In addition to the recent publication of a draft delegated act laying down the technical specifications of the safety features, two other major developments have taken place since the EU Falsified Medicines Directive (2011/62/EU) came into effect in January 2013.
The European Medicines Verification Organisation (EMVO)
According to a European Federation of Pharmaceutical Industries and Associations (EFPIA) press release I, the European Medicines Verification Organisation or EMVO was founded in February 2015 as a “hub” to link national verification systems throughout Europe. Established as a nonprofit organization and located in Luxemburg, the EMVO will play a key role in promoting the European Stakeholder Model (ESM) – “a point-of-dispensing verification system that allows pharmacists to check a unique identification code on each individual pack when it is dispensed to the patient.II”
Not unlike the WCO’s global anti-counterfeiting platform known as IPM III, the idea is that the EMVO will build and provide EU Member States with a database of legitimate pharmaceutical products that can be used to identify fake ones.
Because the FMD requires that “…the costs of the repositories system shall be borne by the manufacturing authorisation holders of medicinal products bearing the safety features” IV, the EMVO also signed agreements with three partners in June 2015: Aegate – a global drug authentication service, Arvato Systems – a systems integrator, and Solidsoft Reply – a Microsoft gold certified partner that will help provide a delivery platform using Microsoft AzureV.
Finally, the EMVO appointed Sonia Ruiz Moran as its new president on June 19, 2015 VI, replacing John Chave, former secretary general of Pharmaceutical Group of the European Union (PGEU). Moran brings a wealth of experience in EU regulatory affairs, having led the European Public Affairs at the General Pharmaceutical Council of Spain, since 2008.
Although a partial solution to implementing the requirements of the FMD, the EMVO is well on its way to providing a mechanism to ensure the safe delivery of medicines in the pharmaceutical supply chain.
The EU Common Logo
In addition to the obligatory application of safety features for the identification and authentication of medicinal products, the FMD also requires the establishment of a “common logo” to help identify websites which sell medicinal products legally.VII
To that end, the European Commission adopted a new common logo on June 24, 2014.VIII The Commission then gave Member States one year to implement this provision. As of July 2015, pharmacies or retailers selling medicines over the Internet in the EU must display the logo.
According to the specifications laid out in the “Common EU logo for online pharmacies/retailers” technical paper IX, the elements of the logo include a white cross with four green lines, the national flag of the specific EU Member State, and text encouraging visitors to click on the logo to verify that the online seller is operating legally.
As with the launch of the EMVO, the introduction of a common logo represents one of several measures to implement the provisions mandated by the FMD. Both developments will likely be closely monitored to assess the impact they have on curbing the availability and sale of counterfeit medicines in the pharmaceutical supply chain and protecting patient and consumer safety in the EU.
II European Stakeholder Model ESM Publication, pgeu.eu June 2012, p. 6
IV Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, from eur-lex.europa.eu p. 8
VII Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products, from ur-lex.europa.eu p. 3