The pharmaceutical pricing, reimbursement and prescribing environment in Italy

The pharmaceutical pricing, reimbursement and prescribing environment in Italy

2002 Decision Resources

D'Ausilio, A. | Negrini, C. | Berto, P. | Volume: 10, Issue: , Pages: 1-14, Environment, Italy,

A generic medicine is a faithful copy of a mature drug – no longer under patent –
marketed with the chemical name of the active ingredient. This article analyses generics
markets in five European countries: France, Germany, Italy, The Netherlands and the UK.
The study investigated all the main issues – patent, approval to market, pricing and
reimbursement, prescription and distribution – which affect the life cycle of a pharmaceutical
product. The situation in the five countries varied widely. Because of European
harmonisation, patent legislation and approval procedures no longer affect much the
development of generics. Only national legislation on patent protection approved before the
EU directive came into force still plays a role. Approval differences seem to be due mainly
to common practice, rather than to the regulations themselves. None of the countries have
an efficient public information system on patent expiry. Generics have had more success in
countries with more flexible pricing policies. Reimbursement has not yet been used widely to
discriminate between generics and proprietary drugs. Financial incentives are based more on
physicians’ prescribing behaviour than on pharmacists. 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
retailers can enhance a competitive market, through horizontal and vertical integration all
along the distribution chain. Such an environment has stimulated the success of unbranded
generics by delegating strong purchasing power to distributors.