In 2014-15, an independent panel consisting of three eminent experts: Emeritus Professor Lloyd Sansom AO (Chair), Mr Will Delaat AM and Professor John Horvath AO undertook a review of the medicines and medical devices regulation in Australia (the Review). The purpose of the Review was to identify:
areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined without undermining the safety or quality of therapeutic goods available in Australia; and
opportunities to enhance the regulatory framework so that Australia continues to be well positioned to respond effectively to global trends in the development, manufacture, marketing and regulation of therapeutic goods.
The Expert Panel issued two reports:
Stage One Report of March 2015 on the Regulatory Framework for Medicines and Medical Devices; and
Stage Two Report of July 2015 on the Regulatory Frameworks for Complementary Medicines and Advertising of Therapeutic Goods.
Following extensive consultation with stakeholders including consumers, healthcare professionals and industry, the Government accepted or deferred 56 of the 58 recommendations of the Review. The two recommendations rejected by the government are:
#29 Chief Medical Officer to become decision maker for all medicines and devices applications – this was considered unrealistic given the high volume of decisions every year requiring specific expertise; delegating decision-making to a single person would have resulted in a backlog of applications; and
#30 the Advisory Committee on Medicines Scheduling to become a sub-committee of the Advisory Committee on Medicines – this was rejected because the expertise and roles involved with considering medicines for TGA registration and for scheduling are quite different.
The Expert Panel Stage One and Stage Two Reports and the government response are available here.
Since 2015 the Australian Department of Health and the TGA have engaged with industry, consumers and healthcare professional communities through public consultations and face-to-face meetings. The therapeutic goods legislation and regulations have undergone significant revisions – the most comprehensive change since the introduction of the Therapeutic Goods Act 1989. More information about the MMDR consultations is available here.
Our submissions to the MMDR consultations have been written in close consultation with our Regulatory Affairs Committee (RAC) and other MTAA committees. We also collaborate with other Australian peak industry bodies such as Pathology Technology Australia, ADIA and AusBiotech and international industry associations MedTech Europe and AdvaMed in the U.S. MTAA submissions can be accessed here.