Confidentiality in Disarray: Should Doctors in Ireland Disclose Genetic Information to Patients' Relatives?

• Date: 01 January 2020

22

Condentiality in Disarray: Should Doctors

inIreland Disclose Genetic Information to

Patients’ Relatives?

SARAH KELLY*

A. Introduction

Genetic information challenges the boundaries of the doctor-patient relationship

in a unique and unprecedented manner. Such medical developments pose complex

questions as to whether doctors should disclose a patient’s genetic information

to relatives, whether genetic data ‘belongs’ to the individual and as to why

condentiality of genetic information is justied. e capabilities of genetic testing

and diagnoses are evolving rapidly,1 enhancing the lives of patients whilst creating

ethical and legal dilemmas for the medical profession.

A core element of the therapeutic relationship is condentiality.2 Recent litigation

before the UK courts, ABC v St George’s Healthcare NHS Trust (‘ABC ’),3 highlights

the tensions caused by the shared nature of genetic information, which may have

implications for relatives of the proband.4 e growing prevalence of genetic

medicine suggests that such conicts will intensify in medical practice, and are

likely to be encountered by doctors in Ireland and further aeld.

is article seeks to respond to issues raised by the clash of interests in genetic

information. It will argue that a patient’s relatives have a right to be informed of

genetic conditions which may aect them. It further proposes that this would be

achieved by introducing a qualied duty, which obliges doctors to disclose genetic

* B.C.L.F. (UCC), LL.M. (LSE). e author would like to thank Professor Emily Jackson O.B.E.

for her advice and encouragement in writing about this subject, and Julia Hagan for her invaluable

comments on previous dras.

1 e largest clinical sequencing project in the world, Genomics England’s 100,000 Genomes Project,

is currently being undertaken in the UK and aims to create a new genomic medicine service for the

NHS. See further: Genomics England, ‘e 100,000 Genomes Project’

co.uk/the-100000-genomes-project> accessed 3 April 2020. See also: National Institute of

Neurological Disorders and Stroke, ‘Huntington’s Disease: Hope rough Research .ninds.

nih.gov/disorders/patient-caregiver-education/hope-through-research/huntingtons-disease-hope-

through> accessed 3 April 2020. Research is progressing towards nding a cure for Huntington’s

Disease.

2 Medical Council, Guide to Professional Conduct and Ethics for Registered Medical Practitioners (7th

edn, Medical Council 2009) 25.

3 ABC v St George’s Healthcare NHS Trust [2020] EWHC 455 (QB); ABC v St George’s Healthcare

NHS Trust [2015] EWHC 1394 (QB), [2017] EWCA Civ 336.

4 e aected individual through whom a family with a genetic disorder is ascertained.

Condentiality in Disarray 23

information to third party relatives. e key distinguishing feature of genetic

data is that it is capable of aecting, and predicting, the health of not only the

individual patient but other family members.5 e shared implications of such

data are juxtaposed with the individualistic concepts of condentiality and patient

autonomy, which dominate medical law.6 Unfortunately the Medical Council has

yet to address the dynamics created by genetic information. Consequently, without

guidelines on how to apply the myriad of legal and ethical sources which bind the

duty of condentiality, doctors are undermined in their role. Reference will be

made to the law and professional guidance in the UK, which are more developed

than that of Ireland, and hence of strongly persuasive value.7

It is unfair to subject doctors to the ‘amorphous and ill-dened duty’8 of genetic

condentiality in the absence of appropriate guidance to make such decisions. e

purpose of this article is to clarify the role of the doctor in relation to disclosure.

It will argue that the Medical Council should regulate the disclosure of genetic

information, by rstly creating a suitably qualied duty to family members, and

secondly establishing a nuanced and transparent framework, in the form of

professional guidance, which doctors may reference to ascertain whether their

obligations to such relatives are engaged in clinical genetics.

While it is recognised that there are multiple potential interests in genetic

information (for example, employers and insurance rms), the scope of this article

is limited to the family milieu.9 e structure of this paper is as follows: Part B will

explore the role of condentiality in the context of genetic information. It will be

argued that the classical autonomy justication for condentiality is insucient to

prevent disclosure. e alternative rationale, utilitarianism, seeks to maximise the

health for the most number of people. is, it will be contended, favours disclosure

of genetic information to at-risk relatives; Part C will identify the sources which

should inform a framework for disclosure of genetic information. It will argue that

these instruments may be interpreted to support disclosure of genetic data in certain

circumstances, in the public interest. e principle of condentiality has been

drastically aected by recent developments in the law, including the introduction

5 Royal Colleg e of Physicians, Royal College of Pathologists, British Society for Human Genetics,

Consent and condentiality in clinical genetic practice: Guidance on genetic testing and sharing genetic

information (2nd edn, 2011) vi.

6 Graeme Laurie, Shawn Harmon and Edward J Dove, Mason and McCall Smith’s Law and Medical

Ethics (11th edn, OUP 2019) 107.

7 Niamh Connolly, ‘e Prospective and Retrospective Eect of Judicial Decisions in Ireland’ in Eva

Steiner (ed), Comparing the Prospective Eect of Judicial Rulings Across Jurisdictions (Springer 2015)

33. Due to the small nature of the state, in which relatively few cases are decided, the law on certain

issues (such as condentiality) is less developed than the UK. e English law is a particularly

persuasive authority in Ireland, due to similar cultural dynamics and shared common law heritage.

8 Graeme Laurie, Genetic Privacy: A Challenge to Medico-Legal Norms (CUP 2002) 3.

9 For discussion of alternate interests in genetic information see: Aisling de Paor, ‘Regulating Genetic

Information – Exploring the Options in Legal eory ’ (2014) 21 European Journal of Health Law

425.

24  

of the General Data Protection Regulation (‘GDPR’), an unprecedented decision

in Ireland, e Child and Family Agency v AA,10 which addressed a doctor’s duty of

condentiality and third parties, and the aforementioned ABC litigation; and Part

D will argue that the Medical Council should introduce a qualied duty to disclose

genetic information, to ensure that the appropriate balance is struck between the

patient’s right to condentiality and the health of aected relatives. It will further

outline the scope and factors which should inform such a duty.

B. Condentiality of Genetic Information

ere are both public and private interests in maintaining condentiality.11 is

section considers the unique nature of genetic information, which challenges the

traditional justications for doctor-patient condentiality. It will argue that the

distinct nature of such information is not congruent with the principle of patient

autonomy, and thus relies on utilitarian justications. is has implications for the

exceptions to condentiality, particularly disclosure to family members.

I. e Unique Nature of Genetic Data

Genetic information is simultaneously comparable with, and distinct from, other

health information.12 Both are revealed in a therapeutic setting and are personal

and sensitive in nature. Similar to genetic disorders, diagnoses of non-hereditary

conditions may indicate the presence of such a condition in another individual.13

Indeed, in ABC, Yip J rejected distinctions between genetic information and ‘other

information that reveals a risk to another’.14

However the distinctive features of genetic information suggest it should be

recognised as a separate category of health information.15 Genetic exceptionalism is

cumulatively justied.16 Not only does genetic testing of a patient reveal indicators

of an additional family member’s health, but also may imply the likelihood of future

health conditions. e predictive aspect of clinical genetics is a powerful medical

tool. Unlike infectious diseases, for example, ascertaining genetic information

10 e Child and Family Agency v AA & Anor [2018] IEHC 112 (‘CFA ’).

11 W v Egdell [1989] EWCA Civ 13.

12 For discussion of types and nature of genetic disease see: Laurie, Harmon and Dove (n 6) 202–

206.

13 Safer v Estate of Pack 677 A 2d 1188 (NJ Superior Court Appellate Division 1996). e Court

draws parallels between HIV and genetic conditions.

14 ABC [2020] (n 3) [184].

15 cf Lawrence O Gostin and James G Hodge Jr, ‘Genetic Privacy and the Law: An End to Genetic

Exceptionalism’ (1991) 40 Jurimetrics 21; Sonia M Suter, ‘e Allure and Peril of Genetic

Exceptionalism: Do We Need to Special Genetics Legislation?’ (2001) 79 Washington University

Law uarterly 669.

16 de Paor (n 9) 428.

Condentiality in Disarray 25

is not dependent on physical contact, as the proband and relatives are passive

recipients of biological factors. Awareness of risk may enable the proband’s relatives

to seek proactive treatment and inform their life choices, signicantly improving

their welfare.

While genetic exceptionalism is not expressly endorsed in professional guidance

or the law, the practice of sharing genetic information with family members is

encouraged17 and generally supported by patients.18 is paper is concerned with

the conicts which arise where the proband chooses not to do so. Consequently,

as the next section will explore, it is imperative to ‘recognise the limitations

of approaches which focus on the individual patient’.19 e unique nature of

genetic information aects the role of condentiality, a dynamic which Lowrance

characterises as the ‘quandary of genetic exceptionalism’.20

II. e Role of Condentiality

Condentiality protects the information we choose to share, based upon

expectations of trust and reliance in the doctor-patient relationship.21 e doctrine

predates genetic medicine, enshrined in the Hippocratic Oath. is section analyses

the distinction between the private and public interests in condentiality. It will

demonstrate that, in the context of clinical genetics, the public interest is more

persuasive due to the unique capabilities of such information. is, consequently,

alters the desired role of condentiality.

e principle of condentiality serves the patient’s fundamental right to privacy.22

ompson identies the three values implicit in condentiality as privacy, condence

and secrecy,23 each of which appeals to the patient’s interest in autonomy. It protects

the patient’s personal information, human dignity and choice.24 Essentially, the

principle of condentiality emphasises patient self-determination, by allowing the

patient to control the disclosure of their personal information. us the private

interest in autonomy strongly justies the protection of medical information.25

17 GMC, Condentiality: Good Practice in Handling Patient Information (GMC 2017) 36.

18 Sandi Dheensa, Angela Fenwick and Anneke Lucassen, ‘“Is this knowledge mine and nobody

else’s? I don’t feel like that” Patient views about consent, condentiality and information-sharing

in genetic medicine’ (2016) 42 Journal of Medical Ethics 174.

19 Royal College of Physicians (n 5) 2.

20 William W Lowrance, Privacy, Condentiality and Health Research (CUP 2012) 111.

21 Daniel J Solove and Neil M Richards, ‘Privacy’s Other Path: Recovering the Law of Condentiality’

(2007) 96 e Georgetown Law Journal 123, 125.

22 Lowrance (n 20) 33.

23 Ian E ompson, ‘e Nature of Condentiality’ (1979) 5 Journal of Medical Ethics 57, 57.

24 Deirdre Madden, ‘Empowering Health Information: Medico-Legal Issues’ (2002) 8 Medico-Legal

Journal of Ireland 7, 11.

25 Patient autonomy is increasingly protected in modern healthcare. See: Montgomery v Lanarksire

Health Board [2015] UKSC 11.

26  

Yet, despite protecting private interests, condentiality appeals to broader societal

values and is ultimately maintained in the public interest.26 e principle promotes

health by encouraging those who require medical care to seek assistance.27

It facilitates trust between the doctor and patient on the basis that sensitive

information will not be revealed.28 is, in turn, enhances eective treatment by

ensuring that doctors are equipped with the requisite information. e utilitarian

function of condentiality, namely improving the health and welfare of society, is

imperative to the public interest.29

Genetic disorders should not be perceived as being merely of private concern. While

transmitted vertically and within the family, such disorders also possess a public

dimension: impact on society; consequential human suering; and economic

burden.30 As Bingham J noted in W v Egdell, condentiality may be overridden by ‘a

stronger public interest in disclosure’.31 ere is clearly a public interest in mitigating

the negative consequences of genetic disorders for the individual and society. By

examining the underlying rationales for the public and private interests in genetic

condentiality, it is clear the unique nature of genetic information aects the dynamics

of doctor-patient condentiality.32 Before exploring the relevant law, it is necessary to

consider the desired role of condentiality in relation to genetic information.

III. ualied Condentiality of Genetic Information

Both the private interest in autonomy and the utilitarian public interest provide

strong justications for protecting health information through the medium of

condentiality.33 Genetic information diers from other medical data, as do the

correlated rationales for maintaining, or breaching, condentiality. e role of

autonomy is contested by the distinctive nature of genetic data. ere are therefore

persuasive reasons for modifying the application of condentiality in the genetic

context, by reference to the public interest.

Traditional medical practices tend to perceive the individual patient to the

exclusion of all others.34 is version of condentiality was relied upon by the

26 W v Egdell (n 11).

27 Taraso v Regents of the University of California (1976) 551 P 2d 334.

28 W v Egdell (n 11).

29 Charles Ngwena and Ruth Chadwick, ‘Genetic Diagnostic Information and the Duty of

Condentiality: Ethics and Law’ (1993) 1 Medical Law International 73, 75.

30 Janet A Kobrin, ‘Condentiality of Genetic Information’ (1983) 30 UCLA Law Review 1283,

1312.

31 W v Egdell (n 11).

32 Conversely, the highly sensitive nature of genetics information, and its interpretative capabilities,

for the individual patient may be identied as exactly the type of data which ought to be protected

by in the doctor-patient relationship.

33 Laurie, Genetic Privacy (n 8) 214.

34 Royal College of Physicians (n 5) 1.

Condentiality in Disarray 27

Defendants in ABC (discussed below) whereby genetic information, like other

health information, was argued to pertain uniquely to the patient.35 e obstacle

presented by this perception, of genetic information ‘belonging’ to the patient,

is that protecting the patient’s private interest in autonomy directly aects the

autonomy of relatives, who are therefore ill-equipped to make their own informed

health choices. As such, Ngwena and Chadwick assert that a patient’s autonomy

does not justify protecting genetic information, due to the signicant consequences

for the autonomy of others.36 Autonomy is predicated on the perception of the

individual as the ‘moral chooser’.37 Yet, in the context of clinical genetics, the

consequences of non-disclosure are particularly severe, especially in relation to

conditions which are not yet physically visible. erefore the autonomy of one

patient should not necessarily supersede the autonomy of another.

It is within the space created by the aws of the autonomy rationale for genetic

condentiality that the concept of ‘relational autonomy’ provides an alternative

response. It envisages the development of patients’ autonomy ‘through social

embeddedness and engagement with others; recognising the impact of one

person’s choice on the autonomy of others’.38 is paper argues that the utilitarian

underpinnings of genetic condentiality favour a relational approach which entails

utilising such information to benet the optimal number of people.

e maxim of utilitarianism is welfare, which strives to bring the greatest good

(or health) to the greatest number of individuals.39 Condentiality achieves this

by, as outlined, encouraging patients to seek medical care. However in the context

of clinical genetics, the question arises as to whether health is best served by

protecting the individual patient, or sharing such information to benet others. In

the absence of autonomy as a decisive factor, taking into account the benets of

limited disclosure, condentiality should be qualied to improve the health of the

family unit.

Recognising the familial implications of genetic information requires reinterpreting

condentiality, through a utilitarian lens, to include a social dimension.40 To justify

disclosure in the public interest, transparency, proportionality and acceptability are

essential.41 Indeed, the Medical Council recognises exceptions to the principle in

35 Roy Gilbar and Charles Foster, ‘Doctors’ Liability to the Patient’s Relatives in Genetic Medicine’

(2015) 24 Medical Law Review 112, 115.

36 Ngwena and Chadwick (n 29) 76–77.

37 Graeme Laurie, ‘Recognising the Right Not to Know: Conceptual, Professional and Legal

Implications’ (2014) 42 Journal of Law, Medicine and Ethics 53, 55.

38 Dheensa, Fenwick and Lucassen (n 18) 174.

39 Mark S Stein, ‘A Utilitarian Approach to Justice in Health Care’ in Rosamund Rhodes, Margaret

Battin and Anita Silvers, Medicine and Social Justice: Essays on the Distribution of Health

(OUP2012) 47.

40 Roy Gilbar, ‘Communicating Genetic Information in the Family: e Familial Relationship as the

Forgotten Factor’ (2007) 33 Journal of Medical Ethics 390, 393.

41 Mark J Taylor, ‘Health Research, Data Protection, and the Public Interest in Condentiality’

(2011) 19 Medical Law Review 273.

28  

certain circumstances: for the prevention of crime; to reduce exposure to serious

communicable diseases; and where failure to do so may expose others to a risk of

death or serious harm.42 A further specic category should be introduced, that of

genetic information.

Ireland provides an example of a jurisdiction where modication of the existing

regime is required. e Medical Council is in an ideal position to adopt a

progressive and nuanced response to the improved capabilities of genetic testing.

Not only does individualistic condentiality clash with mutually shared interests

in genetic information, the consequences of such juxtaposition imply the erosion

of one of the foundational justications for maintaining condentiality: the private

interest in patient autonomy.

Condentiality is qualied by both moral and legal obligations. Despite its dynamic

and multifaceted nature, there is no overarching law or conclusive professional

guidelines on genetic condentiality but rather numerous instruments, which do not

provide a satisfactory framework to answer the question posed by this article. e

following section explores the legal obligations of doctors who are confronted with

the decision of whether to disclose genetic information, and how such instruments

may be perceived to support the disclosure of information to family members.

C. Disclosure to ird Parties: Identifying the Correct Approach

e principle of condentiality and its underlying justications are not absolute.43

e principle is translated into modern terms by the Declaration of Geneva and

the Medical Council Guidelines.44 It is imperative that professional guidance

disentangles the complex web of ethical and legal sources which doctors are subject

to.45 ere is an array of legally binding sources. In particular, the common law

and data protection have evolved signicantly in recent years, underlining the

increasing pressure caused by conicting medical duties. e following discussion

explores the contextual and legal considerations which inform the disclosure of

genetic information, and the regulation thereof.

I. e Unenumerated Constitutional Right to Privacy

e instruments which directly aect condentiality, considered below, must be

applied in the context of the Irish Constitution, which enshrines an unenumerated

right to privacy.46 In Kennedy v Ireland, Hamilton P held that the right to privacy is

42 Medical Council (n 2) 27.

43 Emily Jackson, Medical Law: Text, Cases, and Materials (5th edn, OUP 2019) 468. Jackson posits

that ‘in a wide range of situations, the duty to respect condentiality is suspended or modied.’

44 Madden (n 24) 13; Medical Council (n 2).

45 Ngwena and Chadwick (n 29) 90.

46 Bunreacht na h’Eireann, Article 40.

Condentiality in Disarray 29

a fundamental personal right, which is qualied by the common good and subject

to public order and morality.47 While there has been no express consideration by

the courts as to whether this dictum extends to condentiality, Mills and Mulligan

assert that the ‘constitutional dimension to specically medical condentiality…can

hardly be doubted.’48 Indeed, this assertion was accepted by the Irish High Court

in Rotunda Hospital v Information Commissioner,49 which set out that the ‘common

good’, which qualies the unenumerated constitutional right, is synonymous with

the public interest. While the Constitution aords protection to condentiality,

it will yield in certain circumstances to protect alternative interests. Similarly, the

common law contains analogous limitations in the public interest.

II. Disclosure to Prevent ‘A Risk of Very Serious Harm or Death’

It is principally the common law duty, interpreted in light of broader obligations,

which inuences the disclosure of condential information.50 us the importance

of the CFA decision which addressed doctor-patient condentiality and duties to

third parties is signicant. e Irish High Court held that disclosure of condential

information may be justied to mitigate the risk of death or very serious harm.51

In CFA , the Court was presented with an unprecedented occasion to identify

the circumstances in which a doctor may breach the duty of condentiality for

the benet of a third party. e case did not concern genetic information, but

rather the HIV status of the Defendant. e CFA alleged that the Defendant (a

minor who was born with HIV) was having sexual intercourse with a girl who

was also underage and unaware of his condition. Drawing on UK and Strasbourg

jurisprudence, the Court adopted a reserved approach and found that, in the

particular circumstances, there was no duty to disclose such information to the

third party. It held that the test for breach of doctor-patient condence is whether

‘on the balance of probabilities, the failure to breach patient condentiality creates

a signicant risk of death or very serious harm to an innocent third party’.52 is

mirrors the UK General Medical Council (‘GMC’) guidance, which states that

disclosure of health information, in the absence of consent, may be justied in the

public interest if failure to disclose such information leaves others at risk of death

or serious harm.53

47 [1987] IR 587.

48 Simon Mills and Andrea Mulligan, Medical Law in Ireland (3rd edn, Bloomsbury 2017) 88.

49 [2009] IEHC 315.

50 Victoria Chico and Mark J Taylor, ‘Using and Disclosing Condential Patient Information and

the English Common Law: What Are the Information Requirements for Valid Consent?’ (2017)

26 Medical Law Review 51, 52.

51 CFA (n 10) [73].

52 CFA (n 10) [73].

53 GMC (n 17) 37.

30  

As the sole judicial authority on disclosure of health information to third parties

in Ireland, the CFA test is indicative of the Court’s potential approach to the

disclosure of genetic data. However, it is contended that the test should not be

applied unilaterally to assess disclosure in the context of genetics, as it does not

account for the distinctive nature and implications of such information. Indeed,

the Court asserted that the ‘high bar to disclosure’ was signicant ‘particularly in

relation to preventing the spread of communicable diseases,’54 thus implying scope

for the test to be altered in alternative contexts.

ere are multiple aspects of the CFA test which do not align with the unique

nature of genetic information. Firstly, the risk of developing the condition is not

‘created’ by a doctor choosing to maintain condentiality, but as a result of natural

biological factors. erefore the harm must be perceived as, not the disorder

itself, but the lack of early access to treatment and self-determination. Causation

may be particularly dicult to establish in this context due to the multi-factorial

nature of genetic conditions and the absence of concrete evidence as to how the

claimant ‘would have acted’. us Gilbar contends that relatives may struggle to

prove causation, as the claim would ‘be classied as a failure-to-warn’ or as a ‘loss-

of-chance’ type of case.55 Additionally, the threshold for breaching condence is

somewhat ambiguous. While the risk of death certainly amounts to a ‘compelling

circumstance,’56 the criterion of ‘very serious harm’ is open to interpretation in the

context of genetics. Here the Court suggests that the harm must be balanced with

the interest in privacy, the individual third party at risk and the ‘public interest

in ensuring that the public at large’ has condence in the medical profession to

disclose sensitive details.57 It is argued that this tri-dimensional balancing exercise

is not directly applicable to genetic information, as it omits the public interest in

furthering health and welfare by disclosure of such data.

Despite the explicitly high threshold, the reference to ‘unsuspecting members of

the public’ suggests that the CFA test could be favourable to relatives,58 who are

passive recipients of genetic disorders. Unlike the third party in CFA, who Twomey

J found to have assumed ‘a certain degree of risk’ by engaging in unprotected sexual

intercourse,59 relatives of the proband do not actively aect the inheritance of

genetic conditions.

e decision further indicates that risk may be a relevant factor when considering

disclosure of genetic information. Ngwena and Chadwick posit that while risk is

54 CFA (n 10) [72].

55 Roy Gilbar ‘e Passive Patient and Disclosure of Genetic Information: Can English Tort Law

Protect the Relatives’ Right to Know?’ (2016) 30 International Journal of Law, Policy and the

Family 79, 94.

56 W v Egdell (n 11).

57 CFA (n 10) [74].

58 ibid [69].

59 ibid [71].

Condentiality in Disarray 31

not usually referred to in judgments, it is nonetheless an implicit factor,60 providing

an element of objectivity. e High Court found that there was a 0.04% chance of

HIV transmission where appropriate medication was taken, a level of risk it deemed

acceptable. is may be compared with genetic conditions, which to a certain

degree, present less variables than reliance on a minor’s ability to consistently take

medication. e hereditary condition of Huntington’s Disease (‘HD’), at issue in

ABC, carries a 50% chance of inheritance and thus a greater risk of likelihood to

cause harm. In contrast with HIV, there is no treatment.61 A further comparison

may be derived from the seminal USA case of Taraso v Regents of University of

California, which concerned a patient who disclosed his intention to kill an

identied third party.62 Here the risk analysis is also less reliable than in the genetic

context, where the likelihood is based partly on scientic evidence rather than

wholly medical opinion. It follows that the basis for disclosure in genetics would be

signicantly higher than in either the Taraso or CFA scenarios. However the rule

does not account for the nuances of genetic conditions, particularly where a third

party is at high risk, but there is no cure available.

Ultimately, the threshold established in CFA is ill-suited to clinical genetics,

compounded by issues of the identied harm and causation. Nonetheless there

are certain aspects of the judgment which should inform the regulation of the

disclosure of genetic information. is will be discussed in further detail below, in

relation to a proposed framework of obligations.

Applying the CFA rationale to genetic information highlights the ‘inevitable

tension between an individualistic model of condentiality’ and the ‘inherently

shared nature’ of clinical genetics.63 e case is suggestive of the Irish courts’

reserved and cautious approach to relaxing the principle of condentiality. It

does arm that, in certain circumstances, it is legally permissible to breach

condentiality and conrms that the public interest is a key factor in arriving at

such a decision. Whereas UK courts have directly considered the disclosure of

genetic information, the absence of regulatory response in this jurisdiction renders

the health care professionals in an ‘unsatisfactory state of legal limbo’.64

III. e ABC [2020] Case: A Duty to Undertake a Balancing Exercise

While Ireland lacks authority on disclosure of genetic information to relatives,

the English High Court recently grappled with the subject in ABC v St George’s

Healthcare NHS Trust [2020]. e case illustrates the impact of tort law on

60 Ngwena and Chadwick (n 29) 82.

61 HD is a hereditar y condition, with a 50% chance of transmission. It is a degenerative condition for

which there is, as of yet, no cure available. See also (n 1).

62 Taraso (n 27).

63 Jackson (n 43) 477.

64 ibid 480.

32  

policy. Dove argues that this is not the correct medium to tackle the social policy

issues raised by the evolving importance of genetic information.65 However the

considerable inuence of negligence claims in medical practice and the breadth

attributed to policy considerations by the third limb of the Caparo test for creating

a novel duty of care cannot be disregarded.66 It is likely that ABC will have profound

implications for healthcare professionals in Ireland.67 Signicantly, the High Court

recognised a common law duty to take into account the interests of third parties,

in certain limited circumstances, in relation to condential genetic information.68

As noted by Nicols J, at rst instance, the facts of ABC are both brief and tragic.69

e patient was the Claimant’s father. Despite encouragement from the hospital,

he refused to disclose his genetic condition (HD) to his daughters. e Claimant,

who was pregnant at the time of diagnosis, was partaking in family therapy with

the doctors and her father to come to terms with her mother’s death. e clinicians

discussed informing the daughter, but decided upon respecting the patient’s right

to condentiality. However a doctor accidentally revealed the father’s condition

to the Claimant, who subsequently brought two claims against the hospital;

arguing that the doctors owed her a tortious duty of care and that failure to share

her father’s diagnosis breached her right to private life under Article 8 of the

European Convention on Human Rights (‘ECHR’). Consequently, the High

Court approached the issue of disclosure of genetic information from a tort law

perspective (asserting that Article 8 did not strengthen the claim).70

e claim was struck out at rst instance, however the Court of Appeal held

that the claim was ‘arguable’ and remitted the case for a full trial. e key issue

for determination by the High Court was whether it should recognise a novel

duty of care towards the Claimant. To establish an entirely novel duty of care to

the relatives of the proband, the Claimant was required to demonstrate the three

cumulative elements of the Caparo test: the harm must be reasonably foreseeable as

a result of the doctor’s conduct; there must be a relationship of proximity between

the claimant and defendant; and it would be fair, just and reasonable to impose

such a duty.71 Mitchell et al assert that the third limb provides the greatest scope for

argument in relation to a potential duty of care to genetic relatives.72

65 Edward S Dove, ‘ABC v St George’s Healthcare NHS Trust and Others: Should there be a right to

be informed about a family member’s genetic disorder?’ (2016) 44 Law and the Human Genome

Review 91, 93.

66 Caparo Industries plc v Dickman [1990] 2 AC 605.

67 Connolly (n 7) 33.

68 ABC [2020] (n 3) [189].

69 ABC [2015] (n 3) [1].

70 ABC [2020] (n 3) [254]. See also: Mills and Mulligan (n 48) 85. While the common law exerts

particular inuence on the doctrine of condentiality, it is important to note that it represents one

aspect of a doctor’s obligations.

71 Caparo (n 66).

72 Colin Mitchell and others, ‘A Duty to Warn Relatives in Clinical Genetics: Arguably “Fair Just and

Reasonable” in English Law’ (2016) 32 Journal of Professional Negligence 120, 122.

Condentiality in Disarray 33

Having addressed the rst two limbs of the test, Yip J held that it was fair, just

and reasonable to impose a legal duty on healthcare professionals to carry out a

balancing exercise between the interests of the patient and the aected third party,

and to act on the outcome of such considerations.73 Such a duty will be discharged

where this assessment is conducted in accordance with professional guidance. It

does not oblige disclosure of genetic information, but rather imposes a duty to

consider the competing interests in such data.74

While ABC represents a step towards the alignment of the law and GMC guidance,

the Court’s narrow focus will arguably have limited impact on disclosure of genetic

information to third parties. is is evident in the required degree of proximity

between the parties75 and the ‘considerable latitude’ aorded to clinicians in such

circumstances.76 Such proximity may prove a tenuous aspect of future cases, where

the aected party is not a patient, or in contact with the doctor, but is aected

by such information. Noticeably, the Court in CFA did not limit the scope of the

duty of care to an identiable third party.77 However, in the context of genetics, the

‘proximity’ requirement is a powerful tool in elucidating the appropriate scope for

the doctor’s responsibilities, discussed below. Similar to CFA , the concept of ‘harm

as a result of the doctor’s conduct’ does not refer to the genetic disease itself but

rather the damage caused as a result by a lack of requisite information to make fully

informed decisions. Such data may enable family members to seek preventative

measures or treatments that they would otherwise not have known to access.78 As

previously outlined, causation in such circumstances may be dicult to establish

depending on the facts. e Claimant in ABC argued that the doctors owed her

a duty of care to provide her with information relating to her father’s diagnosis

of HD to enable her to make decisions in relation to her reproductive rights, but

failed to establish a breach of duty or causation.

In Smith & Anor v University of Leicester NHS Trust, McKenna J held that a

doctor’s duty of care does not extend to the patient’s second cousins in relation to

genetic information.79 e distance between the parties was greater in a physical

sense and in terms of awareness of existence than in ABC.80 is approach to the

relationship of proximity is plausible. First degree relatives (such as siblings and

next of kin) present the highest likelihood of genetic similarity and therefore have

73 ABC [2020] (n 3) [189].

74 ibid [193].

75 ibid [196].

76 ibid [193].

77 is may be due to the manner by which HIV is transmitted, which requires physical contact, thus

facilitating identication of aected parties.

78 Anneke Lucassen and Roy Gilbar, ‘Alerting Relatives about Heritable Risks: e Limits of

Condentiality’ (2018) 361 BMJ 1409, 1410.

79 [2016] EWHC 817 (QB).

80 Colin Mitchell and others, ‘Exploring the potential duty of care in clinical genomics under UK

law’ (2017) 17 Medical Law International 158, 177.

34  

the strongest interests in accessing genetic information.81 As such, the introduction

of a new obligation to genetic relatives should be limited to rst degree relatives.82

Turning to the third element of the Caparo test, whether it would be fair, just

and reasonable to impose the novel duty, Yip J conned her considerations to the

present case by asserting it is not for the Court ‘to attempt to dene the limits of

any duty of care’ owed by doctors to third parties.83 us the High Court did not

focus on the broader policy arguments, as raised in the Court of Appeal. Chico

identies three overarching concerns in relation to the proposed duty: the impact

of such a duty on the doctor-patient relationship of trust and condence; doctors

would have no way of knowing who should be informed and would thus be exposed

to extra liability; and that cumulatively these concerns would be burdensome on

doctors, resources and time.84 Undoubtedly the consequences of the ABC decision

will impact the role of health care professionals.

e social dimension of the third limb of the novel duty test appeals to the public

interest. Unfortunately, the balancing exercise proposed by Yip J does not account

for this public interest in disclosure, or indeed the utilitarian values which inform

the role of condentiality in the context of genetics. Rather, the Court considered

the issue exclusively within the boundaries of the doctor-patient relationship,

omitting the ‘views of the ordinary people’.85 While Gilbar and Foster argue that

the Court of Appeal adopted a relational autonomy approach by acknowledging

the implications of a decision made by one individual on signicant others,86 it did

not wholly endorse disclosure to members of the family unit in the public interest.

Similarly, while not emphasising the public interest, the High Court recognised a

common law duty, which runs ‘parallel’ to the professional obligations enshrined in

GMC guidance and aligns with the traditional standard of care principles.87

is article argues that the public interest is reected by ‘progressive familial

interpretation’, as endorsed by professional guidance and in genetic clinical

practice, rather than reliance on autonomy and individualistic perceptions.88 While

the High Court in ABC relies on such guidance and attempts to account for the

realities of clinical genetics, it does so by juxtaposing conicting private interests

in the absence of public interest considerations and values. Arguably, the latter

elements are imperative in the evolution of the doctor-patient relationship.

81 Laurie, Genetic Privacy (n 8) 121.

82 Michael Fay, ‘Negligence, Genetics and Families a Duty to Disclose Actionable Risks’ (2016) 3

Medical Law International 115, 134.

83 ABC [2020] (n 3) [163].

84 Victoria Chico, ‘Non-Disclosure of Genetic Risk: e Case for Developing Legal Wrongs’ (2016)

16 Medical Law International 3, 15.

85 ibid 16.

86 Roy Gilbar and Charles Foster ‘It’s arrived! Relational Autonomy Comes to Court: ABC v St

George’s Healthcare NHS Trust [2017] EWCA 336’ (2018) 26 Medical Law Review 125, 131.

87 ABC [2020] (n 3) [261]; Bolam v Friern Hospital [1957] 1 WLR 582; Bolitho v City and Hackney

Health Authority [1998] AC 232.

88 Chico (n 84) 20.

Condentiality in Disarray 35

Both CFA and ABC reect the evolution of the common law of condentiality

in recent years. While inuential, additional instruments play a signicant role in

the disclosure of genetic information. e following section analyses the GDPR,

which directly impacts the disclosure of genetic information, and should therefore

be taken into account by the professional guidance.

IV. e ‘Shared’ Personal Data Conundrum

Given the trend of digitalisation of health records systems, the most recent GMC

guidance on condentiality is GDPR orientated.89 is reects the increasingly

signicant role of data protection in medical practice, which aims to protect the

fundamental right to the protection of personal data.90 is explicitly includes

genetic data.91 e Regulation applies to the processing of personal data, which

encompasses data used in patient care92 and, importantly, the disclosure of

information to third parties.93 It characterises genetic information as sensitive

personal data, subject to stringent processing requirements.94

Despite the unequivocal inclusion of genetic information within the remit of the

GDPR, its application is questionable as it fails to comprehend the implications

of genetic data for multiple parties and the dynamics created by conicting

interests.95 e denition of personal data envisages that such information ‘relates’

to an individual, by content, purpose or eect.96 Under such a denition, genetic

information relates to multiple individuals, particularly by reference to the third

criterion. is clashes with the GDPR’s perception of the autonomous natural

person, to whom such data uniquely pertains.97 e tension between relational

autonomy and the focus on the individual data subject demonstrates that the

GDPR is one of several sources which informs the doctrine of condentiality,

rather than providing a panacea solution.

89 Catherine Stanton, ‘Patient Information: To Share or Not to Share?’ (2018) 26 Medical Law

Review 328. Similarly to the GMC, although in less depth, the Medical Council references the

relevance of the Data Protection Acts 2003–2018 (Ireland), see: Medical Council (n 2) 48.

90 GDPR , recital 1.

91 GDPR , article 4(13).

92 Becky McCall, ‘ What does the GDPR mean for the medical community?’ (2018) 391 e Lancet

1249, 1250.

93 GDPR , article 4(2).

94 GDPR , article 9(2).

95 Article 29 Data Protection Working Party, ‘Working Document on Genetic Data’ (2004) 1218/03/

EN WP 91, 9 mendation/

les/2004/wp91_en.pdf> accessed 3 April 2020. (‘Art 29 WP’). Art 29 WP recognised the

existence of ‘a new, legally relevant social … biological group’ which is not reected by the GDPR.

96 Article 29 Working Party, ‘Opinion 4/2007 on the concept of personal data’ (2007) 11.

97 Mark Taylor, Genetic Data and the Law: A Critical Perspective on Privacy Protection (CUP 2012) 7.

36  

While the GDPR may be of limited value in deciding whether to share genetic

information,98 it is an authoritative source on how such information should be

disclosed. It claries that in the absence of consent, disclosure may be acceptable for

medical purposes.99 e Information Commissioner’s Oce suggests that sharing

information in the absence of consent, which reveals information about another

individual, may be possible where it would be ‘reasonable’ to do so. is depends on the

type of information, the duty of condentiality and the relevance of express refusal.100

Where possible, such data should be anonymised to reduce the friction between

conicting interests, and protect the right to privacy of the patient.101 Disclosure must

comply with the data processing principles which require that the processing be lawful,

fair and transparent. It must further comply with the purpose limitation and disclose

the minimum amount of data possible. e doctor must demonstrate accountability,

and ensure the condentiality and integrity of such information where possible.102

Despite the inherent limitations of the GDPR in terms of balancing competing

interests in personal data, whether a data subject should be conceived as a ‘third

party’ and the consequences for the public interest,103 data protection law should

undoubtedly be included in a framework for the disclosure of genetic information

as it informs how sensitive data should be shared between parties. In addition to

the fundamental right to data protection, the ECHR must also be considered when

deciding whether to breach condentiality.

V. e Inuence of Human Rights

e ECHR does not contain an explicit right to condentiality.104 However the

ECHR supports the evolution in medical practice from the need for a condential

relationship, to ‘the underlying values that support respect for private life – values

based on privacy and personal autonomy’.105 Arguably, this extends to the rationales

which inform genetic condentiality, identied in Part B, and the disclosure of

such data. Article 8 protects the right to private and family life yet similar to the

Constitution, data protection and the common law, it contains limitations and is

thus far from absolute.106

98 Laurie, Harmon and Dove (n 6) 181.

99 GDPR, article 9(2)(h).

100 Information Commissioner’s Oce, ‘Right of Access’

guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/individual-

rights/right-of-access/> accessed 3 April 2020.

101 Data Protection Commissioner, ‘Guidance Note: Guidance on Anonymisation and Pseudonymi-

sation’ (2019) dataprotection.ie/sites/default/les/uploads/2019-06/ 190614%20

Anonymisation%20and%20Pseudonymisation.pdf> accessed 3 April 2020.

102 GD PR, article 5.

103 Art 29 WP (n 95) 8.

104 e Convention is incorporated into Irish law by the European Convention on Human Rights

Act 2003.

105 Laurie, Harmon and Dove (n 6) 173.

106 Mills and Mulligan (n 48) 89.

Condentiality in Disarray 37

Condentiality is, in eect, an extension of privacy.107 Despite the dismissal of

Article 8 in ABC as ‘an aerthought,’108 private life includes not only the right to

control personal information but also physical and moral integrity, and freedom to

develop one’s personality and relationships.109 e Court was ‘unconvinced’ that the

Convention adds to the common law, or could provide an alternative basis for the

action.110 us Yip J did not entertain the potential conceptual limits of privacy, but

rather noted that the interference with Article 8 was justied and proportionate.111

Gilbar and Foster argue that ABC presented an opportunity for the Court to

engage with Article 8 to promote ‘the important social goals of eliminating or

reducing risk of developing hereditary diseases and their consequential damage’.112

Indeed, the wording of Article 8 invites a more holistic consideration of disclosure

of condential information as the protections aorded by Article 8 are ‘reinforced

by other and wider considerations of the public interest’.113

In Z v Finland, the Strasbourg Court described ‘respecting the condentiality of

health data’ as a ‘vital principle’, crucial for maintaining condence in doctors.114

However it is possible that disclosure may be justied under Article 8(2).

Disclosure, or interference with Article 8, must be necessary in a democratic society,

pursue a legitimate aim and be by proportionate means.115 Arguably, implementing

measures which improve public health and utilise scientic advances respond to a

pressing social need, with instruments such as the GDPR and ethical guidelines

ensuring adequate protection. e potential caveat to disclosure is that Article 8

protects both privacy and the family. us it may be suggested that disclosure of

genetic information interferes with the protection of family life, due to its potential

to negatively aect family dynamics. However, the public interest in maximising

health provides a legitimate aim to justify such interference.

e Irish High Court’s reliance on the Z case in CFA is indicative of the inuence

of Article 8 on the law of condentiality in Ireland. While the Strasbourg Court has

not specically addressed genetic information in the context of the Convention, a

duty to disclose, imposed by the professional regulators may be provided for by the

breadth of Article 8(2). It aords professional guidelines an opportunity to shape

condentiality in a more holistic manner, which accounts for societal values.

107 Bjorn Ketels and Tom Vander Beken, ‘Medical Condentiality and Partner Notication in Cases

of Sexually Transmissible Infections in Belgium’ (2012) 20 Medical Law Review 399, 402.

108 ABC [2015] (n 3) [31].

109 Laurie, Genetic Privacy (n 8) 249.

110 ABC [2020] (n 3) [254]; ABC [2017] (n 3) [65].

111 ABC [2020] (n 3) [257].

112 Gilbar and Foster ‘Doctors’ Liability’ (n 35) 119.

113 Stone v South East Coast Strategic Health Authority [2006] EWHC 1668 (Admin) [44].

114 Z v Finland (1998) 25 EHRR 371 [95].

115 ibid [94].

38  

As discussed, there are multiple sources of condentiality which inform a doctor’s

obligations in relation to genetic information. Each of these creates scope, either

directly or indirectly, for disclosure in the public interest. e public interest, in

the context of clinical genetics, favours a qualied case for disclosure. e Medical

Council should clarify these obligations in genetic-specic obligations and guidance.

D. A Proposal for Medical Council Guidelines on Condentiality

of Genetic Information

Condentiality, in the absence of specic guidance, is in a state of disarray. e

obstacle faced by professional regulators is the identication of the boundary

between clarity and exibility.116 Furthermore, the kaleidoscope of family dynamics

and subjectivity of medical condentiality is not conducive to strict, one-size-ts

all rules in the context of clinical genetics.117

e following sections will assess how ethical and legal considerations, as outlined,

can serve the public interest in relation to disclosure of genetic information.

e Medical Council must respond to the evolving dynamics created by genetic

information, scientic advances and shis in the law. is should comprise two

elements: a limited duty to disclose genetic information to family members, and

an accompanying framework which claries when such a duty is engaged. As a self-

regulating body, the Medical Council is in the ideal position to respond eectively

to tendencies in medical practice,118 and adopt a comprehensive approach, not

conned by the boundaries of tort law as before the courts in ABC.

I. Discretion or Duty?

While the benets of sharing genetic information in the familial context are widely

recognised, and encouraged,119 the means by which this should be achieved in the

absence of consent are strongly contested. Doctors’ obligations are undoubtedly

engaged where disclosure is justied. e question arises as to whether the public

interest in qualied disclosure would be best achieved by creating a professional

discretion or duty to third party relatives.

e complexity of this issue is highlighted by foreign authorities, which fail to

provide a mutually accepted approach. Parallels exist between USA jurisprudence

116 Robert Baldwin, Martin Cave and Martin Lodge, Understanding Regulation: eory, Strategy

and Practice (2nd edn, OUP 2012) 142–146. Self-regulation may be criticised on the basis of

accountability.

117 Dove (n 65) 109.

118 Baldwin, Cave and Lodge (n 116) 140.

119 GMC (n 17) 36.

Condentiality in Disarray 39

and the facts of ABC.120 In Safer v Estate of Pack, the Superior Court of New

Jersey decided that a ‘duty to warn’ existed to warn the daughter who was at risk

of harm from a genetic condition of the doctor’s patient.121 However, the Court

found that there was essentially no distinction between infectious and genetic

diseases, thus holding that the duty to disclose genetic information logically

followed that in relation to infectious disease. is approach conicts with genetic

exceptionalism.122 A more reserved approach was adopted in Pate v relkel.123 e

Supreme Court of Florida found that a duty to warn the children of a patient about

genetic risk was satised by warning the patient. ese two cases demonstrate

the judiciary’s cognisance of the evolving nature of condentiality and doctors’

correlated duties. Such sources are likely to prove persuasive in the Irish context in

the absence of precedent, not in terms of the rationales which were relied upon to

reach the conclusions, but rather the conclusion in itself.

Proposals on how to encourage disclosure of genetic information range from

introducing a more relaxed ‘ethic of care’124 to imposing liability on the patient.125

Weaver proposes the former normative ethic whereby decisions about disclosure

should not abide by a formula or rational decision making, but the needs of the

aected individual, ‘while respecting the communal nature of shared genetics’.126

is construction reects the current arrangement (or lack thereof ) in Ireland,

with additional reference to the applicable laws. Doctors, aware that their duty

of condentiality is not absolute, adopt a default position of an ethic of care. In

England, this ethic is now legally binding as a consequence of ABC. e issue

with such an approach is that the lack of clarity of an ethic of care is inherently

insucient to guide doctors in relation to the complexities of clinical genetics.

A similar, yet more structured, method would be to provide doctors with discretion

to disclose, instead of a duty. Suter frames this conception as a conditional privilege

to warn of genetic conditions.127 A qualied privilege would limit the doctor’s

discretion, without imposing obligations. Similarly, Dove et al propose a duty to

‘consider’ disclosure to genetic relatives.128 However it is probable that in practice

120 Mitchell and others, ‘Exploring the potential duty of care’ (n 80) 176.

121 Safer (n 13).

122 e Genetic Privacy Act 1996 (New Jersey) (GPA) in eect overturned Safer, thus highlighting

the limitations of the decision. Cf Fay (n 82) 125. Fay argues that Safer is an ‘invaluable (if only

persuasive) precedent’.

123 Pate v relkel (1995) 661 So2d 278 (Fla 1995).

124 Meaghann Weaver, ‘e Double Helix: Applying an Ethic of Care to the Duty to Warn Genetic

Relatives of Genetic Information’ (2016) Bioethics 181.

125 Gilbar, ‘e Passive Patient’ (n 55) 79.

126 Weaver (n 124) 185,186.

127 Sonia M Suter, ‘Whose Genes Are ese Anyway? Familial Conict Over Access to Genetic

Information’ (1993) 91 Michigan Law Review 1854, 1883.

128 Edward S Dove and others, ‘Familial Genetic Risks: How Can We Better Navigate Patient

Condentiality and Appropriate Risk Disclosure to Relatives?’ (2019) Journal of Medical Ethics

accessed 3 April

2020.

40  

disclosure would be extremely rare. Not only is discretion unsatisfactory in terms

of consistency but also, and more signicantly, for justice.129 Doctors would be

unlikely to disclose, for fear that their professional discretion would be susceptible

to claims in negligence.130 In addition, the rule of law, which requires transparency

and foreseeability, necessitates that both patients and doctors will be aware of

the implications of their actions, and therefore of the consequences of genetic

information.

e preferable approach is to impose a duty on doctors towards relatives of the

patient specically in relation to genetic information. As genetic and genomic

medicine is becoming more integral to general medical practice,131 doctors’ duties

to family members must evolve to reect and incorporate advances in medicine.

is would guarantee appropriate disclosure, therefore enhancing the health of the

family unit and, more broadly, societal welfare.

Critics of creating a further duty for doctors, rather than discretion, argue it creates

a burden which is too onerous.132 is assertion is tenuous. As science and medical

treatment progress, doctors’ responsibilities must change to accommodate and take

advantage of such developments. If they do not, the benets of genetics would not

be realised.

e role of doctors should reect the public interest, which in certain circumstances

favours disclosure to further the health of third parties. While more onerous than

the obligation to consider as enumerated in ABC, the creation of such a duty

ensures that doctors will comply with their obligations. However, to avoid the

creation of an undue burden, the Medical Council should limit the duty.

II. Scope

e proposed duty is explicitly limited to genetic conditions. It endorses the

concept of ‘relational autonomy,’133 which reects the unique nature of genetic

information in a way which the traditional reliance on autonomy to rationalise

condentiality does not. As previously highlighted, this approach more accurately

mirrors the manner by which ‘real humans’ conduct their lives.134

However, identifying relatives as interested parties does not relieve the ambiguity

of condentiality in this context, but requires further qualication. Not only

129 Ng wena and Chadwick (n 29) 88.

130 Graeme Laurie, ‘e Most Personal Information of All: An Appraisal of Genetic Privacy in the

Shadow of the Human Genome Project’ (1996) 10 International Journal of Law, Policy and the

Family 74, 84.

131 Lucassen and Gilbar (n 78).

132 ABC [2020] (n 3) [177].

133 Gilbar, ‘e Passive Patient’ (n 55) 120.

134 ibid 191, 120.

Condentiality in Disarray 41

is genetic information a distinguishable category of health information, thus

incurring specic duties, such an obligation should be limited to the proband’s

rst degree relatives in a denite manner. Consequently the scope for breaching

condence is restricted, and the principle of condentiality in general healthcare is

not undermined.

e aforementioned ‘relationship of proximity’ criterion of the Caparo test is

relevant.135 While this was emphasised by Yip J in ABC, it was not expressly

considered in terms of the family unit, arising by virtue of the unusual factual

matrix and actual relationship between the Defendant and Claimant. e

identiable victim becomes increasingly remote as the family tree extends.136 First

degree relatives are generally identiable and present a higher degree of risk.137

Following Smith, the scope of a doctor’s duty to the third party should thus be

rened to include this circle of at-risk individuals, which aligns with the Medical

Council’s reference to disclosure in the public interest where it may protect ‘other

identiable people,’ or ‘the community more widely’.138 Furthermore, the identied

scope correctly balances the protection of third parties, without unduly burdening

the doctor. Having established the scope of the proposed duty, the next section

considers the relevant factors which establish when the duty is engaged.

III. A Framework to Guide Disclosure: e Relevant Factors

e purpose of the proposed framework is to enable doctors to assess when their

duty to third party relatives is engaged. Such a framework must rstly clarify the web

of applicable instruments, and secondly apply the derived rationale in the context

of clinical genetics. It should reect the potential of genetic information whilst

assuring the public that the principle of condentiality operates to emphasise patient

autonomy in relation to all other categories of health information. e benets of

disclosure of genetic information are not always axiomatic;139 thus disclosure which

does not bring identied benets to an interested party will not be justied. e

Medical Council must therefore recognise the utilitarian, public interest, value in

relational autonomy, informed by the relevant ethical and legal principles.

Importantly, not all medical information is equally sensitive or revealing.140 e

Royal College of Physicians et al (‘RCP’) caution that a proportionate response

135 Caparo (n 66).

136 Suter, ‘Whose Genes’ (n 127) 78.

137 Smith v University of Leicester (n 79) [29]. e Court held that to extend a doctor’s duty to second

cousins would fail the test of fair just and reasonable.

138 Medical Council (n 2) 27.

139 Ng wena and Chadwick (n 29) 84.

140 Alastair Kent, ‘Consent and Condentiality in Genetics: Whose Information is it Anyway?’

(2003) 29 Journal of Medical Ethics 16. See also: Lucassen and Gilbar (n 78) 2. e 0.1%

dierence in genetic codes leads to genetic sensitivity.

42  

must distinguish between the sensitivity of dierent genetic information.141 e

duty should be restricted to sensitive genetic data. e legal bases for this framework

are rooted in the common denominator of the aforementioned sources: the principle

of condentiality is not absolute. Exceptions may be justied in the public interest.

e limits within which such a duty operates are dictated by the public interest

exception.142 Yet, what exactly is encompassed by the ‘notoriously vague’ concept of

the public interest is not expressly identied by the relevant sources.143

It is apt to rstly consider the most pertinent Irish authority on a doctor’s duty

to third parties. Applying CFA, the justication for disclosure is the avoidance

of harm. e CFA test indicates, as reected by the Medical Council guidance,

where disclosure of genetic information prevents serious harm or death it is

acceptable to breach condentiality. Yet the reality of genetic conditions is not

as simple or conducive to such a test. As outlined, the threshold is too stringent

for genetic disorders with the eect of excluding an array of genetic conditions

from disclosure, which may not amount to ‘serious’ harm. Further, it implies that

conditions where the disorder is not necessarily mitigated, for example HD, would

not merit disclosure.

us the CFA test does not account for the factors peculiar to genetic information.

ese unique features are imperative to policy considerations as to whether it

would be fair, just and reasonable to require disclosure. A Medical Council policy

on genetic condentiality must reect the public interest, which favours qualied

disclosure, in a manner which promotes the utilitarian values of condentiality.

Similarly, the unique nature of genetic information is relevant to Article 8(2),

for the protection of health. us the strict application of the CFA test may not

account for disclosure which is justiable. It should therefore not be applied in

isolation, but rather inform the Medical Council’s approach.

Considering the English position in relation to disclosure of genetic data, the

duty enumerated in ABC is pertinent in that it recognises the sharing of such

health information as legally permissible. It is indicative of the courts’ deference to

professional guidance in this context and thus the importance of comprehensive

Medical Council guidelines. However, the High Court’s approach fails to account

for the unique and shared nature of genetic information.

Where the proband’s genetic information reveals a signicant genetic condition

but the risk cannot be reduced as there is no treatment available; the relative has the

right to be informed. e information may aect their reproductive and lifestyle

choices. Similarly, where the genetic disorder is not severe, but may be treated, there

is a denite interest in being aware of such a condition. However, where a condition

is mild, with no cure and low risk, the relative has no right to be informed.

141 Royal Col lege of Physicians (n 5) viii.

142 Laurie, ‘e Most Personal’ (n 130) 84.

143 Taylor, ‘Health Research’ (n 41), 270.

Condentiality in Disarray 43

What results from these considerations is a scale of obligations, with increased

responsibility correlating with the severity of the genetic condition and availability

of treatment. Where treatment is available, it is imperative that the patient’s relative

be informed. Where it is not, the doctor must consider the severity and impact on

the relative’s life. It envisages a duty that is oen engaged by genetic conditions,

but limited to rst degree relatives. is must be balanced with the issue of how

the relative may react to such information, including the relative’s right not to

know where disclosure could harm the relative.144 Gilbar posits that the practice

of relational genetics requires doctors to engage in attempting to understand

the patient’s family dynamics before choosing to disclose, or withhold, genetic

information.145 is is arguably an impossible task, especially where the doctor

does not regularly interact with all family members. However it is likely that the

scenario where a family member would assert the ‘right not to know’ is rare,146 and

unless otherwise expressly informed by the relative’s health care professional, it is

reasonable for a doctor to assume that the relative would support increased choice

and autonomy in relation to her decisions.

us while aspects of the relational autonomy approach are appealing, a duty to

interpret family dynamics and emotional connections is overly burdensome. It

must thus be limited to specic factors, and to rst degree relatives. Rather than

attempting to understand family dynamics, a relational autonomy approach

essentially requires eective collaboration between doctors and hospitals. With

the transition to online medical records by the Irish Health Service Executive, this

is achievable by building on the existing practice of encouraging patients to share

genetic information.

In terms of the disclosure itself, the doctor must respect, insofar as possible, the

patient’s dignity and privacy. e GDPR is an essential guide when sharing

health information.147 Where possible, the identity of the proband should not

be revealed.148 Disclosure must comply with the aforementioned data processing

principles. In particular the ‘data minimisation principle’ requires that only

necessary information pertaining to the aected individual is revealed. is

protects the patient against arbitrary disclosures which intrude on her personal

life. While the boundaries are blurred by the individualistic conception of the ‘data

subject’ and genetic data which pertains to multiple parties, it can be presumed

that a doctor should only disclose the information necessary to assist the relative in

seeking treatment, within the dened scope of the framework.

144 For a detailed discussion of the right not to know see: Laurie, ‘Recognising the Right Not to

Know’ (n 37).

145 Gilbar, ‘Communicating Genetic Information in the Family’ (n 40) 391.

146 Dheensa , Fenwick and Lucassen (n 18).

147 BM A, ‘Access to Health Records’ (London May 2018) BMA 20180215, 6.

148 GMC (n 17) 13.

44  

e Supreme Court in Montgomery indicated that the law should set the standards

required in professional practice.149 Yet the slow evolution of the law indicates

otherwise; in the context of genetics legal tools are outpaced by the ‘genetic

revolution’.150 In current practice, where doctors choose to exercise discretion

in favour of disclosure, their choices are undermined by the ‘creeping risk of

liability’.151 A duty to disclose, imposed by the Medical Council, would remedy this

by establishing disclosure as accepted practice in context of clinical genetics, whilst

balancing competing public interests.

E. Conclusion

e principle of condentiality should be applied contextually, to reect the

values of society and advances in medicine. It represents an evolution of the ethics

of healthcare.152 Where autonomy cannot be relied upon to justify maintaining

condence, it is utilitarian and welfare considerations which inform disclosure.

ese are expressed in the legal and ethical exceptions to condentiality in the

public interest. Indeed, the public interest in disclosure of genetic information to

at-risk relatives is clear: it may directly reduce the occurrence of such disorders.153

e unique nature of genetic information merits a tailored response. While this

is acutely necessary in Ireland, the GMC and RCP have already taken tentative

steps in this direction, albeit only to highlight the problems, without providing

solutions.154 is article has illustrated that a qualied doctors’ duty to rst degree

relatives of the patient should be introduced, in tandem with a transparent and

comprehensive framework to establish when exactly such a duty is relevant. Suitably

restricted and claried, this obligation would maximise health and welfare, without

undermining the principle of condentiality in healthcare.

e recognition by the Medical Council of genetic information as distinct, and

thus deserving of separate guidelines as a matter of policy, will impact subsequent

legal developments.155 It represents an essential step in clarifying doctors’ complex

obligations, currently in a state of disarray. is article serves as a note of caution to

the professional regulator; doctors should be enabled, rather than undermined, in

the context of clinical genetics. Both action and clarication are required on behalf

of the Medical Council to reect the public interest in eective healthcare.

149 Montgomery (n 25) [93] (Kerr and Reed LJJ).

150 Deirdre Madden, Medicine, Ethics and the Law (3rd edn, Bloomsbury Professional 2016) 344.

151 Dove (n 65) 110.

152 Ketels and Vander Beken (n 116) 401.

153 Kobrin (n 30) 1315.

154 GMC (n 17); Royal College of Physicians (n 5).

155 Laurie, ‘Recog nising the Right Not to Know’ (n 37) 61.