The Council of Europe First International Treaty Against Counterfeit Medical Products

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 counterfeit medical products.

• supplying, offering to supply and trafficking in counterfeit 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, in particular among those states with observer status with the European Pharmacopeia. 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, 15 states have signed the MEDICRIME Convention.

As the counterfeiting of medical products and similar crimes constitutes a global threat, the Convention will be 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 counterfeiting of medical products and similar crimes involving threats to public health.

The EDQM co-ordinates a practical work programme to protect public health from the dangers of counterfeiting of medicines and related crimesthrough 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 counterfeit 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.