Orphan drugs approved in Canada: health technology assessment, price negotiation, and government formulary listing

Author:

Rawson Nigel S B.123,Adams John24

Affiliation:

1. Canadian Health Policy Institute, Toronto, Ontario, Canada

2. Macdonald-Laurier Institute, Ottawa, Ontario, Canada

3. Fraser Institute, Vancouver, British Columbia, Canada

4. Canadian PKU and Allied Disorders Inc, Toronto, Ontario, Canada

Funder

No funding

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Health Policy,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Reference61 articles.

1. Medical products for rare diseases and conditions [Internet]. Silver Spring (MD): Food and Drug Administration; 2022 May 12 [cited 2023 Dec 18]. Available from: https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions

2. Orphan incentives [Internet]. Amsterdam: European Medicines Agency; no date [cited 2023 Dec 18]. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development/orphan-designation/orphan-incentives

3. Orphan drug designation [Internet]. Woden (ACT): Australian Government; 2018 Aug [cited 2023 Dec 18]. Available from: https://www.tga.gov.au/sites/default/files/orphan-drug-designation.pdf

4. Government of Canada improves access to affordable and effective drugs for rare diseases [Internet]. Ottawa (ON): Government of Canada; 2023 Mar 22 [cited 2023 Dec 18]. Available from: https://www.canada.ca/en/health-canada/news/2023/03/government-of-canada-improves-access-to-affordable-and-effective-drugs-for-rare-diseases.html

5. Rawson NSB. Canada falls behind in new drug submissions compared with the United States and Europe [Internet]. Can Health Policy J. Toronto (ON): Canadian Health Policy Institute 2023 [cited 2023 Dec 18]. Available from: https://www.canadianhealthpolicy.com/product/canada-falls-behind-in-new-drug-submissions-compared-with-the-united-states-and-europe/

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