Update: The pCPA has published a summary of feedback and process updates based on the feedback.
The pan-Canadian Pharmaceutical Alliance (pCPA) recently announced it is formalizing and introducing revisions to the Targeted Negotiation Process (TNP).
The TNP is designed to streamline non-complex drug negotiations. According to the pCPA, a negotiation through the TNP “has been shown to be approximately 30-45% faster compared to a typical negotiation.”
Currently, the pCPA initiates the TNP once the CDA-AMC or INESSS publish a final reimbursement recommendation for a drug. Within 40 business days of the recommendation, the pCPA aims to engage the manufacturer in the TNP, with negotiations targeted for completion within 65 business days of that engagement.
To be eligible for consideration under the TNP, drug products must:
- follow the PACES (Pharmaceuticals with Anticipated Comparable Efficacy and Safety) pathway from the CDA-AMC; or
- be assessed as a non-complex drug negotiation; or
- be drugs that are comparable to others already available in the market.
In October, the pCPA also introduced the Early Negotiation Process (ENP) designed for cancer drugs being reviewed under Project Orbis (see our previous article).
Feedback gathered on the ENP and TNP is expected to be shared in a summary report in December 2025.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.