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

A new report has found that investing in new medicines pays for itself by reducing other public health expenditure. The modelling, published in The impact of pharmaceutical innovation on premature mortality, hospital separations, and cancer survival in Australia, was conducted by American economist Professor Frank Lichtenberg.

Medicines Australia CEO Tim James said, “This comprehensive study shows that taxpayers and patients are getting value for money from government investment in the PBS.”

“The report clearly demonstrates that the PBS is highly cost effective and also reduces health expenditure across our hospitals.”

The report estimates that innovative medicines saved taxpayers almost $7 billion in hospital costs for people up to 80 years of age in 2011 – more than the cost of reimbursing these medicines through the PBS.

“Premature mortality for all diseases fell by 24% in Australia between 1998 and 2011 and around 60% of this can be attributed to innovative medicines,” Professor Lichtenberg said.

“This research estimates that innovative medicines saved over 140,000 years of life before the age of 75 in Australia in 2011”.

According to the report, innovative medicines which were first listed on the PBS between 1989 and 2002 cost $5.8 billion in 2011. This period is used because once an innovative medicine is listed on the PBS it takes nine years for it to reach peak usage.

“Without these medicines, the cost of hospitalisation in 2011 would have been 13% or $6.8 billion higher”, said Professor Lichtenberg.

“This modelling identifies that listing innovative medicines on the PBS has effectively delivered an overall saving in health expenditure.”

The report has also estimated how medicines listed on the PBS affected cancer survival. The five year survival rate for all cancers in Australia increased from 49% to 62% between 1986 and 2007. An estimated 40% of this improvement is the result of new medicines listedon the PBS. In the absence of new medicines, the five-year survival rate would have been 57% in 2007.

“This report should provide confidence to the Government that listing new medicines on the PBS is an astute investment”, said Mr James.

“It is an investment not only in Australia’s health it’s an investment in the Budget and the economy.”

The report – titled: The impact of pharmaceutical innovation on premature mortality, hospital separations, and cancer survival in Australia – was released today by Medicines Australia and completed by Professor Frank Lichtenberg from Columbia University. It was funded through an unrestricted grant from pharmaceutical company MSD.

-ENDS-

Notes on the modelling used in the report

Statistical models are used routinely in social science to explain the relationship between different variables. These models mimic experimental research but use data gathered over time rather than results from controlled experiments.

“Difference in differences” models calculate the impact of a particular intervention (e.g. the introduction of new medicines) on an outcome (premature mortality). They do this by comparing how the outcome changes in groups where the intervention is common to groups where it is less common.

Australian data is available for mortality and for the introduction of new medicines for different diseases. It is therefore possible to document the relationship across diseases between the number of new medicines introduced and the decline in premature mortality, and thus to determine the strength of the overall relationship between these two variables.

There are big differences in how premature mortality changed for people with different diseases. For example, for patients with heart disease it fell 42%. However for lung cancer patients it fell by just 9%. A major part of the difference in premature mortality between diseases can be attributed to differences in the number of new medicines listed on the PBS.

Using this “difference in differences” approach, it is possible to estimate how much new medicines contributed to the overall decline in premature mortality observed above. This same approach can be used to estimate the impact of new medicines on other outcomes of interest, including cancer survival and hospital use.

Contact:

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

Medicines Australia has called on the Federal Government to make a patient’s medication records a mandatory inclusion in eHealth profiles to improve the safe use of medicines.

The option has been put in a submission to the Senate inquiry into the Government’s eHealth legislation which seeks to make changes to the Personally Controlled Electronic Health Record (PCEHR).

Each year up to 230,000 hospitalisations are attributed to medication misadventure, many of which may be avoidable. Medicines Australia believes there is an opportunity to reduce these cases through better data collation, coordination and record access via the eHealth system.

The submission from the peak industry body says, “Optimising My Health Record to improve the recording, sharing and management of prescribed (and non-prescribed) medication will enable better monitoring of patients’ medication management through the primary care, hospital, aged care and pharmacy settings. This will in turn reduce duplication, missed or inappropriate prescribing and dispensing, overuse, misuse and abuse of medications.”

Medicines Australia supports the Bill, in particular the decision to enable trials of the proposed opt-out My Health Record system in a manner that retains the patient controls.

Medicines Australia believes an opt-out system will enable the My Health Record to provide better, more useful and usable information to healthcare practitioners, which will in turn lead to improved whole-of-care for patients.

The Medicines Australia submission is available here.

Contact:

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

Mr Wes Cook, Managing Director of Boehringer Ingelheim Australia, has been selected as the interim-Chairman of Medicines Australia.

The appointment was made at the first meeting of the new Board of Directors following the Medicines Australia Annual General Meeting in Sydney today.

The decision to appoint a temporary Chairman follows the retirement of Dr Martin Cross and will allow the Board to conduct a thorough process to appoint a permanent replacement.

Medicines Australia CEO Tim James said, “Wes is a well-known member of the innovative medicines industry and has been a Board Member of Medicines Australia since 2012. As interim-Chairman, Wes will continue to be a strong, effective advocate for our members and the industry.”

“I would also like to congratulate all Medicines Australia Board Members who were selected following the recently conducted members ballot.”

The new Board was also announced at today’s Annual General Meeting and will serve until October 2017.

Board of Medicines Australia 2015-2017
Wes Cook (Boehringer Ingelheim)	James Jones (Takeda)
Brad Edwards (Shire)	Geoff McDonald (GSK)
Dr Susanne Fiedler (MSD)	Kirsten O’Doherty (AbbVie)
David Gallagher (Pfizer)	Svend Petersen (Roche)
Brian Gladsden (Novartis)	James Priour (Amgen)
Chris Hourigan (Janssen)	Paul Spittle (AstraZeneca)

“On behalf of Medicines Australia, I would like thank all outgoing Board members, and particularly Dr Martin Cross, for their selfless service to the industry during their time as Directors and congratulate all members of the new Board on their nominations,” said Mr James.

“This is an exciting and important time for Medicines Australia, its members and the wider industry. There will be many opportunities and challenges ahead and I am confident that the Board will offer strong guidance and insight during their term,” said Mr James.

“I look forward to working closely with the Board and all of our members in the weeks and months ahead.”

Contact:

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

Medicines Australia today announced that its Chairman, Dr Martin Cross, will retire from the Board upon the conclusion of the current Board term on 20 October 2015.

Dr Cross was appointed to the Board of Medicines Australia and made Chairman in 2013 after nearly 30 years in the global pharmaceutical industry.

Among the positive progress made for the sector during the period of Dr Cross’ leadership has been the:

• Re-launch of the Access to Medicines Working Group which is finalising new frameworks for the Managed Access Programme and Post Marketing Reviews and meeting regularly to progress PBS policy improvements
• Recognition by government of the sector is one of five identified in its Innovation and Competitiveness Agenda and the development of an Industry Growth Centre
• Extensive consultation, authorisation and implementation of the 18th Edition of the Code of Conduct which includes sector-leading transparency
• Development of a new, regular industry report, COMPARE, which factually confirms and highlights time to access first-in-class medicines in Australia relative to comparable OECD nations
• Progress being made towards a faster, simpler, national approach to the set-up of clinical trials

Amidst these impressive achievements, Dr Cross also recently expressed to members his disappointment at the failure to reach a Strategic Agreement with government this year and his concern about the impacts of Budget related cuts on the sector.

A new Board of Medicines Australia will be announced at the association’s Annual General Meeting on 20 October and that Board will bring renewal, including to the role of Chairman.

Dr Cross will remain a great friend of and strong advocate for this sector and will continue to serve the health of the Australian people through his extensive involvement with corporate and community boards.

The Board, Staff and Membership of Medicines Australia thanks Dr Cross for his strong leadership, dedication and service over the last two years and we wish him, Anna and their family every continued happiness and success.

Contact:

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

The High Court decision to disallow patenting of isolated genetic materials is of concern to innovative medicines sector.

“It is essential that Australia maintains strong and stable intellectual property protection that will support the development of new biological medicines,” said Medicines Australia CEO Tim James.

“We will need to consider the implications of this decision for patents held by our member companies, a number of which are researching and developing new biological medicines.”

“This could have significant negative impact on access to new and innovative biological medicines in the future. Coupled with weak data protection being maintained in Australia under the recent TPP, these decisions are potentially bad news for patients.”

Whilst the High Court’s decision today relates to particular claims within a specific patent, it potentially will have far ranging effects on other patents and future patents held by the companies that discover, research, develop and bring new biological medicines to Australian patients.

“It is important that Australia maintains strong patent laws, which are interpreted consistently by the courts, to ensure Australian patients can receive the latest and most effective treatments as soon as they become available,” said Mr James.

“Having robust intellectual property laws is critical to developing new medicines and vaccines and Australia needs to ensure it reflects international best practice.”

Contact:

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

The outcomes of the negotiations for the Trans-Pacific Partnership agreed to in Atlanta overnight are a disappointing outcome and a missed opportunity to stimulate and grow the Australian biopharmaceutical industry.

Just last month, the Prime Minister declared that innovation would be at the centre of the Federal Government; the decision not to support greater data protections for innovation sends the reverse signal.

Data protection is a form of intellectual property which is very limited in its application in Australia and is separate to patent protection. It is nonetheless increasingly important as biological medicines become more complex and uncertain in their patentability.

We are aware of some instances already in which biological medicines were not brought to the Australian market due to Australia’s short data protection period.

Increasing data exclusivity periods would have no negative impact on Australian’s access to the latest medicines and would not increase the prices which patients pay through the Pharmaceutical Benefits Scheme (PBS).

In fact, a globally competitive intellectual property system would:

• Increase access to new medicines and vaccines for Australian patients (including early access to medicines via increased clinical trial activity),
• Attract additional global investment in Australia’s research and development efforts,
• Increase the return on inventions and developments made possible by the significant level of public support for medical research in Australia, and
• Provide greater incentive and certainty for the commercialisation of local, Australian health technology inventions and developments – supporting Australia’s rapidly developing biotechnology sector.

Medicines Australia has consistently presented modelling to government which shows that any modest, short-term increase in the amount government spends on pharmaceuticals is well and truly offset by the savings being delivered through recent amendments to the PBS.

The increased data protection would support the economic potential of the Australian biotechnology sector, and could help create new investment opportunities in our best research centres, scientists and doctors and encourage earlier access to new, breakthrough medical treatments for Australians.

This view is shared by many notable experts including philanthropist and former Australian of the Year Simon McKeon AO, who was clear in his review of medical research in Australia, that the Federal Government should bolster and harmonise Australia’s data exclusivity laws with global best practice. Medicines Australia strongly supports this recommendation.

Australia cannot harness the full potential of this innovation unless we have laws that make us competitive with growing biotechnology hubs around the world.

Australia’s current five-year data exclusivity provision lags behind our global competitors and collaborators such as the United States (up to twelve years for biologics), Canada (eight years), the EU (up to eleven years), and Japan (eight years). This puts potential investment in Australian innovation at risk and is one reason why our scientists look overseas to get their inventions turned into widely available products for consumers. That means Australia misses out on the economic benefits of the innovation including jobs and the tax streams from these medical breakthroughs.

It is extremely disappointing that an unfounded, misleading scare campaign has had such a critical impact on the TPP outcomes. It has let down the many Australians who want to see the local biotechnology sector able to thrive, so they can invent and deliver the next generation of medical innovation.

Contact:

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

National health professional and consumer organisations have voiced their support for the transparency changes in the new Medicines Australia 18^th Code of Conduct, which has come into effect from today.

CEO of Medicines Australia, Tim James, said it’s great to see the support of important healthcare leaders including the Pharmacy Guild of Australia, Consumers Health Forum and the Royal Australasian College of Physicians, recognising the importance of setting the benchmark for responsible and ethical self-regulation.

“The new Code is an important development in building on the established, trusted relationship between patients and healthcare professionals,” Mr James said.

“A strong working relationship and ongoing knowledge exchange between the Australian innovative medicines industry and healthcare professionals are critical to better patient outcomes.”

National President of the Pharmacy Guild of Australia, George Tambassis, emphasised the Guild’s support of the new Code and acknowledged the new stronger transparency provisions for payments to healthcare professionals.

“From the point of view of community pharmacy, the purpose of the Code is to ensure that the trust placed in pharmacists by health care consumers is soundly based, and that patients can be confident the medication and advice they receive from their community pharmacist is provided on a transparent, ethical and clinical basis,” Mr Tambassis said.

The 18^th Edition will increase transparency and build consumers’ trust by disclosing companies’ payments to healthcare professionals, such as educational support through airfares and accommodation. It will also require Medicines Australia member companies to publicly report when a company pays a healthcare professional for their service or provides financial support for a healthcare professional.

The Consumers Health Forum of Australia (CHF) also showed its support for the measures which will see the information made publicly available online, saying transparency between healthcare professionals and pharmaceutical companies should give consumers piece of mind that the relationship between the two aren’t compromised.

“Making those relationships public through these measures is an important step in restoring confidence for consumers,” CHF said.

From 1 October 2015, all member companies will be required to collect information about healthcare professionals that receive payments for consulting or speaker services and support, to attend educational events through the payment or provision of airfares, accommodation or registration fees.

Where companies have the agreement of the healthcare professional, the information will be published in a report on each company’s website.

The Royal Australasian College of Physicians (RACP) also supports the new reporting requirements, saying it believes that clear guidelines will be beneficial for both healthcare professionals and industry, and most importantly this initiative will empower patients by providing them with transparent information on payments and support.

Following a 12 month adjustment period, from 1 October 2016 the Code will require public reporting of these payments to healthcare professionals to be mandatory.

Further details about the Code and transparency are available from: www.medicinesaustralia.com.au/code-of-conduct

Or visit www.ama.com.au and search for ‘new code of conduct medical practitioners’

Contact:

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

The 2015 PWC survey of the Australian medicines industry provides an important and timely insight into the challenges and opportunities confronting the Australian innovative medicines industry.

The survey, titled Challenges and Change: A report on the Australian Pharmaceutical Industry provides a snapshot of the health of the local industry and is a rolling scorecard on the economic, regulatory and reimbursement pressures the industry is facing.

Medicines Australia CEO Tim James said, “It’s a time of significant challenges for the local innovative medicines industry”.

“The PWC survey shows that our member companies are facing an increasingly difficult reimbursement process, along with the Federal Budget measures, leading to delayed access to some new medicines.”

Key survey findings included:

• 87% have considered not applying for listing on the Pharmaceutical Benefits Scheme (PBS)
• 80% of companies felt the Pharmaceutical Benefits Advisory Committee (PBAC) processes have not improved or had deteriorated over the last two years
• 65% believe Therapeutic Goods Administration (TGA) processes have not improved or deteriorated
• 80% expect to use a risk sharing agreement with the federal government over the next two years
• 89% believe their compliance costs will rise
• 89% have placed a high priority on strategic alliances and joint ventures
• 66% are anticipating future growth

“It is clear that there is a strong feeling of uncertainty around market access and the current business environment which has been further exacerbated by the recent cuts to the PBS”, Mr James said.

“There needs to be a more stable and predictable policy environment so that innovative medicine companies can make future decisions on a range of investments and product listings to benefit all Australians.”

While the challenges ahead are significant, there are also opportunities.

Many of the surveyed companies have indicated they will be looking for strategic alliances and joint ventures in the next two years which could create opportunities for Australian biotechs, our Universities and our major research centres.
“The innovative, research-based medicines industry can play a key role in delivering a smarter, stronger, healthier Australia,” Mr James said.

“This collaboration and investment could bring enormous benefits to the Australian economy, but to achieve this, our politicians need to help create the conditions that will attract investment, growth and job creation.”

“Medicines Australia stands ready to help the Parliament harness this opportunity so that we see a vibrant medicines industry in the future.”

The PWC Pharma Industry Survey can be found here.

Contact:

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

Alexia Vlahos
Phone: (02) 6122 8503
Email: Alexia.Vlahos@medicinesaustralia.com.au