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

Medicines Australia would like to congratulate all the Ministers sworn-in to the first Turnbull Ministry and is particularly encouraged by the Prime Minister’s focus on innovation.

The new Ministry contains a mixture of continuity, fresh faces and new positions, such as in the areas of rural health and innovation.

At his first press conference Prime Minister Malcolm Turnbull stated that, “The Australia of the future has to be a nation that is agile, that is innovative, that is creative”.

Mr Turnbull added more weight to this statement at his press conference yesterday when he said the Ministry of Industry, Innovation and Science would, “be at the centre, (of) the whole Government, of one of our most important agendas.”

Medicines Australia CEO Tim James said, “It’s encouraging to see that this statement has been backed up through the new Ministry.”

“I would like to congratulate the Prime Minister for placing innovation back into the Industry and Science portfolio and for appointing Wyatt Roy MP to the new and exciting role of Assistant Minister for Innovation.”

“Medicines Australia member companies are at the forefront of innovation. They create medicines which help Australians live healthy and productive lives. This innovation also helps to support local investment in research and development, clinical trials and jobs for thousands of Australian scientists and doctors.”

“We look forward to working with Mr Pyne and Mr Roy in this important portfolio.”

“The new Minister for Education, Sen. Simon Birmingham, will also have an important role in the future of the Australian innovative medicines industry.”

“Yesterday, the Prime Minister also made a point of making University collaboration with industry a major focus of the Government. Our members are already heavily involved in achieving exactly this outcome and we welcome further efforts by the Government to make this investment even easier.”

“Medicines Australia welcomes the retention of Sussan Ley MP as the Minister for Health. It’s important to have continuity in this important portfolio and we look forward to working with the Minister on policies that help Australians to live long, productive and healthy lives.”

“I would also like to congratulate Senator Fiona Nash on her appointment as Minister for Rural Health and Ken Wyatt on his elevation to Assistant Minister for Health. Mr Wyatt has a strong background in Aboriginal Health issues at the NSW and WA Departments of Health, is a longstanding member of the Standing Committee on Health and is currently the Chair of Parliamentary Friends of Diabetes.”

“Medicines Australia looks forward to working with the new Treasurer, Scott Morrison. It’s important that the Government provides Budget policy certainty and stability so that our members can invest in Australia with confidence.”

“I’d also like to acknowledge the good work of the outgoing Minister for Industry, Innovation and Science Ian Macfarlane. Mr Macfarlane has been a staunch supporter of the innovative medicines industry and leaves big shoes to fill.”

“I would especially like to thank him for his efforts in establishing the Health Industry Forum and the Industry Growth Centres which are both positive initiatives for our industry and the nation.”

“With change comes opportunity and Medicines Australia stands ready to help the Turnbull Government to implement a policy agenda which helps to create a smarter, stronger and healthier Australia.”

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

The release of the Final Budget Outcomes for 2014‑15 has revealed policy reforms are continuing to put downward pressure on PBS expenditure.

The final Budget papers released today reveal that forecast PBS expenditure has been continuously revised down, year on year since 2011. The final PBS outcome is $2.56 billion below the original forecast in May 2011 and finished $285 million below forecasts in May this year.

Medicines Australia CEO Tim James said, “These figures confirm that the PBS is on a sustainable path.”

“The further $6.6 billion of reforms announced in this year’s Budget will continue to drive PBS spending down and we are yet to precisely see how these changes will impact on the Budget going forward.”

“The policy reforms up to now have made the PBS sustainable so that the Government can continue to provide Australians with access to the latest available medicines.”

“However, ongoing changes to PBS policy make it difficult for the inventors and makers of medicine to invest in Australia with confidence. A period of policy stability would allow the industry to work with the Government to realise the potential of the local innovative medicines sector.”

“As the forerunners of innovation in medicines, we are keen to work with the Minister for Health, the Minister for Industry, Innovation and Science and their Cabinet colleagues to harness the opportunities for the sector and for Australia.”

“Our industry spends around $1 billion a year on research and development and clinical trials in Australia and is looking for opportunities to collaborate with our best scientists and universities to discover the next generation of treatments for the Australian people.”

“If we bring stability to the medicines sector, it would not only help Australians to live long and healthy lives, but also help support thousands of jobs in universities, hospitals, research centres and biotech companies.

“Together, we can deliver a smarter, stronger and healthier Australia if we get the policy settings right. Medicines Australia stands ready to help the Parliament fulfil this potential.”

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

Medicines Australia is pleased to see the publication of the awaited report from the Senate Inquiry into the Availability of new, innovative and specialist cancer drugs in Australia.

Medicines Australia will take some time to review the report in more detail over the coming days. However, the peak body representing the innovative medicines industry broadly supports the principal recommendations in the report.

In its submission to the Senate Inquiry, Medicines Australia recommended that Government work with industry to develop innovative access models, commit to expert oncology and consumer input as central to the decision making process, and implement system efficiencies to deliver faster access for patients.

Medicines Australia CEO Tim James said, “New, innovative and specialised cancer medicines are a key driver of increases in patient survival, but the waiting time to list cancer medicines on the PBS is taking too long.”

“Australian patients wait six months longer for access to cancer medicines than other types of medicines, and on average 1.6 years from TGA registration to PBS listing. We believe cancer patients, namely the one in two Australians who will develop cancer during their lifetime, deserve better.

“It is promising to see the report recognise that it is time for a thorough examination of options to improve the evaluation, registration and listing processes and speed up access to medicines.”

Mr James says he is also encouraged by the Senators’ backing of Medicines Australia’s call for more consumer and clinician input into the evaluation of new medicines processes.

“Consumers should have a stronger voice in deciding what the system of universal access should fund, as well as providing input to the decision makers about the reimbursement of individual cancer medicines,” Mr James said.

“We also strongly support the Committee’s recommendation to encourage use of parallel TGA-PBAC submissions to accelerate the listing process for innovative cancer treatments.

“The report is confirmation of Medicines Australia’s and other stakeholders long held view that we have a problem with access to cancer and other medicines in Australia.

“Medicines Australia stands ready to help the Parliament and policy makers to implement any recommendations which will improve access for patients.”

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