ers said today.

The report to Government was released today by the Minister for Innovation, Industry, Science and Research, Senator Kim Carr.

It recommends that Government set up a strategic industry investment fund to support major pharmaceutical manufacturing and R&D activity. It also recommends measures to reverse Australia’s declining global competitiveness as a destination for clinical trials.

“I urge the Government to implement the recommendations of this report without delay. These measures will help defend Australia’s pharmaceuticals industry from further job losses and contribute to its long-term viability,” Mr Chalmers said.

“Government inaction on this issue, especially at this time of economic stress, could have heavy consequences for the industry and for Australian jobs.

“The pharmaceuticals industry employs 40,000 Australians in high-value jobs. The industry invests $860 million a year in research and development, and exports $4 billion worth of products a year. That is a major contribution to the national economy.

“Over the past 18 months, more than 500 Australians working in the pharmaceuticals industry have already been made redundant.

“The PISG Report recommendations can help protect against further job losses. They will also help ensure that the pharmaceutical industry continues to contribute significantly to the Australian economy.”

Mr Chalmers congratulated Senator Carr on establishing the Pharmaceutical Industry Strategy Group in May 2008 and on recognising the value of pharmaceutical innovation.

“I commend Senator Carr for instituting this review. This initiative demonstrates foresight and underscores a well-known commitment by the Minister to a viable pharmaceuticals industry in Australia.

“I now call on the Government to quickly implement the PISG recommendations which will help protect Australian jobs and keep Australia’s pharmaceuticals industry viable.”

The report to Government was developed by a panel of industry experts, including senior executives from the biotech, generic and innovative pharmaceuticals industries, as well as representatives of employee groups.

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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 urged the Government not to reduce funding for the Pharmaceutical Benefits Scheme in the 2009 Federal Budget. Mr Delaat said such a move would result in higher costs elsewhere in the healthcare system.

Speaking at the National Press Club, Mr Delaat said any cut to PBS spending would impact negatively on patient health outcomes. He said reducing the PBS as a short-term cost-saving measure would be a false economy.

“To quote the Minister for Health and Ageing, Nicola Roxon, ‘The point we often miss with the PBS is that we are saving money by often spending money on medications,’” Mr Delaat said.

“The PBS delivers those savings because innovative medicines can prevent the need for care at public hospitals, shorten stays in hospitals where they are required and relieve the costs of other institutional care.

“In short, appropriately used medicines help people stay out of hospitals and lead longer, better, more productive lives.”

Mr Delaat said the PBS had to be treated as an investment that offsets the cost of chronic disease.

“Clearly Australia is not immune from the impacts of the current financial uncertainty, and the Federal Government faces some tough calls as we navigate our way through this challenge,” Mr Delaat said.

“But it would make no economic sense for the Government to seek short-term savings by cutting the PBS.

“It would be a false economy to cut a Federal health program that delivers a net saving to the state health system.

“Any cut to the PBS would translate directly to an increase in state healthcare expenditure at the very time when state governments are struggling to adequately fund public hospitals.”

Mr Delaat also pointed to PBS reforms introduced last year, through which the pharmaceutical industry will contribute $580 million in savings to the Government over the next four years, and $3 billion over the next 10 years.

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Contact Person:

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

A new publication released today by Medicines Australia demonstrates the impact innovative new medicines and vaccines have had in tackling illness and disease in Australia.

Innovating for Life was launched by Medicines Australia Chairman Will Delaat at the National Press Club this afternoon.

The book shows how the lives of a handful of ordinary Australians have been affected by asthma, stroke, HIV/AIDS, depression, breast cancer, rheumatoid arthritis and childhood infectious disease, and illustrates the benefits of the respective medicines and vaccines used in their treatment.

“Innovating for Life brings together a collection of real stories about real Australians confronting their health challenges,” Mr Delaat said.

“These are the powerful personal stories which definitively demonstrate the value of medicines and vaccines.”

Innovating for Life tracks the progress in tackling some of the major diseases afflicting Australians today:

• Since 1996 the number of hospital days due to asthma has more than halved.
• In the 11 years following the introduction of highly active anti-retroviral therapy in Australia in 1996, the number of HIV-AIDS deaths fell by 87 per cent.
• Survival rates for some common cancers have increased by between 15 and 20 per cent since the mid-1980s.
• Life expectancy in Australia has risen from 69 years in 1948 to 81 years today.

“Medicines have made a major contribution to these success stories. They save lives, reduce pain and prevent disease,” Mr Delaat said.

“That is why access to medicines is so important. It is why the pharmaceutical industry and the Government must continue to work together to ensure all Australians have timely access to the medicines they need.”

Innovating for Life will be available free for doctors’ surgeries and waiting rooms across Australia, and to key stakeholders in the healthcare sector. It is also downloadable from here

Hard copies can also be ordered by email OR by phoning (02) 6122 8500

Contact Person:

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

The 2008 Pat Clear Award has been won by Mitch Kirkman, manager of clinical research at Novartis Pharmaceuticals Australia.

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

The Pat Clear Award is the innovative pharmaceutical industry’s most prestigious and 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 Kirkman won the Award for his outstanding work as founding chair of Medicines Australia’s Research and Development Taskforce, spearheading the pharmaceutical industry’s efforts to achieve nationally standardised regulation of clinical research in Australia.

Medicines Australia chief executive Ian Chalmers congratulated Mr Kirkman, and said the Award was richly deserved.

“This Award recognises a very significant contribution to our industry,” Mr Chalmers said.

“Mitch has a long and distinguished record of dedicated service to the innovative pharmaceutical industry. He is a very worthy winner of this prestigious Award.

“Under his stewardship, the R&D Taskforce has argued energetically and persuasively for rationalisation of Australia’s fragmented regulatory system for clinical research.

“Clinical trials account for the vast majority of research and development expenditure by Australian pharmaceutical companies. Under Mitch’s chairmanship, the R&D Taskforce has helped secure a much improved regulatory environment for clinical research.

“This means medical research can be conducted more efficiently. Future Australian patients will have earlier access to effective new therapies, unknowingly benefiting from the important work of a classic quiet achiever.”

The Pat Clear Award was established in 2002 to commemorate the contribution Mr Clear made to the pharmaceutical industry in Australia.

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Contact Person:

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

An independent monitoring and audit process of 15,836 educational events sponsored or provided by pharmaceutical companies has found that all but 21 fully comply with the Medicines Australia Code of Conduct.

The 21 events identified by the Code Monitoring Committee as potentially breaching the Code have been referred to the independent Code of Conduct Committee for a final determination.

Medicines Australia chief executive Ian Chalmers said the half-yearly report of member companies’ educational events for healthcare professionals showed that companies were undertaking those events in an ethical manner.

“An independent monitoring process shows that 99.9 per cent of educational events comply with the Code of Conduct,” Mr Chalmers said.

“That is a pretty good record. But we want to get to 100 per cent, so any breaches of the Code won’t be tolerated. We take a zero tolerance approach to this.”

Mr Chalmers said ethical engagement between pharmaceutical companies and healthcare professionals is an important means of keeping prescribers up to date with new developments in medicines.

“Pharmaceutical companies have a responsibility to patients to ensure doctors have the latest information about prescription medicines,” Mr Chalmers said.

“It is critical that healthcare decisions affecting every Australian are informed by dialogue between those who make medicines and those who prescribe them. That is vital for Australian patients.”

The report includes details of educational events provided or sponsored by 40 Medicines Australia member companies during the six months to 30 June 2008.

The cost of hospitality (travel, accommodation and catering) listed in the report is $17.9 million. The total cost of events, including hospitality, speaker costs, event organisational costs, venue hire and other related expenses is $32.6 million.

The total number of healthcare professional attendances is 399,339, with an average hospitality cost of $45 per head.

Mr Chalmers said educational events must be undertaken within strict guidelines.

“The community can be assured that we have a rigorous Code of Conduct, which sets a high ethical standard for these events,” Mr Chalmers said.

“Lavish hospitality is banned, personal gifts are banned and entertainment is banned. We take a tough line on that.”

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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 Ian Chalmers has congratulated the Government on its decision to publish the Pharmaceutical Benefits Advisory Committee’s agenda six weeks in advance of its quarterly meetings.

Mr Chalmers said the measure was an important step in improving the transparency and accountability of the Pharmaceutical Benefits Scheme listing process for new medicines.

“I commend the Minister for Health and Ageing, Nicola Roxon on this important initiative, which is a significant reform to the PBS,” Mr Chalmers said.

“This measure will give patients, doctors and the wider community the opportunity to provide input to the PBAC decision-making process. They can now participate in decisions that will affect their day-to-day life.”

The move to make PBAC agendas available to the public stems from discussions held at the Medicines Australia / Department of Health and Ageing Joint Medicines Policy Conference in 2006.

It is also a result of subsequent work undertaken by the joint industry-Government Access to Medicines Working Group, which was established as a key part of PBS reform to investigate means of improving the process for listing new medicines on the PBS.

“This initiative shows what can be achieved when government and industry work in partnership to deliver improvements to the PBS,” Mr Chalmers said.

“PBS reform sought to provide a better system for Australian patients and this measure is a part of that ongoing improvement.”

The PBAC is the independent body which recommends to the Minister for Health and Ageing which medicines should be subsidised by the Australian Government on the PBS.

–ENDS–

Contact Person:

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

Medicines Australia chief executive Ian Chalmers has urged the Government to implement the recommendations of the Productivity Commission’s new Annual Review of Regulatory Burdens on Business.

The review, released today, recommends a number of important measures which would significantly improve access to innovative new medicines for Australian patients.

Notably, the review recommends: The Pharmaceutical Benefits Advisory Committee should be allowed, when requested by applicants, to conduct its assessment of a medicine for PBS listing in parallel with the TGA’s assessment of the application to register the medicine.

“This one measure could reduce by a full year the time taken to list a new medicine on the PBS,” Mr Chalmers said.

Other key Productivity Commission recommendations include:

• Increasing the cost threshold at which PBS listings require Cabinet approval
• Reducing the time and cost of TGA approval processes
• Introducing a harmonised national system for approving multi-centre clinical trials, to be implemented by the end of 2009.

Mr Chalmers said the Productivity Commission’s recommendations, if adopted, would mean that Australian patients would enjoy much faster access to important therapies.

“I call on the Government to implement these recommendations from the Productivity Commission as soon as possible,” Mr Chalmers said.

“Procedural rigour in the evaluation of medicines is important and must be maintained.

In this context, initiatives that bring innovative, safe and effective new medicines onto the PBS more quickly are great news for patients.”

Medicines Australia has been working closely with the Government to find ways of improving access to innovative new medicines for Australian patients.

Mr Chalmers acknowledged the importance of the Productivity Commission report, which made a raft of recommendations to reduce the burden of government regulation on business.

“I commend the Productivity Commission on a thorough and very constructive report,”

Mr Chalmers said. “I also look forward to a quick and positive response from the Government.”

–ENDS–

Contact Person:

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

Medicines Australia has commenced a Review of its Code of Conduct and invites public submissions.

“Healthcare professionals, consumers, government and industry all need to remain confident that the conduct of the industry, the provisions of the Code and its administration remain appropriate and relevant to their interests” said Ian Chalmers, Chief Executive of Medicines Australia.

“Our Code is already comprehensive and world leading. Nevertheless, we need to ensure that the Code continues to meet public and professional expectations. That is why we have written directly to over 200 organisations and companies inviting their comment and submissions,” Ian Chalmers said.

“Principles of patient safety, quality use of medicines, the appropriate dissemination of information about medicines, and the role of industry in complementing the practice of medicine and pharmacy are central to this Review,” Ian Chalmers said.

Medicines Australia Chairman Mr Will Delaat will chair the panel given responsibility to review the existing Code and draft edition 16. Stakeholder consultations and the drafting processes are expected to take up to a year. Further opportunities to consider the redrafted Code will be extended to stakeholders and industry before it is submitted to the ACCC for authorisation.

The Medicines Australia Code of Conduct sets out the standards of conduct for the activities of companies when engaged in the marketing of prescription products used under medical supervision as permitted by Australian legislation.

There are currently 16 sections of the 215 page Code which cover matters including: responsibilities of companies when making claims, forms of product information, requirements for different types of promotional material, conduct of company representatives, educational events, sponsorship of healthcare professionals and organisations, post marketing surveillance and market research, relationships with the general public and with healthcare professionals, Code administration and monitoring.

The Medicines Australia Code of Conduct is reviewed every 3 years.

The closing date for submissions is Friday 10 October 2008.

–ENDS–

Contact Person:

Donna Edman
Medicines Australia, Public Affairs
Phone: 0419 850 174
Email: donna.edman@medicinesaustralia.com.au

Medicines Australia welcomes the first ever public report on Pharmaceutical Benefits Scheme (PBS) Activity Indicators released today.

The report provides greater transparency to Pharmaceutical Benefits Scheme outcomes. It allows new insights into the decision-making of the Pharmaceutical Benefits Advisory Committee (PBAC), the body which assesses the cost effectiveness of new medicines before they are listed on the PBS.

“This first report on PBS Activity Indicators will now enable patient groups, pharmaceutical company sponsors and members of the public to follow trends in PBAC outcomes. This information will be vital to examining the effectiveness of the PBS listing process into the future” said Mr Ian Chalmers, Chief Executive of Medicines Australia.

“For example, whilst the data shows that last year 55 per cent of major submissions seeking PBS new listing of medicines were recommended, another 41 per cent were not successful,” Ian Chalmers said.

“Unsuccessful submissions can mean lack of access and longer waits for patients to new medicines, very costly extra work for industry and inefficiencies for Government,” Ian Chalmers said. “Medicines Australia will keep working with the Department of Health and Ageing to provide increased access to new medicines for patients. We strive for more effective and efficient processes within the reimbursement system for medicines” Ian Chalmers said.

The PBS Activity Indicators is a joint project between Medicines Australia and the Department of Health and Ageing. A report is expected to be published annually. The joint report presents information on outcomes from the PBAC, including:

• PBAC submissions by outcome
• Submissions on the basis of PBAC recommendation
• Resubmissions by outcome
• Resubmissions on the basis of PBAC recommendation, and
• Changes to PBS listings.

–ENDS–

Contact Person:

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

Medicines Australia has commended Senator Fielding and the federal Opposition for voting today to defeat the National Health Amendment (Pharmaceutical and Other Benefits – Cost Recovery) Bill 2008 in the Senate.

“Medicines Australia maintains its opposition to the introduction of PBS cost recovery” said Ian Chalmers, Chief Executive. “We consistently argued that it is fundamentally wrong for industry to pay for Government procurement decision-making.

The proposal put forward by Government risked Australian patients’ access to medicines, it did not improve the expensive and lengthy process for PBS listing of new medicines and it deterred innovation and investment in the Australian pharmaceutical industry. This Bill deserved to be defeated.

Along with many other stakeholders, the pharmaceutical industry believes there has not been adequate consultation on the PBS Cost-Recovery proposal. At the very least today’s outcome should ensure appropriate and comprehensive consultation on issues fundamental to the sustainability of the PBS.” Mr Chalmers said.

–ENDS–

Contact Person:

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