The Parliament Magazine Special Issue on “Fake Medicines” Makes Case for Strong EC Legislation

By Lewis T. Kontnik, Director, Amgen Brand Protection

This fall the European Parliament and Council of Ministers will consider the European Commission (EC) proposal for a directive on “Falsified Medicines.”  A special issue of The Parliament Magazine, Summer 2009, on “Fake Medicines—Tackling the threat to patients (click here) provides a wealth of support for adoption and strengthening of these proposed measures.

This important anticounterfeiting proposal, amending the current EC directive 2001/83/EC, proposes increased EU-wide controls in the areas (pillars) of: 1) product characteristics/GMP, 2) supply chain/GDP, and 3) active pharmaceutical ingredients (APIs).

Requiring manufacturers to use anti-tamper, authentication safety/security technology features on medicines is one of the key proposals. Parallel trade and repackaging remains an area of discussion in the proposal. While it would place legal liability on repackagers for counterfeits entering the chain through their repackaging, manufacturers want tighter controls.

The special issue of The Parliament Magazine provides a chorus of persuasive voices for the adoption of the proposed directive. The 20 page collection leads off with an article by Gunter Verheugen, vice president, European Commission DG Enterprise & Industry; and contains supportive articles by Goran Hagglund, Sweden’s Minister for Health and Social Affairs; Monique Goyens, director of the European Consumers’ Organization and David Benton, CEO, International Council of Nurses.

Jim Thomson, chair of the European Alliance for Access to Safe Medicines, makes a strong case that repackagers should be leading the charge to ensure that they fully protect the integrity of repackaged medicines by employing truly “equivalent” features on all pharmaceuticals. The special issue provides the latest data on counterfeiting and all authors agree that additional controls are needed to provide for a safe and secure supply chain.

For more information, please click on the following links:

• Council of the European Union Note on Pharmaceuticals package
• European Parliament Draft Report on the proposal for a directive of the European Parliament and of the Council amending Directive 2001/83/EC