I thought that CRI had made some progress in helping industry design labels that were easier for people to use. I also thought that we had made some significant progress in helping government to develop regulations that would support good product information design.
We ran a national forum, showcased good design through our case histories, helped shape new regulations (TGO 69a 2004) and industry codes of practice, and helped many manufacturers improve the quality of their product information. But recent events and government reviews suggest that much of this work is being ignored. If the recommendations given in the latest Consultation Paper by the Therapeutic Goods Administration (TGA) are accepted, future regulations of product information will revert to principles that pre-dated most of our work and which were responsible for requiring industry to create unusable and in some cases dangerous product labelling.
The principle that we sought to overthrow and which is now in danger of re-emerging is what we call ‘content-based’ regulation, where the regulator prescribes the content and appearance of information on the label. In this approach, the question the regulator seeks to answer is: What do we want to tell people about this product? This is an open invitation for lobbyists and advocates to bring pressure on the regulator to include their special interest concerns onto the label.
We introduced what we call ‘performance-based’ regulation. In this approach, the question the regulator seeks to answer is: What do we want people to be able to do with this product? The regulator prescribes the tasks that people should be able to perform with the labels, but leaves the specifics of design and content to the marketer.
Most importantly, at the core of the performance-based approach is a requirement for evidence: evidence that people can perform the required tasks. We produced guidelines for creating labels and testing them to provide the necessary evidence that they work. These guidelines are now incorporated into the pharmaceutical industry’s Code of Practice. At present, government regulations strongly recommend that, to enhance patient safety and minimise risk, the labelling of non-prescription medicines should be designed according to the Code of Practice guidelines.
The guidelines were a result of CRI’s ongoing intensive program of research, testing and experience. Now, unfortunately, it is as if TGA’s entire corporate memory has reverted to a discredited earlier approach to labelling. There is no evidence that TGA’s proposed regulatory changes to non-prescription medicine labelling result from professional evidence-based practice. Moreover, there is no evidence that the proposed labels will be tested to see if consumers can easily find and use the information on them.
Undoubtedly, labelling is due for a review. It’s nearly 10 years since the guidelines were written, and times have changed. But for the sake of the well-being of medicine users, let’s not throw the medicine out with the packaging.