UK Law and Practice Contributed by: Jackie Mulryne, Ewan Townsend, Adela Williams and Libby Amos-Stone, Arnold & Porter
8.5 Regulation of Prescriptions and Dispensing by Pharmacies Community pharmacists purchase products from manufacturers or wholesalers and are reim- bursed by the NHSBSA at the rate specified in the Drug Tariff, or, where no reimbursement price is set in the Drug Tariff, at the manufacturer’s list price. When the price paid by the pharmacist is less than that reimbursed by the NHSBSA, the pharmacist makes a margin of profit. The extent of this margin is monitored by the NHSBSA, and claw-backs are imposed to ensure that pharma- cy profits do not exceed defined limits. There is no generic substitution by community pharmacists in the UK, and the Medicines Act 1968 requires the particular product prescribed to be dispensed. However, in general, doctors are encouraged to prescribe products using their international non-proprietary name (INN). Where a product is prescribed by its INN, the pharmacist may dispense any product that meets the specifications/INN described, and is likely to select the lowest-cost product. Generic substitution is standard practice in the hospital context.
The All Wales Medicines Strategy Group (AWMSG) issues guidance in Wales on new technologies immediately following launch. In Scotland, the Scottish Medicines Consortium (SMC) assesses all new medicines and new indications for existing medicines and issues guidance close to the product launch. In North- ern Ireland, its Department of Health (NI DoH), considers NICE guidance and reviews it for legal, policy and financial consequences only, before deciding on implementation. 8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices In theory, NHS prescribers may prescribe any medicine considered clinically appropriate for their patients but, in practice, NHS commission- ers control which medicines may be prescribed through local or national formularies, largely determined by the cost-effectiveness of indi- vidual products. Treatments recommended by NICE should be included automatically in NHS formularies in England; products not recom- mended by NICE are generally not funded on a routine basis. An equivalent approach is taken to products recommended by the AWMSG, the SMC and the NI DoH.
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