Tag: medicines regulation

Draft National Medicines Policy acknowledges research is key

Following on from our submission last year to the Discussion Paper, Research Australia has welcomed the acknowledgment of the importance of research in the new draft National Medicines Policy (NMP). Research Australia has used our submission to highlight further areas under the policy’s pillars where research can play a critical role, and has called for a dedicated stream of funding for research to support the Policy’s implementation and objectives.

Research Australia believes the Governance and Implementation sections of the draft policy need more work and has joined with the medicines sector and consumer groups to call for further consultation before the NMP is finalised. The Government has now heeded this call, with the Minister for Health announcing on 23 March that there would be further consultation before the Policy is finalised.

Read Research Australia’s submission here.

The 2022 National Medicines Policy was subsequently published on 20 December 2022, and the role of research is recognised in several areas, including as an enabler of the Policy. The Policy is available from the Department of Health’s website here. 

National Medicines Policy- researchers as partners

Research Australia’s submission to the review of the National Medicines Policy has made the case for researchers to be formally recognised as partners in the Policy alongside government, industry, healthcare providers and consumers. We have also supported the expansion of the policy to include vaccines and new health technologies. Our submission provides examples of how the Policy can be more consumer-centric, by making better use of the data already collected to understand consumer behaviour in relation to medicines.

Read Research Australia’s submission.

Research Australia supports TGA reforms

Research Australia made a submission to the Senate Committee inquiring into the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. This Bill is the latest instalment in amendments to implement the recommendations of a Review conducted in 2015 with the aim of improving the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration (TGA), and to provide consumers with better information.

Research Australia supported the amendments to improve access to potentially lifesaving medicines for patients with few or no other options. In doing so, it will implement a scheme that is similar to those already operating in the USA and European Union.

Research Australia also supported the proposed changes to the marketing of complementary medicines, although we urged the Senate Committee to recommend the legislation be amended to include disclaimers to the effect that the efficacy claims for the products have not been independently assessed and/or are based on traditional use rather than scientific evidence.

Research Australia Submission on the TGA amendments.

The Senate Committee issued its Report on 2 February, noting Research Australia’s submissions. It has recommended that the Senate pass the Bill. In responding to concerns raised by the Committee about advertising of complementary medicines, the Department has outlined measures that will be taken to ensure the public is aware that efficacy claims are based on traditional use rather than scientific evidence. The Committee has also urged the Government to ensure the TGA is adequately resourced to undertake its monitoring activities.