Medicines Australia welcomes the announcement of a review of the PBAC Guidelines.

“We are pleased that the Government has announced that a review of the PBAC Guidelines will be undertaken,” Medicines Australia CEO, Tim James, said.

“Any opportunity that we can have to improve the quality of our health technology system in Australia must be taken, for Australia to keep pace with the rest of the world.”

The volume and depth of information provided by pharmaceutical companies to the PBAC in health technology submissions is large and growing. As new technologies are developed and drug discovery and research becomes more complex and targeted to specific genetic variations, it is critical to continuously review the guidelines that underpin the system.

“Medicines Australia is committed to good, high quality health technology assessment in Australia and is always ready to work with the government to ensure this is achieved,” Mr James said.

“Medicines Australia would also welcome regular monitoring and reporting of how the guidelines are being used in practice. This would help to establish whether improving the guidelines leads to improved access to medicines for Australian patients.

“Further, this provides a perfect time to review health technology assessment methods and a timely consideration of how to better capture the full value that medicines provide to the population, as well as to the participation and productivity of Australians.

“The Pharmaceutical Industry is always ready to work with Government to ensure the goals of the National Medicines Policy are supported and advanced.

“We have already demonstrated our commitment to ensuring a sustainable Pharmaceutical Benefits Scheme and we will continue to support measures that recognise the value of innovation through best practice health technology assessment.”

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Contact Person:

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

Medicines Australia CEO, Tim James, today welcomed the authorisation by the Australian Competition and Consumer Commission (ACCC) of the 18^th Medicines Australia Code of Conduct, which requires reporting of payments by pharmaceutical companies to healthcare professionals for services or education.

After a significant period of negotiation and discussion between the ACCC, Medicines Australia and key stakeholders, the authorisation of the Code is another step towards greater transparency as a result of industry leadership.

“The ACCC’s authorisation is a significant step in increasing the transparency of relationships between the pharmaceutical industry and healthcare professionals,” Mr James said.

“This Code shows the leadership and integrity of the Australian pharmaceutical industry. It will also strengthen the transparency and trust which are so important in the relationship between the industry, healthcare professionals and the community.

“Improved transparency shows the community the importance of the work our member companies does with healthcare professionals to improve patient health outcomes.

“Greater transparency also increases confidence by patients that the working relationship between the industry and healthcare professionals is appropriate.”

The new Code will require Medicines Australia member companies to publicly report when a company pays a healthcare professional for a service or for educational purposes, including airfares, accommodation and conference fees.

“Before final acceptance of the Code, Medicines Australia will talk with our members to discuss the conditions proposed by the ACCC in their authorisation, which will need to be considered in detail,” Mr James said.

The new Code of Conduct is available on the Medicines Australia website

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Contact Person:

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

Medicines Australia and medicines industry representatives have appeared before the Senate Inquiry into the availability of new, innovative and specialist cancer drugs in Australia, calling for improvements to create an optimised, modern, and flexible system to ensure access to cancer medicines for Australians.

“Our ability to treat cancer is now far in advance of the system that was designed some time ago, arguably twenty years ago, to provide access to treatments,” Mr Tim James, CEO of Medicines Australia said in his opening statement to the Senate Committee. “New, innovative and specialised 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.”

“In fact, 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.”

Medicines Australia’s submission to the Senate Inquiry provided clear recommendations including the commitment to expert oncology and consumer input to the decision making process as well as streamlined submission pathways.

“Industry, government, healthcare professionals and consumers need to collaborate and take action now to improve access to cancer medicines.”

Based on the COMPARE report, over the period 2009-2014, Australian patients waited an average 1.6 years (573 days) from registration of a cancer medicine in Australia to its reimbursement on the PBS. This is the longest of any National Health Priority area in Australia.

“This delay in waiting times to get access means some cancer patients may die waiting for subsidised access to innovative and effective cancer medicines.

“Across the more than two hundred submissions to this inquiry, there is an overwhelming message of concern that maintaining the status quo is not sufficient.  There is strong and united desire for system improvements. Medicines Australia stands ready, willing and able to work with government and all stakeholders towards solutions.”

The Medicines Australia panel comprised CEO Tim James, MA Board Member and Managing Director of Pfizer Australia, David Gallagher, and Amgen Australia’s Executive Medical Director, Dr Mark Tennyson. Member companies Novartis Oncology, Merck Sharp & Dohme and Roche also presented to the Committee. They reiterated Medicines Australia’s recommendations to the inquiry and provided supporting evidence of company experiences in challenges faced providing access to cancer medicines in Australia.

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Contact Person:

Elizabeth de Somer
Phone: 0418 774 596
Email: elizabeth.desomer@medicinesaustralia.com.au

Latest figures from the Australian Bureau of Statistics show Australian pharmaceutical exports declined by 18 per cent to $2.9 billion in 2014, compared to $3.6 billion in the year before.

Since 2012, when they peaked at around $4.3 billion, Australian pharmaceutical exports have declined by more than 30 per cent.

“These figures are extremely disappointing,” Medicines Australia CEO, Tim James, said today.

“Pharmaceutical manufacturing is precisely the sort of activity that Australia should excel at. We have a highly-skilled labour force, a world-class infrastructure, a history of excellence in manufacturing innovation and, above all, a long-standing and well-justified reputation for manufacturing safe, high-quality medicines and vaccines.

“Despite this, new investment in pharmaceutical manufacturing in Australia remains negligible, which clearly shows that all these factors are simply not enough to keep Australia competitive.”

Unfortunately, the decline in Australian pharmaceutical exports comes at a time when the global market for medicines and vaccines is booming. It is already worth over US$1 trillion per year in sales, and is expected to nearly double in size by 2020.

“Much of this growth is going to come from emerging markets in Asia,” Mr James said.

“But right now, we just don’t have the correct policies in place to capitalise on this growth. If this continues, we will no doubt miss out on this once-in-a-generation opportunity, regardless of how good we may look ‘on paper’.”

Last year, Medicines Australia, in partnership with AusBiotech, submitted a joint proposal to the Australian Government on steps it should take to build a stronger pharmaceuticals industry in Australia.

Broadly, the proposal called on the Government to:

• ensure a stable, predictable and efficient business operating environment,
• strengthen Australia’s intellectual property system,
• enable growth in Australia’s local biotechnology sector, and
• enact globally competitive incentives such as tax breaks to encourage investment.

“Implementing these policies would show that the Australian Government is serious about attracting investment and that Australia is truly ‘open for business’,” Mr James said.

“Globally, the pharmaceutical industry invests billions each year in manufacturing. If we want to attract a bigger share of this investment, we be must be proactive, decisive and coordinated, especially with respect to the policy environment.”

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Contact Person:

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

Analyses released yesterday and today show that government will achieve more than $16 billion in PBS savings from 2010-18, whilst listings of new medicines over this period will cost only $6 billion.

The analysis conducted by PharmaDispatch, translates to government savings of more than $2.70 for every $1 spent on new medicines between 2010 and 2018.

Medicines Australia CEO, Tim James, welcomed the analysis as it demonstrates clearly that ongoing PBS reforms are generating billions of dollars in savings, with enduring mechanisms to continue the generation of savings.

“We know that successive reforms have put the PBS on a stable footing and continue to generate ongoing savings for Government. This report adds further to the large body of evidence that shows PBS expenditure is sustainable,” Mr James said.

“The May 2013 Victoria University report showed PBS reforms will deliver more than $20 billion of savings over the period 2007-18, and most recently the 2015 Intergenerational Report (IGR) which acknowledged growth in pharmaceutical expenditure will remain stable, growing only modestly to 2027-28.”

Of the $16 billion in savings highlighted in today and yesterday’s analyses, $12 billion is from the impact of previous reforms, including mandatory price reductions and price disclosure, with more than $4.3 billion coming from other one-off measures.

“These analyses show categorically that PBS reforms are more than delivering on their stated intent to provide the headroom to list new and innovative medicines on the PBS. These reforms, which were conducted in partnership with the industry, have not only delivered savings, but also entrenched mechanisms in the PBS to generate savings well into the future,” Mr James said.

“With an established body of evidence that shows the PBS is sustainable and delivering major savings to government, it is important now to ensure Australians have timely access to new medicines.”

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Contact Person:

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

New findings released by Newspoll [i] shows overwhelming support for access to new cancer medicines through the Pharmaceutical Benefits Scheme (PBS), for Australian patients.

Newspoll found 97 per cent of Australians strongly support the subsidisation of cancer medicines for curable cancers, including 95 per cent supporting medicines that ease symptoms and extend the life of patients with terminal cancer.

These findings coincide with a new White Paper – Improving access to cancer medicines – released by the Cancer Drugs Alliance (CDA), launched today.

Medicines Australia CEO, Tim James, said these findings further reiterate what the Australian people want from the health system, which is fast access to the best new treatments.

“The CDA White Paper provides significant insights into the Australian community attitudes regarding the importance of access to and the value of medicines. This comes at a time when Australia is lagging behind other countries in terms of access to medicines, as was reported in the COMPARE report, which was launched last week,” Mr James said.

The independent analysis presented in the COMPARE report shows Australia ranks 18^th out of 20 comparable OECD countries, only above New Zealand and Portugal.

“The Newspoll findings and CDA White Paper show that Australians want and expect access to new medicines. The COMPARE report demonstrates we are not getting them as quickly as other comparable OECD countries, and in some case we are not getting them at all. It’s time to take action,” Mr James said.

“These reports come at a time of increased scrutiny of access to new medicines in Australia, with a Senate Committee currently inquiring into the availability of new, innovative and specialist cancer drugs in Australia.

“We need a system that is fit for purpose now and into the future; and we need the emphasis to shift from the cost of medicines to the value they provide in keeping the Australian population healthy, participating and productive.”

Medicines Australia COMPARE report is available at https://medicinesaustralia.com.au/policy/publications/compare/.

1. [i] Community Perceptions of Cancer Treatment Research Report. Nationwide Newspoll omnibus of n=1,214 respondents aged 18 years and over conducted between 12 to 14 December 2014 about perceptions of government subsidisation of medicines through the Pharmaceutical Benefits Scheme.

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Contact Person:

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

Medicines Australian Chairman, Dr Martin Cross has welcomed ongoing collaboration between the pharmaceutical industry and Government in addition to further improvements to the Governments post-market review programme, which was announced today by the Minister for Health, the Hon Sussan Ley.

 “This framework for post-market reviews is the result of collaboration between the Government and Medicines Australia, through the reinvigorated Access to Medicines Working Group (AMWG) and demonstrates that partnerships are crucial in delivering predictability for the Australian medicines industry,” Dr Cross said.

 Post-market reviews are a formal approach to monitoring medicines listed on the PBS.  The programme aims to improve quality use of medicines, education for patients and prescribers, and ensure the cost-effectiveness and ongoing viability of the PBS.

 “The industry had grown increasingly frustrated over recent years with the ad-hoc approach to post-market reviews; and whilst there have been gradual process improvements, until now, no agreed overarching framework existed and there was limited transparency to their conduct,” Dr Cross said.

 Dr Cross further welcomed Minister Ley’s acknowledgement that successful outcomes can be achieved when Government and industry work together to solve a joint area of concern, and encouraged further work through the AMWG.

 “Medicines Australia has consistently shown over recent years that it can work constructively with the Government to ensure the sustainability of the PBS.”

 Dr Cross reiterated the Minister’s statements on collaboration.

 “The reinvigorated AMWG has demonstrated that this is a successful format and has established a strong process for working together to achieve mutual goals,” Dr Cross said.

 “What is needed now is for us to continue the momentum we have gained through the AMWG to ensure that medicines are rapidly listed on the PBS for the benefit of all Australians.”

 The AMWG will continue to address other issues of mutual concern for the industry and Government, including early access to new medicines through a Managed Access Programme, interpretation of section 99ACB of the National Health Act, and improving transparency of inputs and outputs to the PBS listing process.

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Contact Person:

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

A new report released today shows Australians are missing out on too many new medicines,with Australia ranked 18th out of 20 comparable OECD countries.

The COMPARE report – Comparison of Access and Reimbursement Environments –benchmarks Australia’s access to new medicines and will be launched at the National Press Club today by Medicines Australia Chairman, Dr Martin Cross.

“It’s disappointing to see that Australia, which is known for a universal health care system, has fallen behind most comparable OECD countries when it comes to access to new medicines,” Dr Cross said.

“What does this mean for our country? It means Australians are missing out on too many new and innovative medicines, and wait far too long for those we eventually get access to through the PBS. These are medicines which improve health outcomes, quality of life, and the population’s ability to participate as productive members of the workforce.”

The independent analysis of 247 new and innovative pharmaceutical medicines first registered between 2009 and 2014 shows that out of 20 comparable OECD countries, Australia ranks 3rd last, only above New Zealand and Portugal.

“Australians have access to less than 40 per cent of new medicines considered safe and effective since 2009. Patients in many other OECD countries have 75 per cent or more of the new medicines reimbursed and readily available through Government funding,” Dr Cross said.

“This is just not good enough and I’m sure I share the same views as patients when I say access to medicines needs to be modernised. It’s becoming too apparent to patients, clinicians and the industry that Australia’s system for selecting and making new medicines available is struggling.

“The report shows that Australian patients have to wait, on average, more than a year between the medicines being deemed safe and effective and then being made available on the PBS.

“This is compared to many other countries which provide access to their population immediately, or within 3-6 months of the medicine being authorised for sale.

“It’s time to take action and start making the right changes to modernise the way we access medicines. Medicines Australia and the Government have begun the process to ensure the system is fit for purpose now and into the future, however this report shows that there is much more to be done.

“To achieve a more positive policy environment that improves patient access to life-changing medicines, we need the emphasis to shift from the cost of medicines to the value they provide in keeping the Australian population healthy, participating and productive.”

The Report is available here (please follow link)

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Contact Person:

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

The Trans Pacific Partnership Agreement (TPP) will open up vast new markets for Australian companies, including manufacturers of innovative medicines and vaccines, Medicines Australia CEO, Tim James, said today.

 “Pharmaceuticals are already one of Australia’s largest manufactured export, worth around $3 billion each year.

 “But a new trade deal which further reduces trade barriers, improves market access and, above all, establishes high regional standards for intellectual property protection, could help transform Australia into a leading global hub for researching and manufacturing a new generation of highly specialised medicines and vaccines,” Mr James noted.

 In recent weeks, critics have appeared in the media claiming that possible changes to Australia’s IP system as a result of the TPP will lead to higher prices for medicines and “decimate” the Pharmaceutical Benefits Scheme.

 “Ten years ago, when Australia signed a free trade agreement with United States, the same people made the same arguments. They predicted the demise of the PBS,” Mr James said.

 “They were wrong. Absolutely wrong.

 “The PBS today is more sustainable than at any point in its history, and this is because the pharmaceutical industry in Australia is fundamentally committed to PBS sustainability and will always be willing to work with the Government to achieve this.”

 In an ‘open letter’ to Parliament late last week, Medicines Australia, in partnership with AusBiotech and Research Australia, called on policymakers to ignore the hysteria and fear mongering and instead to focus on achieving positive outcomes for Australia through the TPP.

 The letter noted that ensuring Australia has a globally competitive IP system is the key to our future health and wealth.

 “We shouldn’t let fear mongering derail progress on what will truly be a trade agreement for the 21st century,” Mr James said.

 “In terms of IP, there is always too much focus on the ‘cost’ of strengthening Australia’s IP system, and not enough on the benefits, such as job creation and investment in R&D and high-tech manufacturing.

 “Strengthening Australia’s IP system will ensure not only that Australian patients continue to get prompt and affordable access to the latest and most effective treatments, but also enable Australia to attract even more investment in biotechnology and pharmaceutical R&D and manufacturing.”

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Contact Person:

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

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

The Medicines Australia Continuing Education Program Awards are presented annually to sales representatives who achieve the best marks in their compulsory ethical conduct education program.

Medicines Australia Chief Executive Officer, Mr Tim James said the mandatory program, delivered by Medicines Australia and the University of Tasmania, highlighted the industry’s commitment to ethical conduct.

“Medical sales representatives play a really important role in helping doctors stay abreast of the latest information and ensure patients get the best out of the medicines that are available today,” Mr James said.

“Representatives have the 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 important we get it right.

“The continuing education program ensures medical representatives are educated to a recognised industry standard to provide healthcare professionals with accurate and balanced information.

“I congratulate all students who completed the course in 2014 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.”

During his address, Mr James also spoke of the leadership the industry has shown in recent years. “The Intergenerational Report 2015 published last week makes clear that Population, Participation and Productivity are key to Australia’s economic future. Medicines play a fundamental role in relation to each of our nations’ population participation and productivity. The role and real value of medicines will underscore opportunities to lift Australia in these three P’s.”

“The pharmaceutical industry has shown real leadership in three key areas: firstly, there is an effective price signal on medicines; secondly the processes of the PBS require value and ensure ‘bang for tax payer’s buck’; and thirdly the industry has reformed dramatically in recent years delivering seven times the forecast savings to government. It is time for other parts of the health landscape to equally focus upon effective price signals, value and reform.”

The Medicines Australia Code of Conduct Award, for highest marks in the Code of Conduct Program, was presented to Sean Newman (AstraZeneca).

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 Jacqui Bardellini (Sanofi) and Olivia Di Sisto (iNova).

The Medicines Australia CEP Achievement Awards, for the highest marks across all five core Programs went to: Eilise D’Arcy (Alcon), Irma Brink (BMS), Sean Newman (AstraZeneca), Catherine Solomonson (AstraZeneca), Ben Warner (Pfizer), Louise Thomas (iNova), Alex Roytman (Mundipharma), Lawrence Currion (Novartis), Edward Punshon (Alphapharm) and Catriona Truscott (independent student).

Photo description – names left to right: Olivia Di Sisto, iNova,  Irma Brink, BMS, Jacqui Bardellini, Sanofi, Louise Tomas, iNova, Alex Roytman, Mundipharma, Martin Cross, Medicines Australia, Tim James, Medicines Australia, Ben Warner, Pfizer, Sean Newman, AstraZeneca, Catherine Solomonson, AstraZeneca, Paul White (standing in for Lawrence Currion), Novartis, Eilise Darcy, Alcon, Edward Punshon, Alphapharm,  Absent: Catriona Truscott

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Contact Person:

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