In a recent Compare report, Australia is ranked 18 out of 20 OECD countries when it comes to providing access to new medicines. Only 39% of new medicines have made it on to the Pharmaceutical Benefits Scheme (PBS) and this number drops to 27% in relation to ‘innovative’ pharmaceutical medicines.
So why does it take Australia so much longer to provide patients access to, often life-saving, medicines?
Government red-tape approvals process
Before a new pharmaceutical drug can be made available in Australia, it needs to be approved by the Therapeutic Goods Administration (TGA), which can only happen after the completion of successful clinical trials. Once a pharmaceuticals company has lodged an application for approval, the Australian Drug Evaluation Committee (ADEC) assesses the application and approves or denies it for listing by the TGA.
Once approval has been received, pharmaceutical companies can then apply for their new medicine to be covered by the Pharmaceutical Benefits Scheme, which subsidises the cost of medicines; reducing the cost of a new medicine makes it more affordable for patients and broadens its reach in the market. However, in order to be listed on the PBS, a new drug needs to be recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) and some drugs require Cabinet approval.
Obviously, these reviews and approvals take time; on average, it takes seven months from submission to ADEC and a TGA approval and up to 17 months after that if a PBS listing is applied for by the pharmaceutical company.
While some consider these delays frustrating, the government approvals process is in place to ensure the safety of new drugs entering the market and affordability for Australian patients. While bureaucratic red tape may be partially to blame for delays to accessing new medicines, a recent Australian government report shows that pharmaceutical companies themselves are key culprits in delaying access to medicines in Australia.
The report finds that pharmaceutical companies are delaying submitting their initial applications for approval in Australia, leaving Australians waiting for access to life-saving medicines. Compared to the access in the US and Europe,
- New cancer treatments are delayed, on average, by 148 days
- New heart disease medicines are delayed, on average, by seven months
- New nervous system treatments are delayed by up to 15 months
For some, these delays are deadly; for every week a pharmaceutical company delays submitting their application for a new cancer drug (for example), 156 people could lose their battle.
Sourcing medicine from overseas
These delays often lead people to source breakthrough medicines from overseas, but patients should consider all the facts before attempting to import medicines from overseas. The TGA allows importation of certain medications for personal use under the Personal Importation Scheme; this allows patients to source and import a 3-month supply of certain medications from overseas but this can sometimes be dangerous. Dangers include:
- Fake or counterfeit drugs
- Incorrect preparation (too strong or too weak)
- Include dangerous ingredients/undisclosed substances that are illegal or controlled in Australia
- Past their use by date.
Patients should be wary and always consult their health professional before purchasing medication and importing it into Australia.
Can anything be done to quicken the process?
With the exception of lobbying the government for change, there isn’t much that you can do to get medications any quicker in Australia. However, it’s often good to be aware of the procedures in this country in comparison with other nations, so that if the opportunity arises you can choose whether to let your opinion be heard.