New anti-counterfeiting measures for pharmaceuticals issued

01 June 2010

In April this year, Syria issued a new law for the regulation of trade in human medicines. The principal focus of the new law is on the regulation of the trade in and use of substances for the making of medicines and pharmaceutical products through the licensing and control of warehouses. However, the law also contains some important new provisions dealing with counterfeit products.

The new law prohibits the manufacture, preparation, bottling, packaging, transporting, possession, storage, distribution, offering for sale and selling of counterfeit medical products, which are defined as follows:

A medical product is to be considered counterfeit if [a] its production occurred in an unauthorised location, whether or not it contains an effective substance or an appropriate concentration, or [b] it contains a substance different from the one mentioned in the information card for the product, or [c] it uses a trade name or trade mark or other information that is untrue or misleading, or [d] the name of the country of production which is written on the internal container or the outside packaging is not the true name of the country of production, or [e] the certificate of origin has been counterfeited.

A medical product is in turn defined as including "human medicines [being any preparation made from any substance having a protective, diagnostic or remedial character], nutritional supplements and babies milk and food".

Although some of the provisions in the law deal with cosmetic substances, they do not appear to fall within the definition of a medical product and so they are not covered by the provisions relating to counterfeit medical products.

There are a range of punishments laid down for the counterfeiting of medical products. Anyone who counterfeits or participates in the counterfeiting of a medical product, or trades in them, is to be punished by between 5 and 10 years imprisonment with hard labour and by a minimum fine of 5 million Syrian lira (more than $100,000). If the product causes death or permanent disability, the punishment is increased to 20 years hard labour and a minimum fine of 10 million Syrian lira.

Anyone found to be complicit in the manufacture, preparation, bottling, packaging, transporting, trade in or distribution of counterfeit medical products is to be punished by three to five years hard labour and a minimum fine of 1 million Syrian lira. If the convicted person is a medical practitioner, the punishments are to be doubled. There are also punishments for advertising and marketing counterfeit medical products.

The implementing regulations for the law are yet to be issued by the Ministry of Health.