Some shortcomings of the current Guidelnes
The current Readability Guideline is at many points in conflict with the principles of good information design. There are six main reasons:
- The Readability Guideline does not distinguish between different types of users. It assumes that ‘all users are identical, read in an identical way, and understand information in an identical way’.
- The Readability Guideline is not ‘action centered’. It does not provide any advice on different types of actions that people have to undertake when they handle medicines. And the Guideline ignores the contexts of use.
- The Readability Guideline does not provide criteria that can be quantified.
- The Readability Guideline does not support alternative approaches.
- There is no indication of a step-by-step process.
- The terminology is confused, inconsistent and opaque.
The first four reasons are surprising, because the legislation clearly demands information that ‘enables the users to act appropriately’. A Guideline should therefore focus on ‘enabling’, ‘the users’, ‘act’ and ‘appropriately’.
Reason five is an indication that the Guideline does not consider the people who need to apply Guideline. Neither the Marketing Authorization Holders nor the Regulatory Authorities are supported in their tasks. The guideline itself is therefore a good example of very poor information design.
Reason six simply indicates a lack of care.
[Comments about the 2006 Draft Guideline can be downloaded here (pdf 27 pages). The Draft Guideline turned into the 2009 Guideline. Many of the comments remain relevant but the list of comments needs to be updated to show the problems with the actual 2009 Readability Guideline.]