Who decides what medicines are covered by the Pharmaceutical Benefits Scheme (PBS)?
In Plain English
The decision about which medicines are included in the Pharmaceutical Benefits Scheme (PBS) is made by the Minister, based on recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC is an independent group of experts who consider things like how well the medicine works, how safe it is, and how cost-effective it is compared to other treatments. Pharmaceutical companies are also consulted during this process.
Detailed Explanation
The National Health Act 1953 outlines the process for listing pharmaceutical benefits on the PBS.
- Minister's Role: Subsection 85(2) of the National Health Act 1953 states that the Minister can declare which drugs and medicinal preparations are covered by Part VII of the Act, effectively listing them as pharmaceutical benefits.
- PBAC's Role: Section 100A of the National Health Act 1953 establishes the PBAC as an independent expert body. The PBAC makes recommendations to the Minister regarding which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.
- PBAC Considerations: When making recommendations, the PBAC considers factors such as the medical conditions the medicine is approved for, its clinical effectiveness, safety, and cost-effectiveness compared to other treatments.
- Consultation with Pharmaceutical Companies: Pharmaceutical companies are consulted throughout the listing process, including submitting information to the PBAC and participating in negotiations.
- Special Arrangements: Subsection 85(2A) of the National Health Act 1953 specifies that if the PBAC recommends a drug be available only under special arrangements under section 100, the Minister must declare that the drug can only be provided under those arrangements.