Pharmacists to be allowed to copy or download patient information leaflets
The Medicines Control Agency wants pharmacists to be able to photocopy
or reproduce patient information leaflets (PILs) without breaching copyright.
European rules require pharmaceutical products to be packaged with an
approved PIL and United Kingdom legislation means that it is an offence
to supply medicines without one. However, pharmacists’ terms of service
often require packs to be split to meet the exact quantity prescribed,
leaving residual packs which might not contain a leaflet.
In consultation letter MLX 285, issued on 1 August, the MCA says that
one way around this would be for pharmacists to photocopy PILs or to download
them from an approved website such as the Electronic Medicines Compendium
(www.emc.vhn.net).
The MCA is proposing that a new statutory defence against breach of copyright
when leaflets are copied in this way should be established.
For community pharmacies, the Department of Health is proposing to make
one-off payments of £500 to help meet the costs of gearing up to
comply with the law and will be discussing with the Pharmaceutical Services
Negotiating Committee whether there is a case for an ongoing addition
to the global sum. The same arrangement would apply in Wales and Scotland.
Sue Sharpe, chief executive of the PSNC, told The Journal that the PSNC
would be considering the adequacy and practicalities of the MCA’s
proposals, bearing in mind that some PILs were many pages long. Mrs Sharpe
added: “We support the move towards recognition of the need to find
solutions to the present, entirely unsatisfactory position, and will discuss
the proposals with the pharmaceutical industry and other bodies to see
how they might contribute to a sensible solution.”
The Department of Health is also to consider the possibility of allowing
flexibility for pharmacists to dispense products in packs of 28 (or multiples)
when packs of 30 are prescribed, and vice versa. The Department says that
it is following what is happening in Scotland. Frank Owens, chairman of
the Scottish Pharmaceutical General Council, said: “Since last summer,
Scottish contractors have been able to round up or down to the nearest
whole pack where a product is identified as being in a patient pack.”
He added that the SPGC was talking with the Scottish Executive Health
Department about the introduction of a comprehensive patient pack programme
in the near future. Mr Owens said that the MCA’s photocopying proposal
was completely impractical and would take pharmacists away from front-line
patient care.
In a question and answer document to accompany MLX 285, the MCA notes
that all other European Union countries have systems that use whole patient
packs, with the UK being unique in its need to split packs or dispense
from bulk. Moving to using patient packs would “add to NHS costs
without producing any benefit to patients”, it says. The MCA says
that the principal cost to pharmacists would be the time taken copying
leaflets. It assumes that existing equipment would be used.
Comments on the proposal should be sent to Amanda Lawrence, Medicines
Control Agency, Room 14-152, Market Towers, 1 Nine Elms Lane, London SW8
5NQ (tel 020 7273 0366) by 24 October.
Comment, p180
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