The Federal Budget for 2016-17 has promised to improve the regulation of therapeutic goods in Australia, but the mechanisms described in a statement from the Department of Health could do with some fleshing out.
The Department says that “The Government will bring life-saving medicines and medical devices onto the Australian market faster, some by as much as two years sooner, through streamlining of processes and regulations. Costs and administrative burden for industry will be reduced, while maintaining the safety and quality of medicines and medical devices.
“Assessing some products will be shorter and simpler. Some low risk products will be considered for removal from the regulatory scheme altogether. Information about complementary medicines will be made simpler to navigate for consumers and industry through a new catalogue of approved ingredients, and new approval pathways. Advertising for therapeutic products will be simplified. The number of committees that advise the Therapeutic Goods Administration (TGA) will be reduced.”
A number of policy items mentioned above and in a list in the Budget papers could do with more detail before the implications can be considered and discussed. These include:
• “Some low risk products will be considered for removal from the regulatory scheme altogether.” Does this mean that some alt med products that are not seen as harmful – though may very well be useless – will not be assessed or investigated?
• “Information about complementary medicines will be made simpler to navigate for consumers and industry through a new catalogue of approved ingredients, and new approval pathways.” Do the new pathways mean that even more alt med products of dubious efficacy can be listed?
• “Advertising for therapeutic products will be simplified.” The word “simplified” needs explanation. Does this mean less oversight and/or more lenient provisions?
• “TGA investigation and enforcement powers will be strengthened … TGA’s enforcement and compliance powers will be strengthened.” This is encouraging, as the TGA has been regularly described as a ‘toothless tiger’. How far will these powers go? Does it mean the TGA will actually be able to take legal action against non-compliant suppliers?
There are no further details on these policy items in the Budget papers, and at time of writing the TGA has yet to issue a reaction or comment.
The cost of the new policy items will be $20.4 million from 2016–17 to 2019–20. Though the policy statement doesn’t say so, this cost will likely be met out of the TGA’s cost recovery arrangements”.