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Does Australia really take too long to approve the drugs, as the US say?
Jul
The Australian drug approval system is under fire, z Critics in the United States Claiming that it is too ponderous to approve life -saving drugs.
The administration of Australian therapeutic goods balances speed with a stringent assessment of safety, effectiveness and profitability.
Like Australia, it really remains for the USA Food and Drug Administration? And do we need to change the way we confirm the medications?
Drug Development Pipeline
The development of drugs usually begins when something recent about the disease has been discovered. This usually involves the identification of a change in critical protein or finding a recent protein involved in the disease.
When scientists know the shape of protein, they can design a drug that can block or activate it.
Then scientists will take laboratory experiments, like Petri’s dishes to see if the medicine works on the protein in the way they designed. If these tests pass, they will go to testing animals and formulate.
The formula is a step where scientists decide what form the drug will take, for example a tablet, injection or patch. There is more than 150 different pharmaceutical dosage forms to choose from.
The last steps are people tests. This requires the completion of three types Clinical examinations. Everyone tries to answer various specific questions about the drug:
- Phase and: is the drug safe and sound? What are its side effects?
- Phase II tests: Does the drug work?
- Phase III tests: Is the drug better than currently available drugs?
At the end of the research, the company may apply for the administration of therapeutic goods (TGA) for the approval of the market and sales of the drug.
Obtaining drugs on the market is time consuming and high-priced. It will take 15 years From the initial concept and design to the government’s approval and costs more than $ 3.5 billion.
But the failure indicator is high: more than 90% of drugs This succumbing to development never gains the consent of the government.
How are drugs approved in Australia?
The decision to approve recent drugs for sale in Australia is made on the basis of security evidence and effectiveness provided by sponsorship.
After approval, the drug is added to Australian register of therapeutic goods.
Replace the medicine on Pharmaceutical Benefits Program (PBS) is a separate process from approval and is based on financial considerations and analysis of costs and benefits, not security and effectiveness.
TGA usually takes 240 to 260 Working days (around the full calendar year) from receiving a recent application for medicines to the decision on approval. It is longer than requires an American food and medicine agency (FDA) – 180 to 300 days.
Where there is an urgent need, the approval process can be faster. The first Covid treatment was approved in Australia two weeks after presenting it to be considered.
So why do Americans often receive medicines?
There may be several reasons why drug approval may be delayed in Australia when it has already been approved abroad.
First of all, with a population of 27 million out of 8 billion around the world, Australia is a relatively compact market. That is why it is not always a priority for companies to approve here. Regions with enormous populations, such as China, India and Europe, are a larger subject of companies. It can therefore delay when they give in to Australia.
Other reasons for delays may be that TGA requires additional evidence for safety or effectiveness that other regions did not demand or because recent information about the drug has come to featherlight since the approved the drug abroad.
And what about drug delivery delays at PBS?
When the medicine is replaced with PBS, Australians can access the drug for $ 31.60 (or 7.70 USD license) instead of the cost of a private prescription, which can be hundreds or even thousands of dollars.
The time needed to approve by PBS medicines was also criticized.
Advisory Committee for Pharmaceutical Benefits (PBAC), which presents PBS recommendations for the Federal Minister of Health, only sits three to six times for a year.
The Vice President of the American Chamber of Commerce John Murphy claims that PBAC accepts on average, 32 months To issue a recommendation for the list of medicine after submitting the application.
After issuing the recommendation, the minister he usually takes at least five months to make a final decision.
Read more: Australia PBS means that consumers pay less for high-priced drugs. Here’s how this system works
To speed up the process, TGA allows Parallel applications For confirmation of drugs and PBS lists.
The time spent on making the PBS decision is justified, taking into account the total cost of the program. In the years 2023–24 the total cost of PBS for the government was $ 17.7 billion. Thus, the decision about the list cannot be underestimated.
So should Australia change the method of approving medicines?
Criticizing the time needed to obtain regulatory approvals seems to be part of a wider US government attack plan. He exerts pressure on Australia to open its market to higher prices of drugs made by American pharmaceutical companies.
Australia has a world -class regulatory agency in TGA, which ensures that approved drugs are both safe and sound and effective. And the PBS program is a key part of our healthcare system and jealousy of the world.
The Australian government should resist all changes in the regulatory approval processes from the USA.
