In March 2008 the Commission launched a public consultation on ideas for amending the regulatory framework governing the manufacture, trading and distribution of active substances and medicines for human use. The Commission is proposing the following new measures to combat counterfeiting:

• Subjecting all parties in the distribution chain to pharmaceutical legislation
• Improving product integrity and traceability
• Sharpening the technical requirements for GMP and GDP
• Tightening inspections and supervision
• Improving transparency

The Commission is also considering making audits of GMP/GDP compliance by qualified auditors (these might include third-party audits by accredited companies) mandatory. This would apply not only to dealings between manufacturers and contract manufacturers but to the relationship between manufacturers and supplying/purchasing wholesalers, where there were grounds for suspicion of non-compliance. The Commission says that “acceptance of third-party audits by accredited companies could be considered”.

Ideas for improving product integrity include requiring a unique seal for the outer packaging of a medicinal product in its journey from the manufacturer to the retailer or wholesaler. The right to open the seal would be restricted to the market authorisation holder and the end-user of the product (i.e. hospital, healthcare professional, patient). This rule would not apply to all medicines but to certain categories of product identified through a risk-based approach, taking into account the potential public health impact of counterfeiting and the profit strategies of counterfeiters. The move would be backed up by a ban on repackaging.

In terms of traceability, the consultation document suggests introducing an obligatory product pedigree, comprising a “unique and centrally accessible record of all past ownerships and transactions”. The supplied retailer/pharmacy would be the final traceable point in the distribution chain.