In a plan – unveiled earlier today – the Australian Government said it will set up a 10–12 person group which will provide the Therapeutic Goods Administration (TGA) with expert advice from the perspective of consumers, health professionals and the pharmaceutical industry.
Much of the council’s work will focus on improving how the TGA communicates with drug industry and the general public according to Parliamentary Secretary for Health and Ageing, Catherine King, who cited recent criticism that the administration is inaccessible.
"The government is determined to change that and I know the TGA also wants to make its vital work of safeguarding the health of Australians more transparent. That is why I am pleased to see that the Blueprint for reform is well on track."
Fee hike
The announcement follows considerable industry criticism of the TGA’s plans to increase fees 5.6 per cent across the board to fund wide-ranging reforms it proposed in December 2011.
The increase drew criticism from a number of groups – notably Ausbiotech and the Generic Medicines Industry Association, which sent a letter to the minister of Health asking that the increases be reversed.
Generic Medicines Industry Association CEO Kate Lynch told the Australian Life Scientist magazine that: “To ask an industry that’s under economic difficulties to find an additional 2 per cent in fees is unreasonable.
“That money will be going to fund the TGA’s community services, providing information and interaction with the community about what the TGA does. That’s a public good, and as a consequence it should be funded by the public sector. To ask the industry to deliver a public good is outside the TGA’s funding guidelines.”
Implementation plan
Despite the criticism the Government seems determined to enact the reforms. Earlier this month it announced a detailed implementation plan that touches on a huge range of topics from drug advertising and medical device assessments to the regulations cover complimentary medicines.
Among the changes most likely to attract drug industry attention is the proposal to review, update and simplify current Australian Regulatory Guidelines for Prescription Medicines (ARGPM), which have not been revised since 2004.
Other proposals in the implementation plan – such as a system allowing sponsors submit and track applications on-line, the development of a policy on the disclosure of commercially sensitive information and the publication of inspection and compliance actions- are also likely to attract attention.