Madrid, July 21st 2016. The constitution of the organization which will manage the Spanish Medicines Verification System (SEVeM) was signed in Madrid earlier today, in line with the requirements of the European Falsified Medicines Directive and its Delegated Regulation, which shall be fully operative in February 2019. The Spanish Healthcare and Consumers Secretary General, Mr. Javier Castrodeza, alongside the Spanish Medicines Agency (AEMPS) Director, Ms. Belén Crespo, attended the signature act as witnesses.

The Board of the new organization will be composed by the Spanish business Association representing R&D based pharmaceutical industry (Farmaindustria), the Spanish Generics Medicines Association (AESEG), the Spanish General Council of Official Pharmacists’ Colleges (CGCOF), and the Spanish Federation of Wholesalers of Pharmaceutical and parapharmaceutical products (FEDIFAR). The AEMPS will also participate in Board meetings, enabled with holds the function of monitoring the system.

As it has been established in the European legal framework, the pharmaceutical industry will adapt its production lines with the objective of incorporating anti-tampering devices as well as a new bi-dimensional code (datamatrix) in medicines packages, which will contain a unique and randomized serial number for each package. These serial numbers will be uploaded in a European repository so that pharmacies, before dispensing the medicine to the patient, will verify the authenticity of the package through a telematic connection corresponding to the national repository. This end-to-end verification will be completed by wholesalers in cases in which there is a high risk of counterfeiting.

The objective of this European regulation is to avoid the potential risk of entry of falsified medicines in the legitimate supply chain, further strengthening to patients the complete guarantees which are granted to them by medicines dispensed in pharmacies. Spain so adapts itself to this European regulation, even when the manufacturing, distribution and dispensing system currently in force in our country made it almost impossible for falsified medicines to enter the legitimate chain.

SEVeM will officially start its activities in September this year with the incorporation of the key professionals in the managing team. There are left now 30 hard working  months to make this technically complex system a reality with the contribution of all stakeholders. The entities signing the constitution are strongly committed to successfully implementing this important initiative which, apart from improving safety in medicines, will result in a better service for patients.

“The main purpose of the R&D based pharmaceutical industry it to provide society with new medicines which are more effective to fight diseases. This is inseparable from guaranteeing that they reach patients who need them in the most appropriate manner. Thus, we take on this challenge as part of  our commitment with safety and access, and in collaboration with the rest of stakeholders engaged in medicines”; stated Farmaindustria’s President, Antoni Esteve.

From Aeseg, its President, Raúl Díaz-Varela, remarked that “though practically no incidents have been experimented as far as falsified medicines in generics are concerned, we are working together with the rest of industry and competent Authorities so to improve the safety of medicines, as a clear proof of our commitment with patients’ healthcare”.

Jesús Aguilar, President of the CGCOF, maintained that “the main objective of this verification system is to provide with a greater safety, if this were possible, to patients, establishing stronger guarantees within the medicines’ supply chain. A model in which pharmacists, as a healthcare professionals, will once again act as the verification guarantors of the authenticity of the dispensed medicines for citizens”.

The President of Fedifar, Eladio González, stressed the fact the all agents of the supply chain have managed to reach an agreement to create a system which finally complies with the European Falsified Medicines Directive: “FEDIFAR, the business Association which gathers together almost all full range wholesale companies operating in Spain, has always demonstrated its predisposition to collaborate in the setting up of a Spanish Medicines Verification System which will reinforce the protection and safety of citizens as a far as access to medicines is concerned”.

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