Securing the European Pharmaceutical Market
Falsified medicinal products present a significant threat to public health. In addition, they cause severe economic damage. The EU has addressed the situation: From now on, as of 9th February 2019, medicinal products subject to prescription and intended for human use may only be released for sale or distribution in the Member States if they bear specific safety features. In Germany, counterfeit protection is implemented by the verification system securPharm.
Counterfeit medicinal products cannot guarantee their efficacy and can damage a patient’s health. But not only health is damaged. The economic consequences of such illegal practices are also severe: A study conducted by the European Union Intellectual Property Office (EUIPO) has revealed that between 2008 and 2013, pharmaceutical manufacturers and wholesalers lost approximately EUR 10 billion of revenue annually due to the presence of counterfeit medicines in the EU marketplace. According to EUIPO, these lost sales translate into direct employment losses of approximately 38,000 jobs. As a countermeasure, the EU adopted a directive against falsified medicines in 2011. The associated Commission’s Delegated Regulation, published on 9 February 2016, provided new rules for safety features and medicine verification, which had to be implemented within three years after the publication of the regulation in the Official Journal.
Germany’s securPharm system
In Germany, securPharm took over the role of the national verification system.
securPharm is a joint initiative of BAH, other associations of the pharmaceutical industry, pharmaceutical wholesalers and pharmacists. This initiative has been working on the implementation of the national medicines verification system, which has entered its operational phase on 9th February 2019 after several years of thorough preparation.
The aim is to prevent the entry of falsified medicinal products into the legal supply chain in Germany. For this purpose, securPharm has developed a system that ensures that the authenticity and identity of a medicinal product can be verified in pharmacies before dispensing the package to the patient. The responsibility for introducing the new safety features and complying with the European legislation rests with the pharmaceutical companies. Verification is performed by the pharmacist or wholesaler scanning a 2-D barcode that has been affixed on the packaging by the pharmaceutical manufacturers.
Furthermore, an anti-tampering device placed on the box of prescription medicines enables pharmacy staff members and patients to check if the packaging of a medicinal product has been tampered with.
The Delegated Regulation also includes possible exceptions from the requirements for certain medicinal products to bear or not bear the safety features. The list of categories of medicinal products subject to prescription which shall not bear the safety features are set out in Annex I of Commission Delegated Regulation (EU) 2016/161 (“white list”), while the list of medicinal products not subject to prescription which shall bear the safety features are set out in Annex II of the same Regulation (“black list”).
Participation of all EU Members
To ensure a comprehensive implementation of the EU falsified medicines directive, every EU Member State and EEA country established their own National Medicines Verification Organisation (NMVO). NMVOs connect their national systems to the European Hub. The European Medicines Verification System supports this network of national bodies working together to secure the legal medicines supply chain against falsified medicines.
According to a representative survey of the BAH Health Monitor, about half of the patients have great or very great confidence in the safety of prescription medicines. With the implementation of the falsified medicines directive, this share of patients may now distinctly increase.