Max Planck Institute for Foreign and International Criminal Law

Pharmaceutical safety is a vital health policy concern. It is promoted by comprehensive legal regulations that cover the production and marketing of medication, but in the international sphere it is increasingly endangered by the production and circulation of counterfeit products. The consequences of missing, incorrectly dosed, or toxic ingredients range from the failure of so-called "lifestyle" drugs to produce the desired effect all the way to the death of unsuspecting patients. The marketing of counterfeit products on the Internet exacerbates the problem.

Within the scope of this comparative law project, the contribution criminal law can make towards countering pharmaceutical counterfeiting and the difficulties it is confronted with in this process will be investigated. The criminal law instruments must be viewed in consort with diverse administrative regulations and measures that are designed to prevent the production and marketing of counterfeit medications, detect the presence of such medications, and trace them back to their place of origin. The focus of this project, however, is on the function of criminal law.

The goal of the project is to analyze the existing criminal law instruments in selected countries that are affected in various ways by the phenomenon of "pharmaceutical counterfeiting" with a view towards evaluating their efficacy and, where applicable, to develop recommendations for further development. The spectrum of countries included ranges from industrial nations, which are home to producers of counterfeiting-relevant products, to those countries whose distribution systems are especially susceptible to infiltration by counterfeit products. Brazil, China, Egypt, France, Germany, Greece, India, Nigeria, Paraguay, Russia, Switzerland, and the USA (with a focus on California and Florida) were selected. A primary aim is to determine whether "weak spots" are located (more) in the area of legislation or (more) in the area of prosecution. Where available, statistics will also be studied. Current legal policy efforts on the international level (World Health Organization, G8 countries) will be monitored and will receive active academic support.

In a first step, reports based on a uniform project design and containing analyses of the relevant legislation, literature, and case law, as well as – in some countries – results of supplementary expert surveys were prepared by legal scholars from the respective countries. In a second step, these reports will be the subject of a comparative legal evaluation by the project leader.

Initial results illustrate the diversity of modi operandi and manifestations with their differing degrees of criminal intensity, but also a considerable variance with respect to the control mechanisms employed in the relevant criminal offenses. Loopholes in the substantive criminal law emerge because of proof problems that arise when counterfeiting offenses require causation of (at least) palpable dangers to life and/or health. Distinctions made in criminal offense definitions between counterfeited medications and poor-quality genuine medications as the "object of the act" have little if any impact on the legal consequences, at least in cases of intentional crime. Sanctions range from fines and incarceration (with or without probation) to – at the extreme end of the scale – the death penalty. In some countries, damage claims of a penal nature or fines with a compensatory function are possible. The profits and objects used in the commission of the crime can be seized or confiscated in almost all countries studied. As far as its functional limits are concerned, criminal law in this context is, as usual, dependent on general circumstances, such as sufficient personnel, technical, and procedural resources. Other “interfering factors,” however, such as corruption, can also play a considerable role.