While the Australian industry has performed well in recent years – with a recent audit showing it has generated revenues of $4.7 billion due to increasing interest and demand from consumers, both in Australia and internationally – trade association Complementary Medicine’s Australia (CMA) believes greater growth can be achieved amid more favourable government regulations.
In the organisation’s pre-budge submission to the federal government, CMA CEO Carl Gibson, pictured right, highlighted four key priorities.
Firstly, CMA is calling for growth and innovation to be encouraged through further streamlining of the regulatory framework, overseen by the Therapeutic Goods Administration (TGA).
The organisation acknowledges that many of the new policies contained in the Therapeutic Goods Amendment (2017 Measures No. 1) Bill currently being passed through parliament are beneficial – such as a ‘third way’ higher-level health claim intended to encourage innovation and protect investment in research, and a less complex yet more rigorous advertising complaints system – there are fears that other measures could lead to an increase in red tape.
“It must be noted that there are a number of areas where the proposed implementation of the reforms remains a concern as the regulatory burden will increase, with no foreseeable improvement in consumer protection or access to improved health products,” states the submission.
“A large number of firms, especially small and medium enterprises (SMEs) are concerned that the proposed regulatory framework for complementary medicines will be one of rapidly escalating red tape rather than the intended risk-proportionate and streamlined regulatory environment.”
Approved health claims
CMA is especially concerned about a recommendation which directs the TGA to establish a list of ‘permitted indications’ – essentially the list of health claims from which companies must exclusively draw when seeking to get a product listed on the ARTG.
There are fears that that the list has become too restrictive, which will create challenges for firms to continue to market and sell the current range of products or to develop innovative new products.
Furthermore, if a currently permitted claim is removed from the new list, manufacturers will have to apply for the new third level claim, which comes with a $15,600 fee and far more stringent efficacy requirements.
“The significance of the effects upon Australian businesses, particularly smaller and medium sized entities, cannot be overstated. A number of medicines will not be able to transition to the new pathway and will lose the ability to make their existing health claims,” states CMA.
“There is a significant history of use of these indications on products that have been sold in the listed space for many years, and no evidence of harm or need for increased regulation.”
A further concern is that homeopathic products look set to be removed from TGA regulatory oversight, which will prevent these goods from making any therapeutic claims.
CMA says it is vital that there is appropriate evaluation of the regulatory impact of the proposed changes.
“These are major decisions that will affect the business interests of the wider industry and restrict access to these medicines for consumers who choose to use homeopathic products. In addition to traditional history of use, there is a growing body of good quality, peer-reviewed research to demonstrate the effectiveness of homeopathic products as therapeutic goods,” adds the CMA submission.
Prevention not cure
The second major area for government intervention, according to CMA, is to focus on preventive health to build a more sustainable health system.
The budget submission argues there is a need for increased Government funding for prevention initiatives to help slash health costs.
Chronic disease is responsible for 83% of all premature deaths in Australia and 66% of the burden of disease, but only 1.4% of the total health expenditure is spent on public health activities.
CMA is calling for a strategy, developed in consultation with physicians, to increase the uptake of vitamin D supplementation amongst at risk groups, and the introduction of a scheme to provide free vitamins during pregnancy through medical practitioners for women that hold concession cards.
It also wants to see the re-establishment of a national preventive health body to implement and evaluate population-wide initiatives “to improve the health and wellbeing of the community and provide long-term savings for the health budget.”
In part two of this story tomorrow we’ll look at how CMA thinks ministers can help boost supplements exports and encourage greater innovation and investment in research.