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

Medicines Australia welcomes the recommendations of an independent review into the Therapeutic Goods Administration (TGA) which, if adopted, will help to cut time delays and improve Australian’s access to new, innovative medicines.

The Review examined the TGA’s regulatory framework and processes with a view to identifying areas of unnecessary red tape and opportunities to enhance and streamline the regulatory framework.

Medicines Australia CEO, Tim James, welcomed the Report and said the industry is keen to work with the Government to ensure that Australia both maintains and evolves our current world class system.

“It’s pleasing to see that many of the recommendations proposed by Medicines Australia have been adopted in this report,” said Mr James.

“Encouraging work sharing with overseas regulators, accelerated approval pathways and retaining the capacity of the TGA to undertake assessments of therapeutic goods are sensible proposals and it’s good to see that this independent report agrees.”

“Medicines Australia agrees that targeted reform is required so that the Australian regulatory system can better serve the Australian community and that any changes proposed to the current system must firstly be focussed on ensuring the internationally recognised standard for regulation in Australia is retained.”

“We also need to make sure that the TGA has the necessary resources to deliver continuous improvement to approval processes to keep pace with medical breakthroughs and developments.”

“While we welcome the report and once again applaud the Government for bringing about this review, there have been some missed opportunities for further improvements to the TGA registration process. Medicines Australia has repeatedly raised concerns about delays in access arising from the TGA’s burdensome pre-submission period. This results in an approval timeframe that starts at least three months later than those of comparable global agencies.”

“There are many other impediments which slow down the process of getting a new medicine to patients in Australia which need to be addressed.”

“Medicines Australia’s 2015 COMPARE Report found that Australia is ranked 18 out of 20 OECD countries for access to new medicines.”

“Since 2009, just 40 per cent of new medicines approved by regulatory bodies have been made available on the Pharmaceutical Benefits Scheme (PBS) in Australia.”

“For those new medicines that do make it, the time from TGA approval to PBS listing takes on average more than a year. In most OECD countries this process happens within 6 months.”

“Changing government policy also plays a role in delaying medicine access for Australians. This includes PBS pricing cuts within the last Federal Budget, changes to Research and Development tax rules and delays in clinical trial reform which reduce competitiveness.”

“Meaningful and sustainable reform can be achieved through a strong and collaborative relationship between industry, government and the community. These partnerships are critical to ensuring a globally harmonised approach to regulation that facilitates timely access to new medicines for the Australian health consumer.”

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 was pleased to attend the first Health Industry Forum, hosted by Industry Minister Ian Macfarlane MP, Health Minister Sussan Ley MP and Assistant Health Minister Fiona Nash MP at Parliament House today.

The forum provided an opportunity for government and industry to work together to highlight opportunities for future investment and growth in areas such as clinical trials and the manufacture of innovative, new medicines in Australia.

Medicines Australia CEO Tim James said, “This is a welcome initiative by the Federal Government which, if words turn into action, will not only help create jobs and boost the economy but also improve Australians’ access to the latest innovative medicines.”

“We look forward to working with the Government on its plan for an Industry Growth Centre for medical technologies and medicines, which has the potential to improve collaboration between our scientific research agencies and the medicines industry.”

“Today’s forum also highlighted the need to improve and streamline processes for clinical trials, including harmonisation of ethics approval between the different states and local hospitals as well as improving patient recruitment.”

“This is a welcome development. Clinical trials create thousands of jobs and keep Australia at the forefront of innovation, however, in recent years the number of trials here has declined.”

“There is enormous global competition for these research and development investment dollars so we need to work together and harder to make Australia a more attractive place for innovative industries to grow and contribute to the community.”

“There is a lot of work ahead but the Health Industry Forum helps to set the framework for a promising future for the innovative medicines industry.  “

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 extremely disappointed with a last-minute decision by Health Minister Sussan Ley to abandon a Strategic Agreement, which casts a shadow over the future stability of the local medicines industry and also puts patient safety at risk.

The purpose of the Agreement was to provide a level of stability and clarity for the local medicines industry in return for supporting a $6.6 billion savings package of which $4.2 billion was to directly impact our members.

Medicines Australia put forward a proposed Strategic Agreement which met all aspects of the Letter of Intent signed by the Health Minister on 27 May

In the spirit of cooperation, Medicines Australia had also offered to work with the Government on serious patient safety concerns which will allow the substitution of biosimilar medications by pharmacists without appropriate evidence that it’s safe and without the consent of a patient’s GP or clinician.

However, the Health Minister has closed down the negotiations and refused to sign the proposed Agreement. We are concerned that this approach will also fall short of addressing safety concerns on biosimilars.

Medicines Australia CEO Tim James said, “It is extremely disappointing that the Health Minister isn’t listening to widespread concerns about patient safety and the need for some stability for the local medicines industry.”

“The fact that the Minister would walk away from signing an Agreement, which meets all the conditions demanded by the Government, sends a bad message to our industry and to all businesses in Australia.”

“Making new, innovative medicines is extremely expensive. It costs on average $2.5 Billion to develop a new medicine for patients. It also takes 12 to 15 years to get a medicine from initial pre-clinical trials to the pharmacy shelf for patients. If we are to continue to invest and invent these treatments then the industry needs to have confidence that governments won’t constantly change their budgetary decisions.”

“The fact that this Government announces significant, unexpected cuts to medicines on the Pharmaceutical Benefits Scheme, which have already been declared cost-effective – and now won’t provide any guarantee that more cuts aren’t coming – has sent a shiver down the spine of this industry.”

“This puts future investment in medicines in Australia at risk. It puts Australians’ access to the latest, innovative therapies at risk.”

“This is a very poor outcome for Australia.”

Biosimilars substitution

Medicines Australia supports the safe use of biosimilars but remains particularly concerned about the Government’s proposed rules for the substitution of Biosimilar medicines.

“We, along with doctor and patient groups, have continually offered to work with the Government so that safe substitution of biosimilars can go ahead and still provide significant savings to the Budget,” said Mr James.

“Regrettably, it appears that the intent of the Government on this issue is oriented more towards a Budget outcome rather than an evidence-based and safety-first outcome.”

“On biosimilars and across our health care system, notions of safety first, of do no harm and of putting into practice the precautionary principle should always come first.”

The Government will approve biosimilars for substitution based on advice from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC made a public statement that substitution of biosimilars will be its default position. This view has created widespread concern across stakeholder groups.

“We respect the role and independence of the PBAC. We support its role in the approval process for substitute medicines for patients,” Mr James said.

“However, the current PBAC position on biosimilar substitution is out of step with comparable international regulators who are taking a much more cautious approach.”

“There simply is not enough evidence at this stage on the automatic, safe substitution of biosimilars without the appropriate oversight of a doctor.”

“This has been a poorly run process by the Federal Government, which has failed to properly consult with the medicines industry, patient groups and doctors.”

Medicines Australia, patient groups, clinicians and international experts will continue to call for stability and safety first, so that Australia retains its international reputation for the safe approval of and access to medicines.”

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 Grattan Institute’s latest report seems to, again, miss the point. Enduring reforms to the Pharmaceutical Benefits Scheme (PBS) polices are achieving substantial savings for government and the Australian medicines industry is on the cusp of yet another; the biggest reform since 2007.

“Measures currently before the Parliament will generate as much as $6.6 billion in savings from a raft of changes to the PBS over the next 5 years that will significantly reduce medicines prices to government. As well as measures to speed up price disclosure price cuts for off-patent medicines, the government is also introducing additional price cuts for patented, innovative treatments when they have been on the PBS for five years ,“ Medicines Australia CEO, Tim James said.

The therapeutic group policy has become redundant in the current policy setting. Australia has very effective policy settings to ensure a sustainable PBS. The 1 October 2015 price disclosure reductions announced recently have average price cuts of just over 20% for around 70 drugs, in almost 230 dosages and presentations. This is on top of price cuts to over 100 PBS-listed medicines which took place on 1 April 2015.

“The enduring price disclosure policy continues to deliver hundreds of millions of dollars in savings to Government, patients and taxpayers with reduction days every six months for many of the most commonly prescribed medicines,” Mr James said.

“The Grattan Institute also continues to cherry pick policies from different countries and to prosecute the argument for a New Zealand style medicines procurement system that focuses solely on cost at the expense of choice and optimal health outcomes.

“This report, like many others the Grattan Institute have produced, continues to ignore the fact that since 2000, only around 20 per cent of medicines made available in Australia through the PBS have been added to the New Zealand schedule. It is fundamental to recognise that New Zealanders have much poorer access to medicines and worse health outcomes than Australian patients.

“In addition to this, the recent COMPARE report found NZ ranked 20th of 20 countries included in the study, in terms of access to new medicines, and had access to only a third of the new medicines registered since 2009 available in Australia.

“The lack of choice in medicines in New Zealand means doctors cannot tailor treatments that would work best for the patient. So it is unrealistic to assume Australia could adopt New Zealand’s strict tendering and pricing policies, but avoid its negative consequences of reducing patient and prescriber choice.

“Worryingly, the Grattan report states that there will be a positive impact on investment in research and development of new innovative medicines in Australia despite their proposed reforms and savings. Medicines Australia is concerned that in an already contracting sector, further price changes will seriously jeopardise a large number of highly-skilled jobs and investment.”

The one positive noted by the Institute was that the pharmaceutical industry had worked constructively with Governments over recent years to reduce drug prices when appropriate to do so, something Medicines Australia will continue to do as a credible policy partner.

-ENDS-

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, the peak body representing the innovative pharmaceutical industry, has agreed to sign a ‘Letter of Intent’ with the Australian Government for a 5-year strategic agreement.

If finalised, the agreement will provide Australian patients and the medicines industry with a degree of stability and certainty in providing ongoing access to innovative medicines delivered through the Pharmaceutical Benefits Scheme (PBS).

Medicines Australia CEO Tim James said “in response to the Government’s budgetary challenges, we have agreed to meet all of the Government’s savings targets.

“In return for providing the majority of $6.6 billion in cuts outlined by the Government, our members have been given a number of undertakings and concessions regarding any future price-related savings throughout the life of the Agreement.

“Our member companies invest billions of dollars to research, invent and manufacture innovative medicines to treat patients. The continuation of this investment relies on a fair and stable price for a limited period. That is our social compact with governments and patients around the world.

“The continuation of this social compact requires stability in policy making. While this agreement does contain cuts to medicines already proven to be cost-effective, we welcome the limited stability and certainty that this agreement will provide over the coming 5 years.”

Medicines Australia will now undertake a process to consult on these measures with key stakeholders including patient organisations, the medical sector and the broader community to ensure the ongoing viability and sustainability of the PBS.

“Our priority is, and has always been, to ensure all Australians have affordable access to the newest and most innovative medicines in the world.”

“Australia is already ranked close to the bottom of the top 20 OECD countries when assessing both the time taken for patients to access the latest medicines and whether these medicines will even reach our shores.

“The challenge for the Government and our industry is to ensure that the measures in this agreement, while delivering savings for the Budget, improve, not worsen, access to medicines for all Australians,” said Mr James.

Medicines Australia expects to have the letter of intent converted into a binding Strategic Agreement by June 18^th 2015.

-ENDS-

Contact Person:

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

Medicines Australia is pleased to welcome the appointment of Professor Andrew Wilson as incoming Chair of the Pharmaceutical Benefits Advisory Committee (PBAC).

MA also welcomes the appointments of Dr Peter Grimison and Professor Jonathan Craig as members of the Committee.

“I would like to congratulate all the new members on their appointments,” said Medicines Australia CEO, Tim James.

“Professor Wilson has enormous experience in the health sector and as a former member of PBAC will be well prepared for the demanding role of Chair.

“Medicines Australia looks forward to a collaborative, pragmatic and patient focused PBAC under Professor Wilson’s stewardship.

“He has shown a willingness to engage with the medicines industry and has a deep understanding of the issues impacting on our sector.

“Medicines Australia welcomes the reforms to the PBAC proposed by the Health Minister Sussan Ley, which include an expansion of membership and streamlining of operations to help with the increased volume and complexity of the Committee’s work.

“We look forward to understanding the detail of these reforms as it becomes available and to working with the Minister to ensure an efficient, streamlined process.

“We want to work with the PBAC towards what should be our shared priority, namely, the timely listing of new, innovative and cost-effective medicines to the Pharmaceutical Benefits Scheme (PBS).”

-ENDS-

Contact Person:

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

Medicines Australia is pleased to announce two new senior appointments as part of its ongoing commitment to represent and promote Australia’s innovative medicines industry.

James Boyce will take up the new position of Director of Communications and Government Relations and Dr Martin Snoke has been appointed as Manager of Policy and Research.

James will start his role at Medicines Australia this week while Dr Snoke will join the team in June.

James comes to Medicines Australia after almost three and a half years as Senior Press Secretary to Prime Minister Tony Abbott MP.

His experience working closely with members of Parliament as well as a decade of experience as a senior journalist will be a valuable addition to the Medicines Australia team at a crucial time for the local medicines industry.

Dr Snoke currently works for the Parliamentary Budget Office and has previously worked as an assistant director in the Department of Health.

He has extensive experience in economic modelling and policy development and his skills and insights will be an important addition to the Medicines Australia team.

Medicines are one of Australia’s biggest exports with an industry that employs around 15 thousand people who work every day to provide Australians with fast, affordable access to the latest generation medicines so they can live longer, healthier lives.

Both James and Dr Snoke will work closely with members and stakeholders, including government and the community, to promote the important role of the medicines industry in Australia.

-ENDS-

Contact Person:

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

Australia’s innovative medicines industry has called on the Abbott Government to negotiate a five-year strategic agreement after it reached an in-principle deal with the Pharmacy Guild of Australia.

Medicines Australia CEO, Tim James, said the sector that invents and manufactures medicines is seeking certainty from the Government following more than $3 billion in budget savings.

“While Medicines Australia is yet to see the detail of the Pharmacy Guild agreement, the apparent 23% increase in funding will provide certainty for pharmacists and ensure patients are able to have prescriptions filled in much the same way as they always have,” Mr James said.

“Like the Guild, our members are seeking certainty from the Australian Government.

“We all want the very best PBS for Australian patients.”

While the Pharmacy Guild was able to secure certainty with a significant increase in funding for their members, the sector that invents and manufactures medicines is being forced to provide more than $3bn in savings.

“Timely access to medicines is critical in ensuring an effective healthcare system and manufacturers are a vital component to this equation: researching, discovering, developing and bringing new and innovative treatments to Australian patients,” Mr James said.

“However, ad hoc cuts to the medicines budget threaten Australians’ access to new medicines and are a poor choice for government savings. History has shown that most of the savings made in the PBS are not re-invested in innovative new medicines for Australians.

“Medicines Australia believes that an agreement can and should be reached, one that includes all key sectors of the medicines supply chain, to meet the needs of government, industry and consumers.

“We will continue to work on reaching an agreement in the comings days and weeks.

“We remain optimistic this government will adopt a similar constructive, respectful and reasonable approach to that taken when Prime Minister Tony Abbott was the health minister in 2007, and substantial savings were achieved – savings that are still flowing through today.

“Our industry has always worked constructively with government to ensure the sustainability of both the PBS and the innovative medicines industry.

“The Prime Minister was very hands-on during that process to ensure the policy objectives of the executive government were achieved and neither the government nor industry were hindered by potentially narrow, bureaucratic constraints.

”We look forward to hearing from the government about where to go next to ensure there are no barriers to bringing new medicines to the people that need them and to ensuring the viability of such an important industry to Australia’s health.

“We just want to ensure Australians have access to the best PBS.”

-ENDS-

Contact Person:

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