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Too many counterfeit drugs, need stricter rules

Counterfeit DRUGS, stolen and sold illegally. Threats to public health, which, however, are not punished in an appropriate way. The laws on crime, pharmaceutica

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Too many counterfeit drugs, need stricter rules
Counterfeit DRUGS, stolen and sold illegally. Threats to public health, which, however, are not punished in an appropriate way. The laws on crime, pharmaceuticals, in fact, are still insufficient and do not allow prosecutors to punish these crimes effectively. To report it is a study just published by the Council of Europe, signed by Domenico Di Giorgio of Aifa and of the prosecutor of Naples, Diana Russo, who stresses the need to implement the Medicrime Convention, the first international instrument of rules and legal mechanisms that aims to help legislators, regulators and professionals in the fight against counterfeiting, the manufacture and distribution of medicines placed on the market illegally. A convention founded in 2011 and signed by 32 countries, but ratified only by 16, which, for now, it is still our Country.

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The risks for the patients The study, published with the support of the European directorate for the quality of medicines & healthcare (Edqm), stresses that the fake drugs today there is a strong disparity between the risks relatively low, the authors of crimes and the huge ones that these behaviors represent to public health. Focusing on the case of Operation Volcano 2014, on the illegal traffic of an anti-tumor drug Herceptin stolen from Italian hospitals and reintroduced in the chains of distribution for sales across Europe, the study has thus revealed the shortcomings of the current legislative approaches in the field of protection of european patients against falsified medicines.

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The shortcomings of the legislation After conducting a survey of regulatory authorities and public prosecutors in some countries, including Armenia, Belgium, Germany, Italy, Serbia and United Kingdom, experts have noticed the inadequacy of the current legislation on offences analogues: shortcomings in the traceability systems, the fragmentation of the legal procedures and options insufficient for sanctions, incidental, in the light of their serious potential repercussions on public health. From the results, therefore, emerged as the successful implementation of the Medicrime Convention and would, instead, supported the legal proceedings and resulted in effective sanctions against the perpetrators.
operation Volcano In the specific case of the operation Volcano, explain the authors of the study, the criminal charges applicable were for the most part generic in nature and therefore, not suited to the specific implications for public health arising from the falsification of medicines. In fact, from the theft of the goods or the handling of stolen goods to the criminal association (which currently can be punished only in accordance with the provisions of the associations with the mafia, in Italy, or for conspiracy, in the United Kingdom), most of the regulatory frameworks do not take into account the fact that reintroduce the drugs stolen in the markets is a much higher risk to patients than a regular theft. The drugs that are not properly stored or are manipulated, in fact, can put you at serious health risk.
The crime in the pharmaceutical The same way, and the penalties for the manufacture of medicinal products which are illegal or for the handling of medicinal products are authentic, although covered by most of the penal codes, are often subordinated to the test of harm to patients or as a violation of the trademark, contrary to the provisions of the Medicrime Convention which, however, provides charges thanks to its attention to the potential risk to patients.

in Addition to the concept of “illegal possession of drugs”, which is not adequately addressed by the legal systems of most countries concerned (which prohibit only the possession of illegal substances such as narcotics or psychoactive drugs), illegal export can be fined only in the countries of the European Union in accordance with the provisions of the EU directives that require proper licenses for the exchange of medicinal products. For this, the sanctions have led mainly to the simple suspension of the license, or administrative penalties similar. On the contrary, stresses the study, the Medicrime Convention specifically addresses the detention of falsified medicinal products and falsification of related documents, defining it not as a simple fraud, but as a criminal act specific. In the light of the results of the study, conclude the experts, the sanctions applicable global not are still a deterrent strong enough compared to the potential profits that arise from the falsification of medicinal products.

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