New figures from the Therapeutic Goods Administration (see below) show that for the first time in four years the number of clinical trials undertaken in Australia has grown, but that activity still lags behind the long-term average.

The TGA’s latest Half-Yearly Performance Report shows 635 new clinical trials were begun in Australia in 2011, up from 574 in 2010 but still more than 25 per cent down from the 2007 high of 865 trials.

Medicines Australia chief executive Dr Brendan Shaw said while the upturn was encouraging, there remained serious challenges to Australia’s status as a regional hub for clinical trials.

“The latest figures don’t alleviate the need for urgent policy action to drive microeconomic and regulatory reform to secure the future of clinical trials in Australia,” Dr Shaw said.

“The Government’s commitment last year to a series of regulatory reforms to increase Australia’s competitiveness as a destination for clinical trials may have encouraged some investment over the past year.

“But there has been insufficient progress in implementing these regulatory reforms. In the meantime, we have been losing trials to other countries.

“Australia is recognised globally as having some of the best scientists and research infrastructure in the world and that is an important strategic advantage. However, we are facing fierce international competition for clinical trial investment.

“Australia must act now to ensure we remain competitive.

“There is an urgent need for greater political resolve both at Federal and State level to implement these regulatory reforms expeditiously.

“We are renowned as a country of scientific excellence.

“It is very much in the national interest that we do all we can to keep cutting-edge medical science in Australia.”

The Federal Government committed in 2011 to implement all the recommendations from the Clinical Trials Action Group, which was established by the Government to arrest the decline in clinical trials activity, by July 2011.

However, more than 12 months after the report’s release, the Action Group’s major recommendations that will make a real difference to clinical trial investment have not yet been implemented.

More than 18,000 Australian patients are given early access to innovative medicines, medical devices and diagnostics through clinical trials each year, saving Australian taxpayers $100 million a year.

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Contact Person:

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

Winding back the R&D tax credit, which was introduced by the Federal Government last year, would discourage investment in Australia and cost high-value research jobs, Medicines Australia chief executive Dr Brendan Shaw said today.

Responding to recent media reports of possible changes to the R&D tax credit in the Federal Budget, Dr Shaw urged the Government not to tinker with the tax credit.

“Scaling back the R&D tax credit would be extremely damaging to R&D investment in Australia,” Dr Shaw said.

“Such a move would put a brake on investment at the very time when policy makers are trying to stimulate growth. It would effectively add up to 10 per cent to the cost of investing in Australian R&D and would put at risk hundreds of high-skill, high-wage research jobs.

“Australia currently attracts more than $1 billion a year in pharmaceutical R&D investment. That investment would diminish if there were any winding back of the tax credit.

“There would be some companies that would simply stop bringing R&D investment dollars to Australia.

“The tax credit has been operating for less than a year, so we haven’t yet been able to see the benefits it is delivering in terms of investment. Tinkering with the system so soon after it has been introduced would be premature. For a Government that espouses the virtues of evidence-based policy, it simply wouldn’t make sense.

“The Government went through an extensive consultative process in developing the tax credit system to replace the previous tax concession, which was inefficient and ineffective.

“To do a U-turn on such an important policy measure after less than a year would send quite the wrong signal to the investment community.

“It would severely undermine business confidence, send investment offshore and threaten Australian jobs.

“The fact is, the tax credit is the only incentive the Government offers companies to invest in Australian R&D. It absolutely must be retained.”

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Contact Person:

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

The biggest round of price cuts in the history of the Pharmaceutical Benefits Scheme, coupled with historically low spending growth have removed any justification for further PBS cuts in the Federal Budget, Medicines Australia chief executive Dr Brendan Shaw told an industry conference today.

Speaking at the Future of the PBS Conference in Sydney, Dr Shaw said the MoU between the Government and Medicines Australia was expected to deliver more than $1.9 billion in savings to the Budget bottom line.

“In terms of this year’s upcoming Budget and how the PBS will feature in that, our message is actually pretty simple – leave it alone,” Dr Shaw told the conference.

“Whatever measure you use, there’s no case for further savings measures.

“Whether it’s historically low growth in PBS spending, the fact that the PBS is more or less falling after adjusting for inflation, low or falling numbers of PBS prescriptions, or the level of PBS spending in Australia relative to other reimbursement schemes internationally.

“Whatever measure you use, it is virtually impossible to make the case that the PBS is growing too much or, in fact, growing at all.

“There is no need to have any PBS savings measures in the 2012 Budget.

“Literally less than two weeks ago we saw the biggest price cuts in the history of the PBS as a result of the MoU between the Government and Medicines Australia.

“That agreement has delivered massive savings for the Government and for patients.

“And we fully expect there will be more price cuts from the MoU in the future over and above the $1.9 billion savings projected by the Government.

“The bottom line is, it would be a work of fictional fantasy writing to rival Alice in Wonderland for anyone to argue that we have a fiscal problem when it comes to the Pharmaceutical Benefits Scheme.

“Our message is: you don’t need to muck with the PBS.

“Government policy is actually working well in keeping the PBS manageable while, by and large, providing Australians with access to the medicines they need.”

Dr Shaw also urged the Government to complete its review into anti-coagulant medicines as soon as possible and to ensure the new R&D tax credit remains eligible for medicines companies.

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Contact Person:

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

Fourteen medical sales representatives from the Australian medicines industry received the sector’s top accolade for ethical sales and marketing at a ceremony in Sydney last night.

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

Medicines Australia chief executive Dr Brendan Shaw said the mandatory program, delivered by Medicines Australia and the University of Tasmania, demonstrated the medicines industry’s commitment to ethical conduct.

“Medical sales representatives play a critical role in helping doctors keep abreast of the latest information and ensure patients ultimately get the best out of the medicines that are available today,” Dr Shaw said.

“Representatives are a key tool in ensuring that the dialogue between the companies who make the medicines and the doctors that prescribe them is productive, balanced and ethical.

“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 and in particular the award winners.

“The fact that so many students have been recognised for their high achievement in this program signals the importance that students and companies attach to ethical conduct.”

The Medicines Australia Code of Conduct Award, for full marks in the Code of Conduct Program, was presented to Wendy Carrol (Sanofi).

The Medicines Australia CEP Achievement Awards went to: Margaret de Jong (AstraZeneca), Kristen Viero (AstraZeneca), Lucy Nicholson (AstraZeneca), Natalie McLean (Mundipharma), Neil Stilgoe (Boehringer Ingelheim), Maria Lizbeth Piedad (MSD), Carla Silvestri (MSD), Martin Kelly (Novartis), Laurent Wieher (Abbott), Sean Lim (Pfizer).

The Active Learning Awards for the most active and best quality participation in online student group discussion were presented to Joanne Campbell (Novartis) and Kimberly Varga (Amgen).

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Contact Person:

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

Medicines Australia chief executive Dr Brendan Shaw today made the following statement on the passing of Jimmy Little AO:

The death of Jimmy Little AO marks the passing of a truly great Australian. Jimmy was not only a supremely talented musician and entertainer, he was a passionate advocate for indigenous health.

Medicines Australia was extremely fortunate to work with him through the Jimmy Little Foundation to help promote the importance of healthy food choices in remote indigenous communities, particularly among children.

Jimmy was driven by a single-minded determination to ensure the Foundation made a meaningful difference to the lives of indigenous Australians.

While his passing is extremely sad, the Jimmy Little Foundation is a fitting monument to a lifetime devoted to helping other indigenous Australians and will long continue to make a real difference to the lives of many living in remote communities.

Medicines Australia extends its condolences to Jimmy’s family.

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Contact Person:

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

A new round of price cuts for off-patent medicines on the Pharmaceutical Benefits Scheme, which comes into effect from today (1 April), will ensure PBS savings of at least $1.9 billion for the Government, as agreed in the 2010 MoU with Medicines Australia.

From 1 April, the price of 74 commonly used off-patent medicines on the PBS will be reduced by between 10 per cent and 82 per cent.

These cuts are over and above a 16 per cent price reduction that has already been applied to many off-patent medicines.

Medicines Australia chief executive Dr Brendan Shaw said the system of mandatory price disclosure, agreed as part of the MoU, will drive savings through a competitive off patent market and ensure the long-term sustainability of the PBS.

“These types of price reductions which capitalise on market competition provide the Government with the financial headroom to list new medicines whilst ensuring the PBS remains sustainable in the future,” Dr Shaw said.

“The system requires manufacturers to disclose the actual price at which they are selling medicines in the market, allowing Government to adjust the price it pays.

“These are enormous savings but effectively they will mean a better deal for taxpayers and a more sustainable PBS.

“And there should be more such price reduction rounds in the future as more medicines go off-patent and become subject to price disclosure. We expect more savings to accrue to the Government in years to come.

“Expenditure growth of the PBS is already well contained. Mandatory price disclosure will put further downward pressure on growth and negate the argument for further reform.

“The evidence to date strongly suggests that the MoU is working well and is on track to deliver the Government at least $1.9 billion in savings.

“At the same time, it is important to note that these price reductions will cause significant commercial difficulty for many of the companies taking substantial cuts.

“Some companies have taken price cuts of more than 70 per cent for a single medicine, and absorbing reductions of that magnitude is obviously challenging.

“But the MoU will ensure a stable business environment for manufacturers because it carries a Government commitment that industry will not be asked to bear any further price-related savings measures before 2014.”

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Contact Person:

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

The Government’s investment in the Australian New Zealand Clinical Trial Registry will make it easier for patients to identify the clinical trials being conducted Australia, Medicines Australia chief executive Dr Brendan Shaw said today.

The investment will also make it easier for researchers to recruit patients into trials.

Dr Shaw said: “Improving patient recruitment is one area where we can do more, so this announcement is good news.

“Addressing the challenges in patient recruitment is one way to help reverse the dramatic decline we have seen in the number of clinical trials being conducted in Australia.

“Between 2007 and 2010 Australia suffered a 34 per cent decline in the number of new trials.

“Australia needs to take urgent action to rectify this situation. That action includes finalising the implementation of the recommendations of the Government’s Clinical Trials Action Group.

“Yesterday’s announcement was a positive step in the right direction and is therefore welcome.

“Patients who participate in clinical trials get early, and often free, access to new treatments which aren’t widely available to the community at large.

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Contact Person:

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

New legislation overhauling Australia’s patent system will encourage medical research and bring Australia into line with intellectual property systems in other OECD countries Medicines Australia chief executive Dr Brendan Shaw said today.

The Raising the Bar Bill, which was finally passed in Federal Parliament last night, introduces a “research use exemption” which will allow scientists to conduct research on patented inventions without infringing those patents.

“This Bill makes it absolutely clear that scientists are free to conduct research on patented inventions, so long as the purpose of that research is investigation and not the infringement of valid patents,” Dr Shaw said.

“It serves to allay concerns that patents can potentially stifle scientific research.

“The Bill also raises the threshold of patentability for all fields of technology, ensuring that Australian patents can stand up to scrutiny in any jurisdiction around the world.

“Robust IP laws that encourage the development of new technologies are extremely important to innovative industries such as the Australian medicines industry.

“The improved clarity in awarding a patent will also help to resolve the uncertainty associated with patenting of biologic materials, achieving a balance between incentives for innovation and ensuring community access to technologies.

“A strong IP system is critically important to Australia because intellectual property drives innovation. This Bill delivers that.

“These reforms have been a long time coming and it is encouraging to see the Bill finally passed by the Parliament after a number of years of review, consultation, development and debate on the provisions to reform the patent system.

“Four Government inquiries over the last decade, including two by the Australian Senate, have grappled with the question of reform to Australia’s intellectual property system.

“I commend all sides of politics for pursuing those important reforms and delivering an outcome that will benefit innovators, research scientists and ultimately the community.”

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Contact Person:

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

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has announced the revision and expansion of its Code of Practice which governs how companies interact with healthcare professionals and patient organisations.

The Code of Practice, which Medicines Australia helped draft, ensures that engagements with healthcare professionals are undertaken ethically. Under the Code, the provision of company-sponsored entertainment and personal gifts are banned.

Medicines Australia chief executive Dr Brendan Shaw said the IFPMA Code set the principles for the ethical standards expected of the medicines industry globally, and that some countries such as Australia have a more detailed and specific set of standards of conduct in place.

“Medicines Australia endorses the new expanded IFPMA Code of Practice, but our own Code of Conduct goes some way further,” Dr Shaw said.

”The Medicines Australia Code describes in detail the standards expected of companies when interacting with health consumer organisations and individual consumers. It also reinforces specific Australian laws that prohibit advertising prescription medicines to consumers.

“The important interactions between pharmaceutical manufacturers and healthcare professionals mean that prescribers are kept up to date with the latest information about how medicines work.

“Governments, doctors and patients must have confidence that those interactions meet the highest ethical standard. Both the Medicines Australia Code of Conduct and the IFPMA Code of Practice exist to provide that confidence.”

Medicines Australia regularly reviews its own Code of Conduct to ensure it continues to reflect changing community expectations.

A current review of Medicines Australia’s Code of Conduct will be completed by June 2012. The updated Medicines Australia Code of Conduct is expected to be implemented in January 2013.

More information about the IFPMA Code of Practice can be found on their website

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Contact Person:

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

Medicines Australia chief executive Dr Brendan Shaw has congratulated the outgoing Minister for Manufacturing Senator Kim Carr on his legacy of achievement and contribution to industry and innovation policy.

Senator Carr was today sworn in as Minister for Human Services, after four and a half years as Minister for Innovation, Industry, Science and Research and latterly Minister for Manufacturing.

Dr Shaw said Senator Carr had been a consistently passionate advocate for industry generally, and for the Australian medicines industry in particular.

“Senator Carr has long been committed to maintaining and growing an innovative industrial base in Australia and has made a positive contribution to ensuring a viable operating environment for the Australian medicines industry,” Dr Shaw said.

“He has led the clinical trials reform agenda which seeks to ensure that Australia remains competitive in attracting global investment in clinical trials.

“The R&D tax credit legislation, which he stewarded through Parliament, will effectively reduce by 10 per cent the cost of conducting eligible R&D in Australia.

“Senator Carr has also advocated the importance of patent protection, and championed the Raising the Bar Bill, which is currently before the Parliament and which will bring Australia’s intellectual property regime into line with world standards.

“And he established the Pharmaceuticals Industry Strategy Group to develop a blueprint for a sustainable pharmaceuticals industry in Australia.

“I congratulate him on this record of achievement during his time in the Innovation and Manufacturing portfolios and I look forward to working with him as the new Minister for Human Services.”

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Contact Person:

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