Medicines Australia CEO Tim James today called on Government to strengthen Australia’s intellectual property (IP) system.

“IP is at the heart of innovation, and protecting it is critical for future economic growth in Australia,” Mr James told a Parliamentary Friends of Medicines event today.

“For a modern, knowledge-based economy like Australia’s, IP is a particularly valuable commodity, currently worth an estimated $250 billion to the economy, or nearly a fifth of the nation’s GDP.

“Australia’s IP system has traditionally been one of the strongest in the world, but Government actions in recent years, along with long-standing deficiencies in key areas, are undermining global confidence in the strength and stability of Australia’s IP system.

“For example, Australia offers just 5 years of data exclusivity, which prevents imitators from relying on data generated by research-based pharmaceutical companies to obtain marketing approval for equivalent products.

“The 5-year term was introduced in 1998, but since then the world has moved on.

“Most developed countries now offer 8 to 12 years of data exclusivity, and even some developing countries offer more protection than Australia.

“There is 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.”

Debate on IP-related issues in Australia should be well informed, evidenced and fact based. Just this week, the research-based pharmaceutical industry was again accused of seeking to expand IP protections through ‘evergreening’.

“Evergreening as a concept represents a fundamental misunderstanding about how the IP system works,” Mr James said.

“No later patents can extend the term of an earlier one. Once a patent expires, imitators are free to copy these inventions if they choose.

“We urgently need informed discussion on the costs and benefits of strengthening Australia’s IP system.

“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 pharmaceutical R&D and manufacturing.”

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Contact Person:

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

A report released today has provided valuable insight into longevity in Australia, with years added to life expectancy for females and males living down-under.

The Australian Institute of Health and Welfare (AIHW) report, Healthy life expectancy in Australia: patterns and trends 1998 to 2012, shows life expectancy for males has increased by 4 years and 2.8 years for women.

Medicines Australia CEO, Tim James, has welcomed the report’s findings.

“The AIHW report captures how much our length and quality of life has improved over the past 15 years,” Mr James said.

“This report shows that from 1998 to 2012, life expectancy at birth has increased from 75.9 years to 79.9 years for males (an extra 4.0 years) and from 81.5 years to 84.3 years for females (an extra 2.8 years).

“Ground-breaking developments in medicines, vaccines, and innovative new therapies to treat disease have made an essential contribution to this achievement.

“Innovation is the fundamental driver of human development.  Medicines, vaccines and therapies are at the forefront of innovative, scientific development and, in turn, human development.

“Today there is a wider range of accessible treatment options for patients to treat cancer, cardiovascular disease, HIV, multiple sclerosis, diabetes and other diseases, than there was even a few years ago.

“Thanks to the Australian health system and the Pharmaceutical Benefits Scheme, Australian patients are able to access the latest medicines and vaccines so that we are not only living longer, but also enjoying a better quality of life.

“The medicines industry will continue to research and develop innovative solutions and contribute to the health and economic wealth of Australia.

“We will continue to work together with government to ensure that innovation and investment will continue to provide high quality, safe, and effective treatments for all Australians, 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 CEO Tim James today welcomed the new Free Trade Agreement with China and another open door to growth for Australia’s pharmaceutical industry.

“The global market for medicines and vaccines is set to double over the next 10 years, with much of this growth coming from China and other emerging markets,” Mr James said.

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

“It is certainly encouraging to see Australia stepping up to the challenge to grow our economy and opportunities like the Free Trade Agreement with China will add to Australia’s attractiveness as a destination for new investment.”

Pharmaceutical exports to China in 2013 totalled over $500 million, making it one of Australia’s largest market for pharmaceuticals.

“The Chinese pharmaceutical market is currently the 3rd largest in the world and is expected to grow by up to 15 percent per annum,” Mr James noted.

“By eliminating tariffs (of up to 10 percent) and other barriers to trade, this Free Trade Agreement will provide patients in China with access to high-quality, Australian-made medicines and vaccines, and help Australia increase its high-tech exports for our economy.

“Trade agreements with our regional partners make good sense. With the finalisation of this agreement with China and the imminent resolution of the Trans Pacific Partnership Agreement, Australia can continue to build on opportunities for growth and investment.”

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Contact Person:

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

Medicines Australia CEO Tim James said it is encouraging to see such a strong commitment from APEC Leaders to promote ethical business environments in the region.

“Medicines Australia has been an active participant and financial contributor to activities to promote ethical business practices in the biopharmaceutical industry across APEC nations,” Mr James said.

“Ethical business environments support innovation and sustainable growth, reduce corruption and reward merit.

“This is something Medicines Australia and the innovative medicines industry have long supported and adhered to in Australia, so it’s great to see such high level commitment amongst some of our major trading partners.”

Medicines Australia also welcomed the Asia-Pacific Economic Cooperation’s (APEC) new initiatives which have been mapped out at the 26th APEC Ministerial Meeting in Beijing.

APEC announced new actions that will further strengthen the Asia-Pacific partnerships, which focuses on key priorities including fostering greater regional economic integration, promoting innovative development, economic reform and growth, and strengthening infrastructure investment and comprehensive connectivity.

“Medicines Australia looks forward to continuing collaboration among member groups of APEC.  As Asia becomes the epicentre for the global pharmaceutical industry, Australia is well placed to lead, contribute and grow,” Mr James said.

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Contact Person:

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

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