Medicines Australia chief executive Dr Brendan Shaw today welcomed the $466.7 million investment in e-health announced in the Federal Budget.

Dr Shaw said the move to electronic records was a critical step towards delivering a fully integrated healthcare system.

“Electronic health records make it much easier for patients to keep track of their medication and immunisation history and will help ensure doctors’ prescribing decisions are properly informed by appropriate patient health data,” Dr Shaw said.

“That is critical from a Quality Use of Medicines perspective.

“A national e-health record promises a much more efficient system of health delivery.

“It also has great potential to help reduce the number of avoidable adverse events stemming from inadequate patient health information.

“Medicines Australia hopes the investment announced tonight will hasten the delivery of a functional and effective e-health network.”

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Contact Person:

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

Medicines Australia member companies today signed a historic agreement with the Commonwealth Government that will ensure a stable environment for business and continued access to new medicines for all Australians.

The agreement delivers savings to taxpayers of $1.9 billion over five years. It carries a Government commitment that pharmaceutical companies will not be asked to bear any further price-related savings measures before 30 June 2014.

The agreement also introduces some important regulatory reforms to improve patients’ access to innovative new medicines through the Pharmaceutical Benefits Scheme.

Medicines Australia chief executive Dr Brendan Shaw said the savings will enable the Government to redirect funding to its substantial healthcare reforms.

“For the first time in the history of the PBS we have a written agreement that provides government with fiscal certainty,” Dr Shaw said.

“We have always argued that the PBS is the most cost-effective part of the health system and is under control, but we recognise the Government’s policy objective of once-in-a-generation healthcare reform.

“This is a pragmatic and responsible response to an extraordinary convergence of circumstances.

“It is an agreement for the times which brings genuine benefit to all parties and is consistent with the direction of the PBS reforms announced in 2007. It’s good news for the Government, the pharmaceutical industry and Australian patients.

“Importantly, the agreement provides the pharmaceutical industry with business certainty and a predictable PBS policy environment.

“The savings measures will impose a significant burden on Australian pharmaceutical companies, but longer-term business certainty for the industry is paramount.

“Pharmaceutical companies can only invest the large sums needed to bring innovative new medicines to market if they have a stable and reliable reimbursement environment.

“Patients can have confidence that manufacturers will continue to deliver innovative new medicines to this market.

“This agreement provides a framework for investment in the PBS for the next four years.”

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Contact Person:

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

Major policy flaws in the management of the Pharmaceutical Benefits Scheme could be putting patients at risk, Medicines Australia chairman Will Delaat told the Senate Community Affairs References Committee today.

Mr Delaat urged the Committee to recommend the abolition of the Government’s therapeutic group policy, which groups together medicines deemed to be “interchangeable” and links the price of those medicine to the lowest-priced in that therapeutic group. It is not at all clear whether these medicines are interchangeable.

The mandatory Cabinet approval for new medicines costing more than $10 million per annum before they can be PBS listed should also be reviewed so that patients can have earlier access to the medicines they need, Mr Delaat told the Committee.

“This measure was introduced in 2001 and implemented to reduce financial risk to the Government,” Mr Delaat said. “But given Cabinet does not reject new listings on the PBS, it is hard to see what financial risk is being reduced.”

“The real issue is that the need for Cabinet approval can delay the listing of these medicines by up to 12 months or more.

“While patients wait for the Cabinet to review a recommendation that has already been made by the clinical experts at the Pharmaceutical Benefits Advisory Committee, there is no subsidised consumer access to that new medicine.

“As a direct result of this policy, patients may experience deterioration of their condition before gaining access to their medicine – even premature death.

“New medicines undergo a comprehensive cost effectiveness assessment by the PBAC to determine value for money. So the Cabinet approval process doesn’t make sense.

“At the very least, the $10 million cost threshold at which Cabinet approval becomes mandatory should be doubled. That would have an enormous impact, halving the number of medicines that get caught up in the Cabinet process after the PBAC has already deemed them cost-effective, without leading to an increase in expenditure.”

Mr Delaat also raised patient safety concerns arising from the Government’s therapeutic group policy and confusion as to whether or not medicines within the same group were interchangeable.

“The risk for consumers is whether these medicines are truly interchangeable on an individual patient basis – whereby patients are able to switch from one medicine to another medicine in that group, without detriment to their health,” Mr Delaat said.

Medicines Australia’s submission 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 chief executive Dr Brendan Shaw today welcomed the investment by the Commonwealth and Queensland Governments in Australia’s first contract manufacturing facility for biologic medicines.

Responding to the announcement by Federal Innovation Minister Senator Kim Carr and Queensland Premier Anna Bligh, Dr Shaw said the new facility, to be operated by DSM Biologics, could have flow-on benefits for Australian biopharmaceutical companies.

“Medicines Australia welcomes any initiative that encourages biopharmaceutical investment to Australia,” Dr Shaw said.

“The benefit of having a facility in Australia which manufactures biological medicines for use in early phase clinical trials is that a lot of the R&D that currently has to be sent offshore can now be undertaken domestically.

“Biological medicines are an emerging weapon in the fight against disease and this kind of investment brings Australia into the game as a key player in this rapidly growing sector.

“Australia attracts nearly $1 billion a year in R&D investment but we face fierce competition from emerging markets overseas.

“Today’s announcement sends a signal to the R&D investment community that Australia is open for business.

“We need to keep as much clinical trial investment in Australia as we possibly can and today’s announcement is a significant step towards achieving that objective.”

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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 Dr Brendan Shaw today welcomed the finalisation of the Fifth Community Pharmacy Agreement between the Commonwealth Government and the Pharmacy Guild.

Dr Shaw said the agreement would help ensure all Australian patients had easier access to prescription medicines and patients provided with better services from pharmacists.

“Medicines Australia is looking forward to seeing the detail of the agreement but today’s announcement of the agreement’s key initiatives appears to be good news for patients,” Dr Shaw said.

“Medicines Australia member companies manufacture about 80 per cent of all prescription medicines on the Pharmaceutical Benefits Scheme.

“This agreement puts in place the framework to ensure those medicines are available through pharmacies to all Australian patients, even in the most remote locations.

“Timely access to medicines is critical in ensuring an effective healthcare system.

“It is also extremely encouraging to note several medication management initiatives that encourage the principles of quality use of medicines.

“Pharmacy plays an important role in providing advice to patients about how medicines should be used, and the announcement of today’s agreement looks as though pharmacists will have the support and infrastructure available to be able to provide that advice effectively.”

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Contact Person:

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

The apparent surge in pharmaceutical prices included in today’s Australian Bureau of Statistics Consumer Price Index for the March quarter is easily explained by the mechanics of the Pharmaceutical Benefits Scheme safety net, Medicines Australia chief executive Dr Brendan Shaw said today.

“Today’s CPI pharmaceutical price should be considered in the context of the December 2009 CPI, when pharmaceutical prices fell 5.3 per cent,” Dr Shaw said.

“The fall of the pharmaceutical price index throughout the year to December 2009 quarter was largely due to patients reaching the PBS safety net and paying either a reduced co-payment in the case of general patients, or no co-payment in the case of concession card holders.

“As each calendar year progresses, more people reach the PBS safety net.

“On 1 January each year, the PBS safety net is reset and consumers resume paying the normal PBS co-payments until they again reach the PBS safety net.

“That is why the pharmaceutical component of the index rises again the first quarter of each calendar year.

“The apparent annual surge in pharmaceutical prices each March quarter is a product of Government policy rather than any changes in pharmaceutical company pricing policy.

“In previous years this March quarter price surge has been incorrectly interpreted by some observers as a result of undue price rises by pharmaceutical companies.

“However, the apparent increase in consumer medicine prices in the first quarter of each year is due to the impact of Government policy related to PBS safety nets.

“What it shows is that the safety net is working.”

This explanation is provided by the Australian Bureau of Statistics itself in its own statistical release.

“Pharmaceutical prices rose as a result of the cyclical reduction of the proportion of consumers who qualify for subsidised medications under the Pharmaceutical Benefits Scheme at the start of each calendar year,” the ABS analysis said.

The chart below shows the cyclical changes in the pharmaceutical price index in the CPI for the last 10 years

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Contact Person:

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

A grave risk is emerging that the Pharmaceutical Benefits Scheme will be unable to continue supporting the development of new medicines in the future, Medicines Australia chief executive Dr Brendan Shaw told an industry conference today.

Speaking at the Future of the PBS Conference in Sydney, Dr Shaw said there was growing industry concern that the pricing decisions being made by governments globally and in Australia will constrain the future development of new medicines.

“In the drive to cut costs and get today’s new medicines at cheap prices, governments risk limiting the supply of new technologies in the future for our children and grandchildren,” Dr Shaw said.

“It is one of the great intergenerational issues of our age, but one that is not being confronted in Australia at all at the moment.”

Dr Shaw said that due to the long lead time required to develop a new medicine, the pricing policies of governments today affect companies’ commercial decisions about investment in new medicines far into the future.

“The process of developing a new medicine can take between 10 and 15 years and cost around $1.5 billion,” Dr Shaw said. “Only three in 10 medicines that make it to market are profitable enough to recover those high R&D costs.

“The cost of developing new medicines is increasing globally, but the price of the old medicines against which governments compare these new medicines against is falling.

“The result is an alarming disconnect between the reimbursement policies adopted by countries like Australia and the commercial realities of developing new medicines for future generations.

“A case in point is the development of new antibiotics which in many cases have become commercially unviable to develop because of outdated pricing policies.

“Seven thousand Australians die each year from drug-resistant bacterial infections, such as Golden Staph, and concern about the problem is growing. Yet, the pharmaceutical industry has been unable to develop enough new antibiotics to combat the problem, in part due to government regulatory and reimbursement decisions made over the past few decades.”

“It has become so hard for pharmaceutical companies to develop new antibiotics that the European Union is now exploring ways of encouraging the commercialisation of more antibiotics in the future.

“The great challenge facing the Australian Government, and governments around the world, is to encourage the industry to continue to develop these new medicines that will contribute to our children and grandchildren leading longer, healthier lives.”

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Contact Person:

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

In a submission to a Senate Inquiry which was released this week, Medicines Australia has called on the Government to think carefully about how it manages the Pharmaceutical Benefits Scheme.

“There’s a right way and a wrong way to manage the Pharmaceutical Benefits Scheme,” Chief Executive, Dr Brendan Shaw, said.

“Forming therapeutic groups and having a protracted Cabinet review process are some of the wrong ways to manage the PBS.”

Medicines Australia’s submission to the Senate Community Affairs Committee Inquiry into Consumer Access to Pharmaceutical Benefits, which addresses the creation of new therapeutic groups for new medicines, highlights the potential risks of forming such therapeutic groups for patients, Government and industry.

“The key to having a sustainable PBS that can deliver Australians the new therapies they need in the future is ensuring that companies have some predictability about the environment for the new medicines they bring to the PBS,” Dr Shaw said.

“Forming therapeutic groups in the way the Government did last year is just not the way to go.

“There is a lack of certainty around pricing. There is a lack of process around the formation of such groups. There is a clear lack of clinical definitions and eligibility criteria. The industry lacks confidence in the process.

“There is a disincentive for listing new medicines in the future. There are potential risks to patients from possible higher premiums and the risk that patients may miss out on treatments they need.

“All this points to a deeply flawed approach to forming new therapeutic groups in the PBS.

“Through 2006 and 2007 the pharmaceutical industry worked with the Australian Government, with the support of the then Opposition, to introduce a substantial reform program to the PBS that would provide policy and pricing predictability to industry. The creation of new therapeutic groups compromises that policy goal.”

Medicines Australia’s submission also argues that another area that needs review is the Cabinet approval process for new PBS medicines.

Currently, any medicine that has received a positive recommendation from the Pharmaceutical Benefits Advisory Committee and is projected to cost more than $10 million in any one year needs the approval of Federal Cabinet before it can be subsidised by the PBS.

“Requiring Cabinet to approve a new medicine for PBS listing usually delays the subsidy of these medicines by between six and twelve months,” Dr Shaw said.

“That’s six to twelve months of new treatments that patients are missing out on while the administrative processes of Cabinet grind on.

“The $10 million threshold for Cabinet approval was set at the turn of the century and has not been increased since that time, despite a Productivity Commission recommendation in 2008 that it be increased.

“Doubling the threshold to $20 million would be a sensible regulatory reform that improves the system for patients, industry and, frankly, the Government itself.”

Medicines Australia’s submission to the Senate inquiry can be found here

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Contact Person:

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

A report released today by the Australian Institute of Health and Welfare demonstrates the significant impact of medicines in reducing cardiovascular death rates in Australia.

Cardiovascular disease mortality: trends in different ages shows that death rates from cardiovascular disease have fallen since 1987, with the greatest decline in older people.

Medicines Australia chief executive Dr Brendan Shaw said the report underscores the enormous benefit that cardiovascular medicines have been delivering to ordinary Australian patients over the past 25 years.

“One of the key reasons that Australians are less likely to die from cardiovascular disease today compared with 1987 is the range of cardiovascular medicines that the pharmaceutical industry has bought to market over that time”, Dr Shaw said.

“This is a classic example of how new technologies developed by the pharmaceutical industry have resulted in people living longer, healthier lives.

“You have a far greater chance of surviving cardiovascular disease today than you did 25 years ago. That is due in part to the investment the pharmaceutical industry has made in cardiovascular medicines and in part to the preparedness of successive governments to invest in such medicines”.

The AIHW itself identified improvement in the availability and use of medicines as one of the reasons for lower death rates.

“Within Australia, emergency intervention after a heart attack has become more effective, along with long-term treatment of such patients, including the increased use of particular medicines such as angiotensin-converting enzyme inhibitors, statins, thrombolytics and antiplatelet agents,” the report says.

“More generally, the increased use and effectiveness of medicines to lower blood pressure, and a dramatic increase in the use of cholesterol-lowering medicines among the population at risk will have also played a part in reducing the likelihood of heart attacks.

“For stroke, it is likely that the increased use of blood pressure-lowering medicines, antiplatelet agents (such as aspirin) and anticoagulant therapy (warfarin) has contributed to the decline in death rates.”

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Contact Person:

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

Medicines Australia will make a $1m donation to the Jimmy Little Foundation at a Parliament House function this evening (Tue 16 March) to help improve indigenous health outcomes in remote communities.

The donation will be used by the Foundation to fund two separate indigenous health initiatives primarily in northern and central Australia.

The Uncle Jimmy “Thumbs Up!” campaign will deliver healthy eating messages to Indigenous communities, to encourage children and parents to make more nutritious food and drink choices.

A second initiative is the establishment of a mobile renal dialysis unit to be managed by the Western Desert Nganampa Walytja Palyantjaku Tjutaku Aboriginal Corporation based in Alice Springs.

Medicines Australia chairman Will Delaat said both projects reflect the pharmaceutical industry’s commitment to ensuring the donation delivers a practical, on-the-ground difference to the lives of Indigenous Australians.

“Australia’s pharmaceutical industry wanted to invest in an initiative that was going to be worthwhile and that could make a real, long-term difference,” Mr Delaat said.

“If this donation can encourage young Indigenous Australians to choose more nutritious food, and if Indigenous Australians on renal dialysis in the western desert can travel home and have treatment while they are there with their family then this money will have been put to great use.

“The 17-year gap in life expectancy between Indigenous and non-Indigenous Australians is a blight on our nation. It’s an appalling situation and as a community we must do all we can to help change it.

“While this is a relatively modest contribution compared with the vast challenge we all face in closing that gap, it is a positive and responsible step forward in effecting change.”

Medicines Australia’s donation has been funded by fine revenue collected from member companies found in breach of the Medicines Australia Code of Conduct.

“We made a commitment to the community that once administrative costs of running the Code had been covered, any fine revenue would be put to a worthy cause,” Mr Delaat said. “Today we are delivering on that promise.”

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Contact Person:

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