Government's announcement of TGA Blueprint

Media Release        
8 December 2011

Australian Government fails to support a fair and ethical playing field

The Australian Government has today failed both consumers and the therapeutic products industries by refusing to act to support better regulation of the interactions between the industries and healthcare professionals and consumers. This comes despite identifying the need to act in its own position paper and against recommendations of a working group established for the purpose.

Medical Technology Association of Australia (MTAA) Chief Executive Officer Anne Trimmer, who was appointed by the Government to chair the Working Group on the Promotion of Therapeutic Goods, expressed her extreme disappointment after today’s announcement by the Parliamentary Secretary for Health and Ageing, The Hon Catherine King.

“The Government is contradicting its own position paper on which this review was based,” said MTAA CEO Anne Trimmer. “It is ignoring recommendations by a working group of senior representatives from all major therapeutic products industry, healthcare professional and consumer groups which were reached after a lengthy process of submissions and negotiations.”

“It would have been a small step and little effort for the government but it would have meant consumers can be assured that the selection on their treatment options are based on the merit of the evidence and not on inducements of their treating physician or nurse,” said Ms Trimmer.

The ethical promotion of therapeutic products is central to the trust-based framework within which healthcare professionals advise and treat patients. The therapeutic product industries necessarily work closely with healthcare professionals to develop evidence-based approaches to particular treatments, in the development of educational materials on the correct use of products, and to support hands-on learning in the correct use of certain products. However the fundamental trust, and the value of the relationship, can be undermined where the independence of decision-making by healthcare professionals may be seen to be compromised by inappropriate promotion which is not in the best interests of patients or consumers, and which can add to the cost of healthcare.

The recommendations included the alignment of industry codes along common principles, reciprocal healthcare professional codes, the inclusion of all suppliers of therapeutic goods under a code irrespective of association membership and the creation of a single entry point for all complaints.

“Today’s announcement and the refusal by government to implement a simple yet effective solution like adding a tick box on the application form for product registration to bring companies under the umbrella of an industry code flies in the face of public expectation.”

“It also diverges from the recommendation of the Australian Senate Community Affairs Reference Committee in its November 2011 report on the regulatory standards for the approval of medical devices in Australia. The Committee recommended with bipartisan support that the Department of Health and Ageing undertake further work to address the issue of inducements paid by industry to healthcare professionals.”

“As the Chair of the Working Group I am very disappointed by the government’s inaction on the recommendations. Industry groups and healthcare professionals are committed to strengthening their codes yet the government is not supporting use of the same scrutiny to all suppliers. Ethical companies need a level playing field to not suffer adverse consequences from the actions of less ethical businesses,” concluded Ms Trimmer.

The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry.

MTAA media contact: Marion Demann 0416 625 678

Please follow the link to the TGA Blueprint.

Please follow this link to the Working Group report.

Please follow this link to read an article at The Australian online.