EFPIA still looking to EU in fight to end parallel trade

The pharmaceutical industry in Europe, which is still nursing the hope that parallel trade will be done away with and that direct communication about products to patients will be permitted, has suggested measures along these lines to the European Commission.

In its response to the European Commission's consultation on the future of pharmaceuticals in Europe, the European Federation of Pharmaceutical Industries Associations (EFPIA) is also asking for measures on prices and reimbursement and on the protection of intellectual property.

In July the Commission launched a public consultation - recently concluded - that could potentially serve as a basis for new legislation. In its response EFPIA is attacking parallel trade on two fronts: that it distorts trade and that it reduces the safety of the drug distribution chain.

EFPIA is asking the Commission to adopt in its future Communication the principle of "non extraterritoriality of Member States' price controls".

This principle was already set out in "recommendation 6" of the G10 declaration, a forum set up by the Commission that brought together Member States and companies, which was succeeded by the Pharmaceutical Forum in 2005.

This recommendation 6 says that the scope of national price controls should be limited to the territory of the country concerned. EFPIA is proposing a more radical solution: "an alternative way to address the existing EU trade distortions would be for the European Commission to issue legislative proposals to prohibit parallel trade at Community level".

However, it does not suggest how to achieve this ban, given that parallel trade is acknowledged as a legal practice protected by the principle of the free circulation of goods rooted in community law.

Apart from the commercial considerations, EFPIA states that "parallel trade also negatively affects the integrity of the supply chain and gives rise to unnecessary safety hazards". It is therefore asking the Commission to prepare a regulation enacting a ban on repackaging and enabling the implementation of a single system of identification and coding of medicines.

The association is also requesting that legal liability be clearly extended to all distributors and medicine sales points in the case of counterfeit products being circulated.

In addition, EFPIA is asking the Commission to reform before 2009 - i.e. before the current European legislation expires - the current legal framework "to provide legal certainty to the industry in the provision of information on its medicines".

This reform, it claims, could enable "the provision of high quality information to patients on diseases and treatment options, including from the pharmaceutical industry, respecting the highest quality standards". This information would be controlled via "self-regulatory mechanisms".