The European Pharmaceutical Industry Association (EFPIA) has welcomed the European Commission’s public consultation on legislative measures to combat counterfeit medicines.
The Commission’s Directorate-General for Enterprise and Industry launched the consultation on amending the regulation of manufacture, trading and distribution of active substances and medicines for human use.
The consultation comes amid evidence that counterfeit medicinal products are an increasing threat in Europe. EU customs officers seized nearly three million counterfeit products in 2006, representing a 384% rise on the previous year. The EFPIA say that this EU data corroborates their own evidence on the prevalence of counterfeits, and their increasing penetration into the legitimate supply chain.
The consultation document also highlights a worrying move away from counterfeiting of ‘lifestyle’ medicines, such as erectile dysfunction and weight-loss products, towards life-saving drugs.
The EFPIA has previously said that repackaging and breaking of seals in the distribution chain puts patients at risk, and has called for a range of regulatory measures to be implemented. Their suggestions include a ban on repackaging of pharmaceutical products, clearly defined liabilities for all involved in the distribution chain, stricter auditing rules and controls of the supply chain and applying penalties for trafficking in counterfeits. The EFPIA is also preparing to launch a pilot project in the area of mass serialization – a 2D barcoding system – towards the end of the year.
Contributions should be sent by e-mail to EC Directorate-General for Enterprise and Industry by 9 May 2008.