Health care stakeholders have achieved an important goal in securing the legitimate pharmaceutical supply chain in line with the requirement of the Falsified Medicines Directive, with the establishment of the European Medicines Verification Organisation.
The EMVO cannot be a panacea for all the ills associated with the illegal acts of medicines falsifiers, but – make no bones about it – this is a giant leap forward in terms of promoting and protecting patient health by guarding against the emergence of falsified medicines.
Essentially the culmination of four years of intensive development, the formation and launch of the EMVO is all the more impressive because it has brought together major stakeholders within the pharmaceutical sector to focus on a single common interest. Breaking the “silo mentality’ has been key to the success of this project.
Collaborating stakeholders include: the European Federation of Pharmaceutical Industries and Associations (EFPIA); the European Generic medicines Association (EGA); the Pharmaceutical Group of the European Union (PGEU); the European Association of Pharmaceutical Full-line Wholesalers (GIRP); and the European Association of Euro-Pharmaceutical Companies (EAEPC).
The EMVO will reinforce the value of the European Stakeholder Model, which allows end-to end verification of individual medicines packs, firstly at the point of manufacture, through to the point of dispensation to the patient, thereby guaranteeing continuity of protection throughout the entire supply chain.
This is achieved by the manufacturer affixing to the medicines pack an internationally recognized 2D bar code – void of individual patient/prescribing profile information – which is then scanned by the pharmacist before the product is handed to the patient. Any unverified codes will flag an alert to the national verification system that may then be expedited to the European hub. In each case, appropriate safeguarding action may be undertaken.
We are now at a disembarkation point for another stage of the journey and that is bringing European states onboard. Germany has kicked off this phase as the first country to contribute fully to the improved Europe-wide verification system under the direction of EMVO, through its securPharm system, which has been linked to the European hub since July 2014.
As other nations join, the system will obviously become more effective. In fact, for those countries that do not want to set up their own national system, or a unable to do so, we have enabled them to sign up to an existing product verification infrastructure within the framework of the national Blueprint System Template.
It should, therefore, be only a matter of time before we have pan-European protection against falsified medicines in the legitimate pharmaceutical supply chain. This benefits first and foremost patients, but also national health care systems and health care stakeholders.9