Medicines Australia acting chief executive Dr Brendan Shaw has welcomed the ACCC’s decision today to authorise the new, tougher Medicines Australia Code of Conduct.

The Code of Conduct sets the ethical standard for the marketing and promotion of prescription medicines in Australia.

Dr Shaw said the ACCC’s decision reflected the considerable work undertaken by the innovative pharmaceutical industry to ensure its marketing and promotional activities continued to reflect community standards.

“Medicines Australia members have worked very hard over the past three years to demonstrate their commitment to transparency and ethical conduct,” Dr Shaw said.

“The Code provides an ethical framework for companies when they interact with health professionals and consumers. Medicines Australia members are continuously redoubling their efforts to ensure their conduct remains at a high ethical standard and that the Code sets the benchmark for industry self-regulation.

“The ACCC’s authorisation is the culmination of an 18-month consultation process during which Medicines Australia and the ACCC have sought input from patient groups, consumer organisations, healthcare professionals, Colleges, professional associations, academics and other stakeholders.

“I thank the many people who given up their time to make submissions and attend workshops as part of this review process.

“We have listened carefully to their suggestions and recommendations and we have acted upon them. The outcome is a tough and robust Code of Conduct which meets the community’s expectations.

“Medicines Australia members will continue to work towards ensuring the industry maintains the highest standard of transparency and ethical behaviour.”

Areas in which provisions of the Code have been strengthened are:

• Brand name reminders: a ban on brand name reminders that are ordinarily usedutside the surgery (eg pens, coffee mugs, notepads etc)
• Prescribing software: a ban on advertisements for prescription medicines in prescribing software used by doctors
• Support for consumer groups: any support provided by consumer groups must be disclosed on the company’s website
• Fines: the maximum fine for a breach of the Code is increased to $300,000

Edition 16 of the Code of Conduct will come into effect on 1 January 2010.

Edition 16 of the Code of Conduct is available here

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Contact Person:

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

Patients will have better access to information about how prescription medicines should be used, following the publication of Consumer Medicine Information on the website of the Therapeutic Goods Administration.

The Federal Government announced yesterday that the TGA has begun the process of posting on its website consumer information for all prescription medicines.

Medicines Australia’s acting chief executive Dr Brendan Shaw welcomed the initiative, saying it would bring significant benefit to patients and encourage more appropriate use of medicines.

“It is important that patients understand how their medicines work and how they should be properly used because medicines used properly work best,” Dr Shaw said.

“This initiative makes it easier for patients to find reliable, accurate information about their prescription medicines.

“Consumer Medicine Information will continue to be available from pharmacists whenever a prescription medicine is dispensed. But patients will now also be able to find it easily online.

“Pharmaceutical manufacturers provide this information to consumers because they have a responsibility to ensure their medicines are used appropriately.

“Medicines Australia has long argued that Consumer Medicine Information should be freely available on the TGA website. The Government has considered those arguments and has acted on them.

“This is an initiative which shows how Government and industry can work together to deliver a positive outcome for patients.”

The TGA will also publish Product Information, which provides doctors with technical information about the medicines they prescribe.

Consumer Medicine Information and Product Information is available at: http://www.tga.gov.au/meds/picmi.htm

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Contact Person:

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

Today’s announcement by the Government of three measures to further cut its investment in the Pharmaceutical Benefits Scheme undermines the pharmaceutical industry’s ability to bring new medicines to Australian patients.

“The Government’s decision to create three new therapeutic groups, contained in today’s Mid Year Economic and Fiscal Outlook is effectively an unannounced price cut,” Medicines Australia’s acting chief executive Dr Brendan Shaw said.

“It is a substantial blow to companies who have negotiated a fair price in good faith with the Government.

“Last week Victoria University published a major report which concluded that the PBS is sustainable, is one of the most affordable, efficient and effective parts of the health system and requires no further savings measures.

“The measure announced today appears to disregard that evidence.”

The creation of new therapeutic groups effectively lowers the price that the Government pays manufacturers for certain new medicines.

The prices the Australian Government pays manufacturers for new medicines are already the lowest in the OECD.

“Reimbursement prices to manufacturers in Australia are already 19 per cent lower than the OECD average,” Dr Shaw said.

“The Australian Government has a responsibility to pay a fair and reasonable price by OECD standards. The pharmaceutical industry does not expect the Government to pay over the odds, but industry doesn’t expect to be short-changed either.

“At some stage there must be a tipping point where companies will think twice before seeking PBS listing for new medicines.

“Changing the agreed parameters for PBS reform without sufficient warning removes the policy certainty on which companies rely to make their business decisions. This is at odds with the intent of PBS reform.

“The PBS listing environment is becoming increasingly discouraging for global companies making investment decisions about whether or not it is viable to bring new medicines to Australia. That is ultimately bad news for patients.”

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Contact Person:

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

The Pharmaceutical Benefits scheme is a robust policy instrument with which none of the Government’s many health reviews has identified a systemic problem, Medicines Australia chairman Will Delaat told the National Press Club today.

“For all the dysfunction and cost-shifting across the broader health system that has prompted the Rudd Government’s health reforms, the PBS remains a model of effectiveness, efficiency, stability and sound management,” Mr Delaat said.

Mr Delaat said a Victoria University study released this week found that the major PBS reforms of 2008 are delivering the intended policy outcomes.

The report showed that PBS growth is much lower than expected, that savings to Government from last year’s PBS reforms will be much higher than expected and that there is definitive evidence that the PBS is sustainable.

“According to the Victoria University report, average growth of the PBS will be in the order of 3.7 per cent per annum to 2013-14,” Mr Delaat said.

“That is sustainable by any measure, particularly given the ageing population.

“The PBS will continue to account for approximately 0.7 per cent of GDP – where it has been for the past 10 years.

“The fact that the impact of PBS reforms and ongoing mandatory price cuts have ensured the sustainability of the PBS in the medium-term is not open to question.

“The other good news for Government is that despite its own projections of a $3 billion saving to taxpayers from PBS reform over 10 years, the real number looks like being more than double that.

“PBS reform alone will deliver savings to the public purse of $6 billion – $3 billion dollars more than the Government had banked on. Effectively, industry has delivered Government an unexpected $3 billion windfall.

“The industry is alert to fiscal pressures and has tightened its belt accordingly. Prices are low. Savings are being delivered.”

Mr Delaat also told the National Press Club that the prices the Australian Government pays pharmaceutical manufacturers for new medicines are lower than any other government in the OECD.

Reimbursement prices to companies in Australia are 19 per cent lower than the OECD average.

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Contact Person:

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

Medicines Australia chairman Will Delaat today congratulated Paul Smith, of Australian Doctor, on winning the 2009 Medicines Australia Health Journalist of the Year Award.

Mr Smith was named as one of the four category winners for his story Why aren’t they screaming? in Australian Doctor. His prize as overall winner is a study tour to the United States with a focus on the health industry.

The Awards were presented by the Minister for Health and Ageing Nicola Roxon MP at the National Press Club, immediately prior to Mr Delaat’s address to the Club.

“I congratulate Paul and all the category winners,” Mr Delaat said.

“Australia is well served by an especially high standard in health journalism and Medicines Australia is very pleased to continue its support for these prestigious awards.”

The annual Excellence in Health Journalism Awards is hosted by the National Press Club of Australia. National Press Club President Ken Randall said “Paul Smith’s powerful article dealing with end-of-life patient treatment raises confronting ethical and practical issues for policy makers and the lay public, as well as health professionals.”

Mr Randall also thanked the awards corporate supporters – Medicines Australia as Awards Principal sponsor, Pfizer Australia, CSIRO, Australian General Practice Network and Pharmacy Guild of Australia as supporting sponsors.

The full list of winners is:

BEST NEWS FEATURE / ARTICLE OR PRESENTATION

Health, Health Sciences or Innovation

Tory Shepherd – Adelaide Advertiser, My Mary thought she would be cured: Tough questions for alternative medicine

BEST DOCUMENTARY OR DOCUMENTARY SERIES

Health, Health Science or Innovation

Mark Horstman and Dr Holly Trueman – ABC TV Catalyst, Monkey Malaria

BEST FEATURE / ARTICLE OR PRESENTATION

Health Policy, Health Economics and Health Business

Dr Maryanne Demasi – ABC TV Catalyst, Clearing the Fog

BEST NEWS FEATURE / ARTICLE OR PRESENTATION

For reporting on Health, Health Science or Innovation directed to medical professionals

Paul Smith – Australian Doctor, Why aren’t they screaming?

HEALTH JOURNALIST OF THE YEAR

Awarded to the most outstanding entry among the winners of the previous four categories

Paul Smith – Australian Doctor

Media Enquiries:

Maurice Reilly
Chief Executive
Ph: +61 2 61212152 (direct)
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Email: ceo@npc.org.au

A new Federal Government initiative to raise Australia’s profile as a destination for clinical trials will help improve international competitiveness in the $1 billion pharmaceuticals R&D sector, Medicines Australia’s acting chief  executive Brendan Shaw said today.

Dr Shaw said the clinical trials “Action Group” announced today by the Government will help ensure a viable future for clinical trials in Australia.

“I am greatly encouraged by the Federal Government’s commitment to a sustainable future for industry-sponsored clinical research in Australia,” Dr Shaw said.

“Australia attracts $1 billion a year in local and international pharmaceutical R&D investment, but we need to do more to remain competitive in a changing global environment.

“The Federal Government’s Action Group can help strengthen this country’s position as one of the world’s leading investment destinations for clinical trials.

“The pharmaceuticals industry invests hundreds of millions of dollars each year on clinical research in Australia.

“Apart from the economic benefits of this investment, there are tremendous health and professional opportunities for patients and medical researchers when global pharmaceutical companies conduct clinical trials here.

“If the Action Group succeeds in driving reform, it will be directly responsible for ensuring the retention of thousands of high-skilled Australian jobs and ensuring that we protect a significant investment in one of Australia’s most innovative and researchintensive industries.”

The Action Group, to be co-chaired by the Parliamentary Secretary for Health, Mark Butler and the Parliamentary Secretary for Innovation, Richard Marles, has been asked to identify better ways to approve, establish and conduct clinical trials.

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Contact Person:

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

Medicines Australia chairman Will Delaat has been named the 2009 winner of the Pat Clear Award, the pharmaceutical industry’s most prestigious award.

The Award was presented to Mr Delaat at Medicines Australia’s Annual General Meeting today.

The Pat Clear Award is the innovative pharmaceutical industry’s most coveted award. It is presented annually to recognise an outstanding level of commitment by an individual, group or team for the benefit of the Australian pharmaceutical industry.

Mr Delaat has been an active member of the Medicines Australia Board for the past 12 years, as chairman, deputy-chairman and director. He also served as managing director of Merck Sharp & Dohme Australia for 11 years before retiring in 2008.

He is the co-chair of the Industry-Government Access to Medicines Working Group, and chair of the Pharmaceuticals Industry Council.

In 2008 Mr Delaat was a member of the Pharmaceuticals Industry Strategy Group which was established by the Government to develop a plan to attract investment in R&D, clinical trials and manufacturing activity in Australia.

Medicines Australia’s acting chief executive Brendan Shaw congratulated Mr Delaat and said the Award was richly deserved.

“Will has made an extraordinary contribution to the pharmaceutical industry in Australia over 35 years,” Dr Shaw said.

“His leadership and vision for Australia’s pharmaceutical industry is well recognised by those in industry, government, the health sector and the wider community.

“Will has been instrumental in driving significant policy changes that have improved the commercial environment for the innovative pharmaceutical industry in Australia.

“He has been a long-time champion for the industry and this award is a well-deserved recognition of this.”

The Pat Clear Award was established in 2002 to commemorate the substantial contribution Mr Clear made to the pharmaceutical industry in Australia in an illustrious career which spanned 40 years.

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Contact Person:

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

A report on the impact of PBS reform released today by the Centre for Strategic Economic Studies provides conclusive proof that the Pharmaceutical Benefits Scheme is sustainable, Medicines Australia’s acting chief executive Brendan Shaw said today.

The study also shows that the 2008 reforms will deliver the Government an unexpected $3 billion windfall in savings.

“Last year’s reforms of the PBS were a response to concerns raised in the First Intergenerational Report that growth in the PBS was not sustainable,” Dr Shaw said.

“The CSES report shows very clearly that the 2008 PBS reforms are working and that the PBS is now sustainable.

“The Government expected the price cuts announced in the PBS reforms to save the taxpayer $3 billion over 10 years.

“This new report shows is that PBS reform will actually deliver savings to the public purse of $6 billion – $3 billion more than the Government had banked on.

“Effectively, industry has delivered Government an unexpected $3 billion windfall.

“This report reveals that PBS growth is much lower than expected and that savings to Government from last year’s PBS reforms will be much higher than expected.”

The PBS reforms were designed to allow the market to drive down the costs of older, off-patent medicines, allowing the Government to continue to subsidise the latest, most innovative medicines as they became available.

“The report provides hard evidence that the PBS is working well, the reforms are doing what they were designed to do and no further reform is needed in this area,” Dr Shaw said.

“This is proof that the impact of PBS reforms and ongoing mandatory price cuts have ensured that the sustainability of the PBS in the medium-term is not open to question.

“CSES concludes that average growth of the PBS will be in the order of 3.7 per cent per annum to 2013-14.”

“That is sustainable by any measure, particularly given the ageing population. So it’s good news for taxpayers, and it’s good news for patients.”

The Impact of PBS Reforms on PBS Expenditure and Savings is an independent report commissioned by Medicines Australia. It has been validated by Access Economics.

The report is available from here

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Contact Person:

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

Medicines Australia’s Acting Chief Executive Brendan Shaw today congratulated Russell Edwards on his reappointment to the Board of the National Prescribing Service.

“Russell’s reappointment is a positive move in fostering an effective Quality Use of Medicines agenda across the healthcare system,” Dr Shaw said.

“Medicines Australia looks forward to continuing to work closely with Russell and the NPS to help expand industry activity in this important arena.

“I expect that Russell’s exceptional experience and understanding of the pharmaceutical industry will remain pivotal in building on the constructive relationship between the NPS and Medicines Australia.

“Quality Use of Medicines is a key focus of the innovative pharmaceutical industry. It is essential that medicines are chosen wisely and used judiciously, appropriately, safely and effectively.

“The companies that make and supply prescription medicines have an important responsibility to ensure health professionals and consumers have up-to-date and relevant information to make wise choices about medicines.

“Medicines Australia welcomes all opportunities to work more closely with Government and other stakeholders to improve the Quality Use of Medicines.”

Mr Edwards has previously served as a member of the Medicines Australia Board and is currently a chair of the independent Monitoring Committee for the Medicines Australia Code of Conduct.

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Contact Person:

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

A common standard of transparency and accountability should apply across the therapeutics sector to all companies providing or sponsoring medical education, Medicines Australia chairman Will Delaat said today.

Mr Delaat’s comments follow the publication on Medicines Australia’s website of the latest education event reports, which show the detail of costs associated with educational events provided or sponsored by member companies.

“It is important that doctors’ relationships with pharmaceutical companies are based on integrity and transparency,” Mr Delaat said. “That is why Medicines Australia publishes these reports every six months.

“There is no such transparency elsewhere in the therapeutics sector.

“Companies which choose not to belong to medicines Australia have no obligation to publish the details of their engagements with healthcare professionals.

“There is no good reason why there should be one standard for Medicines Australia members and another, lesser, standard for non-member companies.

“There must be a consistent standard and I am encouraged that the Government has indicated its desire for a level playing field.”

The event reports published today show that healthcare professionals attended 31,007 hours of medical education provided or sponsored by Medicines Australia member companies.

The total cost of the 16,020 events was $31.89m, including $15.65m on hospitality.

The average cost of hospitality was $39.22 per attendee.

“Doctors continue to vote with their feet by attending these events because they derive genuine professional benefit from their engagement with pharmaceutical companies,” Mr Delaat said.

“Pharmaceutical companies take very seriously their responsibility to provide doctors with current, accurate and balanced information, which must be consistent with Government-approved Product Information.

“These engagements are legitimate, appropriate and, in the case of Medicines Australia members, transparent.”

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Contact Person:

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