Jan McLucas (Queensland, Australian Labor Party, Shadow Minister for Aged Care, Disabilities and Carers) Share this | Hansard source

I seek leave to incorporate my speech in the second reading debate.

Leave granted.

The speech read as follows—

The purpose of this bill is to amend the Therapeutic Goods Act 1989 (the Act) by creating an exemption to the current certification requirements for registering or listing therapeutic goods in the Australian Register of Therapeutic Goods (ARTG).

The Amendments are a response to concerns raised by representatives from the complementary medicines industry, over-the-counter (OTC) medicines sector and the Australian biotech industry that the current patent certification requirements are more onerous and broader than they need to be.

The bill is proposed to particularly exempt the complementary and OTC medicines industry from the Australia-US FTA requirement which imposes obligations on producers to prove that the products they propose to have listed on the Register do not infringe existing patents, which generally involves conducting expensive global patent searches.

The bill will effectively alter the way these products are brought into the market in Australia by restricting the patent certification requirements for particular products (such as those that do not require manufacturers to submit safety or efficacy data) in their application.

The practical implication of this is that the majority of complementary and OTC products will no longer be subject to certification requirements.

The intent of the FTA as it applied to generic pharmaceutical products was to put up a barrier at the regulatory approval stage to the market entry of generic copies of prescription drugs.

Changes to the Therapeutic Goods Act (the Act) introduced by the Therapeutic Goods Administration (TGA) on 1 January this year went far beyond what was the original intent of the FTA. Complementary and OTC medicines manufacturers, in particular, have been caught up in the onerous requirements.

Once the bill is enacted, it will enable the removal of obligations for parts of the industry which should not have been imposed in the first place.

The amendments seek to rectify an unintended consequence of previous amendments made in light of the Australia-US Free Trade Agreement. These amendments came into force from 1 January 2005 to introduce certification requirements in relation to patents.

This outcome was clearly not intended by the Free Trade Agreement.

Labor will support this bill so that the unnecessary and unreasonable compliance and costs to the complementary and OTC medicines industry caused by the original drafting error are quickly rectified.