Starting point

Aims of this website

Recent reports of the European Commission and the European Medicines agency conclude that it would be beneficial to ‘include principles of good information design’ into the Guidelines and QRD-template.

The main aims of this website are:

  • to explain how the principles of good information design can be related to the six recommendations of the European Commission.
  • to review the consequences and propose a way forward for the development of the legislation, the Guidelines, and the QRD-template.

Historical background

The main steps that have lead to the consideration of information design for the development of information about medicines are:

1. Directive 2010/84/EU (2010) indicates that there are shortcomings in the information about medicines and that these need to be remedied.

2. The Dutch Research organization Nivel wrote two reports (PILS-Box and PIL-S studies) and published these in 2015.

3. The European Commission reacted on March 22, 2017 with a set of six recommendations.

4. The European Medicines Agency published a response on November 14, 2017 in which an outline is given how these six recommendations will be implemented.

The six recommendations of the European Commission

The report of the European Commission (March 22, 2017) makes the following six recommendations.

Recommendation 1. Generally, there should be more focus on improving the PL rather than the SmPC. However, for any potential improvement of the PL it should be also considered whether a corresponding or related change of the SmPC would be appropriate.

Recommendation 2. It should be considered to revise the existing guidelines, in particular the Readability Guideline, the Packaging Information Guideline and, where appropriate, the SmPC 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.

Recommendation 3. The input from patients during the process and the related methodology should be further improved, for example, by considering the requirement to make the user testing process more iterative and to ensure that a sufficiently mature version of the PL is user-tested.

Recommendation 4. Best practice examples of aspects of the PL (and the SmPC) design could be made available for pharmaceutical companies on a platform that would be suitable for that purpose and that could be regularly updated.

Recommendation 5. It is recommended to explore the use of electronic media to provide the information included in the SmPC and PL in the future. It should be further explored what opportunities new technologies offer to optimize the presentation and design of SmPC and PL.

Recommendation 6. More evidence would need to be gathered before considering introduction of a key information section in the Product Information. … Appropriate testing (e.g. user testing) could be a way to demonstrate the clear evidence of the usefulness and added value to patients to introduce a key information section in the PL.