|A new Directive that was approved on February 16 by the European Parliament will reinforce the current instruments that fight against fake medicines. The goal is to better protect patients by securing the distribution chain, particularly on the Internet.|
The Directive, that should enter into force in 2012/2013 calls for the creation of a logo that will identify legal Internet pharmacy sites, the creation of a product traceability system and harsher punishments for traffickers.
Marisa Matias (GUE/NGL, PT) who led the discussions at Parliament, said “Falsified medicines are silent killers, either because they are devoid of effect or because they contain toxic substances that may harm, or even kill, those who take them. The absence of a legal framework encourages counterfeiting, an organized crime. We have been witnessing a huge growth of this criminal activity, with an increase of 400% in seizures of fake drugs since 2005. Protecting patient safety is the core aim of this directive.” She reiterated the terms of the Cotonou Declaration, that was launched by the Fondation Chirac in October 2009 and raises awareness on falsified medicines.
The new Directive is a modification of one that was created in 2001 and its focus is “the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source.” It is part of the “pharmaceutical package”, a list of legislative proposals made by the European Commission in December 2008.
The Directive calls for the creation of new safety features for all prescription medicines in the EU, unless there is clearly no risk. Non-prescription medicines will only be included in exceptional cases when there could be a health risk.
The text also introduced stricter norms for the whole production chain: data retention by wholesalers will be subject to more strict requirements, and the middlemen in the purchase and sales of medicines will have more frequent inspections.
Some of these norms can also apply to non-EU countries: the ingredients used to make the active substances will be subject to best manufacturing practices, whether the ingredients are imported or come from the European Union. Medicines produces in the EU to be exported will also have to meet the standards put forth by the Directive.
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