Brief backround of the project
The EU Directive 2011/62/EU - also called the Falsified Medicines Directive (FMD) - requires that prescription-only medicine packs will include safety features (i.e. a unique identifier or serial number placed on each pack together with tamper evident packaging). This requirement is clearly a significant burden on pharmaceutical manufacturers which requires investment of time, machinery and investment within manufacturing/packing sites. However, the FMD and its associated Delegated Regulation do not only require manufacturers to serialize medicine packs, they also require the establishment of national software systems which allows the verification and authentication of these packs. The costs of developing and managing the software system which will allow Pan-European verification of medicines will also be borne by the manufacturing authorization holders (i.e. manufacturers & parallel traders) of the medicines bearing the safety features.
To this end, European stakeholders EAEPC (parallel distributors), EFPIA and EGA (manufacturers) – collectively the ‘payers’, and PGEU (community pharmacists), GIRP (wholesalers) – have collaborated to promote the development of the European Stakeholder Model (ESM). This System comprises a single European central ‘hub’, which provides a single portal for entry of manufacturer serialization codes, connected to a series of national/regional information databases or repositories that serve as the verification platforms that pharmacies or other authorized parties can use to check a pack’s authenticity, before being ‘checked out’ of the system on being dispensed to the patient.
The European stakeholders have established a not-for profit legal entity, the European Medicines Verification Organization (EMVO) to deliver the ESM by establishing a central European Hub, and offering support to National Stakeholders in the establishment of appropriate National organizations.
In the Czech Republic, the principle representative stakeholder associations namely; AEDL (Association of European Distributors of Pharmaceuticals), AIFP (The Association of Innovative Pharmaceutical Industry), AVEL (Association of Wholesale Distributors of Pharmaceuticals), ČAFF (Czech Association of Pharmaceutical Companies), ČLnK (Czech Chamber of Pharmacists) have created an informal alliance (CZ ESM FMD Partners) to drive a Czech Stakeholder approach which mirrors that of the European model. The ultimate aim is to deliver a CZMVS, aligned and intrinsic to the vision of the ESM and the operational functionality of the EMVS. Again, following the European model the CZMVS will be set-up and managed by CZMVO, a non-profit legal entity under the supervision of the State Institute for Drug Control (SÚKL).
The CZ ESM FMD Partners have agreed a Framework Memorandum of Understanding which describes the principles, conditions and governance arrangements by which the CZMVO (i.e. NOOL) is expected to operate.
There are about 261 pharmaceutical companies consisting of 465 MAHs, 525 distributors of which vast majority are pharmacies with distributor’s license, 15 parallel importers, approximately 200 hospitals and other treatment institutions with own pharmacy and 2 800 pharmacies operating on the Czech Rx market. The market is considered to handle approximately 180 million Rx packs per year.