Patient Information Leaflet user testing could be a thing of the past post-Brexit, but would patients be any better off without it?
Ensuring that patients can understand the technical information that accompanies medicines, produced by medical professionals, is clearly a worthy endeavour.
Article 59 of Directive 2001/83/EC could be seen as classic red tape, a costly administrative burden on the pharmaceutical industry. Indeed, there are those who feel that the requirement to “Consult with Target Patient Groups” has been a missed opportunity.
In particular, Parallel Import (PLPI) companies often state their reluctance to improve the language on their leaflets, as the text has already been approved when the licensed product was user tested. However, the MHRA has long maintained that “changes in the way the information is phrased may be introduced by the PLPI applicant”. Information could be improved from test to test. It’s just easier not to.
Rather than scrapping the user testing requirement, it could be evolved to allow improvements in the quality of leaflets to come from every test, rather than a rigid adherence to previous regulatory rulings.