For over 30 years, the Australian Self-Medication Industry has represented companies involved in the manufacture and distribution of non-prescription consumer healthcare products and related firms.
ASMI is the peak industry body for the Australian self-care industry including consumer healthcare products ranging from over-the-counter medicines (OTC) to complementary medicines.
Also represented by ASMI are companies providing manufacturers with services, such as advertising, public relations, regulatory consultancy, legal advice and industry statistics.
Topics for this month:
* ASMI welcomes Federal Government's Primary Health Care Strategy
* ASMI Submission on the Listing System for Complementary Medicines
* NEW CHAIRMAN APPOINTED FOR THE GENERIC MEDICINE INDUSTRY ASSOCIATION
ASMI welcomes Federal Government’s Primary Health Care Strategy
The Australian Self-Medication Industry (ASMI), the industry body representing non-prescription consumer healthcare products today welcomed the Federal Government’s strategy to promote primary health care.
ASMI supports the strategy which includes measures to address preventative health and the treatment of chronic conditions as well as moves to improve access to a broader group of health professional such as practice nurses, physiotherapists and dieticians.
“The Government’s initiative in placing a greater focus on helping people to remain well and manage chronic conditions is to be welcomed, said ASMI Executive Director, Juliet Seifert.
“There is a great deal that individuals and families can do to manage their health with the assistance of pharmacists and other health professionals before other interventions become necessary”.
ASMI supports a self-care approach as part of a national health strategy, which entails a fundamental shift to achieve a better balance between cure and prevention as part of a focus on holistic health. This includes promotion of a healthy lifestyle including good diet and exercise, as well as use of self-medication to treat minor ailments and some chronic conditions.
“Many Australian are already knowledgeable and willing to embrace self-care to maintain health, to prevent illness and to treat everyday ailments rather than going to the doctor for minor self-limiting conditions”.
The strategy outlined by the Minister for Health and Ageing, Nicola Roxon, is a sound one that has the potential to provide greater flexibility for families looking after their health, as well as potential savings to health budgets.
ASMI Submission on the Listing System for Complementary Medicines
The Australian Self-Medication Industry (ASMI), the industry body representing non-prescription consumer healthcare products today urged that some measures dealing with the regulation of complementary medicines be fast tracked to reassure the public and strengthen the regulatory framework.
The Scientific Director of ASMI, Dr Deon Schoombie said that from a risk management perspective, the current two-tiered regulatory scheme for complementary medicines is sound and consistent with the relatively low level of risk associated with the substances in complementary medicines.
However, ASMI believes that certain measures could be introduced to address public concerns and maintain confidence in the regulatory framework.
“We have a system in place that is designed to ensure that consumers are not exposed to unnecessary risk, but that does not mean there is not room for improvement”.
ASMI’s submission has been provided to the Parliamentary Secretary to the Minister for Health and Ageing, Senator the Hon. Jan McLucas and follows broad consultation with ASMI members. ASMI believes that measures could be introduced to strengthen the system in the following areas:
- Evidence requirements for claim substantiation.
- Availability of up-to-date, independent, evidence-based information about the benefits and risks of Complementary Medicines for consumers and healthcare professionals
- Timeliness of complaint handling procedures
- Sanctions applied to breaches of the Therapeutic Goods Advertising Code
Dr Schoombie said that a number of recommendations made by the 2003 Expert Committee on Complementary Medicines in the Health System that have not yet been fully implemented should be fast tracked for implementation. This includes the revision of the Guidelines for Levels and Kinds of Evidence to Support Indications and Claims and the move to have this document prescribed in the Therapeutic Goods Regulations 1990.
In addition, the registration pathway for complementary medicines should be streamlined to encourage more sponsors to opt for full efficacy evaluation.
A summary of the evidence on which indications and claims of products are based is currently held by sponsors under statutory declaration. He said that requiring sponsors to submit to the TGA, at the time of listing their summary of the evidence would improve compliance with current requirements and therefore enhance credibility and confidence in the system.
The TGA should also increase the level of random auditing and introduce targeted assessment of ‘problem’ categories. The outcomes from these should be made available to industry organisations as part of the bilateral process to assist industry identify problem areas which could be addressed through education and information sharing.
While ASMI argued that advertising controls should not substitute for post-market compliance activities, it believes that the complaints handling mechanism should be adequately resourced to respond in a timely manner to complaints. Appropriate sanctions are also required to act as a deterrent against breaches of the Therapeutic Goods Advertising Code and repeat offences.
NEW CHAIRMAN APPOINTED FOR THE GENERIC MEDICINE INDUSTRY ASSOCIATION
The Generic Medicines Industry Association (GMiA) announced today that Roger Millichamp has been appointed as Chairman of its Board, succeeding Mark Hurley, Executive Director of Alphapharm Pty Ltd who has been Chairman for the past year.
Mr Millichamp, Managing Director of Apotex Pty Ltd, has been a member of the Board of the GMiA for three years.
“I thank my fellow Directors for their support and look forward to working with them in growing the generic medicines industry in Australia.
“The very significant changes to the market following the PBS Reforms, and particularly the 25% price decrease impacting most generic medicines on 1st August 2008 provide an environment of challenge and opportunity for the generics industry.
“As an Industry Association we look forward to meeting these challenges, working closely with all key stakeholders and further broadening the market for generic medicines within Australia”.
Since 1995 generic substitution has resulted in estimated PBS savings in excess of $3 billion. GMiA members supply over 90% of the generic prescription medicines dispensed in Australia, employ around 5,000 people, manufacture in Australia and export to Asia, Europe, North America and New Zealand and are significant investors in R&D.
Contact: Di Ford, 0405 132 895