A predictable regulatory and reimbursement environment, and a long-term policy outlook are essential if patients are to continue to have access to new medicines, Medicines Australia chief executive Dr Brendan Shaw told a key policy conference in Canberra today.

Speaking at the Third Joint Medicines Policy Conference, jointly staged by Medicines Australia and the Department of Health and Ageing, Dr Shaw said policymakers needed to consider the impact policy signals would have on manufacturers.

“When a company is investing an average of 15 years and $1.5 billion to develop a medicine, predictability about how regulators, payers and government are going to treat that medicine is important,” Dr Shaw said.

“The medicines industry has one of the longest lead times for bringing new products from research to market of any high-tech manufacturing industry.

“It takes longer to bring a new product to market for medicines than it does for cars, consumer electronics, medical devices, and semi-conductors.

“That is one of the reasons why the Federal Cabinet’s decision to defer the listing of new medicines earlier this year caused such a stir for the industry, leaving aside the avalanche of criticism from the rest of the community.

“Ensuring that medicines policy is designed with one eye on the impact on the industry is key to future developments in medicine.

“In this time of budget stringency, economic volatility, growing consumer demands and changing priorities, having a long-term view about how industry can be supported and incorporated into a medicines policy is critical.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

New legislation passed by the Senate will help make Australia more globally competitive as a destination for pharmaceutical investment in research and development, Medicines Australia chief executive Dr Brendan Shaw said today.

Dr Shaw said the Tax Laws Amendment (Research and Development) Bill 2010 will introduce a tax credit that will reduce the cost of eligible R&D by up to 10 per cent.

“This legislation will give companies a real incentive to boost their R&D investment in Australia,” Dr Shaw said. “This is a big step in the right direction to ensure Australia remains competitive in the face of strong overseas competition.

“The medicines industry is one of Australia’s key high tech manufacturing industries, employing 14,000 people in high-skill jobs. It exports $4 billion annually, putting it ahead of the car and wine industries.

“Although Australia has strong capability in developing medicines, there’s no doubt Australia’s medicines industry, like much of the manufacturing sector, is under increasing pressure from overseas competition.

“Medicines Australia has consistently supported the Federal Government’s changes and it has been a complex debate over the last two years. Thankfully the R&D tax credit will finally become law. It brings Australia’s R&D tax incentives into the 21st century.”

Last year a KPMG report found that implementing the tax credit would place Australia at the top of the KPMG ranking of the most competitive locations for R&D investment, ahead of countries such as Canada, the UK, Germany, France and the United States.

Dr Shaw said the new R&D tax credit will help keep Australia at the forefront of medical research globally and will help secure high-value research jobs.

“It will help encourage companies to conduct R&D in Australia and attract greater investment to our universities and other research institutions,” Dr Shaw said.

“R&D sustains Australia’s medicines industry and provides thousands of high-paying jobs.

“I congratulate the Parliament for passing this landmark legislation and for making this important change.

“I particularly congratulate the Minister for Innovation, Industry, Science and Research, Senator Kim Carr for patiently championing this important Bill for over two years.”

The medicines industry is Australia’s largest manufacturing investor in R&D, attracting more than $1 billion in R&D investment in 2008-09.

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

The Jimmy Little Foundation has launched a new interactive website called Thumbs Up! to promote healthy eating to indigenous children in the Northern Territory.

The website, funded by Medicines Australia and supported by the Northern Territory Government, aims to encourage indigenous children to make healthy food choices and improve nutrition.

The website includes a teacher section outlining lesson plans which align with the Northern Territory and draft national curriculum, particularly through the Remote Schools Curriculum and Assessment Materials.

Jimmy Little Foundation chief executive Graham “Buzz” Bidstrup said the website would provide vital health and wellbeing information for schoolchildren in their early formative years.

“We hope that the knowledge they gain from this website might reduce their chances of contracting chronic diseases later in life,” Mr Bidstrup said.

“With no geographic boundaries, teachers and young people in classrooms across Australia can go online to learn more about how to lead a healthy, balanced lifestyle.

“This online teaching aid has been developed in partnership with the NT Department of Education. It is fun and interactive and delivers health and nutrition messages from Australian indigenous icon Uncle Jimmy Little and his Thumbs Up! team.

“It’s a really simple message: Good Tucker – Long Life.”

Medicines Australia chairman Will Delaat said the Australian medicines industry was committed to helping improve indigenous health.

This is a response to the Federal Government’s call for assistance in ‘closing the gap’,” Mr Delaat said.

“Medicines Australia is proud of our contribution that assists in advancing improvements in indigenous health.”

The launch of the website at Milner Primary School in Darwin this week was attended by The Hon Dr Chris Burns, Northern Territory Minister for Education and Training.

The Thumbs Up! website is part of a broader Jimmy Little Foundation healthy eating program funded by Medicines Australia.

The Thumbs Up! website is available at: http://www.thumbsup.org.au/

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

A Senate Committee report tabled in Parliament today strongly criticising the Government’s management of the Pharmaceutical Benefits Scheme reflects grave community concerns, Medicines Australia chief executive Dr Brendan Shaw said today.

The Senate Finance and Administration References Committee report on Government Administration of the PBS condemned Federal Cabinet’s decision to defer the listing of new medicines on the PBS.

Dr Shaw said the Committee was sending the Government a clear signal that Cabinet should not interfere with the process of listing new PBS medicines.

“It is extraordinary that apart from the Department of Health, none of the 65 submissions to the inquiry supported the Government’s action on this issue,” Dr Shaw said.

“Patients don’t support it, doctors don’t support it, the broader community doesn’t support it and industry doesn’t support it.

“The community has told the Committee unequivocally that it wants a return to the previous system of listing new medicines on the PBS that has served Australians so well for decades. That sentiment is reflected in the Committee’s report.

“Medicines Australia also welcomes the recommendation that the Government adhere to the intent of the Memorandum of Understanding signed with industry in 2010.”

The report warned that the politicisation of the PBS listing process risked creating two separate classes of people: “those who have access to a suitable medicine that is subsidised and those who do not.”

Dr Shaw said the Committee clearly acknowledged that the Government’s policy on the PBS was threatening to take Australia into a two-tier health system.

“Next week marks six months to the day since Government announced it was deferring the listing of new medicines. Every day that goes by is another day that many Australian patients are being denied access to medicines they need.

“I congratulate the Committee on its excellent report and thank the members of the Committee for the hard work they have undertaken in preparing it.

“Medicines Australia welcomes the Committee’s recommendations and strongly urges the Government to act on them.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Recent submissions on elements of the new R&D Tax Credit system, the gene patents bill and the implementation of the Clinical Trials Action Group’s recommendations are available here (please follow link).

A new section contains information on several current innovation and industry policy issues such as the R&D Tax Credit, clinical trials and patent reform. This new section is available here (please follow link).

New publicly available Government data from Medicare Australia shows that Government expenditure on the Pharmaceutical Benefits Scheme grew by just over 5 per cent in 2010-11 – or less than 2 per cent in real terms.

Medicines Australia chief executive Dr Brendan Shaw said today the new data, coupled with today’s release of the annual inflation figures, show that PBS spending is well under control.

“It’s really time to explode this myth that the PBS is unsustainable,” Dr Shaw said.

“With inflation running at 3.6 per cent and PBS growth at 5.2 per cent, the PBS is actually growing at less than 2 per cent a year in real terms.

“It’s really time for people to wake up and smell the coffee. The PBS is not growing out of control. The evidence shows that real growth is minimal.

“For a major healthcare program to achieve such minimal growth, while still providing universal access to the latest medicines to a growing and ageing population, is quite an extraordinary achievement.

“The Medicare figures show very clearly that there is no need for Government to take a heavy-handed approach to the PBS. There is simply no justification for knee-jerk savings measures such as the Cabinet’s deferral of PBS medicines.

“The Government’s own figures show that the PBS is in good shape. I urge Government to stop and look at this data.

“The Government’s own Intergenerational Report projected that the PBS as a proportion of GDP will be flat right out to 2020.

“The most recent OECD data shows that the Australian Government continues to spend well below the OECD average as a proportion of GDP.

“Now the most recent Medicare data points to the same conclusion. By any definition the PBS is sustainable.”

The Medicare Australia data is available from here (please follow link)

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Federal Cabinet’s decision to defer the listing of new medicines on the Pharmaceutical Benefits Scheme threatens to take Australia into a two-tier health system, Medicines Australia chief executive Dr Brendan Shaw told a Senate Committee hearing today.

Dr Shaw was giving evidence to the Senate Finance and Public Administration References Committee Inquiry into the Government’s administration of the PBS.

Dr Shaw said five months after Cabinet’s announcement to defer the listing of some medicines that had been recommended by the Government’s own expert advisory committee, some patients were still unable to afford those treatments.

“For patients this has meant five months without medicines that would materially improve their lives,” Dr Shaw told the Inquiry.

“Patients suffering from schizophrenia, excessive sweating and chronic pain are all missing out. As more medicines come up for listing, more patients are now anxious they too will miss out in the future.

“We run the real risk of developing a two-tier health system, where the wealthy can afford the most effective and convenient treatment options, while the rest will have to make do with less convenient treatments already on the PBS.

“There are few things more important in government than making medicines affordable for sick people and their families.

“Given Australia is a wealthy country, with one of the best fiscal positions in the industrialised world, we should be able to afford to spend money on medicines for sick people.

“The growth of the PBS is at historic lows. Treasury’s own projections from last year’s Intergenerational Report suggest that growth will remain flat at around 0.7 per cent of GDP until at least 2020.

“The PBS is a sustainable, well run program that delivers major benefits to the health of the nation. These benefits run far deeper than a simple reading of the balance sheet by an accountant would suggest.”

Dr Shaw urged the Committee to recommend that Government list the medicines it has deferred and revert to the previous practice of listing new medicines recommended to it by its own expert advisory committee.

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia welcomes yesterday’s publication of the final report by the Therapeutic Goods Administration Transparency Review panel which has made 21 recommendations aimed at building a more transparent regulatory process in Australia.

Medicines Australia chief executive Dr Brendan Shaw said improving transparency would ensure the TGA was better understood by the community.

“The TGA has made significant progress in reforming its business processes and we are already seeing greater transparency in the prescription medicines sector,” Dr Shaw said.

“These latest reforms being recommended by the TGA Transparency Review panel will help demystify the regulatory process for the ordinary Australians who benefit from it.

“Medicines Australia looks forward to working with Government on the recommendations. While they may take some time to put in place, the TGA has already gone some way towards ensuring they are delivered.

“The quality of information provided by the TGA to companies bringing new medicines to market is now better. Improvements have been made to the TGA website, and particularly to the search functions of the product register. We look forward to further reforms in the months ahead.

“Providing greater transparency and detail on the TGA’s evaluation and decision-making process is a significant step forward. It will provide further confidence in the quality of prescription medicines to which Australian patients have access.

“Considerable effort has gone into this review. The consultation process has been exemplary and the report’s authors are to be commended.

“Medicines Australia looks forward to discussing with the Government how these recommendations can be implemented to best achieve the aim of providing more information to the community about their medicines.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Federal Cabinet’s decision to defer the listing of new medicines on the Pharmaceutical Benefits Scheme means ordinary Australians are missing out on access to new medical treatments, Medicines Australia has told a Senate inquiry into the Government’s administration of the PBS.

Medicines Australia’s submission to the inquiry said Cabinet’s decision shows “the Australian Government is moving towards a two-tier health system”.

“[It] perpetuates a situation where high-income patients can afford better treatments for things like schizophrenia, chronic pain associated with cancer, debilitating excessive sweating and use of combination products, whereas people on lower incomes have to make do.

“The future access of Australians to medicines is being transformed into a political lottery.”

The Government announced in February that it had blocked the listing of eight new medicines, despite recommendations by its own expert advisory committee that the medicines were value for money and should be made available to patients.

The submission notes that 42 per cent of Medicines Australia member companies have said that in light of the Federal Government’s decision, they were considering delaying brining new medicines to Australia.

“A number were seriously considering delaying various new medicines in the areas of cancer, diabetes, cardiovascular and mental health,” the submission said.

“The decision to require Cabinet to approve all new PBS listings and defer the listing of medicines is a bad policy decision.

“Whilst it clearly has an adverse impact on industry, ultimately it is Australians that miss out on access to new medical treatment in the future as a result of the uncertainty created by the Australian Government.”

The submission added: “The Government’s deferrals have not only placed a clinical burden on patients, but a financial burden as well. It was apparent from the initial deferral announcement that the Australian Government was prepared to transfer the cost of treatment to patients.”

Medicines Australia’s submission is available here (Please follow link)

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au