Thursday, 2 April 2015

Predicting the impact of the Falsified Medicines Directive (FMD) - Part 1

Tackling a major threat to public health and safety

Falsified medicines are fake medicines that are passed off as real, authorised medicines and so pose a global threat to patient safety and public health [1]. They may contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabelled with respect to their identity or source; have false packaging; or contain low levels of the active ingredients or the wrong ingredients altogether [2].

Falsified medicines represent a major area of criminal activity. In September 2014, Europol, the EU’s law enforcement body, together with counterparts from the UK, Austria, Belgium, Cyprus, France, Hungary, Slovakia, and Spain seized several fake million pills with an estimated value well in excess of EUR 10 million. The crackdown led to a several arrests and the freezing of more than EUR 7.5 million in financial assets [3].

The scale of this criminal activity has led to fears that fake medicines may penetrate the legal medicines supply chain. Often, falsified medicines are manufactured abroad and imported to the UK [4]. The Medicine and Healthcare products Regulatory Agency (MHRA) has an ongoing strategy to combat falsified medicines and collaborates with international counterparts and law enforcement agencies. Between 2004 and 2011, the MHRA intercepted 18 falsified medicines in the UK supply chain [4]. Most cases were at pharmacy and wholesale level, but in one case a falsified anti-platelet product was identified at clinical trial level [4]. 

The Falsified Medicines Directive

The serious health threat posed by falsified medicines, led to the EU adopting Directive 2011/62/EU, often referred to as the Falsified Medicines Directive (FMD) [1]. This new legislation became applicable across the EU on 2 January 2013. To avoid making EU legislation over-complicated and technical a system exists for delegating to the European Commission limited powers to make minor changes to laws, provided these do not affect the "core" legislation decided by European Parliament and the Council [5]. Therefore, in parallel to the core legislation for the FMD, the European Commission started work on a Delegated Act to ensure uniformity and standardisation of key safety features required by the legislation [1].

The adoption and subsequent publication of this Delegated Act, sets off a three-year timeline for implementation at EU member state level [6,7]. By 2018, the full requirements are envisaged to be implemented across the region. The FMD represents a major development for pharmaceutical manufacturers, wholesalers and pharmacists and will also have an impact on national healthcare providers and regulators. 

Table 1: Some key features of the EU FMD (2011/62/EU) [1,4,8]

An obligatory authenticity feature on the outer packaging of the medicines. This feature was set to be decided at a later stage via a Delegated Act
Safety features of medicines
Barcodes to be printed on or attached to each pack of medicines subject to prescription and other medicines at risk of being falsified. The barcodes will be checked into a database by the manufacturer and checked out when dispensed by a pharmacy.
Supply chain and good distribution practice
Strengthened record-keeping requirements for wholesale distributors. Will be required to verify that they are dealing with authorised suppliers. Brokers will have obligations similar to those of wholesale distributors.
Active pharmaceutical ingredients
Tougher rules on the controls and inspections of producers of active pharmaceutical ingredients
Internet sales
A common, EU-wide logo to identify legal online pharmacies. This will make it easier to distinguish between legal and illegal online pharmacies in the EU.


1. EC (2015). Falsified medicines. European Commission.  
2. EFPIA (2014). Stamping out Falsified Medicines. EFPIA.  
3. International law enforcement action against fake medicines. Europol.   
4. MHRA (2013). Falsified Medicines Directive.  
5. European Parliament (2010). Legislating more efficiently: questions & answers on new delegated acts
6. Aegate.  
7. Jones G. (2015) The Falsified Medicines Directive: time to get it right. The Pharmaceutical Journal. 
8. EMA (2015). Falsified Medicines. European Medicines Agency. 

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