Safety in the Pharmaceutical Market
Falsified medicinal products nowadays present a significant threat to public health. In addition, they cause severe economic damage. The EU has reacted to this: Starting 9 February 2019, prescription-only medicinal products 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 Commission’s Delegated Regulation which was published on 9 February 2016 provides further details. The safety features on the packages of medicinal products which are defined in the regulation must be implemented within three years after publication of the regulation in the Official Journal. The Delegated Regulation also lays down rules for the establishment, management and accessibility of the repositories system.
In Germany, securPharm does it
securPharm is a joint initiative of BAH, other associations of the pharmaceutical industry, pharmaceutical wholesalers and pharmacists. Since the publication of the falsified medicines directive, this initiative has been working on the implementation of the new rules. 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. Verification is performed with the aid of the safety features that have been placed on the packaging by the pharmaceutical manufacturers. The safety features also allow verification where the packaging of a medicinal product has been tampered with. The Delegated Regulation also includes derogations from the obligation. They apply to: medicinal products subject to prescription which are exempted from the obligation to bear the safety features (‘white list’), medicinal products not subject to prescription which as an exemption must bear the safety features (‘black list’).
All EU Members must go along with it
For comprehensive implementation of the EU falsified medicines directive it is important that stakeholders in other Member States also establish national verification systems, so that a EU-wide system for the verification of the authenticity of medicinal products including the connection with the EU-hub can be assured by 9 February 2019. Verification testing is then performed by the pharmacist via the check of the serial number and the product code on the packaging against the national repository. According to a representative survey of the Health Monitor of the BAH about half of the patients have great or very great confidence in the safety of prescription medicines, this sharing may distinctly increase with the implementation of the falsified medicines directive.