The Trans Pacific Partnership Agreement (TPP) will open up vast new markets for Australian companies, including manufacturers of innovative medicines and vaccines, Medicines Australia CEO, Tim James, said today.

 “Pharmaceuticals are already one of Australia’s largest manufactured export, worth around $3 billion each year.

 “But a new trade deal which further reduces trade barriers, improves market access and, above all, establishes high regional standards for intellectual property protection, could help transform Australia into a leading global hub for researching and manufacturing a new generation of highly specialised medicines and vaccines,” Mr James noted.

 In recent weeks, critics have appeared in the media claiming that possible changes to Australia’s IP system as a result of the TPP will lead to higher prices for medicines and “decimate” the Pharmaceutical Benefits Scheme.

 “Ten years ago, when Australia signed a free trade agreement with United States, the same people made the same arguments. They predicted the demise of the PBS,” Mr James said.

 “They were wrong. Absolutely wrong.

 “The PBS today is more sustainable than at any point in its history, and this is because the pharmaceutical industry in Australia is fundamentally committed to PBS sustainability and will always be willing to work with the Government to achieve this.”

 In an ‘open letter’ to Parliament late last week, Medicines Australia, in partnership with AusBiotech and Research Australia, called on policymakers to ignore the hysteria and fear mongering and instead to focus on achieving positive outcomes for Australia through the TPP.

 The letter noted that ensuring Australia has a globally competitive IP system is the key to our future health and wealth.

 “We shouldn’t let fear mongering derail progress on what will truly be a trade agreement for the 21st century,” Mr James said.

 “In terms of IP, there is always too much focus on the ‘cost’ of strengthening Australia’s IP system, and not enough on the benefits, such as job creation and investment in R&D and high-tech manufacturing.

 “Strengthening Australia’s IP system will ensure not only that Australian patients continue to get prompt and affordable access to the latest and most effective treatments, but also enable Australia to attract even more investment in biotechnology and pharmaceutical R&D and manufacturing.”

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Contact Person:

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

Thirteen medical sales representatives from the Australian medicines industry received the sector’s top accolade for ethical sales and marketing at a ceremony yesterday.

The Medicines Australia Continuing Education Program Awards are presented annually to sales representatives who achieve the best marks in their compulsory ethical conduct education program.

Medicines Australia Chief Executive Officer, Mr Tim James said the mandatory program, delivered by Medicines Australia and the University of Tasmania, highlighted the industry’s commitment to ethical conduct.

“Medical sales representatives play a really important role in helping doctors stay abreast of the latest information and ensure patients get the best out of the medicines that are available today,” Mr James said.

“Representatives have the job of ensuring the dialogue between the companies who make the medicines and the doctors that prescribe them is productive, balanced and ethical.

“Interaction between medicines companies and health care professionals is an important part of promoting patient health, so it is important we get it right.

“The continuing education program ensures medical representatives are educated to a recognised industry standard to provide healthcare professionals with accurate and balanced information.

“I congratulate all students who completed the course in 2014 and in particular the award winners. The fact that so many people have been recognised for their high achievement in this program shows pride in the industry, a passion to deliver quality education to healthcare professionals with the purpose of ensuring patients get the best use out of medicines that are available today.”

During his address, Mr James also spoke of the leadership the industry has shown in recent years. “The Intergenerational Report 2015 published last week makes clear that Population, Participation and Productivity are key to Australia’s economic future. Medicines play a fundamental role in relation to each of our nations’ population participation and productivity. The role and real value of medicines will underscore opportunities to lift Australia in these three P’s.”

“The pharmaceutical industry has shown real leadership in three key areas: firstly, there is an effective price signal on medicines; secondly the processes of the PBS require value and ensure ‘bang for tax payer’s buck’; and thirdly the industry has reformed dramatically in recent years delivering seven times the forecast savings to government. It is time for other parts of the health landscape to equally focus upon effective price signals, value and reform.”

The Medicines Australia Code of Conduct Award, for highest marks in the Code of Conduct Program, was presented to Sean Newman (AstraZeneca).

The University of Tasmania Prize for Excellence Awards for the highest quality reflective assignment, active learning and participation in each semester of the course were presented to Jacqui Bardellini (Sanofi) and Olivia Di Sisto (iNova).

The Medicines Australia CEP Achievement Awards, for the highest marks across all five core Programs went to: Eilise D’Arcy (Alcon), Irma Brink (BMS), Sean Newman (AstraZeneca), Catherine Solomonson (AstraZeneca), Ben Warner (Pfizer), Louise Thomas (iNova), Alex Roytman (Mundipharma), Lawrence Currion (Novartis), Edward Punshon (Alphapharm) and Catriona Truscott (independent student).

Photo description – names left to right: Olivia Di Sisto, iNova,  Irma Brink, BMS, Jacqui Bardellini, Sanofi, Louise Tomas, iNova, Alex Roytman, Mundipharma, Martin Cross, Medicines Australia, Tim James, Medicines Australia, Ben Warner, Pfizer, Sean Newman, AstraZeneca, Catherine Solomonson, AstraZeneca, Paul White (standing in for Lawrence Currion), Novartis, Eilise Darcy, Alcon, Edward Punshon, Alphapharm,  Absent: Catriona Truscott

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Contact Person:

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

The release of the highly anticipated 2015 Intergenerational Report (IGR) today reaffirmed the growing body of evidence that shows that the Pharmaceutical Benefits Scheme (PBS) is sustainable.

CEO of Medicines Australia, Tim James, welcomed the release of the Australian Government’s 2015 IGR, and its acknowledgement that growth in pharmaceutical expenditure will remain stable, growing only modestly to 2027-28.

“Medicines are central to achieving better health outcomes for the population. The flow on effects are increased participation and productivity, by people returning to work earlier and using medicines to avoid more costly and invasive treatments later on,” Mr James said.

The IGR showed that expenditure on pharmaceuticals is expected to grow from $420 per person in 2014-15 to $474 per person in 2027-28 (in today’s dollars).

“This is a major downward revision from the 2010 IGR.”

The IGR showed that the overall health budget is expected to grow from 4.2% in 2014-15 to 5.5% of GDP in 2054-55.  The report finds that Medicare services are projected to be the fastest growing component of health expenditure to 2027-28.

“The 2015 Intergenerational Report joins a growing body of evidence that demonstrates the sustainability of the expenditure on medicines through the PBS,” Mr James said.

“The 2015 IGR supports the fact that successive reforms to the PBS have put the PBS on a stable footing, by showing that strong growth of the PBS predicated in previous IGRs will not eventuate.

“It is not surprising that population, participation and productivity are central to this report, and it is clear that medicines are fundamental to all of these drivers. Medicines are an essential enabler of health, and wealth, for individuals, communities and the nation.

“The report shows that Australians will continue to live longer due to advancements in health care and rising living standards. Medicines will be fundamental to ensuring that people can remain productive in the workforce well into their twilight years.

“As the Australian population ages it is imperative that universal access to innovative medicines remains available to keep people productive, healthy and independent.”

Mr James also welcomed the explicit acknowledgement that new medicines and other biotechnology has the potential to provide further dramatic improvements in life expectancy.

“What we need now is the government to ensure a stable policy environment for the pharmaceutical industry and to ensure Australian patients receive early access to medicines.”

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Contact Person:

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

Australian cancer patients don’t have time to wait for access to new cancer medicines.

Australian patients wait longer for access to new cancer medicines compared to patients in other parts of the world, such as the United Kingdom, Canada, France and Germany.

“Australia is the cancer capital of the world.  We are now living much longer, due to a variety of reasons, including good public health policy and extraordinary new treatments. It is also now likely that half of all Australians will develop cancer in their lifetime and one in five will die from it,” Medicines Australia CEO, Tim James, said.

In its submission to the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia, Medicines Australia says the time lag between the Therapeutic Goods Administration’s (TGA) approval and listing on the Pharmaceutical Benefits Scheme (PBS) is costing patients’ lives.

“We need to challenge how the Government values new cancer drugs and better understand how the community values new treatments for themselves, and their family members,” Mr James said.

“The benefits of cancer drugs are realised over time; building on incremental results to produce other treatments that target different cancer groups. It’s almost like a slow domino effect, once one cancer drug shows results it is then used as a stepping stone to develop other treatments. So, the value of cancer medicines grows over time.

“The delay in listing medicines has a detrimental impact on health outcomes for individual cancer patients, their carers and the community as a whole. We are calling on Government to reconsider the system for access to new cancer medicines, because the current process, focussing on cost as opposed to value, is simply not good enough. Cancer patients can’t wait any longer.

“This Senate Inquiry provides an opportunity for Australia to learn from the actions of other countries in order to develop world leading, innovative access approaches within our country, which will ensure ongoing and sustainable access to new and targeted cancer medicines.

“Action is needed now to improve access pathways for cancer medicines.

“Dialogue with industry is critical to achieving workable solutions that support patients. We look forward to working with government and the community towards innovative access models and faster access to medicines.”

Medicines Australia’s submission will be available on the MA website no later than 5pm, 27 Feb 2015; https://medicinesaustralia.com.au/issues-information/publications/submissions/

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Contact Person:

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

Medicines Australia has lodged a submission to the 2015-16 Federal Budget.

In the Submission, Medicines Australia calls on the Australian Government to recognise the ongoing sustainability of the Pharmaceutical Benefits Scheme (PBS), resulting from reforms introduced in collaboration with the industry.

Medicines Australia also seeks a commitment to grow the investment opportunities for innovation and research in the pharmaceutical sector, in addition to recognising the broader value of medicines to patients and society.

“The Australian pharmaceutical industry contributes meaningfully to the health and wealth of the nation, however it requires a stable and predictable policy environment to encourage investment, grow and prosper,” CEO of Medicines Australia, Mr Tim James said.

“We call on Government to affirm a commitment to work with industry to maintain a sustainable PBS; recognise the need for predictability for industry; and to provide certainty by ensuring no new unilateral PBS saving measures are introduced in the 2015-16 Budget.

“A decade of PBS reforms are generating billions of dollars in savings and providing headroom to list new products on the PBS.

“What is needed now is a stable PBS policy environment that delivers new and innovative medicines to patients when they need them.

“We also want to explore options for gaining efficiencies in the regulatory and reimbursement systems and optimise investment opportunities for the industry.

“Medicines Australia remains committed to working with Government to ensure the long-term sustainability of the PBS and the viability of Australia’s medicines industry.

“Incorporating and reflecting Medicines Australia’s recommendations in the 2015-16 Budget will benefit patients, the Government, and the wider Australian community.”

Medicines Australia’s pre-Budget submission can be found on the Medicines Australia website here (please follow link)

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Contact Person:

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

Medicines Australia CEO, Tim James, congratulates Dr Suzanne Hill, Chair of the Pharmaceutical Benefits Advisory Committee (PBAC), on her new role with the World Health Organization.

Today the Minister for Health, the Hon Sussan Ley MP, announced that Dr Hill will step down from her role as Chair of the PBAC following the March PBAC meeting.

“On behalf of the innovative pharmaceutical industry in Australia I would like to wish Dr Hill well as she embarks on her new role at the WHO,” Mr James said.

“The role of the PBAC Chair is demanding and I would like to thank Dr Hill for her contribution and dedication.

“This is an important time for the industry and Australian patients, with many innovative new medicines both in development and about to be launched.

“The priority for the industry and the community is the timely listing of new and innovative medicines on the PBS. This relies on a collaborative, pragmatic and patient focused PBAC.

“Medicines Australia, patients and the pharmaceutical industry look forward to a smooth transition to a new PBAC Chair.”

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Contact Person:

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

Medicines Australia’s critical analysis of successive Intergenerational Reports (IGR) demonstrates that previous successive IGRs seriously overestimated PBS expenditure as a proportion of GDP, and highlights the pitfalls of ignoring significant reforms undertaken in the prescription medicines sector over the last decade.

“Analysis released today confirms that the PBS is sustainable and is well placed to meet the needs of an ageing population,” Medicines Australia CEO, Mr Tim James, said.

“Medicines listed on the Pharmaceutical Benefits Scheme (PBS) continue to be a valuable and a cost-effective investment in Australia’s health, wealth and prosperity.

“Medicines provide a huge advantage to not only the health and quality of life of the individual patient but to our society and economy more broadly, and we will be expecting this to be recognised in the upcoming IGR.

“It’s essential that the 2015 IGR not only acknowledges the savings accrued to date but also the enduring savings mechanisms embedded into the system to ensure the future sustainability of the PBS. It is also important that the report considers the broader benefits attributable to the use of innovative medicines.

“Better health outcomes and increased productivity for Australians, as well as the benefits that flow to Government from reduced pressure on health services and improved labour force participation, are an investment in the future.

“Timely use of effective medicines directly limits government expenditure and patient out of pocket expenses.

“Medicines Australia’s review of previous IGR projections for the PBS, together with the most recently available independent data and projections will help to demonstrate to the Government and the public the long-term sustainability of the PBS.

“The summary of findings shows projected PBS expenditure (as proportion of GDP) was significantly overestimated in the 2002 and 2007 Intergenerational Reports.”

Previous IGR Reports did not foresee or fully estimate the long-term and ongoing effects of price disclosure reforms, which have ensured that the PBS will remain sustainable well into the foreseeable future.

While previous IGR Reports presented the PBS as one of the fastest growing components of Government expenditure, this is no longer the case. PBS expenditure has remained static in real terms over the past 5 years.

“The summary shows price disclosure reforms over the past decade will deliver savings approaching $20 billion by 2017, putting the PBS firmly on a sustainable path – a fact acknowledged in the National Commission of Audit (NCOA) report, and this must be reflected in the 2015 IGR,” Mr James said.

“As the Australian population ages it is imperative that universal access to innovative medicines remains available to keep people productive, healthy and independent.

“The PBS must be recognised, by both the community and Government, as a valuable and cost-effective investment in Australia’s future.”

The analysis PBS Sustainability – A review of previous Intergenerational Reports & the Pharmaceutical Benefits Scheme is available on the Medicines Australia website at http://medicinesaustralia.com.au/issues-information/publications/reports/

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Contact Person:

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

Medicines Australia has put forward its recommendations for consideration in its submission to the Therapeutic Goods Administration’s (TGA) Expert Review of Medicines and Medical Devices Regulation.

CEO of Medicines Australia, Tim James, said targeted reform is required to further develop the Australian regulatory system, ensuring that it’s adaptive and responsive to changes in business and technology.

“It’s important that we can identify ways to restructure Australia’s regulatory framework so that it is fit-for-purpose and globally competitive,” Mr James said.

“This is why Medicines Australia has put forwarded recommendations on optimising work sharing activities with overseas regulatory agencies, creating multiple approval pathways, delivering on long-promised information technology capabilities, and eliminating unnecessary red tape in the registration system.

“Regulation in Australia needs to be retained through an efficient system driven by innovative resources which deliver results that keep pace with medical developments. Updated and harmonised information technology will be critical to achieving success.

“Any changes which are made to the system must firstly focus on ensuring the internationally recognised standard for regulation in Australia is retained.

“We know that Australia must retain its capacity to undertake independent assessments of therapeutic goods, with this responsibility remaining with the Commonwealth of Australia.

“We also know that adoption of expedited decisions from trusted overseas regulators where appropriate will significantly reduce duplication of regulatory effort.

“We believe that targeted reform is required to evolve the Australian regulatory system to better reflect the global environment.

“If our recommendations are recognised and adopted by the Australia Government, it will simplify regulatory processes, harness international efficiencies, and ensure the internationally recognised standard for regulation in Australia meets community expectations and patient needs.”

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Contact Person:

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

Medicines Australia CEO, Tim James, has welcomed the appointment of the Hon Sussan Ley MP as the new Minister for Health.

“I congratulate Minister Ley on her appointment to a portfolio that directly affects the lives of all Australians,” Mr James said.

“This is a critical time for the medicines industry in Australia, and I’ll be working with the Minister and her office to ensure she is fully briefed on our priority issues.”

“As the peak body representing the research based pharmaceutical industry in Australia, Medicines Australia will be able to offer the new Minister detailed advice on the contribution that innovative medicines make to the Australian community and economy.”

“I will also be emphasising the need for a stable and predictable policy environment, to maintain a vibrant medicines industry in Australia.”

Mr James also congratulates the Hon Ian Macfarlane MP for assuming the role of Minister for Science, along with his existing role as the Minister for Industry.

“Our industry strongly depends on scientific advancement and research innovation, and we look forward to continuing to work with Minister Macfarlane in this respect.”

“We also welcome the new Parliamentary Secretary to the Minister for Industry and Science, Karen Andrews MP, to assist the Minister.”

“I also wish to acknowledge the constructive engagement with industry and achievements of Minister Peter Dutton in his time in the Health portfolio,” Mr James said.

“Minister Dutton was instrumental in raising the Cabinet threshold for consideration of new PBS listings, quickly clearing the backlog of listings, and reinvigorating the Access to Medicines Working Group.”

“On behalf of the medicines industry I would like to thank Peter Dutton for all his work, and wish him all the best in his new role.”

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Contact Person:

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

A new report released today shows the Pharmaceutical Benefits Scheme (PBS) is proving a key driver to reducing overall Government spending on health.

Medicines Australia, CEO, Tim James welcomed the Australian Institute of Health and Welfare (AIHW) report Health Expenditure Australia 2012-13: analysis by sector.

“It’s no surprise that the PBS is one of the main drivers of efficiency in the health system. Even back in September the AIHW reported that total Australian Government health expenditure fell in 2012–13, with the PBS acting as one of the main drivers of that decrease,” Mr James said.

“Today’s AIHW report reconfirms that the PBS is a star performer at keeping health spending under control. It’s clearly sustainable, to the point it is having an impact on the wider health system, and so there’s no need for further savings measures in the future.”

The report also noted wider health spending growth is at its slowest since the 1980s, slowing to record levels, and now three times lower than the average growth over the last decade (5.1 per cent). Total spending on health goods and services in Australia was estimated at $147.4 billion in 2012-13 (9.67% of GDP).

In 2012-13, governments funded $100.8 billion of total health expenditure in Australia. This was 1.6 percentage points lower than the previous financial year, the largest reduction of the decade.

“For many years the innovative medicines companies have partnered with governments to reform the PBS. This partnership has created the fiscal head room in the PBS to ensure that Australian patients can continue to afford universal access to the latest innovative life changing medicines in a timely manner,” Mr James said.

“The upcoming Intergenerational Report in 2015 will no doubt highlight Australia’s growing and aging population, and how these factors will put pressure on the affordability of the PBS and wider health system.

“This latest report proves that the medicines industry has already secured a sustainable PBS so that our growing and aging population can live longer, healthier and more productive lives, at a cost the Government can continue to afford.”

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Contact Person:

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