EU Drug Safety Through FMD Serialization Readiness

By Suzanne Elvidge, Contributing Writer
Follow Me On Twitter @suzannewriter

Falsified medicines are a critical challenge to the safety of patients and to the reputation of the pharmaceutical industry. Serialization is a major step toward drug safety across the EU, but has brought with it a set of challenges that national authorities and companies are tackling.

Falsified medicines — drugs that are diverted from legitimate sources, or that contain the wrong active ingredient or the wrong amount of the right active ingredient — are a critical challenge to the safety of patients and to the reputation of the pharmaceutical industry. The cost pressures of legitimate drugs and the ease of buying drugs on the internet are increasing the value of the falsified medicines market. In the July 2014 Life Science Leader article “The Falsified Medicines Directive — What Does It Really Mean?,” the WHO was quoted as estimating the global market to be worth around $77 billion. In January 2018, the WHO suggested that as many as one in 10 medical products in low- and middle-income countries were substandard or falsified, and according to various sources, the value of the falsified medicines “industry” could be worth more than $200 billion. This makes it the most lucrative of all the global falsification markets.