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

Medicines Australia welcomes the Federal Government’s $2.2 billion funding for mental health, but questions the logic of blocking patient access to the latest schizophrenia medicine.

Funding for a mental health commission, early intervention programs and better coordination of social and clinical services for those with a mental illness is an important step towards ensuring the 1 million Australians living with depression are better supported.

Medicines Australia chief executive Dr Brendan Shaw said the Government should be congratulated on its mental health initiative, but that Federal Cabinet needed to ensure the latest mental health treatments were also funded.

“Mental health problems are a major cause of disability in Australia today, affecting many consumers and carers. It is encouraging to see mental health receive the kind of funding it deserves,” Dr Shaw said.

“But it simply doesn’t make sense to make an investment of that magnitude on one hand, and on the other make a political decision to block access to the latest schizophrenia treatment.”

Federal Cabinet delayed the listing on the Pharmaceutical Benefits Scheme of the latest medicine for schizophrenia, even though the Government’s own expert committee said it was value for money, and should be made available.

“Cabinet’s decision is a false economy because independent analysis by Deloitte Access Economics shows that listing this medicine would save the Government $52 million,” Dr Shaw said.

“Prescription medicines have a demonstrable record of improving patient outcomes in mental health, and in keeping patients out of hospital and in the workforce.

“Suicide rates have dropped in adults suffering from depression with the introduction of new anti-depressant medicines. Clearly, however, there is much more to be done.

“It makes no sense to make such an enormous investment in mental health without investing in the latest treatments, particularly when those treatments have been recommended by the Governments’ own independent expert committee.”

Medicines Australia works closely with the Mental Health Council of Australia (MHCA) through the MHCA Pharma Collaboration to improve health outcomes in mental health.

–ENDS–

Contact Person:

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

The Federal Government is ignoring its own growth forecasts for the Pharmaceutical Benefits Scheme, and making policy decisions without an evidence base, Medicines Australia chief executive Dr Brendan Shaw told industry experts in Sydney today.

Speaking at the 8th Annual Future of the PBS Conference, Dr Shaw said the Federal Cabinet would have found no need to block the listing of new medicines on the PBS if it had taken into account its own forecasts of modest PBS growth.

“If the Government had even bothered to look at its own forecasts of what the PBS is going to be doing over the coming years, they would have seen there is no reason for them to take the course of action they did,” Dr Shaw said.

“Treasury’s own forward estimates contained in last year’s Budget show that the PBS is only going to grow by 2.1 per cent per annum in real terms over the next four years.

“Yet the Government chooses to ignore all of its own projections and its own data and continues to impose further ad hoc, knee-jerk cost containment measures.

“The Cabinet’s decision to block the listing of new medicines on the PBS and impose Cabinet scrutiny of all new medicines seeking listing on the PBS is flawed. This is not evidence-based policy making.

Dr Shaw cited the latest Medicare data for PBS growth, the most recent Intergenerational Report, Treasury projections from last year’s Budget, and a PricewaterhouseCoopers report commissioned by the Federal Government in 2010 as evidence that PBS growth was well controlled.

Dr Shaw also lamented that most of the policy debate about the PBS ignored the benefits it provides. He used an example of how the PBS had changed over the last 40 years since 1971 to argue that the PBS provides a range of benefits to the community as it has grown.

“There is little consideration that spending on new medicines generates savings in the health system, making peoples’ lives better, and makes for a more productive, healthy and happy Australian community,” he said.

“Let’s hope future generations of Australians 40 years from now do not look back at us here today and lament that our generation skimped on healthcare, innovation and making new technologies available to Australians through the PBS.”

Transcript is available here

–ENDS–

Contact Person:

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

On 4 May 2011 the Therapeutic Goods Administration will be launching its new website. The TGA website receives on average 200,000 unique visitors every month, and is an important resource for all those interested in the regulation of therapeutic goods in Australia.

There are over 4,000 documents available to you through this website. The redevelopment of the website has involved extensive consultation and testing with consumers, health professionals and industry.

Contact Person:

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

h Treasurer Wayne Swan and Finance Minister Penny Wong, were invited to explain in person why Federal Cabinet is usurping the role of the independent Pharmaceutical Benefits Advisory Committee (PBAC), which recommends new medicines and vaccines for listing on the PBS.

The roundtable will also allow the peak healthcare bodies to reaffirm their strong opposition to Cabinet’s decision and explain to the Minister its impact on consumers, their families and their carers.

The Government has ignored the advice of its own expert committee, which recommended that the new medicines and vaccines be made available to patients through the PBS. Health consumers, clinicians and the companies who have developed these medicines are owed a proper explanation.

This decision puts the price of some medicines and vaccines beyond the reach of many sick and vulnerable consumers.

The current list of delayed medicines treat conditions such as lung disease, chronic pain, schizophrenia and enlarged prostate. A catch-up vaccine to prevent pneumococcal disease in young children was also delayed.

This week a further seven new drugs were recommended by the PBAC for PBS listing.

For Cabinet to be choosing to list some medicines on the PBS and not others raises the question of what expertise and experience they have that enables them to make decisions that contradict the advice of their own expert committee of clinicians and health economists.

Unless Cabinet reverts to the usual practice of accepting the PBAC’s recommendations and only requiring its approval for medicines costing $10 million or more in one year, more and more medicines will be held up in Cabinet, leaving more and more consumers without access to medicines that the PBAC has determined should be publicly available.

If Cabinet does not reverse its decisions, the problems are only going to get worse for consumers, clinicians and industry.

The Government has brought politics into what was an effective and de-politicised process in a highly sensitive area where people’s health, and indeed their lives, are at stake.

We are all aware that the Government has short-term budgetary imperatives and that it is important that the cost of our health system does not spiral out of our control. But it is hard to believe that Australia’s fiscal situation is so bad that we need to deny important medicines to sick people.

The PBS is working well. It is growing at only the rate of inflation and does not need to be tampered with. By not following the advice of the Government’s own independent expert advisory committee, Federal Cabinet has made a short-sighted policy decision, putting short-term fiscal considerations ahead of patient welfare.

The Government should immediately reverse its decision and revert to the practice of acting on the advice of its own independent expert committee, allowing Australians to access affordable medicines in a timely manner.

–ENDS–

Note to editors: Roundtable participants will be available for interview at 12.10pm outside 1 Treasury Place, Melbourne.

For further information:

Peter Logue, Consumers Health Forum 0402 067 614
Jamie Nicholson, Medicines Australia 0419 220 293

The Government’s budgetary concerns over the Pharmaceutical Benefits Scheme have been blown out of the water by the Government’s own figures.

The latest Medicare Australia data released yesterday shows that the Pharmaceutical Benefits Scheme is growing at less than the rate of inflation.

According to Medicare, the PBS grew by 2.8 per cent in the year to March 2011. This compares with the latest inflation figure of 3.3 per cent, also released yesterday by the Australian Bureau of Statistics in the Consumer Price Index for the year to March 2011.

Medicines Australia chief executive Dr Brendan Shaw said the latest data confirmed that PBS spending was under control and was not presenting the Government with any fiscal challenge.

“This data shows the PBS is actually going backwards in real terms,” Dr Shaw said.

“Whatever concerns the Government has about health expenditure, the PBS is one area of spending that it knows is being well contained.

“Given the slow growth of the PBS, the Government should reverse its decision not to list new medicines on the PBS.

“The irony is that just as the Government is restricting Australians’ access to new medicines, Government spending on the PBS is actually falling in real terms.

“The argument that PBS expenditure needs to be micro-managed by Cabinet just does not stack up against the latest available evidence.

“If anything, the fact that Government support for Australian patients is falling at the same time as the Government is seeking to further restrict Australians’ access to medicines should be a concern for all Australians.

“Medicines Australia has negotiated a good framework for managing the PBS with the Government in the form of the Memorandum of Understanding signed with the Commonwealth last year.

“This latest data shows that this framework is working effectively.”

–ENDS–

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 2010 CPI, when pharmaceutical prices fell 6.2% per cent,” Dr Shaw said.

“The fall of the pharmaceutical price index throughout the year to December 2010 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.

–ENDS–

Source : Australian Bureau of Statistics Cat 6401.0, TABLE 13. CPI: Group, Sub-group and Expenditure Class, Index Numbers by Capital City

Contact Person:

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

Medicines Australia today gives its support to the 2011 WHO World Health Day, whose theme is anti-microbial resistance. It focuses on the problem of antibiotics losing their effectiveness over time as bacteria evolve and mutate to become resistant to treatment.

More than 7000 Australians die each year – or 20 every day – from drug-resistant bacteria such as golden staph infections.

Medicines Australia chief executive Dr Brendan Shaw said the problem of anti-microbial resistance requires a collaborative response, bringing together leaders in government, science, economics, public policy and industry.

“The medicines industry shares the WHO’s concerns about the global spread of anti-microbial resistance,” Dr Shaw said.

“Without effective antibiotics, many complex medical interventions like chemotherapy, joint replacements and organ transplants would be very difficult or impossible.

“Governments around the world must work with pharmaceutical companies and other parties to create a policy environment that will prevent and counter the emergence of highly resistant infections.

“There is a desperate need for greater incentives for research into new antibiotics.

“In cancer, governments have been prepared to pay for new treatments as they are developed. The result is that today the industry has over 800 new cancer medicines in development, compared with 83 antibiotics.

“It is alarming that the current generation of Australians have to make do with the same antibiotics our parents used 30 years ago. Patients deserve better than that.”

Medicines Australia endorses the global medicines industry’s proposal to combat anti-microbial resistance, set out in a new position paper to be launched today by the International Federation of Pharmaceutical Manufacturers and Associations.

The paper proposes ensuring medicines are prescribed and used appropriately and greater incentives for companies to invest in the infection area as two important aspects to avoiding a crisis of growing resistance.

In launching the position paper, the global medicines industry commits to continuing R&D investment in the development of new antibacterial agents; working with WHO and national governments in the areas of education, prevention, innovation and access; and supporting the WHO’s work to advise on appropriate use of antibiotics.

–ENDS–

Contact Person:

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

New figures from the Therapeutic Goods Administration (see below) showing the third straight fall in the annual number of new clinical trials in Australia highlight the urgent need for Government to deliver on its promise to fix the problem, Medicines Australia chief executive Dr Brendan Shaw said today.

The Government announced on 2 March that it would implement by July 2011 the recommendations of a report prepared by the Clinical Trials Action Group, which was established by the Government to arrest the decline in clinical trials activity.

The TGA’s latest Half-Yearly Performance Report shows only 574 clinical trials were started in Australia in 2010. That is the lowest number since 2001 and 99 fewer than 2009.

Dr Shaw said the continued decline in the number of trials in Australia underscored the importance of the Government’s commitment to improve the regulatory framework for clinical trials by July.

“The number of new clinical trials in Australia has fallen by an average of 13 per cent every year since 2007,” Dr Shaw said.

“For the first time ever, we’ve seen three consecutive falls in clinical trial numbers, and a 15 per cent drop in the past year.

“These are not the kinds of records we want to be setting. It’s extremely disappointing.

“The very future of Australia’s $1 billion clinical research industry is at stake. I don’t think that is putting it too strongly.

“Clinical trials deliver significant benefit to the national economy and this is crunch time for the industry.

“The competition for R&D investment from countries in Asia and Europe is extremely fierce. Only with the right policy settings can we hope to grow our R&D industry and keep cutting-edge medical science in Australia.

“That would ensure we keep more of our top scientists in Australia and attract greater investment to our universities and other research institutions.

“Implementing these recommendations will help return Australia to the forefront of medical research and ensure the retention of thousands of high-skill Australian jobs.

“Clinical trials also provide early access to innovative medicines for Australians that otherwise would not be available. Sometimes these are life-saving medicines where there is no other treatment, particularly in cancer therapy and for rare diseases.

“These trials save the Pharmaceutical Benefits Scheme $100 million a year, so the more clinical trials we conduct in Australia the greater the saving for the taxpayer.

“It is very much in the national interest that we seize this opportunity, from both a healthcare and an economic standpoint.”

–ENDS–

Contact Person:

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