ASMI welcomes the majority of the Federal Government’s decisions on the regulartion of medicines
ASMI welcomes the majority of the Federal Government's decisions on the regulation of medicines.
Sydney, 15 September 2016 - The Australian Self Medication Industry (ASMI) welcomed the majority of the Federal Government's decisions regarding the regulation of medicines and medical devices. Of all relevant recommendations to non-prescription medicines, ASMI is aligned with almost all of the government's recommendations. However ASMI disagrees with government's decision to retain restrictions on the advertising of Schedule 3 (S3) medicines and to replace the current mandatory advertising pre-approvals system with a self-regulatory system.
ASMI's Chief Executive Officer, Deon Schoombie, said: "Industry is pleased the Federal Government will reform the scheduling framework for non-prescription medicines. The current system does not optimise consumer access to medicines or incentivise innovation and investment, and reform is long overdue. There is an opportunity to expand consumer access to more OTC medicines, thereby improving public health and providing much needed savings to the healthcare budget in the future.
"ASMI supports the Government's decisions on the regulation of complementary medicines. Industry has long advocated for a risk-based approach to regulation and the Government has accepted many of the proposals industry put forward in its submissions to address the acknowledged shortcomings in the current system. We look forward to participating in the reform process.
"We are disappointed that at this point in time the Government has taken no action to remove restrictions on the advertising of S3 medicines. It is difficult to see the public health benefits of keeping consumers in the dark about the availability of safe and efficacious medicines, especially when pharmacists are the gatekeepers of this product schedule with mandatory counselling required prior to the sale of these medicines." ASMI will continue its advocacy for S3 consumer advertising reforms and will be shortly bringing to government research generated by the University of Technology's Centre for Health Economic Research and Evaluation (CHERE) which supports the case that consumer advertising of S3's drives better quality use of medicines outcomes (QUM) for consumers.
"ASMI also opposes the Government's decision to replace the current mandatory advertising pre-approvals system with a self-regulatory system. ASMI believes the mandatory pre-approval of advertisements provides a high level of consumer protection and it also provides for a level playing field for manufacturers. There is clear and compelling evidence that the pre-approval of advertisements ensures high levels of compliance and protects consumers from non-compliant advertising.
"ASMI advocates for a complaints system that is fair, efficient, effective, transparent and applies to all advertisers and all media. There should be one body that receives and determines complaints about advertising directed to consumers and there should be a single body to receive and determine complaints.
"ASMI looks forward to working with the Government, ASMI members and stakeholders on the reform process following the announcement of the government response to these recommendations," he added.