Government legislation and the Therapeutic Goods Administration (TGA) are supposed to protect Australians when they purchase medicines. Prominent health authorities are warning that the Federal Government is trying to bypass these important safeguards.
The Therapeutic Goods Amendment Bill is currently under review by a Senate Committee, but the authorities claim that the Federal Government has tried to bypass the Committee, arguing that the bill is “non-controversial.”
“This bill is anything but non-controversial,” said Professor John Dwyer, from Friends of Science in Medicine, “that is particularly true for changes suggested for the regulation of the advertising complementary medicines.”
As a result of the criticisms of the attempted bypass, Senator Richard Di Natale was asked to arrange for the Bill to be reviewed by the Senate Community Affairs Legislation Committee. Submissions were sought over the Christmas – New Year holiday period but requests for a public hearing were rejected because senators were on holiday.
Concern at this attempted sidestepping of appropriate procedures is so great that a number of civil society organisations have combined to hold their own public hearing to debate contentious provisions of the Bill.
The Hearing is supported by a network of many civil society organizations including:
- Monash University
- The Foundation for Effective Markets and Governance
- The School of Regulation and Global Governance, Australian National University (ANU)
- Friends of Science in Medicine.
The public hearing will be held at the
Australian National University on 24 Jan 2018, from 2:00 – 5:00 pm.
“There are a number of readily supported amendments in the Bill”, acknowledged Professor Alastair MacLennan from the University of Adelaide, “But leading experts in regulation policy, public health, and civil society all agree that it is important to have three very contentious aspects excised so they can receive better consideration,” he said.
The contentious aspects of the bill are that:
- the bill removes pre-approval of advertisements for therapeutic goods in favour of self-regulation;
- there are plans for the TGA to take over the advertising complaint system without ensuring ongoing stakeholder
- input and transparency of complaint outcomes, and
- the Bill will endorse an industry-submitted list of ‘permissible indications’ for complementary medicines.
“The current pre-approval process reviews over 2000 advertisements per year with an average turnaround time of 7 days,” said Professor Ken Harvey, from Monash University, “but it takes a very long time after marketing for inappropriate advertisements to be removed”.
“Vetting advertisements before publication is economically efficient because fraudulent therapeutic claims create unnecessary health expenditure and divert scarce health resources from remedies that work, to ones that don’t,” said Harvey. “Random post-marketing reviews by the TGA consistently find 80-90% of advertisements breach the mandated Code,” he said.
“We want pre-approval of advertisements to continue until the other measures being introduced (increased post-marketing reviews and more stringent penalties for regulatory violations) have shown pre-approval is no longer necessary.”
Released 19th January 2018.