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 ad NICM joint position paper (PDF, 250.94 KB)
Incentives for innovation – Protection mechanisms for evidence-based, pre-assessed complementary medicines
NICM submitted to the Therapeutic Goods Administration (TGA) a proposal in June 2018 on incentives for innovation focusing on data protection. In this submission, NICM 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's submission (PDF, 1585.26 KB)
Innovation and Science Australia's 2030 Strategic Plan Issues Paper
The Australian Government tasked Innovation and Science Australia to develop a Strategic Plan for the Australian innovation, science and research system out to 2030. The Strategic Plan aims to contribute to the wellbeing and prosperity of all Australians by ensuring that Australia reaches its innovation potential.
The Issues Paper nominates six challenges central to shaping the strategy, and suggests themes and questions for discussion.
Innovation and Science Australia are seeking contributions and ideas on the issues raised in the Issues Paper.
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'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'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 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.
3 Vital Investment Priorities
The aim of this report is to leverage government, industry and community support for an evidence based complementary medicines sector.
Read more and download the full Vital Investment Priorities Report
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 submission on Australian Government Rebate on Private Health Insurance (PDF, 1051.12 KB) (opens in a new window)
Preventative Health Taskforce
On 9 April 2008, the Hon. Nicola Roxon MP, Minister for Health and Ageing, announced the establishment of the Preventative Health Taskforce.
The Taskforce, which reports directly to the Minister for Health and Ageing, is responsible for providing evidence-based advice to governments and health providers on preventative health programs and strategies, focusing on the burden of chronic disease currently caused by obesity, tobacco and the excessive consumption of alcohol.
On 11 May 2010 the Minister for Health and Ageing, the Hon Nicola Roxon MP, released Taking Preventative Action (opens in a new window), the Government's response to the report of the National Preventative Health Taskforce.
NICM submission to the Preventative Health Taskforce (PDF, 178.71 KB) (opens in a new window)
Practitioner Regulation Review
In 2006, the Council of Australian Governments (COAG) agreed to a significant national health workforce reform package to enable the health workforce to better respond to the evolving care needs of the Australian community, while maintaining the quality and safety of health services. In particular, the process is designed to promote appropriate and nationally consistent standards of clinical practice and education.
Under the authority of COAG, the Australian Health Ministers' Advisory Council (AHMAC) has initiated a process of review of all major Australian health professions in order to achieve regulatory consistency across States and Territories and to determine the need for national regulation for partially regulated or currently unregulated health professions. AHMAC has previously established six key criteria for the process (Assessing the Need for Statutory Regulation of Unregulated Health Occupations).
The National Registration and Accreditation Scheme (NRAS) (opens in a new window) came into force on 1 July 2010, and includes Chinese Medicine.
NICM submission on Practitioner Regulation Review (PDF, 138.98 KB) (opens in a new window)
Health and Hospitals Reform Commission
On 25 February 2008, the Prime Minister and the Minister for Health and Ageing announced the establishment of the Health and Hospital Reform Commission.
The Commission is responsible for developing a long-term health reform plan for the Commonwealth Government.
In August 2011, the National Health Reform Agreement (opens in a new window) (and the related National Partnership Agreement on Improving Public Hospital Services and the National Healthcare Agreement 2011) was secured.
NICM submission to the Health and Hospitals Reform Commission (PDF, 162.15 KB) (opens in a new window)
Homeopathy Review: Assessment of the evidence - Effectiveness of Homeopathy for Clinical Conditions
NHMRC commissioned this assessment of the evidence to determine the effectiveness of homeopathy for clinical conditions. The assessment was undertaken by independent reviewers from OptumInsight™ (Health Technology Analysts) and was guided by NHMRC's Homeopathy Working Committee.
Read more about the review on the NHMRC website (opens in a new window).
NICM has considered the review findings and has released this statement (PDF, 75.76 KB) (opens in a new window)