Medicines Australia CEO Tim James today welcomed GSK Australia’s announcement to invest an additional $31 million in next-generation manufacturing technology at its site outside Melbourne.

“The pharmaceutical industry is already Australia’s largest exporter of manufactured goods. This latest investment by GSK Australia will further enhance the industry’s contribution to high-tech manufacturing, exports and expert capability,” Mr James said.

GSK’s investment will enable the company to meet growing global demand for asthma medicines, particularly in emerging markets like China, Brazil and Turkey.

“The global market for medicines and vaccines is set to double over the next 10 years. With much of the growth coming from emerging markets, particularly in Asia, Australia is well-placed to capitalise on this growth.

“We are conveniently located and we have a world-class medical research infrastructure, highly-skilled labour force and a well-established reputation around the world for manufacturing safe, high-quality medicines and vaccines.

“With the right policies in place, Australia could more than double its exports of medicines and vaccines by 2024.”

Currently, around 50 global research-based pharmaceutical companies and more than 400 locally-owned medical biotechnology firms and service providers operate in Australia. Together, they employ in excess of 40,000 highly-skilled Australians, generate around $3.5 billion in exports each year, invest over $1 billion in R&D and deliver medicines and vaccines that millions of Australians use every day to live longer, healthier and more productive lives.

“Government policies are fundamental influencers of global company investment decisions in Australia,” Mr James noted.

“Since 2008, several pharmaceutical companies, such as AstraZeneca, CSL, Leo Pharma, and Johnson & Johnson, have invested in new, high-tech manufacturing capacity in Australia. Yet at the same time, a number of global pharmaceutical companies have exited manufacturing in Australia, with a loss of close to 1,000 jobs, due to global competition and local pressures of an unstable and unpredictable operating environment.

“We need a stable and globally competitive environment, including positive policies, to encourage high-tech industries like the global pharmaceutical sector to directly invest here for the long term.”

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Contact Person:

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

A report released yesterday shows Australian patients continue to pay less for medicines, due to a strong rise in the number of prescriptions costing less than the PBS co-payment.

Medicines Australia CEO, Tim James, welcomed the PBS Expenditure and Prescriptions Twelve Months to 30 June 2014 report, which confirms that the cost to fill a script is dropping for both patients and the Australian Government.

“More and more medicines continue to drop below the $36.90 general PBS co-payment, from 62 million to 72.3 million scripts over the period, growth of 16 per cent,” Mr James said.

“These figures confirm what Medicines Australia has been saying for a long time – the impact of price disclosure reforms means that Pharmaceutical Benefits Scheme expenditure is not only currently stable but also sustainable over time.

“What this report also shows is that the average dispensed price per prescription decreased to $42.20 in 2013-14, a fall of close to 3% over the previous year, which means consumers are paying less for their medicines.

“The average government cost of these scripts is $34.83 for the same period, also a drop of 3%.

“The important thing now is to ensure PBS policies and processes allow companies to bring new and important medicines to the Australian community in a timely manner.”

The total PBS expenditure was also confirmed to have only risen by $152 million to $9.149 billion – an increase well below the rate of inflation, and mostly due to a 6.3% rise in total script volumes.

“The tough price disclosure reforms the medicines industry developed and agreed with government over the past eight years are paying off, with massive ongoing savings for taxpayers and consumers,” Mr James said.

“We will continue to work closely with government to ensure Australians have access to affordable and life-saving medicines now and into the future.”

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Contact Person:

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

Medicines Australia welcomes the Australian Government’s plans to improve access to medicines and medical devices by cutting unnecessary red tape.

Medicines Australia CEO, Tim James, has further supported the Government’s proposal to examine whether the Therapeutic Goods Administration should introduce fast-track approvals and reduce the regulatory burden on manufacturers.

“Australia has a world class regulator in the TGA and timely, targeted re-analysis and improvement is a hallmark of that quality. Full marks to the Government in selecting three very distinguished experts in Will Delaat, Lloyd Sansom and John Horvath to undertake this review,” Mr James said.

“This industry has no doubt that they will conduct a full, frank and fair assessment of the regulatory processes in Australia and make sound recommendations on how to further update Australia’s regulatory system.

“We are encouraged by the actions of the Government to date, in its commitment to ease the thicket of red tape around making drugs and medical devices available to Australians as rapidly as possible.

“Medicines Australia has already been actively engaged with Government to reduce unnecessary regulation and cut red tape in the medicines industry.

“We have contributed to the Government’s red tape reduction program through a submission, in May this year, to Parliamentary Secretary the Hon Josh Frydenberg.

“Removing red tape means reducing business costs, allowing greater investment by businesses in Australia, improving patient access to innovative medicines, and making government processes more efficient.”

Mr James also welcomed Minister Peter Dutton’s statements on the subject calling for a ‘modern regulatory framework’ to ensure Australians can access the latest treatments in a timely manner.

“We look forward to working cooperatively with the Government to cut red tape, and maintain and improve access to medicines,” Mr James said.

“It’s important that Industry and Government work closely together to share ideas and issues, and together develop a stable policy framework to deliver the results Australian patients deserve.”

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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 Department of Health’s confirmation that PBS growth was negligible for the 2013-14 financial year.

Appearing before Senate Estimates last night, senior Departmental officers confirmed that the PBS only grew $150 million last year, to $9.15 billion – a growth figure well below the rate of inflation.

“This latest data just confirms what Medicines Australia has been pointing out for a long time,” said Mr James.

“The tough price disclosure reforms the medicines industry developed and agreed with government over the past eight years are paying off, with massive ongoing savings for taxpayers and consumers.

“The rest of the Health portfolio may not have made the tough decisions to bring costs under control, but the PBS is flat as a pancake. There is clearly fiscal room to get new medicines listed quickly for Australian patients.”

Last night’s evidence follows a raft of Budget figures and independent reports confirming that PBS growth is negligible for the foreseeable future.

The 2013-14 Final Budget Outcome, released in September, included a fifth successive write down in PBS expenditure, of $168 million. It showed the PBS costing 14%, or $1.7 billion, less than the Government forecast it would in 2011.

The Australian Institute of Health and Welfare also reported in September that total Australian Government health expenditure fell in 2012–13, with the PBS acting as one of the main drivers of that decrease.

In August, the Parliamentary Budget Office forecast growth in PBS spending will slow to 0.3 per cent annually out to 2024-25.

“With PBS expenditure confirmed as stable and sustainable, now is the time to ensure we improve access to the latest lifesaving medicines,” Mr James said.

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Contact Person:

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

Medicines Australia Chairman Dr Martin Cross today welcomed the release of the Government’s Industry Innovation and Competitiveness Agenda and the announcement of five industry growth centres.

“Australia is uniquely placed to harness our competitive advantages, particularly in the medical technologies, pharmaceuticals and advanced manufacturing sectors,” Dr Cross said.

“The industry is heartened by the policies being put into place that will make Australia a more attractive investment destination.

“I am particularly encouraged by the Government’s commitment to support growth in Australia’s medical technologies, pharmaceuticals and advanced manufacturing sectors, when the global market for medicines and vaccines is projected to double over the next 10 years. With much of the growth coming from Asia, Australia is well-placed to capitalise on this growth.

“We are not only conveniently located but we also have a world-class medical research infrastructure and a well-established reputation in the region for manufacturing safe, high-quality medicines and vaccines,” Dr Cross said.

“With the right policies in place, like those announced by the Government today, Australia could double its exports of medicines and vaccines products by 2024.

“We could also double the level of investment Australia attracts in pharmaceutical R&D and clinical trials.”

Currently, around 50 global research-based pharmaceutical companies and more than 400 locally-owned medical biotechnology firms operate in Australia. Together, they employ in excess of 40,000 highly-skilled Australia, generate around $3.5 billion in exports each year, invest over $1 billion in R&D and deliver medicines and vaccines that millions of Australians use every day to live longer, healthier and more productive lives.

“Like it or not, Government policies are amongst the strongest influencers of global company and local investment decisions,” Dr Cross noted.

“We need a stable and business-friendly policy environment in Australia to encourage high-tech industries like the global pharmaceuticals sector to directly invest here for the long term.

“Today’s announcement is positive step, and industry is looking forward to working with the Government to contribute tangibly to these centres.

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Contact Person:

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

A proposed campaign to stop doctors learning about new treatments from medicines companies is misguided and potentially dangerous for patients, the Medicines Australia Chairman Dr Martin Cross has warned.

A small group of physicians, joined by academics and special interest groups, is reportedly planning to encourage blocking all contact between doctors and medicines companies in the mistaken belief that this will improve prescribing practice and cut costs.

“These campaigners must have very low regard for doctors’ ability to clinically assess and prescribe the most suitable treatment for their patients,” Dr Cross said.

“When I’m a patient, I expect my treating health professional to have the latest information about the range of medicines that would work for me.

“By barring contact with company representatives, it would be like having open heart surgery knowing that the surgeon hasn’t been taught how to use the equipment by the people that made it.

“The role of a company representative is to understand and respond to a GP’s needs: product information, therapeutic area information, journal articles, and literature that will assist their patients to properly use the medicines available to them. An important part of this role is to also receive feedback from GPs about use of medicines, including any reports of adverse effects of the medicines.

“There’s a lot of publicly available information on the internet and elsewhere, but there’s no guarantee it’s correct or beneficial to a specific patient. Doctors have access to clinical guidelines to help select the right treatment, and other education sources – but the idea that you can ignore information from a pharmaceutical company that has conducted extensive research and development to help treat disease is laughable at best and negligent at worst.

“Prescription medicines manufacturers cannot, and do not, advertise prescription products to consumers. It is a well-established practice that the person who needs to know about the medicines in the first instance is the doctor, and it is the doctor’s role to educate and inform the patient.

“Where do these special interest groups think that doctors will get new information if no-one who is involved in the scientific discovery, research, and development of a new treatment is allowed to talk to anyone about it?

“Medicines Australia has a strong and effective Code of Conduct that prohibits companies making false or misleading claims about their products or providing unbalanced information.

“The Code is rigorously enforced and contains significant penalties for breaches – it’s among the toughest such Codes in the world, and provides professionals and patients confidence that they are receiving accurate and up-to-date information.

“The fact is, there is no-one that knows more about a medicine than the company that has researched the medicine for over 12 years before it is approved to be prescribed by Australian GPs,” said Dr Cross. “By blocking that flow of information, this minority group would only serve to leave patients at risk of poorer treatment options.”

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Contact Person:

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

A study claiming to find additional prescription medicine savings appears to have again refused to properly take account of the additional ongoing savings accruing through the current price disclosure policy.

Medicines Australia Chairman Dr Martin Cross has rejected Professor Philip Clarke’s claim that the Government is overpaying $400 million for medicines.

“The current price disclosure policy is working as it is delivering significant savings to government and patients.

“Professor Clarke has fallen into the same trap as the Grattan Institute by cherry picking a few medicines to demonstrate his point.  He is not taking account that PBS price disclosure reforms are permanent, ongoing and unfinished, and that simple price comparisons of a small list of medicines ignore the overall effect across the PBS.

“Professor Clarke can only make claims like this if he completely disregards the estimated $20 billion in savings that will accrue through falling medicine prices by 2017-18, driven by the multiple reforms agreed between industry and governments since 2007.

“These massive savings are going back to taxpayers, and when the drug falls below the general co-payment rate, directly reduce out-of-pocket costs for consumers.

“The current price disclosure policy is based on market competition and means that pharmaceutical prices are dropping significantly through every cycle.

“We are now seeing savings realised every six months under Simplified Price Disclosure. Calls for these savings to be sped up even further, to every three months, are simplistic and could have harmful consequences for access to new medicines and supply of existing medicines if implemented too quickly.  What we need is sensible evolution not revolution,” Dr Cross said.

“The Department of Health recently corrected this spurious claim that Australia is paying far too much for medicines, and confirmed that many commonly-used drugs are significantly cheaper in Australia than in the United Kingdom – for example, the commonly prescribed cholesterol lowering agent, rosuvastatin.

“There are similar outcomes for several cancer treatments: docetaxel, paclitaxel, topotecan and oxaliplatin are all widely used drugs used to treat cancer that are significantly cheaper in Australia compared to other countries. For example according to Department of Health evidence to the Senate Committee, docetaxel is priced at $6.98 in Australia, compared to $252 in the United Kingdom.

“The truth is that prescription, off-patent medicines have fallen in price by up to 98% since 2010, with 17 common PBS-listed drugs dropping by over 80%, and more price drops to come every six months.

“The latest round of price cuts on 1 October has further reduced prices, with the PharmaDispatch Index of commonly prescribed medicines, including widely used treatments for reflux, blood clotting, hypertension, and osteoporosis showing a 35% fall in the combined private market prices of medicines in just the last two years. This has resulted in major cost savings for non-concession PBS patients with most off patent products now falling below the $36.90 PBS co-payment.  Of course most concession patients still only pay $6 per prescription on the PBS.

“The latest OECD benchmarking data of public expenditure on medicines shows that Australia spends 0.7% of GDP. This is well below the OECD average of 0.8% and a true indication the value for money of the PBS.  The recent PBS price disclosure reforms are working and have further driven this figure down to 0.6% of GDP.

“The real issue facing Australian patients today is ensuring the system does not show its age and continues to allow timely, universal access to new and innovative medicines for diseases such as cancer, osteoporosis and hepatitis C, to name a few,” said Dr Cross.

See chart of Percentage price drops from EAPD and SPD 

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Contact Person:

Sam Develin
Phone: (02) 6122 8513 or 0422 049 872
Email: Sam.Develin@medicinesaustralia.com.au

Today’s release of the 2013-14 Final Budget Outcome shows the Government has yet again spent less than they anticipated on the Pharmaceutical Benefits Scheme (PBS).

“The Final Budget Outcome released today has seen yet another write down in PBS expenditure, a write down of $168 million, just in the four months since the 2014 Federal Budget, and the fifth consecutive time the Government has had to revise its figures downwards,” said Medicines Australia Chairman Dr Martin Cross.

“Following the massive reductions in the 2012, 2013 and 2014 Budgets, it is clear now that the PBS is costing 14%, or a significant $1.7 billion, less than the Government forecast it would in 2011.

“The latest Budget figures add to a growing body of evidence showing the PBS is sustainable, and in fact, the PBS has not grown in real terms for five years.

“The price disclosure reforms agreed between Government and industry continue to pay off for Government, with another un-budgeted $168 million in savings over the past four months alone”, said Dr Cross.

“Let’s not forget in August, the Parliamentary Budget Office forecast growth in PBS spending will slow to 0.3 per cent annually out to 2024-25.”

“And earlier this week, the Australian Institute of Health and Welfare reported that total Australian Government health expenditure fell in 2012–13, with the PBS acting as one of the main drivers of that decrease.”

“Over the last 8 years the innovative medicines companies have partnered with governments to reform the PBS, traded the past for the future and created the fiscal head room in the PBS to ensure that our nation can afford to ensure all Australians continue to benefit from rapid, universal access to the latest innovative life changing medicines.”

The following chart shows how every budget forecast since 2010, has overestimated how much will actually be spent in 2013-14, as proven in today’s final budget outcomes.

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Contact Person:

Elizabeth de Somer
Phone: (02) 6122 8525
Email: Elizabeth.deSomer@medicinesaustralia.com.au

The Medicines Australia Board announced today that it has appointed Mr Tim James as the new Chief Executive for the organisation.

Mr James will replace outgoing Chief Executive, Dr Brendan Shaw, who finished in his role on 12 September to take up a senior role with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in Geneva.

Medicines Australia Chairman, Dr Martin Cross, welcomed the appointment of Mr James to the position.

“I’m very happy to announce Tim’s appointment as Chief Executive,” Dr Cross said.

“He brings a wealth of experience in government and policy, professional services as well as the medicines industry to the new role,” Dr Cross said.

“Tim has extensive experience working within both government and in the medicines industry. He understands the opportunities and challenges facing our industry and will be a great asset to Medicines Australia.

“The Board is delighted with the appointment and looks forward to working with Tim to help progress the policy agenda for Australia’s medicines industry.

“There are many issues the industry needs to work on with government and the broader community such as ensuring Australians continue to have timely access to the latest medicines in the future, maintaining the viability of the business environment, and helping build the medicines industry as a key contributor to Australia’s economic future.

“Tim is well placed to take Medicines Australia forward in the future on these important issues.”

Mr James is currently Chief of Staff to the Hon Anthony Roberts MP, Minister for Resources and Energy and Special Minister of State in the New South Wales State Government. Previously Tim worked in the pharmaceutical industry for several Medicines Australia member companies, as well as earlier being a lawyer and an auditor. He also worked as a staffer for former Prime Minister, the Hon John Howard MP and the Hon Joe Hockey MP. He holds a range of academic and professional qualifications, including an MBA from AGSM.

Mr James will commence his new role at Medicines Australia on 20 October.

Dr Cross will be acting Chief Executive in the period from Dr Shaw’s departure on 12 September through to Mr James’ commencement on 20 October.

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Contact Person:

Dr Martin Cross
Phone: (02) 6122 8501
Email: Martin.Cross@medicinesaustralia.com.au

The decision by the Federal Court to allow patenting of genetic materials highlights the importance of maintaining strong intellectual property laws to promote the development of new medicines, the Chief Executive of Medicines Australia Dr Brendan Shaw said today.

“Patents on biological agents such as isolated genetic materials are important because they ensure ongoing investment in developing cutting-edge medicines and diagnostic tests,” Dr Shaw said.

“More importantly, a strong patent system helps ensure Australians have access to the latest and most effective treatments as soon as they become available.

“We have always been concerned that any efforts to restrict patenting of new medical technologies risk undermining the development of new medicines and vaccines.

“Four government inquiries over the last decade, including two by the Australian Senate, have found that there is no case for banning patents on biologicals materials.”

Last year, the McKeon Review also recommended that Government reject calls to exclude biological materials from patentable subject matter.

“In fact, the McKeon Review called on Government to ensure Australia’s IP system is ‘strong, stable, predictable and harmonised with global best practice’,” Dr Shaw said.

“We need more work in this area so that patients in Australia continue to have access to the latest therapies and the biopharmaceutical industry continues to invest in research and development.

“Having robust intellectual property laws is critical to developing new medicines and vaccines and Australian needs to ensure it maintains international best practice in this area.”

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Contact Person:

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