The report, by La Trobe University School of Psychology and Public Health’s Dr Deborah Gleeson was published in the Australian Health Review this week.
Dr Gleeson said the Government could be saving $367-560 million annually if cheaper versions of biological medicines, which are produced from living organisms, were made available in a more timely way.
Dr Gleeson, along with co-author Dr Belinda Townsend from Australian National University found biological medicines make up more than 20 per cent of government spending on pharmaceuticals in Australia, totalling $2.29 billion dollars in 2015-16. They said if biosimilar or generic versions of the drugs had been listed on the Pharmaceutical Benefits Scheme in that year, $367-560 million would have been saved.
“We found annual spending on biologics could be reduced by as much as 24 per cent through the timely introduction of biosimilars,” Dr Gleeson said.
Dr Gleeson said a meeting of trade ministers in Vietnam this week could pave the way for a revival of the Trans Pacific Partnership Agreement (TPP) – a trade agreement containing rules that would keep cheaper versions or biosimilars off the market for at least eight years after the original biological medicine is registered for sale in Australia.
Australian law currently provides five years of data exclusivity for all new medicines, a period of time where manufacturers of biosimilar drugs can’t rely on clinical trial data produced by the originator to register their product for sale. Dr Gleeson said this was different to a patent and in some cases could continue to block competition after patents on a drug had expired.
“The TPP rules for biologic medicines set out two options - eight years of data exclusivity, or five years of data exclusivity together with other (unspecified) measures to deliver ‘comparable outcomes’ in the market,” Dr Gleeson said.
“The second option means Australian law would not need to be changed, but accepting these rules appears to commit countries to ensuring that biosimilars won’t enter the market for at least eight years after the original drug is approved for sale.”
The TPP almost collapsed after US President Donald Trump withdrew the United States earlier this year. However the remaining 11 countries have been meeting to attempt to revive the deal without the US. The biologics rules – among the most controversial and unpopular in the TPP – may be among those suspended.
Dr Townsend from Australian National University said suspending these rules did not go far enough.
“Our research highlights the costs of monopolies on biologic drugs and the savings sacrificed by keeping biosimilars off the market,” Dr Townsend said
“The cost to taxpayers of keeping the biologics rules in the TPP could be prohibitive.
“If the trade ministers agree to reactivate the TPP without the US, the biologics rules should be permanently removed.”
Media contact: Sally Heppleston – s.heppleston@latrobe.edu.au - 9479 5353 / 0408 556 018
Dr Deborah Gleeson
La Trobe University, 0423 209 029
Dr Belinda Townsend
Australian National University, 0431 055 149
