Amendment to TGA Bill for mandatory reporting obligation opposed

MedTech News: Parliament is considering the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022, which among other things would make it mandatory for hospitals to report adverse events involving medical devices.

The AMA had previously expressed support for reforms to product vigilance systems in a 2021 submission to the Therapeutic Goods Administration (TGA), including mandatory reporting by healthcare facilities.

The Australian Greens attempted to amend the Bill to extend the mandatory reporting obligation to all medical practitioners, including GPs. While the AMA encouraged voluntary reporting by medical practitioners, “our earlier submission rejected the approach proposed by the Greens due to the additional compliance burden for doctors and the lack of additional patient benefit if hospitals were already required to make these reports.”

Senator Jordon Steele-John, Australian Greens, WA stated “The very first recommendation of that inquiry was to create a mandatory reporting system that covered healthcare practitioners so that, if in the future such a device [surgically implanted transvaginal mesh] is in circulation, causing pain and harm, the regulator will have the data to alert the community, yet what the government has put forward is a mandatory reporting framework solely for hospitals, for healthcare facilities, missing the vital role of general practitioners in reporting.

“The reality is that when a device such as these [surgically implanted transvaginal mesh] malfunctions, people are not going to go straight to their ED; they’re going to want to talk with somebody they have a relationship with. Because this is clouded in shame, in a context where women’s pain is so often dismissed, people are going to want to talk to a person they have a built trust with, and that is often their GP.”

Anne Ruston, Shadow Minister for Health and Aged Care, said “Everybody would agree that patient safety must always be at the forefront of our thinking when we deal with issues in relation to the health and welfare of Australians.

“We are very mindful of the technical aspects of the implementation of the effects of this particular amendment, many of which have been outlined by the minister. But we also recognise that medical practitioners are under significant pressure due to serious workforce shortages. This is particularly significant for medical practitioners and general practitioners working in rural, regional and remote Australia. We know that’s where workforce shortages are hitting the hardest at the moment.

“While the opposition is opposing this amendment, for the reasons that I have stated, I want to put on the record that patient safety is absolutely first and foremost; however, we must recognise that we need to make sure that the implementation mechanism and method is appropriate and timely and doesn’t have any unintended consequences.”

The AMA worked over a number of days to raise concerns over the amendments put forward by the Greens and this ultimately saw the Government and Opposition combine to vote down the amendment in the Senate.

“Our advocacy has ensured that sensible changes to reporting arrangements are now likely to go ahead, without doctors facing a new and unnecessary compliance burden,” stated the AMA.

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