THE MEDICRIME CONVENTION

The Medicrime Convention: the first legal document criminalizing the production and distribution of counterfeit medical products.

At the end of 2010, the Ministerial Committees of the Council of Europe’s 47 States adopted an open draft Convention: « The European Committee Convention on counterfeit medical products and similar crimes that involving threats to public health,” known as the Medicrime Convention, the only international tool which criminalizes counterfeiting and the production and distribution of medical products put on the market without approval or in violation of safety standards. Opened to signature on October 28, 2011, the Medicrime Convention has today 26 States signatories.

1. Context

Medical products counterfeiting and similar crimes are a threat to public health. In the last several years, this phenomenon has been in constant growth and has achieved worrying proportions. It’s difficult to calculate the exact scale, but it is estimated that today counterfeit products represent nearly 10% of worldwide commercial medicine trade.

Crime linked to medicine counterfeiting is spreading to a global level and spares no country. Beyond an erosion of public trust in health systems, this criminality constitutes an omnipresent threat and danger for people.

Until now, no single internationally-harmonized legislation criminalized these practices and permitted the application of deterring penalties. The Council of Europe therefore considered it the responsibility of the international community to defeat this common scourge.

In this context, since 2004, the Council of Europe has worked on the development of an international criminal bill of law: the Medicrime Convention. Open to signature and ratification to all countries worldwide (not only the 47 states of the Council of Europe) since October 2011, the Convention offers up a powerful international legal instrument criminalizing counterfeiting.

2. The Medicrime Convention

The Medicrime Convention aims to protect public health from the scourge of counterfeit medical products by introducing criminal penalties for certain acts including assisted or attempted counterfeiting, but also by putting in place certain preventive measures and victim protections. It also offers a framework for international cooperation and measures aimed at coordinating efforts at national levels.

In these ways the Medicrime Convention will help reinforce the fight against a lucrative traffic by imposing stricter suppression measures at national levels.

The Medicrime Convention applies to all medical products. The term medical products includes:

• Human and animal medicines;
• Medical devices (intended for diagnostic and therapeutic purposes);
• Diverse active substances, excipients, or elements or materials these are composed of, whether the medical products are covered by intellectual property rights or if they are generic products.

The Convention also applies to similar infractions that cover the manufacturing, storage, trafficking, and sale of medical products deliberately done outside of the control of medical authorities.

2.2 Towards the criminalization of medical product counterfeiting and related/similar infractions

The Medicrime Convention, first international criminal legal instrument, obliges its Member States to introduce criminal penalties to an entire series of crimes because of the risk they represent for public health:

• The intentional production of counterfeit medical products, counterfeit active substances, excipients, parts, materials and accessories, their adulteration (compromising undeclared addition or substitution reducing the quality of a product);
• The intentional supply, offer to supply or trafficking, including storage, import and export of counterfeit medical products. “Supplying” includes acts such as procuring, selling, giving, offering free counterfeits or even promoting these products;
• The production and intentional falsification of documents, notably packaging, labeling, and internet content accompanying the product;
• The unauthorized production or the supply of medical products and medical devices which do not conform to applicable standards;
• Attempted or assisted counterfeiting.

2.3 For effective, proportionate, and deterring sanctions

Proven infractions by an individual, in accordance with the Medicrime Convention, are subject to effective, proportionate and dissuasive sanctions, including criminal reclusion, and imprisonment which can give cause to extradition.

Organizations declared responsible can potentially be subject to other measures such as temporary or definitive prohibition from exercising a commercial activity, a placement under legal surveillance or even a legal/judicial dissolution.

The Medicrime Convention also allows for the seizure and confiscation of products, components, materials and accessories relative to acts of medical products counterfeiting and similar infractions. The Convention also allows confiscation of revenues generated by these criminal activities (money laundering) and the destruction of seized goods.

Medicrime retains numerous facts as aggravating circumstances, including the death of mental or physical damage to a victim, breach of trust, use of mass distribution (including the internet) or the link to a criminal organization or recidivism.

2.4 Solutions to this international-scale scourge

The Medicrime Convention aims for an improvement in national-level cooperation through different administrative, industrial and commercial sectors. It also anticipates better cooperation and information exchange between the different representatives of health, customs and security authorities.

The Convention also facilitates international cooperation between the different State Signatories, from both criminal and administrative perspectives. The criminal cooperation effort will apply to investigations, procedures, execution of confiscations on one hand, and extraditions, mutual judicial assistance on the other hand; in administrative terms, a central referral center per signatory state will assist in the fielding of requests for information or cooperation. Further, development assistance programs could be conducted for the benefit of third parties.

Destined for both public and private sectors, the Medicrime Convention also proposes preventive measures: awareness campaigns regarding ways to avoid dangerous medical products, a warning system, training programs to government agents and health professionals and tools for the identification and monitoring of health threats. Awareness-raising efforts or even agreements with Internet access providers are also anticipated in these preventive measures.

The Medicrime Convention puts a high priority on measures protecting victims with the right to damages and physical, psychological and social rehabilitation assistance. Measures protecting the rights and interests of victims in criminal investigations and procedures are also included in the Convention.

Finally, the Medicrime Convention anticipates the creation of a monitoring body responsible for supervising the implementation of the Convention by its Member States.

2.5 The 27 current Member States

Since the Convention was opened to signature in Moscow on October 28, 2011, 27 states have signed on:

• Austria, Cypress, Finland, France, Germany, Iceland, Italy, Portugal, Russia, Switzerland, Ukraine, and Israel (non-member State of the Council of Europe) upon the Convention’s opening for signatures on October 28, 2011;
• Liechtenstein on November 4, 2011;
• Luxembourg on December 22, 2011;
• Denmark on January 12, 2012;
• Turkey on June 29, 2012;
• Belgium on July 24, 2012;
• Armenia and Moldova on September 20, 2012;
• Spain on October 8, 2012;
• Guinea on December 10,2012;
• Morocco on December 13, 2012;
• Hungary on September 26, 2013;
• Croatia on September 3, 2015;
• Bosnia-Herzegovina on December 4, 2015;
• Albania on December 17, 2015;
• Burkina Faso on February 16, 2017.

9 countries have ratified the Convention:

• Ukraine on August 20, 2012;
• Spain on August 5, 2013;
• Hungary on January 2014;
• Moldavia on August 14, 2014;
• Guinea on September 24, 2015;
• Armenia on February 5, 2016;
• Albania on June 6, 2016;
• Belgium on August 1, 2016;
• and France on September 21, 2016.

The entry into force of the Medicrime Convention is active under the condition of 5 ratifications including at least 3 member States of the Council of Europe. Since the ratification of Guinea on 24 September 2015, the Convention entered into force on 1st January 2016.

2.6 Key dates of the development of the Medicrime Convention

In 2004, the former ad hoc Group of the Council of Europe working on medicine counterfeiting undertook the first systematic study related to legislation, administrative structures and procedures regarding medicine counterfeiting.

In 2005, this ad hoc Group called for the development of a global action plan including concrete legal activities to be undertaken in cooperation with other concerned international organizations in order to effectively fight crime in the pharmaceutical sector.

October 23 and 24, 2006, an international conference, «Europe against counterfeit medicines » was organized in Moscow by the Russian Federation, under the aegis of the presidency of the Committee of Ministers and with the support of the former ad hoc Group and the European Directorate for the Quality of Medicines and Health Care (DEQM). This conference called upon the entire group of public and private actors concerned with pharmaceutical security to take up their charge in terms of protecting public health against pharmaceutical crime by developing a Convention that would combat this kind of crime and create a clean political environment in order to ensure its implementation. The Parliamentary Assembly of the Council of Europe supported these activities through its recommendations.

From 2007 to 2009 the text of the Medicrime Convention was developed under the aegis of the Committee of Ministers of the Council of Europe and thanks to inter-secretarial cooperation between the Directorate General of Human Rights and Rule of Law and the Directorate General of Social Cohesion, by the intermediary of the DEQM.

On April 15 and 16, 2010, The Medicrime Convention was finalized and presented during an international conference of the Council of Europe held in Basle, Switzerland, which aimed at preparing for practical implementation.

December 8, 2010, The Medicrime Convention was adopted by the Committee of Ministers in Strasbourg, at the headquarters of the Council of Europe.

On October 28, 2011, the Medicrime Convention was opened for signatures and submitted for ratification, acceptance or validation in Moscow during an international conference organized jointly by the competent authorities of the Russian Federation, the DG-HL and the DEQM of the Directorate General of Social Cohesion. Twelve Member States of the Council of Europe signed on.

On 21 and 22 November 2013 was held in Madrid (Spain), the Regional Conference entitled “From signature to ratification and implementation of the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (Medicrime Convention)”. Representatives from Andorra, Belgium, France, Germany, Republic of Guinea, Ireland, Italy, Luxembourg, Monaco, Morocco, Portugal, Spain, Switzerland and United Kingdom attended this meeting.

The aims of the Conference are:

• to encourage member states to sign and ratify the Convention;
• to raise awareness among members of parliament, law enforcement, NGOs, the media and other professionals working in the field;
• to discuss the benefits and challenges of ratifying the Convention;
• to exchange experiences, know-how and promote networking.

On January 1st, 2016, the Medicrime Convention entered into force in the 7 States who ratified it (6 European countries and a third country): Ukraine, Spain, Hungary, Moldova, Armenia, Guinea and Albania.

Today, 26 States have signed the Medicrime Convention (as of January 1st, 2016). The entry into force of the Convention Medicrime is active under the condition of 5 ratifications including at least 3 member States of the Council of Europe. Since the ratification of Guinea, on 24 September 2015, the Convention enters into force on 1 January 2016.

For more information

– Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health. October 2011.
Information available at: click here

– Council of Europe. Counterfeiting of medical products Medicrime (Official website).
Information available at: click here

– Explanatory Report of the Council of Europe Convention on counterfeiting of medical products and similar crimes involving threats to public health. October 2011.
Information available at: click here

– Informational page on the Medicrime Council. October 2011.
Information available at: click here

– Council of Europe. The Medicrime Council. Fighting counterfeiting of medical products and similar crimes involving threats to public health. European Directorate for the Quality of Medicines and Health Care (DEQM) and the Council of Europe. October 2011.
Information available at: click here

– European Directorate for the Quality of Medicines & Healthcare – EDQM (Website).
Information available at: click here

–State signatories of the Medicrime Convention.
Information available at: click here

– Regional Conference “From signature to ratification and implementation of the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health”. Madrid (Spain), 21-22 November 2013.
Information available at: click here

– List of declarations made with respect to treaty No. 211. Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health. Status as of: 25/9/2015.
Information available at: click here