Senate inquiry into the current barriers to patient access to medicinal cannabis in Australia
On 14 November 2019, the Senate referred an inquiry into the current barriers to patient access to medicinal cannabis in Australia to the Senate Community Affairs References Committee for inquiry and report by 26 February 2020. Submissions were requested by 17 January 2020.This submission outlines the response of NICM HRI to the Terms of Reference listed for this Senate Inquiry. NICM HRI were consequently asked to present to the Senate in Melbourne at the public hearing, which you can read in the Hansard below. The Senate published their Report on 25 March.
>> Read NICM HRI's submission (PDF, 464.34 KB)
>> Read the Official Committee Hansard (opens in a new window)
>> Read the Senate's Report (opens in a new window)
Medical Board of Australia public consultation paper
In 2019, the Medical Board of Australia (the Board) sought public feedback on options for clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments. In this submission, NICM HRI addresses several issues including the Board’s proposed definition for ‘complementary and unconventional medicine and emerging treatments’ and the regulation of medical practitioners who use complementary medicine as part of integrative medicine practice.
>> Read NICM HRI's submission (PDF, 771.81 KB)
Incentivising Innovation in the CM Industry
For decades there has been recognition that innovation is required to support the development of complementary medicines in Australia. A consultation paper released by the TGA in early 2017 on reforms to the regulatory framework for complement medicines (assessment pathways) detailed possible mechanisms to incentivise innovation for complementary medicines. The Australian Self Medication Industry (ASMI), Complementary Medicines Australia (CMA), and NICM Health Research Institute independently provided submissions to this consultation process to support the reforms recommended under the Review of Medicines and Medical Devices Regulation to enhance incentives for research and innovation for complementary medicines. The following paper sets out the agreed principles and elements considered necessary for a model for incentivisation by industry and academia.
>> Read ASMI, CMA and NICM HRI joint position paper (PDF, 250.94 KB)
Incentives for innovation – Protection mechanisms for evidence-based, pre-assessed complementary medicines
NICM HRI submitted to the Therapeutic Goods Administration (TGA) a proposal in June 2018 on incentives for innovation focusing on data protection. In this submission, NICM HRI outlines a proposal for a limited period of data protection on successful applicants for the AUST L(A) pathway who meet specific criteria and proposes a simple mechanism of implementation to achieve this objective.
>> Read NICM HRI's submission (%asset_summary_143185
Options for the future regulation of 'low risk' products
The Therapeutic Goods Administration (TGA) sought comment on proposed options for future regulation of 'low risk products', noting that decisions on significant changes to the regulatory framework would be made by government. Seeking specific feedback on the potential regulatory options for low risk products that were discussed in the consultation document, including which (if any) might be most appropriate and why. The options presented in the paper represent a range of possible regulatory directions for the identified 'low risk' products.
>> Read NICM HRI's submission (PDF, 467.96 KB) (opens in a new window)
Reforms to the regulatory framework for complementary medicines - Assessment pathways
The Therapeutic Goods Administration (TGA) sought comments from interested parties on a range of reforms to the regulatory framework for complementary medicines to address Government-agreed recommendations from the Review of Medicines and Medical Devices Regulation.
The purpose of this consultation is to provide an opportunity for consumers, health professionals and sponsors to contribute to the development and implementation of a range of reforms aimed to improve the regulation of complementary medicines in Australia. These reforms aim to increase transparency for consumers, provide additional flexibility for industry and support innovation, while maintaining the safety and quality of therapeutic goods available in Australia.
The scope of this consultation includes four elements:
- The development of a three-tiered risk-based framework for the regulation of complementary medicines. This will introduce a new assessment pathway sitting between the existing listed medicine (low risk) and registered medicine (high risk) pathways.
- The development of a list of permitted indications which must be used by the lowest risk complementary medicines.
- Allowing sponsors to claim that their medicine has been assessed by the TGA for efficacy where that medicine has undergone pre-market assessment by the TGA.
- Mechanisms to incentivise innovation for the complementary medicines sector.
Submissions will be reviewed by the TGA and feedback will be provided through the TGA website.
>> Read NICM HRI's submission (PDF, 819.83 KB) (opens in a new window)
Medical Research Future Fund consultation - Strategy and Priorities
The Australian Medical Research Advisory Board held its first meeting at Parliament House on 4 May 2016. The Advisory Board commenced consultation on the development of the Australian Medical Research and Innovation Strategy and related Priorities from 6 May to 6 June 2016, calling for submissions through the Department of Health's consultation hub.
Submissions were limited to three pages and sought from those who deliver, use, or stand to benefit from health services and health and medical research.
Under the Medical Research Future Fund Act 2015, the Strategy is determined every five years and the Priorities every two years.
The Australian Medical Research Advisory Board are to discuss the submissions, and advise on next steps in the consultation process towards the end of June 2016.
NICM HRI submission, Complementary Medicines for Better Health (PDF, 281.54 KB) (opens in a new window), was prepared with input from ASMI and CMA.
The submission advocates for funding of complementary medicine research projects to facilitate informed policy decisions on the use of complementary medicines in preventive health and in promoting general health and wellbeing.
The Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies 2013
The review of the Australian Government Rebate on Private Health Insurance (the rebate) for natural therapies (the review), will examine the evidence of clinical efficacy, cost effectiveness, safety and quality of in scope natural therapies.
NICM HRI submission on Australian Government Rebate on Private Health Insurance (PDF, 1051.12 KB) (opens in a new window)