Potential Sources for Foreign Prices: PMPRB11

Starting with July 1, 2022, the Patented Medicines Regulations require patentees to report the publicly available ex-factory prices at which they sell their products in any of the eleven comparator countries specified in the amended Patented Medicine Regulations as opposed to the list of seven comparator countries that existed previously.

In the countries specified in the Regulations (i.e., Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden, and the United Kingdom), the PMPRB has identified examples of potential sources for the benefit of patentees. Patentees must, nevertheless, consult the appropriate sections of the Regulations and file foreign ex-factory prices in accordance with the Regulations (see s. 4(1)(f)(iii) and s. 4(9)).

A non-exhaustive list of examples of potential foreign sources is set out below.

Australia

Pharmaceutical Benefits Scheme (PBS)
Canberra
www.pbs.gov.au

Belgium

National Institute for Sickness and Disability Insurance (INAMI)
5/01 Avenue Galilée, Brussels
www.inami.fgov.be

France

Vidal
21 rue Camille-Desmoulins, Issy-Les-Moulineaux
www.vidalfrance.com

Germany

Lauer-Taxe
CompuGroup Medical (CGM)
21 Maria Trost, Koblenz
www.cgm.com

Italy

L'Informatore Farmaceutico
Codifa
EDRA SpA
https://www.codifa.it/

Japan

List of NHI price standard listed items
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki Chiyoda-ku, Tokyo
www.mhlw.go.jp/

Netherlands

G-Standaard
Z-Index
11 Alexanderstraat, The Hague
www.z-index.nl/

Norway

NoMA Medicine Database
Norwegian Medicines Agency
26 Grensesvingen, Oslo
www.legemiddelverket.no/

Spain

Order of Reference Prices
Ministry of Health
18-20 Paseo del Prado, Madrid
www.mscbs.gob.es

Sweden

Dental and Pharmaceutical Benefits Agency (TLV)
14 Fleminggatan, Stockholm
www.tlv.se

United Kingdom

Monthly Index of Medical Specialties (MIMS)
Haymarket Medical Ltd.
69 London Road, Twickenham
www.mims.co.uk

 

Where necessary, the PMPRB will seek information from the patentee regarding the source of the price submitted in order to ensure it complies with the reporting requirements.

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