An Australian government review of herbal and complementary medicines looks set to provoke a wave of extensive reforms to the sector, giving the national medicines body greater powers to regulate natural health products.
The report is aimed at restoring confidence in the alternative medicines sector, according to the government. The industry was badly damaged by the largest medicines recall in Australia's history earlier this year, involving leading natural products manufacturer Pan Pharmaceuticals.
The specially convened expert committee, made up of representatives from the industry and academia, calls for the Therapeutic Goods Administration (TGA), which regulates all medicines in Australia, to introduce more rigorous assessment of ingredients used in complementary medicines, and also the evidence to back claims for such products.
Parliamentary secretary for health Trish Worth said the government would move to strengthen the powers of the TGA to ensure that action would be taken immediately against any manufacturer who is not fully complying with the highest standards of good manufacturing practice.
In April the TGA suspended Pan Pharmaceuticals' licence to manufacture medicines for six months after inspectors uncovered breaches of safety and quality, including the substitution of ingredients and substandard manufacturing processes. The move saw hundreds of vitamins and supplements removed from store shelves in Australia and numerous overseas markets, impacting ingredient suppliers and the entire natural products supply chain.
The committee, which was chaired by Dr Michael Bollen AM, a former member of the National Health and Medical Research Council and Australian Pharmaceutical Advisory Council, has recommended that the government take a more active role in ensuring that consumers have access to reliable information about complementary medicines.
It also recommends that homoeopathic medicines and related remedies making therapeutic claims be regulated and practitioners of traditional Chinese medicine also look set to face tighter regulation.
On a more positive note, however, the review is likely to see improved information about natural medicines for health professionals so that consumers are more aware of possible interactions between complementary medicines and conventional drugs.
Research and funding for complementary medicines should go up based on report recommendations, which called on the National Health and Medical Research Council to convene an expert group to identify the research needs.
"This industry is estimated to be worth A$800 million, so it is vital that Australians feel confident in the industry and its products. I will be urging my counterparts in the states and territories to introduce nationally consistent regulations to licence practitioners of complementary medicines. It will go a long way towards maintaining consumer confidence," said Worth.
She added that there will be wide consultation on the committee's findings to help inform the government's response to the report. It will also be sent to more than 80 stakeholder groups, including members of the complementary medicine industry, practitioner and consumer groups, for comments to be provided by the end of January 2004.
A copy of the report, Complementary medicines in the Australian health system, is available on the TGA's website.