Background and scope
The Council of Europe has drawn up the first international treaty against counterfeit medical products and similar crimes involving threats to public health, the MEDICRIME Convention, to establish as offences:
- the manufacturing of falsified medical products.
- supplying, offering to supply and trafficking in falsified medical products.
- the falsification of documents.
- the unauthorised manufacturing or supplying of medicinal products and the marketing of medical devices that do not comply with conformity requirements.
The Convention also lays down a framework for national and international co-operation between the competent health, police and customs authorities on both the national and international levels, measures for crime prevention by also involving the private sector, and the effective prosecution of crime and the protection of victims and witnesses. Furthermore, it provides for the establishment of a committee to follow up the implementation of the Convention by the signatory states.
On 8 December 2010, the Committee of Ministers of the Council of Europe - representing 47 European Countries - adopted the MEDICRIME Convention and invited the Secretary General to disseminate the Convention widely among non-member states that may be interested in becoming parties. On 29 June 2011, the Committee of Ministers decided to open the Convention for signature on 28 October 2011, on the occasion of a high-level thematic conference to be organised in Moscow. To date, 13 countries have signed the MEDICRIME Convention and 15 have ratified it. With the ratification by Guinea, the sixth country, the convention entered into force in January 2016. Burkina Faso was the 10th country that ratified the convention, which triggered the establishment of the Committee of the Parties, the convention’s monitoring body. The Committee of the Parties had its first meeting in December 2018 and it is expected that its Rules of Procedures will be established in the course of 2019.
As the falsification of medical products and similar crimes constitutes a global threat, the Convention is open to member and non-member states of the Council of Europe, as has been the case for other recent conventions. Therefore, the MEDICRIME Convention offers a legal framework for world-wide co-operation to combat the falsification of medical products and similar crimes involving threats to public health.
The EDQM and its committee of experts CMED coordinate co-ordinates a practical work programme to protect public health from the dangers of falsified of medicines and related crimes through risk management and prevention, and improved co-operation between member states and other stakeholders in Europe and beyond. It also collaborates with national and international organisations in efforts to combat falsified medical products and similar crimes.
Signatory states may make use of the expertise and working results co-ordinated by the Council of Europe and its EDQM to support the follow-up of the Convention after its entry into force.
The term "counterfeiting" as used in the Medicrime Convention is meant in its broadest sense of "falsification".