(2002; 166 pages)
The fight against counterfeit drugs in the Russian Federation
Dr Alexander Toporkov, Russian Federation
In recent years, the Russian Federation has faced a marked increase in counterfeit medicines. The data suggest that two-thirds of these fake medicines were made within the country. Most of the fake medicines were found by departments in the monitoring and approval system during quality control and medicine certification operations. In most cases, the counterfeits were discovered during the process of ensuring that their quality complied with the requirements of regulatory documentation, such as description, labelling, authentication and quality.
The most commonly counterfeited drugs are the antibacterials. Cases have been found where the fake medicines displayed the same serial number as the genuine ones.
The reasons behind the increase in fake medicines in the Russian Federation are believed to be:
• shortcomings in the current legislation governing the trade in medicines;
• a large number of intermediary distributors in the pharmaceutical market;
• the gulf between the cost of drugs and the purchasing power of the public;
• inadequate interdepartmental coordination in the fight against fake products;
• easy availability of sophisticated modern equipment for production and packaging of medicines;
• a large number of enterprises that do not conform to GMP.
The problem of counterfeit medicines also leads to economic problems, such as direct losses for Russian and foreign producers, the costs of combating the fake medicines and protecting trade marks, overall costs to the health sector caused by inappropriate treatments, and unpaid taxes and duties.
Because of the inadequacy of the existing legislation, an amendment is being drafted to the Federal Law on Medicines, to introduce the concept of counterfeit medicines, to ban their preparation, production, sale and import into the Russian Federation, and to criminalize their production, advertising, preparation, packaging, labelling, acquisition, storage, or transport for the purposes of sale. The amendment also covers medicines accompanied by false information concerning contents and/or producer.
In August 2001, the Russian Ministry of Health set up a Commission to combat the trade in fake medicines, including personnel from the Customs Committee, the Ministry of the Interior, the Federal Security Service, the Ministry of Industry, Science and Technology, the Prosecutor-General and the Supreme Court.
In December 2001, the Russian Ministry of Health set up the Pharmaceutical Inspectorate to:
• organize inspection checks;
• inform law enforcement and monitoring agencies of violations uncovered;
• collaborate on drafting regulations and laws dealing with quality control;
• set up a database on those parties involved in the trade in medicines for information and analysis.