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Found 7 record(s)
Req # A-2022-05111
Electronic copies of the following documents. In all cases, cabinet confidences may be excluded and draft versions of documents. In all of the requests below, “draft guidelines” refers to the PMPRB Guidelines that were published for comment on October 6, 2022, or any prior drafts or versions of those 2022 Guidelines (for example, if a draft version was circulated to Health Canada for comment in September 2022, it would be part of the “draft guidelines” for the purpose of this request). • Emails or other communications from Health Canada commenting on the draft guidelines, and that were sent between July 1, 2022, and October 6, 2022. • Emails or other communications from the Board members or Board Chair commenting on the draft guidelines, and that were sent between July 1, 2022, and October 6, 2022. • Any training presentations, training manuals, or summaries of the new guidelines prepared for use by the Board Staff, Board, or other governmental departments prepared between July 1, 2022, and October 6, 2022. • Any documents with calculations of how much prices will decrease under the draft guidelines, or under alternative pricing rules, and that were prepared between January 1, 2022, and October 6, 2022 (note the change in date relative to other requests). • Any documents comparing prices or price reductions under the draft guidelines and the old PMPRB Compendium of Guidelines and Procedures. • Any documents, including legal memos, on the compliance of the draft guidelines with legal decisions about the PMPRB, including Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2021 FCA 157, Merck Canada c Canada, 2022 QCCA 240, and Innovative Medicines Canada v. Canada (Attorney General), 2020 FC 725. • Any documents which discuss how a medicine’s therapeutic class and comparator products will be established under the draft guidelines. • Any documents showing how the Board Staff arrived at the exact pricing tests discussed in paragraph 33-35 of the draft Guidelines. • Any documents which discuss how Board Staff will assess whether a price is excessive *after* an investigation has been opened. For context, the backgrounder which accompanied the draft guidelines suggested that staff will consider “the totality of the circumstances surrounding the price of the medicine, through the lens of the section 85 factors.Organization: Patented Medicine Prices Review Board Canada
July 2023
Req # A-2023-025211
With regard to the c. 2003 HDAP Report on New Patented Drug - Angiomax (http://www.pmprbcepmb.gc.ca/view.asp?ccid=583), I am looking for a copy of any supporting research, reports and calculations used to determine dosage regimens. I am specifically interested in how these quantities (in mL) were derived, the benchmark patient weight that was used (in kg) and the timeframe of the dosing.Organization: Patented Medicine Prices Review Board Canada
July 2023
Req # A-2023-025599
For FY 2015-2022 (inclusive), how many investigations into prescription pricing on the basis that the pricing exceeded the guidelines resulted in a public hearing? Of those that resulted in a public hearing, in how many was the pricing found to be excessive? Of those that were found to be excessive, how many resulted in orders to reduce the prescription price?Organization: Patented Medicine Prices Review Board Canada
July 2023
Req # A-2023-025896
For fiscal years 2015-2022 (inclusive), how many new patented medicines were reported to the board by Bayer, Inc.? From among those reports, how many included claims that a price exceeded the guidelines?Organization: Patented Medicine Prices Review Board Canada
July 2023
Req # A-2023-025600
For FY 2015-2022 (inclusive), how many Advance Certificate Rulings were issued by the board?Organization: Patented Medicine Prices Review Board Canada
July 2023
Req # A-2022-13654
Electronic copies of the following documents: 1. A copy of every advance ruling certificate (ARC) issued by the Board, including any reasons in support of the ARC issued by the Board. 2. A copy of the Notice and Comment issued by the Board in response to each of the ARCs. 3. A copy of the patentee's submissions (including any affidavits or other evidence) on each of the ARCs. The Board's ARC for Viread indicates that these submissions are available upon request. 4. A copy of the Board Staff's submissions (including any affidavits or other evidence) on each of the ARCs. Again, the Board's Viread ARC indicates that these are available upon request. 5. A copy of any other submissions received in response to the notice of and comment.Organization: Patented Medicine Prices Review Board Canada
July 2022
Req # A-2021-11082
Copies of all documents presented, and shared with participants related to the symposium organized by the PMPRB with academics during the week of May 31, 2021.Organization: Patented Medicine Prices Review Board Canada
July 2021