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Counterfeiting and illicit trade are now present in almost all industries, with fake and substandard goods getting ever harder to detect. Counterfeiting and illicit trade in medical products has always been an extremely profitable business, with the counterfeiting of medicines being one of the most lucrative sectors among the trade in fake goods. Thus, it is no wonder that during the COVID-19 pandemic, when demand for medicines and other medical goods is high and supply chains are being constantly disrupted due to quarantine restrictions, shortages and increased demand, the volumes of counterfeiting in this sector have surged.

Falsified and substandard medicines have become a threat to public health, and the global pandemic has significantly increased the level of this threat, which is evidenced by numerous reported cases of fake COVID-19 vaccines, test kits, masks and related medical products. In addition to posing a serious threat to patients’ health and wellbeing, fake medical products breach IP rights, have a detrimental economic effect on businesses, and damage the reputation of manufacturers as producers of safe and efficient products. Therefore, it is vital for responsible businesses to be aware of the applicable national anti-counterfeiting and anti-illicit trade legislations in the regions in which they operate.

Our Expert Guide provides high-level information on the legislative frameworks to combat the illicit trade in medical products, as well as on the tools, roles and practice of the competent authorities in eight CEE jurisdictions (Bulgaria, Czech Republic, Hungary, Poland, Romania, Russia, Slovakia and Ukraine). The directions provided in this Guide will help businesses navigate local legislative frameworks and move forward with the best options to counter illicit activity involving their products.