On October 23, 2020, Roman Shabrov, an attorney at BRACE Law Firm, delivered a presentation on "Current Legal Risks in Pharmaceutical Logistics" at a webinar organized by PHARMAPACK titled "Best Practices for Reducing Costs and Risks in the Transportation and Storage of Medicinal Products."

Mr. Shabrov noted that risk constitutes the effect of uncertainty on objectives, defining an effect as a deviation from expected outcomes (whether positive, negative, or both). He characterized uncertainty as a state involving a deficiency—even if partial—of information, comprehension, or knowledge regarding an event, its consequences, or its likelihood.

The sources of legal risks can generally be classified into four primary categories:

• Internal factors and operational vulnerabilities;
• Uncertainty regarding regulatory "rules of the game" and systemic inefficiencies;
• Evolving regulatory updates and legislative amendments;
• Other unforeseeable circumstances and force majeure events.

The speaker identified internal sources of legal risk in the transportation and storage of medicinal products as non-compliance with applicable laws, breaches of contract, discrepancies between internal corporate policies and statutory law, failure to promptly adapt business operations and corporate governance documents to regulatory updates, and inefficient management of legal operations.

Mitigating legal risks during the transportation and storage of medicinal products requires a company to implement the following measures:

• Establish or thoroughly audit the existing document management system;
• Structure a robust counterparty due diligence process;
• Train personnel regularly on regulatory and compliance requirements;
• Optimize cross-functional communication with the corporate legal department;
• Delegate and clearly delineate corporate authority and liability;
• Implement an internal compliance framework and systematic oversight;
• Respond promptly to any material breaches or contractual modifications.

You may review the full presentation here.