Authored By: Bridget Heelan and Siegfried Schmitt, PAREXEL Consulting
The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centered around the Directive on falsified medicines for human use. The European Medicines Agency highlights the problem of falsified medicines and warns that the phenomenon of falsified medicines is on the increase and that these include expensive medicines, such as anticancer medicines, and medicines in high demand, such as antivirals.
In July 2011, the EU strengthened the protection of patients and consumers by adopting a new Directive (https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0074:0087:EN:PDF)1 on falsified medicines for human use. This Directive ensures that only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the internet.
This Directive came into force on 21 July 2011 and Member States had to start applying its measures in January 2013.
As from 9 February 2019, marketing authorisation holders (MAH) are now obliged to place two safety features on the packaging of most prescription medicines and some over-the-counter medicines in the European Union:
The aim of this act is to increase patient safety by introducing new rules that test the integrity of the supply chain and to impede infiltration of the supply chain by falsified medicines. The safety features are placed on the packaging of the medicinal products by the pharmaceutical manufacturer and consist of:
- an anti-tampering device
- a unique identifier, in the form of a 2D data matrix barcode, which allows verification of the authenticity and the identification of an individual pack of a medicinal product.
The pharmaceutical manufacturer on behalf of the marketing authorization holder (MAH) or the MAH itself must upload the information from the 2D data matrix barcode into the central EU repository after certification and before the product is released for sale or distribution. The repository is part of an end-to-end medicines verification system introduced by the Regulation. The 2D barcode will then need to be scanned at various points in the supply chain to verify its identity and the anti-tampering device also needs to be checked. Depending on the supply chain, wholesalers will also need to scan medicines at different points in the supply chain to verify their authenticity. Pharmacies and hospitals will then scan each medicine at the end of the supply chain to verify their authenticity and check them out from the repository before dispensing them to patients.
Once the drug is dispensed to the patient or if the drug is exported, the unique identifier needs to be removed from the system. This is done by scanning the 2D barcode and removing the serial number from the system. When the medicine is dispensed to the patient, it is also necessary to ensure that the anti-tampering device is functional.
The EMA and the European Commission have prepared an implementation plan, including regulatory requirements and timelines, to guide applicants and MAHs of centrally authorized medicines in meeting the requirements (https://www.ema.europa.eu/documents/other/implementation-plan-introduction-safety-features-packaging-centrally-authorised-medicinal-products_en.pdf)2 and the EMA has also revised product information templates to enable companies to implement the new rules.
There are however considerable practical and cost challenges for pharmacies, industry and distributers to implementing this directive in terms of the cost for upgrading IT systems, the need for super-fast broadband and the cost of upgrading packaging lines nor is it clear at present how enforcement will operate.
1 DIRECTIVE 2011/62/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. Official Journal of the European Union. 2011;54:74.
2 Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use, 29 June, 2017 (EMA/785582/2014Rev.2)