Review of the shortcomings of product information for medicines - UK Government view

Medicines regulatory news

4 February 2013

The new Pharmacovigilance Directive [Council Directive 2010/84/EC] requires the European Commission (EC) to produce a report on the shortcomings of product information and to bring forward proposals for legislative change. The EC has engaged consultants to produce this report and publication is expected in the summer of 2013.  

There is a strong evidence base to suggest that changes to the legislation could improve the usefulness and acceptability of patient information. An Expert Advisory Group on Patient & Public Engagement and the Commission on Human Medicines have reviewed the emerging evidence and have advised on the key elements on which it would be useful to influence the debate. The advice proposes changes in the legislation to achieve improvements in the information provided both to healthcare professionals and patients.

The CHM advised the legislation should be amended to require account to be taken of the principles of good information design. This includes setting out the principles that underpin high quality patient information, that information should be capable of targeted and timely delivery, for both patients and healthcare professionals and that information should be balanced. 

In particular, the legislation should;  

  • enable personalised information, allowing for information hierarchy, in order that users can drill down into detail as it applies to them
  • require the provision of information via new media, to ensure timely access at different points in the user journey
  • require a balance of information in the leaflet so the likelihood of benefit is put in the context of the likelihood of harm, and
  • mandate signposting to other sources of information helpful to users.

The advice of the CHM has informed the open letter (link below) setting out the UK position, sent to both the European Commission and the research organisation contracted to produce the report envisaged by the Directive.

Open letter from MHRA regarding review of the shortcomings of product information for medicinesPDF file (opens in new window) (895Kb)

Page last modified: 08 March 2013