Supply Chain Transformations – Health Products
Supply chains for health products in Canada face high barriers to entry due to existing regulations for drugs and natural health product. In order to import or distribute health products in Canada, companies must first demonstrate that facilities involved in supply chains are compliant with Good Manufacturing Practices (GMP). Health Canada standards are rigorous; and receiving a license from Health Canada confirming GMP compliance requires a significant effort. Maintaining compliance can be even more challenging as Health Canada continuously updates their regulations and policies for importing and distributing health products. Execution of change management across a supply chain is particularly difficult for large supply chains as there are many moving parts once the supply chain is up and running. Agile supply chains that can adapt quickly to regulation changes will have a competitive advantage in Canada.
Over the past few years Health Canada has set in place several changes to regulations relevant to health product supply chains. One of these changes saw raw materials, or active ingredients (API) being brought into the scope of products required to be GMP compliant. Health Canada made these changes after noticing a higher risk profile when APIs from foreign non-compliant facilities were used to produce drugs destined for Canada. This change has increased the responsibility of importers of finished drug products who must now ensure their suppliers source raw materials from GMP compliant suppliers.
The rise of antimicrobial resistance (AMR) in Canada and worldwide has resulted in changes to the way veterinary antimicrobials are imported and prescribed in Canada. Evidence suggests that antimicrobial drug use in veterinary medicine and livestock production contributes to resistance bacteria in humans. Adjustments to the Food & Drug Regulations now require a prescription for certain medications. Drug companies that sell a prescription product including a DIN drug premix to pharmacists or veterinarians must now comply with drug good manufacturing practices and obtain a Drug Establishment Licence (DEL) from Health Canada.
Health Canada has responded to the growing concern over nitrosamine impurities contained in drug products by publishing interim acceptable upper limits for nitrosamines in drugs sold/imported into Canada. Health Canada recently updated tolerance limits for impurities that must be followed by sellers of sartan products in Canada. Updated testing limits introduced by Health Canada necessitate full cooperation over supply chain partners involved in foreign manufacturing and importing sartan drugs. This will ensure that test results are reviewed and approved by the appropriate quality personnel of the supply chain before products are released for sale.
The safety of vaping and associated liquids is a major concern throughout North America and Europe. Because these products do not meet the Food & Drugs Act definition of drugs, supply chains for nicotine vape products do not require GMP compliance. In contrast nicotine replacement therapies (NRT) such as nicotine gum, lozenges and patches are regulated as natural health products and therefore supply chains for these products are required to be GMP compliant. Given that these two groups of products are both intended to assist smokers with quitting smoking and are therefore products for improved health, it may be time to bring vaping liquid under the scope of GMP as well. Having raw material suppliers more accountable for their ingredients and any detected impurities might be helpful in getting more answers to the recent illness from vaping liquids.
Unlike supply chains for general retail goods, supply chains for health products have a more rigorous set of regulations to follow when selling health products in Canada. The regulations are subject to change at any time and without notice. Success in supply chain management relies heavily on the ability to transform part or all processes with minimal delay in order to maintain compliance and reduce disruption to services in the health care industry.
