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Publication
Keeping your dawn raid guidance current
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
Author:
Global | Publication | July 2016
On June 24th, the Patented Medicine Prices Review Board (PMPRB) published “PMPRB Guidelines Modernization Discussion Paper” (Discussion Paper). The Discussion Paper is part of the PMPRB’s Strategic Plan for 2015 - 2018 in order to obtain feedback from stakeholders on possible changes to its Compendium of Policies and Procedures (Guidelines) on how the excessive pricing factors under section 85 of the Patent Act are applied (Excessive Price Factors).
The PMPRB monitors prices of patented medicines sold in Canada to ensure they are not excessive and reports on pharmaceutical trends and the research and development spending of patentees. The PMPRB states in the Discussion Paper that is has initiated consultations to reform and modernize its Guidelines based on its observations that Canadian patented drug prices have been steadily rising relative to prices in the seven comparator countries (PMPRB7), while investments in R&D have declined.1
According to the PMPRB, Guidelines modernization is necessary to bring the PMPRB in line with today’s pharmaceutical practices and international best practices.2 In particular, the PMPRB observes the following changes to its regulatory environment that necessitate reform: (i) price and IP are no longer particularly effective policy levers for attracting pharmaceutical R&D; (ii) confidential price discounts frustrate international efforts to contain pharmaceutical spending based on public list prices; (iii) a growing price gap between different payers based on relative negotiating power; and (iv) increasing availability of high-cost speciality medicines.3
The PMPRB notes that although the Guidelines have been revised as recently as 2010, there have been no significant changes to how the PMPRB applies the Excessive Price Factors since 1993. In the Discussion Paper, the PMPRB highlights aspects in particular need of reform, including:
At this stage, the PMPRB is seeking general feedback in the form of responses to a list of 12 broadly formulated questions on the Excessive Price Factors (see page 22 of the Discussion Paper). These broad questions include, for example:
The PMPRB is also looking to receive feedback on other aspects of the Guidelines that are not specifically mentioned in the Discussion Paper that may warrant reform.
Written comments and feedback may be submitted to the PMPRB by October 24, 2016. All comments are public and will be published on the PMPRB website. Following the consultation period, the PMPRB aims to present the proposed changes to the Guidelines in the spring/summer of 2017.
PMPRB Guidelines Modernization Discussion Paper
1. PMPRB Guidelines Modernization Discussion Paper, June 2016, p. 6 (“Discussion Paper”).
2. Discussion Paper p. 10.
3. Discussion Paper p. 12.
4. Discussion Paper pp. 14-15.
5. Discussion Paper, p. 17.
6. Ibid.
7. Discussion Paper, p. 19.
8. Ibid.
Publication
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
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