Government must do more to promote ethical standards in the promotion of health sector products: IVD Australia

IVD Australia, an industry association representing companies who manufacture and supply in vitro diagnostics in Australia, has expressed disappointment at the blueprint document released last week by the Therapeutic Goods Administration on the regulation of therapeutic products in Australia.

The blueprint covers issues such as communicating the role of the TGA to the public, regulations covering the advertising and promotion of therapeutic products and the regulation of complementary medicines.

Chief Executive Officer of IVD Australia, Dr Peter Harman, expressed disappointment that the blueprint fails to adopt all the recommendations made by the 2010 Trimmer Committee report on the promotion of therapeutic goods.

“IVD Australia fully supported the Trimmer Committee’s recommendations regarding the implementation of reforms on the promotion of therapeutic goods. It is very disappointing that the Government has chosen not to take up all the recommendations and has failed to extend them to all parties in the wider health sector.

“This will continue the situation of an uneven playing field where companies who chose the ethical and responsible path are at a disadvantage to those who do not”, he said.

The challenge with the promotion of therapeutic goods is that the industry is self-regulated, but some vendors don’t adhere to the regulations or don’t belong to industry associations that promote them.

This opens the door for unethical behaviours such as offering inducements to health professionals to promote products, which the TGA recognises can influence clinical decisions on grounds other than the best interests of the patient.

The TGA blueprint also acknowledges the lack of consistency in industry codes undermines their application.

In response to these concerns, the blueprint outlines the TGA’s response, which is to continue to promote and strengthen self-regulation by the industry.

The blueprint calls for the industry to develop common high-level principles as the basis for aligning its codes of conduct, which will be done through the Working Group on the Promotion of Therapeutic Products.

“The Government’s preference is to maintain an emphasis on self-regulation and strongly supports industry’s initiative to harmonise their codes of conduct to incorporate the working group’s high level principles,” the blueprint states.

However, IVD Australia is dissatisfied with this option, citing the ease with which companies can avoid the regulations, creating an uneven playing field.

“IVD Australia is also concerned that the costs of including IVDs on the ARTG [Australian Register of Therapeutic Goods] will rise under the ‘Blueprint’ proposals. Australian sponsors bear the full costs of the TGA, unlike other jurisdictions such as the USA which is less than 35 per cent cost recovered,” said Dr Harman.

“IVD sponsors are already incurring large increases in costs to include IVD products on the ARTG and further increases will mean that even more products will not be supplied in Australia post the July 1st 2014 IVD Transition date.”

The full blueprint report can be read on the Therapeutic Goods Administration website.