Potential Sources for Foreign Prices: PMPRB11
Starting with July 1, 2022, the Patented Medicines Regulations require rights holders 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 rights holders. Rights holders 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
Assurance Maladie (The French national health insurance system)
50 Avenue du Professeur André Lemierre
75986 Paris Cedex 20 France
https://www.ameli.fr/
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
National Health Service (NHS) England
PO Box 16738
Redditch
B97 9PT, United Kingdom
https://www.nhs.uk/
Where necessary, the PMPRB will seek information from the rights holder regarding the source of the price submitted in order to ensure it complies with the reporting requirements.