Interview with Medicines Australia chief executive Dr Brendan Shaw, recorded on 27 May 2011 for SCRIP magazine. Topics include: Overview of the Australian medicines industry, Federal Cabinet’s decision to defer new PBS listings, regulatory reform for clinical trials, and gene patents. To view the video in full please follow this link

–ENDS–

Contact Person:

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

Medicines Australia chief executive Dr Brendan Shaw today welcomed the appointment of Dr Suzanne Hill as Chair of the Pharmaceutical Benefits Advisory Committee.

Dr Shaw also congratulated the outgoing Chair Professor Lloyd Sansom, who vacates the position after an illustrious 10 years service.

“Medicines Australia congratulates Dr Hill on her appointment and we look forward to working with her in her new role as Chair of the PBAC,” Dr Shaw said.

“Dr Hill is eminently qualified to bring to the PBAC the high degree of integrity and independence that were the hallmarks of Professor Sansom’s tenure.

“I am sure Dr Hill will bring astute leadership to the PBAC and contribute significantly to ensuring the Committee continues to be held in high regard internationally.

“Medicines Australia looks forward to working with Dr Hill in the years ahead to continue to support the development of the PBAC process in the interests of the community.

“Medicines Australia congratulates Professor Sansom on his distinguished stewardship of the PBAC.

“I personally thank him and wish him well in his future endeavours. He has justifiably earned the trust and respect of industry over the last decade.

“Over that time, industry has worked well with the PBAC to develop the rigor, transparency and community engagement of the process, which now benefits all Australians.

“Under his chairmanship, the PBAC process has become much more open and transparent. The Committee has worked collaboratively with industry to deliver the best outcomes to the community.”

–ENDS–

Contact Person:

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

The Government’s Raising the Bar Bill will encourage medical innovation and bring Australia’s IP system into line with IP systems in other OECD countries, Medicines Australia’s acting chief executive Andrew Bruce said today.

The Bill was introduced into the Senate today by Innovation Minister Kim Carr.

Mr Bruce said a “research use exemption” for which the Bill provides will directly address concerns in some quarters that patents on biological materials can potentially stifle scientific research.

“This Bill makes it absolutely clear that scientists are free to conduct research on patented inventions, so long as the purpose of that research is investigation and not the infringement of valid patents,” Mr Bruce said.

“The Bill will raise the threshold of patentability for all fields of technology, ensuring that Australian patents can stand up to scrutiny in any jurisdiction around the world.

“Robust IP laws that encourage the development of new technologies are extremely important to innovative industries such as the Australian Medicines Industry.

“Intellectual property drives innovation, so a strong IP system is critically important to Australia. That is what this Bill delivers.”

Mr Bruce said the Government’s Raising the Bar Bill is more balanced and constructive than the Private Members’ Bill on Gene Patents, which would undermine Australia’s IP system and which is currently the subject of an inquiry by the Senate Legal and Constitutional Affairs Committee.

The Raising the Bar Bill received support from industry, researchers and consumers in their submissions to that inquiry.

“The Government’s Bill will better serve innovators, research scientists and the Australian community. We therefore urge the Parliament to pass the Bill without delay,” Mr Bruce said.

–ENDS–

Contact Person:

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

The process for listing new medicines on the Pharmaceutical Benefits Scheme has become overtly politicised, following the Government’s announcement today that it would become harder to list new medicines if the Federal Opposition continued to oppose Government health policy.

Medicines Australia’s acting chief executive Andrew Bruce said while the Government had listed some new medicines today, others continued to be deferred by Cabinet despite being recommended by the Government’s own expert advisory committee.

“The Cabinet lottery must end now,” Mr Bruce said.

“There are no apparent criteria to determine which medicines the Cabinet will approve. It has become a fickle and capricious process.

“The Government is bringing politics into clinical decisions where people’s health, and indeed their lives are at stake.

“The Government said today that the future listing of new medicines on the PBS would become contingent on the Federal Opposition supporting Government health policies such as the private health insurance rebate and the chronic disease dental scheme.

“That is unconscionable. The PBS was always meant to be about equitable access to medicines for all Australians. It is now being used as a political football and patients are being caught in the middle.

“The PBS should not be held to ransom by Government’s short-term political agenda.

“The Government’s own expert committee has rigorously evaluated these medicines and found that the health and economic benefits of making them available on the PBS outweigh the costs.

“Cabinet’s decision will mean many patients can’t afford the medicines they need. It’s putting medicines out of reach for many ordinary Australians and threatens to take us into a two-tiered health system.

“It’s bad policy. Australia shouldn’t be a country where we can’t afford to provide medicines for sick people.

“Medicines Australia welcomes the PBS listing for the medicines that were announced today, but we urge Government to end the Cabinet lottery and return to the process of bringing new medicines onto the PBS that has served Australian patients well for decades.”

–ENDS–

Contact Person:

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

The establishment of an Australia New Zealand Therapeutic Products Agency (ANZTPA) must not derail important regulatory reform of the Therapeutic Goods Administration already underway, Medicines Australia’s acting chief executive Andrew Bruce said today.

Renewed negotiations to proceed with the establishment of a joint agency were flagged today by the Australian and New Zealand governments.

“The TGA is part way through its own program of extensive reform which will help ensure Australians enjoy more timely access to new medicines,” Mr Bruce said.

“It is extremely important that those reforms are not adversely impacted or delayed by extra workload associated with establishing ANZTPA,” Mr Bruce said.

“The TGA reforms are in their early stages but are already showing signs of strain due to pressures on resourcing. The Government must ensure that the resource demands of the new joint agency do not impede the progress of a reform agenda whose implementation to date has been patchy.

“The TGA must be properly resourced by Government to take on the additional workload which the implementation of a new joint agency will require.”

Mr Bruce said ANZTPA would provide a single point of entry for the registration of new medicines.

“This is a great opportunity to create a single world-class regulatory agency,” Mr Bruce said.

“We are a global industry and many of our New Zealand affiliates are managed through Australia. We recognise that the New Zealand system needs reform and a joint regulatory agency will deliver that reform.

“As a key stakeholder in regulatory reform, Medicines Australia looks forward to contributing to the new ANZTPA negotiations as we did before the earlier negotiations were suspended in 2007.

“The drive for regulatory harmonisation is an important part of our respective governments’ long-standing Closer Economic Relations policy to reduce trade barriers between Australia and New Zealand across all industries.”

–ENDS–

Contact Person:

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

Medicines Australia today welcomed the Parliament’s passage of a motion that the listing of new medicines on the Pharmaceutical Benefits Scheme should not be “subject to capricious political interference”.

Medicines Australia’s acting chief executive Andrew Bruce said the motion should send a strong signal to Government that Australian voters want a return to the well-established, independent, non-political process for bringing new medicines onto the PBS.

“I congratulate the Parliament for recognising the gravity of this issue,” Mr Bruce said.

“I particularly congratulate the Member for Pearce Judi Moylan MP, the Member for Moore, Mal Washer MP and Tasmanian Senator Guy Barnett for raising this important issue in the House of Representatives and the Senate.

“The Cabinet’s decision to block new listings on the PBS has caused a lot of angst among patients, doctors and the Australian medicines industry.

“The Government is bringing politics into clinical decisions where people’s health, and indeed their lives, are at stake. They are pursuing the political imperative of a Budget surplus and they’re using patients’ medicines to do it.

“This is bad policy, which is hurting society’s most vulnerable.

“It’s putting medicines beyond the reach of many ordinary Australians, and threatens to take us into a two-tier health system, where only the rich have access to the latest medicines.

“Australia shouldn’t be a country where we can’t afford to provide medicines for sick people.

“It’s time for the Government to end this Cabinet lottery and return to the old system that has served patients well.

“These are medicines that the expert Pharmaceutical Benefits Advisory Committee has found to be cost-effective and therefore a sound economic investment. Few, if any, other areas of government expenditure are subject to the same rigorous economic evaluation.”

The motion passed by the Parliament “deplores the Government’s new policy that despite positive recommendations by the PBAC, all applications for listing will be further scrutinised by Cabinet” and that “listing of medicines can be deferred indefinitely”.

–ENDS–

Contact Person:

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

Medicines Australia welcomes the Government’s announcement today that it has the support of the Australian Greens to pass the R&D tax credit Bill in the Senate.

The new tax credit will reduce the cost of eligible R&D by 10 per cent and make Australia more internationally competitive as a destination for medical research investment, Medicines Australia’s acting chief executive Andrew Bruce said.

“R&D sustains Australia’s $18 billion medicines industry and provides thousands of jobs,” Mr Bruce said.

“This legislation will provide companies with an additional incentive to boost their R&D investment in Australia.

“Competition for R&D investment dollars from Asia and Europe is fierce, and we have been falling behind. With the right policy settings we can reverse this decline.

“We have the right people in Australia to run these medicine development programs and we have good infrastructure. We just need to make it attractive for companies to invest in Australia.

“This legislation is a big step in the right direction to ensure Australia remains competitive in the face of strong overseas competition.

“It will help keep more of our top research scientists engaged in Australian R&D and attract greater investment to our universities and other research institutions.

“I congratulate the Government, along with the Australian Greens for supporting this important legislation.

“The Minister for Innovation Senator Kim Carr has long been a strong supporter of Australian research in general and the medicines industry in particular.

“His advocacy of the new tax credit is a great example of that support.”

The Australian medicines industry attracted more than $1 billion in R&D investment in 2010. In any given year around18,000 Australians take part in clinical trials.

–ENDS–

Contact Person:

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

Medicines Australia welcomes Bill Gates’ support for strengthened global immunisation programs against infectious diseases.

Speaking at the World Health Assembly in Geneva last week, Mr Gates praised pharmaceutical companies, global health organisations and governments for their work in providing access to new vaccines in developing countries.

Mr Gates told the assembly that vaccines are the best possible investment in global health.

“They can be inexpensive, they are easy to deliver and they are proven to protect children from disease,” Mr Gates said.

Medicines Australia chief executive Dr Brendan Shaw said strengthening programs for immunisation against infectious disease could save millions of lives.

“The medicines industry is committed to investing in the development of innovative, safe and effective vaccines and making them available through partnerships.

“The innovative vaccines industry has long been working with the global immunisation community, to ensure every country has access to these vaccines through sustainable immunisation programs.

“Medicines Australia members are among the companies working at a global level with governments, NGOs and private foundations to make vaccines available at a price those governments can afford.

“Medicines Australia welcomes Mr Gates’ recognition of the contribution the medicines industry is making to solve the world’s global health problems through the development and supply of new vaccines.”

Over the last decade, the biopharmaceutical research sector has invested over $9.2 billion in direct assistance to improve healthcare throughout the developing world.

Innovative pharmaceutical companies are today working on nearly 400 new medicines and vaccines to combat infectious diseases. Many of these medicines are already in late-stage clinical trials or being considered by the US Food and Drug Administration (FDA) for approval for patient use.

Bill Gates’ address to the World Health Assembly is available here

–ENDS–

Contact Person:

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

The fact that the 2011 Budget had no PBS price-related savings measures, as per the Memorandum of Understanding between Medicines Australia and the Government, is welcome.

The MoU, which was signed in May 2010, was the result of tough negotiations between the Government and industry, and delivered savings to taxpayers, savings to consumers and process improvements to the PBS.

Medicines Australia chief executive Dr Brendan Shaw said: “In respect of delivering savings to the PBS, the MoU is working well and this week’s Budget is testament to that. The MoU provides a good framework for managing the PBS agreed between the Government and industry.

“However, while we appreciate the Government respecting the provisions of the MoU, we strongly disagree with the Cabinet’s decision to block the listing of new medicines on the PBS, which contradicts the intent of the MoU.”

In February, Federal Cabinet deferred indefinitely the PBS listing of seven new medicines and a vaccine which had been recommended for listing by the Government’s own committee of clinical and health economics experts.

Dr Shaw welcomed the eventual decision to subsidise in the Budget the pneumococcal vaccine catch-up for children that had been delayed by Cabinet since February.

“This is a good decision, but we hope the Government will list all other deferred medicines as soon as possible,” Dr Shaw said.

Medicines Australia also applauds the support of the Pharmaceutical Benefits Scheme by the Leader of the Opposition in his Budget Reply speech to the House of Representatives last night.

Tony Abbot said in his speech: “We won’t turn the Pharmaceutical Benefits Scheme from a demand-driven to a budget-limited scheme by not listing drugs that have passed an expert cost-effectiveness test.”

Mr Abbott’s comments reflect the importance of maintaining the integrity of the PBS processes.

Medicines Australia also welcomes the Greens’ support for the timely PBS listing of medicines that have been recommended by the Pharmaceutical Benefits Advisory Committee.

Greens health spokesperson Senator Rachel Siewert noted in a recent media release about the Cabinet’s decision to defer PBS listings:

“This will have significant implications for Australians trying to access these medicines.”

–ENDS–

Contact Person:

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

The Government’s decision to list the Prevenar 13 catch-up vaccine on the Pharmaceutical Benefits Scheme is welcome, but Australian consumers are entitled to be extremely disappointed that the Government continues to delay the listing of seven other medicines.

Prevenar 13 was one of eight medicines and vaccines recommended for listing by the Pharmaceutical Benefits Advisory Committee in November 2010 but blocked by Cabinet in February 2011. These medicines are still not available to the patients who need them.

“I would have hoped that the Government would have used the Budget to announce the listing of these medicines that have been delayed by Cabinet,” Dr Shaw said tonight.

“Australia should not be a country that can’t afford to provide medicines for sick people who need them.

“The Government is penny pinching to get a Budget surplus and they’re using patients’ medicines to do it.

“This decision by Cabinet will mean many patients can’t afford the medicines they need. It puts medicines out of reach for many ordinary Australians.

“The Government’s own expert committee has said making these medicines available is cost effective, value for money and the right thing to do.

“It’s unclear what expertise or experience Cabinet Ministers have at their disposal to override the decisions of their own expert committee.

“It’s ironic that the Government is investing in additional cost-effectiveness analysis of new medicines by the PBAC when Cabinet is not accepting its recommendations.”

Dr Shaw said Cabinet’s delay in listing new PBS medicines undermined business certainty for Australia’s leading manufactured export industry.

“The Australian Medicines Industry makes a significant contribution to the economy. We produce more than $4 billion a year in export earnings, but business confidence is being eroded by ongoing uncertainty stemming from Cabinet’s intervention.

“I am aware of a couple of companies who have already hit the pause button in terms of bringing new products to Australia, until they see evidence of greater policy stability.

“I urge the Cabinet to reverse its decision as soon as possible.”

The MoU between Medicines Australia and the Commonwealth meant there were no PBS savings related measures in the Budget.

–ENDS–

Contact Person:

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