Medicines Australia (MA) is pleased to announce the release of the fourth biannual innovative medicines industry’s transfer of value data to nurses, doctors and other healthcare professionals.

Medicines Australia Chief Executive Mr Milton Catelin emphasised the importance of this initiative.

“This data symbolises the essential partnerships that industry has with the medical community and highlights our commitment to ensuring that practitioners are provided with the most up to date information about breakthrough medicines,” said Mr Catelin.

“These latest transparency reports provide clear information about payments or other support provided to healthcare professionals, so they can access the latest educational opportunities, attend world leading local and international conferences or symposia, or for their services as an expert,’

“By supporting ongoing education, companies can assist healthcare professionals to acquire the appropriate understanding and knowledge of innovative therapies to ensure they are used safely and appropriately by doctors and their patients.”

“These reports, along with previous rounds, also highlight some important data trends, namely, that participating medical practitioners have not ceased interacting with companies since reporting became mandatory,”

The data also shows that healthcare professionals from rural and regional Australia also receive support for their ongoing education, not just those in capital cities, and that year on year the figures are similar.”

“I once again congratulate MA members for embracing a level of openness and accountability with regards to their support for medical educational activities that is certainly not echoed in the wider pharmaceutical space,” said Mr Catelin.

Further information about the transparency requirements of the MA Code of Conduct and hyperlinks to each member company’s reports are available here.

MA encourages consumers to talk to their doctors if they would like to know more about their relationships with different companies and the benefits to patient health.

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MORE INFORMATION: Natalie Wimmer – Communications Manager – 0450 728 660

Medicines Australia welcomes the passing of the PBS National Health Amendment (Pharmaceutical Benefits – Budget and Other Measures) Bill 2017.

This Bill amends the National Health Act to implement measures negotiated with Medicines Australia on behalf of the innovative pharmaceutical industry and announced in the 2017 Budget.

Medicines Australia Chief Executive Mr Milton Catelin said: “This Bill, and the Strategic Agreement that underpins it, represents two years of consultation with industry, government and the wider sector to ensure that cost savings are delivered by industry, into the PBS”

“This serious contribution by the innovative pharmaceutical industry is just one way we provide incredible value to the taxpayer, said Mr Catelin.

“Through the agreement we will deliver savings to the Pharmaceutical Benefits Scheme (PBS) of around $1.8 billion over the five-year term of the agreement,”

“It similarly, enables the Government to continue its commitment to list all medicines with a positive recommendation – a win for Australians who need access to breakthrough medicines.”

“While the passing of this Bill enables implementation of legislation to support the Strategic Agreement, it also reaffirms the joint commitment to the benefits of the agreement that aren’t legislative,” said Mr Catelin.

“This includes the importance of policy stability for the innovative medicines sector, ongoing consultation on processes that have an impact on their businesses, reaffirms that changes are transparent and accountable and that implementation timeframes are considered,”

“This Bill, and its supporting Strategic Agreement are an essential way we contribute to the healthcare system in Australia. Now that they are locked down, it’s important that Government, and the departments work with the wider industry to ensure that the PBS remains well-funded so that medicines can continue to be provided to all Australians,”

“Medicines Australia thanks the Government, Health Minister Greg Hunt and Shadow Health Minister Catherine King for their bipartisan support of this Bill and for their support of the innovative medicines industry,” said Mr Catelin.

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More information – Natalie Wimmer – Communications Manager, Medicines Australia
Ph: 0450728660 – nwimmer@medaus.com.au

Medicines Australia welcomes the release of the 2030 plan by Innovation and Science Australia but seeks clarification on R&D tax incentive.

Milton Catelin, Chief Executive of Medicines Australia stressed the need to continue to improve Australia’s capabilities in innovation and commercialisation and welcomes the Governments renewed commitment to innovation as a driver of economic growth and prosperity.

“A long term vision is paramount in order to cement Australia as a top destination for investment in research and development in the latest breakthroughs, said Mr Catelin.

“We welcome the inclusion of genomics and precision medicines as a key component of an innovative future and the commitment to enhancing trade agreements,” he said.

“Medicines Australia does note that the 2030 plan makes a number of recommendations relating to Australia’s R&D tax incentive that differ from the Government’s 2016 report into the scheme, also led by Bill Ferris, with John Fraser and Alan Finkel.”

“Of particular interest are the 1% trigger to claim the non-refundable tax offset as well as the $4 million annual cap and $40 million lifetime cap on the refundable tax offset. Both of these recommendations are a change in position from the previous Ferris, Fraser, Finkel report.”

“Innovative pharmaceutical companies require long term certainty when making investment decisions in R&D, and, the ongoing uncertainty regarding the future of the R&D tax incentive remains a concern for Medicines Australia and the innovative medicines industry.”

“Medicines Australia, and our members will work through the detail of the plan and consider the impact for pharmaceutical industry growth and investment in Australia in order to brief members.”

“This will include ongoing work with our stakeholders to re-enforce the need to exempt medical research, such as clinical trials, from any future caps to overcome the potential unintended consequences that intensity thresholds may have on the biotechnology and pharmaceutical sector.”

“The recognition of exporting as a strategic opportunity for Australia through Free Trade Agreements is encouraging. Such agreements could offer the opportunity to align our intellectual property protection regime with those of our key trading partners and would boost Australia’s competitiveness and strengthen Australia’s reputation.”

“This will ensure that our members can continue to invest in the health of Australians,” said Mr Catelin.

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More information  – Natalie Wimmer – 0450 728 660

Medicines Australia welcomes the Government’s announcement of an outcome from the Post-market Review of the Life Saving Drugs Programme (LSDP review).

We particularly welcome the recognition that medicines that reduce the level and duration of disability and improve quality of life have a significant impact.

Milton Catelin, Chief Executive of Medicines Australia says the sector is looking forward to working with the Government to develop appropriate guidance on this expanded criteria.

“It is important to bring certainty about access to life saving drugs to the patients who need them. We hope that the changes to the LSDP will provide this,” said Mr Catelin.

“We also welcome the establishment of an expert panel to provide advice and assistance to the Chief Medical Officer (CMO) and will seek to contribute to the establishment of that Committee.”

“The Government’s announcement today signals a willingness to continue to make innovative medicines available to Australian patients and reiterates the commitment made in our Strategic Agreement to streamline PBAC and medicines access processes.”

“The innovative medicines industry is committed to bringing new, life saving medicines to Australia, and will be working closely with the Government to determine the most appropriate policies to underpin this outcome,” said Mr Catelin.

More information – Natalie Wimmer- 0450 728 660

Statement from Medicines Australia:

The Mid-Year Economic and Fiscal Outlook (MYEFO) outlines additional expenditure related to new and amended listings since the Federal Budget.

Medicines Australia welcomes the ongoing commitment of the Turnbull Government to list medicines recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) in a timely manner which will benefit thousands of Australians who need access to the latest developments in medicine.

However, the current reporting of PBS expenditure in the Budget papers lacks transparency which makes a much-needed discussion about the true level of funding for new medicine listings unnecessarily complex.

When rebates to government from medicines manufacturers are removed, expenditure on the PBS has been flat, or even declining in real terms, since 2011.

This has been a remarkable achievement made possible only with the help of the pharmaceutical industry. Medicines Australia has actively supported government in reducing prices it pays for medicines on the PBS, with the latest Strategic Agreement signed this year with the Commonwealth netting at least $1.8 billion in savings on PBS medicines over five years.

However, the lack of growth in funding is clearly unsustainable into the future. On its own, industry efforts to reduce prices will not be able to keep meeting the funding demands to list all recommended medicines by the PBAC over the longer term.

Australians want fast access to the latest medicines subsidised through the PBS. While industry will continue to deliver incredible value for money for those medicines, there is a looming challenge for all policymakers to ensure that Australians get access to the medicines they need when they need them.

If Australia with its ageing and growing population is to continue to enjoy world-class access to the latest innovations in medicines into the future, there needs to be a discussion about how to appropriately invest additional money into the PBS.

Medicines Australia believes this is a challenge that needs to be addressed by all sides of politics to ensure long-term predictability and sustainability of the PBS which is so cherished by the Australian people.

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More information – Natalie Wimmer – nwimmer@medaus.com.au – 0450 728 660

Medicines Australia response to the Senate Select Committee report “Funding for Research into Cancers with Low Survival Rates”

The 25 recommendations released in the Senate Select Committee report reveal the challenges Australia faces to ensure that all Australians get access to the treatments and medicines they need when they need them, regardless of the type of disease.

The report recommendations are a comprehensive response to the issue and cover research funding and coordination; clinical trial awareness, access and approvals for treatment; improving early detection and identification; repurposing existing medicines; fast-tracking innovative treatments and the utilisation of genomic research; patient care; costs; and navigation through the disease processes.

Medicines Australia particularly supports the Senate Committee’s recommendations that call for a more flexible approach for the listing of breakthrough medicines on the Pharmaceutical Benefits Scheme (PBS).

When handing down the report Committee member Senator Stirling Griff said, “there’s also a need to rethink the one-size-fits-all approach to cancer treatment and to eliminate the regulatory hurdles that prevent patients accessing the most appropriate therapy for their particular tumours”.

Medicines Australia Chief Executive Million Catelin says the industry strongly supports this view but Australia must also consider how it will continue to afford breakthrough treatments without considering the future funding of the PBS.

“The treatments for diseases such as cancer are becoming more targeted, more effective but ultimately more expensive to develop, so the easier you make it to list breakthrough medicines on the PBS, the faster these treatments get to the Australians who need them,” said Mr Catelin.

“However, you need to ensure enough money is invested in the PBS going forward to pay for these treatments.”

“Australia already pays some of the lowest prices in the world for innovative medicines and the industry will continue to offer taxpayers incredible value for money, but the PBS has seen no growth in expenditure for almost a decade and that will become increasingly unsustainable in the future.”

“The challenge at all times for industry is to offer value for money for the PBS and for taxpayers; the challenge for governments is ensuring that the PBS is fully funded so that Australians get access to the medicines they need when they need them.”

“We understand the challenge this presents for governments now and in the future, but at some stage we all have to concede that more money is needed and the access to these sometimes life-saving treatments is worth it.”

Medicines Australia also strongly supports the Senate Committee’s recommendations to harmonise, streamline and better fund the clinical trials environment in Australia.

“The innovative pharmaceutical industry invests in about 1000 clinical trials per year within Australia at a cost of about $270 million,” said Mr Catelin.

“We need to have a clinical trials sector that continues to attract investment from industry and the committee’s recommendations to make the listing of some medicines on the PBS more flexible will help to encourage this investment.”

“Medicines Australia would like to send our personal thank you to all Committee member Senators, in particular the Chair Senator Catryna Bilyk, who has been tireless in her work to raise awareness of the issue, and a passionate advocate for improved access to cancer medicines,” said Mr Catlin.

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More information – Natalie Wimmer – Manager, Media and Communications – 0450728660 | nwimmer@medaus.com.au

Medicines Australia (MA), welcomes the Australian Government response to the Senate Community Affairs References Committee Report: Availability of new, innovative and specialist cancer drugs in Australia.

MA members discover, develop and manufacture the latest medicines that are made available to those who need them on the Pharmaceutical Benefits Scheme (PBS).  They also undertake around one thousand clinical trials locally that support the development of new medicines and provide 34 thousand Australians with early access to the latest treatments, including for cancers.

We’re committed to working together with the Government to ensure that access to new innovative medicines remains the highest priority.

It’s encouraging that the Government agrees that improving and streamlining existing regulatory and assessment processes for new medicines are key strategies to ensure Australians have even better access to breakthrough medicines.

As the Government notes in their response, some of the Senate inquiry’s recommendations are currently being addressed through reforms of the Therapeutic Goods Administration (TGA).

In particular, we look forward to the passage of legislation currently before Parliament that includes provisions for another expedited pathway called Provisional Approval that aims to speed up access to new medicines.

The Government’s response also highlights the importance of the Strategic Agreement, signed with Medicines Australia, to address some of the recommendations of the Senate inquiry.

Not only does the Agreement provide $1.8 billion in savings on PBS listed medicines that will be used to pay for new treatments, the Government has committed to reform that will improve and accelerate processes that lead to a medicine being made available on the PBS.

Medicines Australia believes that the Government’s commitment in the Strategic Agreement will make a real difference to access to medicines for Australians.

We’re committed to continuing collaborative discussions with the Government about the future of the PBS and the improved availability of breakthrough medicines to Australians at a price they can afford.

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More information – Natalie Wimmer, Manager Media and Communications –
0450 728 660 – nwimmer@medaus.com.au

Mr Wes Cook, Managing Director of Boehringer Ingelheim Australia, has been re-elected as the Chair of Medicines Australia with Dr Anna Lavelle re-endorsed as Independent Deputy Chair.

The appointments followed the announcement of the new Board of Medicines Australia at the association’s Annual General Meeting in Sydney today (see list below).

Medicines Australia Chief Executive Mr Milton Catelin said, “Wes has shown outstanding leadership as Chair and helped to guide the strategic direction of our industry for quite some time now, including the Strategic Agreement signed earlier this year with the Commonwealth.”

“As our Deputy Chair and independent Board member, Dr Lavelle provides expertise on Board governance as well as invaluable insights into the broader biopharmaceutical and medical research sector from her years of industry experience.”

“I would like to congratulate all new and returning Medicines Australia Board Members who were selected by their peers following the recently conducted members’ ballot.”

The new Board announced at today’s Annual General Meeting will serve until October 2019.

Chair	Mr Wes Cook	Managing Director	Boehringer Ingelheim Pty Ltd
Independent Director and Deputy Chair	Dr Anna Lavelle
Director	Anne Belcher	Vice President/General Manager	GlaxoSmithKline Australia Pty Ltd
Director	Brad Edwards	General Manager ANZ	Shire Australia Pty Limited
Director	Michala Fischer- Hansen	VP and General Manager – Oceania	Novo Nordisk Pharmaceuticals Pty Ltd-Australia
Director	Bruce Goodwin	Managing Director	Janssen-Cilag Pty Limited
Director	James Jones	Managing Director	Takeda Pharmaceuticals Australia Pty Ltd
Director	Melissa McGregor	Managing Director	Pfizer Australia Pty Ltd
Director	Kirsten O’Doherty	General Manager	AbbVie Pty Ltd
Director	Svend Petersen	Managing Director	Roche Products Pty Limited
Director	Brent Pfeiffenberger	Managing Director Australia/New Zealand	Bristol-Myers Squibb Australia Pty Ltd

“On behalf of Medicines Australia, I would like thank all outgoing Board members, for their commitment to the innovative medicines industry during their time as Directors,” said Mr Catelin.

“They deserve enormous gratitude from the sector for their role in developing a Strategic Agreement with the Commonwealth that provides certainty for industry, incredible value for taxpayers and better access for Australians to innovative medicines.”

“The announcement of a new Board is an important milestone for the membership. It provides both continuity as well as fresh leadership that will help to steer the strategic direction of Medicines Australia and the industry more broadly for the years to come.”

“I look forward to working closely with the new Board and once again offer them my congratulations,” said Mr Catelin.

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CONTACT

Natalie Wimmer nwimmer@medaus.com.au Phone: 0450 728 660