TGA Review - government responses to the key recommendations

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Below are government responses to the key recommendations from the review of medicines and medical device regulation. The government only outright rejected two of the review's 58 recommendations, accepting the vast majority, deferring two and accepting four in-principle.

Recommendation - introduction of expedited approval process.

Government response - accepts the recommendation as it "will provide an opportunity for novel and life-saving medicines to be fast‑tracked, either through an accelerated approval process or by offering provisional (time bound) approval. This will have important benefits for consumers who are suffering from serious and life-threatening conditions."

Recommendation - where a medicine is approved under the expedited process, the approval should be time limited and subject to conditions.

Government response - accepts the recommendation and legislation will be required. "...will be implemented for sponsors and assist in achieving earlier access to life-saving medicines for consumers. The Government will consult with stakeholders to ensure the implementation of these reforms maintains timely and sustainable access to medicines for all Australians."

Recommendation - two pathways for the registration of a generic medicine or biosimilar. Pathway one is submission of a complete dossier for de novo assessment. Pathway two is submission of an un-redacted evaluation report from a comparable overseas regulator, along with a copy of the dossier submitted to that regulator and an Australian specific Module 1.

Government response - accepts the recommendation in relation to generic medicines. "...the Commonwealth notes that international experience with the regulation of biosimilars is still developing and, accordingly, implementation of the multiple pathways approach for biosimilars will only be viable in the longer-term."

Recommendation - develop and apply transparent criteria for identifying comparable overseas regulators.

Government response - accepts the recommendation.

Recommendation - review the rescheduling framework and Schedule 3 advertising guidelines.

Government response - accepts the recommendation.

Recommendation - adopt a risk-based approach to the management of variations to registered medicines registered.

Government response - accepts the recommendation. "Implementing a risk-based approach to assessments of variations to registered medicines will benefit consumers through faster access to products and lessen the regulatory burden for sponsors."

Recommendation - develop transparent criteria it will utilise in order to designate suitably qualified bodies within Australia to undertake Conformity Assessments of medical devices.

Government response - accepts the recommendation.

Recommendation - develop transparent criteria under which application may be made for accelerated assessment of novel medical devices for inclusion in the ARTG.

Government response - accepts-in-principle the recommendation, "noting that development of criteria will be subject to further consultation with relevant stakeholders."

Recommendation - undertake a review of the range of products currently classified as Class I medical devices, with a view to reclassifying products as consumer goods in circumstances where the product poses little or no risk to consumers should it not perform as specified or malfunctions.

Government response - accepts the recommendation.

Recommendation - streamline access to medicines and medical devices not currently registered.

Government response - accepts the recommendation. "...minimise the need for health practitioners to repeatedly apply to the TGA for approval to supply certain lower-risk medicines and medical devices under the Special Access and Authorised Prescriber Schemes. Development of an online system also has the potential to reduce administrative costs for health practitioners, and enable better monitoring of the use of these products."

Recommendation - develop a more comprehensive post-market monitoring scheme for medicines and medical devices.

Government response - accepts the recommendation except for the establishment and maintenance of registries for all high-risk implantable devices. "Consideration of registries for high-risk implantable devices is being deferred until other work is undertaken...The development of a more comprehensive post-market monitoring scheme will enhance consumer protection and complement existing post-market monitoring processes."

Recommendation - comprehensive review of the legislative framework underpinning the regulation of therapeutic goods, including a review of the Therapeutic Goods Act 1989 and associated Regulations in their entirety, with a view to simplifying its structure and language to achieve a more user-friendly approach.

Government response - accepts-in-principle. "...will propose amendments to Parliament as required to implement particular recommendations. It will implement the intent of this recommendation (which is to simplify the legislative framework and ensure it is more user-friendly) when implementing agreed changes to legislation and regulations.

"Once legislative changes are implemented, an assessment will be made on the need for a more comprehensive review of the legislative framework underpinning the regulation of therapeutic goods, and whether the benefits of redrafting and implementing new legislation would outweigh the costs of doing so."

Recommendationdecision making process for the inclusion of medicines and medical devices in the ARTG be changed to provide for the Australian Government’s Chief Medical Officer to be the delegate for decisions.

Government response - rejects. "In consultation on the review recommendations, all stakeholders (industry, health professionals and consumer groups) strongly opposed this recommendation, as there was a consensus that delegating decision-making to a single person would slow approval processes and lead to a significant backlog of applications, thus potentially undermining efficiencies gained by implementing other recommendations in the Review. "

Recommendation the Advisory Committee on Medicines Scheduling (ACMS) become a sub-committee of the Advisory Committee on Medicines and make recommendations to that committee about the scheduling of medicines.

Government response - rejects. "as the roles of medicine consideration for TGA registration and for scheduling are quite different."

Recommendation - review and enhance the regulator's funding model, with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and operation are achieved.

Government response - defers. "The Department of Health and associated agencies are scheduled to undergo a Portfolio Charging Review in 2017‑18. A review of the regulator’s funding arrangements should not be conducted in isolation."

Recommendation - gives consideration to improving the competitiveness of the Australian complementary medicines industry by providing incentives for innovation.

Government response - accepts-in-principle. "The Department of Health will collaborate with other Departments (such as the Department of Industry, Innovation and Science) and with relevant stakeholders to consider this issue further. This reform aligns with the Australian Government’s National Innovation and Science Agenda."