The Senate Community Affairs Committee has recommended that the threshold for Federal Cabinet approval for listing new medicines on the Pharmaceutical Benefits Scheme be increased.

In its report released last night, the Committee recommended that the threshold should be immediately increased from its current $10 million to a level reflecting its original 2001 value and that the threshold should be indexed annually to maintain its real value.

“This is a major step forward and will make a big difference to Australian patients if the Government sees the wisdom in implementing it,” said Dr Brendan Shaw, Chief Executive.

“It’s time for the Government to implement this sensible reform to the PBS.”

“We now have both the Productivity Commission and a key Senate Committee recommending to Government that the current $10 million Cabinet threshold be increased and indexed.”

“The fact that the Senate Committee has unanimously recommended this across party lines is particularly significant.”

“We know that the time it takes for Cabinet to approve a new medicine to be listed on the PBS has increased from 6.7 months to 10 months. That’s an additional 10 months after the medicine has been reviewed by a variety of expert bodies for its cost-effectiveness, and it’s an additional 10 months that patients have to wait for new therapies.”

“It makes no sense that patients are being made to wait an additional 10 months for sometimes life-saving treatments by a bureaucratic process whose rationale is unclear at best, when those medicines have already been rigorously evaluated.”

“There are some medicines that simply should not have to grind through the Cabinet process and the Senate Committee has recognised this.”

“Increasing the threshold and indexing it will get subsidised new medicines to Australians quicker. Given the Cabinet has not rejected new medicines for listing, it is also hard to see how increasing the threshold will cost the Government any money.”

Currently, any new medicine that is being considered for listing on the PBS that is expected to cost more than $10 million in any one year needs to be approved by Federal Cabinet before it can be listed.

In its submission to the Committee, Medicines Australia argued that the threshold should be doubled from $10 million to $20 million and indexed.

The Committee also recommended a range of measures to improve the process and transparency around creating therapeutic groups.

“The recommendations to improve the process of creating therapeutic groups will also help improve the PBS processes for patients, industry and the Government.”

The Senate Community Affairs Committee report released last night, Consumer Access to Pharmaceutical Benefits, can be found here

Medicines Australia’ submission to the inquiry can be found here

For media, contact Brendan Shaw on 0413 013 501

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Contact Person:

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

Medicines Australia chief executive Dr Brendan Shaw has welcomed Parliament’s passage of the National Health Amendment (Pharmaceutical Benefits Scheme) Bill 2010.

The Bill legislates price cuts to PBS medicines agreed in the Memorandum of Understanding between Medicines Australia and the Commonwealth.

Dr Shaw said Medicines Australia would work with all sides of politics and other healthcare stakeholders to ensure the MoU was implemented efficiently.

“This legislation will lead to reductions in the price consumers pay for hundreds of medicines on the PBS,” Dr Shaw said.

“It will also ensure that Australian taxpayers get a fairer deal on the price the Government pays for PBS medicines.

“Effectively, this will mean a more sustainable PBS.

“While the cuts contained in the Bill will have a significant financial impact on our member companies, the MoU will provide a period of policy predictability for Australia’s medicines industry.

“This certainty will allow Australia’s medicines industry to get on with what it does best. That is bringing life-saving medicines and vaccines to the community, helping Australians lead healthy and happy lives and investing in research into new therapies.

“It is also about employing thousands of Australians in high-skilled jobs, and generating billions of dollars in high-value manufactured exports for Australia.”

Dr Shaw said Medicines Australia’s focus would be trained on successful implementation of the MoU measures.

“Medicines Australia will work with the Government, the Parliament and other stakeholders to ensure the implementation of the MoU.

“We fully support the introduction of new tracking and monitoring tools, and the range of improvements to the PBS listing process.

“The process improvements, such as parallel regulatory and reimbursement evaluation, managed entry scheme for new medicines, and the maximum six-month time limit for Federal Cabinet approval of new PBS listings will be particularly important for Australian consumers.”

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Contact Person:

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

New reforms to the Pharmaceutical Benefits Scheme being considered by the Senate will reduce by as much as $21 the prices patients pay for many prescription medicines, Medicines Australia chairman Will Delaat told the National Press Club today.

Mr Delaat’s address follows yesterday’s tabling of a Senate Committee report on the legislation, which would also deliver the Government $1.86 billion in PBS savings.

“The benefit for consumers is that those savings will reduce the prices patients pay for many off-patent medicines by as much as $21 per script, per month,” Mr Delaat said.

“It will ensure that Australians pay less for hundreds of commonly used medicines to treat high blood pressure, asthma, depression, cholesterol, arthritis and other conditions.”

The legislation that enables the substantial price cuts for consumers is a part of the Memorandum of Understanding between Medicines Australia and the Commonwealth.

The measures are supported by the Consumers Health Forum, Breast Cancer Network Australia, the National Prescribing Service and the Pharmacy Guild as well as by Medicines Australia’s 50 member companies.

Mr Delaat told the National Press Club that the MoU would deliver a better, more sustainable PBS and a better health system for all Australians.

“Consumers will also directly benefit from the process improvements to the PBS, which will enable medicines to become available quicker to those who need them ….

“As our population ages and the demands on the health budget grow, the only way we can continue to fund the latest life-saving medicines as they come online and ensure the sustainability of the PBS is by driving savings through competition in the older, off-patent market.

“The fact is that while the Australian Government pays on average 20 per cent less than the OECD countries for new, patented medicines, the prices it pays for older, generic medicines are high by international standards.

“For years, while Australia’s low prices for new medicines have led to delays in their listing, Australians have been paying top dollar for old medicines that are cheaper in other markets.”

–ENDS–

Contact Person:

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

Taxpayers will get a fairer deal on the price Government pays for medicines on the Pharmaceutical Benefits Scheme if new legislation for the PBS is passed, Medicines Australia Chief Executive Dr Brendan Shaw told the Medicare Conference in Sydney today.

The National Health Amendment (PBS) Bill will ensure the price the Government pays for a PBS medicine reflects the price at which it is sold to pharmacists.

“The PBS has been blind to the real price of medicines,” Dr Shaw said.

“The new reforms to mandate disclosure of the price at which companies are selling to pharmacists will inform the Government of the true market price and allow it to adjust downwards the price it pays.

“The problem now is that disclosure is often optional. This makes it difficult for the Government to drive a more efficient PBS.

“Government is paying overblown prices for older, off-patent medicines.

“Greater transparency and competition needs to be promoted in the off-patent medicines market.

“If the PBS legislation is not passed by the Parliament these arrangements will continue.

“Patients will also miss out on anticipated price cuts. We can already see the benefit of price disclosure. The antibiotic Vancomycin for example cost $33.30 prior to price disclosure. Post-price disclosure the price is $12.19. That’s a saving of $21.11 that goes back to the patient.

“If the legislation is passed, ordinary Australians will save substantially at the pharmacy counter because price cuts will lead to cheaper scripts.

“The cost of commonly prescribed medicines to treat everyday conditions such as heart disease, arthritis, asthma, depression and diabetes will fall. That is a big saving for Australian consumers.

“Australia has low prices for innovative, new medicines by international standards but the prices of old, off-patent medicines have been high.

“While in markets like the US and the UK typically the price of a medicine drops substantially after patent expiry and the entry of generics, historically in Australia this did not happen, or did not happen to anywhere near the extent as in other countries.”

A copy of Dr Shaw’s speech is available at http://medicinesaustralia.com.au/pages/page9.asp.

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Contact Person:

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

A new report looking at patient access and public coverage of new medicines in industrialised countries shows that Australia ranks in the bottom third by many measures.

The Rx&D International Report on Access to Medicines 2009-10 ranks Australia 23rd out of 31 OECD countries in terms of expenditure on medicines as a proportion of GDP.

Medicines Australia chief executive Dr Brendan Shaw said: “In essence this report measures the willingness of governments to pay for new innovative pharmaceuticals and Australia doesn’t stack up too well.

“I imagine many Australians will be surprised and disappointed by these findings.

“It is quite confronting that Australia underspends the broader OECD on healthcare and innovative medicines.

“We assume that public funding of healthcare in Australia is high by global standards.

“However, Australia is falling behind other countries in making innovative medicines available to patients.

“This report challenges policy makers in Australia to seriously rethink the allocation of the public healthcare dollar.”

Other key findings in the report include:

• Australia ranks 24th out of 30 countries for government’s share of national healthcare expenditure.
• Australia ranks 19th out of 29 in terms of willingness to reimburse new medicines. Of the 150 medicines reviewed in the study, Australia reimburses 60 per cent, compared with the OECD average of 64 per cent.
• The proportion of first-in-class medicines included in the study that were subsidised in Australia is 52 per cent compared with an OECD average of 65 per cent, ranking Australia 20th out of 29.
• In terms of oncology medicines, Australia ranks 20th out of 29 countries when looking at the number of medicines that are subsidised.

The Rx&D International Report on Access to Medicines 2009-10 was commissioned by Rx&D, the Canadian research-based medicines industry association.

Dr Brendan Shaw is available for interview.

–ENDS–

Contact Person:

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

Figures in a new publication released today by Medicines Australia show that Australia’s medicines industry makes a major contribution to the health of Australians and the national economy.

The 2nd Edition of Medicines Australia’s Facts Book provides a wealth of information on medicines, the medicines industry and the health of Australians.

Medicines Australia chief executive Dr Brendan Shaw said the report showed that Australians get a good return on investment from the Pharmaceutical Benefits Scheme.

“Our Facts Book shows that for a relatively small investment of public funds by international standards, Australians get good value for money from the PBS,” Dr Shaw said.

“Subsidised medicines in Australia account for just over half of one per cent of GDP or 8 per cent of all health spending.

“For example, that modest investment included Australians receiving 22 million prescriptions for cholesterol lowering medicines to help prevent heart attacks, 20 million prescriptions of medicines to lower blood pressure, and 16 million prescriptions for medicines to treat stomach ulcers.

“The Australian medicines industry also produced medicines to treat conditions such as HIV, cancer, arthritis, hepatitis, asthma, diabetes and osteoporosis. These include 12 new medicines added to the PBS during 2009-10.

“Death rates from infectious diseases, respiratory disease, cardiovascular disease and cancer have all fallen over the past two decades.”

Five key facts about Australia’s medicines industry:

1. Australia’s medicines industry now exports more and conducts more R&D than the car industry.
2. Private industry funds two-thirds of all the clinical trials conducted in Australia – clinical trials are a key part of the innovative process to develop new medicines – with 55 per cent of these conducted through public hospitals.
3. The PBS accounts for just 8 per cent of Australia’s total health expenditure.
4. In 2010 there were almost 3000 medicines under development worldwide.
5. There are over 800 medicines in development to treat cancer.

The Medicines Australia Facts Book is available here

–ENDS–

Contact Person:

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

Changes to the way the Therapeutic Goods Administration evaluates new prescription medicines will ensure many medicines become available to patients much sooner, Medicines Australia chief executive Dr Brendan Shaw said today.

The TGA’s Business Process Reforms, launched today, will reduce by more than a year the time it takes the regulator to evaluate many medicines for quality, safety and efficacy.

“Australian patients are the big winners out of these reforms,” Dr Shaw said.

“The evaluation and registration of new prescription medicines currently takes up to two years. The new process will reduce that time to between nine and 11 months.

“New submissions lodged with the TGA will spend less time waiting in queues at different stages of the assessment process. That will make for a much more effective and efficient system, without compromising on rigour.”

Dr Shaw said the TGA reforms compounded with the PBS improvements set out in Medicines Australia’s MoU with the Commonwealth should significantly reduce the time it takes a new medicine to become available.

“The MoU will allow the cost-effectiveness analysis of a new medicine for PBS listing to be undertaken at the same time as the TGA evaluation for quality, safety and efficacy.

“These improvements, together with the TGA reforms, can deliver a significant improvement to patient health outcomes.

“Many ordinary Australians will have earlier access to the medicines they need.”

Dr Shaw said Medicines Australia member companies would support the TGA in managing any teething problems that arise from the reforms over the course of the initial 12-month transition period.

“There may well be the odd hiccup in the early stages, but these reforms herald a major improvement in the way innovative new medicines are evaluated.

“The significance of today’s announcement should not be forgotten. Some of these reforms have been waiting for many years to be implemented, so to finally see them implemented today is a credit to the Government, particularly the TGA.

“The constructive way in which the TGA worked with all stakeholders, including industry, to secure these reforms is to be commended and is indicative of the TGA’s professionalism and integrity.

“I congratulate the TGA, and TGA National Manager Rohan Hammett, in particular, on implementing these reforms.”

–ENDS–

Contact Person:

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

The 2010 Pat Clear Award, the Australian medicines industry’s most prestigious award, has been won by Dell Kingsford Smith, an executive of the pharmaceutical company Janssen-Cilag Pty Ltd.

The Award was presented to Ms Kingsford Smith at the Medicines Australia conference last night (Tuesday). It is awarded annually to recognise an outstanding level of commitment by an individual, group or team for the benefit of the Australian medicines industry.

Ms Kingsford Smith received the award for her ongoing leadership of the medicines industry’s engagement with the Government on health technology assessment.

She has been at the forefront of the medicines industry’s negotiations with the Department of Health and Ageing over the past five years that have led to improved transparency of the PBS listing process.

As a result of those negotiations, consumers are now able to contribute to the evaluation process for the PBS listing of new medicines.

Medicines Australia chief executive Dr Brendan Shaw congratulated Ms Kingsford Smith and said the Award was richly deserved.

“Dell has been instrumental in improving access to medicines for Australian consumers over the past five years, both in hospital and community settings.

“She has been a tireless advocate for better assessment processes for health technologies so that Government can make more informed choices about the value of the medicines they subsidise.

“It is because of Dell that Australians can now have more information about the medicines they are taking and how they are assessed for reimbursement.

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

Ms Kingsford Smith is Senior Director of Health Economics and Global Strategic Marketing and Market Access at Janssen.

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

–ENDS–

Contact Person:

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

A new report released by Lateral Economics underscores the social and economic value of medical R&D, Medicines Australia chief executive Dr Brendan Shaw said today.

“This report sets out compelling evidence of the enormous return that Australia derives from investing in medical research,” Dr Shaw said.

“It highlights the importance of a stable, long-term R&D policy environment. We simply can’t afford Australia’s R&D investment commitment to be compromised by short-term fiscal challenges.

“We have some of the world’s best medical research capability and infrastructure in Australia and that’s an advantage we must capitalise on. It puts us in a great position to reap substantial long-term social and economic returns.”

The Economic Value of Australia’s Investment in Health and Medical Research was commissioned by Research Australia and launched today at AusBiotech 2010.

The medicines industry is a major player in Australia’s medical R&D sector, both directly and in collaboration with hospitals, universities and other research institutions.

ABS figures released in September showed that Australia’s medicines industry invested more than $1.023 billion in R&D in 2008-09, up $94 million or 10 per cent from the previous year.

“Pharmaceutical R&D is one of the great success stories of medical research in Australia,” Dr Shaw said.

“We must do all that we can to ensure that we keep more of our top research scientists engaged in Australian R&D and attract greater funding to our universities and other research institutions.

“The Lateral Economics report reasserts Australia’s reputation as a global hub for R&D excellence and sends a powerful signal to policymakers that R&D is worth supporting.”

“Ensuring an efficient regulatory environment for clinical research and implementing the R&D tax credit system are two examples of policy settings that would greatly support Australian R&D.”

The medicines industry conducts more than 800 clinical trials in Australia each year. In 2009 more than 18,000 Australians participated in clinical trials supported by the medicines industry in this country.

The Lateral Economics report is available at http://researchaustralia.org

–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 inclusion of the National Health Amendment (Pharmaceuticals Benefits Scheme) Bill 2010 on the first bills list of the 43rd Parliament.

The legislation will enable the implementation of $1.86 billion in savings from the PBS.

Dr Shaw urged all political parties to support the Bill and ensure its enactment at the earliest opportunity.

“This legislation is supported by the 50 member companies of Medicines Australia who account for 86 per cent of the PBS,” Dr Shaw said.

“This is a common-sense Bill that will benefit taxpayers, patients and industry. It will ensure a stable and sustainable PBS and it merits the support of the Parliament.

“These reforms will reduce the price the Government plays for older, off-patent medicines. That will reduce the prices patients pay by as much as $5 per script each month.

“This legislation will ensure Australians will pay less for commonly used medicines to treat heart disease, asthma, depression, cholesterol, rheumatoid arthritis and other conditions.”

While the Australian Government pays 20 per cent less than the OECD average for new, patented medicines, the prices it pays for older, off-patent medicines are high by international standards.

“Driving savings from a competitive generics market is the key to ensuring the PBS is sustainable in the long-term,” Dr Shaw said.

The National Health Amendment (Pharmaceuticals Benefits Scheme) Bill 2010 is part of a broader package of reforms that will ensure a more efficient PBS for all Australians.

“These reforms, which are currently being implemented by the Department of Health and Ageing, in consultation with Medicines Australia, will reduce the time it takes for new medicines to get on to the PBS,” Dr Shaw said.

“As part of the medicines agreement signed with the Commonwealth earlier this year, the processes of registering a new medicine with the TGA, and listing it on the PBS will be able to run concurrently rather than sequentially. That should mean quicker access to medicines for ordinary Australian patients, and potentially saving lives.”

The agreement also includes a commitment by the Government to ensure medicines requiring Cabinet approval prior to PBS listing are reviewed by the Cabinet within six months of being recommended for listing by the PBAC.

“This is an agreement that delivers Australians a much better PBS,” Dr Shaw said.

–ENDS–

Contact Person:

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