EDQM publishes guidance on strategy to counter medicrime

Published: 15-Jan-2014

Says aligned and close co-operation among authorities and stakeholders is key to fighting counterfeiting and similar crimes

A new Council of Europe publication1 has made suggestions into how European Union (EU) member states might revise their medicine, public health and criminal laws better to protect public health and national healthcare systems from criminals.

The 76-page booklet from the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, which is independent from the EU, outlines how countries may benefit, for example, by ratifying the Council of Europe Medicrime Convention. This, it claims, would boost EU member states’ reputation as states recognised internationally as countries that take pharmaceutical counterfeiting seriously; become part of a network of countries working on this issue; and introduce up-to-date criminal laws for offences involving pharmaceuticals.

The booklet stresses that counterfeiting potentially concerns retail and clinical trial medicines; active substances and excipients.

While conceding that it is impossible to measure the exact extent of medicrime, the publication cites a May 2012 World Health Organisation estimate that global sales of counterfeit medicines were by then worth more than €57bn, having doubled in just five years between 2005 and 2010.

The booklet also stresses the danger of Internet sales of prescription-only medicines, without prescription, with patients buying medicines online despite being aware of the dangers.

Describing the booklet as 'a working text for further field testing and revision', the EDQM stressed that it is a tool to assist policymakers decide how best to protect the health of citizens from counterfeited and other illegal medical products and the officials involved in this process at various stages and levels.

'The legitimate pharmaceutical and therapeutic products industry takes a vital interest in the good health of patients,' said Susanne Keitel, Director of the EDQM, explaining the background to the publication.

She added that the legitimate pharma sector 'is interested in the integrity of healthcare systems and their defence against counterfeit (falsified) and fraudulent products'.

Keitel added: 'Aligned and close co-operation among authorities and stakeholders in the manufacturing and distribution chain is key to fight counterfeiting and similar crimes and to protect public health.'

The EDQM has also made available online without charge two older publications: Counterfeit medicines, facts and practical advice and Counterfeit of medical products and similar crime, risk communication.


1. Counterfeiting of medical products and similar crimes (‘medicrime’): A strategic approach to assist states in protecting the health of their citizens – 2013 Edition. Author: B. Wijnberg. Director of Publication, Dr S Keitel. Published by the EDQM. Council of Europe publication number PUB200104.

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