New figures from the Therapeutic Goods Administration (see below) show that the number of clinical trials undertaken in Australia has fallen for the fourth time in five years.

The TGA’s latest Half-Yearly Performance Report shows 602 new clinical trials were begun in Australia in 2012, down from 635 trials in 2011 – a decline of 5%.

Clinical trial numbers are down 30% from their 2007 high of 865.

Medicines Australia chief executive Dr Brendan Shaw said the ongoing decline highlights the urgent need for the Government to deliver on its promise to implement major reforms that will make Australian R&D more internationally competitive.

“These reforms should have been implemented years ago,” Dr Shaw said.

“While we welcome the Government’s recent re-commitments to the required regulatory reforms, these figures and last week’s McKeon report on health and medical research sheet home the importance of cementing these reforms into place as soon as possible.

“In fact, last week’s McKeon report called for clinical trail reform to be made an ‘urgent national priority’. Medicines Australia shares this view.

“Australia is recognised globally as having some of the best scientists and research infrastructure in the world and that is an important strategic advantage. But we are facing fierce international competition for clinical trial investment.”

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 trials activity.

“Make no mistake, this is a key area of microeconomic reform for Australia,” Dr Shaw said.

“Yet, more than two years after the report’s release, the major recommendations have not yet been implemented. In the meantime, we have been losing trials to other countries.

“There is an urgent need for far greater political activity both at Federal and State level to implement these regulatory reforms.

“We are bleeding clinical trial investment to other countries at the moment.

“These reforms will help return Australia to the forefront of medical research and ensure the retention of thousands of high-skill Australian jobs.

“The very future of Australia’s $1 billion clinical research industry is at stake.

“The competition for R&D investment from countries is extremely fierce. While commitments are important, at the end of the day it is only when the reforms are implemented that they’ll actually make a difference.

“Only with the right policy settings in things like regulatory policy, intellectual property and the Pharmaceutical Benefits Scheme can we hope to grow our R&D industry and keep cutting-edge medical science in Australia.”

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Contact Person:

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

The landmark McKeon report released today sets out a decisive blueprint for the future of health and medical research in Australia, Medicines Australia chief executive Dr Brendan Shaw said.

Dr Shaw said the report’s recommendations to strengthen intellectual property and accelerate improvements to Australia’s clinical trials system would encourage global investment in R&D and lead to a better and more efficient healthcare system.

“This report carries the authority of Australia’s most eminent medical research scientists and business leaders,” Dr Shaw said.

“In particular, it reinforces the importance of a strong, stable and globally harmonised IP system. It exposes the short-sightedness of calls from other quarters to dismantle Australia’s patent system.

“This report focuses on encouraging Australia to do what it does best, which is innovating and creating knowledge.

“It acknowledges that ‘IP is clearly a valuable commodity in Australia’s knowledge-based economy, and skilful IP protection is necessary to ensure inventions are safeguarded’.

“Medicines Australia strongly supports the recommendations that Australia should not ban patents on biological materials nor make it easier to obtain compulsory licences. We strongly support the recommendation that the term of data exclusivity in Australia should align with global best practice.

“I also particularly welcome the report’s recommendations to accelerate the implementation of key reforms that will make Australia a more attractive place in which to invest in clinical trials.

“Significantly, the report recommends this work should be an urgent national priority.

“There has been minimal progress in implementing these reforms since they were announced two years ago. In the meantime, we have been losing trials to other countries.

“There is an urgent need for far greater political resolve both at Federal and State level to implement these key regulatory reforms.

“I congratulate Mr McKeon and his panel on the significant work they have undertaken to deliver such a thorough and comprehensive review.

“These recommendations are worthy of bi-partisan support and should be implemented expeditiously.”

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Contact Person:

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

A new report published by Medicines Australia points to the tough business conditions currently confronting the medicines industry in Australia.

The latest Medicines Australia Facts Book, which contains key industry statistics and other information, shows the medicines industry is facing significant challenges.

The Facts Book reveals:

1. Medical sales and service income for the medicines industry fell to $9.718bn in 2010-11, down from $10.021bn in 2009-10 – a decline of 3%.
2. The number of new medicines listed on the Pharmaceutical Benefits Scheme fell from 22 in 2010-11 to just 15 in 2011-12.
3. The number of Australians employed in the medicines industry declined for the fourth consecutive year, to 13,375; since 2006-07 more than 1300 Australian jobs have been lost from the medicines industry.
4. Annual turnover of the Australian medicines industry in 2010-11 grew by just 2%, from $21.95bn in 2009-10 to $22.46bn.
5. Annual investment in pharmaceutical R&D grew by just 0.3% per cent, from $1.034bn in 2009-10 to $1.037bn.
6. Australia’s R&D investment growth between 2005 and 2010 compares poorly with other markets: 42 per cent, compared with 46 per cent in Africa, 112 per cent in Canada, 303 per cent in India and 455 per cent in Japan.
7. Company tax rate in Australia remains five percentage points higher than the OECD average.
8. Australia remains well below the OECD average total expenditure on health as a proportion of GDP.

Medicines Australia chief executive Dr Brendan Shaw said the report highlighted the impact of a challenging and unpredictable policy environment.

“There’s no way to sugar-coat it, 2012 was a tough year for the Australian medicines industry,” Dr Shaw said.

“While the industry is still proudly one of Australia’s leading manufacturing export industries, generating over $4 billion a year in exports, the fact is jobs have been lost, clinical trial numbers are down more than 30% over the past six years, sales growth is low, patents on many major medicines are expiring, and the operating environment is generally becoming much tougher.

“Late last year we saw several companies announce over 300 job losses in the industry partly due to the tough PBS operating environment from things like listing delays and major price cuts for patented and off-patent medicines.

“We’re keen to build the Australian industry so Australia can capitalise on our great medical research capability.

“The Australian medicines industry makes a considerable contribution to the national economy, with $4 billion in exports, $1 billion of R&D investment and 13,000 high-value Australian jobs.

“There is an opportunity to protect and grow that economic contribution and to protect and grow Australian jobs. What’s needed is a return to a more predictable and stable policy environment.”

The Medicines Australia Facts Book can be downloaded here

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Contact Person:

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

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

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

Medicines Australia chief executive Dr Brendan Shaw said the mandatory program, delivered by Medicines Australia and the University of Tasmania, highlighted the industry’s commitment to ethical conduct.

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

“Representatives have the job of ensuring the dialogue between the companies who make the medicines and the doctors that prescribe them is productive, balanced and ethical.

“Interaction between medicines companies and health care professionals is an important part of promoting patient health, so it is important we get it right.

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

“I congratulate all students who completed the course and in particular the award winners. The fact that so many students have been recognised for their high achievement in this program shows how importantly ethical conduct is regarded.”

The Medicines Australia Code of Conduct Award, for full marks in the Code of Conduct Program, was presented to Sharon Wong (Sanofi).

The UTas Excellence Award for the most active and best quality participation in online student group discussion was presented to Michalina Filipowicz (Lundbeck).

The Medicines Australia CEP Achievement Awards, for the highest marks across all five core Programs went to: Rachel McGregor (Abbott), Sharon Elliott (AstraZeneca), David Tran (Boehringer Ingelheim), Andrea Blank (Boehringer Ingelheim), Helen Duck (GSK), Blessed Ramos (GSK), Jaime Gunther (MSD), Rodney Foong (Novartis), Jessica Ellershaw (Pfizer), Clair Morris (Sanofi), Sally Bishay (MSD).

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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 said: “I encourage pharmaceutical representatives to download and familiarise themselves with the app.”

“It has been designed to make life easier for pharmaceutical marketers and representatives, for managers in marketing agencies and others who regularly refer to the Code of Conduct.”

“The Code and the Guidelines will be presented together, so the information will be much better integrated and easier to use. There are a number of features such as options to bookmark pages, share content and a help desk.”

“The MA Code iPad app will also enable us to share answers to questions and provide updates much more efficiently.”

“With the expected uptake of the new app Medicines Australia will print 10,000 fewer hard copies of the Code of Conduct, so it’s enabling us to cut costs and reduce our environmental footprint.”

The MA Code iPad app was developed by pharmaceutical digital agency and Medicines Australia member Princeton Digital.

The MA Code iPad app can be downloaded from: www.appstore.com/macode

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Contact Person:

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

Patients would be worse off if Australia adopted a New Zealand-style access to medicines policy, Medicines Australia chief executive Dr Brendan Shaw said today.

Responding to a report on pharmaceutical prices published today by the Grattan Institute, Dr Shaw said proposals to cap spending on the Pharmaceutical Benefits Scheme would limit patient’s access to medicines.

“If you want a how-to guide for turning your health system into that a third-word country, this report would be it,” Dr Shaw said.

“Capping the PBS would kill consumer access to new therapies as the experience in New Zealand proves.

“It undermines the fundamental principal of universal and affordable access to medicines that underpins the Pharmaceutical Benefits Scheme and has done for 60 years.

“Anyone who wants to emulate the New Zealand model of medicines policy should remember that New Zealanders have access to less than half the number of new medicines that Australians have and that New Zealand is stone motherless last in the OECD access to medicines rankings.

“So much so that when New Zealanders can’t access a variety of new medicines in their country they come over here.

“That is a direct result of the policies and processes adopted by New Zealand to assess and reimburse medicines there. That’s what happens when you run healthcare on the cheap and focus on cost containment at the expense of health outcomes.

“Australian patients deserve better than this.

“As recently as last week, the Australian Minister for Health said different countries’ pricing policies can’t be assessed in isolation from their impact on health outcomes.

“New Zealand is a basket case when it comes to access to medicines. It’s the last place health policymakers in this country should be looking to for ideas.

“There’s nothing new in this report. Many of the ideas raised in it have been looked at by governments on both sides of politics over the years and been rejected for good reason.

“Some of the proposals included in the report have led directly to medicines shortages in Australian hospitals and other countries.

“Australia’s system of price disclosure was introduced by the Howard government and bolstered by the current Government. The fact is price disclosure works and is delivering multi-billion dollar savings to taxpayers. It has already led to substantial price reductions in a range of medicines of 80 per cent or more.

“It’s a system that works well and ensures patients have good access to the medicines they need.”

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Contact Person:

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

The announcement today of an alliance between Interpol and the global medicines industry to combat the trade in counterfeit medicines is a timely reminder of the dangers of buying prescription medicines over the internet.

The alliance between Interpol and 29 pharmaceutical companies to create a Pharmaceutical Crime Program will focus on preventing counterfeiting of medicines, dismantling organised crime networks and raising public awareness.

Medicines Australia chief executive Dr Brendan Shaw said the initiative is a reminder of the risks of buying medicines on the internet.

“The advice from Medicines Australia is very clear: don’t buy medicines on the internet because you just don’t know what you’re getting,” Dr Shaw said.

“Prescription medicines in Australia are very well regulated to make sure they’re safe and they work properly.

“Consumers can be confident that the medicines they receive through the normal channels in Australia, such as through your pharmacy or hospital, are the real McCoy.

“But there is no regulation of medicines sold over the internet, so you risk serious side effects, allergic reactions or interactions with your existing medication.

“Fifty per cent of medicines bought over the internet from illegal websites are fake.

“That means you just don’t know what you’re buying or where it’s from. And there’s no guarantee that what it says on the box is what’s in the pill.

“Medicines bought over the internet may not have the active ingredients they claim to have, some may not work, or may have other ingredients in them that are actually dangerous. We strongly urge consumers to think about the risks and stay away from online medicines. It’s not worth jeopardising your health.

“Clear evidence is emerging of thousands of websites operating internationally that are engaged in the supply of counterfeit medicines.

“It’s alarming that millions of doses of pills falsely claiming to be antibiotics, anti-cancer, anti-depression, pain killers or treatments for erectile dysfunction from rogue internet sites are finding their way into the marketplace.

“With this new initiative the medicines industry is doing its bit to help combat counterfeit medicines, and the best way for consumers to avoid them is to get prescriptions through the normal channels such as your local community pharmacy or hospital.”

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Contact Person:

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

25 February 2013: Proposals for the Pharmaceutical Benefits Scheme to preference generic medicines over originator brands is not supported by evidence that the Government would realise any savings, Medicines Australia chief executive Dr Brendan Shaw said today.

Dr Shaw said: “Policy makers should consider any proposed changes to the PBS and their costings with great care, as history shows that ad hoc, piecemeal changes to the PBS have ended up being bad for industry, government and patients.

“There is nothing new here. Many of the proposals being advanced today have been around for years, have been considered and have been rejected on good policy grounds.

“Proposals to privilege one group of manufacturers at the expense of another group of manufacturers would distort the medicines market, would undermine the principles of the PBS, would limit doctor and patient choice, and would likely not drive any savings for the Government.

“The hard evidence shows that the current price disclosure system for the PBS, developed by current and former governments, in partnership with the industry, has reduced the price the Government pays for generic medicines and their branded equivalents by as much as 80 per cent.

“If we need a policy discussion on future management of the PBS, then consultation and consideration will better serve that discussion.”

Medicines Australia represents more than 50 companies that supply the majority of the medicines that are available to Australian patients through the Pharmaceutical Benefits Scheme.

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Contact Person:

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

Mark Masterson, Chairman of Medicines Australia, today announced his resignation from the Medicines Australia board. Mr Masterson will be taking up a new business opportunity in a leadership role with a technology company.

The Medicines Australia board accepted with regret Mr Masterson’s resignation, which will take effect at the end of February, and wished him well in his future endeavours.

Mr Mark Fladrich, the managing director of AstraZeneca Australia and New Zealand and a Medicines Australia director, will be acting Chairman until a new independent Chair is appointed.

“It has been an enormous privilege to serve this great industry as Medicines Australia Chairman,” Mr Masterson said.

“The medicines industry in Australia has navigated some significant policy and business challenges during my tenure, and has shown extraordinary resilience in the face of those challenges.

“I thank the board for their support during my term as chairman and I wish Medicines Australia every success.”

Medicines Australia chief executive Dr Brendan Shaw said: “It has been a genuine pleasure working with Mark over the past year. He has provided solid stewardship of the board and the industry and has delivered great support to Medicines Australia.

“We understand his decision and wish him well for the future.”

The Medicines Australia board will shortly commence a search for a replacement independent Chair.

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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 welcomed the Government’s industry and innovation statement released today by the Prime Minister.

“The Government’s positive engagement in this vitally important area of public policy for Australia’s future through the Prime Minister’s Manufacturing Taskforce, the Clinical Trials Action Group and the McKeon Strategic Review of Health and Medical Research is to be applauded,” Dr Shaw said today.

“Innovation by Australian businesses leads to greater productivity, stimulates employment and makes us a more competitive nation in the global economy.

“The Government’s Statement, A Plan for Australia Jobs, describes a number of opportunities for Australia to capitalise on our established strength in medical research.

“The Government’s further commitment to implement clinical trial reforms that were recommended by the Clinical Trial Action Group is especially welcome. Medicines Australia, has been strongly advocating for these reforms since the Action Group reported to Government in March 2011.

“It is encouraging to see funding and policy commitment being directed to these crucial microeconomic reforms for Australia’s innovative future.

“Clinical trial reform has a had a long and rather torturous history – two steps forward, one step back – so it is satisfying to see the Government commit real financial resources to getting this work done.

“Given the disappointments of the past, this is great news and we are very keen to work with the Government to ensure this important area of microeconomic reform is implemented as soon as possible.”

Dr Shaw also applauded the proposed establishment of 10 Innovation Precincts.

“These precincts, supported by the new Industry Innovation Network, will provide opportunities for Australia’s biotech and medicines companies to connect and collaborate with other businesses to create synergies and efficiencies.

“The global bio-pharmaceutical industry is constantly looking for opportunities to partner with research institutions, universities and emergent biotech companies. The Innovation Precinct concept is a real opportunity for Australia to capitalise on opportunities for collaboration.

“The Plan for Australian Jobs is a step up in innovation policy for Australia and should be welcomed by Australian business.

“In an environment where the pharmaceuticals industry has faced over 300 job losses in the last quarter of 2012, we welcome initiatives that will help reverse this trend.

“Medicines Australia and our member companies look forward to working with the Government to finalise and implement clinical trial reforms in a timely manner and to create opportunities for Australia’s medicines industry to build on its success in driving innovation in partnership with the Australian research sector.”

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Contact People:

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

Brendan Shaw
Chief Executive
Phone: 0413 013 501
Email: Brendan.Shaw@medicinesaustralia.com.au