TRANS-TASMAN AGENCY RELEASES DRAFT ADVERTISING RULE
Australia's Therapeutic Goods Administration and New Zealand's Medicines and Medical Devices Safety Authority have issued a draft rule on advertising of therapeutic products.
The draft rule, published in December, follows proposed rules on medical devices, medicines, cost recovery and administration under the proposed trans-Tasman regulatory agency, the Australia New Zealand Therapeutic Products Authority (ANZTPA).
Under the proposed rule, medical device ads cannot refer "directly or by implication" to the products or medical procedures that would be conducted by healthcare practitioners without first having ANZTPA approval. Advertisements in the mainstream media (excepting the internet) that are aimed at consumers would also require prior approval, the document says.
According to the draft rule, "The overall objective of the proposed regulatory model is to provide an appropriate symmetry between the benefits of consumer access to accurate and balanced information and the freedom of speech with the potential for harm from the inappropriate use of medicines and medical devices and other public health and safety issues."
The proposal covers all advertising, including on the internet, of prescription, OTC and complementary medicines and medical devices directed at consumers or health professionals.
Australia currently has no system in place for overseeing advertisements for medical devices. New Zealand reviews device ads on a case-by-case basis.