The pharmaceutical industry is a key reason why countries around the world have been able to respond to the H1N1 pandemic.

“The antivirals, antibiotics and vaccines that are available today to respond to the global H1N1 pandemic are largely the product of investment by the global pharmaceutical industry,” Medicines Australia chairman Will Delaat said today.

“Without these products, it is unclear how countries would have responded to the global H1N1 pandemic.

“Investment by the pharmaceutical industry has provided tools with which we can combat current and future influenza pandemics.

“In Australia, together with doctors, nurses, pharmacists, other health professionals and medical researchers, local pharmaceutical companies, both large and small, are working to protect Australia and other countries from global pandemics.

“Australia’s management of the H1N1 outbreak has been a great success story in terms of public health and industry innovation.

“Investment in medical research, in collaboration with pharmaceutical companies, has been a major weapon in ensuring the H1N1 outbreak has not been the disaster that it potentially could have been.”

–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 tendered his resignation, effective 30 September 2009, completing a three-year term representing the innovative pharmaceuticals industry.

The Chairman of Medicines Australia Will Delaat today paid tribute to Mr Chalmers’ achievements as chief executive.

“Ian has made a very significant contribution to the industry, championing our members’ interests with conviction and passion,” Mr Delaat said.

“On the industry’s behalf, he has navigated an exceptionally challenging policy and economic environment with skill and agility, particularly with regard to bedding down the most extensive reform of the PBS in its 60-year history.

“Ian leaves the association in good shape, with an expanded membership, a strong balance sheet and a robust, respectful relationship with Government.

“I thank him for his contribution over the past three years and I wish him well in his next assignment.”

–ENDS–

Contact Person:

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

Medicines Australia chief executive Ian Chalmers today welcomed the Government’s commitment to pursue a level playing field for marketing obligations within the therapeutic goods industry.

Medicines Australia member companies are obliged to adhere to all provisions of the Medicines Australia Code of Conduct, which sets a high ethical standard for the marketing of prescription pharmaceuticals. Companies that choose not to belong to Medicines Australia have no such obligation.

The Government’s commitment to establishing a level playing field was confirmed last night by the Parliamentary Secretary for Health, Mark Butler.

“Mr Butler’s interest in this issue is very encouraging. I congratulate him on seizing the initiative on this important matter,” Mr Chalmers said.

“There is an uneven operating environment for the conduct of pharmaceutical companies which undermines public confidence in the industry.

“Clearly the Government shares Medicines Australia’s concerns about the lack of a level playing field across the pharmaceutical industry regarding Code of Conduct compliance. That is why Mr Butler has asked the TGA to convene a meeting of the relevant industry associations to resolve this issue.

“I am looking forward to contributing to a Government-initiated solution that ensures all prescription pharmaceutical companies are required to meet a common ethical standard of professional conduct.

“There is no reason why there should be one ethical standard for innovative pharmaceutical companies, and a different, lesser standard for generic companies.

“There must a level playing field that applies to all companies – not just those which choose to belong to Medicines Australia. The public rightly expects appropriate standards of conduct to apply across the board.

“We are not asking generic companies to become Medicines Australia members.

However, we very firmly believe that every prescription pharmaceuticals company should adhere to the high ethical standards set out in the Medicines Australia Code of Conduct.

“Medicines Australia member companies are making considerable efforts to ensure that all promotional and educational activities they conduct accord with the highest possible ethical standards.

“These efforts include strengthening our Code of Conduct, the 16th edition of which has recently been submitted to the ACCC for authorisation.”

–ENDS–

Contact Person:

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

The Federal Government must heed the contribution of innovative medicines and vaccines to preventative health, Medicines Australia chief executive Ian Chalmers said today.

Mr Chalmers said the Preventative Health Taskforce Report provides the Government with a robust framework to tackle the health issues of obesity, smoking and alcohol, but underplays the role of pharmaceuticals.

“Innovative medicines and vaccines have a central role to play in supporting the Government’s key health priorities of preventative health, chronic disease management and easing the strain on the public hospital system,” Mr Chalmers said.

“While non-pharmaceutical interventions such as exercise and diet can be effective means of disease prevention, there are various cost-effective prescription medicines that can play a key role in the battle against obesity and alcohol and tobacco addiction.

“The Taskforce has flagged vaccines and mental health as the focus of its next review.

These are two areas where pharmaceutical intervention is absolutely central and Medicines Australia looks forward to contributing to this important piece of work.”

Mr Chalmers urged the Government to rigorously assess the cost-effectiveness of the preventative health initiatives included in the report.

“The Taskforce has made some bold recommendations to reduce preventable disease,” Mr Chalmers said. “I encourage the Government to consider applying a cost effectiveness assessment to all of the initiatives outlined in the Report to ensure implementation of these recommendations deliver value for money.

“This is crucial in an environment where the Government is determined to drive maximum value from every health dollar.

“Minister Roxon rightly emphasised the importance of reducing pressure on the hospital system by keeping people healthy and out of hospital. Innovative medicines and vaccines help control health care costs by preventing the need for care at public hospitals, shortening stays in hospitals where they are required and relieving the costs of other institutional care.

“I commend the Taskforce on this report and I look forward to working with the Government to help guide its implementation, particularly with regard to quality use of medicines strategies.”

–ENDS–

Contact Person:

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

The National Health and Hospitals Reform Commission’s recommendations offer Australian patients the prospect of a more efficient and better integrated healthcare system, Medicines Australia chief executive Ian Chalmers said today.

Responding to yesterday’s launch of A Healthier Future for all Australians, Mr Chalmers congratulated the Commission on its report.

“The Government’s investment in this report demonstrates the priority of healthcare reform as a policy issue for Australia,” Mr Chalmers said. “Reform of the health system stands as one of the great challenges of the 21st Century.

“As an integral part of that system, it is important that the innovative pharmaceutical industry is engaged in the implementation of the Commission’s recommendations, to ensure that patient access and choice is maintained and enhanced.

“The Commission is to be congratulated for recognising the importance of ensuring that Australian patients have a sustainable healthcare system, but one which is equipped to deliver patient health outcomes effectively and efficiently.”

Mr Chalmers said the absence of any recommendations of further major funding reforms for the Pharmaceutical Benefits Scheme suggested that the Government should allow the reforms to run their course.

“Medicines Australia argued strongly for the maintenance of current funding arrangements for the PBS,” Mr Chalmers said.

“The principles of PBS reform – namely delivering savings while ensuring universal access to new medicines – remain critically important. I applaud the Commission for recognising this.”

Medicines Australia also welcomed recommendations for the Commonwealth to assume greater responsibility for primary healthcare policy and funding.

“I fully support the move to address healthcare management holistically,” Mr Chalmers said.

Mr Chalmers further welcomed the recommendation to implement a national e-health system and the linkage of health data.

“Obviously all these recommendations will need to be carefully considered and debated by government, stakeholders and the community. However they have the potential to deliver significant benefit to patients,” Mr Chalmers said.

–ENDS–

Contact Person:

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

The Federal Government’s decision not to rush the clinical trial of the H1N1 swine flu vaccine is entirely responsible and in the best interests of patients, Medicines Australia chief executive Ian Chalmers said today.

“The Minister for Health and Ageing, Nicola Roxon has confirmed that the Government is not prepared to rush these trials through without first being certain that the vaccine is safe and effective,” Mr Chalmers said.

“This is a safe and responsible approach which will serve the community well in the long run.

“The pharmaceutical industry is currently in the process of developing a number of vaccines and anti-viral medicines.

“Companies are working as fast as they can to develop effective responses to the swine flu virus, but it is critical that new medicines and vaccines are shown to be safe and effective before being released to the public.

“The swine flu vaccine clinical trial under way in Adelaide is important and a very significant development in the fight against swine flu. It is absolutely appropriate for the manufacturer and the Government to responsibly insist on waiting for the evidence that the vaccine is safe and effective.

“Clinicians need to understand how a new medicine or vaccine will work in humans. That is why clinical trials take time.”

–ENDS–

Contact Person:

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

A National e-health record promises to ensure patients have access to more expedient and better informed medical treatment, Medicines Australia chief executive Ian Chalmers said today.

Welcoming today’s decision by the Australian Health Ministers’ Conference to move towards establishing a secure national e-health system, Mr Chalmers said patients and healthcare professionals would be the big winners.

“If healthcare professionals understand what treatments a patient has received and what medications have been previously prescribed and dispensed, they will be much better placed to determine quickly the most appropriate treatment option.

“This initiative goes to the core of Quality Use of Medicines.

“An e-health record will help ensure doctors and other health professionals prescribe the right medicine to the right patient at the right time and at the right dose.

“This is a significant step in ensuring medicines are used correctly and avoiding adverse outcomes through the misuse of prescription medicines.”

Mr Chalmers said a national e-health record would also provide an important opportunity to deliver an advantage to Australia’s extensive clinical trial capability.

“There is an opportunity to capture greater value from an e-health record system by ensuring the system also provides remote access to the medical records of trial participants in Australia who have consented to such use of their details.

“Remote access to trial data would remove geographical barriers to participation in clinical trials.

“This would shorten the time taken to complete clinical trials in Australia and would therefore improve Australia’s attractiveness as a destination for global investment in clinical research.

“Medicines Australia has long argued for a national e-health system. I congratulate the Australian Health Ministers’ Conference for taking forward this initiative.

“It is important that all stakeholders have the opportunity to consider this proposal carefully. I look forward to engaging with the Health Ministers during the consultation period.”

–ENDS–

Contact Person:

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

A proposal to dramatically weaken intellectual property legislation could lead to the loss of thousands of high-skill jobs and millions of dollars of global investment in Australian R&D, Medicines Australia chief executive Ian Chalmers said today.

“Weakening Australia’s IP regime would have a negative impact on Australian R&D and is fundamentally at odds with the Prime Minister’s own commitment to make innovation a way of life in Australia,” Mr Chalmers said.

Generic medicines manufacturer Hospira is seeking changes in the IP laws to allow generic copies of innovative medicines to be manufactured for export while those medicines are still patent-protected, effectively cutting short patent life.

“The idea has no merit beyond the commercial agenda of a single pharmaceutical company and could spell disaster for medical innovation,” Mr Chalmers said.

“We are a country that boasts a sustainable competitive advantage in attracting and conducting high-quality, outcomes-oriented R&D. Australia’s pharmaceutical industry alone attracts more than $1 billion a year in global R&D investment.

“That investment generates smart jobs, provides highly skilled work for scientists and supports Australia’s aspiration to become a global leader in medical innovation.

“Such investment depends heavily on a consistent and predictable business environment with strong protection of IP rights. If predictability is undermined and IP legislation weakened, global companies will seek other investment destinations.

“Apart from the potentially disastrous economic ramifications, there are other reasons why weakening Australia’s IP laws would be counterproductive.

“It would contravene Australia’s obligations under the World Trade Organisation’s intellectual property laws. It would also likely provoke retaliatory measures by our key trading partners, with possible market access implications for our $4 billion in pharmaceutical exports.

“It would damage multi-lateral efforts to implement globally harmonised standards of IP protection. It would also undermine the rights of patent holders in Australia.

“From trade, innovation and economic perspectives, a move to effectively shorten patents in Australia would have dramatic consequences. It just doesn’t stack up.”

–ENDS–

Contact Person:

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

The innovative pharmaceutical industry is committed to ensuring any animal-based research meets the high regulatory standards set by independent ethics committees, Medicines Australia chief executive Ian Chalmers said today.

Mr Chalmers said Medicines Australia member companies are also committed to reducing animal-based research where other methods of laboratory testing are equally effective.

“Animal research in Australia can not proceed until it has been scrutinised by appropriate ethics committees and has Government approval,” Mr Chalmers said.

“This area of research is highly regulated to ensure animal use in research is valid, humane, justifiable and considerate.

“Animal-based research is not undertaken lightly. The reality is that it is an essential part of the process that ensures new medicines are adequately safe to test in people.

“No regulatory authority would allow patients to take a medicine that had not been appropriately tested on animals to ensure safety and efficacy. If animals were not used in research, there would be far fewer medicines available to patients, nor could their safety be assured.

“The industry is constantly striving to discover alternative methods of researching and developing new medicines. Reducing the number of animals that must be used in important tests is a key element in this process.

“But we have not yet reached the stage where cell culture work and computers can tell us everything we need to know about how a medicine will behave in the human body.

“Until those alternative methods become available, animal use is the only means of gathering vital information for the development of safe and effective medicines.”

Medicines Australia works closely with the NSW Government on this issue and is represented on the NSW Government’s Animal Research Review Panel.

–ENDS–

Contact Person:

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

Medicines Australia chief executive Ian Chalmers said tonight he was disappointed by the Government’s decision to reintroduce legislation forcing the pharmaceutical industry to fund the Government’s own Pharmaceutical Benefits Advisory Committee.

Mr Chalmers said the Government’s move to recover the cost of the PBAC’s decisionmaking was inappropriate and would put at risk access to new medicines for small patient-population groups.

“We have consistently argued it is fundamentally inappropriate for the industry to pay for Government procurement decision-making. Our view has not changed one iota over the last three years,” Mr Chalmers said.

“The procurement of pharmaceuticals for the PBS is a government function and it’s unreasonable for industry to be expected to pay for the business of government.

“The proposal put forward by Government risks Australian patients’ access to medicines. It does not improve the expensive and lengthy process for PBS listing of new medicines and it deters innovation and investment in the Australian pharmaceutical industry.

“Frankly, it has no merit.”

Mr Chalmers said cost-recovery was particularly unwelcome at a time when the pharmaceutical industry in Australia was being forced to cut the price of its medicines by a further $175 million as a result of additional savings measures announced in tonight’s Federal Budget.

–ENDS–

Contact Person:

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