The creation of this specialized WHO group was approved by the 160 participants of the International Conference of Rome in 2006, representing 57 national drug regulatory authorities, 7 international organizations, 12 international associations of patients, health professionals, drug manufacturers and pharmaceutical wholesalers.

INTERNATIONAL ACTIVITIES

Think and Act Globally

False drug trafficking is a global scourge that requires a concerted and adequately dimensioned response from the whole of the international community.

False drug trafficking is a global scourge that requires a concerted and adequately dimensioned response from the whole of the international community. Now that they are fully aware of the problem, the commitment of decision makers is accelerating and giving rise to concrete measures. Ever more numerous and intensified, the prevention and enforcement actions undertaken at the international level are broadly supported and are meeting with growing success. As spearheads of these actions, the major specialized international organizations are at the front line in the battle against traffickers.

By their vocation and missions, several international organizations are directly responsible for protecting against the dangers of fake drugs and for eliminating their traffic.
These organizations develop strategies to combat the traffic and coordinate their implementation.
In addition to the major actors presented here, numerous professional associations or NGOs also play a more local or more discreet but very important role in this fight.

The WHO and the International Medical Products Anti-counterfeiting Taskforce (IMPACT):

IMPACT aims to build coordinated networks within and between countries in view of halting the production, trading and sale of fake medicines around the globe.
IMPACT is a partnership comprised of all the major anti-counterfeiting players, including international organizations, NGOs, health agencies, pharmaceutical manufacturers associations, regulation authorities …
IMPACT’s mission is to promote the sharing of expertise between these stakeholders, to identify problems, to find solutions and, finally, to coordinate activities in the fight against fake drugs.

IMPACT has created 5 working groups, each one devoted to specific aspects of the anti-counterfeiting program:
–Legislative aspects: The objectives of this group are for example to assess gaps in national and international law, to develop model legislation or to encourage legislators to promote the adoption of new laws.
–Regulatory Aspects: The objectives of this group are inter alia to promote the implementation of good manufacturing and distribution practices, to develop training and data collection tools or to encourage the implementation of operations of repression.
–Aspects concerning Enforcement, repression: Examples of the objectives of this group are to promote the increase of the resources available for the practical implementation of the measures, to promote initiatives facilitating coordination between countries or to develop tools to improve the skills of field officers.
–Technological aspects: The objectives of this group are, for example, to assess or, if necessary, to pilot projects aimed at developing technologies to prevent trafficking, to deter criminals, to detect counterfeit products or to facilitate the sharing of information.
–Communication: Examples of the objectives of this group are to develop messages tailored to different targets, to ensure a better dissemination of information and to assist the authorities of each country in their awareness campaigns.

Interpol
Centralize intelligence and coordinate the response of police everywhere in the world.
Composed today of 190 member countries, Interpol is the largest international organization of police in the world. Interpol has for mission to facilitate cooperation between police services and to provide support and assistance to all services, organizations and authorities engaged in preventing and fighting crime.
Member of the Group IMPACT of which it is the main body of repression, the international criminal police organization has for mission to initiate and coordinate police forces involved in major operations of repression against the traffickers of the world (Storm, Mamba, Pangea…).
Interpol is a major player in the combat against trafficking in fake medicines and in line with its commitment, the Organization has created the specialized “.Medical Products Counterfeiting and Pharmaceutical Crime» (MPCPC) unit.

World Customs Organization (WCO)
Provide assistance in the tracking of falsified medicines.
Composed today of 176 members, three quarters of which represent developing countries, the World Customs Organization (WCO) aims to improve the efficiency of customs administrations around the world, and to help them to fulfil their double mission of trade security and trade facilitation. As such, the WCO also has the role of consolidating the efforts to combat fraudulent and criminal activities.
The WCO is the organization in charge of ensuring cooperation between the customs services of the countries responsible for more than 98% of world trade, and as such it is at the forefront in the fight against the falsification of drugs.
It has thus created model legislation to combat counterfeiting as well as a web portal, IPM (for Interface Public Member) – a tool allowing secure communication between rights holders and customs authorities.
The WCO oversees the seizures made in raids coordinated at the international level.
It is also the natural relay of information between the different customs services of the world.

The United Nations Office on Drugs and Crime (UNODC)
Facilitate the implementation of international treaties and conventions. UNODC is an organ of the United Nations Secretariat. It was founded in 1997 following the merger of the United NationsInternational Drugs Control Program (UNDCP) and the Centre for International Crime Prevention (CICP).
Its mission is to assist Member States in achieving their objectives of security and justice and to help to roll back crime, narcotic trafficking and terrorism.
As a new and important source of income for criminal organizations, false drug trafficking is a growing concern for UNODC.
The “commission on crime prevention and criminal justice” adopted a resolution in 2011 (20/6) entitled “countering fraudulent medicines, in particular their trafficking” inviting States to get organized and to combat this scourge. In line with its mandate, this resolution encourages the UNODC to provide technical assistance to the members who request it.
Beyond its role as the reference source of information on global developments in the various forms of crime and corruption, UNODC is a leader in helping countries develop better legal tools to facilitate the implementation of international treaties and conventions such as the conventions on Narcotic Drugs (1961), on psychotropic substances (1971), on illicit trafficking (1988) and on transnational organized crime (2000).

European Commission
The Commission is divided into different services and into departments known as “Directorate-Generals” (DGs). The Commission’s services deal with general administrative questions or have a specific mandate for example to combat fraud or establish statistics.
In the battle against false drugs, some of the Directorate-Generals are more directly involved.
Taxation and Customs Union Directorate-General (TAXUD)
Plan the European action and enforce the intellectual property law.
The Directorate General of taxation and customs union (TAXUD) is a body of the European Commission responsible for managing, defending and developing the Customs union as a vital part of the protection of external borders of the European Community. As such, it establishes the Community regulations defining the intervention of Customs authorities in the case of infringement to intellectual property rights (the last Community regulation is no 1383/2003 of 22 July 2003).
The TAXUD is particularly responsible for enforcing the resolutions of the European Commission against counterfeiting and the Customs Action Plan to combat violations of intellectual property rights (IPR) for the period 2009-2012. The plan includes 50 targeted measures.
The TAXUD coordinates a group of experts to deal with the particular issue of counterfeit drugs.

DG SANCO (DG for health and consumers)
DG Sanco is the competent Directorate-General for the respect and the protection of public health.
It makes sure that a high level of human health protection be ensured in the definition of all Community policies. It is therefore directly concerned by the risks associated with counterfeit drugs.

DG ENTERPRISE
This DG is competent in the fields of European competitiveness, the free movement of goods and entrepreneurial health. In the healthcare industries sector, its mission is to develop and maintain a favourable environment for medicinal products, to contribute to the completion of the community’s single market and to foster the creation of an environment conducive to innovation.
The DG Enterprise is the tutor of the European Medicines Agency (EMA).*
* The European Medicines Agency (EMA)
“Created in 1937, attached to the DG Enterprise (and not to the DG Sanco, which did not exist at the time), the. EMA is the competent authority for medicines in Europe. The Medicines agency is responsible for coordinating the scientific resources of each of the Member States, in order to assess and monitor human and veterinary drugs. The Agency is responsible inter alia for the coordination of activities related to pharmacovigilance at European level, and the coordination of inspection activities in the medicine industry sector. »

DG MARKT (DG Internal Market and Services):
This DG’s mission is “to develop and maintain a dynamic and open European single market that enables citizens to meet the challenges of globalisation”. Its purpose is “to provide a regulatory environment that enhances competitiveness, stimulates innovation, and promotes financial stability.
In this context, the Internal Market and Services Directorate-general is directly responsible for proposing and – once laws are adopted by the European Parliament and Council – controlling the implementing of a European legal framework in the following specific areas: regulated professions, services, company law and corporate governance, public procurement, intellectual and industrial property and postal services.”
(Source: site of the European Commission http://ec.europa.eu/index_fr.htm)

The European Observatory on counterfeiting and piracy
To strengthen collaboration between consumers, Governments and businesses, the European Commission created, in April 2009, the European Observatory on counterfeiting and piracy, which serves as a platform facilitating joint actions, exchange of experience and information and the sharing of best practices regarding enforcement.
The Observatory also has the function is to centralize, evaluate and report crucial information to better understand the danger posed by counterfeiting and piracy.

Europol
Europol, the European Police Office, was created in 1992 to address the information relating to criminal activities in Europe. Its seat is in the Hague, in the Netherlands. Its staff includes representatives of the national law enforcement agencies (police, customs, immigration services, etc.) and its Board has one representative per Member State of the European Union.
The objective of Europol is to help the Member States of the European Union to cooperate more closely and more efficiently in the prevention of organized transnational crime.
Europol answers to the “Justice and Home Affairs” Council, i.e. to all of the Ministers of Justice and Home Affairs of the European Union.

Eurojust
Eurojust is a European Union body established in 2002 to encourage and improve the coordination of investigations and prosecutions between the competent authorities of the Member States of the Union responsible for dealing with cross-border organized crime.
Eurojust was established by Council decision of 28 February 2002 to strengthen the fight against serious forms of crime
Its objectives are to:
-encourage and improve coordination between national authorities in cases of investigations and prosecutions concerning two Member States or more.
-improve cooperation between the competent authorities, in particular by fostering mutual legal assistance and the implementation of European arrest warrants.

Eurojust is composed of 27 national members, one per Member State. Eurojust fulfils its tasks through its national members or as a college.
The regional international organizations and communities
International communities specific to certain regions of the world or to certain types of exchange contribute significantly to raising awareness of the danger posed by the falsification of drugs.
Vectors for the transmission of information as much as tools to federate national authorities, these communities naturally provide the means for information exchange and spaces for public awareness crucial to mobilization.

Examples of these regional organizations are:
• Association of the South East Asian Nations (ASEAN)
• The Asia-Europe Dialogue or Asia-Europe Meeting (ASEM))
• West African Economic and Monetary Union (WAEMU)
• The East Africa community (EAC)
• The Economic Community of the West African States (ECOWAS)
• The international organization of la Francophonie (OIF)
And many others ….

It is also important to mention the Jacques Chirac Foundation, in respect of its action against fake medicines. Thanks to the launch in 2009 of the Cotonou appeal against the trafficking of fake medicines (more than 50 signatories to date) and to its many initiatives, this foundation contributes actively to raising awareness among African peoples and to the fight against pharmaceutical crime. The Cotonou appeal corresponds to one of the four objectives of the Chirac Foundation, that of “promoting access to medicines and quality healthcare” This call aims to mobilize actors at the highest level to combat fake drugs.
http://www.fondationchirac.EU/programmes/acces-aux-medicaments/mobilisation-internationale-contre-trafic-faux-medicaments/

From awareness to action
The major milestones marking the commitments of the international community against the falsification of drugs.
1985: 1st international reference
During the Conference of experts in Nairobi on the rational use of drugs, the problem of counterfeit medicines is officially discussed for the first time at international level.
1988:1st programs of action.
The World Health Assembly adopts the resolution WHA41.16 which requests the Director General of the WHO to institute programs to prevent and detect the export, import and smuggling of pharmaceutical preparations that are falsely labelled, forged, counterfeit or non-compliant with standards.
1992: 1st definition
The first international meeting on counterfeit drugs results in the first official definition of a counterfeit drug.
1994: Support to States
The World Health Assembly adopts a new resolution (WHA41.13) which requests the Director-General of the WHO to support Member States in their efforts to ensure that the available drugs are of good quality and in their fight against the use of counterfeits.
2006: Rome Declaration and the creation of the IMPACT group.
The WHO organizes a major international conference during which the global community recognizes drug counterfeiting as a “vile and serious criminal offence which puts human lives at risk and undermines the credibility of health systems.”. This conference resulted also in the creation of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) group.
October 2009: the Cotonou Appeal.
In Benin, the former French President Jacques Chirac appeals to the international community to effectively mobilize against the trafficking of counterfeit medication. Since its launch, more than 50 rulers, heads of States or Governments around the world have signed this appeal and are engaged in the fight against the traffic of fake drugs.
October 2010: 13th Conference of the Heads of States and Governments of the countries sharing the French language
A resolution against fake medicines Signed by 40 Heads of State, political leaders and leaders of international organizations, is adopted at the 13th Summit of the Francophonie.
November 2010: Resolution of the 92nd session of the Council of Ministers ACP (Africa Caribbean Pacific)
This resolution concerns the struggle against the production and marketing of fake medication and encourages the development and strengthening of actions combating fake drugs.
November 2010: resolution of the Interpol General Assembly in Qatar (AG-2010-RES-06) to “Improve international cooperation and provide support to the General Secretariat of INTERPOL in the fight against counterfeit medical products and pharmaceutical crime” and to recommend ” that Interpol member countries consider the fight against counterfeit medical products and other pharmaceutical crime offences as a priority for the services in charge of the application of the Law”
December 2010: Medicrime Convention
The Council of Europe adopted the Medicrime convention, the first international dispositive in the field of criminal law that obliged the member States to criminalize:
•the manufacture of counterfeit medical products;
•the supply, the offer to supply and the traffic of counterfeit, medical products
•the falsification of documents;
•the manufacture or supply of non-authorized medical products and the placing on the market of medical devices not fulfilling compliance requirements.

This convention was officially opened for signature on October 26, 2011 in Moscow
During the official opening ceremony by the Ministry of Health of the Russian Federation, 12 States, Germany, Austria, Cyprus, Finland, France, Iceland, Switzerland, Italy, Israel, Portugal, Russia and Ukraine signed the MEDICRIME convention.
This Convention which will be signed in priority by European Union member countries and observers, is open to the signature of all the other countries of the world. The Chirac Foundation invites all of the signatories of the Cotonou appeal to sign the Médicrime Convention.

June 2011: new European directive 2011/62/EC of 8 June 2011 amending directive 2011/83/EC establishing a Community code relating to medicinal products for human use, aimed at preventing the introduction of falsified medicines in the legal supply chain.
A new 2011/62/EC, validated by the European Parliament, strengthens the dispositives to fight against fake drugs by securing distribution circuits, especially on the Internet. The 2011/62/EC directive includes the creation of a logo that will identify legal pharmacy internet sites, the creation of a system of traceability of products and stronger sanctions against traffickers.