State of play of Serialization in Europe

© Shutterstock
© Shutterstock
Counterfeit or falsification is a scourge that affects all consumer products. Medicines are not spared and prove to be a very profitable market in which falsification of products is seldom punishable by law (in France, up to 7 years imprisonment and a fine of € 750,000) [1]). The global percentage of falsified medicines would be around 6-16 % of the market according to WHO, but remains difficult to quantify. Developing countries are most affected by medicine falsification due to a lack of regulation and control. Moreover, with the developing of internet borders are erased: 50 % of the total counterfeit medicine sales are operated on the internet.[2]
To counter drug falsification, a process, which scale and impact increases every year, Turkey, Brazil, China and India have implemented serialization systems to detect counterfeits. In Europe and the USA pilot systems are under consideration.[3]

Serialization

Serialization consists in linking each drug box with a unique number to verify its authenticity. The numbers are stored in a database that can be verified at any time. The support for this coded number can be a bar code, a matrix barcode (Datamatrix), or a Radio Frequency Identification (RFID).

In Europe

European Directive 2001/83/EC[1] was amended by Directive 2011/62/EU.[2]. This latter introduced the term « unique identifier » that will allow the “verification of the authenticity of the medicinal product, and to identify individual packs” (Article 54). Delegated acts shall specify “characteristics and technical specifications of the unique identifier” and list “the medicinal products or product categories which (…) shall bear the safety features” as well as the “modalities for the verification of the safety features” (Article 54a). A public consultation was opened, preliminary results seem to orient the text to a harmonized coding across Europe, in the form of a 2D data matrix encoding the unique identifier which shall contain serial number and the manufacturer product code which could be added the following information : the batch number, expiry date and if applicable national reimbursement number. The verification of the authenticity of the product would be done at the dispensing point or by wholesale distributors under certain conditions (supply outside of holder of the manufacturing/ marketing authorisation or return drugs). The verification system should be set up and managed by the parties under the supervision of the competent authorities. A text should be proposed and voted by the European Commission and the European Parliament in March / April 2015, and could be published in the Official Journal by September 2015. Companies will be granted a period of 3 years to implement the system.

Examples of proposed systems

In order to comply with Directive 2011/62/EU and pending of delegates texts, systems are developed, here are some examples:

European Medicines Verification System[3] (EMVS) proposed by the European Stakeholder Model is usable by each country but also allows countries to connect to their own system.

Etac[4] proposed by l’ European Directorate for the Quality of Medicines & HealthCar allows patients to check themselves the authenticity of their medication via an application.

SecurPharm[5] is a model developed in Germany, a test to link the system to EMVS is underway[6].

Conclusion

To allow a good efficiency of this future system, it is necessary for each player of the supply chain to be involved and it goes without saying that additional control means will need to be developed.

Prevention by educating patients, the first impacted by the falsification of medicines, is an essential step. Thus, IRCAM provides an awareness training course to the problem of falsification of medicines.[7] Indeed the patient informed of health risks related to the use of falsified medicinal become player in the fight against counterfeiting by choosing a secure circuit to obtain supplies.

The introduction of higher penalties to deter counterfeiters and the establishment of a global collaboration to fight against counterfeiting should be developed.

These measures should help limit the penetration of counterfeit medicines in Europe. But what to think about the patients in developing countries? And what are the limitations of these systems?

BY: GAELE FRESNE

 

[1] Site Eudralex, vérifiéé le 12 décembre 2014,

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001L0083&from=EN

[2] Site Commission Européenne, consulté le 12 décembre 2014, http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf

[3] Site AFPIA, vérifié le 12 décembre 2012, http://www.efpia.eu/uploads/images/EFPIA%20European%20Pack%20Coding%20Guideline%20V3_6%20(Final).pdf

[4] Site Council of Europe, vérifié le 12 décembre 2014, https://www.edqm.eu/fr/eTACT-1466.html

[5] Site SecurPharm, vérifié le 12 décembre 2014, http://www.securpharm.de/international-sites/english.html

[6] Site EFIA, vérifié le 12 décembre 2014, http://www.efpia.eu/mediaroom/147/43/Progress-towards-a-European-Medicines-Verification-System-the-European-Stakeholder-Model-and-securPharm-link-up

[7] Site IRACM, vérifié le 12 décembre 2014, http://www.iracm.com/elearnlanding/