Medicines Australia has signed a Strategic Agreement with the Australian Government that will support ongoing access to the latest innovative medicines for patients, significant savings to taxpayers and provide much needed stability for the innovative medicines industry.

The five year agreement will deliver $1.8 billion in savings that will be reinvested into the supply of medicines, including more breakthrough therapies on the Pharmaceutical Benefits Scheme (PBS). The Agreement also incorporates significant process improvements to update the PBS, as well as measures that will help to accelerate access to the latest medicines for Australian patients.

The changes will see single brand (innovative) medicines reduced in price after being on the PBS for 5, 10 and 15 years respectively. On entry of brand competition, there will be an increase from the current 16% reduction to 25%.

Medicines Australia Chairman Wes Cook says, “This agreement upholds the key principles sought by Medicines Australia, such as the need for policy predictability and certainty for industry; acknowledgement that the industry is currently delivering savings through recent reforms and that the additional savings generated for taxpayers will be reinvested into new medicines on the PBS.”

“The decision to sign the Strategic Agreement ends a long period of uncertainty for industry and will help to improve the confidence of our members to continue to bring innovative medicines to Australia and to invest in local research and development, such as clinical trials,” said Mr Cook.

“This agreement is a significant step towards creating an environment that encourages growth in the Australian pharmaceutical industry which has been identified as one of the key sectors for our nation’s future economic success.”

“Medicines Australia entered into this agreement with a number of key principles that were not only important for our sector but also vital for prescribers, patients and the future of the PBS.”

“Fundamental to all discussions was the principal that a physician has the right in consultation with their patient to determine the exact treatment that is prescribed and dispensed. This principle is upheld in the agreement with appropriate, physician- determined introduction to biosimilar and generic medicines,” said Mr Cook.

Medicines Australia Chief Executive Milton Catelin acknowledged the support of pharmaceutical companies in helping to design these reforms that will help to shape the local industry.

“Over the past decade our members have worked with successive governments to ensure the PBS has remained sustainable. But with so much change for so long there is a need for a period of stability and certainty,” said Mr Catelin.

“That’s why it’s so important for our members that a fundamental condition of the Agreement is that no additional pricing reforms will be implemented over the five year term.”

“This will be one of the key factors helping to encourage the industry to continue to invest with confidence in Australian medical research and science, including much needed clinical trials.”

“We want to see an environment that will help this industry continue to grow to provide more opportunities for Australian medical science and better health outcomes for all Australians.”

“The agreement is one of the important enablers for this much-needed investment by our members, along with a world class regulator, a robust intellectual property regime and globally competitive tax arrangements.”

“Medicines Australia looks forward to discussing this important agreement with the Parliament and other stakeholders integral to the supply chain, to outline its benefits to patients, taxpayers and the local industry,” said Mr Catelin.

The Strategic Agreement will take effect from 1 July 2017 and expire on 30 June 2022.

Department of Health – Landmark compact with Medicines Australia

09 May 2017 Strategic Agreement with Commonwealth

09 May 2017 – Summary Document – Strengthening the PBS

Ends

CONTACT:

James Boyce – Director External Relations and Communications – 0423 239 265

Natalie Wimmer – Media Communications Manager – 0450 728 660

Commercialisation of Australian medical research is under serious threat if the package of measures put by the ‘Ferris, Finkel, Fraser’ Review of the Research & Development (R&D) Tax Incentive is adopted and Australia’s medical technology, biotechnology, and pharmaceutical (MTP) sector is urging the Federal Government not to devastate Australia’s most innovative industry.

The R&D Tax Incentive is the most critical centre-piece program in the translation of Australia’s world-class research into treatments, cures, diagnostics, medical devices and vaccines. The program has been successful in helping attract more investment in R&D and fostering a strong Australian life sciences clinical trials and R&D sector.

The changes proposed, especially the $2 million cap and the ‘intensity threshold’, will have significant, disproportionate and negative impact on the MTP sector. Only around 5.5% of research expenditure registered for the R&D Tax Incentive relates to MTP(1), however comments from the Report’s authors that the impact of the $2 million cap will be “slight” or that other policy measures, like the Biomedical Translation Fund, will balance out damage, fail to understand the impact likely in the sector, its broader ecosystem, or the nature of clinical trials. Relative to other sectors, the commercialisation of MTP has longer timeframes, due to significant scientific and regulatory hurdles to reach patients and there is higher expenditure on R&D, particularly in later stage clinical trials.

We understand the need for the Government to ensure that the tax incentive is sustainable during challenging budgetary conditions; however, the scheme must be viewed as a tool to encourage long-term investment in Australia that creates highly-attractive jobs, attracts clinical research and grows the local economy.

Ensuring that any redesign of the tax incentive does not act as a handbrake on this investment is imperative, so that Australia can continue to thrive as a home for some of the world’s most talented scientists and medical researchers, improve its position as a centre for high-quality R&D in medical science and receive the related spill-over benefits.

The Federal Government has recognised the potential economic benefit of innovation via the National Innovation and Science Agenda and the MTP sector through its designation as one of six industry sectors of competitive strength and strategic priority (MTPConnect). The CSIRO and MTPConnect believe the MTP sector can create a further 28,000 jobs and deliver $18 billion in added value to the Australian economy within the next ten years(2).

According to the 2017 AusBiotech CEO Industry Position Survey(3) of 46 member companies implementing a $2 million cap will impact the ability to employ staff for 58% of companies, while 45% of companies will be have a reduced capacity to employ STEM graduates, 81% will be affected in their capacity to attract investment and 75% will be less able to compete globally. Companies were on average able to leverage the non-dilutive capital provided by the R&D Tax Incentive at $8 for every dollar spent.

In results from BioMelbourne Network survey(4) of 32 member companies in late 2016: 45% indicated that their R&D Tax Incentive refund would be over $2 million in 2015/16. 77% would undertake less R&D activity, 71% would decrease their clinical trial activity, 74% would reduce late stage research programs in Australia.More than half (52%) said they would move R&D activity offshore, 48% would reduce the level of collaboration with research organisations. More than one third of companies would incur direct job losses (38% surveyed), resulting in reduction of the workforce estimated to be between 10 – 25% and 85% of companies said that the $2 million cap would decrease their current or future outsourced R&D jobs to the wider sector.

A 2016 study of 41 biotechnology companies by the University of Sydney(5) found that 78% viewed the R&D Tax Incentive is either important or very important to the decision for their firm to undertake research and development in Australia and 61% of firm managers said their firm would change their R&D investment strategy if the government were to further modify the R&D Tax Incentive.

Clinical trials give early access to new treatments for Australians and have a pivotal role to play in the economy of the future, which will strongly rely on innovative jobs, exports and productivity. Clinical trials bolster the economy and are already supporting its transition from a post-mining boom. Beyond the economic benefit to Australia, R&D in the life sciences can develop therapies, cures, medical devices and diagnostics for patients around the world.

The MTP sector does not support the proposed changes as a package, most notably the proposed $2 million cap and the ‘intensity threshold’. It is a firm belief that this effort to limit or divert the R&D Tax Incentive will damage the country’s hard-won momentum in life sciences, especially the stimulation of the clinical trials environment which we are fighting hard to keep.

About AusBiotech AusBiotech is Australia’s biotechnology organisation, working on behalf of members for 30 years to provide representation and services to promote the development, growth and prosperity of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural, environmental and industrial sectors.

---

About Research Australia

Research Australia is the national peak body representing the entire health and medical research pipeline advocating for health and medical research in Australia. Independent of government, Research Australia’s activities are funded by its partners, donors and supporters from leading research organisations, academic institutions, philanthropy, community special interest groups, peak industry bodies, biotechnology, medical technology and pharmaceutical companies, small businesses and corporate Australia.

About Medicines Australia

Medicines Australia represents the discovery-driven pharmaceutical industry in Australia. Our member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community, which keeps Australians out of hospitals, prevents disease and play a pivotal role in ensuring a productive and healthy community. Medicines Australia’s mission is to drive the creation and development of a predictable environment for the continued, sustainable growth of the innovative and research-based prescription medicines industry.

About BioMelbourne Network

The BioMelbourne Network is a membership-based, industry forum representing over 185 organisations and business leaders in biotechnology, medical technology and health innovation industries in the State of Victoria. Our role is to foster links between companies, research organisations, financial markets and government to create an environment for that enables conversation, collaboration and prosperity.

About Medical Technology Association of Australia (MTAA)

The Medical Technology Association of Australia represents manufacturers, exporters and suppliers of medical technology products used in the diagnosis, prevention, treatment and management of disease and disability.

References:

1. Innovation Australia 2014-15 Annual Report, Figure 2.3: Field of Research (data set) Column D, analysis by Research Australia
2. CSIRO and MTP Connect, The Medical Technologies and Pharmaceuticals (MTP) Roadmap – unlocking future growth opportunities for Australia, February 2017
3. AusBiotech 2017 Biotechnology Industry Position Survey, due for release 1 May 2017
4. BioMelbourne Network survey, December 2016: http://biomelbourne.org/wp-content/uploads/sites/65/2016/11/RD-Tax-Incentive-submission-BioMelbourne-Network-October-2016-Final.pdf
5. The University of Sydney, Marieke D’Cruz, Committing to the Innovation Nation: Why the R&D Tax Incentive is so important for Australia, February 2017.

Medicines Australia warmly welcomes the commencement of The Bridge Program – an initiative of a consortium of Australian innovative pharmaceutical companies and Medicines Australia, together with QUT and Medical Technologies and Pharmaceutical Growth Centre (MTPConnect) – who will translate Australia’s impressive innovation and discovery research into the marketplace.

The Bridge Program will commence in June this year for 100 participants and will also give two participants a travel scholarship to visit overseas pharmaceutical research facilities and develop global experience and business networks.

This industry-led initiative will create commercialisation opportunities for Australia’s bioscience research sphere and Australia’s pharmaceutical and biotechnology sectors.

Medicines Australia Chief Executive Milton Catelin said the kick off of The Bridge Program is a step in the right direction in filling the gap between the research sector and the marketplace.

“The Bridge Program will foster opportunities for researchers to make the connections necessary for commercialisation and to ultimately deliver better health outcomes for Australian patients by leveraging the extensive knowledge of the innovative pharmaceutical sector,” said Mr Catelin.

“Collaborative programs such as this one boost opportunities for commercialisation and investment, and sets the nation on a path to a more innovative and entrepreneurial economy.

“The innovative pharmaceutical sector has long been identified as a strategic pillar of growth for the Australian economy by the Federal Government and this initiative will help realise that.”

“The Bridge program provides, through training and networking, the knowledge transfer that happens naturally in other countries,” he said.

“In fact, initiatives such as The Bridge program are an essential tool to ensure Australia remains globally competitive in the innovative medicines space,” said Mr Catelin.

Contact:

Natalie Wimmer – Communications Manager
Phone: 0450 728 660
Email: Natalie.Wimmer@medicinesaustralia.com.au

Medicines Australia is delighted to announce appointments to our new Advisory Council – including the former Chief Scientist of Australia.

The future focused Advisory Council under the leadership of its Chair, Dr Anna Lavelle (recently appointed Independent Director of Medicines Australia) will provide the Board with strategic advice on trends and issues impacting the Industry in the medium to long term.

Milton Catelin, Chief Executive of Medicines Australia said the formation of the Advisory Council will help set the future strategic priorities for Medicines Australia and the innovative medicines and vaccines industry more broadly.

“We had over 72 applicants to join our Council,” said Mr Catelin, “There were some incredible candidates from within industry and externally, with complementary expertise.”

“I’m thrilled to announce that Professor Ian Chubb AC has accepted a position on the Council.

“He brings to the Council a wealth of experience within academia and a deep understanding and appreciation of our industry – including that of Chief Scientist of Australia.

“His commitment to knowledge and furthering scientific research is unparalleled and his drive to ensure this industry has a healthy future by encouraging the STEM industries in Australia is well known,” said Mr Catelin.

Joining Professor Chubb is another respected Australian thought leader.

Dr Jeff Harmer AO, has occupied a range of executive leadership positions across a number of Commonwealth Departments, playing a pivotal role in numerous significant reforms made under the Howard, Rudd and Gillard governments.

“Jeff’s experience within the APS has given him a deep understanding of the machinery and motivations of government and the challenges that arise from portfolio and election changes.

Dr Harmer is deeply aware of the challenges faced by an ageing population and has participated in other advisory groups which have had health reform at their core,” he said.

Also on the Advisory Council as an independent member is a person that many within the pharmaceutical industry will be familiar with – Ms Catherine McGovern.

Ms McGovern has  worked in policy as a Ministerial Advisor for the Australian Government, and government relations and policy roles for GSK in Australia and the UK, and finally as the General Manager of Government and Public Affairs at Medibank Private.

“Her extensive experience will bring to the Advisory Council an international industry perspective and knowledge of global pharmaceutical trends,” said Mr Catelin.

Adding another dimension to the Advisory Council is Mark McCrindle.

Mark is a social researcher with an international following. He is recognised as a leader in tracking emerging issues.

“Mark’s understanding of key social trends and future directions will be a critical element to the forward looking nature of this Council,” said Mr Catelin.

Joining this distinguished group is patient advocate Ms Carol Bennett.

Ms Bennett has been chief executive of some of Australia’s leading health organisations including the Consumers Health Forum of Australia, the Australian Rural and Remote Workforce Agencies Group and the Victorian Alcohol and Drug Association and is currently the CEO of Snowy Hydro SouthCare.

“Ms Bennett’s commitment to improving the health outcomes for Australians is unparalleled,” said Mr Catelin.

Also participating in the Medicines Australia Advisory Council are four industry representatives from diverse roles within the innovative pharmaceutical sector.

David Grainger, Global Public Policy Director at Eli Lilly, Andrew Carter, Managing Director at Commercial Eyes, David Herd the Director Healthcare Environment at GSK and Nicola Richards, Director of Commercial Operations at MSD will bring their extensive knowledge and experience to the team.

“To have such a wealth of industry experience on our Advisory Council is testament to the extraordinary talent of this remarkable industry,” said Mr Catelin.

“This outstanding collective are all big picture thinkers. They form part of a team that pools together a diverse range of experiences, from difference facets of our industry and the broader community, and we can’t wait to see what they come back with.”

Applicants for the Advisory Council were assessed by a panel.

ENDS

Contact:

Natalie Wimmer
Phone: (02) 6122 8500
Email: Natalie.Wimmer@medicinesaustralia.com.au

About Medicines Australia

Medicines Australia Ltd. (MA) is the peak body representing the innovative medicines and vaccines industry in Australia and is based in Canberra.

MA is committed to delivering a longer and healthier life for all Australians through availability and choice of world leading innovative medicines. Its members are companies that invent, manufacture, export and supply innovative medicines and vaccines to the Australian community.

MA’s mission is to drive the creation and development of a predictable environment for the continued sustainable growth of the research based prescription medicines industry to enable Australians to lead longer healthier lives.

MA strives to deliver smart and effective solutions to empower and improve the position of member companies and the communities they serve.

The establishment of the Advisory Council

The Advisory Council is being established to support the Board’s role in shaping strategy and maintaining appropriate continuity of direction. The future focussed Advisory Council will provide the Board with advice on trends and issues impacting the Industry in the medium to long term (3 to 10 years).

It will also provide a strategic and more diverse perspective of the environment with a view to positively shaping the future of the Industry. The Council will be chaired by the Deputy Chair of the Board of Directors.

Medicines Australia does not accept the findings of this latest inaccurate, selective and misleading Grattan Report on medicine prices.

Australia’s Pharmaceutical Benefits Scheme (PBS) is the envy of the world because of its ability to provide universal access to breakthrough innovative medicines and generics at tremendous value for taxpayers and affordable prices for Australians who need them.

Medicines Australia Chief Executive Milton Catelin said the latest Grattan report relies on a tiny sample of medicines that have no correlation to the system wide savings being generated through years of PBS reforms.

“Unfortunately, the Grattan Institute and the authors of this report demonstrate little regard for how the PBS works and its benefits to the Australian people,” said Mr Catelin.

The report also ignores the multiple PBS pricing policies that frequently adjust medicine prices across groups of medicines used for the same condition.

The Grattan Institute has a history of misleading reporting on medicine prices in Australia. They persistently ignore ongoing, significant reforms to medicines price policies, including the ability to change prices six times per year, not two, as claimed.

Readers of the report would think the highly successful price disclosure measure has failed, in fact, it is expected to continue to deliver several billions of dollars of ongoing savings in the coming years.

A recent study undertaken on behalf of Medicines Australia by Prof. Frank Lichtenberg (University of Columbia) found that the last three decades of investment in new medicines is saving Australian and state governments around $7 billion a year in hospital costs.  Another economic study, soon to be released, has modelled the significant economic and budgetary benefit of investing in the latest medicines.

For Australia to continue to receive these benefits it needs to maintain and invest in the PBS, not diminish Australia’s ability to deliver a world best practice health care system.

Medicines Australia will continue to engage and partner with government to ensure that the Australian people are getting fast, universal access to the latest medicines at a price that delivers incredible value for money to taxpayers.

Contact:

Natalie Wimmer
Phone: (02) 6122 8500
Email: Natalie.Wimmer@medicinesaustralia.com.au

Greater education and awareness about the contribution of innovative medicines and vaccines to preventative health is critical.

Medicines Australia Chief Executive Milton Catelin said: “Increasing vaccination rates is in the interests of the whole Australian community as well as individual children”.

It is one of the safest and most cost effective ways of preventing communicable diseases.

Vaccines are not included in the National Immunisation Program until they have been approved for use by the Therapeutic Goods Administration (TGA) to make sure they meet strict safety guidelines and comply with manufacturing and production standards.

Immunisation not only protects the individual, but also protects families and local communities from the spread of infection.

“Vaccines are one of the key reasons the death rates from infectious diseases have plummeted since the 1920s. The investment by medicines manufacturers in vaccines has helped save lives over several generations,” Mr Catelin said.

Every day, immunisation makes it possible for around 3 million people to live free from the illnesses or disability caused by many preventable diseases.

But there is no room for complacency. One of the reasons for vaccine refusal is because of lack of knowledge and understanding, leading to people believing disproven material claiming that vaccines cause illness. If immunisation rates were to fall diseases such as measles, mumps, rubella and varicella may start to rise again which are a serious threat to children.

In 2014 the World Health Organization declared that measles has been eliminated in Australia. But it is important to maintain high levels of vaccination against measles, because it can still be imported by travellers from other countries.

Clear information about the safety and efficacy of immunisation helps get the right message to parents. We need to be ever vigilant about this to ensure immunisation rates remain high in the future.

Contact:

Natalie Wimmer
Phone: (02) 6122 8500
Email: Natalie.Wimmer@medicinesaustralia.com.au

Thirteen company representatives from the Australian medicines industry received the sector’s top accolade for ethical sales and marketing at a ceremony in Sydney yesterday.

The Medicines Australia Continuing Education Program (CEP) Awards are presented annually to company representatives and independent students who achieve the best marks in their compulsory ethical conduct education program.

Medicines Australia Chief Executive Mr Milton Catelin, said the mandatory program, run through the University of Tasmania, highlighted the industry’s unparalleled commitment to ethical conduct.

“The innovative pharmaceutical industry relies on a partnership between sales representatives and healthcare professionals to help deliver effective new life-changing treatments to Australians,” Mr Catelin said.
“These representatives 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.

“Interaction between medicines companies and health care professionals is an important part of promoting patient health, so it is essential we get it right.

“The continuing education program ensures company representatives are educated to the highest industry standard to provide healthcare professionals with accurate and balanced information.

“I congratulate all students who completed the course in 2016 and in particular the award winners. The fact that so many people have been recognised for their high achievement in this program shows pride in the industry, a passion to deliver quality education to healthcare professionals with the purpose of ensuring patients get the best use out of medicines that are available today.”

The University of Tasmania Prize for Excellence Awards for the highest quality reflective assignment, active learning and participation in each semester of the course were presented to Alex Pietzsch from Boehringer Ingelheim and Mandy Brown, an independent student.

The Medicines Australia Code of Conduct Award included all students who achieve the highest mark for Program 1 and was presented to Dr William Ho, an Independent Student.

Also recognised at the awards ceremony were Judy Edmondson from Hahn Healthcare, Matthew Douglas from Commercial Eyes, Lucimar Nielsen from AstraZeneca, Nishant Baksh, Bessy Basso and Alex Pietzsch from Boehringer Ingelheim, Irina Savinykh from Seqirus, Catherine Van Daele from Shire, and Marissa Otley and Matthew Jones who are both independent students.

Contact:

Natalie Wimmer
Phone: (02) 6122 8500
Email: Natalie.Wimmer@medicinesaustralia.com.au

Pharmaceutical companies and medical professionals share an important partnership. We collaborate on clinical research, share knowledge and support education to ensure that medicines are constantly improving and are used safely and appropriately by doctors and their patients.

Our member companies are committed to transparency in their interactions with medical professionals and regularly publicly report on them. The Medicines Australia Code of Conduct is the national standard for industry self-regulation and is leading the way on transparency.

This Code has been authorised by the ACCC

The innovative Australian medicines industry is putting patients first by showing the value of industry partnerships and taking the lead within our wider eco-system to boost transparency.

The reports, published today, provide clear information about payments to a medical professional for sharing their expertise and knowledge with pharmaceutical companies or leading medical education for other healthcare professionals.

In reporting this, MA hopes consumers will be able to better understand the critical interactions that their medical professional and other healthcare professionals have with the innovative medicines industry.

The reports, which are now available from each Medicines Australia member company’s website, make it easier to understand how important ongoing education is to healthcare professionals to acquire the appropriate understanding and knowledge of these innovative therapies.

This collaboration is also critical to the development of new medicines and better patient health. The innovative pharmaceutical industry relies on the advice of independent healthcare professionals to help deliver effective new life-changing treatments to Australians.

Medicines Australia and its member companies are proud of their role in developing the code, which ensures the medicines industry leads the health sector in transparency. Our high standards of ethical conduct and transparency will help drive further improvements to Australia’s health care system.

The Australian Code is part of an international movement to improved transparency through greater reporting measures.

Further information about the transparency requirements of the Medicines Australia 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 various companies and the benefits to patient health.

CONTACT: Natalie Wimmer – Communications Manager – 0450 728 660

Medicines Australia, the industry association for the innovative pharmaceuticals industry welcomes Labor’s Better Budgeting discussion paper released today.

Medicines Australia Chief Executive Milton Catelin said: “Labor has asked a number of key questions that warrant careful examination.”

“One of the major public policy challenges is how to ensure Australians continue to receive world-class healthcare that improves lives and boosts the economy while also maintaining Budget rigour and fiscal sustainability,” Mr Catelin said.

“We entirely agree with the proposition that best outcomes in public policy emerge when the budget process is open, accountable, and transparent,” he said.

“How Australia’s healthcare system is managed, including the Pharmaceutical Benefits Scheme (PBS), is a key factor in Australia’s future. Research shows that medicines help to reduce expenditure elsewhere in the health system by keeping people healthy, reducing their stay in hospitals or preventing other more expensive treatments.”

Medicines Australia’s pre-budget submission argues for the inclusion of better productivity measures as part of Australia’s long-term research and data programme.

In its submission, Medicines Australia also outlines the need for clearer and more transparent information about PBS expenditure.

“These changes would significantly enhance the way in which the impact of health expenditure can be evaluated by policy-makers,” Mr Catelin said.

“We are actively engaged in policy debate about better budgeting and look forward to consulting with Labor following the release of this important paper.”

CONTACT: Natalie Wimmer – Communications Manager – 0450728660