Control over the circulation of the counterfeit medical devices – MEDICRIME Convention.
The circulation of counterfeit medical devices (MD) and other medical products* is a global problem that poses a risk to public health and can cause significant economic damage. In this regard, there was a need to develop a single document aimed at combating counterfeit medical products. This was the MEDICRIME Convention.
The MEDICRIME Convention (Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health) is an international criminal law convention of the Council of Europe aimed at achieving the following objectives (art. 1):
a) providing for the criminalization of certain acts
b) protecting the rights of victims of the offences established under this Convention;
c) promoting national and international co-operation.
The Convention was prepared by 2011 and entered into force in 2016. The document has been ratified by 19 countries (13 EU members and 6 other countries). The Convention was ratified in the Russian Federation and entered into force in 2018.
What is counterfeit as defined by the Convention? This shall mean a false representation as regards identity and/or source.
It is clear that the provisions of the Convention are generalized and tend to refer to the domestic legislation of individual countries. However, the main ideas of the Convention regarding international cooperation are quite specific. Some of them are:
- Each party may “consider this Convention as the legal basis for extradition or mutual legal assistance in criminal matters in respect of the offences established in accordance with this Convention”.
- “The Parties shall, without prejudice to their internal reporting systems, designate a national contact point which shall be responsible for transmitting and receiving requests for information and/or co-operation in connection with the fight against counterfeiting of medical products and similar crimes involving threats to public health”.
- “The Parties shall co-operate to the widest extent possible in pursuance of the relevant applicable international, regional and bilateral treaties on extradition and mutual legal assistance in criminal matters concerning the offences established in accordance with this Convention”.
*According to the Convention, “medical product” shall mean medicinal products and medical devices;