Australian patients are missing out on some new medicines because the process of listing them on the Pharmaceutical Benefit Scheme (PBS) has become too difficult, say industry leaders.

"We have now reached the point where companies are simply unable to make some new treatments available on the PBS," said Dr Brendan Shaw, chief executive of the research-based industry association Medicines Australia.

"We have treatments for melanoma and rare diseases where the sponsoring companies have abandoned plans to list on the PBS, and other treatments for prostate cancer, melanoma and stroke prevention that have been recommended for listing but are still awaiting funding," he said, as the industry group outlined its requests to politicians ahead of Australia's federal election, to be held September 14.

"It’s absurd that melanoma treatments that are freely available in countries like Poland and Belgium are not available in Australia, the melanoma capital of the world. We have a medicine for Pompe's disease that is publicly-funded by governments in Greece, Cyprus and Italy, but is not publicly-funded in Australia," added Dr Shaw.

"The process for PBS subsidy is getting more difficult, more complicated and more unpredictable," he claimed, and called on the future government "to restore transparency, certainty and confidence to the PBS listing process and ensure all Australians have timely access to the treatments they need."

Meantime, the government and Medicines Australia have clashed over the industry's election document and recent reports issued on the PBS. Last week, they jointly released Trends In and Drivers of PBS Expenditure, which reports that spending on the Scheme has been increasing by A$500 million a year, to reach A$8.9 billion in fiscal year 2010-11.

The report "confirms growth in PBS spending is lower than forecast, as taxpayers reap the benefits of 2010 legislation which is bringing government subsidies into line with prices pharmacists pay their suppliers, saving A$2 billion over the forward estimates," said Health Minister Tanya Plibersek, referring to the price disclosure reforms to the A$6.5 billion-a-year Scheme agreed with the industry in 2010.

The report also finds that Australia's ageing population and the increased incidence of chronic disease are putting upward pressure on PBS spending, she added. "More than half of PBS spending goes to people aged over 65 years old, with 86% of PBS expenditure going to concessional patients who pay just A$5.90 a prescription," said Ms Plibersek.

However, earlier this month Medicines Australia released another report, commissioned from the Centre for Strategic Economic Studies (CSES) at Victoria University, which said that the number of new medicines listed on the PBS during 2011-12 was the lowest for 20 years.

The study also estimated that reforms to the PBS agreed by the government and industry over the last decade will deliver savings of up to A$18 billion to 2017-18.

But, said Medicines Australia's Dr Shaw, while theses savings were intended to fund new medicines on the PBS, the low level of additions in 2011-12 was "very alarming because it means many patients who need new treatments aren't getting them."

"This decline is not due to any fall in the number of new therapies being proposed by companies. It has been due to things like higher rejection rates at the Pharmaceutical Benefits Advisory Committee and delays in the listing process for new medicines," he said.

Ms Plibersek has responded that the CSES study contains “errors, inaccuracies and selective use of statistics."

"The independent experts who recommend listings for the PBS make their decisions based on the clinical benefits of medicines, whereas Medicines Australia represents pharmaceutical companies which are driven primarily by profit,” she said, and added that the industry report "chose to only identify drugs recommended for listing on the PBS for the first time, completely ignoring 85 new indications for treatment listed by the government in 2011-12."

The Generic Medicines industry Association (GMiA) commented that while the findings of the CSES report were good for the government in the short term, it was “very concerned about the medium-term consequences of reaping such significant sums of money from the generic medicines industry and the ramifications this will have on the continued surety of supply of generic medicines to patients."

The report also "fails to appreciate that the supplier of generic medicine is virtually completely reliant on sales in the off-patent market, unlike suppliers of the original brand, whose key profitability is derived from the more profitable patented medicines sector," added the GMiA.

And the Pharmacy Guild of Australia said that the CSES report’s estimates of PBS savings over the next five years are likely to be understated because they do not take account of additional impacts such as the increasing number of prescriptions which Australian pharmacies are dispensing privately, and which are further reducing government and consumer costs.