The term counterfeit medicines refers to medicines which are fraudulent imitations of medicines available on the market.
Falsified medicines are fake sub-standard medicines which attempt to pass off as real, bona fide medicines. They may contain ingredients but are of low quality or in the wrong dosage
Falsified medicines are a risk to patient safety in both the developed and developing countries across the globe.
Falsified Medicines are a Global Issue
According to the WHO falsified medicines are responsible for over 100,000 deaths in Africa. The organisation International Policy Network, estimates 700,000 deaths a year are caused by fake malaria and tuberculosis drugs.
The Royal Pharmaceutical Society estimates around half a million packs remained in the hands of patients in one of the 15 incidents of fake medicines entering the legitimate supply chain in the UK over the period between 2005 – 2011.
It is thought that the introduction of stringent new EU 2013/C 343/01 Good Distribution Guidelines and the Falsified Medicines Directive (2011) may have stymied fake drugs entering the legitimate supply chain in the UK, although experts estimate that around 1% of drugs in may still be fake.
The majority of fake drugs are purchased via internet pharmacies and it is hoped the introduction of the new EU Common Logo will help buyers identify websites that care licensed to sell medicines.
In the developing countries dangerous medicines are sold in registered and unregistered pharmacies, street vendors and market traders.
Poor regulation in the developing world and weak supply chains offer a lucrative multi billion pound incentive to criminal gangs linked to money laundering, drug trafficking and terrorism.
The WHO estimates between 10% and 30% drugs sold in developing countries are fake although this is higher in some parts of Africa e.g. Angola where approximately 70% of medicines used by the Angolan population are forgeries.
Criminal gangs operate across borders under the cover of false identities, documents and fictitious companies to avoid detection.
The Falsified Medicines Directive aims to prevent falsified medicines from reaching the patients by introducing harmonised, pan-European safety and control measures. These measures will ensure easier identification of falsified medicines, and improved verifications and controls at EU borders and within the EU.