A senior executive at US-based PhRMA has 'called' Australia over a failure to implement its obligations under the countries' bilateral trade agreement.
Writing on the organisation's website, Jay Taylor, PhRMA vice president of international advocacy, explicitly pointed to Australia as one of several countries failing to live up to its trade obligations.
"Ignoring these obligations erodes R&D incentives, harms U.S. companies and jobs, and threatens global access to life-saving treatments," he said.
"In Australia, for example, patent disputes are lengthy and, in direct opposition to their trade obligations, Australia does not notify U.S. innovators of a third party’s intention to market a follow-on product until after it is registered as a generic," said Mr Taylor.
The bilateral US-Australia Free Trade Agreement (FTA) requires both countries to maintain systems under which pharmaceutical patent holders are notified when a third party seeks marketing authorisation for a generic.
The US FDA maintains a list of products and current uses under patient in its 'Orange Book'. It will not grant marketing approval for a generic copy of a product that would infringe a patent listed in the 'Orange Book'.
In contrast, while a system was introduced in Australia following ratification of the FTA, it does not involve any substantive role for the TGA and gives patent holders virtually no capacity to challenge a product until after it is registered.
The system requires companies seeking marketing authorisation to simply declare to the TGA their application does not breach any patent. The TGA will not register a product if a company declares it will infringe a patent. Yet the regulator has no obligation to test an applicant's declaration.
Patent holders have no ability to challenge the veracity of the declaration until the product appears on the Australian Register of Therapeutic Goods. This delay is the basis of PhRMA's argument Australia has failed to implement its obligations under the FTA.
