United States and Europe have reacted in different ways to the increasing cost (and price) of pharmaceuticals during the last few years: 10 years ago European Union was a larger pharmaceutical industry market, while currently the United States represents 60% of drugs makers' profit. These figures are the direct consequence of 2 opposite attitudes and actions: in the United States there was a complete lack of any drug price policy and control, while on the contrary, most European governments implemented different but quite incisive strategies to control the pharmaceutical prices.

The objective of rationalizing the drug market was pursued in a context quite different from the United States. Europe, despite the recent acceleration in the process of harmonization, is still quite a heterogeneous continent, with striking differences in terms of cultures, languages, and politics. Nevertheless, most of the developed European countries have a (single-payer) national health service (NHS) that, in principle, offers universal healthcare and coverage, managed by each national government, which is responsible for both funding and supplying services to the population. In most countries, all citizens have full access to healthcare. Until a few years ago most of the medical services provided were free, or small co-payments were requested at the point of use for specific procedures/prescriptions. Recently, in the context of the efforts to control (the rising) costs while maintaining universal coverage, the impact of co-payment has increased for both diagnostics and medicines.

Nevertheless, most of healthcare-related expenditures are covered by the national health service/system: as an example, Italy, which has always spent less on healthcare than do other European countries (Italy at present spends about 8% of its GNP on healthcare, approximately half of what the United States spends), spends 15% of all the health costs on drugs, and 71% of expenditures for drugs prescribed in the outpatient setting in 2001 was directly covered by the NHS. The control of drugs costs was achieved in Italy using a combination of interventions, such as price cuts and a new reimbursement list. These initiatives, together with the patient co-payment (a fixed charge per script) introduced at regional levels by several regional health authorities, had a damping effect on spending (in the first quarter of 2003, a decline of 10.3% of spending on reimbursed medicines was observed over that in the same period of 2002), with a major effect in those regions that also implemented a co-payment. The downward trend should be attributed to an impressive fall in the number of prescriptions in the first 2003 quarter (-6.3%), compared with a 14.9% increase during the first 2002 quarter.

The articles included in this special issue of the Journal of Ambulatory Care and Management have the objective to increase the understanding of the European policies governing the pharmaceutical market by American colleagues. This should facilitate a cultural debate on these issues and the identification of actions that could also be experimented in the US setting.

Operationally, we have selected articles that describe the current European efforts to harmonize the drug market and furnish examples of the efforts carried out at national level to guide and monitor the drugs costs and expenditures. In addition, when possible and appropriate, a comparison with the US setting has also been carried out. Operationally, the issue is organized in 4 sections: the first provides information about the European regulatory system, including articles that criticize the current system, and a comparison with the United States in terms of regulatory agencies and drugs costs; the second describes the past and current initiatives to govern the drugs costs in Italy and UK; the third focuses on citizens and their advocates; and finally, the last discusses the role of ethics committees to modulate the impact of the pharmaceutical industry on biomedical research and on drugs market in Europe.