With ‘D-Day’ of February 9, 2019 fast approaching, the pharmaceutical industry must ensure that it has its house in order, so as to be able to comply with the onerous legal obligations ensuing from the EU’s fight against falsified medicines. 

The EU’s Falsified Medicines Directive makes provision for harmonised measures to fight medicine falsifications. Falsified medicines are often disguised as authentic medicines but may contain ingredients of toxic quality or in the wrong dosage. Since these medicines would not have been adequately checked for quality, safety and efficacy, in line with legal requirements, they pose a real risk to human health. 

The objective of the afore-mentioned directive is therefore to ensure that the medicines which reach consumers are safe and that the trade in medicines is rigorously controlled. It seeks to reach such objectives by imposing an obligation on member states to ensure that any medicines which are authorised to be placed on the market have certain safety features on the outer packaging. In a 2015 delegated regulation, the European Commission provided for more detailed rules as to what this obligation actually entails and manufacturers and distributors now have until February 9 to ensure that any medicines for which they seek authorisation comply with these rules.

The objective of the directive is to ensure that medicines which reach consumers are safe

The safety features consist namely of two elements placed on the packaging of a medicinal product: a unique identifier which is a unique sequence carried by a two-dimensional barcode allowing the identification and authentication of the individual pack on which it is printed and a device allowing the verification of whether the packaging of the medicinal product has been tampered with. 

The Commission’s Regulation lays down rules relating to the characteristics and technical specifications of these safety features, as well as rules relating to the ways in which such safety features must be verified by manufacturers, wholesalers and pharmacists. 

The safety features need not be applied on all medicinal products for human use. In fact, the regulation provides a list of those medicines on the packaging of which the safety features ought to be applied as well as of those on which such features ought not be applied.

The setting up of a repository system where all the information on the safety features of different medicines are stored is also obligatory. This system must be set up and managed by a non-profit legal entity established in the EU by manufacturers and marketing authorisation holders of medicinal products bearing the safety features. The cost of the system must be borne by such manufacturers. National competent authorities are obliged to supervise the functioning of any such repository physically located in their territory, in order to verify that both the repository and the legal entity responsible for its establishment and management comply with the requirements found in the regulation.

Various obligations fall on pharmacists. One such obligation is precisely that of verifying the safety features and decommissioning the unique identifier of any medicinal product bearing the safety features prior to supplying the public with such a product. In practical terms, this means that, prior to dispensing such products, pharmacists are obliged to link to the established repository system, scan the serialised bar code of the product and mark this code as dispensed in the repository system. The said system can then either approve the dispensing of the product or, in the case of falsified or stolen medicines, provide the pharmacist with a warning and hence impede the supply of the product to the public. The relevant authorities would then investigate the incident in order to ensure that patient safety is guaranteed.

As falsified medicines become more sophisticated, the risk of such products reaching consumers is becoming more and more of a reality. Though admittedly the means to avoid such risks comes at not a little inconvenience and cost to the pharma industry, it is indispensable that human health comes first and foremost and that any risks to same are thwarted in the most efficacious way possible.

Mariosa Vella Cardona, M’Jur, LL.D, is afreelance legal consultant specialising in European law, competition law, consumer law and intellectual property law. 

mariosa@vellacardona.com