When there is enough evidence from clinical trials that a new treatment is better than the existing standard treatment, there are still a number of steps before people can have access to the new treatment. These steps are to make sure that only the safest and most effective treatments are made available.
Therapeutic Goods Administration
If a number of trials find a new treatment to be effective and safe, an application is made to the Therapeutic Goods Administration (TGA) to have the treatment licensed for use in Australia. Not every new treatment needs TGA approval, only drugs and medical devices. The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. It aims to ensure that the Australian community has access, within a reasonable time, to therapeutic advances. Unless exempt, therapeutic goods (either drugs or devices) must be entered as either 'registered' goods or 'listed' goods before they may be supplied in, or exported from Australia. For more information on the TGA go to: http://www.tga.gov.au/
The TGA has a committee that assesses in detail the information submitted. If the committee feels that the drug or medical device is effective and is safe, it is likely it will be approved. A drug that is approved by the TGA can be prescribed by your doctor. The problem is that it may be very expensive. In some circumstances the drug may be paid for by the hospital where you are being treated or it may need to be paid for by the patient.
Australian Drug Evaluation Committee
The Australian Drug Evaluation Committee (ADEC) was formed in 1963 and given the role of providing independent, scientific advice on new drugs to the federal government. The ADEC is appointed by the Minister for Health and Ageing and provides advice to the Minister and the Secretary of the Commonwealth Department of Health and Ageing through the Therapeutic Goods Administration. It reviews:
- the quality, risk-benefit, effectiveness and access within a reasonable time of any drug referred to it for evaluation
- medical and scientific evaluations of applications for registration of prescription drugs (e.g. new chemical entities, new forms of previously registered drugs and therapeutic variations to registered drugs).
The Committee also provides services to other government departments, committees and community-based organisations on a wide variety of regulatory matters related to prescription medicines. For more information see: https://www.tga.gov.au/committee/australian-drug-evaluation-committee-adec#:~:text=The%20Australian%20Drug%20Evaluation%20Committee,on%20Prescription%20Medicines%20(ACPM).
Pharmaceutical Benefits Advisory Committee and Scheme
In most circumstances drugs approved by the TGA are then assessed by the Pharmaceutical Benefits Advisory Committee (PBAC), which makes recommendations about drugs which may be listed on the Australian Government's Pharmaceutical Benefits Scheme (PBS). By being listed on the PBS, drugs are made available at a subsidised rate to people who need them. The PBS provides reliable, timely and affordable access to a wide range of medicines for all Australians. For more information on the PBAC and PBS go to:http://www.pbs.gov.au/
The main priority for the PBAC is to consider the effectiveness and cost of a proposed benefit compared to alternative therapies. If it is felt the drug is cost effective, then the cost of the drug will be subsidised by the federal government. This means that there is a minimal cost to patients relative to the true cost to the drug. Not all drugs approved by the TGA are approved by the PBS. The assessment process by the TGA and PBS can take time. In some circumstances a particular drug may be available overseas before it is subsidised in Australia.