The pharmaceutical industry will soon be forced to undergo an extensive transformation as the serialization of prescription medicine packages will be mandatory in all European Union countries by 2019.
Pharmaceutical factories will be required to place an individual and traceable bar code on medicine packages to enable pharmacies, hospitals and consumers to verify the origins of a given medicine. Despite serialization becoming necessary due to the counterfeit medicines market, which has caused harm to pharmaceutical companies and the individuals they are intended to serve, factories see it an expense they will be obligated to pay.
While there are currently 15,000 prescription medicine production lines in Europe, only 30 percent have the capacity to actually put serialization into effect. Some lines may have to replaced and automated in order to trace the origins of medicines, which is likely to be very costly.
“The costs of the investment cannot be added to the price of prescription medicines because the prices are regulated," Denmark-based NNE Pharmaplan Senior Consultant Pasi Kemppainen said. "Implementation is the key: The more efficiently a solution is implemented, the less it will eat into the margin and the competitiveness of pharmaceutical companies."
The mandatory serialization of prescription medicine packages in Europe is part of a regulation adopted by the European Commission last month.
“So far, pharmaceutical manufacturers have waited to see how the legislation will evolve," Finland's Servicepoint Oy Serialization Expert Iiro Jantunen said. "Soon, everyone will be rushing at the same time and only the most progressive ones will make it on time, because the delivery times of equipment suppliers are becoming longer."