes stored was important to judges Whilst storage for treatment attracted property interests, storage for (eg) research may not 2.

• Yearworth permits compensation for owners of damaged gametes - but same men would be prohibited from selling sperm samples Dichotomy which warrants review 3.

If gametes are capable of being property, what about the embryos that they produce?

Apothecaries' Hall - 7 March 2015

Property Interests and Control (7)

• • • • Roche v Roche (2009) Mr & Mrs R had successful IVF using fresh embryos in 2002, leaving 3 embryos in storage Subsequently separated and Mrs R sought to use embryos – contrary to wishes of Mr R • Mrs R argued that embryos enjoyed protection under Irish Constitution: “The State acknowledges the right to life of the unborn and, with due regard to the equal right to life of the mother, guarantees in its laws to respect, and, as far as practicable, by its laws to defend and vindicate that right” (Article 40.3.3) Did frozen embryos constitute human life within meaning of 40.3.3?

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Property Interests and Control (8)

• Murray CJ: Not for courts to pronounce on when human life begins but for legislature – therefore not justiciable • • • • • Denham J: Concept of ‘unborn’ envisages a state of being born or potential to be born This occurs only after an embryo is implanted Article also envisages a balance between interests of mother and unborn child – cannot arise in this context where embryos in storage Article 4.3.3 does not apply to pre-implantation embryos No contractual claim or implied agreement between Mr & Mrs R Apothecaries' Hall - 7 March 2015

Property Interests and Control (9)

• Hardiman J:

“There has been a marked reluctance on the part of the legislature actually to legislate on these issues: the court simply draws attention to this. That is all it can do.

… If the legislature does not address such issues, Ireland may become by default an unregulated environment for practices which may prove controversial or, at least, to give rise to a need for regulation.”

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Property Interests and Control (10)

Evans v Amicus Healthcare Ltd & Ors (Court of Appeal, 2003): • •

Article 2 ECHR (the right to life)

High Court (Wall J):

“There is no property in an embryo, but in contrast to a foetus, both gamete donors have an interest in, and rights over, the embryos they have created … The embryo, however, cannot be considered a person, or to have a qualified right to life.”

Court of Appeal:

“In our domestic law it has been repeatedly held that a foetus prior to the moment of birth does not have independent rights or interests. Thus even more clearly can there be no independent rights or interests in stored embryos.” “Article 2 protects the right to life. No convention jurisprudence extends the right to an embryo, much less to one which at the material point of time is non viable.”

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Pre-implantation Genetics

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Pre-implantation Genetics (1)

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Pre-implantation Genetics (2)

• • • September 2001 Application by CARE to treat Hashmis November 2001 HFEA agrees restrictive policy on tissue typing, distinguishing between cases where risk to future child, and those without February 2002 HFEA Licence Committee

grants

licence to CARE to treat Hashmis Apothecaries' Hall - 7 March 2015

Pre-implantation Genetics (3)

Paragraph 1(1)d of Schedule 2 of 1990 Act allows HFEA to issue treatment licences for:

“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”

using the definition of treatment services in Section 2(1):

“medical, surgical or obstetric services provided to the public or a section of the public for the purpose of assisting women to carry children”

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• • • • •

Pre-implantation Genetics (4)

12 July 2002 CORE granted permission to judicially review Hashmi decision July 2002 HFEA Licence Committee

refuses

licence to ARGC to treat Whitakers December 2002 CORE judicial review succeeds at first instance – HFEA not empowered to licence tissue typing May 2003 Court of Appeal overturns first instance decision September 2004 HFEA Licence Committee

grants

licence to ARGC to treat Fletchers Apothecaries' Hall - 7 March 2015

Pre-implantation Genetics (5)

“Our inquiry has tried to focus on the legislative and regulatory needs of the future, yet its policy and licensing decisions on PTT have undermined our confidence in the HFEA’s understanding and/or use of the law … The development of the HFEA’s policy and licensing decisions on preimplantation tissue typing has been highly unsatisfactory. We share the Chair’s contentment with its current policy and agree that revised legislation must make it clear that preimplantation genetic diagnosis and preimplantation tissue typing can be undertaken within legal restraints.”

House of Commons Science and Technology Select Committee (2005) Apothecaries' Hall - 7 March 2015

Research

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mtDNA Research (1)

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Normal mtDNA

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Normal mtDNA Abnormal mtDNA

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Enucleation Normal mtDNA Abnormal mtDNA Pronuclei removed

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Enucleation Normal mtDNA Abnormal mtDNA Pronuclei removed

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Enucleation Normal mtDNA Abnormal mtDNA Pronuclei removed Normal mtDNA Parents pronuclei

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• • • •

mtDNA Research (7)

May 2004 Licence application from Newcastle University to study methods to prevent transmission of mtDNA disorders September 2004 HFEA

refused

to grant a licence November 2004 HFEA

granted

licence after hearing representations 2008 1990 Act amended to address mtDNA research, and to give Secretary of state regulation-making powers Apothecaries' Hall - 7 March 2015

• • • •

mtDNA Research (8)

May 2010 Nature paper and presentation to HFEA Scientific and Clinical Advances Advisory Committee – confirmed the further safety and efficacy investigations required June 2010 Discussed at HFEA Horizon Scanning meeting in Rome

November 2010 Formal request for Secretary of State to exercise regulation-making power

February 2011 Secretary of State commissions HFEA to assess safety and efficacy Apothecaries' Hall - 7 March 2015

• • • •

mtDNA Research (9)

April 2011 1 st HFEA Scientific Review: not unsafe, but recommended further research to provide safety data September 2012 HFEA public consultation March 2013 2 nd HFEA Scientific Review: further safety and efficacy studies needed February 2014 Government consultation on draft Regulations: positive Apothecaries' Hall - 7 March 2015

• • •

mtDNA Research (10)

June 2014 3 rd Scientific Review: not unsafe, though more experiments to do February 2015 House of Commons and House of Lords pass Regulations 4 March 2015 Minister signs Regulations Apothecaries' Hall - 7 March 2015

The Welfare of the Child

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Welfare of the child (1)

Section 13(5): “

A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for supportive parenting), and of any other child who may be affected by the birth.”

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Welfare of the child (2)

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Welfare of the child (3)

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Welfare of the child (4)

• 52 year old female, educated to PhD level, independent means, UK residence and various holiday homes, no previous children • Male Partner 42, consultant cardiologist, teenage children from previous relationship, underwent vasectomy aged 35 • Able to fund treatment Apothecaries' Hall - 7 March 2015

Welfare of the child (5)

• • • • • • Female age 39, head teacher, fit and well Male aged 42, banker in receipt of large bonuses Neither partner has children Male has been questioned twice in the last 5 years in relation to the possession of child pornography but no charges have yet been made.

Also questioned, aged 21 in relation to an assault on a minor Able to fund own treatment Apothecaries' Hall - 7 March 2015

Welfare of the child (6)

• • • • • Female aged 36, one child aged 7 from current relationship Underwent radical abdominal surgery, colostomy, fed by tube, has been warned that pregnancy would give rise to a 50% chance of serious illness or death Male partner aged 38, fit and well Female partner is main carer for existing child Able to fund treatment Apothecaries' Hall - 7 March 2015

Welfare of the child (7)

• • • • • Female aged 29; fit and well, no children Male partner aged 34, no children Female partner has informed clinic that male partner has assaulted her regularly over a 5 year period and that the police have been involved more than once: female partner has been admitted with broken ribs and a dislocated jaw following one assault, but has refused to press charges Couple have separated twice, but say they are now committed to each other – male partner claims to have turned over a new leaf, and believes he deserves a fresh start Couple unable to fund their own treatment but eligible for NHS funds Apothecaries' Hall - 7 March 2015

A Right to a Child?

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Restrictions on Funding

• • • 2011 All Party Parliamentary Group on Infertility Report: • • • • 70% of PCTs ignoring NICE Guidelines Guidelines never fully implemented across NHS Not prepared for

“…the existence of so many conditions and restrictions that are placed upon infertile couples even in PCT areas that offer IVF treatment”

2012 NIAC Report: Around ⅓ women entitled to receive IVF incorrectly denied by GP • • NICE Guidelines positive but not mandatory CCG’s retain discretion, subject to equality and non-discrimination requirements Courts reluctant to intervene in re scarce resource allocation Apothecaries' Hall - 7 March 2015

Restrictions on Access to Treatment

.

.

Unavailable

Prohibitions of certain procedures Regulatory restrictions Licence conditions Professional regulation Duties of care Common law duties Restrictions on funding

Unrestricted

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• • •

ARGC v HFEA (1)

HFEA Code of Practice (5 th Edition, 2001):

“No more than three eggs or embryos should be placed in a woman in any one cycle, regardless of the procedure used."

H sought treatment with more than 3 embryos HFEA refused:

“The Authority did not agree that in this patient's case the transfer of more than 3 embryos in one treatment cycle would significantly increase the chances of a live birth without a more than negligible increase in the risk of a higher order multiple pregnancy. Accordingly, the Members did not feel that this case could be regarded as an exception justifying departure from the guidance in the Code of Practice.”

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ARGC v HFEA (1) contd.

• Court of Appeal:

“Disagreements between doctors and scientific bodies in this pioneering field are inevitable. The UK, through the [1990] Act, has opted for a system of licensing and regulation. The HFEA is the body which is empowered by parliament to regulate. Like any public authority, it is open to challenge by way of judicial review, if it exceeds or abuses the powers and responsibilities given to it by parliament; but where, as is manifest here from an examination of the facts, it considers requests for advice carefully and thoroughly, and produces opinions which are plainly rational, the court, in our judgment, has no part to play in the debate, and certainly no power to intervene to strike down any such decision. The fact that the appellants may disagree with the Authority's advice is neither here nor there.”

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ARGC v HFEA (2)

• May 2011 – HFEA agreed to vary all licences by adding: • • • • T123: The Centre must not exceed the maximum multiple birth rate specified by Directions.

Only Licence Condition of its kind Breach of a Licence Condition may be a basis for licence revocation Any clinic may make representations in relation to a proposed variation Potentially significant impact on clinical decision making Apothecaries' Hall - 7 March 2015

ARGC v HFEA (2) contd.

• • • • • • Clinic’s submissions: Not a challenge to policy or targets – only to condition Condition was unnecessary – sector complying well according to HFEA Clear that eSET not suitable for all patients – should be considered on a case by case basis Interference with clinical judgment – right clinical decision should not be retrospectively punished Improper exercise of regulatory power Unworkable Apothecaries' Hall - 7 March 2015

ARGC v HFEA (2) contd.

HFEA’s submissions:

true “[A] firmer regulatory approach was both necessary and proportionate. It is … that at the time of introducing the licence condition the sector had been largely compliant. But it is the duty of a responsible regulator to anticipate the are faced with challenges ahead and meet those challenges before you widespread noncompliance.” “… as for the Code of Practice, it is accepted that … a failure to observe the Code of Practice can be taken into account when considering whether to vary or revoke a licence. But that’s the most that can be done. It’s a factor to take into account. Whereas, in comparison, a licence condition does give you a concrete requirement against which you can enforce. And a failure to comply with a licence condition can lead to a revocation of the licence by the authority. So in that sense it’s a much more clear and robust means of enforcing compliance with the targets.”

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ARGC v HFEA (2) contd.

“In my judgment the defendant has no power to impose a condition which takes effect on a licence prior to completion of the full statutory process up to and including the appeal process provided for in section 20 of the 1990 Act.”

(Mrs Justice Patterson, 18 October 2013) Apothecaries' Hall - 7 March 2015

Natallie Evans

• Article 12 ECHR (the right to marry and found a family)

“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.”

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Dickson v UK

• • • • Secretary of State refused request for access to donation insemination services Judicial Review in UK was unsuccessful Complained to ECtHR of violations of Articles 8 and 12 • • • • Held: Prisoners do not lose Convention rights merely because of incarceration, or to satisfy public opinion Legitimate to take account of the welfare of the child Requirement of ‘exceptional circumstances’ too high Violation of Article 8 Apothecaries' Hall - 7 March 2015

Conclusions

• • • • • Patients very rarely have an unrestricted right to treatment The law has never recognised ‘a right to a child’ A positive right to a child would necessarily extend beyond IVF and become unworkable Access may be qualified and/or restricted by clinical, regulatory, legal, professional, and financial elements Clinic staff need to ensure compliance with a range of duties whilst also respecting rights, interests and particular circumstances of patients – and of prospective children Apothecaries' Hall - 7 March 2015

Legal Information

• • • The information in this presentation is provided for information purposes only.

The information is not exhaustive. While every endeavour is made to ensure that the information is correct at the time of publication, the legal position may change as a result of matters including new legislative developments, new case law, local implementation variations or other developments. The information does not take into account the specifics of any person's position and may be wholly inappropriate for your particular circumstances.

The information is not intended to be legal advice, cannot be relied on as legal advice and should not be a substitute for legal advice.

Unless otherwise stated, the information is limited to the position in England and Wales.

Copyright: Lawford Davies Denoon Ltd retains copyright in the material and all rights are reserved. None of the information may be copied (whether in whole or in part).

Apothecaries' Hall - 7 March 2015

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