The Medicines Australia Board announced today that it has appointed Mr Tim James as the new Chief Executive for the organisation.

Mr James will replace outgoing Chief Executive, Dr Brendan Shaw, who finished in his role on 12 September to take up a senior role with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) in Geneva.

Medicines Australia Chairman, Dr Martin Cross, welcomed the appointment of Mr James to the position.

“I’m very happy to announce Tim’s appointment as Chief Executive,” Dr Cross said.

“He brings a wealth of experience in government and policy, professional services as well as the medicines industry to the new role,” Dr Cross said.

“Tim has extensive experience working within both government and in the medicines industry. He understands the opportunities and challenges facing our industry and will be a great asset to Medicines Australia.

“The Board is delighted with the appointment and looks forward to working with Tim to help progress the policy agenda for Australia’s medicines industry.

“There are many issues the industry needs to work on with government and the broader community such as ensuring Australians continue to have timely access to the latest medicines in the future, maintaining the viability of the business environment, and helping build the medicines industry as a key contributor to Australia’s economic future.

“Tim is well placed to take Medicines Australia forward in the future on these important issues.”

Mr James is currently Chief of Staff to the Hon Anthony Roberts MP, Minister for Resources and Energy and Special Minister of State in the New South Wales State Government. Previously Tim worked in the pharmaceutical industry for several Medicines Australia member companies, as well as earlier being a lawyer and an auditor. He also worked as a staffer for former Prime Minister, the Hon John Howard MP and the Hon Joe Hockey MP. He holds a range of academic and professional qualifications, including an MBA from AGSM.

Mr James will commence his new role at Medicines Australia on 20 October.

Dr Cross will be acting Chief Executive in the period from Dr Shaw’s departure on 12 September through to Mr James’ commencement on 20 October.

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Contact Person:

Dr Martin Cross
Phone: (02) 6122 8501
Email: Martin.Cross@medicinesaustralia.com.au

The decision by the Federal Court to allow patenting of genetic materials highlights the importance of maintaining strong intellectual property laws to promote the development of new medicines, the Chief Executive of Medicines Australia Dr Brendan Shaw said today.

“Patents on biological agents such as isolated genetic materials are important because they ensure ongoing investment in developing cutting-edge medicines and diagnostic tests,” Dr Shaw said.

“More importantly, a strong patent system helps ensure Australians have access to the latest and most effective treatments as soon as they become available.

“We have always been concerned that any efforts to restrict patenting of new medical technologies risk undermining the development of new medicines and vaccines.

“Four government inquiries over the last decade, including two by the Australian Senate, have found that there is no case for banning patents on biologicals materials.”

Last year, the McKeon Review also recommended that Government reject calls to exclude biological materials from patentable subject matter.

“In fact, the McKeon Review called on Government to ensure Australia’s IP system is ‘strong, stable, predictable and harmonised with global best practice’,” Dr Shaw said.

“We need more work in this area so that patients in Australia continue to have access to the latest therapies and the biopharmaceutical industry continues to invest in research and development.

“Having robust intellectual property laws is critical to developing new medicines and vaccines and Australian needs to ensure it maintains international best practice in this area.”

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Contact Person:

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

Medicines Australia today congratulated Mr Martin Bowles on his appointment as Secretary of the Department of Health.

Chief Executive of Medicines Australia, Dr Brendan Shaw, said the industry welcomed the opportunity to work with Mr Martin Bowles as head of the Department of Health.

“We look forward to working with Mr Bowles to maintain and develop Australia’s system of providing medicines to the Australian community and improving the health of Australians,” Dr Shaw said.

“With Mr Bowles’ extensive knowledge and expertise working as Secretary and Deputy Secretary for several government departments, we are confident our collaborative approach with the Department of Health and the broader government will continue.

“There are a range of critical medicines policy issues for Australia’s future where government-industry engagement is crucial.

“Mr Bowles’ appointment provides a great opportunity to take that engagement forward in the future and we wish him well in his new role.”

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Contact Person:

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

The Grattan Institute’s PBS savings proposal has been proven wrong after their admission this week that the savings figure was artificially inflated by (at least) $165 million, or almost 40%.

Appearing before the Senate Community Affairs Committee this week, the Institute acknowledged that the proposed annual savings from benchmarking 20 commonly-used drugs against UK prices was not $580 million, as originally claimed, but actually closer to $415 million.

Medicines Australia Chief Executive, Dr Brendan Shaw, said the figures put forward by the Grattan Institute and its savings proposal based on those figures were incorrect.

“This is what Medicines Australia has been arguing for quite some time. We agree with other commentary that such forecast savings were only possible if you ignored the upcoming 1 October price cuts, and included a medicine still listed in the F1 formulary,” Dr Shaw said.

“The fact is 160 PBS-listed medicines have experienced price cuts under the Expanded and Accelerated Price Disclosure regime, with the average price cut reaching 42.5 per cent and 10 drugs experiencing price cuts over 80 per cent.

“These ongoing price reductions translate to almost $20 billion in ongoing savings by 2017-18, which makes the Institute’s $415 million proposal almost look like a rounding error.

“Turning to the PBS for further savings on top of these massive price cuts, to counteract expenditure increases in other areas of health, will ultimately be counterproductive.

“The Grattan Institute assumes that the pharmaceutical sector can continue to take hits, year after year, and keep researching, developing, trialling and rolling out new medicines. But lump on further cost-cutting reforms, as proposed by the Institute and sooner rather than later the system will break.

“We know that any further cuts to the PBS will reduce access to medicines, leading to heavier reliance on the wider health system to care for patients.”

The lowered estimate also now falls below the Government’s forecast of co-payment savings in the final year of the forward estimates – putting in serious doubt the Institute’s claim that benchmarking instead of co-payment changes would be a ‘win-win’ for patients and Government.

“The issue now is making sure these savings deliver what was intended – getting new medicines to Australians,” Dr Shaw said.

See chart of PBS price disclosure cuts 

Contact Person:

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

Australia’s medicines exports fell by 13.5 per cent to $3.363 billion in 2013-14, the lowest level since the 2005-06 financial year, highlighting the need for a new emphasis on growing the Australian industry.

“While the Australian medicines industry remains one of Australia’s leading manufacturing exporters, a fall of 13.5 per cent in exports in one year is a real worry,” said Medicines Australia Chief Executive Dr Brendan Shaw.

“For years the medicines industry has been a beacon of hope in Australia’s innovative manufacturing sector, averaging $4 billion in exports each year for the past several years.

“While the downturn in Australia’s medicines exports may reflect ongoing restructuring in the Australian industry, fundamentally Australia has some real strengths and competitive advantages we must build on.

“What’s needed now to grow Australia’s innovative medicines industry is a supportive policy environment in PBS policy and intellectual property, reform in regulations for clinical trials and data, and initiatives to develop a competitive tax environment and a culture of collaboration between public research and private industry.

“There are examples of success stories in the sector, be it international companies manufacturing and exporting from Australia or fantastic R&D collaborations that are developing the next generation of medicines and vaccines for the global community.

“But the challenge now is to reverse this fall in medicines exports, and ensure we build capability for the future to develop new investment, jobs, exports and R&D for Australia.

“These are the ideas we have put to the Government and the Parliament and we are keen to develop a strategy to build on Australia’s strengths in medical research, clinical trials, manufacturing and exporting that demonstrates that we are open for business.”

Medicines Australia’s submission to the Senate Economics References Committee’s inquiry into the Australian innovation system can be found on the MA website.

Contact Person:

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

Data newly released by the Organisation for Economic Cooperation and Development (OECD) reveals that Australia is not matching other industrialised countries in investing in medicines to treat disease.

The new OECD Health Data 2014 report shows that Australia’s public spending on pharmaceuticals is at 0.7 per cent of GDP, compared with the OECD average of 0.8 per cent, on the most recently available international data.

Medicines Australia Chief Executive, Dr Brendan Shaw, said these figures are very worrying.

“Australia is investing proportionately less of its income on new treatments for things like cancer, diabetes, rare diseases and cardiovascular disease than many other OECD countries,” Dr Shaw said.

“The OECD data shows that Australia has consistently committed lower levels of public spending on medicines than the OECD average for many years.

“These OECD figures don’t even take into account the massive price reductions and billions of dollars in savings delivered in Australia over the last 12 to 18 months through price disclosure reforms.

“We’ve seen from the latest Federal Budget figures that public spending on medicines as a proportion of GDP has fallen even further, to 0.6 per cent last year.

“While some critics lament Australia’s spending on medicines, the fact is we spend much less compared to many industrialised countries. We are underperforming, and will continue to lag behind countries such as Germany, Japan, and even Greece.

“Without action, it’s likely that Australia will fall further behind the OECD average in coming years.

“We don’t have good data on the effect of long term under-investment in medicines on other parts of the health system. But given that medicines have directly contributed to falling death rates in cardiovascular diseases and cancer, it may well be that this under-investing is also leading to higher spending in other parts of the health system.”

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Contact Person:

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

Medicines Australia today applied for authorisation of the 18th Edition of its Code of Conduct to the Australian Competition and Consumer Commission.

“Medicines Australia’s member companies are taking the lead in setting new standards of transparency in Australia’s health sector with this new Code,” Medicines Australia Chief Executive, Dr Brendan Shaw, said.

“Interactions between healthcare professionals and pharmaceutical companies are essential for ensuring that patients have the best care. They ensure healthcare professionals have up to date and comprehensive information about medical developments.

“This new Code sets new standards in the transparency in these interactions which is unprecedented in the Australian health sector.

“While the journey of delivering greater transparency isn’t easy, these new transparency measures are an important step forward for industry, healthcare professionals and importantly Australian patients.”

“We want to work in partnership with healthcare professionals, consumers, other industry sectors and the broader community to make this new era of transparency work,” Dr Shaw said.

The new Code will introduce expanded transparency reporting that will require Medicines Australia member companies to report on an individual basis a wide range of payments and transfers of value to individual healthcare professionals, as well as sponsorships of third party educational meetings and symposia.

The ACCC authorisation process is expected to take around six months and, if authorised, the new Code will come into effect in January 2015, with the new transparency reporting starting in October 2015. Under this new transparency model companies will seek consent from healthcare professionals before disclosing payments or transfers of value made to them.

“Medicines Australia’s members support a strong industry code that evolves with changing community expectations. We have consulted with a wide range of stakeholders in the development of the new code, including consumer and medical groups, some of whom actively participated through representation on the Code Review Panel,” Dr Shaw said.

“Medicines Australia looks forward to other industry sectors following this lead towards greater transparency.”

For more information go to the Medicines Australia website Code of Conduct Review page.

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Contact Person:

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

New figures on the number of clinical trials demonstrate that reforms to improve the regulation of clinical trials are more important than ever.

Figures from the Therapeutic Goods Administration show that the number of clinical trials commenced in Australia fell by 10% in 2013. Since 2007 the number of new clinical trials conducted has fallen by 21%.

There was one bright spot in the latest numbers, with Phase I clinical trials conducted in Australia increasing by over 40% in 2013, compared to 2012. However, overall activity was down. The TGA’s latest Half-Yearly Performance Report shows 681 new pharmaceutical clinical trials were begun in Australia in 2013, down from 759 trials in 2012 – a fall of 10%.

Medicines Australia Chief Executive, Dr Brendan Shaw, said that the latest figures highlight the need for the Government to move quickly to implement reforms to make Australia a more competitive destination for clinical trial investment.

“These new figures showing a fall in the number of clinical trials reiterate the importance of the Australian Government’s clinical trial regulatory reform agenda,” said Dr Shaw.

“We are really encouraged by the actions of the Government to date, such as its election commitments to accelerate the pace of reform, a commitment of $10 million to implement the reforms, and the creation of the new Clinical Trials Action Committee.

“But the challenge now is to ensure that the reforms identified over three years ago are implemented as quickly as possible.

“Australia has real potential to grow in this area given our excellent research capabilities, good reputation and high international standing.

“While the increase in Phase I trials is encouraging, we know that Australia has not benefited from the massive shift in clinical trial investment away from traditional centres like North America and western Europe to the Asia-Pacific.

“Clinical trial investment in regional centres like Singapore, South Korea and Japan has increased by as much 300% since 2007 while Australia has struggled to even maintain existing levels of investment.”

Last year the McKeon Review of Health and Medical Research called for clinical trial reform to be made an ‘urgent national priority’ and in May this year, the Federal Government committed $10m to progress key reforms.

“We look forward to working with all stakeholders, including state and territory governments, on these important reforms because together we can make this country a leading destination for global investment in clinical trials for years to come,” Dr Shaw said.

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Contact Person:

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

Yet more price cuts announced yesterday to come into effect on 1 October for 300 medicines reaffirms that the Pharmaceutical Benefits Scheme is sustainable.

“We have been saying for a long time that these cuts will continue and, frankly, it’s no surprise. Some arguments that have been made about generic medicine pricing are clearly outdated,” Dr Brendan Shaw, Medicines Australia Chief Executive, said.

Generic medicines on the PBS will see price cuts of up to 62 per cent on October 1 when the first round of simplified price disclosure takes effect.

“The key issue for the PBS now is access to new medicines.

“We want to make sure that Australians can have the latest safe, effective and cost-effective treatments but the Australian medicines industry needs predictability and stability in policy.”

“Make no mistake, these reforms have hit the industry particularly hard. PBS reforms have secured an enduring savings mechanism through price disclosure,” Dr Shaw said.

“The important thing now is to ensure a predictable PBS that allows companies to work with the government to bring new medicines to the Australian community.”

Price cuts on two of the highest cost medicines on the PBS, cholesterol-lowering atorvastatin and rosuvastatin, will deliver the Government around $1 billion over the next four years from this one round of price disclosure alone. This is the second big price cut for atorvastatin from price disclosure.

Other medicines to treat depression, diabetes and cancer will also see price cuts including Chemotherapy medicines oxaliplatin with a 41 per cent price cut and paclitaxel with a 28 per cent price cut. Paclitaxel is also undergoing multiple rounds of price cuts.

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Contact Person:

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

This week it was announced that Medicines Australia Chief Executive, Dr Brendan Shaw, will be appointed to a position as Assistant Director General at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, Switzerland.

Dr Shaw will finish his tenure as Medicines Australia Chief Executive on 12 September and take up his new position at the IFPMA in Geneva in December.

Dr Shaw will have overview of global health policy for the IFPMA, reporting to the Director General and working on a range of issues including reimbursement, health technology assessment, access to medicines, vaccines and communications.

Medicines Australia Chairman, Dr Martin Cross, welcomed the announcement of Dr Shaw’s new role.

“This is a real credit to Brendan and recognition of his contribution to the industry in Australia and internationally,” Dr Cross said.

“While Medicines Australia will be sad to see him go, I have every confidence he will make a great contribution to the global pharmaceutical industry.

“His appointment is also a credit to the Australian pharmaceutical industry, being recognition of the high standing of Medicines Australia and the Australian industry internationally.

“We congratulate Brendan, wish him well and look forward to working with him in his new role at the IFPMA.”

Dr Cross also confirmed that Egon Zehnder had been appointed to work with the Medicines Australia Board in the search for a new Chief Executive.

“This is an important time for the industry in Australia and the Medicines Australia Board is keen to identify a strong candidate to take over the role from Brendan,” Dr Cross said.

“We have commenced a search process with Egon Zehnder and look forward to announcing Medicines Australia’s new Chief Executive in due course.”

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Contact Person:

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