Australia-United States Free Trade Agreement: Fact sheets
Pharmaceutical Benefits Scheme [PBS]
- Australia has made improvements to the transparency and process of the PBS and provided more opportunities for companies seeking listing of new medicines on the PBS to have input to the process.
- Access by Australians to affordable medicines under the
PBS is maintained under the AUSFTA.
- The price of prescription medicines will not increase as a result of the Agreement.
Pharmaceutical Intellectual Property
- The Agreement reinforces Australia's existing framework for intellectual property protection of pharmaceuticals.
- Agreed measures include:
- preserving arrangements under which generic medicines manufacturers can obtain marketing approval overseas once a patent extension has been granted for the patented product; and
- retaining the five years of protection for test data submitted with an application for marketing approval.
- The Therapeutic Goods Administration (TGA) marketing
approval process ensures that a generic manufacturer is not
able to enter the market with a generic version of a medicine
before a patent covering that product has expired.
- in those limited cases where a generic manufacturer considers a patent to be invalid, and intends to enter the market before that patent expires, the patent owner will be notified when the generic manufacturer applies to the TGA for marketing approval of the generic version of the patented product.
Plasma Fractionation Arrangements
In 2006, Australia undertook a review of its blood plasma fraction arrangements as agreed under the AUSFTA. The review, chaired by Mr Philip Flood, presented its report to the Government on 13 December 2006.
Under the National Blood Agreement, the Commonwealth, State and Territory Governments must all agree before any change to Australia’s blood plasma fractionation arrangements can take place.