Government position paper on promotion of therapeutic products
The Parliamentary Secretary for Health, Mark Butler, released a Position Paper outlining the Government’s intentions with respect to the self-regulatory codes of conduct of the therapeutic industry bodies. The Position Paper states the Government’s policy objective of ensuring that decisions on health treatment options are based on sound clinical evidence and not driven by incentives, and that the codes are effective in supporting this objective.
The Government proposes that the relevant therapeutic industry associations standardize self-regulation through development of an industry framework which ensures universal adherence to consistent industry-wide codes based on a set of common high level principles. It also suggests that if arrangements are not implemented by 2012 then the Government will look to legislate universal coverage and consistency.
One of the areas of concern to MTAA has been the unequal position in the market between companies bound by an industry code through their membership of an industry association and companies which are not members and which might behave in a manner that does not comply with a code. The Government’s Position Paper anticipates that all sponsors, in applying for the registration of higher risk medical devices, prescription medicines and over-the-counter medicines, will be required to nominate the industry code by which they agree to be bound. Complaints about possible breaches of a code by a non-member will be referred to the relevant code of conduct committee. At this stage promotion of lower risk listed therapeutic goods will continue under the current self-regulatory arrangements.
The second significant aspect of the Position Paper is that industry is encouraged to engage with the Australian Health Practitioner Regulation Agency (AHPRA), established under the new National Registration and Accreditation Scheme for healthcare professionals. This body has responsibility for the development of health profession standards. There is merit in having complementary provisions in the industry codes and the healthcare professional codes on issues such as conflict of interest and promotion of products.
MTAA CEO, Anne Trimmer has been asked by Mark Butler to chair the industry committee which will have carriage of the work outlined in the Position Paper.
