캐나다의 특허 의약품(신약) 약가 결정방법

Compendium of Guidelines, Policies and Procedures

Schedule 3 - International Price Comparison

1. Concept
The general objective of the international price comparison is to compare the price of the DIN under review with the prices of the same dosage form and strength of the medicine sold in the countries listed in the Patented Medicines Regulations.

2. Methodology
2.1 Whenever possible, the price of the drug product under review will be compared with the simple average of the ex-factory prices of the same strength and dosage form for each country listed in the Patented Medicines Regulations (the Federal Republic of Germany, France, Italy, Sweden, Switzerland, the United Kingdom and the United States).

2.2 When a direct comparison of the drug product under review is not possible for a given country, the most similar strengths of comparable dosage forms per Schedule 7 will be considered.

2.3 When the International Price Comparison is being conducted to determine the median price and the drug product is sold in an even number of countries, the median will generally be the simple average of the middle two prices.

2.4 When the International Price Comparison is being conducted to determine the median price, an interim median international price will be used in cases when the medicine is sold in fewer than five countries at the time of its introduction. Unless it is excessive, the introductory price will be treated as the interim benchmark price. The interim benchmark price may be reviewed at the end of three years or when the medicine is sold in at least five countries, whichever comes first.

3. Exchange Rates
3.1 In order to apply the highest-price Guideline outlined in 7.1 of Chapter 1: Excessive Price Guidelines, the exchange rates used are ordinarily the simple average of the thirty-six monthly average noon spot exchange rates for each country (taken to eight decimal places), as published by the Bank of Canada for the thirty-six months ending with the last month of the pricing period under review.

e.g.: The pricing period under review is July to December 1993. The exchange rates used, for the purposes of the highest-price Guideline, are for the months of January 1991 through December 1993.

3.2 To review the introductory price of a new drug product, the exchange rates used are the simple average of the thirty-six monthly average noon spot exchange rates for each country (taken to eight decimal places) as published by the Bank of Canada for the thirty-six months ending four months before the date of the first sale of the drug product.

e.g.: If the new drug product under review was first sold in October 1993, the exchange rates used are for the months of July 1990 through June 1993.

3.3 The Guidelines provide that under certain exceptional circumstances, it may be appropriate to review a benchmark price. In such a case, the exchange rates used are ordinarily the simple average of the thirty-six monthly average noon spot exchange rates for each country (taken to eight decimal places), as published by the Bank of Canada for the thirty-six months ending four months before the new benchmark period.

e.g.: The new benchmark period for the drug product is May to June 1993. The exchange rates used are for the months of February 1990 through January 1993.

3.4 In the course of an investigation, the PMPRB may conduct retrospective price reviews. In these cases, the exchange rates used are ordinarily the simple average of the thirty-six monthly average noon spot exchange rates for each country (taken to eight decimal places) as published by the Bank of Canada for the thirty-six months ending with the last month of the pricing period under review.

e.g.: The pricing period under review is July to December, 1993. The exchange rates used, for the purposes of an investigation, would be for the months of January 1991 through December 1993.

4.0 Publication

Exchange rates are published on the PMPRB web site on a monthly basis.

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Last Updated: 2004-01-28 Important Notices