Bringing pharmaceutical production into compliance with European requirements demands significant investments from Ukrainian pharmaceutical manufacturers, which could lead to higher production costs, according to Anatoliy Reder, CEO of the pharmaceutical company “Interchem.”
“We are operating within the paradigm that our country is currently moving toward—alignment with European requirements. We must understand that compliance with European standards, EU directives, and the principles and approaches currently in effect in Europe will require significant additional investments from us—in production, regulatory processes, research, and so on. In other words, this involves enormous additional costs in order to meet, within a relatively short period of time, the requirements that are currently the norm in the European Union. With a gradual transition to these requirements, it must be acknowledged that production costs will rise significantly,” he said in an interview with the “Interfax-Ukraine” news agency.
As Reder noted, compliance with European standards—particularly those incorporated into Ukraine’s law on medicinal products—will automatically require additional investments, which will inevitably lead to price increases.
“We need to speak openly about this. You can’t make pills out of thin air. If additional controls are needed, additional costs will be incurred. Today, we monitor every batch of manufactured products throughout their entire shelf life—something that wasn’t required before—and this involves hundreds and thousands of manufactured batches and, consequently, enormous costs. The additional control points in production required of us by European Union legislation—this means additional equipment, additional laboratory staff, and additional production processes—represent objectively large-scale investments. These costs will inevitably lead to price increases,” he stated.
