Informal Request for ATI Records Previously Released

Organization: Patented Medicine Prices Review Board Canada

Year: 2023

Month: July

Request Number: A-2022-05111

Request Summary: 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.

Disposition: Disclosed in part

Number of pages: 197

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