Government senator's minority report
Introduction
1.1
Government senators have considered the majority report and disagree
with its findings: the evidence taken during the inquiry does not support the
position that the Government's decision to defer the listing of certain
medicines under the Pharmaceutical Benefits Scheme (PBS) is a major change in Government
policy. It has always been the role of the Pharmaceutical Benefits Advisory
Committee (PBAC) to provide expert recommendations to the Government on listings.
Similarly, it has always been the role of Government to make final decisions on
listing of medicines under the PBS, based on the recommendations made by the PBAC
and the Pharmaceutical Benefits Pricing Authority (PBPA).
1.2
The current Government remains committed to timely and affordable access
to medicines for all Australians, and to delivering policy outcomes as outlined
in the Memorandum of Understanding (MOU) with Medicines Australia. The
Government continues to implement reforms to improve the operation,
cost-effectiveness and timeliness of the PBS system in consultation with
industry and other stakeholders.
1.3
The deferrals announced on 25 February 2011 are just that: deferrals
based upon a financially responsible approach to funding the PBS. It is
erroneous to suggest that the deferral of six medicines will in any way undermine
the healthcare of Australians. Government senators note that the Government
continues to be supportive of a viable medicines industry in this country for
the current and future benefit of all Australians.[1]
Process of listing medicines on the PBS
1.4
The PBS has served Australians well since 1948. The PBAC was established
under the National Health Act 1953; one of its principal roles is to
recommend to the Minister for Health and Ageing which medicines should be
subsidised by the Government under the PBS. In doing so, PBAC considers both
the effectiveness and cost of the proposed medicines.
1.5
Many submitters praised the independent role that the PBAC has played,
and continues to play, since its establishment. In fact Mr David Learmonth,
Department of Health and Ageing (DoHA), noted that 'Every submission to the [committee's]
inquiry and participant at the hearing praised the rigour of the PBAC process'.[2]
Mr Robert Pask from the National Advocates Program, Multiple Sclerosis
Australia, for example, told the committee:
We have the utmost respect for the PBAC. We have been
fortunate enough to meet with Professor Sansom and, from what we have seen of
the process, we would like to see it stay.[3]
1.6
Government senators are similarly supportive of the invaluable role
played by the PBAC in conducting intense and rigorous scrutiny of individual
drugs, and note submitters' evidence that the PBAC process is world class.[4]
However, the role of the PBAC is directed at the evaluation of medicines; it is
the role of the Government to take into account wider considerations including
fiscal matters. As Minister Roxon stated:
...by limiting its own investigations to the drug in
question, it can concentrate on the merits or otherwise of that particular
drug, not wider competing priorities.
But just because PBAC doesn't consider these other priorities
does not mean that nobody else should. In fact I would argue governments would
be remiss if they don't.[5]
1.7
This is an important point: it always has been the obligation and
responsibility of Government to consider recommendations from the PBAC on the
suitability of listing particular drugs. The process is not now, and never has
been, a 'rubber stamping' process. Decisions on listing remain the
responsibility of Government. Mr Learmonth, DoHA, explained in detail this
point:
The PBAC is not a statutory authority such as the Reserve
Bank or Civil Aviation Authority and does not make the decision regarding the
listing of the medicine as a pharmaceutical benefit. This fact seems to be
misunderstood in a number of the submissions to the inquiry, which infer that a
positive recommendation to the PBAC is or should be binding on government.
While the minister cannot list a medicine as a pharmaceutical benefit unless a
positive recommendation is received from the PBAC, a positive recommendation
allows the minister to consider a medicine for listing as a pharmaceutical
benefit. It does not compel a government to give effect to that recommendation.[6]
1.8
Many submitters demonstrated an appreciation of the decision-making role
of Government. Ms Carol Bennet of Consumers Health Forum of Australia stated, 'In
fact we fully accept that the Government has the right and should make the final
decision about which drugs are listed'.[7]
This was echoed by Mr Mark Glover of Allergan Australia who noted 'There is
always the prerogative of government to manage expenditure'.[8]
1.9
Professor Lloyd Sansom, Chair of the PBAC also emphasised these separate
roles of advisory committees and the Government:
[Advisory committees] advise governments, and we have a
democracy where governments make decisions.[9]
1.10
During the inquiry it was suggested that by exercising its role, the
Government would undermine the position of the PBAC. Government senators remain
unconvinced by this speculation. The PBAC is an independent statutory authority
which has an enviable history of rigorous and exacting assessment. There is no
risk to the standing of the PBAC through the Government continuing to exercise
its separate, and legitimate, decision-making role in relation to listing of
medicines.
1.11
Government senators note that eight medicines were considered and
deferred by Cabinet in February 2011; two of these were subsequently
reconsidered and listed. The Minister explained the deferrals:
In most cases this is where there are existing, or
alternative treatments that are already available, or there's no added clinical
benefit although there may be some other convenient method for taking the
medication.[10]
1.12
Government senators are of the view that the deferral of six medicines
has been blown out of proportion for political gain. We note that these
medicines will be listed when circumstances permit.[11]
Arguments that suggest that the deferral will have a significant impact on the
quality of healthcare provided in Australia fails to recognise that there are
existing or alternative treatments or no added clinical benefit for most of the
medicines. In addition, only six medicines were deferred. This is a very small
number compared with the number of medicines listed already this year.
1.13
The committee heard evidence that in 2011 alone 152 medicines have been
approved and/or listed at a cost of nearly $850 million.[12]
Over the last four years the Government has added almost 500 new medicines or
brands of medicines to the PBS, at a cost of around $4 billion.[13]
In 2011 eight medicines were deferred by the Government, and of these only six
remain deferred. These six medicines represent less than 3.9 per cent of 2011
listings.[14]
1.14
Government senators observe that deferral of listing of a small number
of medicines in February 2011 is not without precedent. In the past, the Government
of the day has not listed other drugs that had been positively recommended by the
PBAC. By way of example in 1994, a Federal Labor Government decided not to list
nicotine patches; and in 2002 a Federal Coalition Government decided not to
list sildenafil citrate (Viagra®).[15]
Mr Learmonth, DoHA, outlined the similarities in these situations:
...in each case the pressure that we have spoken about on the
PBS is significant and in those circumstances the government of the day has
made judgements about what it believes ought to be a priority for funding not
just of the PBS but, as a consequence, of course, across the remainder of
government activity in health and beyond.[16]
1.15
Similarly, Government senators note that in relation to other matters sometimes
the government of the day accepts the recommendations of the PBAC and sometimes
it does not. This is explained in answers to questions on notice by Professor
Lloyd Sansom, Chair, PBAC:
Governments have also accepted other PBAC recommendations,
such as price reductions for biological disease-modifying antirheumatic drugs
listed on the PBS for the treatment of rheumatoid arthritis and recommendations
that certain medicines should comprise therapeutic groups...Previous
governments have decided not to accept other recommendations of the PBAC. For
example, the recommendation of the PBAC in 2001 to maintain the price
relativity between the ACE-inhibitor class of drugs and the ATRA class of
drugs.[17]
1.16
The majority committee report makes much of assertions that the
Government's decision to defer listings and refer all recommendations to
Cabinet will make the decision-making process susceptible to influence through
lobbying by pharmaceutical companies and consumer groups. Government senators
reject these assertions. We are at a loss to understand why it would be
asserted that lobbying could increase when Cabinet is considering all listings with
a financial impact. As Mr Learmonth explained:
Ultimately, it remains the case that the PBAC process goes
on. Any drug or medicine that the government lists on the PBS must be
recommended by the PBAC. That remains the hurdle. That has not stopped
companies in the past lobbying. I am sure that they will continue to do so in the
future.[18]
1.17
Government senators note that Cabinet has access to expert advice to
assist them in their decision-making processes about listing of medicines on
the PBS. The exhaustive process of PBAC considerations, including
considerations of 'safety, clinical effectiveness and cost effectiveness
(value-for-money) for the intended use, in comparison with other available
treatments'[19]
provides an excellent basis on which Cabinet is able to make assessments and decisions.
1.18
In addition, Cabinet is able to rely on 'the expert advice from the
Department of Health and Ageing and the Chief Medical Officer'.[20]
With these various forms of advice available to it, Cabinet is able to make
considered decisions regarding impact of listing on the Budget, and subject
listing applications 'to the same rigorous scrutiny that we put all new
proposals in the Health portfolio through'.[21]
1.19
While Cabinet relies on its considered judgement, rather than formal
criteria, in its decision-making process, it was noted by Government senators
that the Government has stated a commitment to prioritising 'listing medicines
on the PBS that treat serious and life threatening conditions where there are
no alternative treatments on the PBS'.[22]
Government senators remain assured that access to affordable medicines will
remain a central feature of the PBS.
Financial impact on the Commonwealth budget
1.20
Government senators note that the Government is responsible for the
overall budget, which includes the health budget. Every dollar spent on the
health budget adds value but there are many calls on the budget. This means
that sometimes difficult decisions need to be made. This point was noted by Ms Liliana
Bulfone from Deakin University:
In a perfect world there would be no need for a cabinet
review of PBAC decisions, but we do acknowledge that affordability of
medications in the short term is definitely an issue that the government may
need to consider, particularly in circumstances where the drug has an effect
over a very long time horizon.[23]
1.21
Government senators recognise that the Government has had to make
difficult decisions in the interests of prudent financial management, and are
supportive of the Government's decisions to prioritise medications that are
life-saving and where there is no alternative that's available to patients.
This rationale was explained by Minister Roxon on 25 February 2011:
...the Government has to make a decision, especially on every
decision that has financial implications, taking account of all the
circumstances, and having done that we've made a decision that a number of
medicines won't be listed this time. We're being public about that. We're
making sure that everyone, who is an applicant in the pharmaceutical industry
and the consumers, have that information available to them.[24]
1.22
However, the Minister noted that the Government remains committed to
listing new medications as evidenced by the number of new medicines listed in
2011:
...even in difficult fiscal circumstances this Government is
willing to consider proposed listings within required timeframes, and to list
new drugs that come with a substantial cost.[25]
1.23
Government senators note that maintaining affordable access to medicines
through the PBS, while preserving its long-term financial sustainability has
been a matter of concern for successive governments over the years. The PBS,
however, has continued to grow over the last ten years:
...averaging growth of about nine percent a year and it is
estimated it will cost about $9 billion this financial year (2010–11). This
growth rate is higher than the six percent annual increase for general hospital
and medical services, and much higher than the Consumer Price Index.[26]
1.24
The committee heard that not only is the PBS one of the fastest growing
programs in the health portfolio, it is also a high growth rate from a very
large base.[27]
Consequently it has a very significant fiscal impact.[28]
The Government has worked towards ensuring that costs are contained while
ensuring that Australians continue to have access to the best available
medicines.
1.25
Government senators further note that the Government is addressing these
issues in a variety of ways. By way of example, we note that with the enactment
of the Therapeutic Goods Administration (TGA) Amendment Act 2011 it is
no longer possible for initial-brand sponsors to use copyright of the product
information to block and/or delay follow-on generic medicines from entering the
market.[29]
This is a significant initiative on the part of the Government and will assist
in consumers accessing generic medicines.
1.26
Government senators note that the small number of medicines that have
had listing deferred have not disappeared from the Australian market. The
committee heard that while medicines may not be available under the PBS for a
subsidised price, if they are approved by the Therapeutic Goods Administration
(TGA), consumers in Australia still have access to those medicines.[30]
The Memorandum of Understanding with Medicines Australia
1.27
The MOU between Medicines Australia and the Government was concluded in
May 2011, and was subsequently announced in the 2010–11 Budget. The purpose of
the MOU is spelled out in Clause 3:
...both parties intend that the MoU will promote the
efficiency and sustainability of the PBS and support, by provision of a stable
pricing policy environment, a viable and responsible medicines industry in
Australia, consistent with the objectives of the National Medicines Policy.[31]
1.28
As noted by Dr Brendan Shaw, Medicines Australia, 'The MOU is an example
of how policy can be developed and improved through constructive collaboration
between government and business'.[32]
1.29
The committee heard that there are suggestions that the intent of the MOU
has been breached. It is the view of Government senators that this is not
correct. There has not been any departure from the provision of a stable
pricing policy environment as outlined in Clause 3 above.
1.30
Furthermore, the specific commitment to maintaining current pricing
policy, outlined in Clause 4 of the MOU has been maintained. As Mr Learmonth, DoHA,
noted 'the intent of the MOU was to provide pricing stability—nothing else'.[33]
Clause 4 states:
The Commonwealth undertakes not to implement new policy to
generate a price-related savings from the PBS during the period of the
agreement, that is, measures that would change the ex-manufacturer price of
particular medicines, other than reflected by this MOU.
1.31
Similarly Government senators refute the suggestion that the
Commonwealth has departed from Clause 29 of the MOU:
For those submissions required to be approved by Cabinet,
the Commonwealth will use its best endeavours to implement a maximum time frame
of six months for consideration and decision by Cabinet.
1.32
It is of note that not only has the Government abided by this
timetable, it has in fact done better than promised 'with two of the last
high-cost listings being considered by Cabinet within one month of pricing
being agreed'.[34]
A healthy pharmaceutical sector
1.33
Government senators note that only a very small proportion of medicines
have been deferred compared with the significant number which have been listed
since 2007:
Since 2007, over 500 medicines or brands of medicines have
been listed on the PBS, the Life Saving Drugs Program and the National
Immunisation Program, at a cost of over $4 billion over five years. In 2011
alone, the government has approved and/or listed over 152 medicines, at a cost
of nearly $850 million. In all this, only eight medicines were deferred by the
government on 25 February this year, of which only six remain deferred. These
six medicines represent less than 3.9 per cent of all listings in 2011 and less
than one per cent of listings over the past four years.[35]
1.34
Further, Government senators note that deferrals are not permanent, and
the Government has undertaken to reconsider the listing of deferred medicines
as circumstances permit. This is evidenced by the recent listing of some of the
deferred medicines. In addition, no medicines recommended by the PBAC at its
March 2011 meeting have been deferred. Mr Learmonth, DoHA, stated:
Finally, whilst eight deferrals were announced in February
this year, two of these have subsequently been listed. No medicines recommended
by the PBAC, at its March 2011 meeting, were deferred by the government and, by
September this year, 152 new drugs or amendments to listings of existing drugs
will have been listed on the PBS, reflecting the government's continued
commitment to list medicines.[36]
1.35
The committee heard that the process of making submissions, applying for
listings and running clinical trials is a lengthy process. Industry in
Australia is looking at working through issues with the Government to address
concerns, rather than packing up and leaving the market:
The fact that we are here talking to you means, hopefully, we
are not going to be pulling investments out of Australia or stopping clinical
trials or research and development. We are here to work with you...[37]
1.36
There is evidence of continuing support for the Australian market by
pharmaceutical companies with no decrease in the number of submissions being
received by the PBAC:
Companies are still actively seeking listing on the PBS, as
evidenced by the fact that there has been no change in the total number of
submissions received for consideration by the PBAC over the last three months.
On the contrary, the July meeting of the PBAC received a record number of
submissions.[38]
Business as usual – a stable
investment environment
1.37
The committee was at pains to ascertain whether any particular
investment decision by a pharmaceutical company had been changed as a result of
the deferral. Witnesses informed the committee that decisions pertaining to the
launch of certain products will be postponed and delayed as a result, but Government
senators note that witnesses were unable to identify a specific investment
decision which had been changed as a result of the deferral.[39]
1.38
Government senators note evidence provided by DoHA which explained that
the deferred listings represent less than one per cent of all listings since
2007, and 3.9 per cent of all listings in 2011. Mr Learmonth put the view
that in comparison with the level of risk associated with applying for PBAC
approval, Cabinet consideration of listings presents a low level of risk to
companies when they are making investment decisions:
I would argue that the biggest hurdle for a company as to
whether a drug ends up being subsidised on the PBS remains the PBAC, the
Pharmaceutical Benefits Advisory Committee.
In 2010, 63 per cent of all first-time, cost-effective
submissions were rejected by the PBAC. This is not a one-off statistic but a
consistent marker of the rigour of the assessment process undertaken. It is
this assessment process which I would suggest is the main decision point for
companies in determining whether to bring a drug to the subsidised market in
Australia.[40]
1.39
Government senators note that Cabinet consideration of listings is not
an additional risk or extra hurdle, as 'It has always been the case that
cabinet makes decisions on which medicines should be listed and which should
not'.[41]
Mr Learmonth further explained:
I do not think there has ever been any advisory committee for
any government whose recommendations have always been automatically accepted by
government. Certainly in the case of the PBAC it has always been the case that
government has considered the recommendations, and certainly in the past there
have been occasions when government has chosen not to accept those recommendations.[42]
1.40
In response to suggestions that companies are able to more easily
calibrate the risk involved in the PBAC assessment process, as it is a known
quantity, with clear requirements and criteria, Mr Learmonth stated that
despite any familiarity with the PBAC process, listing applications will often
not be accepted on initial submission:
Does that always pan out in terms of the behaviour of the
companies in so far as they all bring beautifully evidenced, competitively
priced product? No. Sometimes they do and they are accepted and other times
not. Despite all that transparency and familiarity, we will see products that
take seven cycles through the PBAC and take a 70 per cent price drop to
actually get through...Equally, there are no strict guidelines around PBAC
approvals. There are guidelines around what a submission needs to look like but
there are no, for example, guidelines that specify the incremental
cost-effectiveness ratio at which the PBAC will find a medicine cost-effective.
There has never been and it allows some judgment by the PBAC.[43]
1.41
The suggestion was put to the committee that the Government's decision
to defer listings has resulted in the waste of stock. However, the committee
heard that this will not be the case where a product can be used for other
indications:
In relation to us, Botox fortunately has PBS funding for
eight different indications so far, ranging from kids with cerebral palsy to
adult spasticity post-stroke to movement disorders. It has been around a long
time and it is well funded...It is less of an issue for us because Botox is
used for a lot of other very valuable medical indications.[44]
1.42
The Department of Health and Ageing substantiated this point:
Decisions about whether to obtain stock, ahead of formal
advice from the Department one month prior to the actual date that the listing
will proceed, are commercial decisions made by individual companies. Companies
are not required to pre-stock, in anticipation of a positive listing outcome.
They are only required to assure the Department, that, when listing does
proceed, they will be able to make stock available on the PBS. Once approval to
list on the PBS is known, companies are able to proceed with their projected
listing date or defer listing if they are unable to supply by that date.
It is not for the Department to speculate on each individual
company’s capacity to supply prior to advising of the approval to list.
In relation to the six PBS listings that remain deferred,
companies can still sell stock privately and to hospitals. Further, it should
be noted that of the six PBAC recommendations that remain deferred, three of
the medicines are already subsidised through the PBS for other indications.
These are:
- Botox®
($11.8 million in PBS expenditure in 2009-10);
- budesonide
with eformoterol (Symbicort® - $66.3 million in PBS expenditure in 2009-10 for
asthma); and
- dalteparin
sodium (Fragmin® - 0.9 million in PBS expenditure in 2009-10)[45]
1.43
Government senators also note the comments of Professor Sansom.
Professor Sansom has been chair of the PBAC since 2001 and has an in depth
knowledge of the pharmaceutical industry in Australia. Professor Sansom was of
the view that the Australian market is stable and the supply of medicines will
not be affected:
We have a high reputation. We are highly skilled in clinical
science. I think companies will make the judgement. This is quite a stable
market. Once you get listing, this is a very stable market. I think it is a
commercial decision and I do not believe it will have a major impact at all.[46]
Research and Development
1.44
Government senators note that the Government is working through the
Pharmaceuticals Industry Council and related programs and initiatives to
attract clinical research to Australia and build on the country's intellectual
capital.[47]
An example of the Government's commitment to advance and encourage more
research and development and investment is the implementation of the R&D
tax credit, which will 'reduce the cost of R&D by 10 per cent and make
Australia more internationally competitive as a destination for medical
research investment'.[48]
In addition the Government has been working to implement the recommendations of
the Clinical Trials Action Group to streamline the clinical trial approval
process.[49]
1.45
Mr Learmonth, DoHA, further stated that he could not see the link
between the deferral of certain listings, and implications for research and
development and clinical trials in Australia:
They are quite different decisions, though—having a clinical
trial in Australia versus accessing the funded market. Clinical trials are
conducted as propositions internationally. As I say, these are large
multinational pharmaceutical companies. On the innovative side, they will
locate their clinical trials—and they are often multisite clinical trials—in
circumstances that most suit them in terms of generating the evidence that they
will use to claim reimbursement all around the world in various markets and
from various payers. Those will go to a range of things, such as availability
of populations, price and clinical infrastructure. They will make a lot of
judgments about where they locate trials, having regard to how best and most
cost-effectively to generate evidence. That is an entirely separate matter
from, having obtained that evidence, how and where they choose to take that
evidence and seek reimbursement in particular markets. So I cannot see the
link.[50]
The Australian medicines market - available and accessible medicines
1.46
The committee heard that while medicines may not be available under the
PBS for a subsidised price, if they are approved by the Therapeutic Goods
Administration (TGA), consumers in Australia still have access to those
medicines.[51]
Witnesses further confirmed that there is a small private or hospital market
for some of the deferred medicines.[52]
1.47
Government senators note that, with the exception of Botox®, there are alternative
medicines available to those which have been deferred, and therefore patients
will still be treated. While the effectiveness and appropriateness of those
alternatives for an individual may be debated, alternative treatments are
available for those medicines, with the exception of Botox®.[53]
DoHA submitted:
Based on the evidence provided to the PBAC which is reflected
in the PBAC recommendations, four of the six medicines that remain deferred to
date, paliperidone (Invega Sustenna®), budesonide with eformoterol
(Symbicort®), dalteparin sodium (Fragmin®) and nafarelin (Synarel®) produce
similar health outcomes to existing PBS-listed therapies. They did not
demonstrate superior clinical benefits to those items already on the PBS, but
had an additional cost to the Commonwealth budget.
With respect to oxycodone with naloxone (Targin®), the PBAC
considered that it could provide an alternative pain management therapy to
opioids alone or in conjunction with prophylactic laxatives. This was reflected
in the cost of this medicine which was similar to oxycodone plus an
over-the-counter laxative. The potential for reduction in illicit drug use
claimed in the submission to the PBAC was not based on evidence.[54]
1.48
Furthermore, Government senators note that the PBAC did not find any
evidence of clinical superiority in relation to the deferred medicines, and the
medicines in question were deferred on a sound basis:
Most of these drugs were cost-minimised or 'me too' drugs,
with no added efficacy or health outcome and no less toxicity than existing
treatments but with a net cost to the government.[55]
1.49
While the alternatives may not be the most preferable treatment for all
individuals, Government senators note evidence provided by Professor Sansom
that there will always be some patients who will not have access to a
particular medicine under the PBS, as it is not sustainable to list every
single medicine:
Even when PBAC says, 'No, the drug is not cost effective,' we
know that there will be patients who may have benefitted from that drug. That
pertains to every decision that PBAC makes. Let me put it another way: for any
country to go to a purely individualised patient system—that would mean you would
make every drug available without any restrictions so you can try as many as
you like—the system would be broke in a very short space of time.[56]
1.50
Mr Learmonth, DoHA, explained that the concerns about increased
uncertainty impacting on commercial decisions to make medicines available in
Australia needs to be put in context:
...the risk to the extent that you can characterise it as
risk in making this decision to enter the market is at the PBAC end where over
60 per cent of first-time cost-effective applications are rejected. That is
where the significant uncertainty is. The uncertainty, if you want to
characterise it as that, represented by deferrals is extremely small in
comparison.
Finally, I would say that these are large, sophisticated,
multinational companies. They make their investment decisions in a range of
markets. They will look at what is going on and they will take a very
hard-headed business approach to understanding what the risk is. The principal
risk remains the PBAC's consideration and the rigorousness of that process.
They will have looked at the pattern of what the government has approved—and it
has approved over 150 new medicines and listings this year and it has continued
to defer only six—and they will make their judgments accordingly, and I believe
they will continue to bring things to market in Australia where they believe
they are good products.[57]
1.51
Indeed Mr Mark Glover of Allergan Australia emphasised that the major
concern for industry is the accessibility of medicines for patients, rather
than the availability of the medicines in Australia:
I do not think anybody is saying from the industry point of
view—and certainly I have not said it—that medicines are going to stop coming
to Australia as a result of this deferral policy.[58]
1.52
Mr John Latham of Pfizer Australia echoed these sentiments:
When you look at the role of the pharmaceutical industry and
what we do, our role is really to innovate and work in a system that discovers
and brings new medicines to market. Those medicines are there to treat
diseases. For critics to say that the industry are threatening to not bring new
products to Australia because we do not like the system is rubbish. We are here
and our job is to discover medicines and bring them to citizens around the
world.[59]
Government senator's view
1.53
Government senators, having considered the evidence provided to the
committee, are of the view that the Government's decision to defer the listing
of certain medicines under the PBS is not major change in Government policy. The
final decision on listing of medicines on the PBS has always be the
responsibility of Government.
1.54
In this instance, the Government has taken a difficult decision on the
ground of financial responsibility. It has also ensured that most of the medicines
deferred have an alternative already listed on the PBS. In addition, the PBAC
found that for most of the medicines there was no added efficacy or health
outcome and no less toxicity than existing treatments. Government senators also
note that no medicines approved for listing by the PBAC at its March 2011
meeting have been deferred and that the Government continues to approve listing
of high-cost drugs.
1.55
There were suggestions during the inquiry, that the Government, by its
actions had jeopardised the access of Australians to medicines. This is not
true. The Government continues to support the role of the PBAC while
undertaking a responsible approach to the financial sustainability of the PBS.
Government senators do not consider that the pharmaceutical companies present
in the Australian market will withdraw. The Australian market is stable and
provides a good investment environment for those companies. In addition, there
has been no evidence of a decrease in the number of submissions to the PBAC for
consideration.
1.56
The Government will continue to work towards ensuring that affordable
and effective medicines are available in a timely manner for Australian
consumers. Government senators note that the MOU with Medicines Australia will
continue to deliver improvements and point to the Government's commitment to a
viable medicines industry in this country. Suggestions that Australians are
facing a system similar to that in place in New Zealand are far from reality.
1.57
Finally, Government senators reiterate that the PBS has served
Australians well since 1948 and we see no reason to change it.
Senator Helen Polley Senator
Anne McEwen
Deputy Chair
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