Table 1 Overview of pharmaceutical regulation in Europe
From: Pharmaceutical regulation in Europe and its impact on corporate R&D
| 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 |