The government's long-awaited response to the Review of Medicines and Medical Devices Regulation (PD yesterday) has elicited a wide range of reactions from across the sector.
While Complementary Medicines Australia (CMA) ceo Carl Gibson has praised the "transformational recommendations that will be of immense benefit to the complementary medicines industry and to consumers", health activist Ken Harvey has been scathing of proposed changes to advertising regulations, particularly the abolition of pre-clearance.
"In addition, the worst offenders of misleading and deceptive claims are not members of industry associations, so self-regulation offered by industry associations will not pick these up," he said.
"The horses will bolt!"
Harvey gave guarded support for some principles in the review but emphasised that "the devil is in the detail", with special concerns around soft levels of severity and lack of timeliness of penalties for breaking the rules.
"We are currently running at 80% regulatory non-compliance with TGA post-marketing reviews and 98% upheld complaints by the TGACRP," Harvey points out, adding that, "In short, there is money to be made in breaking the rules!"
He also supported the proposed "more efficient, effective complaint system" but has "concern that the dead hand of the TGA may try and take this over; their current track record and lack of transparency is appalling!"
However CMA's Gibson said the robust way the review had been conducted was a "benchmark process, with wide stakeholder consultation, and while the details of the implementation will be critical to ensure delivery on the intent, the recommendations outline a regulatory framework for complementary medicines that will be critical to the continued growth of the industry and its contribution to Australia's preventive health agenda."
MEANWHILE The Australian Self Medication Industry (ASMI) welcomed the majority of the goverment's decisions about the review recommendations, but disagrees with retention of restrictions on advertising of S3 products and the implementation of a self-regulatory process.
Further, the Generic and Biosimilar Medicines association (GBMA, formerly GMiA) supported the streamlining of therapeutic goods by "removing duplicative and inefficient processes without undermining the safety and quality of medicines", reducing the red-tape burden for generic and biosimilar medicine suppliers.
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