The Counterfeit Medicines Directive and Its Impact on the Production Chain

The Counterfeit Medicines Directive and Its Impact on the Production Chain

Mach FTD, a significant provider of industrial technical solutions, along with its partner, the English company Domino Printing UK, organized a conference on November 14th addressing the "Counterfeit Medicines Directive," with a focus on Directive 2011/62/EU.

As a special guest at this event, the EU Life Sciences Sector Manager within Mach presented the implications of this directive to the attendees. The discussion covered not only its effects on the medicine production process but also its impact on the entire supply chain of the pharmaceutical industry.

Furthermore, pharmaceutical manufacturers and distributors, who were invited to the event, learned more about the inscription solutions proposed by Domino and witnessed a series of demonstrations by Mach FTD specialists.

Counterfeit Medicines – A Global Issue

According to the World Health Organization, approximately 15% of all medicines are counterfeit. Between 2005 and 2011, there was a 92% increase in counterfeit medicines, and in 2011 alone, 11 billion non-compliant pharmaceutical products were intercepted at the borders of the European Union. The global pharmaceutical industry loses over $200 billion annually due to counterfeit drugs.

In this context, a new directive, 2011/62/EU, addressing counterfeit medicines was published in the Official Journal of the European Union on July 1st, 2011. Out of the 28 EU member states, 23, including Romania, have transposed the directive into national law, while the remaining five countries—Finland, Italy, the Netherlands, Poland, and Slovenia—have been warned by the EU with infringement procedures.

The new law came into effect on July 1st, 2013, and EU member states are required to fully comply with the directive's requirements starting from January 1st, 2016.

Provisions of Directive 2011/62/EU

To combat the counterfeiting of pharmaceutical products, the new European directive proposes measures in four distinct areas: active ingredients, distribution, the internet, and security measures.

The new directive imposes stricter requirements for controlling and verifying manufacturers of active pharmaceutical ingredients. Suppliers must be audited for each Manufacturing Authorization Holder (MAH) authorization. Additionally, equivalent rules are applied to India and China. Only Japan and Switzerland are exempt from certification requirements due to their already stringent legislation. "It's important not to have false ingredients because we can impose rules and regulations on packaging, product, and distribution levels, but if the purchased active ingredients are counterfeit, we jeopardize public health," explained Bart Vansteenkiste.

According to the legal provisions, pharmaceutical manufacturers are obliged to print a unique matrix code on the external surface of packaging for products sold in the European Union. This code is scanned with a specialized device in pharmacies to confirm their authenticity. This process is known as serialization, and all pharmaceutical manufacturers must adhere to these rules by 2016 to sell their products in the European Union. Additionally, products must be sealed to ensure that authentic medications are inside the box and have not been replaced during distribution. Distribution is a key focus of the new directive. "You must make it impossible for counterfeit medicines to enter the supply chain," said Bart Vansteenkiste. With the application of the directive, good distribution practices will become more rigorous. "The idea is to make the pharmaceutical supply chain more transparent. Products are transported from one country to another, from one warehouse to another, and the entire process is not always very transparent."

Starting this year, the Eudra GMDP database, implemented by the European Medicines Association, is in operation. This database contains the authorizations of all distributors, GDP certifications, non-compliant declarations with GDP criteria, producer registrations, importers (including supplier information), and distributors of active substances. Each company involved in the distribution chain is required to verify its partners' certifications. "This way, the association ensures that everyone checks everyone and that there are no companies that can introduce counterfeit medicines into the distribution chain."

Another security measure outlined in this directive is the establishment of a central European registry—a database that will allow authentication of medicines before they are handed to patients. These safety measures apply to all prescription-based medicines on the blacklist with a higher risk of being counterfeited, even if they are not produced in the European Union. Over-the-counter (OTC) products are not within the scope, but the directive provides for periodic risk assessments for both lists.

"Another pressing issue is the internet, as most counterfeited products are sold there," said Bart Vansteenkiste. Hence, the directive mandates that every company selling medicines online displays the new common logo across all such websites, along with a hyperlink to a dedicated website to verify product authenticity. The total costs for implementing the new system for all European companies are estimated between 6.8 to 11 billion euros. As for the implementation period, estimates suggest that a manufacturer will need 2-3 years to become compliant with the new legal provisions.