The storage and transportation of pharmaceutical products generally requires the compliance with specific regulations regarding the integrity, safety and traceability of these products (e.g., EU Good Distribution Practice (GDP) Guideline, World Health Organisation (WHO) GDP Guidelines, Food & Drug Administration (FDA) regulations and various other regional and national legal and regulatory provisions). This concerns all possible means of transportation, including sea-freight.
The main regulatory purpose is to assure that pharmaceutical products are continuously stored, transported and handled under appropriate conditions to maintain the integrity of the product and secure the patient´s safety. Critical factors - especially regarding deviations from defined temperature ranges but also other external harmful influences – need to be averted.
Any deviation from agreed frame conditions will most likely be considered as a critical breach and therefore a damaging event. A liability can also arise from a delayed delivery. Regarding the usually high value of pharmaceutical products, the liability risks for service providers are high and require specially tailored contractual solutions and also corresponding insurance coverage. Depending on which law is applicable it is at least questionable if a service provider can rely on certain liability limitations specific to transportation law or be confronted with the risk of an unlimited liability.
This leads to the special operational and legal challenges regarding a worldwide distribution of COVID-19 vaccines. While “standard” pharmaceutical products require a handling, storage and transportation in a temperature range of +2°C to +8°C or +15°C to +25°C the current existing information regarding COVID-19 vaccines indicates that extraordinarily low temperature conditions will be required (-70°C).
The current existing operational resources regarding storage and especially transportation of goods under such ultra-deep-frozen conditions are very limited. The state-of-the-art method of logistics handling is the use of special passive cooled boxes containing dry ice. Critical from a legal point of view are of course long transport periods (which especially concerns sea-freight) and the challenge of a consistent security over a complete supply chain with changing means of transportation. It also needs to be considered that dry ice (carbon dioxide) itself is regulated by the Dangerous Goods Regulations (DGR).
Not only are these special requirements of the vaccines an important subject from a legal point of view but also the fact that these products will have a high risk of theft, resulting in an additional liability risk and need for adequate insurance.