Table 1.

Overview of pharmaceutical regulation in Europe

Instrument	Countries
Supply side regulation: in patent drugs
Price controls: administrative or statutory pricing	All EU Member States except Germany, UK and, to a certain extent, Sweden
External reference pricing	All EU Member States except UK, Germany, Sweden
Rate of return regulation	UK
Negotiations and price-volume agreements	France, Italy, Austria
Direct expenditure controls: payback	France, Portugal, Austria
Direct expenditure controls: price volume agreements	France
Cost-plus pricing	Spain
Supply side regulation: off patent drugs
Tendering for generics pharmaceuticals in primary care	Netherlands, Germany
Price capping for generics and linking these to the originator price	Italy, Greece, France
Supply side regulation: reimbursement methods
Positive and negative formularies	All EU Member States
Internal reference pricing	Germany, Netherlands, Czech Republic, Italy, Spain, France, Hungary
Health Technology Assessments (HTA)	UK, Sweden, Netherlands, Hungary, Poland, Finland, Estonia, Latvia, Lithuania. In France only assessment of clinical benefit
Innovative pricing and reimbursement schemes	Italy, Germany, UK, Finland
Demand side regulation: policies towards physicians
Clinical practice guidelines	All EU Member States
Compulsory generic prescribing	UK, Denmark, Estonia
Financial incentives	France, UK
Prescription monitoring and audit	Belgium, UK, Netherlands, France, Denmark, Sweden, Estonia
Demand side regulation: policies towards pharmacies
Control of remuneration (e.g. margins, fees) including contractual arrangements	All Member States
Generic substitution	France, Italy, Spain, Sweden
Demand side regulation: policies towards patients
Cost-sharing	All EU Member States
Encouraging use of over-the counter medicines and “de-listing”	UK, Germany, Sweden, Netherlands

Source: Kanavos et al. [11].