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

The listing of nine prescription medicines on the Pharmaceutical Benefits Scheme announced by the Federal Minister for Health Tanya Plibersek will provide patients with affordable access to cost-effective treatments, Medicines Australia chief executive Brendan Shaw said today.

Dr Shaw said the new listings would provide additional options for patients suffering from conditions including juvenile arthritis, chronic myeloid leukaemia and myocardial infarction.

“The PBS listings will be welcomed by patients and I am encouraged by the Government’s commitment to making these medicines available,” Dr Shaw said.

“It is critical for patients that the Government maintain a consistent approach to the listing of medicines recommended by the Pharmaceutical Benefits Advisory Committee.

“This task has been made easier by the Memorandum of Understanding between Medicines Australia and the Commonwealth that will deliver taxpayers $1.9 billion in PBS savings.

“If this is a return to business as usual by the Government it is very welcome. However, the Government does not yet have a clean slate with listing new medicines on the PBS.

“Having gone through the TGA process, the PBAC process, the PBPA process and the Cabinet process, the anti-stroke medicine Pradaxa is now being made to go through another unanticipated hurdle: the anti-coagulant review process.

“I urge the Government to conduct this review as quickly as possible given Pradaxa was first considered by Cabinet in September 2011.”

The nine new PBS listings are:

• Ticagrelor (Brilinta®), for acute coronary syndrome, manufactured by Astra Zeneca;
• Cefuroxime axetil (Zinnat®), antibiotic, GlaxoSmithKline;
• Dasatinib ((Sprycel®), chronic myeloid leukaemia, Bristol-Myers Squibb;
• Nilotinib (Tasigna®), chronic myeloid leukaemia, Novartis;
• Dalteparin sodium (Fragmin®), anti-coagulant, Pfizer;
• Epoprostenol sodium (Flolan®), pulmonary arterial hypertension, GlaxoSmithKline;
• Morphine sulphate (Kapanol®), pain management, GlaxoSmithKline;
• Tocilizumab (Actemra®), juvenile arthritis, Roche Products;
• Abatacept (Orencia®), rheumatoid arthritis, Bristol-Myers Squibb.

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Contact Person:

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

New export figures published by the Australian Bureau of Statistics reveal that the Australian medicines industry was the nation’s most valuable hi-tech exporter in 2011.

According to the Australian Bureau of Statistics, exports of pharmaceutical and medicinal products were worth $3.744 billion in 2011 compared with $3.998 billion in 2010. Exports for the car industry in 2011 were $2.539 billion, and for the wine industry $2.034 billion (see chart below).

Medicines Australia chief executive Dr Brendan Shaw said the Australian medicines industry’s exports had held up well in the face of a challenging global economy.

“The latest ABS data shows that pharmaceutical exports have remained more or less flat, despite an exceptionally tough global market,” Dr Shaw said.

“These numbers underline the significant contribution Australia’s medicines industry continues to make to the economy.

“The Australian medicines industry has continued to export more goods around the world than any other hi-tech industries. This reaffirms the pharmaceutical sector as one of the unsung heroes of Australian industry. It is a real export success story.

“Australia has an opportunity to build on the hi-tech export capability of its medicines industry if we can get the health, innovation and industry policy settings right.

“As a nation we already export more medicines than cars or wine, but with revamped policy settings and incentives from Government we could build the Australian medicines industry into one of our key innovative export industries for the future.”

Asian countries account for approximately half of pharmaceutical exports from Australia. South Africa, Europe and New Zealand are the other major export markets.

Dr Shaw said export earnings for the Australian medicines industry had grown 1200 per cent since 1990.

“At a time when Australia is debating the future of manufacturing in this country, this data underscores the important economic contribution the Australian medicines industry is already making to the community,” he said.

The Australian medicines industry employs 14,000 people.

NOTE: The export figures can be downloaded from the ABS website: ABS catalogue 5368.0 International Trade in Goods and Services, Australia, Table 12a. MERCHANDISE EXPORTS, Standard International Trade Classification (1 and 2 digit), FOB Value, Dec 2011

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Contact Person:

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

The Australian medicines industry endorses a historic global initiative to tackle 10 neglected tropical diseases, Medicines Australia chief executive Dr Brendan Shaw said today.

The initiative, announced this week, brings together 13 medicines manufacturers, the United States, United Kingdom and UAE governments as well as the World Bank and the Bill and Melinda Gates Foundation.

The initiative will expand existing medicine donation programs to meet demand through to 2020 and accelerate R&D of new medicines.

Dr Shaw said the campaign will improve the lives of 1.4 billion people.

“This is a concerted drive to eliminate or control some of the most terrible diseases afflicting the developing world, and the medicines industry is central to that effort,” Dr Shaw said.

“The medicines industry will donate an average of 1.4 billion treatments a year to those who need them.

“Internationally the medicines industry is already increasing its research effort into neglected tropical diseases at a faster rate than contributions from other sectors like governments and not-for-profit groups.

“I’m very encouraged that the role of the global industry in tackling neglected tropical diseases is being acknowledged by organisations such as the Gates Foundation and the World Health Organisation.”

This latest announcement follows other recent collaborative initiatives to further enhance access to treatments for these diseases for people in the poorest developing countries.

“It is yet another example of companies in the medicines industry partnering collaboratively with public and private sector players to develop constructive solutions to the world’s health problems,” Dr Shaw said.

Speaking on behalf of the global medicines industry, Sir Andrew Witty, chief executive of GlaxoSmithKline, said: “Many companies and organisations have worked for decades to fight these horrific diseases. But no one company or organisation can do it alone. Today we pledge to work hand-in-hand to revolutionize the way we fight these diseases now and in the future.”

Sir Andrew will be the keynote speaker at the Medicines Australia Parliamentary dinner on 29 February.

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Contact Person:

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

The Australian medicines industry is making a major contribution to returning the Federal Budget to surplus, Medicines Australia chief executive Dr Brendan Shaw reminded Treasurer and Deputy Prime Minister Wayne Swan today.

In Medicines Australia’s pre-Budget submission to the Treasurer, Dr Shaw underscored the importance of Medicines Australia’s Memorandum of Understanding with the Commonwealth which was delivering $1.9 billion in savings to the Pharmaceutical Benefits Scheme.

Estimates commissioned by the Government show that the original 2007 reforms to the PBS will generate up to $5.8 billion in savings by 2018, Dr Shaw told the Treasurer.

The PBS grew by just 2.4 per cent in nominal terms in 2011, less than the inflation rate of 3.1 per cent, suggesting that Government spending on the PBS fell in real terms in 2011.

“Medicines Australia has worked constructively with Federal Governments over the years to ensure that the Pharmaceutical Benefits Scheme remains sustainable,” the letter says.

“The MoU between the Government and Medicines Australia has now started to deliver significant savings to the Government.”

Medicines Australia has highlighted the importance of business predictability for the medicines industry.

“It is critical for our industry that the predictable pricing-policy environment agreed in the MoU is respected,” the letter says.

“Any further policy and savings measures at this time would compound an already challenging environment and would be difficult for the industry to absorb.

“It is for these reasons that the Government’s explicit commitment in the MoU not to implement new policy to generate price-related savings in the PBS over the life of the agreement needs to continue.”

Medicines Australia told the Government that developing a strategy for developing the industry in Australia was another important task.

“While the industry is going through very challenging times here and internationally, there are significant opportunities for Australia to develop its capability in researching, discovering, developing, manufacturing and exporting high-tech medicines if we can get the settings right in health policy and industry policy.

“The industry has the potential to help Australia set itself for a post-mining boom future.”

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Contact Person:

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

The Australian medicines industry’s contribution to the economy grew by an estimated $1 billion year-on-year, and its turnover rose by almost $400 million according to a new industry “Facts Book” published today.

The Medicines Australia Facts Book Update contains key industry statistics and other information. It highlights the contribution of the local medicines industry to the health and economic wellbeing of Australians.

The Facts Book Update also shows medicines R&D investment almost matched that of the primary mining and mineral resources sector in 2009-10.

And the medicines industry’s $3.8 billion in export earnings topped the wine and car industries.

Medicines Australia chief executive Dr Brendan Shaw said the information, compiled by Medicines Australia, demonstrates the value of the Australian medicines industry to the health and wealth of the nation.

“Australians can be very proud that fellow-Aussies have been working relentlessly to bring new medicines and vaccines that prevent, treat and cure disease,” Dr Shaw said.

“These figures show the Australian medicines industry is making a significant economic contribution.

“We are investing over $1 billion a year in R&D, and exporting medicines worth nearly $4 billion all over the world. That’s a real success story that we shouldn’t lose sight of.”

Key facts you may not know about Australia’s pharmaceutical industry:

• Local pharmaceutical companies contributed $8.66 billion to Australia’s economy in 2008-09, an increase of almost $1 billion on the previous year.
• Turnover for the Australian medicines industry in 2009-10 was $21.95 billion, up $400 million on the previous year.
• The Australian medicines industry employs 13,400 people.
• The Australian medicines industry brought 21 new medicines onto the Pharmaceutical Benefits Scheme in 2011.
• The number of new medicines in development globally grew to 3050 in 2011, up 100 on the previous year.

The Medicines Australia Facts Book is available here

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Contact Person:

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

Substantial price cuts to medicines on the Pharmaceutical Benefits Scheme announced by the Government will yield taxpayers major savings that will keep the PBS affordable, while providing the Government with the capacity to list new medicines in the future.

The Government had agreed as part of the 2010 Memorandum of Understanding with Medicines Australia a new round of market-based price cuts to deliver an average price reduction for off-patent medicines of 23 per cent on 1 April 2012.

The price cuts follow this month’s Mid-Year Economic and Fiscal Outlook which forecast lower than expected PBS spending to the tune of $1.8 billion.

Medicines Australia chief executive Dr Brendan Shaw said the latest price cuts, coupled with MYEFO means the Government will book hundreds of millions of dollars in PBS savings in coming years.

“These additional savings, together with future price disclosure related cuts and the current low growth rate of expenditure all add up to a manageable PBS.

“It effectively removes the case for further PBS reform.”

Dr Shaw said the price cuts would cause significant commercial difficulty for many of the companies taking substantial price 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,” Dr Shaw said.

“But we have agreed to these reductions because Medicines Australia member companies recognise the importance of keeping the PBS sustainable.

“This creates the financial headroom that allows the Government to bring the latest medicines on to the PBS whilst keeping expenditure under control.

“The good news for patients is that as well as providing financial headroom for listing new medicines, the price reductions that will occur on 1 April should lead to price reductions on medicines for patients as well as the Government.”

The system of mandatory price disclosure was legislated as part of the MoU to drive savings through a competitive generics market and ensure PBS sustainability.

“The system requires companies to disclose the discounted price at which they are selling medicines in the market, allowing Government to adjust the price it pays to the price the medicine commands in a competitive market place,” Dr Shaw said.

The savings announced by the Government are provisional, pending a short period in which companies can ask for a review if they believe the price reduction has been incorrectly calculated

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Contact Person:

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