Health Minister Sussan Ley has criticised pharmaceutical companies for dragging their feet on bringing new drugs to the Australian market and prioritising applying to lucrative markets overseas.
“It is supported by world-class drug approval systems that balance fast access to the latest drugs for patients with strict public safety protections that are based on clinical evidence, not just the claims of drug companies. I make no apologies for this.
“Our approval systems also include safeguards to ensure taxpayers are not overpaying for drugs that do not deliver on what they promise patients.
“This has allowed our Government to deliver on our promise to list new drugs quickly, with 798 new and amended listings added to the PBS since we came to office in 2013. This is the more than double the 331 new and amended drug listings delivered in Labor’s final term in half the time.
“Unfortunately Australia is disadvantaged because drug companies often delay bringing new medicines down under – sometimes by up to 15 months – in favour of making applications in more-lucrative markets such as the US and Europe first.”
As an example, Minister Ley says the recent independent Expert panel review of medicines and medical device regulation found Australians waiting on average about six months longer than the US and Europe for drug companies to apply to list new medicines here.
This includes 148 days (or about five months) for anti-cancer medicines; 231 days (or about seven months) for cardiovascular medicines; and 467 days (or about 15 months) for nervous system medicines.
“This is despite Australia being on average 90 days – or three months – faster to approve new drugs as safe than world-leaders such as Europe,” she says.
The same independent expert report therefore found: “These submission gaps may be contributing to a perception that the TGA is slow to approve new drugs for market, as observers will not necessarily be aware the dossier was not submitted in Australia at the same time as it was submitted in, for example, the US.”
“This delay is something I am determined to overcome and I am currently working with the entire pharmaceutical chain, including consumers, to institute reforms,” says Minister Ley.
“This includes current consideration of recommendations of an independent review into strengthening and streamlining Australia’s world class drug approval systems so that they deliver even more for patients.
“Discussions about drug listings are often a difficult and emotive issue and its important patients are able to access the facts, not just perceptions and propaganda.”