Background: Review of the Medicines and Medical Devices Regulation (MMDR)
The Expert Review of Medicines and Medical Devices Regulation (MMDR) was announced in October 2014 by the Department of Health, following the launch of the Federal Government’s ‘Industry, Innovation and Competitiveness Agenda’ (IICA).
The Review was undertaken by a panel, which included Emeritus Professor Lloyd Sansom AO (chair), Mr Will Delaat AM and Professor John Horvath AO, to evaluate regulatory framework and processes in the Australian medicines and medical device sector, focusing on opportunities to streamline and improve regulation. The panel consulted with health professionals, industry, consumers and other stakeholders to explore ways in which the Government could reduce regulatory burden in the medicines and medical devices sector.
2014: beginning of the review
The Review commenced with a forum held in November, exploring the duplication of regulatory processes; flexibility of regulatory frameworks; regulation requirements and risk; regulatory process requirements; and complexity of the regulatory framework.
The Government said it would adopt the principle that if a system, service or product has been approved under a trusted international standard or risk assessment, then Australian regulators should not impose any additional requirements, unless there is a good and demonstrable reason to do so. This will reduce costs and delays for businesses, increase the supply of products into the Australian market and allow regulatory authorities to focus on higher priorities.
2015: First MMDR report released
The Review of Medicines and Medical Devices Stage One Report, the first report discussing the MMDR, was released on 31 March 2015. It included 32 recommendations, including:
- Expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in defined circumstances.
- Identifying comparable overseas regulators using transparent criteria.
- Enhancing post-market monitoring of medicines and medical devices and streamlining post-market requirements in respect of products in the Australian Register of Therapeutic Goods.
- Improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products.
AusBiotech made a submission to the Review and represented industry at invitation-only forums following the release of the report, which focused on medicines, medical devices and unapproved products, in addition to the practical implications of the approach proposed by the first report on the Review.
The first report was viewed as a positive and welcome approach, with AusBiotech expressing support for the expedited pathway for assessment of novel medical devices for inclusion on the Australian Register of Therapeutic Goods (ARTG). However, AusBiotech warned that novel products were less well understood and as a result, could pose a great risk to public health than device that are known to the Therapeutic Goods Administration (TGA). AusBiotech suggested that this risk could be minimised by identifying and supporting innovators early in the regulatory process.
2016: MMDR features on the Federal Budget
Life-saving medicines and medical devices would enter the Australian market faster, some by more than two years, through removing or streamlining unnecessary or efficient processes.
This announcement was revealed in the Health Budget Briefing in the May 2016 Federal Budget, which demonstrated that AusBiotech’s extensive advocacy was a valuable contribution to the MMDR.
Following the Federal Budget, the Therapeutic Goods Administration (TGA) opened a number of consultations in regards to the MMDR.