Regulation of complementary medicines needs a 'right-touch' approach

The Australian complementary medicines industry has recently welcomed publication of the discussion paper for complementary medicines regulation by the expert panel undertaking the review of medicines and medical devices regulation. 

This review is seen by many as a once in a lifetime opportunity to help frame a regulatory system that is “light touch, right touch” and designed to enhance access for Australians to complementary medicines, without undermining the safety or quality of the complementary medicines available in Australia. 

Deregulation relevant to complementary medicines is mainly aimed at achieving the most productive framework arrangements that support improved consumer health outcomes, with the most streamlined administrative arrangements—not necessarily less, just better; evolution not revolution.

Quality and safety standards are mandatories, so this is not even up for discussion. Consumer safety is one of the major underpinnings of the strength of the local market in Australia and the incredible export opportunity that’s before the industry right now.

Consumers stand to benefit from continued access to consistent and high quality products, produced to GMP standards and administered under what is rightly acknowledged as one of the toughest and most rigorous regulatory regimes on the planet. 

Virtually unique worldwide, in Australia these low-risk, high-quality products are administered by the pharmaceuticals regulator. Part of the evolution of a better framework is matching any requirements for regulation to the risk profile for these products, achieved in agreed timeframes.

Local manufacturers in one of the last advanced manufacturing sectors still booming in Australia are seeing a significant upturn in exports to Asia, following on from the 20 years of intense promotion of Australia as a clean, green, safe and quality source for food and drinks, that's now driving preference for Australian-made complementary medicine products. 

Yet manufacturers offshore, with very different regulatory environments, are able to supply products over the internet to Australian consumers with virtually no audits, no traceability and no marketing or advertising or claims defensibility.  Evolving the system to reduce such loopholes will support consumer safety. 

To fully capitalise on the Australia’s exporting opportunity today and up to 2020, most manufacturers are planning to significantly expand onshore processing. By 2030, Asia will represent 59% of middle-class consumption, compared to 23% in 2009.

In the evolved deregulated environment as envisioned by Complementary Medicines Australia, all complementary medicines are still administered by the Therapeutic Goods Administration through an appropriately delegated, resourced and effective complementary medicines branch. 

They are all manufactured to GMP standard. They can only be manufactured from permitted ingredients evaluated by the TGA for quality and safety, and in a facility that has been audited to TGA standards. 

New ingredients are evaluated and approved in a relevant and expedited manner should they have approvals from trusted international regulators, and if not, then an evaluation should be undertaken within an agreed timeframe. 

Advertising pre-approvals are not mandatory, as the industry must comply to the letter of the law as to ACCC's Australian consumer law, and the checks and balances therein, or suffer the significant and binding legal consequences. 

Marketing approvals are needed as current and manufacturing facilities are audited by trusted international organisations, which are not necessarily regulators. 

If already licenced by trusted international regulators, a rapid and relevant clearance is achieved. If not, then an audit needs to be conducted, again possibly most effectively by trusted international organisations and within agreed timeframes. 

A further evolution of the current regulatory settings that improves consumer access to new products could be reward those that invest in science and research with a relevant window of specific marketing to justify the investment—even novel foods under Fsanz gain 18 months clear run to earn a return on investment—stimulating a race to the top for the best science and research behind the best products delivering the best preventive health outcomes.

The opportunity before us now across industry, consumers and government is to evolve to a best practice framework still based on quality and safety, operating with a real time, cost effective, risk relevant approach, locking in the great health and economic benefits that the complementary medicines industry and associated manufacturing and exports can secure for Australia.