The Board of Medicines Australia today announced that it has appointed Dr Martin Cross as the new Chair of Medicines Australia.

“The Medicines Australia Board has unanimously agreed to appoint Dr Cross as Chair and looks forward to working with him to progress the issues of the innovative medicines industry in Australia,” said interim Medicines Australia Chair, Mark Fladrich.

“Dr Cross has a wealth of experience in the industry, recently working in the generics industry after more than 20 years working in the innovative industry. He is a passionate advocate for, and supporter of, the sector in Australia which fits well with the purpose and objectives of Medicines Australia.

“This is an important and challenging time for our members so having someone of Dr Cross’ calibre at the helm is exciting and I am sure he will serve our industry with distinction.”

Most recently, Dr Cross was Managing Director of Alphapharm, Chair of the Generic Medicines Industry Association and Chair of the Pharmaceutical Industry Council. He has previously been Managing Director of Novartis in Australia and a member of the Medicines Australia Board. He has also previously worked over many years for ICI, Zeneca and AstraZeneca, another Medicines Australia member company.

Medicines Australia Chief Executive, Dr Brendan Shaw, said he was delighted with the announcement.

“This is a great appointment,” Dr Shaw said.

“Martin and I have worked together on various industry issues over the years, so I’m looking forward to working with Martin to prosecute the range of issues on the agenda for Medicines Australia.

“I also want to acknowledge Mark Fladrich’s leadership of Medicines Australia over recent months while a search for a permanent Chair progressed and thank him for his contribution.”

Dr Cross’ appointment commences in early November. Mr Fladrich will continue as interim Chair of Medicines Australia until that time.

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Contact Person:

Emma Pearson
Phone: (02) 8281 3280
Email: emma@ogilvyprhealth.com

Medicines Australia today welcomed the Coalition’s commitment to accelerate the implementation of reforms to make Australia a more competitive destination for global clinical trial investment.

“I welcome the Coalition’s announcement last night that, if elected, it would move swiftly towards a nationally consistent approach to the way clinical trials are overseen and conducted in Australia,” Dr Shaw said.

“The commitments by the Opposition Leader and the Shadow Health Minister on these reforms are to be congratulated.”

“Earlier this year, the McKeon Review of Health and Medical research called for clinical trial reform to be made an ‘urgent national priority’. Medicines Australia shares this view.”

The Federal Government committed in 2011 to implement all the recommendations from the Clinical Trials Action Group, which was established by the Government to arrest the decline in clinical trial activity in Australia.

“The Government’s commitment of $10 million in February made by both the Health Minister and Industries Minster to expedite clinical trial reforms was very welcome.”

“The Coalition’s announcement last night that it will expedite clinical trial regulatory reform measures means we have bipartisan political support to implement these important reforms.”

“Clinical trials are important not only for the massive investment they bring to Australia, but also for the role they play in improving Australia’s healthcare system. For instance, they deliver early and often free access to new healthcare technologies, which saves Australian taxpayers an estimated $100 million each year in hospital and PBS costs.

Patients also directly benefit by having clinical trials in Australia by getting early access to new therapies.”

“Australia is recognised globally as having some of the best scientists and research infrastructure in the world. Despite this, the number of clinical trials conducted here has declined by over 30% since 2007.”

“Australia faces fierce competition for clinical trial investment, but regulatory inefficiencies and extraordinarily high costs make it even harder to attract that investment here.”

“The commitments by the Coalition are great news and come on the back of the Government’s commitment to implement these important reforms,” Dr Shaw said.

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Contact Person:

Emma Pearson
Phone: (02) 8281 3280
Email: emma@ogilvyprhealth.com

Medicines Australia welcomes the release today of the Transparency Working Group’s model for reporting the payments made to healthcare professionals by pharmaceutical companies.

The Working Group has developed a model similar to the US Physicians Payments Sunshine Act, under which companies must disclose all payments to healthcare professionals over a nominal value.

Medicines Australia chief executive Dr Brendan Shaw said the release of the transparency model for consultation was a key milestone in the process established by Medicines Australia to provide greater transparency to the important relationships between the industry and healthcare professionals.

“The model provides greater transparency in the legitimate payments companies make to doctors and healthcare professionals,” Dr Shaw said.

“Medicines Australia members overwhelmingly support greater transparency so that the nature of their relationships with doctors is open to greater scrutiny. Member companies, like other stakeholders can now examine the detail of the model developed by the Transparency Working Group.

“Transparency is important because it builds public trust and confidence in those relationships.

“Engagement with doctors is important and legitimate because patients want to be sure that their doctors know how to use the medicines they’re being prescribed.

“I thank the Transparency Working Group for investing considerable time and care in developing a transparency model, in particular the chair of the Working Group Dr Dominic Barnes (Shire), and other Medicines Australia Board members who contributed, Geoff McDonald (GlaxoSmithKline) and James Jones (Takeda).

“The working group process has been an encouraging one and an example of constructive cross-sectoral collaboration and dialogue.”

Medicines Australia will now consider the model and consult with its member companies and the broader community. The model will be part of broad industry and external consultation during the review of the Medicines Australia Code of Conduct, which begins in July 2013.

Information on the Working Group, the transparency model and transparency principles can be found here (please follow link)

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Contact Person:

Emma Pearson
Phone: (02) 8281 3280
Email: emma@ogilvyprhealth.com

New legislation implementing the ‘TRIPS Protocol’ will give Australian companies the ability to help respond to future health crises in less developed countries Medicines Australia Chief Executive Dr Brendan Shaw said today.

“Medicines Australia strongly supports the implementation of the TRIPS Protocol in Australia,” Dr Shaw said.

The Intellectual Property Laws Amendment Bill 2013, which was introduced in Parliament last month, contains provisions that would allow third parties to seek a compulsory license from the Federal Court to manufacture patented medicines for export to developing countries facing health emergencies.

“Medicines Australia, its members, and other stakeholders worked closely with the Australian Government to design a system that would not only be consistent with the principles of the Doha Declaration on the TRIPS Agreement and Public Health but would also protect the rights of Australian patent holders,” Dr Shaw said.

“The global medicines industry has long been at the forefront of the effort to bring life-saving medicines to the world’s poorest. Since 2000, it has invested over $15 billion in public health programs in some of the world’s least developed countries and donated over 2 billion doses of vaccines and medicines for infectious and chronic diseases.

“It’s efforts like these which led Bill Gates to comment recently when in Australia that companies in the medicines industry are ‘good citizens’.

“The Bill also reforms other areas of Australia IP laws, including the clarification of Crown Use provision that were, again, developed in consultation with a range of stakeholders including industry.

“The Bill achieves the right balance between assisting people in developing countries to access treatments and safeguarding intellectual property to ensure new medicines and vaccines are developed for future generations.

“It’s a good example of how government, industry and stakeholders can work together to develop good policy and legislation that achieves common goals.

“I commend all sides of politics for pursuing these important reforms and delivering an outcome that will benefit patients around the world.”

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Contact Person:

Emma Pearson
Phone: (02) 8281 3280
Email: emma@ogilvyprhealth.com

Medicines Australia today welcomed the Coalition’s announcements that it will reduce red tape, protect medical research funding and provide policy certainty in medical research.

“Regulatory reform is an important part of encouraging medical R&D and the Coalition’s recent announcements on this are welcome,” said Dr Brendan Shaw, Chief Executive.

“Reforming the regulation of things like medical research, R&D and clinical trials is a key part of developing Australia’s future competitiveness in high skill, high wage, innovative industries.

“The Australian medicines industry is one of Australia’s real opportunities to secure Australia’s competitiveness in a post-mining boom future.

“The industry already invests $1 billion a year in R&D in Australia, much of it in clinical trials and in partnership with public research institutes, universities and hospitals.

“This is a key part of Australia’s medical research investment.

“The Coalition’s announcement that it will reduce red tape to free up businesses and researchers to spend more time and resources on research is very encouraging.

“One area of reform where we need to keep the momentum going is the reform of regulation around clinical trials of new medicines.

“Australia has great capabilities in medical research but we need to continue regulatory reform around things like clinical trials to ensure Australia remains competitive in the face of growing competition from other countries.

“Together with the Government’s welcome focus on improving the regulatory environment for clinical trials, the Coalition’s announcements move towards a bi partisan approach in this important area of microeconomic reform.

“We have a real opportunity to capitalise on Australia’s talents in medical research for the benefit of our economic future, which is why the Coalition’s announcement is welcome.

“We look forward to working with all sides of politics on this important area of microeconomic reform to secure Australia’s long term economic future.”

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Contact Person:

Emma Pearson
Phone: (02) 8281 3280
Email: emma@ogilvyprhealth.com

Medicines Australia chief executive Dr Brendan Shaw will again brave the depths of Canberra’s winter this year, sleeping rough in a cardboard box to raise money in support of homeless Australians.

Dr Shaw will be participating in the St Vincent de Paul CEO Sleepout on 20 June, in Civic Square in Canberra. The Sleepout is conducted at centres around Australia.

“It’s a great thing to do for a good cause,” Dr Shaw said.

“With overnight minimums in the capital already falling below zero, I certainly have some reservations about sleeping out in the middle of a Canberra winter.

“Having done this before, I know that sleeping rough can be an extremely cold, wet and miserable experience.

“Last year was a salutary lesson for me in how not to build a cardboard shelter in the rain. I learned things such as don’t build your shelter in a drain, be alert for water running into your sleeping bag, and remember to wake up when your cardboard collapses on you in a storm at 3am.

“Of course many people simply don’t have a choice about whether or not to sleep out, they just have to. As a community we need to do all we can to help homeless people get off the streets and into proper accommodation.

“There is more we can do to support the homeless and work towards ending homelessness, so I’m very pleased to be able to help out in is way.

“We need to be much more aware of the plight of homeless Australians. I hope the CEO Sleepout will help give this serious issue the attention it deserves.

“There are many issues that homeless Australians have to confront every night which very often we don’t even think about. The CEO Sleepout gives participants a much better insight into some of those issues.

“Hopefully I can raise enough money to help make a difference and give me some solace through the night.”

If you would like to sponsor Dr Shaw’s participation in the CEO Sleepout and help raise money for St Vincent de Paul you can sponsor him at: http://www.ceosleepout.org.au/ceos/act-ceos/brendan-shaw-medicines-australia

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia today launched its 2013 Federal Election document, calling on all sides of politics to fix deficiencies in the Pharmaceutical Benefits Scheme and restore confidence in the process that makes new medicines available to patients.

Launching Medicines Now: the 2013 Federal Election, Medicines Australia chief executive Dr Brendan Shaw said patients were already missing out on some new medicines because the PBS listing system had become too difficult.

“The PBS listing process needs to be reviewed and fixed urgently because patients are missing out on new medicines,” Dr Shaw said.

“We have now reached the point where companies are simply unable to make some new treatments available on the PBS.

“We have treatments for melanoma and rare diseases where the sponsoring companies have abandoned plans to list on the PBS and other treatments for prostate cancer, melanoma and stroke prevention that have been recommended for listing but are still awaiting funding.

“It’s absurd that melanoma treatments that are freely available in countries like Poland and Belgium are not available in Australia, the melanoma capital of the world.

“We have a medicine for Pompe’s disease is publicly funded by governments in Greece, Cyprus and Italy, but is not publicly funded in Australia.

“The bipartisan intention of PBS reform has always been to use savings from older medicines to fund new medicines, to avoid a situation where the wealthy can afford new medicines by paying full price for them, but other Australians go without because those medicines are not being subsidised on the PBS.

“The process for PBS subsidy is getting more difficult, more complicated and more unpredictable. Australia’s a wealthy country and we should be able to afford medicines for sick people.

“I call on a future Government to restore transparency, certainty and confidence to the PBS listing process and ensure all Australians have timely access to the treatments they need.”

Medicines Australia’s election document also calls on an incoming government to commit to listing all medicines recommended by the Government’s expert advisory committee, to strengthen intellectual property provisions, ensure a predictable and stable business environment, and encourage investment in the medicines industry.

Medicines Now: the 2013 Federal Election is available here

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

The number of new medicines listed on the Pharmaceutical Benefits Scheme in 2011-12 was the lowest for 20 years, according to a ground-breaking report released today by the Centre for Strategic Economic Studies.

The Impact of Further PBS Reforms study also found that reforms to the PBS agreed between the Commonwealth and Medicines Australia over the last decade will deliver up to $18 billion in savings.

The report further concludes:

• Patients’ out-of-pocket costs for prescription medicines have fallen by an average 6 per cent as a result of the PBS reforms agreed between the Government and the medicines industry.
• PBS spending over the next seven years is likely to be constrained due to the reforms and savings from medicines coming off-patent, assuring the sustainability of the PBS to at least 2018.

Medicines Australia chief executive Dr Brendan Shaw said the analysis quantifies for the first time the magnitude of savings flowing from reforms to the PBS in the eight years to 2017-18.

“These savings were intended to fund new medicines on the PBS, but this report shows that the number of new PBS medicines listed last year was the lowest in 20 years,” Dr Shaw said.

“That’s very alarming because it means many patients who need new treatments aren’t getting access to them. Consumers expect better than that. Australia should be a country that can afford new medicines for patients.

“This decline is not due to any fall in the number of new therapies being proposed by companies. It has been due to things like higher rejection rates at the Pharmaceutical Benefits Advisory Committee and delays in the listing process for new medicines.

“The real challenge now is to ensure these multi-billion dollar savings are used to get new therapies to patients.

“The rationale behind PBS reforms with successive governments was to drive savings in the off-patent market, and use those savings to list new medicines. Those savings have been delivered; the issue now is ensuring new medicines can be listed.

“This report and the Government’s own Budget last week; both confirm that PBS reforms implemented over the last decade are driving substantial savings for government and consumers.”

The Impact of further PBS reforms was commissioned by Medicines Australia and is available here

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

Medicines Australia chief executive Dr Brendan Shaw tonight welcomed the Government’s recognition in the Budget that the Memorandum of Understanding with Medicines Australia continues to keep the Pharmaceutical Benefits Scheme sustainable.

Dr Shaw said the Budget reflected the Government’s commitment to the MoU, which agrees to no further price related savings measures for the life of the agreement.

“This Federal Budget shows the value of a collaborative, negotiated approach to managing the PBS,” Dr Shaw said.

“PBS spending growth is currently at historically low levels, so it’s clear that the MoU and previous reforms are working, and it’s clear that the PBS is sustainable.

“The $2.3 billion downward revision on PBS expenditure can be directly attributed to the agreement between the industry and the Commonwealth.

“It shows that responsible agreements such as the MoU provide a robust framework for managing the PBS. They provide material benefits to governments and taxpayers.

“This Budget outcome should also provide the Government with the confidence that it can act expeditiously on PBAC recommendations and provide Australian patients with timely access to new medicines.

“Medicines Australia will continue to work with the Government to ensure Australians get such access.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au

A report comparing the Australian medicines system with that of New Zealand highlights why Australian policymakers should not seek to emulate the New Zealand model, Medicines Australia chief executive Dr Brendan Shaw said today.

The report by Medicines New Zealand shows that in June 2012 Australian patients had access to 94 more prescription medicines than New Zealanders.

The report also shows that New Zealand spends significantly more on healthcare as a proportion of GDP than Australia.

“What this report clearly shows is that patients would be worse off if Australia adopted a New Zealand-style access to medicines policy,” Dr Shaw said.

“For all the recent debate we’ve had in Australia about cutting healthcare costs and adopting a New Zealand model, it’s very clear that patients across the Tasman just aren’t getting the access to medicines they need.

“That’s what happens when a healthcare system focuses on cost containment at the expense of health outcomes. Australians deserve better than that.

“Historically, the Australian system has been able to provide a range of treatment options and newer medical technologies for patients than has the New Zealand system.

“The higher level of spending on overall health in New Zealand might reflect the fact they don’t invest enough in new medicines in their health system. There have been a number of studies over the years showing that the more a country invests in newer medicines, the less it spends in overall healthcare.

“Late last year the US Congressional Budget Office concluded that a 1 per cent increase in the number of prescriptions filled causes US Medicare spending to drop by roughly 0.2 per cent.”

The Medicines New Zealand report concluded that health authorities in New Zealand   “… try to further constrain cost-effective spending on medicines in order to continue their own spending on interventions that are often less cost effective.

“A better approach to allocating the medicines budget would result in a more efficient health system overall, while allowing New Zealanders to get closer to Australia in medicines access.”

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Contact Person:

Jamie Nicholson
Media Communications Manager
Phone: 0419 220 293
Email: Jamie.Nicholson@medicinesaustralia.com.au