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CHAPTER 3 - WHETHER THE GOVERNMENTS RESPONSE TO THE
ALLARS INQUIRY RECOMMENDATIONS HAS BEEN FAIR AND ADEQUATE
3.1 As noted earlier the Allars report, containing 11 major recommendations,
was tabled on 28 June 1994. The former Government responded to the report
on 7 November 1994 by announcing a $10 million package of measures to
implement the report's recommendations. The then Minister, Dr Lawrence,
said at the time that the funds would `ensure that pituitary hormone recipients
and their families receive ongoing medical, counselling and support services'.[1]
3.2 Central to the package was the establishment of the Human Pituitary
Hormones Trust Account (the Trust Account) with an allocation of $5 million
in 1994-95 to provide an ongoing commitment to fund counselling services
until at least 2002-03 and to fund State based support groups until at
least 2010. A copy of the Management and Administration Guidelines relating
to the Trust Account is at Appendix 4.
3.3 In relation to this particular term of reference, the CJD Support
Group Network (CJDSGN) commented that the terms of reference of the Allars
Inquiry were broad when it came to investigation but very narrow as to
what could be recommended. Consequently the recommendations `worthy though
they are, fail completely to address the striking examples of negligence
that the body of the Report reveals.'[2]
3.4 Professor Allars referred to this aspect, submitting that `neither
compensation nor the issue of criminal or civil liability of medical practitioners
were part of my terms of reference. Consequently I made no recommendations
on these issues. I make no comment on them now.'[3]
3.5 The CJD Support Group Network noted, and this Committee has also
found, that at the time the Allars Inquiry was established little action
had occurred to address the issues raised by the realisation that the
AHPHP had resulted in deaths of Australians. However, during the period
of the Allars Inquiry activity increased. The CJDSGN has commented that
`looking now at the Allars recommendations it is clear that many of the
things that recipients asked for in the course of the inquiry were found
not to be as important as more information became available'.
3.6 Professor Allars submitted that the response made by the government
to her recommendations:
was fair and adequate. Indeed in some respects it exceeded my
expectations. I say this in particular with regard to the allocation
of $10 million towards the response, including establishment of a trust
fund of $5 million which is available to finance the medical care of
any hormone recipient who falls ill with CJD. This was a response more
generous than the recommendations. The broad recommendations dealing
with the needs of recipients were met.[4]
3.7 The CJDSGN generally supported these comments, concluding that:
the Government's response to most of the recommendations of Allars
has been adequate and within the spirit if not the letter of the recommendations.
The exception is Recommendation 5 where the remedy is within the scope
of the Department but the situation has not changed.[5]
3.8 The action taken in response to each of the Allars recommendations
is detailed below.
Allars recommendation 1: That research funds be allocated for:
provision of adequate laboratory facilities equipped to conduct
research into the infective CJD agent; study of the nature of
the infectious CJD agent, including through genotyping for increased
susceptibility to CJD infection; extension of the period of retrospective
analysis of CJD cases by the CJD Registry to 1973 and prospectively
to 2005, with a review at that time; an epidemiological study
of hormone recipients in Australia be commenced, coordinated with the
work of the CJD Registry; development of an effective therapy
for CJD; and development of improved methods of diagnosis of
CJD.
3.9 The CJDSGN prefaced its comments on this recommendation by noting
that at the time of the Allars report there had been little research into
transmissible spongiform encephalopathies in Australia. The Support Group
Network submitted that `at the time it seemed reasonable to search for
diagnostic tests and therapies and to monitor the health of recipients.
As the Department and recipients grew to understand more of what the situation
really was, priorities changed.'[6]
3.10 By June 1994 the Pituitary Hormones Task Force (PHTF), which had
been established within the Health Department in May 1993, sought the
National Health and Medical Research Council's (NHMRC) advice on how Australian
researchers could be encouraged to undertake more research in this area.
A three year grant was subsequently approved for the University of Melbourne
to undertake a research project. The NHMRC advised the Committee that
it has awarded $252,385 to a number of projects specifically directed
to CJD research since 1994.[7]
3.11 The package of measures announced in November 1994 in response to
the Allars report included funding of $1.1 million over four years for
research. This funding was in addition to that approved by the NHMRC for
CJD related research. However, before these funds could be allocated,
research priorities needed to be clearly established.
3.12 An International Scientific Research Workshop on CJD was organised
by the Department and held in Melbourne on 28-29 May 1995 to discuss the
genetics, pathology and diagnosis of CJD, transmission and the nature
of the CJD agent, as well as epidemiology and infection control. The primary
goal of the Workshop was to identify the priority areas for scientific
and medical research into CJD internationally and in Australia.[8]
3.13 An extraordinary meeting of the National Pituitary Hormones Advisory
Council (NPHAC), attended by overseas experts, was held immediately following
the Workshop, to decide on research priorities. The areas of research
identified were seen as having long term benefits towards the development
of preventive therapy, diagnostic tests and possible cures for CJD. Following
a process of advertising, assessment of grant applications and interviews,
two research grants were approved - to Dr Roberto Cappai, University of
Melbourne and Dr Jill Gready, John Curtin School of Medical Research,
ANU. These research projects commenced on 1 January 1996 and are still
in progress.[9]
3.14 A number of recipients expressed an interest in being kept informed
of progress with current research. NPHAC indicated that a plain English
summary of current research had been prepared for the information of recipients
and their families. The summaries would also be published on the Internet.[10]
The Committee notes that the September 1997 HPH Newsletter refers
to the availability of these research summaries from a departmental freecall
number.
3.15 NPHAC decided that a survey of recipients should be conducted before
proceeding to a full epidemiological study. The survey, distributed in
June 1995 to 1580 recipients, sought information as to whether recipients
would be prepared to participate in an epidemiological study and whether
they would agree to information that was collected being used for epidemiological
research. Of the 676 respondents, 538 indicated that they were prepared
to participate in an epidemiological study.[11]
The CJDSGN submitted that:
There was considerable variety of opinion among recipients about
the aim of such research. Many saw the proposed study as a chance to
investigate possible side effects of the hormone treatment. Others were
alarmed at the potential invasion of their privacy in such a study.
Very few appreciated the original purpose of the study, which was to
watch all recipients for up to thirty years in order to see how many
cases of CJD developed and if possible draw conclusions.[12]
3.16 In August 1995 NPHAC discussed the appropriateness of conducting
an epidemiological study in light of the responses to the survey. A Working
Group was organised to consider whether or not an epidemiological study
should proceed. The Working Group recommended in January 1996:
That no epidemiological study be undertaken, apart from that
encompassed by the CJD Case Registry and Human Pituitary Hormone Data
Base for the following reasons:
- there are no current measures of the disease and no way of
knowing what number of recipients were exposed to the disease;
- it is impossible to calculate the risk of the disease for
individual recipients with only potentially a statistically small
number of recipients at risk. Any results would be very unlikely to
ever reach statistical significance;
- the study would be of limited value because of the small number
of recipients participating and potential selection bias of such a
volunteer group; and
- intrusion into the privacy of recipients is not justified
without potential benefits.[13]
3.17 NPHAC endorsed this recommendation in February 1996. The Department
indicated that the funding which had been allocated for the epidemiological
study should be transferred to the research grants fund. NPHAC requested
its Scientific Research Subcommittee (SRSC) to identify research priorities
for the allocation of the funds. Research priorities identified by the
SRSC the establishment of `Case Match Controls' for the CJD Case Registry
and an additional research position for Dr Cappai's project were endorsed
by NPHAC in July 1996.
3.18 The Committee notes that one of the reasons advanced for not undertaking
the study was its `limited value because of the small number of recipients
participating'. However, the survey had indicated that over 25 per cent
of known recipients were willing to participate, a surely not insignificant
sample.
3.19 The Committee received evidence that a number of recipients believe
that they have suffered, or have had accelerated, other health problems
as a result of being on the AHPHP. The Committee is unaware of any coordinated
approach to testing whether these health problems are linked to HPH treatment
or not. In this respect the Committee considers that any data from the
recipients in relation to possible long term side effects from the treatment
must be better than no data at all.
Recommendation 1: The Committee recommends that the decision not to
proceed with an epidemiological study be reconsidered. However, any future
study should not be limited only to the Allars recommendation that it
be undertaken in the context of monitoring past and possible cases of
CJD in the recipient community.
3.20 The CJD Case Registry was established in May 1993 at the instigation
of Professor Colin Masters, Head of the Pathology Department, University
of Melbourne.
3.21 In response to that part of the recommendation relating to the CJD
Case Registry, an Agreement was reached between the Commonwealth and the
University of Melbourne in July 1994 for the continuation and maintenance
of the CJD Case Registry by the University of Melbourne. Funding of $300,000
was provided as part of the November 1994 package of measures to extend
the period of prospective analysis of CJD cases to 2010 five years beyond
that recommended by Professor Allars.
3.22 As at July 1997, the functions of the CJD Case Registry, are to:
- Obtain a better understanding of the risk factors and demographic
trends associated with the occurrence of CJD in Australia and New Zealand,
leading to recommendations to the Australian Government on the best
way to manage the problem of CJD and related prion diseases.
- Monitor and review the scientific and medical developments which relate
to CJD and related subjects and provide advice to the Department as
appropriate. Specifically:
- ongoing monitoring and review of the scientific and medical literature
which relates to CJD and related subjects;
- providing a current awareness service for the Department bringing
to its attention any major developments that might be of concern
to people treated with human pituitary derived hormones;
- a quarterly review of major findings or research developments
relating to CJD and other prion diseases, which could be included
as part of the quarterly report of the CJD Case Registry, in addition
to any major developments as outlined above;
- the provision of both timely and accurate advice to the Department
in response to periodic requests for information on scientific matters
relevant to CJD and pituitary hormone treatment from the Department;
and
- maintain and update a database of CJD and related references.
- Improve awareness of the disease in the medical and general communities
to prevent future iatrogenic transmission of CJD occurring.
3.23 Currently, the CJD Case Registry is funded to:
- Collate and analyse cases of CJD as they occur in Australia over the
period 1993-2010;
- Retrospectively analyse the CJD cases occurring in Australia over
the period 1973-1992;
- Identify the clinical characteristics, possible risk factors and geographic
distribution of the disease occurring in the Australian and New Zealand
populations;
- Work on a collaborative basis with similar registries overseas, particularly
that being established in New Zealand and with the UK Surveillance Unit;
- Monitor the incidence of CJD in Australia and overseas (including
the UK, EC, and USA) in human pituitary hormone recipients and in the
population in general;
- Provide timely and accurate advice on scientific and medical developments
relating to CJD and related subjects on a regular basis, on request
and as otherwise appropriate; and
- Actively promote the CJD Case Registry functions within relevant bodies
in the medical and scientific communities.[14]
Allars recommendation 2: That the Advisory Committee monitors the
approval and conduct of such research to ensure compliance with counselling
procedures and with ethical standards. 3.24 The Scientific Research
Subcommittee (SRSC) of the Advisory Committee (NPHAC) was established
on 17 February 1995:
to provide the breadth of expertise to cover the range of medical/scientific
disciplines in which research is currently being undertaken, to ensure
that related research and issues across disciplines are identified and
that all relevant research developments are taken into account in working
towards an improved understanding of the disease and a diagnostic test
and treatment.[15]
3.25 The SRSC provides advice to NPHAC and the Department on:
- research which may have a bearing on the welfare and well-being of
human pituitary hormone recipients;
- overall trends and developments in research drawing on the range of
disciplines and expertise of the Subcommittee;
- identify research priorities and assist in the promotion of research
into CJD and related diseases in Australia;
- in cooperation with the NHMRC, through mechanisms to be developed
by the Department, assess the technical merits and viability of solicited
and unsolicited research proposals seeking funding in the NPHAC's research
priorities; and
- monitor progress of research projects funded through the Department
and in conjunction with the NHMRC.[16]
3.26 The CJDSGN noted that this recommendation was based on the assumption
that recipients would be involved in research. As indicated in Recommendation
1 above, the research which was undertaken did not involve social or epidemiological
research, so that the SRSC has to date not had a need to consider compliance
with counselling procedures.
Allars recommendation 3: That the CJD [Pituitary Hormones] Task Force:
continue to trace recipients of pituitary derived hormones and maintain
its current staffing until that task nears completion; continue
to publish `CJD News' on a regular basis; develop the database
so that it provides a useful resource for recipients, subject to Information
Privacy Principles; subject to compliance with Information Privacy
Principles, within the next eight months administer a survey to recipients
in order to supplement the material in the database with further information
relevant to the needs of recipients; ensure that an information
evening about pituitary hormones and CJD is held in each capital city
in Australia at six monthly intervals, with a review of the need for
further evenings after 12 months.
3.27 The package of measures announced by Dr Lawrence allocated $3.9
million for the Pituitary Hormones Task Force to continue its work in
these areas.
3.28 The CJDSGN has commented that when the Allars Inquiry concluded
the Task Force was reasonably well staffed, headed by an SES officer with
direct day to day involvement and with a Medical Adviser whose primary
role was to provide information to recipients and their health care providers.
However, in the last 18 months the Task Force has been disbanded and responsibility
moved to the new National Centre for Disease Control. There is no longer
a senior officer involved on a daily basis, nor a dedicated Medical Adviser.
The CJDSGN asserts that this `has resulted in cooperation between the
Support Group Network and the Department reaching its lowest point ever'.[17]
3.29 In respect of the specifics of this recommendation, the Department
indicated that a number of strategies have been used to trace recipients
treated through the AHPHP. In November 1990 original treating doctors
under the AHPHP were asked to contact all hormone recipients, advise them
of the association between their treatment with pituitary derived hormones
and CJD and counsel them not to donate tissue organs and blood. After
the second death was confirmed a further letter was sent to the original
treating doctors. However, by November 1992 only a third of former recipients
had been traced.
3.30 Other strategies used by DHFS included placing advertisements in
the Australian Women's Weekly, New Idea and Who magazines
variously in December 1992, January 1993 and August/September 1994; matching
names against the Health Insurance Commission's Medicare records in March
1993; and a data matching exercise conducted in consultation with the
Australian Electoral Commission in October/November 1994.
3.31 However, as at July 1997 only 90.2 percent of all recipients treated
through the AHPHP had been traced.[18]
This figure does not include the unapproved recipients. Tracing efforts
have now largely ceased.
3.32 The CJDSGN commented in relation to tracing that:
Unfortunately much of the onus has been placed on recipients
to put themselves in contact [with the Department]...Each round of media
publicity brings a new rush of anxious people who believe they might
have received pituitary hormone treatment but were unaware that support
and counselling services were available. In some Statesit seems that
there was a breakdown between the initial letter from treating doctors
and establishing contact with the Department.[19]
3.33 The Committee considers that the attempts by the Department to trace
hormone recipients have been totally inadequate, especially at a personal
level given the nature of the risk recipients have been subjected to.
Considerable anecdotal evidence was received by the Committee that rather
than being `traced' by the Department's actions, many recipients only
learnt of the risk resulting from their participation on the AHPHP through
TV current affairs shows and magazine articles. Discovering their risk
in such a manner caused considerable shock, anxiety and distress for many
recipients. The unsatisfactory nature of this aspect is commented upon
further in Chapters 5 and 7.
3.34 The CJD News, which changed name to the HPH Newsletter,
was produced quarterly during 1995. Following a recommendation by NPHAC,
it was reduced to a six monthly publication alternating with the production
of National Network News by the CJD Support Group Network. The
Department agreed to produce special edition newsletters or flyers if
events occur which recipients need to be made immediately aware. The special
edition published to advise recipients of this inquiry is an example.
3.35 The CJDSGN commented that the range of information offered in the
HPH Newsletter `has shrunk considerably with the shrinking of Departmental
staffing and with the hiving off of responsibility for keeping abreast
of scientific issues to other Departments'.[20]
3.36 The Department advised that from November 1993 a new database called
the AHPHP Patient Database was developed in consultation with staff from
the Pituitary Hormones Task Force. The aim `was to develop a more user
friendly database which looked to the future, presented patient records
in a clearer and more accessible manner and had greater reporting capacity'.[21]
The Department indicated that:
The AHPHP Patient Database holds data relating to people who
applied for or received treatment with human pituitary derived hormones
under the AHPHP. Data is also held for people who are known to have
received treatment with human pituitary derived hormones outside the
provision of the program. [The position of these unapproved recipients
is considered in Chapter 7]. Also recorded are the names and addresses
of doctors associated with the treatment, and names and addresses of
general practitioners nominated by recipients.[22]
3.37 The Committee notes that the Allars recommendation for the development
of the database was `so that it provides a useful resource for recipients'.
However, the Committee received evidence that some recipients held concerns
about the type of information retained on the database and the use to
which it is put.[23]
3.38 A survey was distributed on 20 June 1995 to 1580 recipients for
whom the PHTF had an address, seeking information to verify the personal
details contained on the PHTF's database, asking whether recipients would
be interested in taking part in an epidemiological study, and feedback
on services currently provided. A total of 676 recipients (or 44 per cent)
responded. A report on the survey was released in April 1996. The main
issues arising from the survey, namely: conducting an epidemiological
study, sharing of information, information strategies, and delivery of
services, are discussed in the DHFS and NPHAC submissions.[24]
3.39 The Department indicated that 11 information sessions were held
throughout Australia during 1994. In February 1995 a communication strategy
to improve information dissemination for recipients and their families
was implemented. This involved the release of an information brochure
titled Treatment with Human Pituitary Hormones and the risk of Creutzfeldt-Jakob
Disease; the release of an information video Understanding CJD
which was designed to target recipients unable to attend support group
meetings or information sessions, particularly those in rural/remote areas;
translation of the information brochure and executive summary of the Allars
report into seven languages, and their transcription into talking tapes
for recipients who have difficulty reading or have a visual impairment;
and, the addition of an information homepage to the Department's Homepage
on the Internet.
3.40 NPHAC advised that an index for the Executive Summary of the Allars
Report was produced in July 1995.[25]
The Committee believes that an index for the Allars Report should be prepared
to assist people in finding information which is contained in the very
detailed Report. Such an index should be made readily accessible for all
recipients and other interested parties.
3.41 The CJDSGN commented that the information sessions were often `large
and angry occasions' with recipients who `had been systematically prevented
from gaining information [taking] the opportunity to berate Departmental
representatives for past grievances'. The Support Group Network acknowledged
that when the sessions were curtailed in 1995 they `had probably run their
course, there was little new information to provide and they were certainly
very expensive exercises. Support Group meetings are probably better venues
for information sharing and these are held regularly.'[26]
The Committee notes that many recipients have chosen not to participate
in the Support Groups. These people are potentially being deprived of
a source of information.
Allars recommendation 4: That the Commonwealth Department of Health
initiate and coordinate the development of a uniform Federal/State approach
to access to medical records and their disposal, which:
applies not only to records held in public hospitals but also to
records held by private hospitals and private medical practitioners;
and creates legally enforceable rights of patients with regard
to access and disposal of such records, either through the extension
of freedom of information legislation in each jurisdiction or through
the application of conditions to providers under the Medicare scheme.
3.42 During the period since Allars reported, recipients have continued
to experience difficulties in gaining access to their records of treatment
by their medical practitioners and hospitals. The Medical Adviser to the
PHTF assisted recipients by gaining information on records held by a number
of institutions and medical practitioners, and on how these records may
be accessed. Formal procedures such as Freedom of Information often needed
to be followed. While the Medical Adviser presented a report to NPHAC
in August 1995 based on his contact with a number of treating doctors
and hospitals,[27] the law in
the area of access remained uncertain.
3.43 In September 1996 the High Court, in the case of Breen v Williams,
decided that patients do not have a common law right to have access to
their medical records. The High Court decided that it was up to Parliament
(Federal and/or State) to legislate for the right of patients to have
access to their medical records. This decision applies to records held
in the private sector. Records held in the public health system are accessible
(with certain limitations) through State and Territory Freedom of Information
legislation.
3.44 This issue was the subject of a recent inquiry by this Committee
which tabled a report, Access to Medical Records, in June 1997.
Whilst the Government considers its response to this report, the Minister
for Health and Family Services is establishing a working party to examine
the development of a voluntary health information privacy code relating
to medical records held by private medical practitioners. The Department
believes that such a privacy code could contribute to minimising inconsistent
privacy standards across the public and private sectors.[28]
Allars recommendation 5: That section 135A of the National Health
Act 1953 (Cth) be amended; and the Department review its policy on access
to information with regard to release of information directly to members
of the public rather than through the intermediary of the medical practitioner.
3.45 The Department submitted that, in essence, s.135A of the National
Health Act protects information with respect to the affairs of third persons
which is held by the Commonwealth. Access to the information is permitted
only to the person whom it concerns, or persons they authorise, except
for a number of limited situations mainly concerned with the administration
of the law, or where the Minister certifies that release is `necessary
in the public interest'. Section 135A provides interalia:
Officers to observe secrecy 135A. (1) A person shall
not, directly or indirectly, except in the performance of duties, or
in the exercise of powers or functions, under this Act or for the purpose
of enabling a person to perform functions under the Health Insurance
Commission Act 1973, and while the person is, or after the person
ceases to be, an officer, divulge or communicate to any person, any
information with respect to the affairs of a third person acquired by
the first-mentioned person in the performance of duties, or in the exercise
of powers or functions, under this Act. Penalty: $5,000 or imprisonment
for 2 years, or both.
(2) Where the third person mentioned in subsection (1) is a
party to an action or proceeding before a court, nothing in that subsection
precludes the disclosure to the court of information with respect to
the affairs of the third person.
(3) Notwithstanding anything in subsection (1), the Secretary
may: (a) if the Minister certifies, by instrument in writing, that it
is necessary in the public interest that any information acquired by
an officer in the performance of duties, or in the exercise of powers
or functions, under this Act, should be divulged, divulge that information
to such person as the Minister directs;
(b)...
(c) divulge any such information to a person who, in the opinion of
the Minister, is expressly or impliedly authorised by the person to
whom the information relates to obtain it.
3.46 This recommendation was considered by the Australian Law Reform
Commission (ALRC) in the context of its review of portfolio legislation.
The ALRC recommended in Report No.72 that all information held by government
should continue to be protected, but that personal information in particular
should be protected with criminal sanctions for both unauthorised release
and unauthorised solicitation.
3.47 According to DHFS this recommendation led the Department to the
conclusion that it was desirable to maintain s.135A once it was satisfied
the provision did not prevent access by individuals to their own records.
The Department submitted that:
Release of their own information under s.135A has been made available
to all hormone recipients on request, including explanation and contextual
information provided by release through a treating medical practitioner...
Information which does not refer to the personal affairs of a third
party is provided to the inquirer once that person is identified as
the person to whom the information refers, generally through a nominated
general practitioner who knows the person and who is available at the
time of the release of the information to provide counselling should
the information be distressing or confusing.[29]
3.48 In summary, the Department made the following statement:
The Department takes its obligations in respect of the medical
information of individuals very seriously, and believes that most members
of the public would be concerned to see the continued maintenance of
stringent controls to safeguard their privacy. It is an inevitable concomitant
of such a system that information may not always be automatically available,
however, the Department believes that the very least that can be done
in this respect is to ascertain the identity of the person asking for
their records. Similarly, the release of information through a medical
practitioner is in fact a mechanism for providing more and better quality
information, by providing explanations, context and counselling, and
is only one of the options available for access. It is preferred because
the Department understands the sensitivity of the records and the anxiety
and concern that may be quite unnecessarily exacerbated by inadequate
information on the face of the record, or by conflicting information
coming from other sources such as the media. However, as indicated above,
the Department has upon being requested, forwarded medical information
directly to hormone recipients provided that the person has been positively
identified as the hormone recipient to whom the information relates.[30]
3.49 The Committee received anecdotal evidence from a number of recipients
challenging these comments. In relation to this recommendation the CJDSGN
commented that:
This recommendation arose out of frustration suffered by people
who suspected they were treated with pituitary hormones and were unable
to verify this with the Department except by having information sent
to a nominated doctor. To many people this represented unacceptable
delay in accessing their own medical history and required them to share
information with another party whether they wished to do so or not.
Despite many representations from the Support Groups and from NPHAC
it is still the case that initial confirmation that you have been part
of the pituitary hormone treatment program must go via a nominated doctor.
Opinion seems divided as to whether the purpose of this is to ensure
that informed interpretation is available immediately or to ensure that
the information only goes to the person it concerns. Whichever may be
the reason, it is a process which is unacceptable to many recipients.
They feel they have a right to receive such information directly and
to choose for themselves whether they need to share it with their medical
practitioner.[31]
3.50 The difficulties experienced by a number of recipients who described
to the Committee their attempts to obtain information, especially through
freedom of information procedures, and directly access their own records,[32]
supports these views expressed by the CJDSGN. The Committee considers
that, on balance, the part of this recommendation to facilitate the release
of information directly to recipients has not been satisfactorily addressed.
The Committee feels that renewed pressure will be put on the Department
to provide individual information, particularly batch number and treatment
information, following the notification of the probable sixth CJD case.
The Department's interpretation of s.135A and the release of information
is discussed further in Chapter 4.
3.51 The Department noted that the Attorney-General's Department is reviewing
existing secrecy provisions with a view to coordinating them and promoting
a consistent approach. It maintained that any proposed amendment to s.135A
should await the outcome of this review.
Allars recommendation 6: That the counselling service for recipients
provided by Marriage Guidance Australia continue to be funded.
That the counselling of recipients for whom the service provided by
Marriage Guidance Australia is inaccessible or unsuitable should be funded
and made available in accordance with published principles. 3.52 The
provision of counselling services for recipients has been a particularly
significant and highly contentious issue during the 1990's.
3.53 The first nationally available counselling service for recipients
was established through what was then Marriage Guidance Australia (later
Relationships Australia) in October 1993. The Department chose to give
a national contract to one organisation rather than have a series of State
specific providers.
3.54 The package of measures announced by Dr Lawrence in November 1994
provided continued funding for free counselling services through Relationships
Australia to be available until the year 2002-03. This would be provided
through the $5 million Trust Account established for medical and other
care costs, including funding future counselling and support services.
Ongoing funding requirements for counselling services is to be evaluated
in 1997-98 by the PHTF.
3.55 In addition, a one-off amount of $50,000 was provided to cover the
costs of private counselling in a small number of cases where a therapeutic
relationship had developed before October 1993 when the national counselling
service became available and counselling was required to be undertaken
through Relationships Australia. Guidelines for Access to Funding for
Special Counselling were prepared by the PHTF and a Counselling Services
Review Panel was established to assess the eligibility of claims for reimbursement
made under these guidelines and any need to review special counselling
arrangements. However, the Committee received evidence that the procedure
for reimbursement prescribed by the government was `cumbersome and difficult'.
One reimbursement offer was apparently only made after `extensive correspondence
and haggling'.
3.56 The CJDSGN wrote that the Marriage Guidance Service had problems
from the beginning. Many of those wishing to access their services were
restricted to telephone counselling or had to travel great distances at
their own expense to see a counsellor. Over time the Support Groups received
more and more complaints about limited access to counselling and the CJDSGN
became concerned that very few recipients (allegedly dropping to less
than one hundred people across Australia) were in fact receiving counselling
for the high fee (about $500,000 per annum) being paid to Relationships
Australia.[33]
3.57 The Committee also received considerable anecdotal evidence which
supported this view of the difficulties experienced by recipients with
the counselling arrangements offered through Relationships Australia.
Many of the personal submissions described individual problems recipients
had with the counselling service. In particular, some recipients found
the free counselling to be not appropriate for their circumstances and
continued private counselling at considerable personal financial cost.
3.58 NPHAC discussed the difficulties experienced by recipients with
counselling at meetings in May and August 1995. From this time, the community
members of NPHAC began a concerted campaign to make the counselling service
more accountable and flexible. In February 1996 NPHAC established a Counselling
Services Subcommittee to document problems with existing services, define
the nature of counselling required by recipients and their families, list
the expectations of recipients and their families regarding the delivery
of counselling services, and propose options on the future direction for
the provision of counselling services.
3.59 The Subcommittee reported in August. NPHAC endorsed the Subcommittee's
recommendations and presented them to the Department in the Report
of the NPHAC on the Future Direction of Counselling Services for Human
Pituitary Hormone Recipients and their Families in September 1996.
A copy of this report is at Appendix 5. The Department accepted the recommendations
with some minor changes.
3.60 The Human Pituitary Hormone Counselling Service, which implements
the recommendations in the NPHAC report, came into operation on 1 October
1996. These new counselling arrangements provide a network of organisations
and individuals certified to offer appropriate and free counselling to
recipients and their families. Under the new arrangements, recipients
can choose their own counsellor or use an already accredited provider.
Suitably qualified professionals from Relationships Australia, other non-government
agencies, private psychologists and social workers can apply for approval
through the Counselling Panel. Recipients need to provide their names
but these are kept confidential. Payment is made directly to the providers
on an agreed scale. All recipients and family members are entitled to
fifteen counselling sessions, after which a panel of clinical psychology
experts assess their ongoing needs.
3.61 The Counselling Panel's role is to:
- certify providers;
- provide recommendations to the Department on exceptions to length
of counselling or the provision of services outside the normal counselling
parameters; advice concerning group proposals or the appointment of
an established provider who may fail to meet all essential criteria;
and
- act as a resource for recipients and their families.
3.62 Disputes between recipients and counselling providers would be handled
by the counselling provider's professional association or organisation
employing the individual provider. The Counselling Panel may provide advice
to recipients on how they might make their complaint.[34]
3.63 The Department emphasised that the intention of the new counselling
arrangements was to provide more flexibility so that people from disciplines
such as psychiatry could be included, rather than confining the counselling
arrangements to one organisation. The Department confirmed that since
the new arrangements had been introduced no one had been refused approval
for counselling. Approval being given either on the basis of the counsellor's
credentials or on the basis of an ongoing counselling relationship with
a recipient. The Department also explained that the fifteen counselling
sessions benchmark was chosen not to refuse service, but to trigger reconsideration
of whether counselling sessions were the most appropriate mechanism of
providing ongoing care to that recipient. Reconsideration would be undertaken
by an independent panel of clinical psychology experts which would not
include the Department or recipient representatives.[35]
3.64 The CJDSGN advised that the new counselling service has been well
documented with both the HPH Newsletter and the National Network
News having informed recipients of their rights to access the service.
The Support Group Network commented that `the new service has met with
approval from recipients. So far, no request for certification has been
denied, although some providers are accredited only for one recipient
because they meet specific needs, but not the standard to be accredited
for general access.'[36]
3.65 The Committee heard evidence that some recipients continue to hold
concerns about access to the counselling service and that, while recipients
should now have the choice of counsellor, some counsellors `are not acceptable
to the Department'. However, the Committee did not receive direct evidence
of any person or counsellor having been denied access since the introduction
of the new arrangements. The arrangements do contain a large degree of
flexibility and a dispute resolution process.
3.66 The Committee considers that additional effort may be required to
ensure that the new counselling arrangements are widely understood and
are able to be accessed by all recipients requiring such a service. In
particular, emphasis should be given that these arrangements are distinct
from, and specifically overcome the difficulties associated with, the
previous monopolistic counselling arrangements.
3.67 The need for improved information on the new counselling arrangements
can be seen through comments such as those by one medical practitioner
who submitted that there has been an upsurge in counselling since the
settlement offer was made.[37]
The distressing news of another probable case of CJD may also lead to
renewed need for and usage of counselling services.
Allars recommendation 7: That the National Advisory Group be replaced
by an Advisory Committee with the functions of providing advice to the
Task Force on:
how the Task Force may meet the needs of recipients; fostering
support groups; the operation of the database; the conduct
of the survey; and the conduct of research in which recipients
are subjects.
3.68 The National Pituitary Hormones Advisory Council (NPHAC) was established
in December 1994, to provide independent, expert advice to the Minister
on:
- how the Pituitary Hormones Section may meet the needs of recipients;
- the ongoing needs for treatment and care and counselling of recipients;
- the development and fostering of the National Support Group Network
of self-help support groups;
- the objectives and priorities with respect to research and epidemiological
studies;
- the conduct of research in which hormone recipients may be subjects
and compliance with counselling procedures and ethical standards;
- the operation of the database, the conduct of the survey of hormone
recipients and their information needs; and
- public health issues relating to people who have received treatment
with pituitary derived hormones.
NPHAC also provides advice on the welfare of hormone recipients and their
families, including current medical, legal, scientific and social issues.
3.69 NPHAC's membership comprises:
- an independent Chair;
- 6 representatives of the recipient community, including the National
Coordinator of the CJDSGN;
- 5 expert members specialising in the field of clinical research, medical/scientific
research, epidemiology, the law and counselling; and
- 2 ex-officio members from the Department.
3.70 Community representation is based on categories of recipients, rather
than geography. There were four distinct groups to take account of: female
infertility, male infertility, growth and families of deceased recipients.
Although the groups varied greatly in size, it was acknowledged that there
might well be issues particular to each of them, whereas there seemed
no real difference in issues between States. Whilst the initial membership
did not include a growth hormone recipient, with representation by a growth
hormone parent, a growth hormone recipient now sits on NPHAC.
3.71 The CJDSGN has indicated that the way NPHAC is constituted is somewhat
different from what Professor Allars envisaged. Rather than remaining
a purely recipient group advising the Task Force, NPHAC includes expert
membership and is responsible for advising the Minister. Nevertheless,
according to the CJDSGN:
recipients generally were satisfied with the process and the
results. NPHAC has worked well in providing a means of gaining expert
member support for measures seen as necessary by recipients, but not
fully embraced by the DepartmentThe Support Groups have been very pleased
with the calibre and commitment of the expert members of NPHAC [finding]
them very open to recipient concerns and attitudes and more than willing
to apply their wide experience to finding solutions.[38]
3.72 Alternative views were also put to the Committee, with concerns
being expressed about difficulties of access to NPHAC and for recipients
to be able to convey their views and opinions on various issues if they
were not linked with Support Groups.
Allars recommendation 8: The NHMRC `Code of Practice for Transplantation
of Cadaveric Organs and Tissues' be revised to set out the procedure by
which hospital authorities should obtain consent from relatives for removal
from cadavers of organs and tissue for therapeutic medical or scientific
knowledge including the purposes of research and medical education. The
Code should include a consent form for signature by the relatives, itemising
the organs and tissue to be removed and the purpose for removal in each
instance. 3.73 A revised Code, renamed Recommendations for the
donation of cadaveric organs and tissues for transplantation, was
developed and endorsed by the NHMRC in June 1996. The Code was renamed
Recommendations due to the speed of change in the number and variety of
transplantation treatments, and the parallel evolution of consistent legislation
in the States. The NHMRC hoped that the Recommendations would offer a
broadly useful reference for all those involved in identifying, retrieving,
and storing donor organs and tissues, approaching families for consent,
and fulfilling legal and ethical obligations.
3.74 The Recommendations cover legislative and social aspects and clinical
aspects of cadaveric donation of organs and tissues, including who has
the authority to remove organs and tissues, and who has responsibility
to consent to the donation, removal of organs and tissues, autopsy, and
approach to Coroner. Although Professor Allars recommended that the Code
include a consent form, the NHMRC agreed that this not be included as
different hospitals and States have different reporting requirements on
these issues. The NHMRC considered that the basis of this recommendation
was met by outlining the key components of consent including the need
to specify organs or tissues to be removed.[39]
3.75 Ethical issues involved in the donation of organs and tissues by
living donors have been the subject of four discussion papers prepared
by the Australian Health Ethics Committee (AHEC) and endorsed by the NHMRC
in June 1997. The aim of these papers is to inform and deepen public understanding
of the ethical aspects of transplantations.
Allars recommendation 9: That section 100 of the National Health
Act 1953 (Cth) be repealed and replaced by a provision which specifies
clearly the circumstances where by reason of physical and similar factors
associated with the distribution of a pharmaceutical benefit `special
arrangements' are appropriate.
3.76 Review of s.100, which relates to special ministerial arrangements
for the provision of pharmaceutical services was referred to as part of
the reference by the Attorney-General to the ALRC of the portfolio legislation
of the Department of Human Services and Health.[40]
3.77 The Committee appreciates the broadly-based nature of this review
which includes the recommendations relating to ss100 and 135A of the National
Health Act. Professor Allars also acknowledged that these `two recommendations
which have not been implemented fully are in a different category because
they require long-term effort relating to reform of the law'.[41]
Nevertheless, the Committee notes the period of time which has elapsed
since Professor Allars reported, and considers that the review of the
sections in question should be expedited.
Allars recommendation 10: That the NHMRC:
review the Statement on Human Experimentation to ensure that:
it provides guidance with regard to decisions as to whether treatment
in a therapeutic setting constitutes an experiment; and a procedure
is developed by which such decisions are scrutinised and not left entirely
to the treating medical practitioner.
issue a Supplementary Note on Reproductive Technology Procedures which
ensures that new procedures, including the use of drugs in new treatment
regimes, are:
registered with the Health Ethics Committee of the NHMRC; and
approved by the institutional ethics committee of the institution
in which the procedure is carried out; and consent is made on
the basis of full information regarding risks and outcomes as defined
in the Supplementary Note 2 on Research on Children, the Mentally Ill
and Those in Dependent Relationships or Comparable Situations.
3.78 Revision of the NHMRC Statement on Human Experimentation
to be undertaken by AHEC was commenced in December 1996. The commencement
was delayed pending the completion, in March 1996, of a Ministerial review
into the operations of Institutional Ethics Committee system in Australia.
Revising the ethical guidelines for the conduct of medical research involving
humans will be a two stage public consultation process. The revision of
the Statement on Human Experimentation will address the issue of
responsibility for ethical approval of research or innovative therapy.
It is envisaged that the revised document will be released for second
stage public consultation in early 1998. Final guidelines are expected
to be released later that year.[42]
The Committee notes that this revision is scheduled to take over two and
one half years and considers that the review should be expedited.
3.79 The Committee was advised that AHEC has not met since September
1996 and that appointments under s.36 0f the NHMRC Act for the 1997-99
triennium have not yet been finalised.[43]
Whilst the Committee understands that the chairman and one member have
been appointed and that the remaining membership is still under negotiation,
the Committee is concerned at the continuing delay in making these appointments.
The Committee believes that this situation could further delay the review
of the Statement on Human Experimentation and urges the Minister
to finalise the appointment of members to AHEC as soon as possible.
3.80 Ethical guidelines on assisted reproductive technology were
released by the NHMRC in November 1996. These guidelines, which replaced
the previous Supplementary Note referring to in vitro fertilisation and
embryo experimentation, addressed innovations in clinical practice as
well as research. However, while Allars recommended that new procedures,
including the use of drugs in new treatment regimes should be registered
with the Health Ethics Committee of the NHMRC, the NHMRC advised that
in accordance with the role and functioning of AHEC pursuant to the NHMRC
Act, the registration of new treatment regimes or drug treatments is not
a function of the AHEC. The receipt of information on the registration
of new drugs rests with the Therapeutic Goods Administration.[44]
3.81 The ethical guidelines require Institutional Ethics Committees to
approve and reconsider procedures/practices in the event of major changes
to programs or research. The guidelines also provide for informed decision
making and consent, in particular who is required to provide information,
who can consent following the provision of that information and issues
of counselling.
3.82 The NHMRC referred to a report it released in November 1995 on Long-term
effects on women from assisted conception. In reference to the AHPHP
recipients who had died of CJD, the NHMRC emphasised the need for information
about the possibility of long-term effects of new treatments and the importance
of informed decision making about any proposed treatment. The report made
some recommendations similar to Allars recommendation 10, particularly
that AHEC should review the definition of `experimental' and `non-experimental'
treatments to clarify for patients or consumers the status of the specific
use of drugs, devices and procedures. Work to implement this recommendation
began in December 1996.[45]
3.83 The report also recommend that the outcomes for HPH recipients should
be included in general studies of the outcomes of assisted ovulation.
The report suggested a number of research studies, one of which could
investigate whether women who received hPG had higher incidence or death
rates of cancer, particularly ovarian or breast cancer, than the general
population of women of comparable age. The NHMRC report commented that
NPHAC could consider including ovarian and breast cancer as outcome measures
in a broader epidemiological study of the health of HPH recipients.[46]
As noted earlier NPHAC decided that the epidemiological study recommended
by Allars would not proceed. It is the type of information sought in this
proposal which is the basis of the Committee's recommendation to reconsider
undertaking an epidemiological survey.
Allars recommendation 11: That the NHMRC review the `General guidelines
for medical practitioners on providing information to patients' to ascertain
whether they are adequate in the light of the response made by medical
practitioners to the cessation of the Australian Human Pituitary Hormone
Program and the deaths of hormone recipients in Australia. 3.84 A
working party was set up by the National Health Advisory Committee (NHAC),
a principal committee of the NHMRC, to consider this recommendation.
3.85 The NHMRC indicated that the working party acknowledged that the
guidelines were intended to guide medical practitioners in providing information
to patients prior to an intervention. They were not intended to cover
instances after the intervention had occurred, such as in the CJD case.
The Working Party made three recommendations:
1. That the General guidelines for medical practitioners on providing
information to patients not be revised in light of recommendation
11 of the Allars Report; 2. That NHAC consider preparing a stand-alone
statement on providing information to patients who may no longer be
a patient, when a risk becomes apparent some time after the intervention;
and 3. That NHAC consider relaunching the guidelines.
NHAC agreed in November 1996 that recommendation 1 be adopted and that
recommendations 2 and 3 be referred to the incoming NHAC for consideration
during the next triennium. The newly appointed NHAC is due to meet in
August 1997.[47] 3.86 A related
project completed by the NHMRC was the release in December 1995 of Creutzfeldt-Jakob
Disease and Other Human Transmissible Spongiform Encephalopathies: Guidelines
on patient management and infection control. This document was produced
to contribute to the reduction of risk of the transmission of CJD by providing
infection control guidelines for the management of, and for medical surgical
procedures including autopsies on, patients with or at risk of developing
CJD. The NHMRC noted that the unique nature of the infectious agent of
CJD, particularly its resistance to routine autoclaving and chemical disinfection,
necessitates the formulation of disease-specific infection control procedures.[48]
3.87 At the request of NPHAC copies of these guidelines were sent to
a range of medical and scientific individuals and organisations. The guidelines
were also advertised in the HPH Newsletter in March 1996.
3.88 By July 1996 NPHAC noted that there were continued problems among
some members of the recipient community regarding the guidelines. In particular,
some recipients had met the Victorian Dental Association about individual
dentists' problems with the infection control guidelines. In September
1996, the Scientific Research Subcommittee of NPHAC noted the concerns
expressed to some members of the recipient community by dentists regarding
the procedures for autoclaving dental instruments outlined in the guidelines.
The SRSC noted that the guidelines had the approval of the Australian
Dental Association. The SRSC also noted that there has been no written
feedback from dentists regarding the guideline. The NPHAC subsequently
agreed in July 1997 that it would write to the NHMRC indicating that there
is a need for revision of the infection control guidelines in the light
of the concerns expressed by the recipient community.[49]
3.89 The Committee has concluded that generally the actions taken by
government in response to the Allars Inquiry recommendations have been
fair and adequate. Nevertheless, the Committee has a number of reservations
which it believes need to be addressed before the Allars recommendations
can be regarded as fully and equitably implemented. These are addressed
in the following recommendation.
3.90 The Committee notes that funding commitments apply to the State
based support groups until 2010 and counselling services until 2002-03
(subject to an evaluation by PHTF this financial year). The Committee
believes that in order to allay any recipient concerns, especially in
view of the probable new case of CJD, the Government should re-affirm
these funding commitments - including the possibility of extending the
provision of counselling services for a longer period of time.
Recommendation
Recommendation 2: The Committee recommends that the following areas
of concern relating to the implementation of the Allars recommendations
be addressed:
(a) Counselling Ensure that the revised arrangements introduced
in October 1996 to assist all recipients and their families who need
counselling, are understood and are able to be accessed by all recipients.
In particular, that these arrangements are quite distinct from, and
alleviate the difficulties associated with, those which previously operated.
In addition, that counsellors who may have been providing a service
to the satisfaction of particular recipients are not precluded from
assistance under the revised arrangements;
(b) Epidemiological study That the decision not to conduct an epidemiological
study be reconsidered, though any future study should proceed with broader
objectives. (This is the subject of a separate recommendation);
(c) Tracing recipients That renewed efforts be made to identify
and trace remaining approved and unapproved recipients, with due sensitivity
in recognition of the time which has elapsed since the Program concluded.
(This is also the subject of separate recommendations);
(d) Access to information That treatment records and other information
requested by recipients be provided directly to them without adopting
a restrictive interpretation of s.135A of the National Health Act;
(e) Index to Allars Report That an index to the Allars Report be
prepared and made readily accessible for all recipients and other interested
parties;
(f) NPHAC Ensure that NPHAC's processes and procedures are sufficiently
open and flexible to enable it to receive views and opinions from all
members of the recipient community on issues under consideration by
the Council; and that all recipients are kept informed of decisions
taken by NPHAC and their outcome;
(g) Statement on Human Experimentation That the review of the Statement
on Human Experimentation which is not due to be finalised until late
1998 be expedited. To ensure that this review is not delayed, the Committee
urges the Minister to finalise the appointment of members to the AHEC
as soon as possible;
(h) Amendment of s.135A of the National Health Act That s.135A of
the National Health Act be amended to ensure that personal information
can be disclosed directly to the people about whom the information relates
(such as in the case of people who received hormone treatment) and that
the Attorney-General's Department broader review of existing secrecy
provisions, which includes s.135A, be expedited; and
(i) Amendment of s.100 of the National Health Act That the ALRC
review which includes consideration of the Allars recommendation to
repeal and replace s.100 by a provision which specifies clearly the
circumstances where by reason of physical and similar factors associated
with the distribution of a pharmaceutical benefit `special arrangements'
are appropriate, be expedited.
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Footnotes
[1] News Release, Dr Carmen Lawrence,
CL 305/94, 7 November 1994.
[2] Submission No.24, p.3 (CJDSGN).
[3] Submission No.92, p.2 (Professor
Allars).
[4] Submission No.92, p.1 (Professor
Allars).
[5] Submission No.24, p.8 (CJDSGN).
[6] Submission No.24, p.3 (CJDSGN).
[7] Submission No.9, p.1 (NHMRC).
[8] Submission No.85, pp.5-6 (DHFS).
[9] Submission No.42, pp.2-4 (NPHAC).
[10] Submission No.42, p.4 (NPHAC).
[11] Figures from Submission
No.85, p.16 (DHFS) and Submission No.42, p.10 (NPHAC).
[12] Submission No. 24, p.4 (CJDSGN).
[13] Submission No.42, p.6 (NPHAC).
[14] Submission No.85, pp.7-9
(DHFS).
[15] Submission No.85, p.11 (DHFS).
[16] Submission No.42, p.7 (NPHAC).
[17] Submission No.24, p.5 (CJDSGN).
[18] Submission No.85, p.12 (DHFS).
[19] Submission No.24, p.5 (CJCSGN).
[20] Submission No.24, p.5 (CJDSGN).
[21] Submission No.85, p.18 (DHFS).
[22] Submission No.85, p.18 (DHFS).
See also Transcript of Evidence, p.146 and DHFS, supplementary
information, 22.8.97, attached NPHAC agenda paper for more detailed information
on database development and improved information sharing.
[23] Transcript of Evidence,
12.8.97, pp.34-5.
[24] See Submission No.85, pp.16-17
(DHFS) and Submission No.42, pp.10-11 (NPHAC).
[25] Submission No.42, p.8 (NPHAC).
[26] Submission No.24, p.5 (CJDSGN).
[27] Submission No.42, pp.11-12
(NPHAC).
[28] Submission No.85, p.18 (DHFS).
[29] Submission No.85, p.20 (DHFS).
[30] Submission No.85, p.21 (DHFS).
[31] Submission No.24, p.6 (CJDSGN).
[32] For example Submission No.2,
21.7.97, p.2 and Submission No.14, p.2.
[33] Submission No.24, p.6 (CJDSGN).
[34] Information in this section
is from Submission Nos.24, pp.6-7 (CJDSGN); 42, pp.14-15 (NPHAC); 85,
pp.21-22 (DHFS) and Transcript of Evidence, pp.108-110.
[35] Transcript of Evidence,
pp.232-234.
[36] Submission No.24, p.7 (CJDSGN).
Submission No.18, p.1 provides similar comments.
[37] Submission No.83, p.2.
[38] Submission No.24, p.8 (CJDSGN).
[39] Submission No.9, pp.1-2
(NHMRC).
[40] Submission No.85, p.24 (DHFS).
[41] Submission No.92, p.1 (Professor
Allars).
[42] Submission No.9, pp.2-3
(NHMRC).
[43] NHMRC, supplementary information,
22.8.97; and Community Affairs Legislation Committee, answer to question
on notice, 1997-98 supplementary estimates hearings.
[44] Submission No.9, p.3 (NHMRC).
[45] Submission No.9, p.5 (NHMRC).
[46] Long-term effects on
women from assisted conception, NHMRC, 1995, p.31.
[47] Submission No.9, p.4 (NHMRC).
[48] Submission No.9, p.4 (NHMRC).
[49] Submission No.42, p.18 (NPHAC).