Temperature-controlled pharmaceutical transportation has been a common talking point since the first coronavirus vaccine was developed. We have taken a look at this topic from a logistical perspective for you, and provided information on the legal background.
To say that vaccines will be a hot topic in 2021 would almost be an understatement. Since the global coronavirus pandemic broke out, the rapid development of vaccines has been eagerly followed by the world community, from Anchorage to Adelaide and from Cape Town to Tromsø. The approval of the vaccines at the end of 2020 seemed to people like the long-awaited light at the end of the tunnel. Following on from the scientists' supreme achievement, the organisational and logistical Herculean task of distributing the vaccines has become the focus of attention, alongside plans for their safe storage and damage-free transportation.
For pharmaceutical logistics specialists, temperature-controlled transportation is an everyday task. Active temperature control ranging from two to eight and from 15 to 25 degrees Celsius is one of the industry's standard offerings. Contrary to some claims, even the active ingredient in the BioNTech/Pfizer vaccine does not have to be transported at minus 70 degrees Celsius for every application, as the route in the truck to the vaccination centre can instead be used for thawing before the vaccine is used. In the digital age, leading carrying companies produce ‘temperature CVs’ for these orders, in which the freight carriers document their compliance with the specifications.
Who has the burden of proof?
Despite all precautionary measures, interruptions in the cold chain can occur from time to time in everyday life, resulting in loss or damage. Logically, the question of liability then comes into focus. In the past, the Brandenburg Higher Regional Court (Oberlandesgericht) ruled on a dispute regarding temperature control under the case number 7 U 119/18.
In this case, after the vaccine arrived at its destination, it was discovered that the goods had been damaged during their journey from the UK to Germany. The customer who placed the transport order – the plaintiff here – was of the opinion that the defendant, the carrier on the second leg of the journey, should be liable for the damage incurred.
The court did not follow this line of argument. According to Article 17(1) of the Convention on the Contract for the International Carriage of Goods by Road (CMR), a freight carrier is not liable if the goods are handed over to it already in a damaged condition. In this case, there were two legs and intermediate storage at a wholesaler in France. The plaintiff did not succeed in proving that the damage only had to have happened on the route between the French wholesaler and the destination in Germany, i.e. during the partial transport performed by the defendants. The consignment note, which contained the obligation to transport the goods within the contractually agreed temperature of two to eight degrees Celsius, was not sufficient for this.
Existing responsibility must be documented precisely
Whether the defendant was rightly found innocent of causing the damage or was simply lucky due to a lack of documentation by the plaintiff is almost irrelevant to the ‘moral of the story’. The case sheds light on an important aspect of the transport business in general and goes beyond the specialist discipline of vaccine logistics. Audit-proof transportation documentation may save a trip to court, as it will be clearer where the disaster, which may have been virtually unavoidable due to technical defects, took its course.
Ideally, careful handling of the goods at all times prevents them from being damaged. The fact that useful assets, such as temperature sensors in refrigerated trucks, truck telematics, and the precise control of digital data, can increasingly take on a preventive function allows us to look to the future with hope – in the same way that vaccines are driving back the pandemic.