EU Moves toward Pan-European Law

Directive takes aim at “falsified” medicines, distinguishing them from “counterfeit.”

In February 2011, the European Parliament adopted the “Falsified Medicines Directive.” The legislation is intended to protect EU citizens from falsified medicines, which are defined as products that “may contain ingredients in the wrong dosage or no active ingredients at all.” A distinction is made between “falsified medicines” and “counterfeit medicines,” which are defined as “medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights.” According to a memo issued February 16, the Directive on falsified medicines does not deal with counterfeit drugs.

European Commissioner of Health and Consumer Policy, John Dalli, stated in February: “Falsified medicines are a serious public health risk in the EU. They have not been subject to an authorisation procedure where aspects of quality, safety, and efficacy of the medicine are verified. The law passed today introduces harmonized, an-European safety measures that provide the highest possible level of assurance that only high-quality medicines are sold within the legal supply chain in the EU. It also addresses sales of falsified medicines over the internet by providing for an obligatory trust mark on websites of legally operating online pharmacies. I look forward to a swift implementation of this Directive by the Member States.”

According to the European Commission (EC), new measures include:

•    An obligatory authenticity feature on the outer packaging of the medicines. (This feature will be decided at a later stage, when the commission works with each member state to develop national law.)
•    Strengthened requirements for control and inspections of plants manufacturing active pharmaceutical ingredients.
•    Strengthened record-keeping requirements for wholesale distributors.
•    Strengthened rules on inspections.
•    The obligation for manufacturers and distributors to report any suspicion of falsified medicines.

The EC defines the “authenticity feature” as “a unique identifier on the outer packaging which allows verification of the authenticity of the medicinal product. Up to now, the regulation of authenticity features on medicines was conducted at Member State level. This Directive addresses this aspect at EU level. It provides a legal basis for establishing details for these safety features and the level of their control in the distribution chain.”

EFPIA, an organization representing the pharmaceutical industry in Europe, describes the unique identifier as “a pan-European system to provide unique serial numbers (such as two-dimensional bar codes) on each genuine medicine pack. . . . to ensure maximum effectiveness it is vital that all medicines are verified systematically at pharmacy level.”

According to EFPIA, “the next step will be for the Council to formally approve the final text before it can come into force.” The Directive must be transposed by the Member States into national law within 18 months. Some measures, such as those related to the safety feature, have a longer implementation time, the EC reports.

Brian Ager, director general of EFPIA, was pleased by the EU Parliament’s vote. “Implementation of the Directive will require the involvement of all key stakeholders - manufacturers, pharmacists and wholesalers but also patients – to ensure success. With their involvement in the design, implementation, and running of systems, we can deliver the highest possible level of patient safety, the fastest roll-out in member states at the optimal possible cost.”

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