Submitting generic drug products
Last updated on January 24, 2024Under the Pharmaceutical Services Act and the Drug Price Regulation, manufacturers must apply to PharmaCare to have generic drugs considered for benefit status.
PharmaCare reviews submissions and updates the generic formulary each month. Drugs remain on the PharmaCare formulary at their current reimbursement level until price changes are made or the drug’s coverage is ended.
PharmaCare reimburses generic drugs in categories that fall under the Low Cost Alternative (LCA) Program based on the Maximum Accepted List Price (MALP) and a tiered pricing framework.
PharmaCare’s generic drug reimbursement policies are consistent with agreements developed between the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA).
On this page: Maximum accepted list price | The pan-Canadian Tiered Pricing Framework | Benefit status of generic drugs | Generic drug submission procedures and checklist | History of generics pricing in B.C. | Resources
Maximum accepted list price (MALP)
The Drug Price Regulation establishes a maximum accepted list price (MALP) for every generic drug in the Low Cost Alternative (LCA) Program. The MALP for each LCA category is based on a brand name drug for that category.
The MALP for oral solids is 25 per cent of the brand reference drug price for categories established on or after April 1, 2019, or which had a drug added or removed on or after April 1, 2019; it is 20 percent of the brand reference price otherwise. The MALP for all other drugs (i.e., those that are not oral solids) is 35 percent of the brand reference drug price.
The pan-Canadian Tiered Pricing Framework (TPF)
The pan-Canadian Pharmaceutical Alliance (pCPA) and Canadian Generic Pharmaceutical Association (CGPA) have agreed on a tiered pricing framework (TPF) for generic drugs. PharmaCare implements the TPF in its generic drug pricing where possible. Tiered pricing does not supersede existing PharmaCare regulation and policies, such as the MALP.
Tiered pricing applies to certain LCA categories based on the number of competitors in that LCA category.
| TPF Tier Description | % of Brand Reference Pricing | Notes |
|---|---|---|
| Tier 1: Established when the generic product is a single source (i.e., only one manufacturer of a generic product in the Canadian market) |
1a. Market Entry: Priced at 85% of brand reference price if PLA or pricing agreement for brand product does not exist or never existed at any time in the past. 1b. Market Exit: A single source generic for which no PLA or pricing agreement exists currently or in the past, will be limited to a maximum of 85% of brand reference price. 2a. Market Entry: Priced at 75% of brand reference price if PLA or pricing agreement exists or existed at any time in the past. Automatically reduces to 55% of brand reference price after three months of public funding. The three-month period is specific to each jurisdiction. 2b. Market Exit: A single source generic if PLA or pricing agreement exists or existed at any time in the past, will be limited to a maximum of 55% of brand reference price. |
The Tiered Pricing Framework does not fetter the authority of any participating jurisdictions to make decisions with respect to coverage of drugs. |
| Tier 2: Established when there are two generics in the Canadian market | Priced at 50% of brand reference price | |
| Tier 3: Established when there are three or more generic products on the Canadian market | Priced at 25% of brand reference price for oral solids and at 35% for all dosage forms other than oral solids (e.g. liquids, patches, injectables, inhalers, etc.) |
Drug manufacturers are expected to submit prices in accordance with the TPF. If an increase in the number of competitors causes a tier change, manufacturers must reduce their list price to the appropriate tier for their drugs to be considered for coverage.
PharmaCare can adopt brand reference prices from other jurisdictions for existing or new LCA categories in cases where specific criteria are met. See the flowchart for determining which LCA category adopts brand reference prices (PDF, 169KB).
All generic drugs submitted by manufacturers priced at or below the MALP are considered for PharmaCare coverage. Exceptions are made on a provisional basis, usually because of a drug shortage within an LCA category or if listing the drug is in the public interest. PharmaCare reserves the right to rescind the exception, remove the full benefit status, and delist the drug.
Prices for the pan-Canadian Select Molecules are set at fixed prices and are not part of the TPF process. The prices set for these molecules are contingent on their being covered by the public drug plan in the respective jurisdiction. Some listed drugs may not be PharmaCare benefits, and therefore not subject to negotiated prices.
Benefit status of generic drugs
Generic drugs in an LCA category are listed only as full benefits.
PharmaCare reimburses pharmacies for full-benefit products to a maximum of the supplier list price plus a markup of 8%. Drugs subject to the High-Cost Drugs Policy — Section 5.8, PharmaCare Policy Manual are reimbursed to a maximum of the supplier list price plus a mark-up of 5 percent or less.
If a drug is subject to either or both the LCA program and the RDP, the lowest maximum reimbursement amount applies.
Generic drug submission procedures and checklist
All prescription drugs submitted to PharmaCare are reviewed and subject to the LCA or RDP programs and the TPF. Submissions are accepted at any time throughout the year.
Before submission, manufacturers must submit a Market Entry – Generic Pricing Confirmation Form to the pCPA. For further details, refer to the Generic Pharmaceutical Manufacturers section of the pCPA web page.
As part of the submission, manufacturers must confirm supply and complete the appropriate workbook, in the required format.
Submissions must include the following:
- Signed British Columbia Generic Drug Listing Terms and Conditions (PDF, 119KB)
- Generic Listing Submission Workbook (XLSX, 44KB)
- Notice of Compliance (NOC) issued by Health Canada, showing the applicable Drug Identification Numbers (DINs)
These documents must be attached in a single email to generic.submissions@gov.bc.ca with the subject line: "Generic listing submission for [chemical name of drug] from [manufacturer name]."
Submissions that are not complete and delivered this way will not be reviewed. PharmaCare reserves the right to request additional information.
Submissions for different strengths of the same chemical in the same formulation must be included in a single submission email, using one common Generic Listing Submission Workbook (XLSX, 44KB).
Submissions for different chemicals or different formulations of the same chemical must each be submitted as a single email with all supporting documents attached.
Notification of listing decisions
PharmaCare publishes listing decisions online in the LCA/RDP Data Files, which are updated on the first Thursday of the month. Drug manufacturers who made the submission are also emailed with the listing decision.
Notification of price changes resulting from tiered pricing framework
To help pharmacies manage their inventory and to lessen the impact of price adjustments, pharmacies are given 14 days advance notice of price changes resulting from the tiered pricing framework in the LCA/RDP Data Files. During the 14-day notification period, suppliers are not obligated to change their drug price.
Submitting price changes
To request a price change (increase or decrease), refer to Submitting Price Changes.
History of generics pricing in B.C.
2023: Effective October 1, 2023, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) have agreed to a new three-year pricing initiative with the option to renew for an additional two years. Quebec is included as a participant in the new agreement. Overall, the new agreement does not include any new savings for BC PharmaCare but does maintain current pricing for most generics.
2019: B.C. amended the Drug Price Regulation to enhance generic drug coverage. This includes the removal of exclusive drug listings, an increase to the Maximum Accepted List Price (MALP) in a Low Cost Alternative (LCA) category, and the ability of B.C. to adopt brand reference prices from other jurisdictions. Refer to the 2019 Amendments to B.C. Drug Price Regulation (PDF, 266KB).
2018: The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) announced a five-year initiative to reduce prices of most common generic drugs. For information and a drug list, see the PharmaCare Newsletter 18-004 (PDF, 270KB).
2016: The Drug Price Regulation is amended. PharmaCare no longer has an annual confirmation of generic drug pricing.
2014: The pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association (CGPA) agreed on a Tiered Pricing Framework (TPF) for generic drugs.
Resources
Manufacturers with questions about specific generic drug submissions or the generic drug submission process may contact PharmaCare at generic.submissions@gov.bc.ca.