Medicinal Products and Medical Devices

The presence of counterfeit health products on the market is on an increase in the whole world lately. Especially omnipresent is a trend of counterfeiting medicinal products and it is estimated that the market of counterfeit medicinal products itself represents 10 percent of the global sale of medicinal products in total today.

Counterfeit medicinal products and medical devices become an increasing problem in the world, since they endanger health of the patients and represent a risk to public health. Regulatory bodies for medicinal products and medical devices, police, customs, inspection services, judicial bodies and the very pharmaceutical industry are involved in disclosing and preventing the trade in such products. As a rule, counterfeit medicinal products appearing on the market is a result of organized crime activities of placing fake medicinal products on the market for the purpose of making illegal profit, without taking account of their quality or consequences for consumers. The Croatian Medicinal Product Act defines a counterfeit medicinal product as a medicinal products whose identity and/or origin is fraudulently mislabelled, and it can contain proper or wrong components, be without active substances or contain wrong quantity of active substances and be in a wrong or counterfeit packaging. Counterfeit can be both an original (innovative) medicinal products and an equivalent (generic) medicinal product. Counterfeiting does not refer to legitimate production of generic medicinal products.

In the Republic of Croatia, it is prescribed that medicinal products can be purchased in authorized retail sale shops exclusively: in pharmacies and specialized retail sale shops of medicinal products, namely, only medicinal product with an approval of the Agency for Medicinal Products and Medical Devices (HALMED), which means that they underwent all the necessary prior quality controls, application safety and efficiency.

In Croatia so far, there has not been recorded counterfeit medicinal products appearing in authorized supply chains, or in a legal distribution network of public and private pharmacies, hospital pharmacies, wholesale of medicinal products and specialized retail sale shops of medicinal products. Hence, not one case of a counterfeit medicinal product appearing in authorized points of sale in Croatia has been recorded, because prior to coming to these points of sale, all medicinal products have to undergo a mandatory quality control, safety and efficiency at HALMED.

On the other side, on a black market (internet, advertising leaflets, electronic mail and the like) there sometimes appear medicinal products originating from other countries and not having an approval to be placed on the market in Croatia, being as such of a questionable quality and safety.
In developed countries, the greatest danger for the sale of counterfeit medicinal products is the internet, enabling counterfeiters an access to millions of users. Today, there is a large illegal market of counterfeit products on the internet that can be dangerous to life and health of users. Since the internet is not controlled, neither quality nor the origin of medicinal products thus advertised has been verified. It is estimated for more than half of the medicinal products advertised via the internet to be counterfeit. Illegally advertised and sold via the internet are mostly medicinal products for erectile dysfunction treatment, weight loss, then anabolics, analgesics, antibiotics and other anti-infectives. When buying medicinal products on an illegal market, users expose their health and life to a great risk. Therefore, in order to protect the users, the Croatian legislation does not permit to buy medicinal products via the internet.