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

Medicines Australia chairman Will Delaat announced today that he will retire from the position in February 2012.

Mr Delaat has served on the board of Medicines Australia since 1998 and has been chairman since 2008. He was previously chairman between 2003 and 2005.

Mr Delaat said: “I leave at a time when the industry is well placed to capitalise on key opportunities. PBS expenditure growth is extremely low, export earnings are high and meaningful progress is being made to build on our clinical trial investment.

“We have a very solid base upon which to build for the future.

“It has been a genuine privilege to serve this great industry as chairman of Medicines Australia and an honour to work alongside such an inspired Board.”

Medicines Australia chief executive Dr Brendan Shaw said Mr Delaat had been a passionate advocate for the Australian medicines industry for many years and had played a central role in driving improvements to the policy environment for the industry.

“Will has made a colossal contribution to Medicines Australia and Australia’s medicines industry,” Dr Shaw said.

“He has been a champion of National Medicines Policy over a long and successful career.

“He led the industry through major reforms of the Pharmaceutical Benefits Scheme, including the negotiation of the historic Memorandum of Understanding between Medicines Australia and the Australian Government that have resulted in a sustainable, well-managed PBS with low expenditure growth.

“Will has also been instrumental in driving key industry policy change and securing a viable investment environment for the medicines industry in Australia.

“Will has been a great leader, an inspiring mentor and a good friend. We wish him well in his future endeavours.”

Mr Delaat will remain on the boards of Pharmaxis, EnGeneIC Ltd and the Fragile X Association of Australia.

Medicines Australia expects to announce Mr Delaat’s successor in early 2012.

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Contact Person:

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

A new state-of-the-art mobile renal dialysis unit funded by Medicines Australia will be launched in Alice Springs tonight (Monday) by the Minister for Indigenous Health, Warren Snowdon MP.

The truck will mean patients from remote communities in the Western Desert who are receiving dialysis treatment at hospitals in major centres can return home from time to time to visit family.

The $400,000 truck is part of Medicines Australia’s commitment to helping improve indigenous health, and will be presented to the Western Desert Nganampa Walytja Palyantjaku Tjutaku Aboriginal Corporation.

Medicines Australia chairman Will Delaat said the “Purple Truck” would make an important contribution to improving indigenous health in the Western Desert.

“We are thrilled with the truck,” Mr Delaat said.

“This is a state-of-the-art mobile medical facility and it looks magnificent.

“It will give patients undergoing treatment in regional centres opportunities to visit their own communities and stay better connected with those communities.

“Medicines Australia is delighted to be part of WDNWPT’s vision. The Purple Truck is a dream come true for the communities of the Western Desert and we are proud to be part of their story.

“The medicines industry is responding in a practical way to the Federal Government’s call to help ‘close the gap’ in indigenous health.

“We have committed to funding several projects that would help improve indigenous health outcomes and we are delivering on that commitment.”

Today’s launch will also be attended by Dr Andrew Laming, Federal Opposition Spokesperson for Indigenous Health, and Karl Hampton, the Northern Territory Minister for Central Australia.

The Purple Truck is on display today in Todd Street Mall, Alice Springs.

The truck will make its maiden road-trip to Papunya in the Western Desert on Tuesday (tomorrow) to begin its important work.

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Contact Person:

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

Medicines Australia congratulates outgoing Minister for Health and Ageing Nicola Roxon and outgoing Innovation and Industry Minister Senator Kim Carr on their contributions to their respective portfolios over the past four years.

Medicines Australia chief executive Dr Brendan Shaw also welcomed the appointments of Tanya Plibersek as Minister for Health and Greg Combet as Minister for Industry and Innovation.

“Both Minster Roxon and Minister Carr have ensured constructive policy dialogue between the Government and the Australian medicines industry,” Dr Shaw said.

“Both have been willing to engage with the industry and work collaboratively to develop sound policy.

“At the same time, I congratulate Minister Plibersek and Minister Combet on their appointments and Medicines Australia looks forward to working constructively with them and continuing the important work in these two key portfolios.

“Minister Roxon has consolidated the 2007 reforms to the Pharmaceutical Benefits Scheme.

“She was instrumental in securing the Memorandum of Understanding between the Australian Government and Medicines Australia which has delivered savings to the Government and a degree of predictability for industry.

“Under her leadership, the PBS has been well managed and is now enjoying record low growth, which creates the capacity to bring new medicines onto the PBS.

“Minister Carr has been a passionate advocate for the Australian medicines industry. He has achieved the introduction of the R&D tax credit and has been central to the reforms to improve our international competitiveness in attracting clinical trials to Australia.

“We look forward to continuing to work with Minister Carr, in his new capacity as Minister for Manufacturing.

“We also look forward to working with Minister Plibersek, who has shown a strong interest in health issues throughout her parliamentary career.”

Dr Shaw also congratulated Minister for Mental Health and Ageing Mark Butler on his elevation to the Cabinet.

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Contact Person:

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

Medicines Australia is disappointed at the Government’s decision not to accept the key recommendations of the Trimmer Review into the promotion of therapeutic goods, but will continue to push for a level playing field for promotional activity.

Medicines Australia chief executive Dr Brendan Shaw said it was disappointing that the Blueprint for TGA’s Future, released by the Government today, did not address the issue of different ethical standards within the therapeutics sector.

“The review into promotion of therapeutic goods argued for a consistent ethical standard across the sector between members of industry associations and non-members, but that recommendation has not been accepted,” Dr Shaw said.

“That is very disappointing. This was a rare opportunity for stakeholders across the health sector to implement important regulatory reform which was identified by Government as a gap in industry self-regulation.

“The fact is we need a common ethical standard across the sector. There is no reason why Medicines Australia member companies should be required to adhere to one standard while non-members adhere to a lesser standard.

“We need to make sure our member companies are not disadvantaged by doing the right thing. In releasing its response to the Trimmer Review, the Government stated its support for strong and effective industry self-regulation.

“We need to prevent behaviour that undermines public confidence in the pharmaceutical industry.

“Medicines Australia’s member companies have worked hard over the years to have a Code of Conduct that enshrines ethical standards that meet community expectations.

“There needs to be a level playing field that applies to all companies – not just those who choose to belong to Medicines Australia. Appropriate standards of conduct must apply across the board.”

Medicines Australia welcomes the Government’s commitment outlined in the Blueprint to ensure more transparent regulatory processes in Australia.

The Government’s endorsement of the transparency reforms for the TGA is a step forward for the health system.

“These reforms aimed at greater transparency will help demystify the regulatory process for the ordinary Australians who benefit from them,” Dr Shaw said.

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Contact Person:

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