PDCI Market Access offers on-site workshops, training seminars and
presentations on all aspects of the PMPRB (see the
outline below). These sessions can be arranged throughout the year and can
be tailored to the client’s specific needs or provided on a general basis.
On-site workshops are a cost effective way to ensure that all sectors of the
company (marketing, government affairs, finance, etc.) are aware of the
implications of PMPRB policies and guidelines. For more information,
please contact
Neil Palmer at (613) 742-7523.
|
Outline |
|
Legal Basis
- Patent
Act
- Patented Medicines Regulations
- Excessive Price Guidelines
|
Mandate and Scope of Jurisdiction
- Patent Status
- Patent Dedication / Patent Pending
- Rx vs. OTC
|
|
Filing requirements
- Notification of Intent to Sell
-
Form-1 Identity of Medicine
-
Form-2 Prices
and Sales
-
Form-3 Research
& Development Expenditures
|
Excessive Price Guidelines
- Existing
Medicines
-
CPI Test,
International Price Comparison
-
New Medicines
-
Scientific
Review Procedures
Categorization
-
(1) Line
Extensions
-
(2)
Breakthrough/ Substantial Improvements
-
(3)Other
- little, moderate or no improvement
Comparators and Dosage Regimens
-
Price Tests
- Reasonable Relationship Test
- Therapeutic Class Comparison Test
- International Price Comparison Tests
|
|
Strategic Planning for New Medicines
- Setting
clear objectives
/ Developing
a realistic plan
- Timing and information gathering
- Impact Analysis / Risk Assessment
- Understanding PMPRBs objectives and concerns
- Effective presentations to PMPRB staff
- Building a working relationship with Board staff
|
New Medicine Submissions
- Layout
- Description of Medicine and Patentee
- Scientific Review
- Application of Excessive Price Guidelines
- Cost Effectiveness
- Appendices
- Follow-up
|
|
PMPRB
Compliance and Enforcement:
Policies and Procedures
- Investigations
into excessive pricing
- Voluntary Compliance Undertakings
- Price Reductions
- Repayment of Excess Revenues
- Hearings
- Board Orders
- Double Damages
- Appeals to the Courts
|
Case Studies
- International
Price Guidelines
- Discounting /Average Selling Prices
- Level Pricing / Titration Strengths
- Patent Pending / Patent Dedication Comparators
- Alternative Price Tests
- Advanced Ruling Certificates
- Voluntary Compliance Undertakings
|
|
Future Directions of the PMPRB
|
- Mandate
-
Advisory
Assistance
-
New Medicine
Reviews
-
International
Price Comparisons
|
- Enforcement
-
Transparency
-
Consultations
-
Roles of
Stakeholders
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