Guidelines

The readability guideline.

The main Guideline that is applicable to the information about medicines is the ‘Readability Guideline‘.

This guideline was published on January 12, 2009. The following three points are relevant:

  1. The first paragraph of the Readability Guideline states that all medicines in Europe must be accompanied by ‘labelling and package leaflet which provide a set of comprehensible information enabling the use of the medicinal product safely and appropriately.’
  2. The aim of the guideline is described as: ‘The main purpose of this document is to provide guidance on how to ensure that the information on the labelling and package leaflet is accessible to and can be understood by those who receive it, so that they can use their medicine safely and appropriately.’
  3. The Guideline states in Chapter 1: ‘Companies are encouraged to seek advice from specialists in information design when devising their house style for the package leaflet to ensure that the design facilitates navigation and access to information.’

In the next section lists some specific shortcomings of the Readability guideline, but there are at least three fundamental issues too:

  1. The first point seems to extend the reach of the legislation (article 63). The legislation only requires that package leaflets must enable appropriate use, but the Readability guideline extends this to include all labelling. This would include the outer packaging and the inner packaging. Point 2 repeats this extension.
  2. On the other hand, the legislation mentions ‘users’, while the Readability focuses on patients only (‘so that they can use their medicines’). The guideline thereby reduces  the scope from ‘all users’ to ‘patients only’.
  3. The recent report of the European Commission on the shortcomings and the EMA-reaction seem to come to conclusions in 2017 that was already included in a European Guideline in 2009. The Commission (page 6) recommends on March 22, 2017: ‘It should be considered to revise the existing guidelines, in particular the Readability Guideline … to include principles of good information design and consider allowing more flexibility in the information recommended in the QRD template, as long as the relevant legislation allows it.’

The Report of the commission does not question why the advice in the 2009 Readability Guideline is not adhered to, and why it is still necessary in 2017 to repeat this as a recommendation.