Madrid, October 13th 2016.- The pharmaceutical industry based in Spain will invest around €200M over the next two years in order to adapt their production lines thus incorporating the technical requirements of the new system for the unitary verification of medicines. These are the economic estimations of the sector, based on an average cost of €300,000 per line.
Unit verification of medicines in Europe is a requirement originating from the European Falsified Medicines Directive and its delegated Regulation. Its aim is to avoid the risk of falsified medicines entering the legitimate supply chain of medicines dispensed in pharmacies, further strengthening for the patient the full guarantee of medicines dispensed in pharmacies. Spain has adapted to this European regulation, even when the current manufacturing, distribution and dispensing system in our country today makes it barely impossible for falsified medicines to enter this legal channel.
These investments in production lines are the first step in attaining the full operation of the verification system taking into account that, afterwards, companies will have to face a series of diverse expenses, such as the ones derived from the maintenance and printing of datamatrix and serialization, the latter representing a figure which could amount up to half a million € per production center.
On the other hand, each laboratory will have to take on the appropriate fee in order to develop and maintain the Spanish Drugs Verification System (SEVeM), which should be at full capacity, as in other countries of the European Union from February 2019. Thus, the launch of the verifiable system requires between 10 and 13 million Euros of investment and an annual support of between 5.5 and 8 million Euros from this year.
According to European regulations, adaptation of the production lines will work in a way so that packaging will incorporate closures to allow for verification that it has not been tampered with, and a new two-dimensional code (Datamatrix) containing a unique and random serial number for each package. These serial numbers will be placed in a European repository and pharmacies, before dispensing the medication to the patient, will need to verify the authenticity of the package by a corresponding telecommunications link with the national repository, managed by the SEVeM.
During this adaptation period of these new requirements, it is expected that the Administration will regulate certain aspects that European legislation leaves at a purely national level. In this sense, FARMAINDUSTRIA maintains a close relationship with the Spanish Agency for Medicines and Health Products (AEMPS) that will contribute to the industry allowing for them to adapt to the new requirements in an environment of ongoing dialogue.
However, the high costs involved for the production centers introducing technical requirements and maintenance derived from a system of drug verification, which responds to a request from a European character, would justify the adoption of measures supported by administrations.
In this sense, FARMAINDUSTRIA is working on different proposals so that the economic impact of the verification system is acceptable, especially for small and medium-sized enterprises, because in some cases they will have serious difficulties in coping with the expenditure required to get it up and running.