Canada’s National Pharmacare Act, passed in 2023, marks a significant step toward universal access to affordable medicines while embedding supply chain transparency as a core element of pharmaceutical governance. In addition to creating a national framework for drug coverage, the Act introduces provisions that require enhanced oversight of pharmaceutical supply chains. These provisions are designed to ensure that medications procured under the national program are not only safe and effective but also sourced through ethical and reliable supply networks. The legislation places particular emphasis on active pharmaceutical ingredients (APIs), mandating that both domestic manufacturers and importers implement rigorous due-diligence processes when selecting and monitoring suppliers of critical raw ingredients. This is especially vital in light of past challenges related to API quality, supply disruptions, and the global opioid crisis.
Canadian pharmacies participating in the National Pharmacare program are expected to integrate open data tools provided by Health Canada into their supply chain management practices. One key resource is Health Canada’s Open Drug Data platform, particularly the Opioid Monitoring dataset, which offers transparency into controlled substances distribution and highlights patterns that could signal potential supply chain vulnerabilities. Pharmacies should leverage this data to cross-reference their procurement records, ensuring that suppliers of opioid APIs and related precursors are fully compliant with Canadian regulations and do not present risks of diversion or illicit distribution. This practice can help identify red flags early and prevent problematic suppliers from entering the national pharmaceutical supply network.
Due-diligence efforts should extend beyond compliance checks for controlled substances. Pharmacies and pharmaceutical distributors should implement a robust process for validating the legitimacy, quality, and sustainability of all API sources, especially those located in jurisdictions with weaker regulatory oversight. This can be achieved by combining Health Canada’s Open Drug Data with other government and international datasets, such as those published by the World Health Organization’s Prequalification Program and the US Food and Drug Administration’s drug registration databases. By layering data sources in this way, pharmacies can build comprehensive supplier profiles and make informed decisions that align with the Pharmacare Act’s supply chain transparency requirements.
To operationalize these requirements, pharmacies should adopt a workflow that maps raw ingredient flows through to finished drug lots. This process begins with supplier onboarding, during which pharmacies should require API manufacturers to disclose detailed information about production sites, including addresses, certifications, inspection histories, and relevant regulatory actions. This data should be validated against open regulatory datasets and stored in a centralized compliance management system. Next, pharmacies should establish lot-level tracking protocols that link incoming API shipments to the specific batches of medicines produced or dispensed. This can be achieved through the use of standardized barcoding and serialization practices, which are already common in many parts of the pharmaceutical industry. By linking raw ingredients to finished products in this way, pharmacies gain the ability to trace the origin of each medication dispensed under the National Pharmacare program, thereby enhancing accountability and facilitating rapid response in the event of a recall or quality issue.
Digital tools and supply chain software platforms play a critical role in enabling this level of traceability. Pharmacies should invest in systems that support automated data integration from Health Canada’s Open Drug Data platform and other trusted sources. These systems should offer dashboards and reporting capabilities that allow pharmacy compliance teams to monitor supplier performance, identify anomalies, and document adherence to the National Pharmacare Act’s transparency obligations. In parallel, pharmacies should establish internal protocols for periodic reviews of supplier data, ensuring that all records remain current and reflect any changes in supplier operations, regulatory status, or product offerings.
Supplier engagement is another vital component of a successful pharmaceutical supply chain monitoring program. Pharmacies should clearly communicate their expectations regarding transparency, regulatory compliance, and data sharing to all API suppliers. Contracts should include provisions that require suppliers to notify pharmacies promptly of any regulatory actions, quality issues, or changes in manufacturing sites. Where appropriate, pharmacies should consider conducting periodic supplier audits, either directly or through trusted third parties, to validate the accuracy of supplier-provided data and confirm adherence to good manufacturing practices. This approach not only supports compliance with the Pharmacare Act but also helps build stronger, more resilient supplier relationships.
The transparency provisions of the National Pharmacare Act offer pharmacies an opportunity to strengthen public trust and demonstrate leadership in responsible pharmaceutical procurement. By implementing rigorous due-diligence processes, leveraging open data tools, and adopting advanced supply chain technologies, pharmacies can help ensure that Canada’s national drug supply remains safe, ethical, and secure. These efforts also align with broader public health goals, including the reduction of opioid misuse, prevention of counterfeit medicines entering the supply chain, and promotion of sustainable pharmaceutical manufacturing practices.
Looking forward, pharmacies should view compliance with the National Pharmacare Act’s supply chain transparency requirements not as a one-time initiative but as an ongoing commitment. The regulatory and risk landscape for pharmaceutical supply chains is constantly evolving in response to new challenges, including emerging public health threats, geopolitical instability, and environmental concerns. By establishing dynamic compliance systems, investing in staff training, and participating in industry and government dialogue on supply chain integrity, pharmacies can position themselves as proactive stewards of Canada’s national drug supply and contributors to the success of the Pharmacare program.