ABPI News, September 2002

The question of copyright has once again come to the fore in the delivery of prescription medicines. The Government has announced plans to allow pharmacists to photocopy vital information leaflets about medicines - a move that will not only breach copyright laws, but will also put patients' safety at risk.

Under European and UK law, all patients must receive a patient information leaflet (PIL) when they collect their medicine from a pharmacy. But because the Government has refused to implement a scheme to introduce 'patient packs', this has not always happened.

Now the Government is planning to allow pharmacists to photocopy PILs when necessary so that the leaflets can always be handed out. This means that the Government is planning to ensure one law is obeyed by breaking another - that on copyright of printed material.

Under the patient packs scheme, the pharmaceutical industry spent millions of pounds switching to integral packs containing a comprehensive PIL with the medicine, rather than giving patients medicines in brown bottles without any detailed information.

Allowing pharmacists to photocopy PILs will mean breaking open the pack, with the distinct possibility of confusion over which leaflet belongs with which pack. It will also cause a problem when leaflets are updated.

As part of GMP manufacturers, rightly, have stringent safeguards to ensure that the assembly of the leaflet and the medicine in one pack is carried out with strict quality control measures. The new proposals would flout these controls, with the resulting risk to patient safety.

ABPI has already publicly expressed its opposition to the proposals and will be responding appropriately to the consultation paper.