During the European Parliament plenary session held in Strasbourg on 16 February, MEPs gave green light to the proposed Directive to prevent fake medicines from entering the legal supply chain. Under these new rules, manufacturers will have to include new safety features on the packages and new rules will apply to on-line sales, as well as to distributors and intermediaries.

An estimated that 1% of medicinal products currently sold to the European public through the legal supply chain are falsified and the share is growing. In other parts of the world, up to 30% of the medicines on sale may be fake. In particular, more and more innovative and life-saving drugs are counterfeit. Selling these type of products not only endangers patients treatment because they do not have the appropriate effect, but they can even have some dangerous contraindications in some particular cases.

For that reason, the European Parliament has approved a new Directive in order to prevent fake medicines to be put into the market in the European Union. The  resolution was adopted with 569 votes in favour, 12 against and 7 abstentions. With this decision, the Parliament aims to put EU citizens' health fisrt.

Regulating on-line medicine sales

Although the original Commission's proposal did not cover internet sales, MEPs deemed it necessary to regulate internet sales of medicines because this is a key route by which fake ones enter the EU market. In fact, this position was already adopted by the European Parliament in 2009 when it called for more security in Internet transactions, including those affecting medicines.

Under the new law, in those EU Member States where internet pharmacies are allowed to operate, they will need to be authorised to supply pharmaceuticals to the public. Besides, Internet pharmacy sites will be required to display a common logo, which should be recognisable throughout the EU, so as to help the public to ascertain that they are linked to an authorised pharmacy. All authorised internet pharmacies will be linked to a central web site in each Member State and will be listed on that web site.

Security, traceability and medicines import-export

The legislation updates current rules and provides for new safety features to be placed on individual packs in order to identify them, guarantee their authenticity, and enable pharmacists to check whether the outer packaging has been tampered with. These safety features, which still need to be developed by the European Commission, could for example include a serialization number which can be "read" by the pharmacy to ascertain that the pack is authentic.

As a general rule these features would apply to all prescription medicines, unless there is clearly no risk. They will also apply in  some exceptional cases to some OTC medicines (over-the-counter), where there is a risk of falsification. This will enhance traceability within the system, allowing to withdraw from the market any suspicious drug, and even from the patient within a 24 hours delay.

Furthermore, under these new rules, not only distributors will have to be registered by authorities, medicinal product brokers will also need to do so. Regarding medicines international trade, and at Parliament's request, all relevant rules on information will apply to the supply of medicines to authorized persons in third countries too.