The European Parliament has approved a new law to help prevent fake drugs from entering the supply chain. The legislation introduces new safety regulations, traceability measures and sanctions against counterfeiters.
The problem of counterfeit drugs is a growing concern throughout the world. Researchers estimate that 1 percent of medicinal products sold to the European public through the legal supply chain are now fake. In other parts of the world, more than 30 percent of the medicines on sale can be fake, and counterfeiters appear to be increasingly targeting innovative and life-saving drugs.
An article at PharmaTimes outlines provisions of the new EU legislation. For instance, the new regulations require that:
Online pharmacy sites display a common logo.
All authorized internet pharmacies will be linked to a central website in each member state. That site will, in turn, be connected to an EU site.
Individualized packs will be labeled to "guarantee their authenticity, and enable pharmacists to check whether the outer packaging has been tampered with". Specifics about this identification process are still under development.
"This vote clears the way for concrete measures to help protect patients in Europe from counterfeit medicines. As counterfeit medicines endanger the health and lives of patients, we now urge that these measures are implemented as rapidly as possible so that citizens benefit from these added safety provisions," Brian Ager, the Director General of the European Federation of Pharmaceutical Industry Associations (EFPIA), said. "Implementation of the Directive will require the involvement of all key stakeholders - manufacturers, pharmacists and wholesalers but also patients to ensure success. With their involvement in the design, implementation and running of systems, we can deliver the highest possible level of patient safety, the fastest roll-out in member states at the optimal possible cost."
These tougher counterfeit drug laws, which have been in the works for more than two years, now need to be ratified by the Council of Ministers. Once it is signed into law, EU countries have 24 months to make any necessary changes to their national legislation.