Humberto Arnés, director of SEVEM
The management of the Spanish System of Drugs Verification (SEVEM) already has a board of directors to ensure the implementation and compliance of Directive 2011/62/UE with its recent amendment, the Delegated Regulation (UE) 2016/161.
We recall that this extension of the rule deals with the anti-counterfeiting measures of medicines, trying to exercise directives to ensure the safety of patients and the system in general. In particular, emphasis on the development of containers with tamper protection and printed with a two-dimensional code (Datamatrix) which includes a unique and randomly designated serial number for each package that is marketed.
The Board of Directors of SEVEM was established in Madrid on September 5th, and will be presided by Humberto Arnés, CEO of Farmaindustria (Spanish pharma industry association). The executive board is complemented by three Vice Presidents: Ángel Luis Rodríguez, Director Ggeneral of the Spanish Association of Generic Drugs (AESEG); Jesus Aguilar, President of the General Council of Colleges of Pharmacy (CGCOF) and Eladio Gonzalez, President of the Federation of Pharmaceutical Distributors (Fedifar).
The system will also have seven board directors belonging to the associations present in the pharmaceutical sector. As support, the board will complement its team with a Secretary and a Vice Secretary, positions that will be permanent like the rest of the members.
Furthermore, a few days earlier, Maria Angeles Figuerola, head of the Department of Pharmaceutical Technology of the Ministry of Industry was appointed to the position of Managing Director of SEVEM. Figuerola is a key player for the successful management of this board, given her wide experience in the pharmaceutical sector and in the technological innovation area.
The main duties and issues that SEVEM will deal with, linked to the verification and control of the adaptation of the industry to the new European norm, are as follows:
- Ensure continuous protection throughout the entire distribution chain.
- Ensure coding and unique identification for each drug.
- Consolidate a database for verification of drugs.
- Check each medicine at a dispensing point level.
- Maximize the potential benefits of mass serialization.
- Focus on patient safety by protecting their privacy.
- Create a single combined serial code with an efficient method of tamper evidence.
- Use simple, robust and effective security methods at a reasonable cost.
- Work together for the benefit of patient safety.
- Involve all stakeholders of the system.
Once established the governing body of SEVEM, the roadmap of this organization for the development of the management of drug safety continues its course. Thus, the next steps involve the selection of the technological provider and the later development of the system.