Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure: SOR/2021-117
Canada Gazette, Part II, Volume 155, Number 12
Registration
SOR/2021-117 June 1, 2021
PATENT ACT
P.C. 2021-467 June 1, 2021
The Patented Medicine Prices Review Board, pursuant to subsection 96(2) footnote a of the Patent Act footnote b, makes the annexed Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure.
Ottawa, April 22, 2021
Mitchell Levine
The Chairperson of the Patented Medicine Prices Review Board
His Excellency the Administrator of the Government of Canada in Council, on the recommendation of the Minister of Health, pursuant to subsection 96(2)footnote a of the Patent Act footnote b, approves the making of the annexed Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure by the Patented Medicine Prices Review Board.
Rules Amending the Patented Medicine Prices Review Board Rules of Practice and Procedure
Amendments
1 The definition respondent in Rule 1 of the Patented Medicine Prices Review Board Rules of Practice and Procedure footnote 1 is replaced by the following:
- respondent
- means a rights holder, or a former rights holder, against whom an order of the Board is proposed to be made under the Act. (intimé)
2 Paragraph 6(1)(b) of the Rules is replaced by the following:
- (b) take notice of facts that may be judicially noticed and of any generally recognized scientific or technical facts, information or opinions concerning patented or protected medicines;
3 Paragraph 14(2)(b) of the Rules is replaced by the following:
- (b) the filename of an electronic document must include the name of either the patented or protected medicine or the company if the hearing does not relate to a specific patented or protected medicine, the name of the party filing the document, the title of the document and the date which appears on the document or must meet alternative requirements, if any, set out by the Secretary; and
4 Paragraphs 15(3)(a) and (b) of the Rules are replaced by the following:
- (a) in the case of an allegation of a patented or protected medicine sold at an excessive price, a statement of allegation set out in consecutively numbered paragraphs containing the material facts, the allegations and the order sought by Board Staff in the proceeding; or
- (b) in the case of an allegation of a failure to provide information and documents related to a patented or protected medicine, a notice of application set out in consecutively numbered paragraphs containing a statement of the relief sought by Board Staff, the grounds for the relief and the material facts on which Board Staff intends to rely.
Coming into Force
5 These Rules come into force on the day on which section 46 of the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, chapter 6 of the Statutes of Canada, 2017, comes into force, but if they are registered after that day, they come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Rules.)
Issues
As a result of amendments to the Patent Act made by the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act, similar technical amendments must be made to the Patented Medicine Prices Review Board Rules of Practice and Procedure in order to ensure that their wording is consistent with that of their enabling legislation (the Patent Act).
Objective
The amendments have the following objectives:
- to harmonize terms used in the regulations with those used in the enabling statute or related regulations
Description and rationale
Change 1: “patented medicine” is to be changed to “patented or protected medicine.”
- Affected provisions: paragraphs 6(1)(b), 14(2)(b), 15(3)(a), and 15(3)(b)
Change 2: “patentee” is to be changed to “rights holder.”
- Affected provision: section 1
One-for-one rule and small business lens
The one-for-one rule does not apply to these amendments, as there is no change in administrative costs or burden to businesses.
The small business lens does not apply to these amendments, as there are no costs to small businesses.
Contact
Isabel Jaen Raasch
General Counsel
Legal Services
Patented Medicine Prices Review Board
Telephone: 613‑288‑9619
Email: isabel.jaenraasch@pmprb-cepmb.gc.ca