On October 23, 2020, Roman Shabrov, attorney at BRACE, spoke at a webinar organized by PHARMAPAK, “Practice of reducing costs and risks during transportation and storage of medicinal products” with a report on the topic: “Actual legal risks of pharmaceutical logistics”.
As Roman Shabrov noted, a risk is the impact of uncertainty on goals. In this case, influence is a deviation from what is expected (positive and/or negative). Uncertainty, however, is a state of inadequacy, even partial, of information, understanding, or knowledge about an event, its consequences or its possibility.
The sources of legal risks can be conditionally divided into:
- uncertainty of the “rules of the game” and inefficiency of the system;
- regulatory changes;
Internal sources of legal risks in the transportation and storage of medicines were identified as non-compliance with legislation, violation of contract terms, the inconsistency of internal documents with legislation, inability to timely bring its activities and internal documents in line with legislative changes, as well as the ineffective organization of legal work.
To minimize legal risks during transportation and storage of medicines, the company must to:
- build a document management system (check the current system);
- build a system for checking contractors;
- train staff;
- build a system of interaction with the legal department of the company;
- to distribute powers;
- build a control system;
- respond promptly to all significant violations or changes to contracts.
The presentation can be found here.