Today marks international Clinical Trials Day. It is a time to recognise the contribution clinical trials make to the global efforts to find discover and develop the latest breakthrough medicines and vaccines, as well as celebrating some remarkable advances in Australian medical science.

Medicines Australia Chairman, MrWes Cook, said Medicines Australia members conduct around 600-700 trials nationally each year in partnership with hospitals, universities and other research institutions.

“Clinical trials benefit Australian patients because they allow faster access to new treatments”, Mr Cook said.

“Clinical trials bring health professionals together to deliver better care for patients, while Australia’s scientists, doctors, nurses and specialists also benefit through their exposure to the very latest methods of treatment.”

“Clinical trials also boost the economy, with innovative projects supporting thousands of jobs in science, technology, engineering and mathematics (STEM),” Mr Cook said.

Australia enjoys one of the highest life expectancies in the world. Between 2003-2011, the Australian Institute of Health and Welfare (AIHW) recorded a 15% reduction in the fatal burden of disease.

“These gains remind us of the role that advances in modern medicine play in reducing the overall burden of disease and premature deaths”, Mr Cook said.

Other studies in Australia have found that investment in new, innovative medicines significantly impact on cancer survival rates and reduce hospital expenditure by around $7 billion per year.

Many are surprised to learn that it takes around 12-15 years for a new therapy to go from discovery to launch.

“Here in Australia we need to continue to reform the regulatory environment for clinical trials. The processes and red tape in setting up and getting clinical trials started is still too long and too complex. These processes need further streamlining and simplification so that new and better treatments can be offered to patients faster” Mr Cook said.

The Australian Clinical Trials Alliance (ACTA) together with Medicines Australia, AusBiotech and Research Australia are hosting a special event to celebrate Australian leadership and excellence in clinical trials. The inaugural ACTA Trial of the Year Award will be presented in Melbourne today, making international Clinical Trials day a day to celebrate.

“Clinical trials continue to evolve and it is important, on this day, to celebrate excellence in new approaches and technologies that deliver so much for the Australian community”, Mr Cook said.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

The innovative medicines industry acknowledges the Australian Government’s commitment to maintaining funding levels within the Federal Budget for the Pharmaceutical Benefits Scheme (PBS). The PBS is designed to ensure that Australian patients receive timely access to innovative medicines.

“We believe tonight’s budget provides predictability in PBS arrangements, improvements to registration processes for new medicines coupled with company tax cuts for business are welcome policies which help to create a more conducive environment to attract investment,” Chairman of Medicines Australia, Mr Wes Cook, said.

Predictability in Australian Government policy beyond 2016 is essential to allow our research-based, innovative medicines sector in Australia to effectively plan for the future and continue to invest.

A predictable business environment for the medicines industry also contributes to the ongoing supply of safe and effective medicines to Australian patients.

“Our member companies invent, manufacture and supply innovative medicines and vaccines for the Australian community. These medicines keep Australians out of hospitals, prevent disease and play a pivotal role in ensuring a productive and healthy community,” he said.

Medicines Australia also welcomes the $20.4 million investment over four years in response to the Medicines and Medical Devices review (MMDR) that will facilitate life-saving medicines coming to the Australian market faster, through removing or streamlining unnecessary or inefficient processes.

Following years of significant reform to the PBS, the fact that there are no new PBS cuts in the 2016-2017 budget is welcome.

Medicines Australia notes the new PBS listings announced in the Budget that will provide further important health benefits for patients.

While Medicines Australia broadly welcomes the outcomes of the Federal Budget, we are looking forward to understanding the document in more detail over the coming days.

Medicines Australia remain committed to working with the Australian Government, Departments and agencies across Government to deliver on our shared objectives of improving health outcomes while also encouraging greater innovation through industry investment in Australia’s talented scientists, medical practitioners, universities, research centres and biotechs.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia notes the release of the draft report from the Productivity Commission concerning Australia’s Intellectual Property (IP) arrangements.

While the 400 page draft has only just been made available, we do have a number of concerns with the interim-findings which we believe may inadvertently lead to public misunderstanding of patents and IP as it applies to medicines.

To address this, we will be responding to the draft report, with the key concerns outlined in our original submission remaining pertinent.

We look forward to working with the Commission to better understand their initial conclusions and help to provide insights for their consideration before the final report is delivered.

Intellectual Property directly benefits patients by driving and incentivising Research and Development (R&D) of the latest breakthrough therapies to treat and cure disease. It is imperative that Australia maintains a strong, robust IP system to ensure that all Australians can continue to have a first world health system with early access to the latest innovative treatments.

It must be remembered that generic medicines (copies of innovative medicines) would not exist if it was not for the high risk and costly R&D undertaken and supported by innovative pharmaceutical companies.

Our members spend approximately $1 billion every year on R&D in Australia. IP is one important factor among many which is taken into consideration before these investment decisions are made. Maintaining an environment that supports this investment is crucial for the thousands of Australian scientists, research organisations, Universities and local Biotechs which rely on this investment from our members to discover and innovate for the benefit of all Australians.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia acknowledges World Intellectual Property Day, an international initiative celebrating the role intellectual property plays in stimulating innovation.

Medicines Australia represents the research-based innovative medicines industry in Australia. Our members invest more than $1 billion every year in Australian-based research and development such as clinical trials and partnerships with Australian Universities, Biotechs and research centres.

There are more than 50 pharmaceutical companies and around 400 locally-owned medical biotechnology firms operating nationally. World Intellectual Property Day reminds us that industries such as the innovative medicines sector that rely on intellectual property play a central role in driving economic growth, jobs, and competitiveness in Australia.

However, the value of our industry must also be recognised for its broader contribution to the health and livelihoods of all Australians. Innovative medicines that deliver new treatments and cures to patients contribute to higher productivity and lower health care spending.

The pharmaceutical industry invests more in Research & Development (R&D) than any other business sector in the world. Investment in R&D enables the development and commercialisation of important Australian discoveries

We must ensure that Australians continue to benefit from innovation through a robust intellectual property regime that supports the development of new medicines.

On this day when intellectual property is being celebrated around the world, let’s be proud of Australia’s innovative achievements.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia welcomes the announcement made by the nation’s Health Ministers in Perth to work towards a national framework for clinical trials.

A new commitment was made by the COAG health council to identify more ways we can improve Australia’s attractiveness as a preferred destination for clinical trials. This type of reform is exactly what a nation which is looking to harness a more innovative future should be supporting.

Each year the pharmaceutical industry initiates and invests in around 700 new clinical trials in Australia which not only supports thousands of jobs for local scientists and medical practitioners, it provides early access to the latest developments in medical science to patients.

Despite a global reputation for great scientists and doctors, more can be done to reduce the complexity of initiating a clinical trial in Australia, with each state and often every hospital or research centre having its own unique rules and red tape burden. This confusing and complex approach means we are less competitive with regions such as Asia for clinical trial investment.

Australia needs to reduce the red tape involved in initiating a new clinical trial by delivering a more sophisticated and consistent framework.

The Australian Health Ministers Advisory Council has been tasked to develop models of best practice options for sites. The Council has also been commissioned to consider ways to better engage sponsors, such as innovative pharmaceutical companies, and improve trial start up times and outcomes.

It is particularly encouraging that the Ministers agreed that clinical trials are a critical pathway to enabling better access to new medicines for patients.

Any moves to advance clinical trial sites will require careful planning and collaboration. Medicines Australia looks forward to participating in discussions with the advisory council over the potential models given that the medicines sector are important partners.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Consumers, taxpayers and the national health system will benefit from the significant savings being delivered by medicine suppliers since 1 April.

The direct contribution the medicine supply chain is making to these savings will ensure the PBS is sustainable into the future, enabling the reinvestment savings into the funding of new, breakthrough medicines for Australian consumers.

The key players in the medicines supply sector said the consumer benefits of the latest round of PBS reforms – the costs of which are being borne across the sector – are helping to ensure that the PBS remains one element of Australia’s health system that is fiscally sustainable.

Over the weekend, Health Minister Sussan Ley announced that some 400 medicines will fall in price as a result of the PBS reforms that are being funded by the medicines supply sector, and which took effect on 1 April.

Over the five years from 2015 to 2020, these reforms will result in the Federal Government saving around $17 billion in medicine costs to the benefit of taxpayers and individual patients.

While these reforms impose a considerable burden on the medicines supply sector, they are ensuring that the PBS remains fiscally affordable and sustainable into the future. Because of these reforms, the annual budgetary cost of the PBS in recent years has been flat or falling in stark contrast to other areas of the health system such as hospitals and the MBS.

The Parliamentary Budget Office has projected that PBS costs will grow at a rate that is less than the overall economy through to 2025.  This an extraordinary turnaround given the earlier predictions in multiple Intergenerational Reports that the PBS could effectively break the Federal Budget.

At a time when the sustainability of Australia’s health system is headlining public debate, it needs to be acknowledged that the contribution of the medicines supply sector in delivering this ground-breaking PBS reform stands out like a beacon for the wider health sector.

Joint statement issued by: Medicines Australia, the Generic and Biosimilar Medicines Association, the Pharmacy Guild and the National Pharmaceutical Services Association, representing the manufacturers, wholesalers and dispensers of PBS medicines.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

The 2016 Pat Clear Award, has been won by Ms Zarli French, Senior Manager External Affairs at MSD.

This prestigious award is presented annually to recognise outstanding contributions by those who work in the Australian medicines industry.

Ms French has been working at MSD for 30 years. She is well known for her outstanding achievements in best practice collaboration with health advocacy organisations.

Medicines Australia Chairman, Mr Wes Cook, said Ms French is an outstanding recipient for the award.

“Zarli is a particularly valuable employee within the industry because of her commitment to ensuring the patient voice is always put first,” Mr Cook said.

“She has a passionate belief in the social value of the work she does at MSD as part of the Australian Pharmaceutical Industry,” he said.

Throughout her career at MSD, Ms French has managed a range of corporate communication and stakeholder liaison roles. Over that time she has developed an in-depth understanding of the issues confronting health consumers.

Ms French has served on a number of Medicines Australia committees, including most recently the Working Together Guide Review Committee. The guide provides health consumers organisations and pharmaceutical companies with a roadmap than can help to achieve the best outcomes for health consumers, carers and families.

The Pat Clear award was founded in 2002 to honour the substantial contribution Mr Clear made to Australia during his distinguished career in the innovative medicines industry.

“Like Pat Clear, Zarli French is demonstrating the important role for all of us within the industry in building a healthy, cohesive community,” Mr Cook said.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

The Board of Medicines Australia has appointed Mr Lee Hill to the role of Interim CEO.

Mr Hill joins Medicines Australia with over 10 years of experience as a senior business leader, having held CEO and Managing Director roles in a number of leading companies and consultancies across Australia.

Mr Wes Cook, Chair of Medicines Australia stated, “Over his career Mr Hill has built a strong reputation for exceptional strategy development and delivery in difficult environments.”

“This is an important time for the Australian medicines industry as we work to further build understanding of our contribution to Australia’s health and economy with our stakeholders, including members of the Australian Government.”

“During the next six months our shared aim is to ensure Medicines Australia remains agile in response to our rapidly changing environment and well-equipped to meet the evolving needs of member companies.”

It is expected that Mr Hill will hold the role of Interim CEO until June 2016. During this time the MA Board and CEO will work closely together to clearly identify the needs of the organisation that will ensure long-term success and will work to enable a smooth transition to a permanent full-time successor.

Mr Hill stated, “I am excited to join the innovative medicines industry and strongly share the commitment to improve the health and quality of life of Australians. I am particularly looking forward to working with the great team at Medicines Australia as well as members of the broader medicines and health industries to continue the evolution and growth of Medicines Australia to best support its mission.”

Mr Hill will officially take up his duties as interim-CEO on 25 January 2016.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia CEO Tim James today announced his resignation effective January 2016 from the leadership role of the pharmaceutical sector peak body.

Medicines Australia Interim Chairman Wes Cook thanked Tim for his strong contribution to the Australian medicines industry during a very difficult period for the sector:

“Tim has been a passionate advocate for the industry during his tenure as CEO through a most challenging period and he departs with our deep thanks and best wishes.”

Mr James said he was ready for a new challenge in the new year and eager to be able to lead and shape reform in other sectors of the economy during this era of disruption and innovation.

“I will make an announcement about my future in due course. In the meantime I’m looking forward to spending time in Sydney with my young family, to whom I owe so much after this year.”

Working in close partnership with member companies across Australia Mr Cook pointed to a number of achievements under Tim’s leadership including:

• successfully finalising negotiations for the latest five-year edition of the MA Industry Code of Conduct and smoothly implementing its new measures
• elevating the communications function and bringing MA into the digital and social media era with a new website and social platforms
• strongly seeking and supporting recent positive measures for the sector including the Industry Growth Centre, Health Industry Forum, Innovation Statement, Free Trade Agreements, and the Medical Research Future Fund, and
• fostering improved engagement with patient organisations including the launch of the updated edition of the Working Together Guide.

On behalf of the Board and Membership of Medicines Australia, Interim Chairman Wes Cook said:

“Tim has a very positive and exciting future and we’re grateful for his strong advocacy and initiative on behalf of our industry. We wish him every success in the future.”

James concluded:

“It has been a tremendous honour and privilege to lead this innovative industry in Australia. I thank the Board, Membership and Secretariat for the opportunity and I’m proud of all we have achieved together. I will always be a passionate supporter of the sector.”

The Board will commence a process to recruit for a new CEO in 2016.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia welcomes the Turnbull Government’s National Innovation and Science Agenda and its recognition that innovation is a key to economic growth.

The growing policy focus on innovation from all sides of politics is positive news not only for the Australian economy, but ultimately the livelihoods and health of all Australians.

Medicines Australia CEO Tim James said, “The interest from our politicians in unlocking the opportunities for Australian innovation and ingenuity should be commended.”

“The right innovation policies can enable industry to invest in highly-valued jobs within sectors such as the Australian biopharmaceutical community which is good for the economy and the community,” said Mr James.

The Government’s Innovation Agenda has several initiatives which Medicines Australia will review and assess the potential benefits for the broader sector.

The Biomedical Translation Fund; the creation of Innovation & Science Australia; intangible asset depreciation; investment in world class national research infrastructure; a greater emphasis on commercial outcomes for University research; and encouraging more women to work in STEM jobs will all help to support the ecosystem which the Australian biopharmaceutical sector operates, collaborates and invests within.

Medicines Australia also welcomes the recognition afforded to intangible assets such as patents, as critical to driving growth and ensuring that Australia’s IP regime remains internationally competitive.

“Ultimately, in our sector, it’s important that innovation policies help stimulate Australia’s capabilities to discover and develop the next generation of breakthrough medicines because this delivers not just economic but also health benefits for the Australian people,” said Mr James.

“Our members already deliver more than $1 billion every year to Australian research and development and the more our politicians deliver policies which encourage innovation the more chance for this investment to grow.”

“There have been some positive signals from our politicians to the world that Australia wants investment, it wants opportunities for its people and we look forward to seeing more of it in 2016. A key opportunity will be to ensure it leads to better lives for all Australians in the years ahead.”

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au