Drug manufacturers back 'flexible' anticounterfeiting law
European medicine manufacturers have supported drafting an EU law to fight the counterfeiting of pharmaceuticals, but warned against prescribing specific technical solutions.
European medicine manufacturers have supported drafting an EU law to fight the counterfeiting of pharmaceuticals, but warned against prescribing specific technical solutions.
In a public consultation, the European Commission received comments from 100 pharma sector players, including industry associations, manufacturers, distributors, suppliers of active ingredients and consultants.
In a summary of responses, the Commission noted: "There was nearly unanimity that enforcement is a crucial element. This should entail the recall of licenses for noncompliant firms, penal sanctions, tighter checks at the outer borders of the EU and better information-sharing of customs authorities."
It added, however, that industry respondents regarded legislation mandating a specific safety/authenticity feature for medicinal products as "premature, ineffective and even counter-productive". They argued because of the multitude of anticounterfeiting techniques on the market, there was a "need for flexibility", some maintaining that the choice of a technology should be left completely to the manufacturer.
That said, there was almost total support for creating a "good distribution practice" database to help verify traders and end "today's practice where wholesale licenses are simply copied to support alleged compliance" with anticounterfeiting controls. The present system of batch numbers was comprehensively criticised as being unreliable.