The Pharmaceutical Journal
Vol 269 No 7217 p430
28 September 2002

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Ombudsman rules against DoH and MCA over patient information leaflets

The Parliamentary Commissioner for Administration (ombudsman) has ruled that the Department of Health and the Medicines Control Agency were guilty of maladministration in their handling of the requirement for all dispensed medicines to be accompanied by patient information leaflets.

In an as yet unpublished adjudication, the ombudsman says that the Department should have said how the requirement was to be satisfied. The complaint was brought by a member of the public.

The Journal understands that MLX 285, issued by the MCA recently (PJ, 10 August, p181) is the Department's plan for recovering from the complaint. MLX 285 proposes a statutory defence against breach of copyright for health professionals who photocopy PILs.

The Pharmaceutical Services Negotiating Committee says that, although a one-off payment of £500 and a small annual fee have been proposed to help pharmacy contractors, the requirement places a considerable burden on pharmacists and that it cannot see a practical way to meet it.

Not all PILs are available on the internet and the paper of many of those provided with medicines is so thin that they cannot be photocopied. Other PILs, notably those provided with oral contraceptives, take the form of small booklets.