23 February 2021
Following our last update in July 2020 announcing the introduction of the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020, further amendments have been undertaken. These follow industry concerns about limitations of the original data protection scheme.
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020(opens in a new window) was passed in both houses of Parliament on 18 February 2021. This Bill introduces a five-year data protection scheme for Assessed Listed Medicines. It is anticipated this will further encourage innovation and investment in the complementary medicines industry and provide added confidence for clinical research.
The revised scheme sees much welcome changes to the flexibility and breadth of the initial scheme. Sponsors and researchers will now be allowed to publish essential aspects of their clinical trial research for ‘Assessed Listed’ complementary medicines with an ‘intermediate’ level indication whilst ensuring data protection for a five-year period. This will prevent competitors marketing generic copies of the approved medicine therefore allowing the sponsoring company to benefit from their investment into clinical research and generate a commercial return prior to others.
Additional amendments to the Bill allow medicines with the same indication as another listed medicine but with different active ingredients, to access data protection hence encouraging research into novel therapeutic uses for a medicine.
“This represents a great opportunity for the Australian complementary medicine industry and is world-leading,” said Emeritus Professor Alan Bensoussan.
“By introducing data protection in the Australian market, it is an incentive for industry to invest in clinical research leading to the development of new products. Driving more evidence-based research will also enable growth of consumer assurance in the efficacy of complementary medicines.”
“It is still early days and industry is yet to work through the new TGA process. However, we welcome this very progressive change and the prospects it can create to stimulate innovation”
The intellectual property reforms have been created as part of the Australian Government’s Review of Medicines and Medical Devices Regulation (MMDR). They follow two decades of NICM HRI lobbying the Australian TGA together with Complementary Medicines Australia and numerous industry members.