1 October 2015 – A unique international tool criminalizing the trade of counterfeit medicines, the Medicrime Convention, will enter into force on 1st January 2016, after 5 countries1 out of its 24 signatories completed the ratification process. The Medicrime Convention, launched by the Council of Europe in December 2010 is opened for signature by all countries in the world and aims to curb what it defines as counterfeit (falsified) medicines2, that is medicines whose identity and/or source have been falsely represented.

IFPMA, EFPIA, PhRMA, IGBA, EGA, and GPhA and their members – the global innovative and generic/biosimilar pharmaceutical industries – welcome such a significant development and the role played by the European Directorate for the Quality of Medicines and Healthcare (EDQM) of the Council of Europe. They stand ready to work closely with all those engaged in the fight against fake medicines and share their expertise where they can to help with the implementation and enforcement of Medicrime.

“The fight against counterfeit medicines is gaining momentum. Strong legislative frameworks are necessary to combat counterfeit medicines and Medicrime is a unique tool that can curb this problem, said IFPMA’s Director General Eduardo Pisani. “Medicrime introduces criminal sanctions targeting both those who manufacture counterfeit products and who distribute them. Perpetrators involved in the production and traffic of counterfeit medicines are criminals and should be prosecuted as such.” he explained.

Counterfeit medicines can have the wrong active ingredients, the wrong dose or dangerous substances and could result in drug resistance, further illness or disability or even death. All medicine categories are affected, be it originators’ or generic, prescription-only or over-the-counter medicines.

“Counterfeit medicines, which are mainly linked to organized crime, have considerably grown in recent years, given the high profits and opportunities offered to criminals, including through the spread of e-commerce. Yet, in many countries, the trade of counterfeit medical products is even less sanctioned than selling narcotics for instance and such impunity does come at the detriment of patients’ health”, said EFPIA’s Director General Richard Bergstrom.

“Counterfeit medicines are a serious public health threat.” IGBA Chair Jim Keon said. “This international tool can help strengthen the global pharmaceutical supply chain to stop the spread of counterfeit medicines and ultimately protect patients”.

Global pharmaceutical associations share the view that there is a global shared responsibility to tackle the issue effectively and promptly. All associations join forces to protect patients, by improving product security through, e.g., the European Medicines Verification System, and by raising awareness about the dangers of counterfeit medicines, as does the Fight the Fakes campaign which gives a voice to the victims and shares the stories of those working to put a stop to this threat to public health.

“Counterfeit medicines frustrate the concept of quality of medicines. Where quality is not ensured, patient safety is at risk” said Adrian Van Hoven, EGA Director General. “Fake medicines are a global concern and people in low- and middleincome countries are especially at risk. The proportion of fake medicines is as much as 10% globally, while in some areas
of Asia, Africa and Latin America, fake medicines may account for up to 30% of medicines in circulation3. In Africa, onethird of all malaria medicines are probably fake4. This threat requires a multi-stakeholder and multi-disciplinary collaboration both at local and global levels”, he added.

While the entry into force of the Medicrime Convention is a decisive milestone, the fight against counterfeit medicines requires even more widespread support. EFPIA, IFPMA, PhRMA, IGBA, EGA, GPhA and their members encourage other countries worldwide to sign and ratify the Convention.

What is Medicrime?

Medicrime refers to the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health. It was adopted on 8 December 2010 by the Committee of Ministers of the Council of Europe and was actively supported by the European Union. It is the first international treaty to establish a criminal legal framework to prevent and combat threats to public health, by providing tools to fight against falsified medical products and similar crimes, through 3 pillars (Article 1):

1) Criminalisation of certain acts;

2) Protection of the rights of the victims of the offences as established per the Convention;

3) Promotion of national and international cooperation.

Key elements:

➢ A wide scope. The Convention concerns all counterfeit medical products, whether IPR-protected or not, generic/biosimilar medicines or not (Article 3) including all medicines, even investigational, medical devices, active substances, excipients, components and accessories. The Convention is not concerned with IP infringements but defines “counterfeit” as products with a “false representation as regards identity and/or source”.

➢ Substantive Criminal Law. Medicrime establishes as offences, when committed intentionally, the manufacturing of counterfeit medical products (Article 5); supplying, offering to supply and trafficking in counterfeit medical products (Article 6); the falsification of documents (Article 7); ‘similar crimes’ (Article 8); and aiding and abetting the commission of crimes under the Convention (Article 9). It aims to both prevent and combat ‘medicrime’ by providing for sanctions and preventive measures that are ‘effective, proportionate and dissuasive’ (Article 12).

➢ Victims are defined broadly and given strong protection under the Convention (Articles 19 and 20), but the Convention is also designed to strengthen public confidence in health authorities and healthcare systems through enhancing and protecting the legal distribution chain.

➢ Jurisdiction in Medicrime is established so as to ensure that no criminal acts go unpunished, therefore giving jurisdiction the greatest possible number of states (article 10).

➢ Effective Cooperation. Parties must take the necessary measures to ensure exchanges of information and crossborder cooperation between health authorities, customs, police and other competent authorities in the operational management of cases on both national and international levels.