All medicines are required by European and UK law (Council Directive 92/27/EEC) to be accompanied by a Patient Information Leaflet (PIL) setting out comprehensive information which is accessible to and understandable by those who receive it, so that they can use their medicine safely and appropriately
So PILs assist medicine users in taking safe and accurate decisions about their medicines and now user testing has been introduced to properly demonstrate that PILs are legible and understandable.
These tests have been compulsory for all new drugs across the EU since 1st July 2005 and PILs relating to all existing products will need to be tested by July 2008.
The law states:
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible clear and easy to use...The results of assessments carried out in cooperation with target patient groups shall also be provided to the competent authority
Details can be found at: http://medicines.mhra.gov.uk