EU: Counterfeit medicines: consultation of European Commission

09 May 2008

Armand Killan, Manon Rieger-Jansen

Counterfeit medicines have become an increasing threat to public health over the past few years. Not only has the quantity of counterfeit medicines on the market increased, in particular through the classical supply chain and the internet, but there has also been a rise in instances of defective manufacture and impurities in active substances by the counterfeiters themselves. There has also been a shift in the focus of counterfeiters away from just ‘lifestyle’ medicines such as erectile dysfunction and weight loss medicines and now towards life-saving drugs as well.

On 11 March 2008, the Directorate-General Enterprise and Industry of the European Commission launched a public consultation in preparation for a legal proposal to combat counterfeit medicines for human use. The aim of this public consultation is to amend current European pharmaceutical legislation.

Three areas have been identified where the regulatory framework for medicines should be improved. These relate to:

  •  medicinal products placed on the market: issues of traceability, product integrity and distribution chains;

  •  medicinal products that are imported, exported and in transit (transhipment);

  •  manufacture and the placing active ingredients on the market: issues of regulation of active substances.

Key proposals may include:

  • ·Subjecting all parties in the distribution chain of medicinal products to pharmaceutical legislation, i.e. the obligations for wholesalers will apply to other parties such as brokers, agents and retailers as well;

  • Tightening the rules on inspection and supervision, in particular regarding inspections in third countries;

  •  Improving product integrity through an obligatory sealing of the outer packaging, which would reveal any subsequent opening or tampering. The right to open the unique seal should be restricted to the marketing authorisation holder and the end user;

  • Introducing a central and efficient traceability system for medicinal products such that there is a unique and centrally accessible record of all past ownership and dealings with a medicinal product (the so-called pedigree). This pedigree would include transactions between the manufacturer, the wholesaler(s) and the supplied retailer/ pharmacist. Further, traceability should not be limited to batches but additionally to specific packages which should also be traceable by coding (mass serialisation);

  • Tightening requirements for the import/export/transit of medicinal products. Ensuring that imported medicines intended for export (not necessarily subject to marketing authorisation) are subject to the rules for imports into the EU.

  • Submitting the manufacture and import of active ingredients to a mandatory notification procedure for manufacturers/importers of active substances and improve audit and enforceability of GMP and inspections.

Stakeholders and other interested parties, such as industry and healthcare professionals, are invited to submit their comments to the European Commission by 9 May 2008 at the email address: