Give us evidence, transparency


Pharmacy, medical and consumer groups reveal broad support for proposed CM regulatory reforms

The TGA’s proposition of a new (third) pathway for sponsors to seek entry onto the ARTG for complementary medicines has been met with widespread support, consultation submissions show.

The new option is an intermediate pathway for medicines to be approved following self-assessment, coupled with TGA assessment of efficacy evidence.

Most stakeholders also welcomed the recommendation that – through the pathway – sponsors can present product efficacy to consumers via an easy-to-recognise claimer i.e. ‘tick of approval’ symbol or statement.

Complementary Medicines Australia (CMA) says it “strongly supports” the implementation the new assessment pathway as an opt-in option for sponsors.

“The new pathway will offer consumers additional confidence in the available and growing body of evidence, in addition to established safety and quality principles, to support informed choice when self-selecting complementary medicines,” CMA says.

But it adds the TGA should not require products with indications that are currently permitted in listed medicines to be ‘up-graded’ into the new pathway or otherwise have the indications removed.

AMA disagrees, saying it is “pleased” the TGA intends to pursue sponsored of listed medicines that would not comply under the new requirements, and cause them to amend their indications rather than just ‘grandfathering’ them.

ASMI has welcomed regulatory reform initiatives and is “supportive of the majority of proposed recommendations”.

But it expresses concerns that the current approach is segmented, with a lack of transparency of the projected final product.

It also notes the regulatory changes are likely to have a “marked impact on the entire regulatory framework”, which will come with business impacts and costs, and requests a full regulatory impact statement from the TGA to address these concerns.

ASMI also emphasises that “it is essential that all reforms maintain consistency with the overall framework, do not create consumer confusion in relation to other product types, do not introduce unnecessary complexity, and do not introduce excessive regulatory burden.”

PSA says it is supportive of the proposed reforms, and also supports the use of claimers in improving the transparency of efficacy claims for consumers.

However it “strongly believes” more rigorous compliance audit processes should be implemented and greater penalties applied if there are any breaches.

The Pharmacy Guild of Australia similarly takes a hard line towards regulation in its submission.

It calls for the TGA to implement “transparent and stronger licensing and marketing processes for complementary medicines sold in Australia to provide the community with confidence with regards to safety, efficacy and responsible marketing”.

The Guild says the CM industry needs support to research and publish the necessary evidence so that “only credible products are marketed in Australia”.

It adds that there should be appropriate surveillance, and “strong action” should be taken when it is found therapeutic claims are not supported by evidence.

The Consumers Health Forum of Australia (CHF) says it supports the introduction of the new pathway, and calls for a requirement for evidence from an independently randomised, placebo-controlled trial with blinding of outcomes.

Public health advocate Dr Ken Harvey and colleague Dr Prasad Ranaweera agree, adding that any findings should be published in peer-reviewed journals, with importance placed on replication and follow up of results.

“Evidence changes with time; initial small studies, often funded by the sponsors, may be positive, but these findings can be contradicted by subsequent, larger, better conducted trials,” Dr Harvey and Dr Ranaweera write.

And CHOICE says the regulatory reforms will help consumers better understand the efficacy and claims of products on face value.

“This new assessment pathway will signal to consumers that a product is effective and has been scientifically proven to do what it says it does,” says CHOICE.

“If properly implemented, consumers should find it easier to avoid products which have not been independently assessed, should they choose to do so.”

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1 Comment

  1. Ronky
    14/07/2017

    Seems to be mostly positive though limited steps in the right direction.
    Given that only 13% of consumers know about AUST R and AUST L numbers and only 5% understand what they mean, I worry that the creation of 3 rather than 2 classes of medicines has the potential to create even more confusion. As the consumer groups recommended, there should be much clearer information provided to consumers, e.g. a “traffic light” system of a big green light on labels of products the TGA has accepted as proven safe and effective for the claimed indications, a big red light for those only proven safe and with at least plausible efficacy (for a very limited list of permissible indications), and amber for the in-betweens which have some limited evidence of efficacy.
    Those products without satisfactory evidence of safety or which have no plausible efficacy should not be permitted on the market.

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