The EC has proposed in a consultative document to legislation combatting counterfeit medicines that there should be stricter auditing of active ingredients and their production plants. The commission claims that a tendency not to manufacture active ingredients in conformity with GMPs or in declared sites could facilitate a rise in counterfeiting.
A sharp increase in seizures of counterfeit medicines in the European Union—almost fivefold in 2005 alone—and signs that fake drugs are entering the European market has sparked the commission into taking action. In fact, there has been evidence of Europe becoming a base for the assembly of counterfeit medicines, their packaging, and distribution to markets outside the region, mainly Africa and Latin America.A key feature of the EC's proposed legislation, which would take effect in two to three years if passed, is that it would apply to all participants in the supply chain—not only manufacturers and wholesalers, but also traders, agents, and brokers. In particular, those involved in re-exporting operations and business-to-business activities would have to comply with the new regulations.
Audits, defined as verification of compliance with standards of an economic operator by another economic operator, would be mandatory between a manufacturer and contract manufacturer and also between a supplying wholesaler and purchasing wholesaler. The EC suggests that auditing of suppliers by purchasers could be carried out by accredited and professionally qualified third parties.
The commission also believes that testing of supplies of active substances by efficient analytical methods such as fingerprint techniques and near-infrared spectroscopy should be mandatory. These methods could help to detect residues and impurities indicating that active substances have been manufactured with undeclared processes or at uncertified sites.
Rather than being applied as a guideline, GMP principles in active substances would be legally binding as they currently are with GMPs for finished medicinal products.
"It's taken a long time but at last the commission seems to have acknowledged that what we have been asking for makes a lot of sense," says Guy Villax, chief executive of the Portuguese active ingredients producer Hovione and a board member of the European Fine Chemicals Group. "About 80% of APIs used to make EU medicines come from outside the EU, most of which are now off patent. It is even more important now that CGMPs are effectively enforced, otherwise the cheats and rogue middlemen trading in substandard and often counterfeit active ingredients will not be put out of business."
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the EU's primary trade body for medicines, has urged not only the introduction of stricter auditing rules but also more inspections of active ingredient plants outside Europe by inspectors from national European licensing authorities and the European Medicines Agency.
"That means the provision of a lot more resources," says Ann Robins, EFPIA's legal affairs director. "But the EU should be able to back up its commitment to tighter compliance with GMP standards by making more funds available for enforcement of regulations."
The EC has proposed an EU-wide introduction of a system for tracking and tracing specific packs of medicines with electronic pedigree data on past ownerships and transactions. This could be achieved through a mass serialization scheme based on 2D-data matrix barcoding for which California is providing a legislative model with a regulatory system due to be implemented in early 2011. EFPIAis hoping the EUmay also have legislation ready for an e-pedigree scheme by then.
The association is planning to launch a data matrix-based serialization pilot project this year to use as a model for a uniform Europe-wide system. Some parts of the industry worry that EU legislation on counterfeiting may come too late to prevent individual countries adopting their own different pack-specific tracing systems.
Sean Milmo is a freelance science writer based in Essex, United Kingdom.