Healthy Skepticism Library item: 18396

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Stronger self-regulation?
Pharmacy Daily 2010 July 1
www.pharmacydaily.com.au

Full text:

THE Federal Government has today released a proposal paper calling for stronger self-regulation by the pharmaceutical and therapeutic industries in relation to their promotional activities directed at healthcare professionals.

“Doctors and other health professionals should prescribe drugs or medical devices because of the benefit to their patients, not because they could receive an incentive or a gift,” said Parliamentary Secretary for Health, Mark Butler.

As part of its position, the Government is calling on all members of the therapeutic goods industry to band together to develop stronger standards and enforcement for the promotion of medicines and devices to healthcare professionals.

“If the industry cannot provide the tough self-regulation that consumers deserve, the Government will have to bring in legislation,” Butler said.

Butler also hinted that if “consistent arrangements” were not realised in the near future, then legislative options could be put in place as early as 2012.

The paper itself, stipulates that the current range of promotional codes, existent across a number of the therapeutic goods industry associations are “inconsistent in terms of their requirements, application, enforcement and penalties” and have the potential to undermine public confidence in the public sector.

The paper also argues that current self-regulation codes have “created an uneven playing field” within the therapeutic goods industry.

As such, it is argued that the industry needs to strengthen and standardise self-regulation through the development of an industrywide framework based on a “common set of high principals”.

Suggested principals include: common core standards; principles of conduct including specific elements required for each code; and governance arrangements such as compliance training, reporting and independent complaint mechanisms.

“The application process for the registration of these products on the Australian Register of Therapeutic Goods would provide an opportunity for sponsors to nominate the code with which they intended to comply,” the paper said.

The Government has also said that in order for the proposed code to be effective, “there is a need to ensure the standards for conduct of healthcare professionals align with the standards expected of the therapeutic goods industry”.

The consultation paper on advertising is now open for comment until 27 Aug – for info see www.tga.gov.au.