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Background
Generic prescribing offers advantages: it saves money as generics are almost always cheaper than branded products; it reduces the potential for confusion as only one name for a drug is used; it provides a guide to the drug's pharmacology as the generic name normally indicates its chemical class; and it increases the likelihood of undergraduate and postgraduate education influencing practice since teachers use generic names almost universally. 1 However, any potential gains from using generic drugs are only justifiable if these versions are therapeutically equivalent to the branded product. To this end, legal and professional arrangements are in place in the UK to oversee the quality of all medicinal products and to help ensure that where generic alternatives are available, they are truly equivalent.
Legislation
Prescribing and dispensing
When a non-dispensing GP writes a prescription using the generic name, it is left to the pharmacist to decide which brand, or generic version of the drug, to dispense. If a prescription bears the brand name, only the branded product can be dispensed. In hospitals, by contrast, the pharmacist can substitute, according to agreed protocols, a generic equivalent for the brand-name product prescribed.
Whatever product is dispensed, pharmacists are required by their professional code of ethics to dispense only medicines (whether branded or generic) that have a product licence, 6 unless the particular product is exempt under the Medicines Act . The licence number, which is printed on the pack, starts with the letters PL (Product Licence) or, for a drug that has been imported from elsewhere in the European Union (EU), possibly PL(PI). Such 'parallel importing' (hence PI) is permitted only when the medicine is the version of a branded medicine that already has both a UK product licence (now referred to as a marketing authorisation) and a marketing authorisation from an EU member state. Pharmacists must also be satisfied that "both the supplier and the source of any medicine purchased are reputable". 6
Manufacture
The 1968 Medicines Act was introduced to ensure that medicines licensed for use in the UK are safe, effective and of adequate quality. 7 EU regulations, which take precedence over the Act, have a similar effect. They require a manufacturer to obtain a marketing authorisation that specifies the name...