Skip to main content

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

  1. Source: Kanavos et al. [11].