PPRI (Pharmaceutical Pricing and Reimbursement Information) Report

At the manufacturer level, pharmaceutical prices are controlled in 24 of the 27 monitored countries. No price control at manufacturer level is exercised in Denmark, Germany and Malta. In most countries (e.g. Slovakia, Hungary, France), price control only pertains to pharmaceuticals which are eligible for reimbursement, whereas there is free pricing for nonreimbursable pharmaceuticals, which are often OTC (Over-the-Counter) products. The most common pricing policy is statutory pricing (incl. Slovakia), where the authorities set the price on a regulatory basis. In a few countries (e.g. Italy, France) pharmaceutical prices are negotiated between the manufacturer (or wholesaler) and the government authority. A special case is the UK, where there is no direct price control, but the prices of NHS (National Health Service) pharmaceuticals are indirectly controlled via a profit control scheme, which allows companies a pre-determined maximum profit on their product portfolio. 22 of 27 countries (incl. Slovakia) apply external price referencing (international price comparisons or price benchmarking), comparing their prices to those of the same products in other countries as a basis for their own pricing or reimbursement decisions. The reference countries are normally chosen due to their geo-strategic position (neighbouring countries, historic links) and to the price level (either a mix of high and low price countries or a focus on low price countries). Another commonly applied comparison tool is internal price referencing (used in Slovakia as well), comparing the prices of products to those of their equivalents (e.g., generics) and/or similar products within the same country and using this as basis for a pricing or reimbursement decision.

In 16 countries the controlled price type is the ex-factory price (manufacturer price) (e.g. Czech Republic, Hungary, Austria, Germany, France), 9 countries (e.g. Poland, Netherlands, Finnland, Sweden) fix pharmaceutical prices at the pharmacy purchasing price (wholesale) level, whereas 2 countries (Slovakia and Luxembourg) determine the pharmacy retail price. At distribution level, 21 countries have statutory wholesale mark-ups, either in form of a linear mark-up or a regressive scheme (e.g. Slovakia). Cyprus (for imported pharmaceuticals), Denmark, Finland, Netherlands, Norway and Sweden apply no statutory wholesale mark-up, and since the controlled price type is the pharmacy purchasing price, the ex-factory price is an outcome of negotiations between the manufacturer and the wholesaler. Pharmacy margins are regulated in all 27 countries. Usually, they obtain the form of a regressive scheme (e.g. Slovakia) or a linear mark-up. Pharmacy remuneration occurs via a fixed fee per prescription in the Netherlands and in Germany (together with a linear mark-up). Pharmacists in Slovenia and the UK receive a fee-for-service remuneration. In several countries (e.g. Slovakia, Czech Republic, Hungary, Austria), statutory wholesale and pharmacy mark-ups cover all pharmaceuticals. A few countries apply the distribution regulation only to reimbursable pharmaceuticals (e.g. Poland, France, Italy) or to prescription-only medicines (e.g. Bulgaria, Portugal).
The product-specific approach (i.e. eligibility for drug reimbursement is determined on product level) is applied in 18 countries (e.g. Slovakia, Czech Republic, Germany, Greece, Italy, Slovenia, UK). Further eligibility criteria can be the disease (e.g. in the Baltic States) and the population groups concerned (e.g. Ireland, Turkey). In Denmark and Sweden, reimbursement coverage increases with rising pharmaceutical consumption (i.e. pharmaceutical expenditure within a year). This implies that in the beginning the patients have to pay 100% of their medication themselves, but after they have passed respective spending thresholds their medication is reimbursed at rising rates. A reference price (base price for reimbursement) system is in place in 18 countries. Ten of these countries (e.g. Denmark, Italy, Portugal) base their reference groups (i.e. groups of interchangeable pharmaceuticals) on substance level according to the Anatomical Therapeutic Chemical (ATC) classification, whereas 7 other countries (Slovakia, Czech Republic, Hungary, Poland, Latvia, Germany, the Netherlands) also consider therapeutically similar pharmaceuticals as interchangable.
Nearly all countries have introduced mechanisms to protect vulnerable groups from excessive out-of pocket payments. Specific population groups are granted a 100% reimbursement (e.g. in Hungary, Portugal), a higher reimbursement rate than the standard one (e.g. in Belgium, Estonia) or exemptions from the prescription fee (e.g. in Austria). The total amount of co-payment may be limited (e.g. a maximum co-payment per prescription like in Belgium, or annual ceilings of private expenses on pharmaceuticals and/or on health care in the Czech Republic, Germany and Luxembourg).
In most countries the value-added tax (VAT) ratefor pharmaceuticals is lower than the standard VAT rate (incl. Slovakia). Exceptions are Austria, Bulgaria, Denmark, Germany and Norway, where the VAT rate on pharmaceuticals is the same as for other goods. A few countries have split VAT rates, with no VAT or a lower rate for a specific group of pharmaceuticals (e.g., for prescription-only medicines in Sweden or NHS pharmaceuticals in the UK).

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