Falsified Medicine – in the best case they are not effective, in the worst case they are a cause of death.
Yet the range is rather broad: Illegal pharmaceuticals sold as generic drugs composed of active substances still subject to patent protection; sub-standard drugs which are produced in a way that they do not meet best manufacturing practices – in particular with respect to purity of substances and content of active substances – culminating in adulterations where the composition was manipulated. Besides reports of eye witnesses from manufacturing sites in emerging and developing countries in which rats and other small animals scrimmage and where, inter alia, also polluted water was used for production, there were recently again reports regarding both falsified as well as expired, re-packed pharmaceuticals which reportedly entered the supply chain. Those medical products included pharmaceuticals used in connection with a number of carcinosis in Austrian hospitals: ex post it is de facto not possible to verify whether a patient received a falsified anticarcinogenic drug, whether the treatment had the desired effect, and whether side effects can be related to falsifications. It can no longer be denied that falsified medicine is a global phenomenon which is steadily growing and which constitutes a global threat. Although by far not limited to intangible property rights issues (piracy of products) legislation is only slowly taking one step after the other.
Already more than 25 years ago the World Health Organization (WHO) made first efforts to strengthen international co-operation in fighting against falsified medicine. Already back than there had been pressure for creating a legal framework in order to take separate criminal prosecution against the manufacturing and the distribution of falsified medicine. The global criminal law convention against falsification of medicine proposed by the WHO was never signed – apparently due to varying opinions of different countries. 2011 in Moscow, in the course of the presentation of an international convention ready for signing – the MEDICRIME CONVENTION – the project to take criminal law action against falsified medicine was finally realised: until now, 21 countries signed it and the convention entered into force at the beginning of this year. At the same time at EU-level the Directive 2001/83/EC was amended by the Directive 2011/62/EU providing for the prevention of falsified medicine being released for free circulation. In Austria, those two legislation documents with respect to pharmaceuticals were already implemented by the Federal Law Gazette I 2013/48 which came into effect on 13 March 2013. In particular additional crimes were included into the Pharmaceuticals Act (Arzneimittelgesetz – AMG) regarding falsified medicine: the falsification of medicine with the intention to leave them to a third or with the intention to offer, procure, let, store, import and export thereof is to be punished with imprisonment of up to 3 years, and in case of committing such crime on a commercial basis with imprisonment of up to 5 years. Yet illegal manufacturing, import and export, offering, letting or procurement of narcotics which exceeds the threshold (e.g. > 3 g heroin/15g cocaine) are already subject to an imprisonment of up to 5 years and in case of such crime being committed on a commercial basis, up to 10 years. If one considers that falsification of medicine yields much higher profits as illegal drugs as, e.g., heroin or cocaine, it is not astonishing that more and more criminal organisations discovered that business for themselves and serve that business with their relating criminal organisation and professionalism. It is evident that the prosecution and prevention of falsification of medicine is not facilitated. Safety warnings like "Users and pharmacists are requested to especially turn their attention on the pharmaceuticals concerned before using and preparing them." do yet produce hardly the desired relief. Additionally, the processing of some falsifications is that professional that they may be identified hardly or only by using special methods. Based on the Directive 2011/62/EU the European Medicines Verification Organisation (EMVO) was launched in 2015 in order to implement a European E-verification system for pharmaceuticals by means of a "Data-Matrix-Code". The hope remains that these new efforts and their implementation contribute to better put an end to falsification of medicine. Euro notes are protected by more than 8 integrated security features against counterfeiting – additionally to strict criminal law provisions. One is tempted to believe that money is still our greatest asset...
By Monika Hupfauf, Senior Associate, DLA Piper