29 September, 2016
The Australian Government has released its response to the Review of Medicines and Medical Devices Regulation, with reforms to be progressively rolled out over the next 2 years.
Background and scope of review
An independent review of medicines and medical devices regulation by an expert panel was announced in October 2014. The expert panel reports on Medicines and Medical Device Regulation were published in July 2015 (available here), including 58 recommendations for reform.
The scope of the review was to benchmark TGA regulatory requirements against international authorities, to ensure there is an appropriate balance between risk and benefit in the regulation of prescription, over-the-counter, complementary medicines and medical devices and to simplify and streamline the approval processes undertaken by the TGA.
The Review did not concern any aspect of the Pharmaceutical Benefits Scheme or reimbursement or subsidy of medicines and medical devices.
The Government released its response to the expert panel reports on 15 September 2016 (available here) and, for the most part, has accepted the recommendations made by the expert panel.
Key aspects are identified below:
New pathways for approval of medicines and medical devices
The proposed reforms contemplate new pathways for approval of medicines and medical devices in Australia.
One new pathway would permit sponsors to use evaluations and marketing approvals of comparable overseas regulatory authorities for registration of medicines and medical devices in Australia. The Government will develop a set of "transparent criteria" against which overseas regulators would be assessed as "comparable" and "trusted".
Another new pathway would allow for expedited approval of a medicine or medical device in certain circumstances.
The Government also supports new pathways for registration of generic medicines and biologics, but has indicated that international regulation with respect to biosimilars is still developing and implementation of a "multiple pathway approach" for biosimilars will only be viable in the longer term.
Faster access to unapproved products
The proposed reforms contemplate faster access to products not listed on the Australian Register of Therapeutic Goods under the special access scheme for individual patients.
This will involve the TGA developing transparent criteria for identifying category B SAS applications that would be subject to "automatic approval". It has been suggested that one criteria for automatic approval would be where a product has been approved for a proposed indication by a comparable overseas regulatory authority.
No more pre-approval of therapeutic product advertising
The Government has supported a recommendation that the process of vetting and pre-approval of advertisements for therapeutic products to the public is removed and replaced by an increased self-regulatory regime.
This represents a significant shift from the current regime.
The Government response notes that, in implementing this reform, it will be critical for there to be a broadening of enforcement powers to deter inappropriate and misleading advertising of products, as well as development of sponsor education programs to assist sponsors and advertisers in understanding that their obligations will be particularly important under a self-regulatory regime.
New complaints management mechanism
The Government accepted the recommendation that current mechanisms for managing complaints be disbanded and a new mechanism established consistent with best practice principles for complaint handling – including a single agency responsible for receiving and managing complaints on the advertising of therapeutic products to the public.
The Department of Health is to consult with stakeholders on the appropriate design of the new complaints-management process.
Complementary medicines and listed products
The Government accepted the recommendation that it undertake a review of the range of complementary medicinal products currently listed in the ARTG with a view to ensuring that products might be best regulated under other regulatory frameworks are removed from the auspices of the Therapeutics Goods legislation, noting that this review will involve consultation with consumers, industry, health professionals and other Commonwealth regulatory bodies.
Whilst still recognising the low-risk nature of complementary medicinal products, the regulation of complementary medicinal products will be reformed to provide new pathways where evidence of efficacy is to be reviewed by the TGA prior to market and compliance powers strengthened.
A more comprehensive post-market monitoring scheme
The Government also accepted the recommendation for developing a more comprehensive post-market monitoring scheme for listed medicinal products including complementary medicinal products.
This will include enhanced collaboration with overseas national regulatory authorities to share information relating to safety and efficacy; and the implementation of a scheme to alert practitioners and consumers that a drug is newly registered and to encourage reporting of adverse events.
The Government deferred its consideration of registries for high-risk implantable devices.
Timing for implementation
The Government has indicated that the reforms will be progressively rolled out by the TGA over the next 18 to 36 months in order to maintain continuity of business, with new regulatory pathways for some medicines in place within 12 months.
For further information, please contact:
Elisabeth White, Partner, Baker & McKenzie
elisabeth.white@bakermckenzie.com
