Drug companies cause slow access to new medicines: Ley


Sussan Ley in Parliament (in Opposition): today she has lauded the wider PBS reforms package

Health Minister Sussan Ley says she wants to turn around the issue of ‘slow’ access to new medicines, which she says is caused by drug companies.

Medicines manufacturers prefer to test drugs in larger markets before making them available in Australia, she says.

She says the independent review of the TGA’s medicines and medical devices regulatory framework shows Australian patients are being forced to wait up to 15 months longer to access the latest breakthrough medicines.

The review finds Australia’s safety regulator has one of the most efficient and consistent approval processes in the developed world, Minister Ley says.

This includes Australia being on average 90 days – or three months – faster than world-leaders Europe to approve new medicines as safe.

However, the review has also confirmed Australia is being categorised as ‘slow’ when compared to the rest of the world because some drug companies were making Australians wait for medicines while they first tested them in bigger markets like the US and Europe.

For example, the review found Australia 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.
    • 467 days (or about 15 months) for nervous system medicines.

Mnister Ley says Australia continues to list drugs as quickly and efficiently as possible and is committed, through this review, to working with medicines manufacturers to improve approval process times, and cut red tape, without compromising quality.

“The Abbott Government continues to demonstrate our commitment to listing new drugs as fast as possible on the Pharmaceutical Benefits Scheme by doubling Labor’s effort in half the time,” she says.

“To continue to achieve this – and encourage even greater access to new drugs for patients – we want to ensure Australia’s drug safety approval system is even faster and more-efficient while maintaining our high safety standards.

“This review proposes a number of ways to achieve this, including cutting red tape and reducing international duplication of drug approvals, and we are considering it closely.

“However, this independent expert review also debunks the myth that Australia is slow at approving new medicines when compared to the rest of the world.

“For example, it finds Australia has one of the most consistent and reliable approval system of key developed countries and on average was about three months faster than world-leader Europe.

“Yet, the review also finds Australians are being delayed access to new innovative and potentially life-saving medicines by drug companies by an average six months longer than the US or Europe.

“This is a trend I want to turn around because it’s important Australians get fast access to new breakthrough medicines and I’m committed to working closely with medicines manufacturers to make our world-best approval system even better.”

For example, the review finds that when comparing drug safety approval systems like for like, Australia is on average 90 days faster than Europe:

    • Australia (TGA) – takes an average of 391 days to approve a new drug as safe.
    • Europe (European Medicines Agency or EMA) – takes an average of 481 days to approve a new drug as safe.

However, the review also finds Australia receives drug applications on average six months after the US, compared to just 20 days on average for Europe. Therefore, when factored in, this leads to a significant blow out in Australia’s approval times for new drugs when compared to the rest of the world.

    • Australia (TGA) – total approval times of 572 days (lag-time of 181 days compared to US).
    • Europe (EMA) – total approval times of 501 days (lag-time of 20 days compared to US).

The TGA Review makes a total of 32 recommendations, including new ways to expedite drug approvals through a multi-tiered approval system that will potentially include allowing drugs approved in other countries with similar health and safety standards as Australia to be considered for fast tracked approval if the evidence stacks up.

Minister Ley says in addition to the strong performance of the TGA on the world stage, Australia also has one of the fastest turnarounds for listing drugs for government subsidisation once approved as safe in the world, with the nation’s independent expert Pharmaceutical Benefits Advisory Committee averaging 17 weeks from submission to recommendation.

Previous TGA review could improve new medicines access: Medicines Australia
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