The Council of Europe has taken a major step to in its effort to fight the growing problem of counterfeit medicines by adopting a convention that includes, for the first time, criminal penalties for counterfeiting medicines, marketing medicines without authorization, being non-compliant with conformity requirements or falsifying related documents.
The scope of the “Medicrime Convention,” published in late October, includes drugs and medical devices for human or veterinary use as well as the active substances, raw materials, excipients and components used in their manufacture.
The convention directs its signatories to “take the necessary legislative and other measures to ensure that the offences established in accordance with this Convention are punishable by effective, proportionate and dissuasive sanctions, including criminal or non-criminal monetary sanctions, taking account of their seriousness.” Penalties will be applicable to both individuals and corporations.
The Convention will be open to member and non-member States of the Council of Europe and available for signature later this year.
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