In a speech to the Australian Clinical Trials Alliance today, Medicines Australia Chief Executive, Dr Brendan Shaw, called on the Government to work with the industry to implement its election promise to accelerate clinical trial regulatory reform.

“Despite a recent increase in clinical trial activity in Australia, our share of the global investment in this area continues to decline,” Dr Shaw said.

“We know what the problems are: high costs, regulatory inefficiencies, low patient recruitment rates and a public health system where research is an extra-curricular activity.

“The solution is to implement reforms identified over three years ago and do this within the next 12 months.

“Last year, the McKeon Review of Health and Medical Research called for clinical trial reform to be made an ‘urgent national priority’. Medicines Australia shares this view.”

The Australian Government made a commitment during last year’s election campaign to accelerate the pace of clinical trial regulatory reform.

“We are delighted by this commitment and we look forward to working with the Government on its implementation,” Dr Shaw said.

“This is a great opportunity for Australia if we can move towards a more efficient and attractive environment for clinical trials in Australia.

“Clinical trials are important not only for the massive investment they bring to Australia, but also for the role they play in improving Australia’s healthcare system.

“Australia is recognised globally as having some of the best scientists and research infrastructure in the world. Despite this, Australia has not benefited from the dramatic shift in

global R&D spending in the pharmaceutical industry away from Europe and North America towards markets in the Asia-Pacific region.

“Australia faces fierce competition for clinical trial investment, and regulatory inefficiencies and extraordinarily high costs make it harder to attract that investment here.

“Together with government, we can make this country a leading destination for global investment in clinical trials for years to come.”

A copy of Dr Shaw’s speech is available here (please follow link)

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Contact Person:

Alexia Vlahos
Phone: (02) 6122 8503
Email: Alexia.Vlahos@medicinesaustralia.com.au

In his address to the country at the National Press Club in Canberra yesterday, Chairman of Medicines Australia, Dr Martin Cross, emphasised the sustainability of the Pharmaceutical Benefits Scheme and the importance of working closely with government.

“Australians enjoy amongst the highest life expectancy in the world thanks in large part to the medicines available through the PBS,” Dr Cross said.

“However, to ensure the future viability of the PBS, it is vital that we have a stable policy framework between government and the industry, despite the challenges we have faced in the past.”

Dr Cross also said pragmatic solutions are now required to ensure Australians continue to have universal, timely access to the latest medicines and the industry remains a strong contributor to the wealth as well as the health of the nation.

Medicines Australia also hosted its annual Parliamentary Dinner last night at Parliament House with guest of honour, Health Minister, Peter Dutton, and keynote speaker, Professor John Shine, Chairman of CSL.

Mr Dutton told the gathering the Parliamentary dinner is a good opportunity for industry to showcase their work, so government can get a better understanding of how it can provide support, including support for the growth of what is a viable sector.

“The Government is committed to working with industry, especially during what is a fiscally tight environment,” Minister for Health, Peter Dutton, said.

“For any government, especially in these fiscal circumstances, first year budgets are always difficult, but we want to make sure we can work closely with industry and sectors.”

Keynote speaker, Professor Shine, said that predictability in the policy environment was critical to future investment.

“With greater certainty around PBS assessment and reimbursement, industry can turn its mind to growing its business interests in Australia as a key partner in the future vision for Australia as a world-class centre of innovative drug development, manufacturing and healthcare delivery,” Professor Shine said.

Copies of these speeches will be available soon on Medicines Australia’s website at: http://medicinesaustralia.com.au/media-events/

To view the NPC address, go to the ABC News website at: http://www.abc.net.au/news/2014-03-19/national-press-club-dr-martin-cross-medicines/5331914

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Contact Person:

Alexia Vlahos
Phone: (02) 6122 8503
Email: Alexia.Vlahos@medicinesaustralia.com.au

Government expenditure on the Pharmaceutical Benefits Scheme (PBS) is currently not only sustainable, but actually declined last financial year.

In the past few months, major reports from three separate government agencies have confirmed that PBS expenditure is contained and that price disclosure is delivering savings far in excess of what was expected.

The regular Medicines Partnership of Australia (MPA) PBS Scorecard update released today outlines the current state and trajectory of PBS spending, as confirmed by the Department of Health, the Federal Treasury, and the Productivity Commission.

The Medicines Partnership welcomes the statement from the Minister for Health, Peter Dutton, that Australia needs “to have a national discussion about who pays for what and how the Government pays going forward.”

As part of that national discussion it is important to acknowledge that price disclosure has been and continues to be an extremely effective tool in ensuring that PBS expenditure remains contained and sustainable.

The most current update on PBS expenditure is in the Medicines Partnership of Australia scorecard, issued today.

The Medicines Partnership of Australia is: The Pharmacy Guild, Medicines Australia, the Generic Medicines Industry Association, the Australian Self-Medication Industry, the Pharmaceutical Society of Australia and the National Pharmaceutical Services Association.

Click here to view the PBS Scorecard (please follow link)

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Contact Person:

Alexia Vlahos
Phone: (02) 6122 8503
Email: Alexia.Vlahos@medicinesaustralia.com.au

Medicines Australia has called on the Australian Government to save the Pharmaceutical Benefits Scheme (PBS) by delivering stable policies that support the medicines industry and ultimately Australian patients.

“Medicine Australia’s pre-Budget submission sets out six measures that will protect the PBS for future generations,” Medicines Australia Chief Executive, Dr Brendan Shaw, said.

“It also outlines what measures are needed to maintain a viable and thriving medicines industry, which last year generated over $4 billion in exports, and invested over $1 billion in research and development for the fourth consecutive year.”

The submission details the significant savings to the Australian Government achieved through successive rounds of reforms in 2007, 2010 and 2013.

“The PBS reforms have secured an enduring savings mechanism through price disclosure. The work has been done,” Dr Shaw, said.

“Importantly, these reforms, delivering up to $18 billion in savings, were achieved through collaboration between government and industry. As a result, the cost of the PBS is actually falling, in stark contrast to the rest of the health system.”

Furthermore, the submission calls on the Government to work with industry to improve the listing of new medicines on the PBS over the life of the next Parliament, and to continue to reform and improve Australia’s intellectual property policies and laws.

“The key issue now is that it is becoming harder and harder for new medicines to get listed on the PBS and provided to Australian patients in a timely manner. We can do better than this and we have to,” Dr Shaw said.

“The PBS only contributed 10% of the total growth in Federal Government health spending over the last decade.

“The considerable savings being realised provide ample scope for this Government to fund new and innovative treatments as they become available.

“Despite the challenges we have faced and the losses incurred, Medicines Australia believes that a stable policy framework between government and the industry is the best way to ensure the future viability of the PBS.

“There’s a real opportunity here for the Australian medicines industry to help build manufacturing and R&D in Australia if we can get predictable, supportive policies in place in areas like PBS policy, innovation and intellectual property.”

Recommendations:

1. Commit to PBS policy certainty and to maintain access to medicines
2. Commit to no new PBS savings measures in the 2014-15 Budget
3. Use savings in the PBS to secure new and innovative treatments into the future
4. Continue agreed measures within existing arrangements as ongoing policy settings for medicines, and work on process improvements and expansion to new areas as necessary
5. Stimulate global competitiveness in Australian pharmaceutical innovation, retain a commitment to clinical trial reform and settle global concern in Intellectual Property rights
6. Strengthen confidence locally and globally in Australian taxation policy

Medicines Australia’s Budget submission can be found here

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Contact Person:

Alexia Vlahos
Phone: (02) 6122 8503
Email: Alexia.Vlahos@medicinesaustralia.com.au

Medicines Australia has welcomed the extended 10 week publication time for the agenda for Pharmaceutical Benefits Advisory Committee meetings that comes into effect today.

The agenda for each PBAC meeting will now be published 10 weeks prior to the meeting, as opposed to the six weeks that had been normal practice until today.

“Medicines Australia supports the longer time period of publication of the PBAC agenda prior to each meeting,” said Medicines Australia Chief Executive, Dr Brendan Shaw.

“It means consumers, consumer groups, and members of the general public will now have more time to prepare submissions and make comments to the PBAC on new medicines and vaccines seeking listing on the Pharmaceutical Benefits Scheme.

“Industry has worked with government, technical experts and patient groups to secure this improvement to the PBAC system.

“This included having to manage important commercial-in-confidence issues.

“Industry supports this increase in transparency because it makes sense, it’s practical, it’s meaningful and it serves a real purpose for the end user – the consumer.

“It’s an example of what can be achieved when stakeholders work collaboratively with industry on an important policy issue.

“Some years ago, industry worked with government and consumer groups to have the PBAC agenda published which was a real innovation at the time. Now we have agreed to publish the agenda earlier to give people more time to input into the PBAC process.”

The agenda for the upcoming March 2014 PBAC meeting can be found at: http://pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda

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Contact Person:

Rachel Beck
Phone: (02) 8437 5393
Email: rachel@ogilvyprhealth.com

New price disclosure reductions on the prices of medicines on the Pharmaceutical Benefits Scheme announced late yesterday show that the pricing model proposed by the Grattan Institute would cost taxpayers millions of dollars more.

“While some commentators continue to criticise the PBS price disclosure arrangements, these same policies are actually pushing the price of many Australian medicines below those of comparable markets overseas,” Medicines Australia Chief Executive, Dr Brendan Shaw, said today.

“The fact is if Australia used the pricing model recommended by the Grattan Institute, the Australian Government would be paying much more for medicines,” Dr Shaw said.

For example, 20 mg docetaxel – used to treat a range of cancers – will cost A$6.89 in Australia from 1 April, compared to A$275 in the United Kingdom, meaning the UK pays about 40 times more than Australia.

“Under the Grattan model of pricing to international benchmarks, the Australian Government would pay millions of dollars more a year for docetaxel treatment than it will under the price disclosure policies,” Dr Shaw said.

“In fact, some of the medicines used by the Grattan Institute in its original March report now have Australian prices below those of international benchmarks as a result of the price disclosure policy.

“Medicines like ramipril for blood pressure, omeprazole for stomach ulcers and amlodipine for blood pressure are now cheaper here than in Canada.

“It’s galling that while the Australian industry is copping massive price reductions that have pushed prices below international benchmarks and led to job losses, we have commentators arguing prices are too high.

“The fact is that the prices of many medicines in Australia, patented and off-patent, are well below prices found in other comparable markets.”

Over 120 medicines will have their prices cut by up to 90% on 1 April next year as a result of price disclosure, with the top five price reductions announced late yesterday for 1 April including:

• Docetaxel (cancer) – 90% reduction
• Oxaliplatin (cancer) – 60% reduction
• Valaciclovir (herpes) – 56.5% reduction
• Topotecan (cancer) – 56% reduction
• Fluconazole (anti-fungal) – 53% reduction.

A full summary of all 1 April price disclosure price reductions can be found here: http://www.pbs.gov.au/info/industry/pricing/eapd/price-reductions-04-2014.

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Contact Person:

Alex Chapman
Phone: (02) 8281 3204
Email: alex@ogilvyprhealth.com

The Mid Year Economic and Fiscal Outlook released today again proving that the Pharmaceutical Benefits Scheme is financially sustainable.

The MYEFO shows that the PBS is a major parameter saving in the Budget, with spending in 2013-14 to be $526 million lower than budgeted just seven months ago, equivalent to an additional $2.7 billion in savings over the next four years.

“The cat is out of the bag,” said Medicines Australia Chief Executive, Dr Brendan Shaw.

“The MYEFO shows that savings from PBS price disclosure are still confounding the Treasury bean counters almost as much as the Australian bowling attack is outwitting the English batsmen.

“Given the savings being delivered now, the Commission of Audit may as well pack up and go home as far as the PBS is concerned because the work has already been done.

“While other areas of the health budget may be growing, the fact is the PBS is not one of them.

“The issue for the PBS is not whether it is financially sustainable, but whether the savings being delivered from PBS reform are actually being used to provide Australian with new medicines in the future, as was always intended,” Dr Shaw said.

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Contact Person:

Alex Chapman
Phone: (02) 8281 3204
Email: alex@ogilvyprhealth.com

Figures contained in a report released this week by the Parliamentary Budget Office confirm that the Pharmaceutical Benefits Scheme has not been the major driver of growing Commonwealth health expenditure over the last decade.

“This is the first outbreak of sanity in the debate about PBS spending we’ve seen in a long time,” Medicines Australia Chief Executive, Dr Brendan Shaw, said today. “If we’re not careful we might actually start basing the PBS debate on facts, rather than the ill informed musings we’ve seen from commentators and think tanks in recent times.

“The report shows that the PBS has not been the main driver of growing health expenditure over the last decade. It’s not the villain some people have painted it as.”

The Parliamentary Budget Office report shows that:

• Federal Government spending on pharmaceutical benefits grew by an average of 2.7% per annum in real terms over the decade to 2012-13
• This is less than growth in overall Federal Government health spending of 4.8% per annum and, remarkably, even less than growth in the overall economy of 3% per annum over the same period
• The PBS only contributed 10% of the total growth in Federal Government health spending over the last decade, despite accounting for 16% of health expenditure (see chart attached)
• The Medical Benefits Scheme accounted for 44% of the growth in Federal Government health spending over the last 10 years, general health services 25%, and hospital services 19%, and
• In 2012-13 Federal Government spending on pharmaceuticals fell by an historic 3.5% and only grew by 1.5% in 2011-12. These years were when major price disclosure price reductions for hundreds of generic medicines started flowing through the PBS.

“It’s ironic that in the ten years since the 2002 IGR predicted the PBS would bankrupt the country, it turns out the PBS only made a small contribution to health expenditure growth and grew slower than the economy,” Dr Shaw said.

“There’s no doubt that reforms agreed between industry and governments have been key to keeping the PBS sustainable – at no small cost to the industry – while providing new medicines for things like cancer, arthritis, blindness, high cholesterol, high blood pressure, diabetes and mental health to the Australian community over the last decade.

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Contact Person:

Alex Chapman
Phone: (02) 8281 3204
Email: alex@ogilvyprhealth.com

Medicines Australia’s submission to the National Commission of Audit, released today, shows that the key issue for the Pharmaceutical Benefits Scheme is ensuring it is fit for purpose for listing new medicines.

“The bottom line is that a lot of the work to make the PBS financially secure in the long term has already been done,” said Medicines Australia Chief Executive, Dr Brendan Shaw said today.

“The industry has worked with successive governments over the last decade to ensure that the PBS is financially sustainable.

“The PBS is seeing falling spending levels, substantial price cuts, falling PBS to GDP ratios and is falling as a share of the health budget. This shows the reforms have delivered financial sustainability to government and the community.

“The important thing now is to ensure the PBS is able to list new medicines in a timely manner and that savings are re-invested in new therapies for the future.”

Medicines Australia’s submission call on the National Commission of Audit and the Government to:

1. Acknowledge that structural reforms have delivered a sustainable model for funding pharmaceuticals through the PBS, with enduring mechanisms to generate ongoing PBS savings, such that no further savings measures are warranted.
2. Review the Pharmaceutical Benefits processes, including the administration of the programme and its associated statutory structures (e.g. PBAC) to remove red tape and make them fit for purpose for the future
3. Remove unnecessary processes which are now redundant in light of PBS reforms
4. Commit to working with the pharmaceutical industry and relevant stakeholders to ensure a stable and predictable business operating environment in Australia
5. Commit to working with the pharmaceutical industry and relevant stakeholders provide a stable industry and regulatory policy setting and encourage favourable investment strategies

Medicines Australia’s submission can be found here

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Contact Person:

Alex Chapman
Phone: (02) 8281 3204
Email: alex@ogilvyprhealth.com

A new Galaxy poll of people taking prescription medicines released today reveals that Australians overwhelmingly support the Pharmaceutical Benefits Scheme, support R&D and are concerned about delays in accessing new medicines.

“This survey shows that the medicines industry’s concerns about protecting the PBS and ensuring new medicines are made available quickly are shared by the Australian community,” said Medicines Australia Chief Executive, Dr Brendan Shaw.

“When 86% of people say that the PBS is a good use of taxpayers’ money, this is a strong signal that the community supports the current scheme.

“That 80% of people are concerned about reports of delays in listing new medicines on the PBS is a wakeup call.

“It proves that the concerns the industry has raised about the efficiency of the PBS listing process are shared by the Australian public.

“Australians are really concerned if they think they are missing out on new medicines for things like cancer, diabetes and rare diseases compared to other countries.

“A majority of Australians also believe that pharmaceutical R&D will improve the treatment of their condition in the future, which suggests that Australians value the $1 billion invested in R&D each year by the Australian medicines industry.

“Australians recognise the value of the PBS, the value of the medicines on it, and the value of the investment in developing these medicines.”

Key findings from the survey include:

• 51% of Australian adults take a prescription medicine daily – equivalent to 9 million adult Australians
• 86% of Australians taking a medicine think the PBS is a good investment of taxpayer dollars
• 80% of Australians taking a medicine are concerned about reports that there are delays in accessing new medicines in Australia compared with other countries, and
• 60% of Australians taking a medicine believe that pharmaceutical R&D will improve the treatment of their condition in the future.

The survey of 1,000 Australians taking a prescription medicine daily conducted by Galaxy and sponsored by research firm Ethical Strategies and trade journal Pharma Dispatch.

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Contact Person:

Alex Chapman
Phone: (02) 8281 3204
Email: alex@ogilvyprhealth.com