A generic medicine is a faithful copy of a mature drug - no longer under pa
tent - marketed with the chemical name of the active ingredient. This artic
le analyses generics markets in five European countries: France, Germany. I
taly. The Netherlands and the UK. The study investigated all the main issue
s - patent. approval to market, pricing and reimbursement, prescription and
distribution - which affect the life cycle of a pharmaceutical product. Th
e situation in the five countries varied widely. Because of European harmon
isation, patent legislation and approval procedures no longer affect much t
he development of generics. Only national legislation on patent protection
approved before the EU directive came into force still plays a role. Approv
al differences seem to be due mainly to common practice, rather than to the
regulations themselves, None of the countries have an efficient public inf
ormation system on patent expiry. Generics have had more success in countri
es with more flexible pricing policies. Reimbursement has not yet been used
widely to discriminate between generics and proprietary drugs. Financial i
ncentives are based more on physicians' prescribing behaviour than on pharm
acists. The freedom of pharmacy ownership and the consequent possibility of
dispensing pharmaceuticals through different channels affects dramatically
the structure of generics markets. A free market of wholesalers and retail
ers can enhance a competitive market, through horizontal and vertical integ
ration all along the distribution chain. Such an environment has stimulated
the success of unbranded generics by delegating strong purchasing power to
distributors. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.