TGAs New Penalties To Deal With Illegal Supply

By Australian Dental Industry Association, 12 September, 2017


 

Proposals that will give the nation’s regulator of medical devices an enhanced ability to deal with instances of illegal supply have been welcomed by the Australian Dental Industry Association (ADIA), the peak business organisation representing dental product manufacturers and suppliers.

Responding to an exposure draft of a Bill to amend the Therapeutic Goods Act (Cth) 1989 released by the Therapeutic Goods Administration (TGA) for comment, ADIA says that it is pleased that long-overdue reforms in this area look to be considered by the parliament.

“For far too long patients have been put at risk when dental products are illegally imported from overseas, having often been purchased via the internet and used on patients without the necessary market approval having been obtained. With the passage of the proposed legislation, the TGA will have a greater range of sanctions and penalties to address this behaviour,” said Troy Williams, ADIA Chief Executive Officer

The reforms are set out in an exposure draft of the Therapeutic Goods Amendment (2017 Measures No. 1) Bill (Cth) 2017 that will allow the TGA to respond appropriately to the full range of non-compliance from repeated minor breaches through to serious non-compliance. ADIA has been a strong and enduring proponent for this legislative change over the years, having raised it in the course of two Senate inquiries into the TGA’s regulatory framework for the approval of dental products.

“The dental industry could not be happier that the Australian Government has acknowledged the risks associated with the illegal supply of dental products and is proposing legislative reform to address them,” Mr Williams said.

The issues will be discussed further when ADIA meets with the Minister for Health, the Hon. Greg Hunt MP, at the annual Dental Industry Meets Parliament Roundtable to be held on 13 September 2017 in Parliament House, Canberra.

Source: Australian Dental Industry Association