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

Medicines Australia is concerned about assertions contained in media reports today bringing into question the safety and ethics of clinical trials.

Each year thousands of clinical trials are undertaken around the globe with more than 600 of those trials in Australia. This is vital work that ensures new breakthrough medicines are thoroughly tested for safety and effectiveness before they are available for wide public medical use.

Without the support of innovative medicine companies many of these trials would simply never go ahead. That would mean more effective medicines would be unavailable and Australian patients would miss out on the early access to these treatments that clinical trials bring.

Clinical trials are conducted by the best doctors and scientists and go through rigorous processes just to get off the ground. Their conduct is transparent and their results are independently peer reviewed and published.

In Australia, all the clinical trial data must be made available for the Therapeutic Goods Administration (TGA) who scrutinise the information before it is approved as safe for use. If future data contradicts this information it must immediately be made available to the TGA.

Australia and the innovative, research-based medicines industry have an excellent reputation for their work in research and development. Australians can have great confidence that the work they do always puts the safety of patients first.

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 notes with concern the recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) that pharmacists be allowed to substitute biosimilars in place of biologic medicines prescribed by a patient’s doctor.

The so-called “a-flagging” means that pharmacists can make this substitution without the knowledge or consent of the patient’s specialist doctor, GP or even the patient.

This decision by the PBAC announced today, goes against all the advice they have received from international and local experts that there is an absence of an agreed evidence base to support the safety and efficacy of repeated, or multiple, switching between a biologic and one or more biosimilar medicines.

Medicines Australia absolutely affirms the safety and efficacy of biosimilars that have undergone a thorough assessment by the expert Therapeutic Goods Administration. This is not in question.

Biosimilars can treat the same condition as the reference original biologic, but they can and do have a range of variations which may or may not have an adverse impact on patients. Biologic medicines are not generic medicines.

Therefore, it is critical that a patient’s doctor is involved in any decision to move a patient from one biologic or biosimilar medicine to another and they need a strong evidence base to rely upon to make that decision.

Medicines Australia represents the majority of companies that are developing biosimilar medicines for the Australian market. We strongly support the introduction and uptake of biosimilar medicines but this must be done appropriately and based on reliable evidence to build public confidence in their quality use. This will ensure that biosimilars can make a significant contribution to the health of Australians and the sustainability of the Pharmaceutical Benefits Scheme (PBS) well into the future.

The medical and patient community need confidence that the Australian Government and its appointed advisory bodies are making the right decisions in the interests of their health and safety and not based on the Governments own bottom line savings targets.

Medicines Australia strongly urges the Government to begin a formal process of consultation with all relevant stakeholders, including patient groups and doctors to develop a comprehensive biosimilars policy, based on evidence, and including appropriate education, which puts patient safety first.

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 continuing decline in Australian exports of medicines has highlighted the enormous challenges facing the local industry as they struggle to remain competitive in the global pharmaceutical industry.

Just five years ago, medicines were Australia’s largest manufactured export, bringing in more than $4 billion to the local economy.

Today, manufactured medicines have slipped to second place behind the motor vehicle industry. If the trend continues, medicine manufacturing will shortly drop to third.

The latest figures released by the Australian Bureau of Statistics reveal that in the first 6-months of 2015, Australian manufacturing exports were $1.06 Billion, compared to $1.49 Billion in the first half of 2014, representing a 28.5 per cent decline.  Pharmaceutical exports were 30 per cent lower in June 2015, compared to June 2014.

Such a dramatic fall in the rankings should be ringing alarm bells in Canberra.

At a time of growing demand for innovative, safe and effective medicine products in Asia, particularly in China, Australia is set to miss out on an enormous economic and job creating opportunity if our politicians fail to get the policy settings right.

The Government must do more if it wants to fulfil its promise to encourage growth in the biopharmaceutical sector.

A shrinking Australian dollar can help to make our exports more competitive, but on its own, it will not reverse the trend.

A lower dollar also cannot compensate for the enormous challenges facing industry and the broader Australian economy as the mining boom comes to an end.

In a submission to the current Senate inquiry into Australia’s Innovation System, Medicines Australia outlined key principles to invigorate the Australian medicines industry, which included:

• Secure the existing investment we have in Australia to ensure it stays here;
• Encourage the development of Australia’s local bio-pharmaceutical sector; and
• Attract new direct foreign investment to Australia.

The submission argued that by following these key principles, Australia could take advantage of the Asia boom and at least double current medicine exports, but with stiff competition from nations such as Singapore and Japan, the time to act is running out.

Medicines Australia is encouraged to see that the Australian Parliament is beginning to identify science and innovation as a key future economic and employment driver for this country, however, the rhetoric needs to be matched with action.

To further support the Australian pharmaceutical industry, Government must urgently identify additional ways to encourage more local innovation and adopt policies that will lead to more research and development, clinical trials, and advanced manufacturing investment.

This is the opportunity that Medicines Australia has been highlighting to policy makers for some time.

Medicines Australia and its member companies stand ready to work with Government to achieve this important goal.

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

An informative source of key statistics and trends in the Australian and International medicines industry has today been published in the latest edition of the Medicines Australia Facts Book (4th Edition).

The findings show that the global market for medicines and vaccines is set to double over the next decade, with much of the growth coming from Asia.

These opportunities for investment and manufacturing in Australia should be used to boost Australia’s exports and create more jobs leading to economic growth. This can only be achieved through strong collaboration between policy makers and industry.

The publication also points to pressures and challenges on the local industry in the competitive global market for new medicines. Industry craves a stable and globally competitive policy environment to optimise its prospects for success on the world stage and to attract further investment locally.

What we do know is Australians are living longer thanks to a number of health outcomes including the development of new innovative medicines and treatments, reducing the number of disease-related deaths.

The medicines industry continues to develop thousands of new medicines and vaccines, which currently includes more than 900 new ‘biologics’. (Biologics are complex molecules derived from living cells and they represent the cutting edge of modern medicine).

Biologics have already revolutionised treatment for some diseases and are expected to deliver the most effective means of treating a growing variety of illnesses and disabilities over time.

Better health is vital to a productive and participative society and industry will continue to drive health outcomes across the Australian population working in collaboration with government.

The Facts Book also includes data on research and development, registration and reimbursement, manufacturing and sales, health outcomes and expenditure, and biotechnology and the broader medical research sector in Australia.

For more information, the Facts Book is available on the Medicines Australia website at https://medicinesaustralia.com.au/policy/publications/facts-book/.

Follow us on Twitter at https://twitter.com/medicinesaus.

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

Australia’s innovative medicines industry body has provided a supplementary submission to the Senate Inquiry into Corporate Tax Avoidance addressing several issues raised at the public hearing in Sydney this month.

Global tax arrangements such as transfer pricing are complex measures which are easily misunderstood. This can unfortunately lead to confusion within the community and erode public confidence in Australia’s robust, transparent tax system.

Medicines Australia’s supplementary submission aims to address a number of key misconceptions which have arisen from the July hearing in which a number of member companies provided detailed answers to the Senate Economics References Committee.

The submission gives a detailed breakdown of the rules relating to transfer pricing and the ‘arms length’ principle, comparative pricing, and Advanced Pricing Agreements (APAs) with the Australian Taxation Office (ATO). It also seeks to clarify the role of Senior Executives in the pricing process and also outlines how the PBS provides a government subsidy to patients not companies.

Medicines Australia is determined to eradicate these misconceptions which have been left to stand without scrutiny.

More than fourteen thousand people work for our member companies in Australia. They take great pride in their work which helps to provide the most innovative medicines and vaccines to the Australian people.

While it is the responsibility of Senators and Members of Parliament to set laws and determine what is an appropriate, fair and just tax system; it is the responsibility of the community, including business, to always adhere to that law.

Medicines Australia member companies view and undertake their tax, legal and community obligations with the utmost care, diligence and responsibility. They are valuable, ethical contributors to the Australian economy and the ongoing health and wellbeing of our community.

The submission also makes it clear that the Medicines Australia Code of Conduct is strong and effective in addressing matters of conduct (including overseas examples raised) and bringing about ethical behaviour. Our members take great pride in the Code of Conduct which is now 55 years strong and represents the gold standard in Australia for ethical, responsible industry self-regulation.

The supplementary submission aims to provide the community with greater clarity and confidence in the Australian tax system and the ongoing work of our member companies to pay the right and fair amount of tax.

A competitive tax system and stable policy setting is vital for Australia to attract more investment into the various stages of research and development, clinical trials, access to medicines in Australia, more jobs and to capitalise on potential growth in export markets.

All of this would result in increased economic activity, productivity and ultimately, higher tax revenues for Australia.

However, if unilateral action is taken on tax policy, there is significant risk to the long term viability of the pharmaceutical industry in Australia.

A copy of the supplementary submission to the Senate Economics References Committee into Corporate Tax Avoidance is available on the Medicines Australia website at https://medicinesaustralia.com.au/policy/publications/submissions/

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 has tabled a submission urging the Parliament to pass legislation that will create the Medical Research Future Fund (MRFF).

However, if the MRFF is to succeed in addressing the health needs of the future it needs close collaboration with Australia’s innovative medicines industry.

The MRFF can be a positive step forward for Australia, creating an environment in public and private research which can deliver the results that Australian patients deserve.

Medicines Australia CEO Tim James said, “We are keen to work with the Australian Government to make this research fund a reality.”

“The MRFF will help to assist growth in Australian exports through commercialisation of new therapies and meet global health needs, including generating economy wide dividends for Australia.”

“To ensure the greatest value from the MRFF, Medicines Australia recommends involvement of relevant partners to ensure alignment between the MRFF and the Medical Technologies and Pharmaceuticals Growth Centre, and importantly consultation on policies to improve Australia’s competitiveness through innovation, for instance R&D credits and clinical trial reforms.”

“It’s important that Government collaborates with Industry to discuss and develop how to leverage growth in medical research funding to ensure we can commercialise it for the benefit of Australia and build our innovative economy.”

“By leveraging Australia’s local strengths, including the quality of our medical research and health system, we can provide stronger competitive advantage for the nation and the health of Australians.”

“We know the MRFF could be harnessed to improve Australia’s economic future, encouraging greater collaborative links between the public research and the business sectors, including Australia’s pharmaceutical industry.”

“We have an economic opportunity for Australia, especially when our country currently exports medicines to over 70 countries. This means the right policy settings could see Australia potentially double its share of the global pharmaceutical market over the next decade.”

“The MRFF Bills if passed will provide a unique chance to reinvigorate investment to conduct R&D and to manufacture medicines in Australia. It could also bolster the Australian innovative medicines industry as a dynamic, vital part of the Australian economy and society.”

“Medicines Australia looks forward to having the opportunity to work with Government to assist in ensuring the MRFF creates a positive public and private research environment to deliver the results that Australian patients deserve.”

The submission is available on the Medicines Australia website at https://medicinesaustralia.com.au/policy/publications/submissions/

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 remains concerned by the increasingly alarmist and misguided reporting by sections of the media on negotiations for the Trans Pacific Partnership (TPP) and its impacts on the prices for medicines in Australia.

“The same fearmongering about price rises for medicines and the collapse of the Pharmaceutical Benefits Scheme (PBS) happened a decade ago when Australia negotiated a Free Trade Agreement with the United States and those claims have proven to be completely false,” said Medicines Australia CEO Tim James.

“The PBS is more sustainable than ever before and the innovative medicines industry is committed to ensuring that this will always be the case.”

“Trade deals, including the TPP, are good for the Australian economy. They open up vast new markets for Australian companies, such as the makers of innovative medicines and vaccines, because they reduce trade barriers.”

“At $3 billion per year, medicines are already one of Australia’s largest manufactured exports and the TPP will only see that figure grow.”

“Importantly, a regional trade agreement, such as the TPP, has the potential to establish high regional standards for intellectual property (IP) protection which can help transform Australia into a leading global hub for research, development and manufacturing of the next generation of highly specialised medicines and vaccines.”

“This will bring enormous benefits to the Australian people, not only through jobs and investment, it will also improve and accelerate patient access to the latest, innovative medicines.”

“Australia must find ways to encourage more investment in research and development, clinical trials and the manufacturing of medicines, not give in to fear by maintaining or putting up more barriers to success.”

“We shouldn’t let the alarmists derail progress on what will truly be a trade agreement for the 21st century.”

Earlier this year, Medicines Australia wrote an ‘open letter’ to Parliament, in partnership with AusBiotech and Research Australia. It asked policymakers to ignore the hysteria and fear mongering and instead to focus on achieving positive outcomes for Australia through the TPP.  That letter remains as relevant today as it was in March.

The letter outlined the need for Australia to have a globally competitive IP system  as the key to our future health and wealth.

“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,” said Mr James.”

“The Liberal Government and Labor Opposition are quite rightly focussing in on the need for more collaboration between our universities and industry in scientific research. This partnership will provide enormous benefits to patients, but only by strengthening the IP system will Australia reap the financial rewards of discovering and creating the next generation of treatments.

“Medicines Australia supports the Government in its efforts to sign a TPP that will benefit the Australian people and the local economy.”

Contact Person:

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

Medicines Australia welcomes the Federal Government review of University research funding and policy which aims to find more ways to turn the hard work of Australian scientists into commercial success.

Medicines Australia CEO Tim James said, “Australia’s Universities have a great reputation for research and development around the world but they have often found it hard to turn this into a commercial reality in Australia.”

“Science has the potential to be one of the great industries for the Australian economy that will only grow in importance as traditional industries such as mining and heavy manufacturing decline. However, for this to become a reality we need to see the good words of the Government become strong actions.”

“We welcome the appointment of Dr Ian Watt AO to lead the review into University research funding and policy, however, it is disappointing that the review panel will not include a single member from a research-based industry such as the makers of innovative medicines.”

“Our members spend a billion dollars every year on research and development in Australia and they rely on world class scientists to help create the next generation of medicines and therapies for the Australian people.”

“Medicines Australia is keen to work with Dr Watt and his team and will provide whatever expertise and insights we can to ensure that this review is a success.”

“For Australia to reap the financial rewards of scientific research we need to see more collaboration between Universities and industry, especially in medical and pharmaceutical research and development.”

“Not only will this be good for the Australian economy, it will also mean Australians get better, faster access to innovative medicines in the future.”

“Medicines Australia is pleased to see that both the Government and the Labor Opposition have developed a keen interest in science and innovation. This is a good sign for the Australian economy and we look forward to working with all sides of politics to develop policies that boost the economy and make Australia world leaders in the scientific development of medicine.”

Contact Person:

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

An awareness campaign has been launched by Medicines Australia to ensure healthcare professionals are aware of and understand the effects of new transparency enhancements contained in our updated Code of Conduct.

From 1 October 2015, Medicines Australia 18^th Edition of its Industry Code of Conduct will require payments to healthcare professionals to be disclosed online to the public for the first time.

This additional transparency will further enhance the Australian medicines industry’s reputation for world-leading self-regulation.

Medicines Australia CEO Tim James said “Our members are proud of the work that we do to ensure that the public can continue to have confidence in our local medicines industry. Transparency is a key component of the bond of trust with the Australian public.”

“A strong working relationship and the ongoing exchange of knowledge between the medicine makers and healthcare professionals are critical to better patient outcomes.”

“Expert advice from experienced healthcare professionals is important to ensure vital new medicines are developed and used safely and effectively.”

The new Code requires 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 to engage in education, including airfares, accommodation and conference registration fees.

From October 2015, all member companies will be required to collect and report payments where they have the agreement of the healthcare professionals who are receiving payments. Following this 12 month period of adjustment, from 1 October 2016, the Code will require reporting of all these payments to healthcare professionals to be mandatory.

Medicines Australia consulted comprehensively with doctor, patient and consumer groups when developing the new transparency measures within the Code.

To ensure healthcare professionals and the community are fully informed about the incoming transparency changes, further detailed information is now available from the Medicines Australia website.

Educational material will also be provided to healthcare professionals’ member organisations, colleges and other trusted sources of information within the community.

Medicines Australia has also written to all key healthcare member bodies offering to support any member briefings that they undertake.

“The new Code ensures that the innovative medicines industry continues to set the benchmark for successful, responsible and ethical industry self-regulation,” said Mr James.

“We are proud of our role in developing it and enforcing its high standards.”

Further information: medicinesaustralia.com.au/code-of-conduct

Contact Person:

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