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Combating Counterfeit Pharmaceutical Products: the Need for Binding International legal instruments

The spread of counterfeit goods in general and of counterfeit pharmaceutical products in particular has become global. Among 10% of medicines available on the global market are counterfeit (according to Parliamentary Assembly of the Council of Europe Recommendation 1794 (2007) „ The quality of medicines in Europe“ ). Counterfeit medicines not only waste government’ s healthcare budgets, reduce legal industries’ revenues, damage the reputation of brand names, distort competition and bypass state tax systems but they are likely to put the patient’ s health and life at risk and thus they represent a serious threat to public health. There is an urgent need for action to raise awareness of the dangers that counterfeiting represents to the individual and collective safety of the public and to shape coherent policy for the prevention, deterrence and repression of counterfeiting pharmaceutical products (the PACE report). Recently substantial initiatives in the fight against counterfeiting have been taken by WHO, Council of Europe and European Union. However, we are still lacking internationally recognized harmonized legal definition of counterfeit medicine and unified international enforcement practice to fight against counterfeit medicine. This paper will discuss crimes in the pharmaceutical field: the scope of products they should cover (medical products and medical devices only, or food supplements and cosmetics as well), the offences that need to be criminalized (counterfeiting of pharmaceutical products and related offences such as mislabeling, adulteration, trafficking, tampering, etc., unauthorized clinical trials, intentional production of substandard pharmaceutical products and others) ; how far we should reach in criminalizing different conduct (for example is strict liability allowed or the criminal intent is necessary, could we criminalize abstract endangerment already, what is with corporate liability), the appropriate sanctions, the preventive measures that would contribute to further suppression of pharmaceutical crimes. The counterfeiting of pharmaceutical products raises at least two major concerns: violation of intellectual property rights and public health risks. This paper will address the matter of pharmaceutical crimes primarily from the perspective of the need to protect public health and safety. The aim of the paper is to propose harmonized legal definitions for pharmaceutical crimes and legal framework to combat them suitable for binding international legal instrument.

Combating Counterfeit Pharmaceutical Products; Binding International legal instruments

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