Key issues
2.1
Regulation has an important role in protecting the quality, safety and
efficiency of health services. However, regulation can be costly and burdensome.
The Department of Health (Department) aims to ensure that regulation within
the Health portfolio remains efficient and fit-for-purpose.[1]
2.2
However, submitters and witnesses described how health regulation does
not always conform to the Regulatory Reform Agenda, being sometimes costly,
excessive, ineffective and outdated. Consequently, red tape is adversely
affecting health services, providers and consumers.[2]
The Australian Dental Industry Association (ADIA) submitted, for example:
Red tape invariably leads to increases in treatment costs, limitations
on the variety of treatment options, and the restriction of the growth, sustainability,
international competitiveness, and job creation capacity of industry.[3]
2.3
This chapter discusses some of the issues raised with respect to:
-
the effect of red tape on the Australian economy;
-
specific areas of burdensome and duplicative red tape;
-
the need for harmonisation in certain areas; and
-
the Review of Medicines and Medical Devices Regulation.
Effect of red tape on the Australian economy
2.4
Submitters and witnesses highlighted the important role of their sectors
in the Australian economy, and argued that red tape is impeding competition,
growth, viability and efficiency, with subsequent effects for the provision of
high quality health care to Australian consumers.
2.5
Roche Products Pty Ltd (Roche) submitted that the pharmaceutical
industry's contribution to research in Australia is important for investment
and jobs. In 2015, for example, investment in active clinical trials was
over $1 billion, which supported a minimum 6,900 highly skilled jobs.[4]
However, there is significant competition in clinical research within the Asia-Pacific
region and Australia is not as competitive as it could be:
It is concerning that the opportunity for Australia to lead
the Asia Pacific region in clinical trials continues to elude us. Persistent
challenges are research costs, red tape around study start-up and slow
recruitment.[5]
2.6
Day Hospitals Australia submitted that private stand-alone day hospitals
are a growing part of the health system. Increasingly, patients are choosing to
have surgical, diagnostic and medical treatment as day patients, rather than in
overnight hospitals. Further, 'the sector delivers a safe, quality, low risk,
cost effective care option for consumers'.[6]
However, Day Hospitals Australia cautioned:
There are significant challenges to running a day hospital in
the current legislative, regulatory and accreditation environment. Some of
these conditions imposed on the day hospital sector severely impact financial
viability and thus provision of services to patients.[7]
2.7
The Royal Australian College of General Practitioners (RACGP) and the
Medical Oncology Group of Australia (MOGA) argued that general practitioners
(GPs) and oncologists unnecessarily spend a large amount of time on management
and administration. Both indicated that this expenditure burdens doctors and could
be better spent on the delivery of health services.[8]
For example, RACGP submitted:
The removal of red tape, or streamlining processes, would
reduce the amount of time GPs and other clinical staff spend on administration,
allowing more time to deliver safe, high-quality health services.[9]
2.8
The Australian Dental Association (ADA) claimed that dental practices
are subject to a much higher level of regulatory oversight than medical GPs.
Its submission conservatively estimated compliance costs at $397 million
in 2016 ($84 400 per practice), which typically affects small businesses:
Regardless of the type of red tape that currently exists in
the dental sector, dentists are required to spend more time and resources to
ensure compliance with red tape. This burden of compliance makes dentists less
likely to be innovative and entrepreneurial; not to mention they will be less
able to treat more patients. Similarly, the time and resources required to navigate
and comply with red tape will lead to higher costs of care for patients. These
barriers in turn are the hardest to overcome by the disadvantaged. In some
instances, people could be dissuaded from undertaking a career as a health
practitioner due to the regulatory burden. Ultimately, this is not in the
public interest.[10]
2.9
Private Healthcare Australia (PHA) presented the view of private health
funds that, in 2015–2016, contributed $14.9 billion (8.8 per cent) of health
expenditure.[11]
It emphasised the integral role of private health insurance (PHI) in Australia's
healthcare system, but argued that indexation and other changes to the PHI
rebate are decreasing affordability and participation. It contended that a
continuation of this trend:
...will exacerbate an affordability crisis in PHI that will
have flow‐through
impacts on the public sector in key areas of non‐emergency
surgery waiting lists, mental health and dental care. A 'tipping point' has
been reached for the sector.[12]
Committee view
2.10
The committee is concerned that various healthcare professionals
continue to experience red tape that significantly affects their business and
the services that they can provide to healthcare consumers. As indicated in
chapter one, the Australian Government has not published savings in the Health
portfolio for a couple of years. This lack of transparency does not assist the
committee in assessing recent efforts to reduce red tape.
Recommendation 1
2.11
The committee recommends that the Australian Government publish without
delay the red tape reduction reports for 2016 and 2017.
Specific areas of burdensome and duplicative red tape
2.12
Submitters and witnesses described specific areas of burdensome and
duplicative red tape that are of concern to their industry. The committee also
received information that businesses are affected by ineffective regulation. For example,
the Pharmaceutical Society of Australia outlined several red tape issues
associated with the PBS Safety Net, the PBS authority system, and the lack of
an electronic prescribing and electronic prescriptions system.[13]
2.13
The following sections discuss red tape issues associated with the Health
Technology Assessment (HTA) process and PHI reforms.
Health Technology Assessment
process
2.14
The HTA process informs decisions about the registration of health
technologies and the Australian Government's subsidisation of the costs of health‑related
goods and services (for example, listing on the Pharmaceutical Benefits Scheme
(PBS)).[14]
There are four HTA agencies with discrete functions, and complex and
inter-dependent relationships.[15]
The current HTA processes for market entry and reimbursement processes are
shown in Figure 1 below.
Figure 2.1: HTA processes for market entry and
reimbursement processes
Source: Department of Health, Health Technology Assessment
(HTA) overview, http://www.health.gov.au/internet/hta/publishing.nsf/Content/commonwealth-1,
accessed 22 March 2018.
2.15
Medicines Australia acknowledged steps undertaken by the Australian
Government to streamline HTA processes and expedite access to some high
priority medicines. Its submission expressed support also for the new Provisional
Approval pathway process that will facilitate the registration of new
prescription medicines.[16]
2.16
However, Roche argued that the HTA process for PBS listing is
unnecessarily complex and lengthy, and denies timely access to affordable
medicines:
There are opportunities to reduce the number of submissions
and resubmissions to the Pharmaceutical Benefits Advisory Committee (PBAC) for
reimbursement of new medicines, which can delay patient access to new
treatments. Whilst there have been commitments and progress made by the
Government and Department of Health to streamline the process and implement
different pathways for submissions, it is imperative that the system is made
fit-for-purpose.[17]
2.17
David Pullar, Head of Government Affairs and Public Policy at Roche, said that
Australia's 'assessment process is generally viewed as one of the fastest in
the world' (17 weeks). However, Mr Pullar indicated that this reputation does
not match the reality:
An analysis of new cancer drug submissions from 2010 to 2016
found that no more than 50 per cent of recommendations were ever positive,
meaning that most medicines required resubmissions and took around two years to
list after being approved by the [Therapeutic Goods Administration (TGA)]. In
the meantime, patients have to pay out of pocket or not access the medicines at
all. We're currently ranked 17 out of 20 developed countries for access to new
medicines. Because of the fixed assessment cycle, a medicine that's rejected
can't be resubmitted for another four months, then recommended another four
months after that. Yet in practice, after the first submission price is often
the outstanding issue. This could easily be handled by an out-of-session
negotiation rather than a comprehensive dossier assessment, which is what's
currently required.[18]
Committee view
2.18
The committee notes that the Australian Government, in consultation with
stakeholders, is currently progressing reforms to HTA processes. The committee
suggests that assessment processes associated with listing new medicines on the
PBS, or through other funding arrangements, be considered as part of this
reform.
Private health insurance reforms
2.19
In 2017, the Australian Government announced a package of PHI reforms.[19]
PHA welcomed these reforms which it anticipates will 'put downward pressure on
premiums and make it easier for consumers to choose and use their health
insurance'. PHA added that further reform is necessary to address inflationary
dynamics and 'correct regulatory settings currently constraining the industry
from evolving to meet the needs of modern consumers'.[20]
Out-of-hospital care
2.20
Dr Rachel David, Chief Executive Officer of PHA, indicated that one of
the most frustrating red tape issues is the prohibition against health funds funding
out‑of‑hospital care. Dr David contended that this prohibition is
no longer practical or appropriate:
It is quite possibly the stupidest way you could run a health
fund. If someone has cancer these days, they have their surgery in
hospital; we can cover them for the out-of-pocket for that; but they get
the rest of their care—their chemo, pathology, imaging—out of hospital. We
can't cover the co-payment—it's against the law. That means that people, even
though they have private health insurance, are faced with this huge out‑of‑pocket
cost. Pregnancy and obstetrics: can we cover for management of the pregnancy?
No, only the birth. We can't cover out-of-hospital admissions or consultations
with a psychiatrist in private, but we can cover someone to be admitted to
hospital and have the same consultation there. If they're admitted to
hospital, that's $1,000 a day. If they have a consultation in a doctor's room,
it's $300. This is what is forcing premiums up. It is absurd.[21]
Prostheses List
2.21
In October 2017, the Australian Government announced that the minimum
benefits payable by private health insurers for devices on the Prostheses List
would be reduced from 1 February 2018, with further reductions in August 2018
and February 2020. The reductions are expected to reduce expenditure on
prostheses and lower PHI premium increases.[22]
2.22
PHA argued that further reform could be directed toward more savings and
increased transparency in the medical devices supply and benefit system.[23]
For example, Dr David said there is a popular view in the PHI industry
that the Australian Government should transition away from fixing prices in
this area. Instead:
We need to transition to a shared purchasing arrangement that
is separate from Commonwealth intervention so that a market is able to operate
where there is some reference pricing to real market prices in Australia and
around the world. There are transparency measures that are implemented by the
existing regulators, like the ACCC, that look at the rest of the retail market.[24]
2.23
The committee heard that such a transition would be difficult, as there
are vested interests militating against change.[25]
The committee notes however that the Australian Government and the Medical
Technology Association of Australia have signed an agreement to improve access
to innovative medical technology and the affordability of medical devices for
consumers holding PHI. An element of this commitment is to establish:
...an industry working group by 31 March 2018 to develop a
revised framework for benefit setting and benefit review, reflecting use of
health technology assessment including evaluation of value, cost-effectiveness
and innovation; use of post-market review and the operation of competitive
markets in the Australian context.[26]
2.24
The committee recognises that the Australian Government is currently
working toward stabilising the cost of items on the Prostheses List, which will
occur over the next five years.
PHI rebate
2.25
Dr David also drew attention to cost drivers that she argued continue to
increase the cost of premiums:
The reality is that health fund premium increases are going
up in lockstep with demand for health care, and it's because health funds are
paying for more health care that premiums go up. This is the effect of the baby
boom population now moving through the health system and starting to become
unwell. The effect is also being felt on the public hospital side, as their
costs have been going up by seven to eight per cent over the same time frame
and very consistently. Without addressing those underlying cost drivers and
removing every dollar of waste, inefficiency, inappropriate care and payments
on the supply side, we are not going to be able to really bring the cost of
premiums down.[27]
Committee view
2.26
The committee accepts that it would be beneficial to consumers if PHI
were to cover the cost of out-of-hospital care. Such cover might also assist in
reducing the cost of PHI premiums as consumers receive care in the primary care
setting, rather than the secondary (or acute) setting. The committee suggests
that it might be useful for the Department of Health to further explore this
issue.
Recommendation 2
2.27
The committee recommends that the Department of Health investigate the
merits of allowing private health funds to fund out-of-hospital care.
Recommendation 3
2.28
The committee recommends that the Australian Government review cost
drivers for private health insurance, to identify and better manage their
ongoing effect on the cost of private health insurance.
2.29
The committee is not convinced that either consumers or industry players
are benefiting from government intervention in the prostheses market. Assuming
product safety and efficacy are confirmed, a free market would seem likely to
result in reduced costs and better patient outcomes.
Recommendation 4
2.30
The committee recommends that the Australian Government consider ceasing
regulation of the prostheses market, apart from maintaining standard consumer
protection.
Duplicative regulation
2.31
Medicines Australia submitted that regulators must coordinate with one
another, particularly where there is a risk of jurisdictional overlap. By way
of example, its submission cited overlap between the TGA and the
Australian Competition and Consumer Commission (ACCC): 'potential inconsistent
regulatory approaches must be avoided in order to reduce the risk of
unnecessary red tape'.[28]
2.32
ADIA expressed particular concerns with the ACCC's involvement in
certain (teeth-whitening) product supply issues. ADIA argued that this
involvement creates regulatory inconsistencies and compliance challenges, as
states/territories already regulate according to the Poisons Standard.[29]
ADIA submitted:
The lack of clarity and certainty that has arisen from this
unjustified regulatory duplication subjects industry to the costs of additional
regulatory burden, limits treatment options available to healthcare
professionals, and undermines the Australian Government's efforts to
support the Council of Australian Government's (COAG) development of nationally
consistent standards.[30]
2.33
The ACCC has a regulatory role in teeth-whitening products as a consumer
good, whereas the TGA has a regulatory role in respect of therapeutic goods
that contain medicines or poisons.
2.34
The ADA raised for consideration a different example of regulatory duplication.
ADA submitted that its regulatory body, the Dental Board of Australia (DBA),
requires dentists and dental practitioners to comply with professional
infection control guidelines in order to renew their registration each year.[31]
At the same time, governments impose additional infection control requirements:
These different sets of rules, imposed by different tiers of
government entities and jurisdictions, effectively duplicate requirements that
form part of every registered dental practitioner's scope of practice as set by
the regulator.[32]
2.35
Dr Carmelo Bonanno, Vice President of the ADA, described the situation
as one of 'bombardment', where national registration requirements should
suffice.[33]
In his view, self-regulation is more appropriate given the dental industry's
expertise and high levels of professional communication:
We have our own version of the standards and we actually put
out our own infection control manual, which is the only up-to-date infection
control guideline for dental practitioners...we have an infection control
committee. The membership of the committee are some of the best minds in
dentistry, who are up to speed with the latest infection control issues and
advances. Therefore, we're able to have a document that is a live document. We
can amend it and any time we like and it is available to all of our members at
any time.[34]
2.36
Dr Bonano told the committee that practice accreditation (with similar
duplication) might shortly become compulsory, meaning that government
regulation might shortly increase for the dental industry.[35]
Department response
2.37
A departmental officer advised that both the ACCC and TGA have roles
with respect to teeth-whitening products. However, the committee heard that the
regulatory inconsistency raised by ADIA has now been addressed, with the ACCC
having 'withdrawn its statement from its website'.[36]
Committee view
2.38
The committee agrees that duplicative/inconsistent regulation should be
avoided, as it creates unnecessary red tape burdens. The committee notes that
the Regulatory Reform Agenda requires a whole-of-government effort toward red
tape reduction. In fulfilling this agenda, the committee encourages all
departments and agencies to be aware not just of their regulatory environment
but also those with which they interact.
2.39
In relation to guidance around infection control, the committee is
not convinced that there is a need for government regulation in this area.
Information presented to the committee suggests that the highest possible national
standards for dental practice can and are being addressed by the profession.
Need for harmonisation in certain areas
2.40
Submitters and witnesses commented that there is a lack of uniformity in
some Commonwealth, state and territory regulation. For example, Day Hospitals
Association identified variable licensing and accreditation requirements as
problematic for its members.[37]
The Pharmaceutical Society of Australia commented that legislative arrangements
need to be harmonised for the regulation of medicines.[38]
2.41
The following sections focus on three specific areas—digital technologies,
clinical trials, and diagnostic imaging equipment—which the committee heard
need to be harmonised in the interests of healthcare providers and consumers.
Digital technologies
2.42
Some submitters and witnesses contended that red tape in the provision
of health services could be significantly reduced with up-to-date digital
technologies. For example, the RACGP indicated that GPs' non-patient care
workload is increased by:
-
many processes and administrative tasks not being modernised with
the introduction of new technologies; and
-
secure electronic communications not being the preferred and
default method of communication between health services, government agencies
and general practices.[39]
2.43
Dr Nathan Pinskier, Chair, RACGP Expert Committee, eHealth and Practice
Systems, argued that the lack of interoperable government automated and
integrated systems to manage key information capture and data transfer is a key
cause of red tape in general practice:
This is equally true at both the Commonwealth and state or
jurisdictional level. Many of the administrative tasks that GPs are required to
undertake to support direct-care delivery and to allow patients to access
additional care or services can be improved and modernised through the better
use of technology, which should be a core consideration of the government's
digital transformation requirements. General practice is predominantly
electronic at both an administrative and a clinical level, yet it interacts
with a healthcare world that still relies heavily on paper and faxes. To state
the obvious, this is out of step with the massive changes that have occurred in
other sectors of the economy.[40]
2.44
Part of the problem appears to be the need for secure communications
that support the National Privacy Principles. Dr Pinskier indicated that 'the
government hasn't actually chosen a standard for its own sector, federally or
at a state level'.[41]
He suggested that the data transfer standards created by My Health Record
could be enhanced to significantly reduce red tape:
The My Health Record is in itself not a communications tool;
it's a repository of information that can be accessed as and when appropriate.
What we need to do is to build on those standards to ensure that they are
embedded into what we call provider-to-provider communication or point‑to-point
communication. So if a patient goes to hospital, when the patient's discharged,
rather than a letter or a fax, I would get an electronic message directly into
my inbox. That would significantly reduce red tape and improve healthcare
delivery.[42]
2.45
Dr Bonanno agreed that there is a need to securely access and transfer digital
information in order to effectively treat patients.[43]
MOGA similarly submitted:
A common, shared infrastructure for the storage, archiving
and retrieval of digital records is recommended. This would assist in
addressing delays in patient treatment and management, potential complications
and in reducing patient risk nationally. Despite a substantial amount of
Federal funding having been committed to Australia's eHealth system a more
targeted and comprehensive Government-led approach is needed.[44]
2.46
In another example of digital red tape, Dr Pinskier drew attention to
the registration and management of healthcare professionals. He described a
'bizarre' situation where professionals are issued with multiple identifiers for
practice purposes, and queried why these identifiers could not be streamlined:
There's a whole lot of bureaucracy. Just to register a doctor
in the system in my practice takes 15 forms. That is 15 forms to complete just
to get the doctor into the system. I have provided these to Medicare, the department,
the digital healthcare agency and other organisations. Everyone says, 'Yes,
that's terrible,' but nothing ever gets done about it. We have a great opportunity
as part of the digital transformation and the current review of Medicare's
claims and payments back-end processes to streamline all this and reduce it
down to the minimum number of numbers that we need to run an efficient and
effective system.[45]
Department response
2.47
A Department representative advised that harmonisation of health
regulation is an ongoing matter: 'there would not be a single [Australian
Health Ministers Advisory Council] meeting where there isn't an issue that
involves some degree of harmonisation...between the regulatory approaches'.[46]
2.48
In response to the concerns identified by RACGP, the officer said
that 'Australia has arguably got the most contemporary and best piece of
legislation to enable a national digital health effort'. He conceded however that
there is still a lot of work to be done:
It's complex. Some of it is about legislation; some of it is
about regulation; a lot of it is about change management. Also a lot of it is
making sure all the different parts of the healthcare system are able to target
their investments around a common legislative and hopefully standard-setting
framework that enables their investments to deliver the necessary benefits to
them, their businesses and ultimately to patients.[47]
2.49
To illustrate the argument, an officer described various levels of
responsibility and internal/external roles associated with the transition to
electronic signatures, concluding:
It's a joint piece of work that needs to be put together in
relation to the jurisdictions and how their different legislative frameworks
work and then the alignment with the National Health Act to ensure that we have
a mechanism that people can roll out nationally.[48]
Committee view
2.50
Digital technology is a critical concern for GPs, who are the backbone
of primary health care. The committee recognises that governments are
progressing ad hoc reform in this area. However, the committee notes
that the Department did not provide any specific information on its achievements
to date; for example, how far discussions might have progressed in relation to
secure communications. The committee suggests that the Department could do
more to inform stakeholders of its efforts, milestones and outcomes in this
area.
2.51
On a different matter, the committee cannot perceive any logical reason
why healthcare practitioners should require multiple identifiers for practice
purposes. As part of digital reform, the Australian Government should
streamline these identifiers to reduce the red tape burdens that they create.
Recommendation 5
2.52
The committee recommends that the Australian Government, through the
Council of Australian Governments, streamline the identifiers issued to healthcare
practitioners for practice purposes.
Clinical trials
2.53
Submitters and witnesses stated that regulatory variation adversely
affects competition and investment in clinical trials in Australia, as well as
consumer access to new medicines. Roche, Medical Technology Association of
Australia and Medicines Australia all agreed that there is a need for greater national
consistency, including in the area of ethics approval.[49]
2.54
Helen Aunedi from Roche explained that 'the issue here is the national
coordination of human research ethics committees'. Although some committees
work well, there is 'huge variation' which causes unnecessary difficulties for sponsors
of clinical trials, particularly when they involve multiple sites and
institutions. Ms Aunedi emphasised that streamlining and harmonising
processes is about 'putting patients first; the quicker we can start a trial,
the quicker we can get access to treatment for our patients'.[50]
2.55
The committee heard that there have been numerous attempts to harmonise the
state-based ethics approval processes (including by the National Health and
Medical Research Council).[51]
However, Medicines Australia indicated however that reform is taking too long: 'we
would support measures to further expedite their overdue implementation'.[52]
2.56
Witnesses described a range of options that have been considered. For example,
Mr Pullar referred to mutual recognition and consistent performance standards.
However, Roche's preference would be:
...to eventually have a single committee that would specialise
in multicentre trials, which everyone could then just outsource to. They might
still conduct the ethics review of what their own institution is doing just
within their institution, but if it's a multicentre trial—you could certainly
aim to have that best practice.[53]
2.57
Elizabeth De Somer, Director, Policy and Research, advised that
Medicines Australia favoured national coordination at the COAG level:
There are opportunities to create national coordination that
may not require the institutionalisation of an office. It's not unprecedented
to have national coordination across activities with the states and
territories. Indeed, that's why the COAG exists. The best way to do that might
be discussion with the COAG on what their appetite for change is. Clearly, each
of the states and territories have an interest in improving clinical trial
activities.[54]
2.58
The committee notes that the Senate Select Committee into Funding for
Research into Cancers with Low Survival Rates recently examined the issue of
ethics approvals. After considering a large volume of submissions and evidence,
that committee supported the expeditious streamlining of ethics and
governance approval processes for clinical trials, and recommended:
...that the National Health and Medical Research Council develops
a standard template and associated guidelines, including timeframes, for ethics
and other governance approvals for consideration and possible adoption by each
state and territory.[55]
Committee view
2.59
The committee is concerned that, again, submitters and witnesses have
highlighted an area that is ripe for reform, yet reform is slow to arrive.
The committee considers that governments could reduce the red tape associated
with clinical trials, by standardising and harmonising the ethics approval
process. The suggestion for the development of a standard template and
associated guidelines is practical and sensible, with clear benefits for
industry and consumers.
Recommendation 6
2.60
The committee recommends that the Australian Government, through the Council
of Australian Governments, develop a standard template and associated
guidelines, including reasonable timeframes, to streamline ethics and
governance approval processes for clinical trials across Australia.
Diagnostic imaging equipment
2.61
Some submitters and witnesses drew attention to state/territory
licensing requirements that affect businesses which supply, own and operate
diagnostic imaging equipment. ADIA, for example, submitted that regulatory
variation creates a compliance burden for suppliers and healthcare
professionals:
Inconsistencies make it difficult for the dental industry to
furnish oral healthcare professionals across the country, and the compliance
burden associated with it imposes costs on business. These costs are passed on
to patients and governments in the form of increased diagnostic imaging costs.[56]
2.62
ADA submitted that there is inefficient and unnecessary duplication:
Currently, across most jurisdictions in Australia, dentists
are required to purchase two sets of licences with respect to radiation
machines such as intra-oral, rotational tomography X-rays and Cone Beam
Volumetric Tomography (CBVT). One licence is to own or possess the machine, and
the other is to use it. The same duplication with two licences applies for
Class 4 laser equipment, one to possess and one to use...Ultimately there
should be a greater move towards harmonisation and mutual recognition of
licensing requirements and licences provided and obtained for the operation and
use of radiation machines.[57]
2.63
In evidence, Dr Bonanno questioned why it is so difficult to achieve
national consistency in this area. He referred to the National Registration and
Accreditation Scheme, where over 600 pieces of legislation were consolidated
into 80 pieces of legislation to achieve the national registration of dentists:
That made sense. Why couldn't we do it with everything else?
Why have we gone from state based registration as health practitioners,
singling that out, but left everything else state based?...A lot of work was done
there, but the thing is that we have a system now which is working better as it
evolves, so there's no reason why that can't happen with these other areas of
duplication.[58]
2.64
Mr Troy Williams, Chief Executive Officer of ADIA, suggested one answer:
'the current system isn't broken to the extent that it's not working, so
there's just no impetus for reform'.[59]
Committee view
2.65
The committee is aware that the Senate Community Affairs References Committee
has recently inquired into the 'Availability and accessibility of diagnostic
imaging equipment around Australia'.[60]
2.66
The committee acknowledges there are many harmonisation issues requiring
attention from COAG, with some matters more pressing than others. However, the
committee heard that regulatory variation with respect to diagnostic imaging
equipment is a significant and ongoing concern for dental practitioners.
The committee agrees that there is clear scope to reduce red tape in the
licensing of this equipment.
Recommendation 7
2.67
The committee recommends that the Australian Government place licensing
requirements for the supply, ownership and operation of diagnostic imaging
equipment on the agenda for consideration by the Council of Australian
Governments.
Review of Medicines and Medical Devices Regulation
2.68
The 2015 Review of Medicines and Medical Devices Regulation identified
ways to improve access to therapeutic goods for consumers and to reduce
unnecessary red tape for industry, while maintaining consumer safety. The Australian
Government accepted nearly all of the 58 recommendations, which are being
implemented in a staged approach through to 2019.[61]
The Department submitted:
As a result, medicines and medical devices will be able to be
brought to the Australian market more quickly. The reforms will benefit
consumers, the therapeutic goods industry and health professionals and are
expected to deliver red tape reductions of $74.9 million annually.[62]
2.69
Several submitters acknowledged the Australian Government's positive efforts
to reduce red tape in response to the Review.[63]
However, ADIA cautioned against the literal interpretation of one
recommendation, which called for the regulation of medical devices to be
aligned with that of the European Union (EU) (Recommendation 20). ADIA argued
that such alignment should occur 'only when there is a reason to do so...[and]
conditional on such reform aligning with an Australian Government approach to
regulation making'.[64]
It argued that the EU approach should be seen as an upper limit, with a lower
level of regulation sometimes being more appropriate.
2.70
Mr Pullar from Roche assured the committee that the TGA does not
automatically adopt overseas decisions, at least in relation to medicines:
Generally the review came to the conclusion that we would
still like some oversight in Australia. I think that's a community expectation.
What they can do is: they can take evaluation reports, they can take some of
the critique that has been done overseas, and use that to speed up their own
assessment. So we'd still be making a distinct Australian judgement about
whether to approve a medicine.[65]
Concluding comment
2.71
The Australian Government's 2013 Deregulation Agenda aims to reduce
excessive, unnecessary and complex regulation to lift productivity and boost
growth. The committee supports this objective but has found that there are
areas in which red tape continues to affect health services.
Senator David Leyonhjelm
Chair
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