Submission to the 2013 Review of Medicines and Poisons Scheduling Arrangements - Consumers Health Forum of Australia

The submission period for this review commenced on 2 April 2013.

Page last updated: 14 May 2013

Review of Arrangements for Scheduling Substances, Part 6-3 of the Therapeutic Goods Act 1989

The Consumers Health Forum of Australia (CHF) welcomes the opportunity to provide input into the Therapeutic Goods Administration (TGA)’s Review of Arrangements for Scheduling Substances, Part 6-3 of the Therapeutic Goods Act 1989 (the Review).

CHF is the national peak body representing the interests of Australian healthcare consumers. CHF works to achieve safe, quality, timely healthcare for all Australians, supported by accessible health information and systems.

The health and safety of consumers underpins decisions relating to the availability of medicines. The current system, whereby a medicine is classified under one of nine possible schedules, is an effective way for the TGA to assess risks and the level of control required over the substance. Given only the medicine’s sponsor and the TGA are able to provide input up to stage of scheduling a medicine, and that consumer representation already occurs in the relevant TGA Expert Advisory Committees, CHF has only minor comments for the Review.

Communication surrounding scheduling decisions must be transparent and clear to consumers, and CHF would welcome efforts by the TGA to enhance consumer understanding of the basis and implications for such decisions. The information on the TGA’s website relating to the scheduling of medicines is comprehensive, however, it is neither concise nor written in a way that facilitates consumer understanding. The information on the website also does not clearly illustrate the link between the scheduling decisions by TGA and its implications for medicine advertising, promotion, and packaging and labelling, which will subsequently affect consumers.

CHF’s members have reported confusion over the arrangements surrounding medicines regulation, finding them to be inconsistent, complex and difficult to understand. These factors may discourage consumers from reporting concerns, adverse medicine events or making complaints about medicines and the conduct of sponsors of scheduled medicines.

Although this may not be within the scope of the Review, CHF considers that enhancing communication should be considered in context of any proposed changes to the scheduling regulatory system. As effective as the scheduling system is in ensuring consumer health and safety is maintained, the TGA should also invest resources in clearly communicating this process and its implications to consumers.

CHF appreciates the significant reform agenda currently being conducted by the TGA to progress the recommendations contained in the TGA Reforms: A Blueprint for TGA’s Future document. CHF hopes that communicating the issues and outcomes from this Review to consumers are also part of TGA’s efforts to improve transparency about its activities.

CHF appreciates the opportunity to provide a submission to this review and awaits the outcomes of the Review with interest. If you would like to discuss the issues raised in this submission in more detail, please contact Mr Carlo Malaca, CHF Project and Communications Officer.