The Council of the European Union has formally adopted the Falsified Medicines Directive[i] ("the Directive") which had been approved by the European Parliament in February 2011.  The Directive brings in numerous new initiatives to help safeguard the medicines supply chain and protect patients in order to prevent the circulation of falsified medicines.  While its aims are generally welcomed, the Directive will impact businesses at all levels of the supply chain and its measures are expected to be expensive to implement.

Scope of the Directive

A falsified medicinal product is defined by the Directive as:

"any medicinal product with a false representation of: (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients; (b) its source, including its manufacture, its country of manufacturing, its country of origin or its marketing authorisation holder; or (c) its history, including the records and documents relating to the distribution channels used". 

The Directive does not deal with unintentional quality defects or the protection of intellectual and industrial property such as registered trade marks or patent rights.  The focus and purpose of the Directive is to protect against the major health threat that can arise from falsified medicines.

The measures introduced by the Directive will apply generally to all prescription products unless they are specifically exempted, but not to non-prescription medicines unless they are considered to be at high risk of falsification. 

Safety Measures

The Directive establishes new safety measures including the introduction of safety features on packaging such as serial numbers and tamper evident seals and more rigorous rules on importing active pharmaceutical ingredients ("APIs"), including ensuring that marketing authorisation holders are responsible for verifying that APIs are made in accordance with Good Manufacturing Practice and distributed according to Good Distribution Practice.

At present, internet sales of medicinal products are the most important channel by which falsified medicines enter the EU market.  The Directive has therefore also introduced a number of processes for the sale of medicines over the internet, although it does not harmonise the rules and regulations for online pharmacies in the EU, which remain at the discretion of each Member State.  One of the key features in this respect is the introduction of "trust marks", which are to be located on the websites of approved online pharmacies and will link the user to an official national register of all approved pharmacies.  This will allow members of the public to identify legitimate websites and thus buy medicines online with greater security.

The repackaging of medicines by parallel traders will still be permitted but they will be required to replace the safety features by equivalent ones when repackaging the products.

Enforcement

The Directive adds obligations for customs, in co-operation with other authorities, to prevent medicinal products suspected of being falsified from entering into circulation.  Furthermore, the Directive requires Member States to impose severe sanctions against those who manufacture, distribute, import or export falsified medicines.

Implementation

Member States are required to transpose the Directive into their national legislation within 18 months. However, certain processes, such as those relating to the safety features enabling the verification and identification of the medicinal product, have a longer implementation time, which could take as long as 5-6 years in order to allow for the necessary technical adaptations.

In parallel, the European Commission will be drawing up provisions on the types of safety feature required, a list of products that will need to carry such features, and the kind of product verification system to be introduced.

Comment:  The increasing prevalence of and trade in "falsified medicines" is of considerable interest internationally and there are a number of global initiatives whose aims are to tackle the problem.  This Directive is therefore generally welcomed by the industry, although concerns have been expressed as to the technical details of the verification system and other safety features to be introduced, particularly from the perspective of the costs of such systems.  Similarly, there is concern that the requirement for manufacturers to ensure their suppliers comply with GMP could lead to a significant increase in their costs.  As always, the extent to which these issues are realised will depend on the finer details of the systems and measures to be introduced.