Medicines Australia announce the resignation of CEO, Milton Catelin

Medicines Australia announce the resignation of CEO, Milton Catelin

Medicines Australia CEO Milton Catelin today announced his resignation from the peak body representing the innovative medicines industry, ahead of a move back to the United Kingdom (UK).

Medicines Australia Chairman Wes Cook thanked Milton, stating, “On behalf of the Board and our members I would like to thank Milton Catelin for his contribution to the innovative medicines industry.”

‘Milton is leaving Medicines Australia following a period of significant transformation and growth for our sector.”

“As an industry body we have benefited from his leadership of a highly experienced team who together have delivered meaningful health policy outcomes, for example the successful negotiation of the modification of the Government’s skilled migration occupation lists.”

“Milton has also worked closely with the members of the Medicines Australia secretariat and member companies to build strong and meaningful partnerships with our stakeholders, culminating in the highly engaging PharmAus event at Parliament House in September last year”, Mr Cook said.

Milton Catelin thanked the Board for their support over the past 18 months.

“As a group of highly engaged Managing Directors, they have worked cohesively to support myself and the secretariat to achieve some outstanding outcomes,” said Mr Catelin.

“I leave medicines Australia and the innovative medicines industry at a time of great strength. We’ve worked hard to establish the Strategic Agreement and developed firm partnerships with Government. Importantly, we have also mobilised and united as a membership like never before,” he said.

“I am privileged to have been able to contribute to this extraordinary sector,”

“I’d also like to thank the MA secretariat and wider membership for their commitment. Throughout my tenure, I have witnessed a passion and dedication that highlights how meaningful this industry is to the health of Australians,” Mr Catelin said.

Looking forward, Mr Cook said, “Today, with a highly engaged membership and experienced Secretariat, Medicines Australia is incredibly well positioned to contribute to the development of good health policy in Australia.

“I sincerely wish Milton all the very best on his future and his important move back to the UK to join his family,” concluded Mr Cook.

A sub-committee of the Medicines Australia Board will now commence a process to recruit a new CEO.

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More information: Natalie Wimmer – Communications Manager, Medicines Australia

Ph: 0450 728 660

E: nwimmer@medaus.com.au

21st Annual Medicines Australia CEP Award Winners Announced

21st Annual Medicines Australia CEP Award Winners Announced

Today, Medicines Australia recognises the Australian pharmaceutical industry’s commitment to training and supporting our highly skilled and dedicated Medical Representatives.

This mandatory program highlights the innovative pharmaceutical industry’s diligent commitment to ethical conduct.

The Medicines Australia Continuing Education Program has been in existence for over 45 years.

A total of 659 students commenced their CEP journey through the University of Tasmania in 2017.

The aim of the CEP is to educate company representatives to a recognised industry standard in order to provide health care professionals with accurate, balanced information in an ethical manner that will enhance the quality use of medicines.

These representatives of the innovative pharmaceutical industry have the important job of ensuring the dialogue between the companies who make the medicines and the doctors that prescribe them is productive, balanced and ethical.

Medicines Australia would like to congratulate the following CEP award recipients:

Code of Conduct – Outstanding Achievement Award
This award is presented to the candidate who achieves the highest mark in Program 1, the Code of Conduct Program.

Simon McErlane who was working with Alexion Pharmaceuticals

Continuing Education Program – Top Achievers
Winners in this category are students who achieve the highest aggregate marks in all five core Programs of the CEP.

  • John Seeto – Hahn Healthcare
  • Anwar Johnson – Novartis Pharmaceuticals
  • Shaynora Prasad – Previously Hahn Healthcare
  • Joshua Lennox – Hahn Healthcare
  • Marion Arnott – Mundipharma
  • Nina Clifford – Boehringer Ingelheim
  • Monica MacGregor – Sanofi
  • Luke Mirabilio – Hahn Healthcare
  • Briar Tietjens – Novartis Pharmaceuticals
  • Wynette Monserrat – Independent.

The 2017 University of Tasmania Prize for Excellence
A prize is awarded for each semester and is based on the level and quality of students’ reflective assignments, exam results, active learning and participation in a Program.

  • Jennilee Davidson – Boehringer Ingelheim
  • Katie Barrett – Servier Laboratories

Medicines Australia would like to congratulate these worthy award winners and recognise the achievements of the 205 graduates of the 2017 Continuing Education Program.

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More information – Natalie Wimmer – 0450 728 660

Industry partnerships educate doctors

Industry partnerships educate doctors

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

MA welcomes passing of PBS Amendment Bill

MA welcomes passing of PBS Amendment Bill

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

Industry needs clarity to invest in Australia

Industry needs clarity to invest in Australia

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 LSDP review outcomes

Medicines Australia welcomes LSDP review outcomes

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

Vale Donna Staunton

Vale Donna Staunton

Medicines Australia is saddened to hear about the passing of Donna Staunton.

Donna was a tireless advocate for improving access to medicines for all Australians, and leaves a tremendous legacy.

Donna’s contributions to improving the efficiency  of the supply chain, through the NPSA and the Medicines Partnership of Australia was exceptional and her commitment, passion and willingness to collaborate were of immense value to our industry.

Staff at Medicines Australia who have worked alongside Donna in many walks of life, held her in very high regard and have looked to her for guidance and advice.

Donna was also a strong role model for women in business, and a mentor to many within the wider healthcare sector.

Donna was highly respected by all who worked with her and she will be missed for her significant contribution.

Our thoughts are with her family at this difficult time.

Statement from MA on MYEFO

Statement from MA on MYEFO

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

It’s the law, not the Code – MA’s Director of Ethics and Compliance – Deborah Monk

It’s the law, not the Code – MA’s Director of Ethics and Compliance – Deborah Monk

The Director of Ethics and Compliance at Medicines Australia Ms Deborah Monk is troubled that there may be a lack of understanding by some, about the requirements of the Therapeutic Goods Act 1989 (The Act) and the guidance provided in the MA Code of Conduct.

The Medicines Australia Code is a self-regulatory Code, which necessarily must be consistent with all Australian legislative requirements.

However, we can all agree with Carlo Montagner in his recent opinion piece, that we want patients to have access to new treatments that will help them lead longer and healthier lives, and if necessary, this includes medicines that are not yet approved in Australia.

Pharmaceutical companies provide numerous opportunities for patients to gain early access to innovative medicines. That’s something that our industry does extremely well. Not only do they provide access through clinical trials during the development of a medicine, but also through compassionate access or other early access programmes, aimed at providing patients with the treatments they need until the regulatory process concludes and the medicine is registered and more importantly available through the Pharmaceutical Benefits Scheme (PBS). Companies also provide clinicians with early access to medicines through Product Familiarisation Programmes (PFPs), which inform clinicians about how to use new medicines appropriately and manage their patients care when receiving a breakthrough medicine.

Nevertheless, the laws are clear. There is a specific section in the Therapeutic Goods Act that prohibits a person from publishing or broadcasting an advertisement about any therapeutic good that is not included on the Australian Register of Therapeutic Goods (ARTG).

The Act also makes it an offence for any person to make a claim, by any means, that they or another person can arrange the supply of therapeutic goods that are not registered or listed goods.  These legal requirements should always be carefully considered before communicating with doctors about being able to prescribe an unapproved medicine.

Medicines Australia and our members do not support promotion or advertising of compassionate access that falls outside the laws in Australia.  The MA Code of Conduct is intended to apply the Therapeutic Goods legislation to the activities of member companies when they interact with doctors.

If the TGA forms a view that companies can proactively inform doctors about the availability of an unapproved medicine through compassionate access programmes, Medicines Australia – and the innovative medicines industry – would be fully in support of it.

Medicines Australia and the TGA are working with doctors to consider a range of options to enable appropriate information on compassionate access programmes to be more accessible to clinicians who can then inform their patients.

As a result of these discussions, we are examining possibilities such as optionally listing compassionate access programmes on a third-party web site that is only available to doctors. This may represent a workable solution in line with the Therapeutic Goods Act, while still ensuring that the trusted role of the doctor as the primary source of information about a medicine is protected.

So, the question about information, advertising, promotion and the role of medical practitioners in this, is a timely discussion to have, particularly through engaging with the administrator of the legislation, the TGA to understand their perspective.

We would welcome constructive dialogue on this, and the Code of Conduct from members and non-members alike.

Prioritise investment in the PBS to improve access to all cancer medicines

Prioritise investment in the PBS to improve access to all cancer medicines

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.

ENDS

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