New Zealand Law Students Journal
Last Updated: 24 October 2012
IS THE NON-CONSENSUAL USE
OF WOMEN’S HEALTHCARE RECORDS TO EVALUATE
THE NATIONAL CERVICAL SCREENING PROGRAMME JUSTIFIED?
Cervical cancer is one of the few cancers that can be prevented. A screening programme that tests women on a regular basis can detect pre-cancerous lesions and treat them before invasive cancer develops.1
To be of real benefit to women, the screening programme itself also needs
to be regularly monitored. An important part of that
investigation of the smear histories of women enrolled in the
programme and those diagnosed with cervical
cancer to determine why cancers
still develop despite the existence of a screening programme. An evaluation
of this kind uses
information that identifies individual women and also
information beyond that which is held on the programme’s
register, including primary health care records. Until very recently, evaluators
of New Zealand’s National Cervical Screening
Programme (the NCSP) had to
obtain the consent of individual women to access this kind of personal
identifying health information.2 This requirement meant that
a comprehensive and statistically meaningful evaluation of the NCSP’s
performance in its
first decade of operation was never completed.3
To ensure effective evaluation can
∗ LLB (Hons) BA, University of Canterbury.
1 Kirsten Coppell, Charlotte Paul and Brian Cox, ‘An Evaluation of the National Cervical
Screening Programme Otago Site’ (2000) 113(1104) The New Zealand Medical Journal 48, p.
2 Section 74A(5) of the Health Act 1956 prevented disclosure of information on the
NCSP Register without the woman’s consent.
3 Euphemia McGoogan, Report on the National Cervical
Screening Programme and progress towards Implementation of the Gisborne Inquiry
Recommendations (June 2003)
Also see the Gisborne Cervical Screening Inquiry, Report of the Ministerial
Inquiry into the Under- reporting of Cervical Smear Abnormalities in the
Gisborne Region (2001)
2 The New Zealand Law Students’ Journal (2006) 1 NZLSJ
be carried out, the Health Act 1956 was amended in March 2004 to allow
evaluators full access to a woman’s health information held by the NSCP,
the Cancer Registry
and any health practitioner, laboratory or hospital,
without her additional consent.4
The Amendment Act was controversial as many women were
concerned about evaluators having access to sensitive and intimate
about them, without their knowledge or consent. The legislation is based on
the decision that this invasion
of privacy is justified by the need to
properly evaluate the NCSP and the resulting benefits of that which will accrue
women. It is an example of the classic public health dilemma: the
clash of individual and community interests. The public controversy
surrounding this aspect of the Amendment Act make it worthy of critical
attention. This essay will examine the
justifications for removing
the requirement of individual consent to access primary and hospital care
records for evaluation
of the NCSP. They will be assessed against the
standard that, especially in the health care context, any such
into personal autonomy ought to be only what is necessary and as
minimal a derogation as possible. On the whole, the policy
conform to these parameters however there are aspects that remain a
cause for concern for women. The apprehension
about these changes
also provides an insight into how New Zealanders view the balance between
confidentiality and public health.
The power to adopt this policy is not being
questioned; the focus is on whether the justifications given for it are
quell public concern.
A: The National Cervical Screening Programme
The National Cervical Screening Programme was established in 1990 in response
to a recommendation in the 1988 report of the Cartwright
The committee, led by Judge Silvia Cartwright (as she then was),
investigated a long-running research study at National Women’s
in Auckland where women underwent repeated cervical smear tests and biopsies
without being offered adequate
4 Health (National Cervical Screening Programme) Amendment Act 2004.
5 Committee of Inquiry into Allegations Concerning the Treatment of Cervical Cancer at
National Women’s Hospital and into Other Related Matters, Report (The Cartwright Report)
(1988). Also see Gisborne Cervical Screening Inquiry, Report,
supra n. 3, [3.2].
Non-Consensual Use of Healthcare Records 3
abnormalities that were discovered.6 The majority of women were
not informed that they were participating in a research study and
it appeared that obvious
symptoms of invasive cancer were overlooked or
downplayed. Some health professionals had been calling for New Zealand
follow the lead of other countries and establish a cervical screening
programme and the Cartwright Inquiry recommendations
matter.7 It is important to recognise that New Zealand’s
cervical screening programme was at its inception, and continues to be, closely
tied to the sad events at National Women’s Hospital. Rightly or wrongly,
this has certainly influenced the way many women
feel about the Amendment
The NCSP is an ‘opt-off’ programme: women are
automatically enrolled after their first smear test or other
but they can choose to withdraw at any time. This ensures the Programme has a
high participation rate which
is essential to its success in reducing
incidence of, and mortality from, cervical cancer. Women must be
of their enrolment and at that time provided with information about
regular screening, the NCSP, what information is collected and
held, who has
access to it and what for.9 The NCSP Register holds the results
of a woman’s smear tests, her contact details and other
including her ethnicity. The core functions of the
screening programme are to ensure that women are tested regularly (every three
years in New Zealand) and that tests that report abnormalities
are followed up appropriately. To this end the
NCSP uses the information it
holds to remind women when they are overdue for a smear test and to contact
women who need further treatment.
Since becoming operational in 1990, the NCSP has contributed to a
nearly 40 percent reduction in the incidence of cervical cancer
6 The study ran from 1966 to the mid 1980s. The practitioners involved were testing the theory that carcinoma in situ was not a precursor to invasive cervical cancer.
7 Gisborne Cervical Screening Inquiry, Report, supra n. 3, [3.2].
8 McGoogan [Recommendation 11.13]. Professor McGoogan notes in that paragraph that “[t]he time has arrived for the National Screening Programme to be treated as a medical programme which is part of a national cancer control strategy. In the past its link with the Cartwright Report has at times resulted in its purpose as a cancer control strategy being compromised for non-medical reasons.”
9 Health Act 1956, section 112F.
percent reduction in deaths from the disease.10 Even so,
there have been failings. The most notable is of course the under-reporting
of abnormalities in cervical smear slides
in the Gisborne region which led to
the Gisborne Cervical Screening Inquiry in 2000. The Inquiry Report
released in 2001
revealed many specific failings with regard to the practice
of cervical cytology in certain laboratories but also identified
systemic issues that contributed to the problems of the NCSP. One of
these was the “failure to ensure that there
was legal power to do what
was needed for the Programme to be effective.”11
B: The Health (National Cervical Screening Programme) Amendment Act
The Gisborne Inquiry Report described the law surrounding evaluation of the
NCSP as a “legal quagmire.”12 In order to determine
whether there had been systemic under-reporting on a national
scale13 and whether invasive cervical cancers were detected by
regular screening, an evaluation of the smear histories of individual women
to be carried out. Achieving this would mean accessing identifiable
information on the NCSP Register. Section 74A(5)
of the Health Act
however effectively prevented any such evaluation taking place.14
It stated that “no person may disclose information on the
register that identifies a woman” without her consent,
and none of the
listed exceptions applied to the independent auditors. To overcome this, the
Inquiry Committee issued a subpoena
under section 4D of the Commissions of
10 Hazel Lewis, ‘New cervical screening legislation: access to clinical records’ (2004) 117 (1191) The New Zealand Medical Journal 829, p. 829.
11 Gisborne Cervical Screening Inquiry, Report, supra n. 3, [6.74].
13 Term of Reference Three for the Gisborne Cervical Screening Inquiry, supra n. 3.
14 The Gisborne Inquiry also outlined other legal barriers that prevented the evaluation
taking place. The Privacy Act 1993 regime (specifically Rule 11(2)(c)(iii)
of the Health Information Privacy Code) was mistakenly
applied to the
identifiable information held on the national Cancer Registry which required the
evaluators to obtain ethics committee
approval for disclosure of the
information. The ethics committees around the country however held that the
evaluators had to obtain
consent before accessing the identifiable information.
This put evaluators in an impossible situation, unable to access
information that would identify women who had developed cervical
cancer. See Gisborne Cervical Screening Inquiry,
Report, supra n. 3,
Act 190815 requiring the Ministry of Health to produce the
relevant information to the evaluators. The Ministry resisted production under
section 74A(5) of the Health Act. The impasse could not be broken and the
Committee considered referring the question of its subpoena power to the High
for a ruling.16 This was abandoned however as a draft of
the New Zealand Public Health and Disability Act submitted to the
this power from Committees of Inquiry into health matters,
making the question purely academic in the view of the Committee
members.17 The concern of the Committee that an audit of
cervical cancer cases be carried out was also somewhat allayed by Ministry of
assurances that their national evaluation of the NCSP would include a
Even if the Ministry had released the information on subpoena
however, the resulting legal situation would hardly have
been desirable as
evaluation would require the relevant information to be produced by compulsion.
In addition, had the evaluators
been able to progress to an audit of individual
cases of cervical cancer as they intended, the consent of each woman would need
be obtained to access her primary and other health care records. This too
was a less than ideal situation for the evaluators, a
point that will be
The Ministry had failed to ensure the necessary legal powers to
administer the NCSP were present, and the recommendations
of the Gisborne
Inquiry Report were unequivocal: section 74A of the Health Act 1956 had to be
amended to give appropriately qualified evaluators ready access to all
information on the NCSP19 and all medical files of women diagnosed
with cervical cancer recording the treatment of the cancer by all health
providers involved.20 This is precisely what the Amendment Act
15 The Gisborne Inquiry Committee was established under section 47 of the Health and Disability Act 1993. Section 47(3) of that Act gave the Inquiry Committee the powers of a Commission of Inquiry under the Commissions of Inquiry Act 1908.
16 Commissions of Inquiry Act 1908, section 10.
17 The relevant provision is section 77(j) of the New Zealand Public Health and Disability Act 2000. Also see Joanna Manning, ‘Review: Health Care Law’  New Zealand Law Review 189, pp. 192-193.
18 Gisborne Cervical Screening Inquiry, Report, supra n. 3, .
19 Ibid., [11.14].
20 Ibid., [11.17].
The purpose of the cervical screening programme is to reduce the incidence
and mortality rates of cervical cancer. The Amendment
Act supports this by
assisting the evaluation of the NCSP through easier access to a wider scope
of information. One of the
objectives of the NCSP listed in the Amendment Act
is to facilitate ‘continuous quality improvement’ by allowing and
performing regular evaluations of the Programme.21 Evaluations
are specifically stated to include the review of and investigation into
the cases of individual women.22 In accordance with
this new emphasis on evaluation, the Act provides for screening programme
evaluators to have full access
to relevant information about
individual women held by the NCSP, the Cancer Registry, and records or
specimens held by
hospitals, laboratories and any health practitioner,
including primary care records.23 Additional consent from
the relevant women is not required and health practitioners must
comply with an evaluators’
women’ are those enrolled on the NCSP (whether or not they develop
cervical cancer) and women who develop cervical
cancer (whether or not they
are enrolled on the NCSP).25 In contrast to its predecessor, the
Amendment Act gives evaluators fairly extensive powers of access. There are
important limits however.
The information evaluators collect must be relevant
to their evaluation26 and the Director-General of Health can
impose specific limits on what information can be accessed.27
There are also strict confidentiality requirements placed on the
evaluators,28 similar to the duty imposed on a medical professional
in a therapeutic relationship.
C: The competing principles
It is the ability of screening programme evaluators to access the primary
care and other health records of women without
knowledge or consent that has caused the most controversy. Green Party MP,
Sue Kedgley, described the law
change as “tragic” and
21 Section 112A
22 Section 112T
23 Section 112X
24 Section 112ZB
25 Section 112X(1)
26 Section 112X(4)
27 Section 112U(3)
28 Section 112Y(3)
that it “spells the end of doctor-patient confidentiality for the one million women enrolled on the NCSP.”29 On this view, women are forced to choose between confidentiality of their medical records and their health. Other writers have also been sceptical of the Amendment Act and questioned the efficacy of the limits placed on evaluators.30
Many women are concerned that evaluators will have access to sensitive
personal information, specifically about intimate matters such
sexual abuse, sexually transmitted infections, and psychiatric
conditions.31 The concern is that much of this information could
be considered relevant to an evaluation of cervical cancer as most cases of the
cancer are caused by the sexually transmitted, and very common, human
The 2004 Health Amendment Act exemplifies the classic public health dilemma
where personal autonomy and privacy is in opposition
with the public good.
The confidentiality of health records “is a subject in which autonomy and
beneficence clash head
The individual’s right to privacy is “essential to human dignity
and liberty”34 and is recognised as such in many
jurisdictions, often at the constitutional level. In terms of medical
ethics it is
an aspect of consumer autonomy and in this specific context it
is manifested in the right to have health information kept
People have a
29 Sue Kedgley, A million NZ women lose their medical privacy tomorrow, Press Release (6 March
2005), http://www.greens.org.nz/searchdocs/PR8368.html. The New Zealand Medical
Association also expressed concern about the harm that might be done to the doctor/patient relationship. See Sandy Elkin, ‘Bioethics Commentary’  February New Zealand Bioethics Journal 4, 5.
30 Elspeth McLean, ‘Dear Aunty Karen’ Otago Daily Times (Dunedin), 22 March 2005, 15
Elspeth McLean, ‘Prayer for the screening programme’ Otago Daily Times (Dunedin), 14
April 2004, 25.
31 Joanna Manning, ‘Health Care Law Part 2 – Legislative Developments’  New
Zealand Law Review 385, 399.
32 About 70 percent of cervical cancers are caused by two different strains of this virus.
See Denise Grady, ‘Vaccine Prevents Most Cervical Cancer’ New York Time (New York, USA), 7 October 2005, http://www.nytimes.com (Copy on file with author).
33 Sir Douglas Black, ‘Access to records for epidemiological research’ (1992) 304 British Medical Journal 987, quoted in Professor David Skegg’s Second Brief of Evidence at the Gisborne Cervical Cancer Inquiry (2001) . http://www.csi.org.nz/proceedings/skegg2nd.pdf, para. .
34 Barbara von Tigerstrom et al, ‘Legal Regulation of Cancer Surveillance: Canadian and
International Perspectives’ (2000) 8 Health Law Journal 1, p.
discrete autonomy interest in controlling access to their personal health
information, regardless of consequence.35 In New Zealand this
interest is protected by the Health Information Privacy Code (the HIPC). The
basic rules relevant here
are first, that personal
(identifiable) information can only be used for the purpose for which
it was collected36 and secondly, the health agency
cannot disclose the information unless one of the listed exceptions
applies such as
when the individual consents or where consent cannot be obtained
and the disclosure is necessary to prevent or lessen a serious
imminent threat to public health or safety.37 The HIPC clearly
covers primary care records that are the subject of concern here. Preserving
the confidentiality of this information
is important not only for consumer
autonomy but also to protect the therapeutic relationship: a patient
must be able to
share the intimate, and sometimes embarrassing, details of their
health to receive the best care. Following the passage of the
some writers expressed the concern that women would opt off the NCSP to
prevent this invasion of their privacy.38
The other principle in contention in this debate is the good of public
health. While there is no specific legal duty on governments
to advance public
health it is certainly a moral imperative and a strong incentive to override
the individual’s right in
confidentiality of their information.
Historically, public health activities have “no doubt exerted much more of
effect on the longevity and physical, mental, and social
well-being of the general population...than have advances in
medicine, important though the latter may be.”39 The ethical
principle of beneficence is clearly applicable here. In the context of
cervical screening programmes it is essential
that smear tests are read
accurately so that abnormalities are detected early and treated. To ensure
this is happening, the
programme must be evaluated and monitored. A
screening programme operating without evaluation puts women at
35 Helen Davidson, John Dawson and Andrew Moore, ‘Law, Ethics, and Epidemiology: The Case of the Cervical Screening Audit’ (2001) 2 (2) June New Zealand Bioethics Journal 8, p. 20.
36 Rule 10.
37 Rule 11.
38 Kedgley, Press Release, supra n. 29 and Manning , supra n. 31, p. 400.
39 Marshall B. Kapp, ‘Book review Essays’, reviewing Lawrence O. Gostin, Public Health
Law: Power, Duty, Restraint (2000), (2001) 22 Journal of Legal
Medicine 581, p. 581.
greater risk by giving them, and their doctors, false assurance.40
It is unethical to “exhort apparently healthy people to undergo
medical procedures, when adequate steps cannot be taken
to monitor the
quality of the process or the outcomes achieved.”41
There is an obligation to evaluate.
There is a risk of very serious harm to the community in allowing
personal interests in confidentiality to prevent the
proper evaluation of the
NCSP, as evidenced by the Gisborne Inquiry. When the conduct of an individual
can cause harm to the
community, the question of whether the general
welfare will be promoted by interfering with the individual’s right
becomes open to discussion.42 With regard to evaluation
of the NCSP, it was decided that the general welfare would indeed be
significantly promoted by removing
the need for additional and specific
consent from women to access their health records, overriding the usual
The law certainly allows for this resolution of the
debate in favour of the public health interest. The right to privacy, though
fundamental, is not absolute. The exceptions to the rule of
non-disclosure in the HIPC show how even in the context
health information, the right to privacy and confidentiality can be limited.
More importantly, the rules in
the Privacy Act and HIPC give way to any
contrary statutory provision that authorises or requires the disclosure of
Before considering the justification for the Amendment Act policy it is
necessary to address an exception to the rule of non-disclosure
be relevant here. Rule 11(2)(h)(ii) provides that a health agency may disclose
information if they believe on reasonable
grounds that it is either not
desirable or not practicable to obtain authorisation from the individual for
the release, and
the disclosure is required for a professionally
required external quality assurance programme. Evaluators cannot
rely on this provision to gain access to the information they need.
First, the health agency may release the
40 Gisborne Cervical Screening Inquiry, Report, supra n. 3, [6.72].
41 Professor David Skegg quoted in Gisborne Cervical Screening Inquiry, Report, supra n.
3, [6.72]. See also Davidson, Dawson and Moore, supra n. 35, p. 13.
42 Margaret Brazier and John Harris, ‘Public Health and Private Lives’ (1996) 4 Medical
Law Review 171, p. 177, quoting John Stuart Mill, On Liberty (1869).
43 Privacy Act 1993 section 7.
information; the power is discretionary.44 Secondly, the usual
practice regarding external evaluations is to require ethics committee
approval and as was noted above, this
cannot be guaranteed. The Amendment Act
is rightly characterised as a statutory override of the HIPC rules rather
under an exception.
D: Justifying the removal of the consent requirement
The subpoena issued by the Gisborne Inquiry Committee, their recommendations
for legislative change and the resulting Health Amendment
Act all rely on the
same core rationale to override the individual interest in
confidentiality of medical records:
that it is necessary to ensure the
quality and effectiveness of what is a very valuable screening programme
the legislation only goes so far as is necessary to meet this
1. Establishing the need to override
The necessity argument is grounded in the value of the cervical screening programme to women. Both internationally and in New Zealand screening programmes have been shown to significantly reduce the incidence of, and number of deaths from, cervical cancer.45
That the NCSP is a good and valuable programme, and that it needs to be
monitored to remain so, cannot be disputed. The facts
that gave rise to the
Gisborne Inquiry make it plain that a great deal of harm can result from poor,
or in fact non-existent, quality
control. The ethical principle of
beneficence is very important in this context as it is in the best interests of
all women that
the cervical screening programme is of a high standard. The
value of the screening programme can only be maintained through
Attention must then turn to the requirements of such an evaluation. The aim
is to assess the appropriateness of follow up and treatment
of women with
abnormal smears and to determine why cases of cervical
44 Dr Tricia Briscoe notes, and it is discussed below, that in some instances medical practitioners would be ethically bound to refuse evaluators access to patient files. See Dr Tricia Briscoe, ‘Medical Ethics – Curly Questions’ (Paper presented at the Fifth Medical Law Conference, Wellington, 30 May 2004). http://www.nzma.org.nz/news/issues/medical-ethics.pdf (Copy on file with author)
45 Coppell, Paul and Cox, supra n. 1, p. 48.
cancer still occur despite the existence of the screening programme.46
This type of evaluation requires access to the smear test results and other relevant medical histories of individual, identifiable women. A vital element of any meaningful and effective evaluation is a high participation rate among the population being assessed – accurate results depend on complete data.47 Without this, the study will yield biased conclusions that cannot be relied upon and the evaluation is pointless.48 Further, as the number of women whose histories need to be reviewed is small, access to close to one hundred percent of records is needed for the results to be epidemiologically meaningful.49
Researchers proposing evaluations of the NCSP have argued that it is not possible to obtain this level of consent.50 This was exactly the case for the Ministry of Health review of the NCSP conducted in 2001, although it must be noted that a 2004 Auckland University audit of cervical cancer cases suggests the difficulties of securing the consent of women are not insurmountable.51 Even so, 19.2 percent of the women contacted for the Ministry’s review refused access to their records and
24.3 percent of women could not be located. The overall response rate was
only 56 percent and it was even lower for Mäori (28
percent) and Pacific
Island (31 percent) women who have the highest incidence of, and mortality rates
from, cervical cancer.52 These figures support Parliament’s
conclusion that it is simply not desirable or practicable to require
The provisions of the Amendment Act and the
recommendations of the Gisborne Inquiry Committee are clearly grounded in
belief that effective evaluation cannot be guaranteed if
46 Lewis, supra n. 10, p. 829.
47 Davidson, Dawson and Moore, supra n. 35, pp. 9 and 14.
48 Ministry of Health, Progress in Implementing the Recommendations of the Cervical Screening Inquiry (February 2002), http://www.oag.govt.nz/HomePageFolders/Publications/Cervical_Screening/cervical- screening.pdf, [5.10].
49 Lewis, supra n. 10, p. 829. Access to clinical records will focus on the group of about
150 to 200 women who develop cervical cancer each year.
50 Elkin, supra n. 29, 5. See also McGoogan, supra n. 3, p. 7.
51 University of Auckland, The New Zealand Cervical Cancer Audit Report 2000 – 2002, (2004)
52 Ministry of Health, Progress in Implementing the Recommendations, supra n. 48, [5.3 n. 22].
Regarding cervical cancer incidence in Mäori women see University of Auckland, The
New Zealand Cervical Cancer Audit, supra n. 51, p.
women’s consent is required. From this view, it is a stark
choice between privacy and safety.53
2. A limited override
Supporters of the Amendment Act provisions emphasise that evaluators will only be concerned with women’s smear histories and that they will be bound by stringent confidentiality requirements.54
Health practitioners can also oversee an evaluator’s access to their
patient files.55 These limits are designed to give
women greater confidence in the integrity of the NCSP and assurance that there
is no threat
to the confidentiality of the doctor-patient relationship or to
a woman’s privacy. This is because the powers are (arguably)
what is strictly necessary to complete an effective evaluation.
The Gisborne Inquiry and independent experts have strongly argued that
evaluator access to health care records cannot be considered
a dangerous foray
into personal privacy as evaluation of care is a ‘part in parcel’ of
treatment.56 The proposed audit was described as “a routine
component of quality control in many countries.”57 An example
of this is Scotland, where there is a public health audit of the women
who develop cervical cancer.58 The point is that evaluation of the
screening programme is an integral aspect of the treatment women
receive through the
programme, not an external or additional imposition on
A further protection for women is that the Director-General of Health is
obligated to inform them that evaluation is
one reason their
information is collected and what exactly evaluators will have access to and how
they will use it.59 The argument is that any perceived intrusion in
privacy is therefore lessened and no longer represents a harm
53 C Paul, ‘Should the law require doctors to make records available for audit of cervical screening?’ (2001) 114 (1143) The New Zealand Medical Journal 499, p. 499.
54 Lewis, supra n. 10, p. 829 and Health Act 1956, sections 112X(4), 112U(3) and 112Y(3)
55 Health Act 1956, section 112X(6).
56 Gisborne Cervical Screening Inquiry, Transcript, 25 September 2000
http://www.csi.org.nz/proceedings/CSIev25092000.pdf, C/601, lines 1-6.
57 Skegg, Second Brief of Evidence, supra n. 33, .
59 Health Act 1956, section 112F.
women. In essence, they know about the evaluation and so are
consenting to the use of their information for that purpose.
The final factor
to consider is that most women, when approached, would consent to
evaluators having access to their medical
records for quality assurance
purposes.60 Essentially, the policy makers have arrived at the same
decision the majority of women would themselves make, given the chance.
Despite the inconsistency with the concerns about low consent rates noted
above, respect for hypothetical consent
does appear to be an
underlying justification for the Amendment Act provisions. The Gisborne
Report stated that “[i]t
is difficult to see why women might object
to an independent evaluation team seeing information to which those
persons who are involved in their treatment have unrestricted
These arguments work to justify overriding confidentiality not by
establishing a need to do so, but by demonstrating that there is
either no real
invasion of privacy at all, or that it is such a minimal incursion as to not
attract any significant weight when considering
E: Assessing the legitimacy of justification arguments
The personal autonomy of women has assumed a position of great
importance in relation to New Zealand’s cervical screening
many people, it remains linked to the abuses of trust at Auckland National
Women’s Hospital that led
to the Cartwright Inquiry.
Overseas reviewers of both the NCSP and BreastScreen Aotearoa have recognised
that this has
led to an over zealous protection of patient confidentiality
and informed consent and a strong ‘privacy at all costs’
among the public and health professionals. 62 There is
certainly truth in this statement, particularly evident in the now repealed
section 74A(5) of the Health Act. The Amendment Act 2004
withdraws this promise of confidentiality63 in favour of
the public health need to evaluate but the significance of individual
60 Davidson, Dawson and Moore, supra n. 35, pp. 20-21.
61 Gisborne Cervical Screening Inquiry, Report, supra n. 3, [6.98].
62 McGoogan, supra n. 3, . Professor McGoogan refers to the independent review of
BreastScreen Aotearoa conducted in February 2002 by Professor Jocelyn Chamberlain.
63 Privacy Commissioner (NZ), Improving the National Cervical Screening Programme (23 July
autonomy cannot be relegated completely. If it is accepted that
confidentiality of medical records is an important right, then
distribution of benefit and burden will be when that right is infringed to the
smallest extent necessary in order to meet
the public health
On a broad analysis the policy of the Amendment Act 2004 does meet the least
harm standard. First, there is a pressing need to evaluate
the NCSP and
audit cases of cervical cancer. Secondly, overriding the consent
requirement is the best way to
guarantee a meaningful evaluation and
the access powers of evaluators are constrained. On a closer inspection
are a number of issues that give legitimate cause for
1. Opting off the NCSP
A decision to opt off the NCSP is, in many respects, an empty gesture as it
does not ensure the privacy of a patient’s records.
smear history and treatment record of a woman who opted off the NCSP and is
diagnosed with cervical cancer can provide
valuable information about the
screening programme so the records of this class of women have been brought
within the scope of
an evaluator’s access powers. Their
epidemiological value however, does not seem to provide sufficient
for accessing the records without the individual woman’s
knowledge or consent. In such a case, the Amendment Act is not
removing the need for a positive consent; it is overriding a decision that is
analogous to a competent refusal of medical
treatment. As stated by the New
Zealand Law Society in their submission on the Bill, “[i]t seems hard
to justify the
non-consensual accessing of a person’s medical
records to evaluate a screening programme in which that person does not
actually participate. [emphasis added]”66 Further,
64 This is broadly analogous to the regulations and standards for research using identifiable health information. Both in New Zealand and overseas the emphasis is on pursuing research in a manner that will cause the least harm to the individual involved whether their consent is required or not. For the United Kingdom see Medical Research Council, Personal Information in Medical Research (January 2003) http://www.mrc.ac.uk/pdf- pimr.pdf. For New Zealand, see generally Davidson, Dawson and Moore, supra n. 35.
65 Manning , supra n. 31, p. 400.
66 New Zealand Law Society, Submission on the Health
(Screening Programmes) Amendment Bill (18 March 2003).
m. (Emphasis added.)
benefit that would mitigate the intrusion of privacy accrues to the
woman who has opted off the NCSP.
2. Selection of relevant information
Primary health care records frequently contain sensitive information
about the individual. Although the Clinical Leader of
the NCSP and the
Director-General of Health have both stated that evaluators will only be
interested in a woman’s smear
history,67 this limit is not
found in the words of the statute. Evaluators are given full access to all
information held by a hospital, laboratory
or health practitioner on a
relevant woman subject only to limits the Director-General may chose to impose
at some stage, and
the oversight of the woman’s doctor. Some
writers have questioned the ability of evaluators to accurately identify
all relevant information from patient files without “trawling
through a woman’s life history”.68 The dubious
efficacy of the limits on evaluators reduces their value in being able
to allay the privacy intrusion and so
justify it. It also means the
Amendment Act goes well beyond the standard expressed in the HIPC that in
any case where
information is released, “it must only be the minimum of
information to secure the desired result.”69
3. Obtaining consent
A crucial aspect of the case supporting the Amendment Act access
provisions is the contention that it would be impossible
consent from the necessary number of women to make an evaluation worthwhile.
Some women may refuse access to their
files and others will have died or
otherwise not be traceable. This was a key concern about the national
evaluation and cancer
audit that the Gisborne Inquiry Committee sought.
The intended time frame for consideration was the first decade of the
operation so concerns about the ability to obtain the requisite
level of consent are very reasonable. The same cannot be said
contemporary evaluation and audit which
67 See respectively Lewis, supra n. 10 and National Cervical Screening Programme, Sample Letter Important information about the National Cervical Screening Programme (21
February 2005). http://www.healthywomen.org.nz/NCSP/ncspPDFs/letter_QandA.pdf.
68 McLean, ‘Dear Aunty Karen’, supra n. 30, p. 15.
69 Briscoe, supra n. 44.
will become the norm under the Amendment Act. An Auckland University audit of cervical cancers diagnosed between 2000 and 2002 achieved very high response rates to consent for an interview and consent to access medical records: 85 percent of the women approached consented to at least one form of data collection, and 78 percent consented to all forms. The authors of the report note that their results indicate that “with appropriate resources and processes, it is possible to obtain high consent rates from both Mäori and non- Mäori women for interview and access to medical records.”70
Professor McGoogan in her report on the NCSP also notes that
obtaining individual women’s consent for participation
in the audit has
been relatively successful, though fairly slow.71
The results of the Auckland University audit also challenge the view that
the participation of all relevant women is necessary for an
evaluation or audit to be accurate and worthwhile. As noted earlier, a more
data set produces more accurate results. The Amendment
Act is clearly grounded in the belief that access
to the histories of all
women enrolled on the Register and those who develop cervical cancer is vital to
an accurate and meaningful
evaluation, a view shared by the Ministry of
Health and Gisborne Inquiry Committee. The question of what is an
level of accuracy for this kind of study is an epidemiological one.
However, the measure of this is not. The level of accuracy must
be necessary to
meet the public health goal of evaluation of the NCSP and not merely be an
additional bonus of an efficient data
If the Auckland University levels of consenting participation can be
replicated in further evaluations and audits, and it
can be shown that they
produce meaningful and accurate evaluations, then a core
justification for removing the consent
requirement no longer exists. Further,
and this point will be returned to below, it shows that there is another
option that would obviously involve less harm to
70 University of Auckland, The New Zealand Cervical Cancer Audit, supra n. 51,p. 3.
71 McGoogan, supra n. 3, .
4. Informing women
The information provided to women about the Amendment Act changes could be seen as somewhat misleading as they are less than forthright about important details. The main contention is not that the information is inaccurate, but that it does not clearly or directly describe the scope of access that evaluators of the NCSP now have.72
A letter sent to all women enrolled in the NCSP73 is couched
in the language of discretion and limitation: “evaluators may
need to look at the personal health records of some women” to get
information about what smears a woman has had, how often she
has been tested,
and the results of those smears. The background to the passage of
the Amendment Act and the words
of the statute clearly show however that
evaluators will be looking at the health records of many women and
that they have full access to any information contained therein that they
deem relevant to their evaluation. Regulations that could limit this
scope74 have not been established and are unlikely to
significantly curtail the powers of evaluators as this would defeat the purpose.
In his submission on the Ministry of Health’s discussion
document proposing the changes to the Health Act, the Privacy Commissioner
queried the lack of clear and specific statements about what relevant
information is, what evaluation
involves and what exactly will be
audited against what standards.75 This lack of precision
persists and tends to undermine the claim that women are adequately informed
so as to justify or remove
any invasion of their privacy.
5. The benefit to women
In general women will certainly benefit from a quality assured cervical
screening programme. What is less clear is that there
can be direct
benefit from the use of their health records. If an evaluator considers a woman
needs follow up treatment or
becomes concerned about a health
practitioner’s competence they may disclose the information
72 See McLean, ‘Dear Aunty Karen’ supra n. 30, 15 and McGoogan, supra n. 3, . Professor McGoogan notes that “institutional ‘speak’ and jargon is commonly used” by the NCSP and that communication with the public could be improved.
73 National Cervical Screening Programme, Sample Letter, supra n. 67.
74 Health Act 1956, section 112ZF.
75 Privacy Commissioner (NZ), supra n. 63.
the relevant people76 but there is no duty for them to
act.77 If the core premise of the argument in favour of the
changes is that they will ultimately benefit women, it begs the question
evaluators are not obligated to act in these circumstances. This is
especially surprising when viewed against the history
of the NCSP.
6. Medical ethics
The medical practitioner’s duty to keep confidential the
secrets confided in her is integral to the ethical basis
of her practice, and to
the patient-doctor relationship. Patients must trust in this confidentiality to
ensure good health care.
Medical ethics and the law do not always agree
however, and in the case of NCSP evaluations there is a tension between the
of epidemiologists and the ethics of clinicians. The New Zealand
Medical Association remains concerned that if a woman who has
opted off the NCSP
and has developed cervical cancer refuses to allow evaluators access to her
records, ethically her doctor ought
to defy the Act.78 In so doing,
the doctor will be exposed to a fine of up to $10 000.79
Medical professionals are left in an uncomfortable position between
the basic duty of confidence they owe to their
patients and the law
The overarching justification for the policy of the Amendment Act is that
removing the requirement for additional consent from
women is the only
desirable and practicable way to meet the public health need to evaluate the
NCSP. The existence of other viable
options that involve a lesser incursion
into individual women’s rights of privacy would severely diminish
of this argument. The obvious alternative is to reinstate the
consent requirement and the University of Auckland Audit shows that
work. Another possible solution is for the decision on whether consent is
necessary or not to be left to ethics committees
to decide on a case by case
basis. This would involve the
76 These are: the authority responsible for the registration of practitioners of the profession that the person concerned practises, the Accident Compensation Corporation or the Health and Disability Commissioner.
77 Health Act 1956, section 112Y.
78 Briscoe, supra n. 44, p. 7.
79 Health Act 1956, section 112ZP.
newly established National Ethics Committee revising ethics committee
guidelines to require consideration of the “moral obligations
audit” when making decisions.80 While this cannot guarantee
the participation of all eligible women in all audits or evaluations,
ethics committee oversight
is itself an important quality control
mechanism in their design.81
The Health (National Cervical Screening Programme) Amendment Act
2004 highlighted for New Zealanders the tension between individual and
community interests that is the central clash of any
public health law.
The individual right to confidentiality of personal health
information is deeply entrenched,
especially in the context of cervical
screening. The controversy is that in this instance, the debate has been
resolved in favour
of the community interest in evaluation of the
NCSP. Fundamentally, the underlying rationale of the Amendment Act is sound.
Overriding consent requirements is the best way to guarantee a thorough audit
of the NCSP and cervical cancer cases in order
to make the screening
programme better. Importantly however, the above analysis shows that
there are key aspects
of the policy that cannot be justified. Women
who opt off the NCSP and develop cervical cancer are still subject
the Amendment Act despite an explicit decision not to participate, simply as
a result of the disease they are diagnosed with.
The emphasis on limits to the
type of information that will be collected is rhetoric only with no specific
grounding in the legislation.
There are also significant flaws in the
content of the justification arguments: obtaining consent from a sufficient
of women to make the evaluation meaningful is not necessarily
unduly onerous; the information available to women is not
candid about the use
of their primary health care records or the specifics of opting off the
register; evaluators are not
obliged to act on evidence of
practitioner incompetence or the need for further treatment; and, there are
alternatives that are less of an intrusion on women’s
80 Paul, supra n. 53, p. 500.
81 Ministry of Health, Progress in Implementing the
Recommendations, supra n. 48, [6.4].
New Zealanders do not have a good understanding of public health
screening programmes and what they necessarily entail.82
The Gisborne Cervical Screening Inquiry demonstrated that this has
to change and evaluation and audit accepted as
an integral part of
screening programmes. This will not happen if the policy adopted
appears to be unjustified and venture
too far into the realm of personal
autonomy. There are a number of significant legal and ethical concerns that
underlie the public
controversy about the Amendment Act and these ought to
be addressed in order to meet the least harm standard and dispel women’s
unease about this use of their personal health information. Even so, the
Amendment Act provisions are grounded in concern for women’s
they will ensure the quality of New Zealand’s National Cervical
Screening Programme. Ultimately, the decision
to allow the non-consensual use
of women’s health records to facilitate this is the right
82 McGoogan, supra n. 3, .