EU launches consultation on customs enforcement of IPR

The European Commission has launched an online public consultation to review the EU legislation on customs enforcement of intellectual property rights (IPR).

The move comes after a series of controversial incidents in which EC Regulation 1383 has been invoked to seize pharmaceutical shipments in transit through the EU to other parts of the world because they are suspected of IPR infringement.

Last November, for example a shipment of 1.74 million tablets of the anti-platelet drug clopidogrel - manufactured by an Indian company and destined for Latin America - was seized by French customs. 

Under the law - and although clopidogrel is still under patent by Sanofi-Aventis in a number of EU and world markets - the shipment should not have been detained because those patents are not recognised by the country of origin and destination.

The latest case was resolved with the shipment released quickly after a request by Sanofi-Aventis, but others in the last couple of years which have seen medicines detained for several months have led to accusations of interference with legal generic trade and inhibiting access to essential medicines in developing countries.

Non-governmental organisations (NGOs) such as Health Action International have called for the EU to revisit Council Regulation No. 1383/2003, claiming its differing interpretation by customs officers across Europe lies at the heart of the confusion between counterfeit pharmaceutical products and generic medicines.

In the Netherlands, for example, a so-called 'legal fiction' exists which states that even when both the origin and destination of a product are outside the EU, if it touches ground in the EU it is considered to be subject to standard customs procedures.

That led to another case in December 2008 which a large shipment of generic medicines en route from Indian to Latin America were seized. In this case the IPR holder exerted its patent rights, leading to a lengthy delay before the shipment was released and a major international incident - still not fully resolved - in which a complaint was filed with the EC.

According to one prominent brand security director at a Big Pharma company who talked to SecuringPharma.com recently, the furore over IPR enforcement and access to medicines in Europe has made some companies "enormously cautious" about asserting intellectual property and even trademark rights.

Because the current system relies so heavily on the manufacturing authorisation holder (MAH) asserting their IPR, he said, that reticence is playing into the hands of counterfeiters.

The EC's review of Regulation 1383 is one opportunity for clarity in the area of border control, which is a key battleground against counterfeiting. A key premise of the consultation is to explore and clarify "the situations in which customs may take action, in conjunction with the possible infringements of rights conferred to the right holder by substantive law."

The consultation period, which is being carried "in close collaboration with the member states" according to the Commission, is open for comment until 25 May.


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