The European Commission published a report on the results of the implementation of the Directive on the falsification of medicines 2011/62 / EC. The latter was adopted in 2011. as an amendment to Directive 2001/83 / EC for defining measures to combat the threat of counterfeit medicines in Europe.

The Directive on counterfeit medicines since 9 February 2019. introduces mandatory requirements for the safety of prescription drugs and some OTC medicines, requirements for wholesale distributors, strengthens the rules for the importation, control and inspection of active pharmaceutical ingredients and their manufacturers, as well as the requirements for Internet distribution medicines.

One of the requirements of the Directive (art.. 118a) is the report of the European Commission on the measures taken by the EU member states to effectively combat falsification.

According to this report, in all 28 Member States at least some activities related to drug fraud are a criminal offense. In 21 EU Member States, the production, distribution, mediation, import, export and remote sale of counterfeit drugs are criminal offenses. In 7 other EU member states, some activities are covered by civil (such as fines) rather than criminal sanctions. The maximum prison terms vary from 1 to 15 years (figure), and fines can range from 4,300 euros in Lithuania to 1 million euros in Spain or have no restrictions, as in the UK (table).

In Bulgaria, criminal penalties apply only to the import or export of counterfeit medicines; Other activities are covered by civil sanctions. In Finland there are no specific sanctions for mediation or export, but they are covered by more general provisions. In Latvia, criminal penalties include the production, distribution and mediation; there are civil fines for imports and exports. In Romania, imports and exports are covered by civil, rather than criminal sanctions. In Poland and Sweden, criminal sanctions do not apply to exports, but this is subject to civil sanctions. In Lithuania, imports are covered by civil sanctions.

Falsification of active substances entails criminal liability in 23 EU member states and 26 - civil sanctions (fines).

In general, the European Commission assessed the fight against drug fraud as satisfactory and, according to preliminary estimates, the implementation of the Directive helps to reduce falsification by 25%. Further cooperation is needed to strengthen measures to combat falsification and improve their overall effectiveness.

Recall that since October 24, 2017.

The State Service of Ukraine for Drugs and Drug Control has launched the first phase of a pilot project to introduce an automated tracking system for the circulation of medicines from the manufacturer to the end consumer using marking (codification) and identification. During the implementation of the pilot project, domestic "Interhim" ODO will produce and distribute 1000 packages of the drug "Amiksin ІС" with the appropriate coding via the distributor "БаДМ" and the retail network of the "Pharmacia".

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