Given what is describes as "an alarming increase of medicinal products detected in the European Union which are falsifications in relation to their identity, history or source," the Commission has proposed action to protect the legal distribution chain from the infiltration of fake medicines. This will help to ensure confidence of distributors, health care professionals and patients in the medicinal products they trade, prescribe and purchase in the legal supply chain.
Falsified drugs are usually unsafe, inefficient or low-quality products as they generally do not include the correct, or any, active ingredient or are not manufactured at the declared sites. The number of detected false products - or counterfeit drugs - is on a steady rise. In addition the risk profile has changed. While previous figures indicated that the risk related more to so-called "lifestyle" drugs, there are strong indications that the number of false representations of innovative and life-saving medicines is increasing (Marketletters passim). Moreover, to increase the volume of fake medicines, these products are channelled through the legal supply chain towards patients.
What are the key measures proposed?
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