The Current Regulatory Environment: the EU and the USA

For most people, the laws surrounding the transportation of food, medicines, and commodities, is not common knowledge. Nevertheless, for a transportation company or a business, such guidelines are very often a determining factor in how they operate, and how large they can increase their margins. As a case study of this topic, some of the most important regulations in the EU and the USA are discussed below: such illustrations serve the purpose of explaining exactly why Ambrosus will be useful beyond the benefits it can provide to the end consumer.

The EU: Food and Pharmaceutical Regulation

In Europe, a number of requirements exist, that require companies to ensure they are effectively protecting their food and medicine. In relation to European pharmaceutical policy, a clear authority on the matter is the European Commission’s guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01 “Official Journal of the European Union). Such legislation has stringent requirements which necessitate pharmaceutical wholesalers and distributors to demonstrate that pharmaceutical products “have not been exposed to conditions that may compromise their quality and integrity”. Further legislation in the same document explains how thorough pharmaceutical companies must be, in order to meet regulatory standards:

Chapter 4, Sections 4.1 and 4.2: “Good documentation constitutes an essential part of the quality system. Written documentation should prevent errors from spoken communication and permits the tracking of relevant operations during the distribution of medicinal products. Documentation comprises all written procedures, instructions, contracts, records and data, in paper or in electronic form. Documentation should be readily available/retrievable.”

Such a policy indicates the need for a way to track and trace the ID’s of Assets throughout its journey on the supply chain, while also ensuring that it can be easily accessible.

Chapter 5, Section 5.1: “All actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain.”

The company must therefore demonstrate that they have taken care of the medical product, while also providing correct information about the product on the package labelling.

Chapter 5, Section 5.8: “For all supplies, a document (e.g. delivery note) must be enclosed stating the date; name and pharmaceutical form of the medicinal product, batch number at least for products bearing the safety features; quantity supplied; name and address of the supplier, name and delivery address of the consignee (1) (actual physical storage premises, if different) and applicable transport and storage conditions. Records should be kept so that the actual location of the product can be known.”

In other words, the quality assurance of medicine alongside detailed records of each batch made, must be kept by the company in question for safety purposes.

Chapter 9, Section 9.4: “For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature-controlled vehicles) should be used to ensure correct transport conditions are maintained between the manufacturer, wholesale distributor and customer.”

Effective supply chain management practices must be implemented to ensure the correct transporation of medicine in light of temperature, storage, and lighting requirements.

While these examples are only illustrations of the full scope of such legislation, the underlying message is that for pharmaceutical products in the European Union, the location, security, time, travel conditions, and ID of each product must be kept according to the law.

With Ambrosus, pharmaceutical companies have an opportunity to easily integrate their current IT systems, so as to track and trace such products and validate them on a blockchain. The real value to this method is that it can be used to easily comply with regulations, while at the same time it can also provide better oversight to things like inventory or problems within the supply chain.

For one use-case Ambrosus is currently working on, the ability to trace such products allows the user to utilise such information as a ‘warranty’ of sorts in order to gain access to supply chain insurance: in the future, users will be able to receive compensation for a transportation failure or other unforeseen supply chain challenges, while also complying with regulations at the same time.