TGA Reforms On The Complementary Medicine Industry – What You Need To Know
The Therapeutic Goods Administration of Australia (TGA) is currently (*) proposing to change a number of regulations regarding the advertising of natural medicines.
Some of the reforms may have a positive outcome on the control of advertising of therapeutic goods to the general public.
However others will significantly and adversely impact the entire natural medicine industry, from manufacturers to practitioners and consumers.
If accepted, these reforms are set to be implemented by July 2014.
There has been surprisingly little news coverage of the reforms put forward by the TGA, and only a matter of days left to submit a response to the TGA.
(*) Submissions closed 19 July 2013.
An Outline of the Proposed TGA Reforms
Complementary Medicine (CM) practitioners, associations and industry bodies are particularly concerned about TGA Proposals 5 and 6 of the 8 in total.
These proposals intend to reduce the rights of practitioners to advertise certain natural medications and in-clinic testing facilities. A change that would affect how many practitioners practice and their business viability.
The reforms will also affect what advertising material and education on natural medicines is available to CM practitioners, specifically Naturopaths, Herbalists and Homeopaths.
As these professions are not currently covered by the National Registration and Accreditation Scheme administered by the Australian Health Practitioner Regulation Agency, practitioners will be viewed as members of the general public by the TGA.
In other words, qualified Naturopaths, Herbalists and Homeopaths will be considered consumers and not health professionals, and have limited or no access to vital educational material on natural medicines that they are still, at this stage, able to prescribe.
Nonsensically, other nationally registered practitioners who have no training or qualification in Complementary Medicines such as dental hygeinists will have access to this information.
This discrepancy highlights the dire need for a uniform regulatory body for the CM industry, which would only recognise qualified CM practitioners and eliminate any threat to the public created by inadequately qualified practitioners.
However, as no regulatory body such as this currently exists, it seems obvious that reforms to reduce the amount of information available to practitioners would place the public at more risk of harm from natural medicines, rather than less.
Qualified CM practitioners undertake comprehensive training and education in their disciplines to be able to safely prescribe appropriate supplements for patients based on their individual health needs and circumstances.
To continue to practice in a safe and effective way, Practitioners require access to vital information relating to the ingredients used in products, their therapeutic actions and mechanisms of action, the conditions or population groups a product is most suitable for and actual or theoretical contraindications.
Public safety is already compromised by the self-prescription of natural medicines, which is why appropriately educated practitioners are so important to the Complementary Medicine industry and to consumer safety.
Some other questions that have arisen from the CM industry in response to these changes include the following:
- How can the government place restrictions on Complementary Medicine practitioners who have undertaken government accredited training and education, and who have government accredited qualifications?
- How can the public benefit from the newest health research and natural medicine developments when their practitioner’s access to this information is restricted?
- How will the public be able to gain Private Health Insurance Rebates for Complementary Therapies if the TGA recognises Naturopaths, Herbalists and Homeopaths as ‘general public’? Furthermore, how will this impact CM Practitioners and their businesses?
In summary, these reforms will not restrict CM practitioners access to natural medicines but will restrict the provision of advertising and educational material by the product suppliers to practitioners which forms a vital component of the CM industry.
Although not all of the reforms tabled by the TGA under the guise of ‘Public Safety’ will negatively affect CM practitioners or the public, we need to question if they just are another step towards reducing public access to natural healthcare and to quash the rights of Complementary Medicine practitioners.
If the reforms start here, where will they end?
It should be noted that at this stage the reforms mentioned above are just proposals and future recommendations will be informed by submissions made in response to this consultation.
The information in this article is intended to be informative, not alarmist and we will endeavour to provide you with updates on this process as they occur.
We thank you for your support.