Brussels reveals plans to combat counterfeit medicines

The European Commission's DG Enterprise is proposing as part of its plans to combat counterfeit medicinal products that packages of genuine medicinal products should be hermetically sealed.

In a working document submitted for public consultation DG Enterprise proposes a series of measures to reinforce legislation in order to guard against counterfeit drugs in the EU. It has been working on the document since 2006. The public consultation will be used as the basis for draft legislation and is open to all stakeholders, who have until May 9 to send in their contributions.

Among the measures put forward, it is proposed to place a seal on the outer packaging of various product categories, which have yet to be defined. Only holders of the relevant marketing authorisation and end-users would have the right to open the packaging. This measure will be accompanied by a ban on repackaging; the European Commission will specify this point in its future proposal.

Although parallel traders repackage products, it is not explicitly mentioned that the ban applies to them. Furthermore, according to the document, holders of the relevant marketing authorisation will have the right to open packaging. Observers note that as well as manufacturers, parallel traders also fit this category.

Another proposal concerns improving product traceability by setting up a compulsory "pedigree" chart detailing each of the stages a batch has gone through. The players involved in the distribution chain will be able to consult the chart. Within the framework of reviewing good distribution practices, the World Health Organisation (WHO) is currently discussing this "pedigree" system.

DG Enterprise has indicated that mass serialisation will be needed to ensure any specific pack can be traced. Currently, it is only possible to trace products through batch numbers. But DG Enterprise is not pressing for any specific technology and points out that the industry is discussing several options.

In addition, it suggests setting up a community data base of authorised wholesalers, specifying good distribution practices. It is also proposed to extend the legal obligations of wholesalers to all players involved in distribution, with the exception of doctors and pharmacists. Regular audits to ensure compliance with good manufacturing practices (GMP) and good distribution practices (GDP) may be made compulsory.

DG Enterprise also proposes moves to reinforce inspections in overseas territories and to include specific harmonised measures for inspecting distribution chain players. It is also planned to tighten up the rules covering the import/export and transit of pharmaceutical products.

The active substances used to manufacture medicinal products are also affected by counterfeiting. With this in mind, DG Enterprise is planning a compulsory notification procedure for active substance manufacturers and importers. Moreover, those manufacturers and importers will also be subjected to regular audits to ensure they comply with GMP.

DG Enterprise has also suggested that whenever scientifically possible, analytical technologies should be used to check the active substances. It would like to make this measure compulsory.

Parallel traders have backed the DG Enterprise proposals to combat counterfeit medicines, particularly where the re-packaging issue is concerned.

The European Association of Euro Pharmaceutical Companies (EAEPC) said the document incorporated "many of our suggestions and policy recommendations". The association added: "In particular, DG Enterprise confirms the principle, supported by the EAEPC, that repackaging should only be carried out by market authorisation holders, which includes manufacturers and licenced parallel importers."

For the EAEPC, repackaging is "a prerequisite for the free movement of medicines within the internal market and takes place under strict national and EU legal and regulatory obligations".

The EAEPC requests more rigorous controls at EU external borders since it considers that the major threat to European patients lies in the entry of counterfeit medicines "through illegal channels" and through unregulated internet sites.