Potential Sources for Foreign Prices: PMPRB11
Starting with July 1, 2021, 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.
Pharmaceutical Benefits Scheme (PBS)
National Institute for Sickness and Disability Insurance (INAMI)
211 Avenue de Tervueren
21, rue Camille-Desmoulins
25 Maria Trost, Koblenz
List of NHI price standard listed items
Ministry of Health, Labour and Welfare
1-2-2 Kasumigaseki Chiyoda-ku, Tokyo
NoMA Medicine Database
Norwegian Medicines Agency
26 Grensesvingen, Oslo
Order of Reference Prices
Ministry of Health, Consumption and Social Welfare
18-20 Paseo del Prado, Madrid
Dental and Pharmaceutical Benefits Agency (TLV)
20 Fleminggatan, Stockholm
Monthly Index of Medical Specialties (MIMS)
Haymarket Medical Ltd.
69 London Road, Twickenham
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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