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Regulation of prices or reimbursement prices of medicines, a) 2013
Scope of price regulation
Method(s)
Belgium
Maximum ex-factory price is set for listed
medicines.
Prices of innovative drugs set with a premium over
comparators. Prices of less innovative drugs set
using international benchmarking and therapeutic
referencing.
Denmark
No price regulation at market entry, but periodically price cap agreements between the
Ministry of Health and the association of
pharmaceutical companies.
International benchmarking for hospital drugs
(Commitment of the industry).
France
Maximum statutory price for medicines listed
for outpatient care and for a list of expensive
hospital medicines, set at the time of listing.
International benchmarking for most innovative
drugs; Internal/therapeutic referencing for less
innovative ones.
Germany
Since 2011: Statutory price negotiated after
market entry RP for clusters of equivalent
products ( ATC 4, 5).
Therapeutic referencing (and international benchmarking).
Italy
Maximum statutory ex-factory price for outpatient reimbursed medicines and for expensive
hospital medicines, set at the time of listing.
Therapeutic referencing.
Netherlands
Maximum wholesale price for outpatient prescription-only medicines (listed or not) and
expensive hospital drugs. RP for groups of
interchangeable products (ATC 4 & 5).
International benchmarking.
Spain
Maximum ex-factory prices for reimbursed
medicines.
International benchmarking and therapeutic referencing.
Sweden
In order to be reimbursed, the manufacturer
must propose a price at which the drug will be
considered cost-effective. Purchase and retail
prices are regulated.
United
Kingdom
No direct price control, but possible price
agreement following NICE negative recommendation based on economic assessment.
In case of price negotiation, the ICER is used to
determine the acceptable price.
Norway
Maximum pharmacy purchase price set for all
prescriptiononly medicines, at the time of
market entry.
International benchmarking and therapeutic referencing for reimbursement price.
Australia
Maximum ex-factory price is set for listed
medicines. RP for classes of interchangeable
products.
Therapeutic referencing and cost plus.
Canada
At Federal level: Maximum ex-factory price for
all patented Medicines. Provinces and Territories level: Maximum prices set for drugs covered by public drug plans.
Federal level: International benchmarking for most
innovative drugs and therapeutic referencing for
less innovative ones.
Japan
Reimbursement price for medicines included
in the positive list.
Therapeutic referencing.
Korea
Maximum reimbursement price.
Assessment of the reimbursement committee,
international benchmarking; Budget impact; R&D
costs for drugs launched first in Korea.
Drug plan level: Therapeutic referencing.
(a) This table refers to price regulation potentially applicable to on-patent products. It only refers to Reference Prices (RP) policies when they have the potential to influence the price of new products (i.e. when RP are not limited to
clusters of generic equivalents but can include patented products).
Source: Value in Pharmaceutical Pricing, OECD Health Working Papers No. 63, 2013, p. 21.
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