Pharmaceutical regulations to be reviewed by Cabinet Office this year
Legislation affecting pharmacies and pharmaceutical manufacturers is to be reviewed this year by the Cabinet Office Regulatory
Impact Unit.
The RIU 2005 scoping report, outlining areas under consideration for
review, includes pharmacy contract controls in England, generic substitution,
the Drug Tariff and Braille labelling, among matters that might be subject
to detailed scrutiny.
Contract controls
proposed for England in the wake of the Office of Fair
Trading’s call for all restrictions to be scrapped (PJ,
21 August 2004, p245) are to be re-examined because of complaints that
the effect
of exemptions — particularly those for one-stop health centres
and large shopping developments — are likely to be difficult to
predict.
Generic medicines concerns
· GP prescribing software can contain information on branded medicines
without mentioning generic alternatives; this could push up NHS
costs
· Can, or should, more be done to promote use of generics in primary
care?
· Should reimbursement prices for generics be fixed by the Drug
Tariff?
· Does annual tendering for NHS supply contracts unnecessarily
increase business risks for manufacturers or cause problems for
short shelf-life products, like vaccines? |
Generic substitution and related issues also look likely to be
examined because they come up in four of the nine areas proposed for
detailed
examination (see Panel). Other matters put forward for possible regulatory
impact assessment include the EU clinical trials directive, the duration
of drug company data exclusivity for licensing purposes and animal testing.
Braille labelling might be examined because EU law requires medicines
to be labelled with their names in Braille from 30 October. Companies
are concerned that this will be difficult in practice and that there
is ambiguity about what is meant by “name”.
Although pharmaceutical regulation will be a main strand of the unit’s
work this year, inclusion of any area in the scoping report does not
mean that it will necessarily be subject to detailed scrutiny. Similarly,
omission does not mean that an area will not be examined. Topics are
selected for detailed scrutiny after responses to the scoping report
have been gathered and the benefit of, and potential for, change assessed. |
The
Pharmaceutical Journal
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