MEDICRIME Convention Position Paper of the European Federation of Pharmaceutical Industries & Associations

The European Federation of Pharmaceutical Industries & Associations (EFPIA) welcomes the MEDICRIME Convention launched by the Council of Europe in December 2010 and opened for signature on 28 November 2011 at a high-level conference in Moscow. EFPIA regards the Convention, which criminalises the manufacture and supply of counterfeits as well as similar offences, as a breakthrough in bringing a new approach and renewed focus to the fight against counterfeit medicines. EFPIA supports the Conventions broad definition of counterfeit medicinal products, i.e. products where a false representation has been made as regards identity and/or source. The Conventions Explanatory Memorandum (EM) makes clear that this definition is not limited to IP infringing products. This broadened scope is a timely development as falsified medicinal products and IP infringements in the field of healthcare have in the past been too often combined resulting in paralysis and lack of concrete action. The definition will allow for filling in gaps in certain national legislations in which criminal and administrative liability for manufacturing, distributing and selling of falsified medicines is not covered outside the scope of trademark & patent legislation. The Convention provides that sanctions and measures should be effective, proportionate and dissuasive. At European level, the transposition of the Falsified Medicines Directive should be the opportunity to align EU Members States criminal law provisions with the requirements of the Convention. Key provisions to be highlighted amongst others include: Protective measures set out must apply irrespective of whether certain medical products are protected by IP (patent, trademark, etc.) legislation or not (Article 3); Falsification of documents (Customs documents, invoices, certificates, labeling etc.) established as offences (Article 7); Liability for intentional manufacturing, distributing and selling of medicines that are without the authorisation required under domestic law (article 8); Proceedings may continue even if the victim withdraws his/her complaint. If the defendant settles with the victim (such as by paying substantial compensation or by intimidation) that should not mean proceedings are automatically dropped given the risk to public health and safety (Article 15); Signatories to the Convention must establish quality and safety requirements of medical products (medicines and devices), creating a "safety net" to catch products that for example may be sold as herbal treatments (not requiring approval as medicines) but in fact include active pharmaceutical ingredients (Article 18); Possibility for non-Member States of the Council of Europe to ratify the Convention (Article 28).

Fdration Europenne dAssociations et dIndustries Pharmaceutiques

Leopold Plaza Building Rue du Trne 108 Bote 1 B-1050 Bruxelles

T +32 2 626 25 55 F +32 2 626 25 66 www.efpia.eu

EFPIA welcomes the fact that twelve countries have already signed the Convention (Austria, Cyprus, Finland, France, Germany, Iceland, Israel, Italy, Portugal, Russia, Switzerland and Ukraine) and encourages other countries, Council of Europe members as well as beyond, to sign too. Besides establishing criminal measures against counterfeiting, the Convention will bring a renewed focus on enforcement actions and, in particular, collaboration between signatory countries. In that respect, EFPIA and its members invite the Committee of Ministers to focus their efforts on mobilizing the developing countries which are the most affected by counterfeit medicines and assisting them in deploying the measures necessary to comply with the Conventions requirements. EFPIA and its members stand ready to work in partnership with all signatories on implementation and enforcement.

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Fdration Europenne dAssociations et dIndustries Pharmaceutiques

Leopold Plaza Building Rue du Trne 108 Bote 1 B-1050 Bruxelles

T +32 2 626 25 55 F +32 2 626 25 66 www.efpia.eu