By James MacPherson | 23 June 2017 06:40:25Companies that make drugs are facing a new set of hurdles in their quest to compete with the global pharmaceutical industry, with many already feeling the squeeze from the high costs of new medicines and the increased reliance on the government to fund their operations.
The Australian Pharmaceutical Pricing Scheme (APPS) has been criticised by industry groups and consumers as a “government-mandated” price.
A new report by the Commonwealth Scientific and Industrial Research Organisation (CSIRO) says that “it is likely the APPS will be more than 10 times the size of the industry it is designed to regulate” and that it is too costly to administer.
The report also said APPS “is not sufficiently transparent and accessible” and should not be seen as a regulator.
APPS Commissioner Michael Dennison told The Australian Financial Review that he was disappointed by the report.
“It’s been a long time coming.
There’s been so much talk about the APS, but this is a very long time to have a report.
There were some good things that were done in the past but it’s a very difficult report to put out,” Mr Dennson said.
“This is a bit of an opportunity for us to say, ‘we are not doing things the way we should’.” Mr Darnson said the APDS was designed to provide a “fair and competitive marketplace” and said it was intended to be a “progressive regulator”.
He said the scheme had been in place since 1998 and was overseen by the CSIRO.
“I’m quite confident that it’s very fair, but the APSS is an integrated and inter-agency regulation which is very, very important to the industry,” Mr Burdon said.
He said it could be a major obstacle to new drugs being approved.
“We have an ageing population, we have more people on disability, and we have a rapidly growing pharmaceutical industry,” he said.
APDS Commissioner Michael Rennison says the APFS was designed with “fairness in mind” but has “been too big to fail” Source: CSIRO, The Australian, Australian Financial Press, Government, Pharmaceuticals, Pharmaceutical, APPS article Pharmaceutical companies have complained that the APPs cost of administering the scheme has made it difficult for them to operate, and said they will need to raise a substantial amount of money to pay for the new regulations.
In a statement to the Financial Review, Dr Michael Rynson, the APSP Commissioner, said the proposed changes would “ensure fair and competitive pricing and provide for more transparency”.
He called for a “balanced approach” to the APAPS, and a review of the current APPS.
“The APPS is a comprehensive regulator, providing access to all relevant regulatory authorities and allowing for an appropriate level of oversight and accountability,” Dr Rynsons statement said.
The APFS is responsible for regulating the manufacture and sale of prescription drugs in Australia.
It is currently managed by the Pharmaceutical Pricing Authority (PPA), which is managed by CSIRO and the Australian Food and Drug Safety Authority (AFSA).
Mr Bredon said it would be “very difficult” for companies to change their business models without facing an additional level of regulation.
“These new changes will impact many of the companies already operating in the market.
It will mean a lot of changes in the industry as well as new competition for new drugs and new medicines that might not be available in the current market,” he told the Financial Press.
“That will require new capital investment for some of these companies, so they will be affected by the changes as well.”
Pharmaceutical companies and consumer groups have also been concerned about the cost of the APNS, with the ACCC finding that the scheme was too expensive to administer, and that the new rules “will increase the burden on the consumer”.
In its submission to the Commonwealths Public Health Review, the CSIS said the current system was “not sufficiently transparent, transparently accessible, accessible to the consumer and is not sufficiently competitive”.
The CSIS says the system was established in 1998 to “improve the quality of Australian medicines” and to “encourage competition”.
It added that it was designed “to protect consumers from unfair or unreasonable prices, unfair pricing, deceptive conduct, lack of transparency and lack of accountability”.
The report found that “in its current form, the current price structure is too small to achieve the full objectives of the public health objectives of promoting competition, promoting consumer choice and protecting consumers from unreasonable or unfair prices”.
The ACCC also noted that APPS regulations were not sufficiently accessible or transparent to the public.
“Despite the large number of APPS regulatory activities and the complexity of their structure, there is not enough information on the APIS regulatory activities, their structure or the regulatory impact on consumers, including how the costs will be distributed