Key Point
- It is expected that by April 2006, following passage of the Therapeutic Goods Amendment Bill (No.2), most complementary medicine listing applications will no longer need to include a patent certification.
Five months after first being introduced, the Therapeutic Goods Amendment Bill (No.2) 2005 ("Bill No. 2") was passed by Parliament earlier this month, with proclamation scheduled for 3 April 2006. This Bill limits the patent certification requirement to applications for registration or listing where the applicant is required to submit safety and efficacy data and relies on evidence that another person submitted for goods already registered or listed. It is expected that by April, the Therapeutic Goods Administration ("TGA") will have made the necessary changes to the Electronic Listing Facility ("ELF") system for it to accept applications for listing that are not supported by a patent certification.
Background
Bill No. 2 was introduced to the Federal Parliament on 14 September 2005. Under the current legislation, sponsors of both listed and registered medicines are subject to patent certification requirements under the Therapeutic Goods Act 1989 (Cth) ("the Act"). This means that prior to applying for the inclusion of a product on the Australian Register of Therapeutic Goods ("ARTG"), sponsors must conduct patent searches, and an analysis of any identified patents, to certify to the TGA that they will not enter the market in a manner which will infringe a patent, or if they intend to enter the market before the expiration of a patent, that they have notified the patent owner prior to their entry. This requirement has been in place since 1 January 2005.
Listed medicines include most complementary medicines and a minority of over-the-counter products (such as sunscreens). The purpose of Bill No. 2 was to remove the patent certification requirement for listed medicines and to restrict the requirement to applicants who have to submit safety or efficacy data for their products as part of their application for inclusion of their product on the ARTG (for example, sponsors of prescription medicines, a majority of over-the-counter medicines and a minority of complementary medicines).
Impact
Bill No. 2 will eliminate the need to undertake patent searches (and review the results) for applications for registration or listing of low risk medicines, which will result in significant cost savings for sponsors.
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