The country’s Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020, includes new protections for intellectual property, has now passed its latest parliamentary hurdle.
It includes Schedule 9 - a data protection regime for medicines and complementary medicines that are listed in the TGA register, which have been assessed for efficacy before they are given marketing approval.
This will provide five years protection for new clinical trial information that a sponsor submits in support of an application, if that information was not previously available. This mirrors the existing regime for innovative prescription medicines.
Carl Gibson, Chief Executive of CMA said: “This initiative is truly ground-breaking. Australia is leading the world by rewarding investment and protecting research. In a world first Australia will protect clinical trials for complementary medicines. So no more copycat cut and paste - but rewards for companies with the evidence base.”
Regulatory overhaul
It follows a number of beneficial regulatory changes in Australia in recent years.
For example, the Medicines and Medical Devices Review (MMDR), provided a new approval a pathway for listing complementary medicines with higher therapeutic indications and health claims.
The new 'Aust-Listed Assessed' health claim sits between the current, low-risk listed classification for complementary medicines, and the higher level classification for pharmaceuticals.
To qualify to make the new higher level claims, products must be supported by rigorous scientific evidence, and tested by regulator the Therapeutic Goods Administration (TGA) for efficacy.
Under this new system, companies that invest in innovation and research will also enjoy a two-year period of market exclusivity for newly approved ingredients.
Another measure included in the MMDR is about to come into force on July 1; namely the end of pre-approval for advertising in specified media.
While the regulation of advertising content remains, supplement firms no longer need to get the green light to market products, but must still ensure that their ads meet the requirements under the therapeutic goods legislation and advertising code.
Speaking of the latest IP developments, Gibson added: “Taken together with the recent introduction of market exclusivity for new propriety ingredients, and a new 'Aust-Listed Assessed' Registration pathway which provides higher level claims for higher levels of evidence; Australia is set to become the innovation nation for complementary medicines.
“Industry has been campaigning since the 1980s for better protection of clinical trials and this is fantastic news, a real boost for the industry for the next generation.”
