Medicines should be safer for European consumers and patients after leading bodies involved in the pharmaceutical supply chain agree a memorandum of understanding to set up a European Medicines Verification System (EMVS), which is to be run through a European Stakeholder Model (EMS)
The European Association of Pharmaceutical Full-line Wholesalers (GIRP) teamed up with the European Federation of Pharmaceutical Industries and Association (EFPIA), the Pharmaceutical Group of the European Union (PGEU) and the European Association of Euro Pharmaceutical Companies (EAEPC).
The Memorandum of Understanding has been in principle endorsed by the all stakeholder partners. The document details the possible legal, practical and technical aspects of the planned EMVS, and forms the basis of the discussions between the involved partners and with the European Commission in the months ahead as the preparation of the Delegated Acts evolves.
EFPIA, GIRP, EAEPC and PGEU are jointly working on the European Stakeholder Model (ESM), a European medicines verification project with the aim of preventing falsified medicines from entering the European supply chain and ensuring patient safety.
GIRP President Mr. Rene Jenny states that “GIRP’s endorsement shows how deeply committed our sector is to the development of a practical and cost-effective system that will meet the key objective of protecting patients from falsified medicines. Stakeholders such as those involved in the EMVS’ development must be the key drivers in any authentication system as demanded by the Falsified Medicines Directive. Together with our main supply chain stakeholder partners we have the depth of expertise and knowledge to bring the concept to reality.”
The overriding objective is to develop a system that provides security for patients while being cost-effective and integrating it effectively into existing structures and practices in the pharmaceutical supply chain.
The coalition say theFalsified Medicines Directive is an important step in better protecting patients from counterfeit medicines.
The directive introduces mandatory, harmonised pan-European safety features in the form of tamper-evident packaging and a “unique identifier” or serial number that will be applied to medicines, subject to possible exclusions based on risk assessment. The European Commission will define the mechanics of how this system will work in Delegated Acts that are to be adopted by 2014. In such they will define the characteristics and technical specifications of the “unique identifier”, which will enable identification of individual packs, and the accessibility of product databases or repositories to verify each dispensed pack.
GIRP supports this legislation and is pleased to work with stakeholder groups and the European Commission in establishing an effective system in the interests of patient safety.
GIRP insists that the batch number and expiry date be included in a machine-readable format (2D matrix code). If not, wholesale distributors will not be in a position to effectively meet their obligations within the Falsified Medicines Directive to record the batch number of each product supplied.
“While GIRP welcomes the additional layers of security for the safe supply of medicines, the cost implications of a systematic product verification would endanger the economic viability of our sector”, GIRP President Mr. Rene Jenny emphasised.
“The numbers speak for themselves and a logical understanding of operations at the wholesale distribution level proves the disproportionate, costly and ineffective approach of systematic product verification at the level of the wholesale distributor”, GIRP Director General Ms. Monika Derecque-Pois stressed.