Counterfeiting of health products is a serious and growing concern, since this practice endangers patients’ safety and health. A counterfeit medical device is one which is deliberately and fraudulently mislabelled with respect to identity and source.
The EU’s combat against counterfeiting is part of a general regional and international effort to offer authentic devices to populations.
The consequences of counterfeiting are numerous.
- Health and safety: Counterfeit medical devices can have adverse effects, including potentially lethal consequences, as they are often non-sterile, of poor quality, contain inappropriate materials and be of questionable effectiveness
- Economic: Counterfeit medical devices distort competition, damage legitimate producers’ interests and their brand names, undermine employment and reduce tax income. Manufacturers can experience loss of sales and see their reputation tarnished if the counterfeit medical device uses their company’s trademark.
The Commission issued a study on distribution channels dealing with counterfeit issues. The goal is to assist and encourage the development and implementation of government policies and regulations that combat and dissuade the production and trade of counterfeit medical devices.
