The European Parliament has adopted Directive 2010/84/EU (the ‘Directive’) aimed at preventing the entry of medicinal products which falsely indicate their identity, history or source into the legal supply chain. The Directive was adopted in February 2011 and amends Directive 2001/83/EC.
The term “falsified” is used to distinguish the issue from that of counterfeiting, which is an IP violation. Falsified medicines are a major threat to public health and safety as they may not contain active ingredients, or may contain ingredients in the wrong quantities. Their quality, safety and efficacy has not been verified as they have not been subjected to an authorisation procedure. The risk that falsified medicines reach patients in the EU is increasing every year, not least because these medicines are becoming more and more sophisticated and difficult to identify. There is also a significant cross-border aspect as the legal supply chain of medicines within the EU often covers different Member States.
The European Commission previously adopted the proposal on 10 December 2008, following the launch of a public consultation on combating falsified medicines on 11 March 2008. Now that the European Parliament has adopted the Directive, only the approval of the European Council is outstanding.
The European Commission proposes a number of measures to provide the highest possible level of assurance that only high-quality medicines are sold within the legal supply chain. New safety features will be introduced in order to identify any false representations and ensure full traceability of each individual package of high-risk products. The control at the EU external borders shall be improved in order to prevent the entry of false medicinal products. The European Commission also aims to ensure that the active pharmaceutical ingredients are of high quality and are not falsified.
Specifically, the new measures include an obligatory sign of authenticity to be featured on the outer packaging of medicines. This sign will not only verify authenticity but will also act as a unique identifier for each medicine. Previously, the regulation of signs of authenticity on medicine packaging has been dealt with at Member State level. A number of identification systems, such as Radio Frequency Identification (RFID) and 2-dimensional bar code labelling (Data Matrix), have been used. Under the Directive this will now be addressed at EU level. The obligation will apply to all prescription medicines except for those that, via risk assessment, have been shown not to be at risk. This means that over the counter (‘OTC’) medicines would ordinarily be excluded from the need to diplay a sign of authenticity as these products are not usually targeted by falsifiers (though they may be required to exhibit authenticity signs in exceptional cases). The exact nature of the authenticity signs will be decided at a later stage by delegated legislation. There is currently debate concerning which technical system would be most appropriate and convenient.
The Directive also addresses the sale of falsified medicines over the internet, which has become a particular problem. The Directive obliges websites of legally-operating online pharmacies to exhibit a “trust mark”. By clicking on the trust mark, the consumer can access an official national register listing all legally-operating pharmacies. By clicking on the register, the consumer is linked back to the website of the legally-operating pharmacy. The structural weakness is that the Directive does not harmonise the rules and regulations for online pharmacies in the EU. Member states maintain discretion in deciding whether medicines can be sold over the internet, and how they can be sold. This could lead to practical issues in implementing a high safety standard with regards to internet distribution.
The Directive also introduces more onerous record-keeping requirements for wholesale distributors and stronger powers of inspection. Manufacturers and distributors will also have to report any suspicion of falsified medicines via a rapid alert system. To achieve this, they will need to set up compliance systems.
The Directive, once accepted by the Council, must be transposed by the Member States within 18 months. Some measures however, such as those related to the safety features, have a longer implementation time (approximately five to six years) in order to allow for the necessary technical adaptations.
In the long run producers of prescription drugs, and those operating in the legal supply chain, will be facing increased controls and product identification measures. This will be particularly challenging for small and medium sized companies as the measures are likely to be expensive. Future developments concerning the exact type of safety features should be followed closely by manufacturers and distributors in order to ensure compliance with the legal requirements imposed once the new provisions of the Directive fully apply.