Repression as a strategy to fight against counterfeit medicines

The success of such a globally coordinated operation is not an isolated one. In recent years, the intensification of targeted repression against organized crime networks and the growing success of police operations attest to a true efficiency of repression measures put in place around the world.

These operations rely on the marriage of expertise between the major agencies in charge of repression internationally (Interpol, OMD…) and on even broader cooperation between the national authorities of the countries concerned.

REPRESSION

Tracking and condemning fake drug traffickers.

The magnitude of global fake-drug trafficking today makes punishment a compelling need and priority. Successful implementation includes collecting evidence, identifying offenders, arresting them and bringing them to court, and dismantling organized criminal networks.
To be effective, there must be coordinated and simultaneous progress in various areas – the legal framework, investigational practices and the level of cooperation between police forces, customs services, departments of justice and health agencies.

In most countries, the manufacturing and marketing of fake drugs fall within the scope of criminal law.
However, legislations diverge with respect to the definition of drug counterfeiting and to the sanctions that should apply.
Specifically, fake drug trafficking-related crimes can be brought before the courts on various criminal accounts:
-violation of the protective laws of intellectual property.
-crime of deceit and falsification
-misleading or fallacious information and advertising
-violation of pharmaceutical rules regarding dispensation
-import and distribution of products without marketing authorization
-illegal practice of the pharmacist profession
-forgery and use of forgeries
-extortion
-laundering money obtained by false drug trafficking
-criminal association
-endangerment of the lives of others
-voluntary injury
-homicide

Moreover, whenever it is determined that false drug trafficking is carried out by an organized group, the dispositions taken in signed international conventions or treaties may apply.

  • The United Nations Convention of 15 November 2000, called the “Palermo Convention” on transnational organized crime defines an organized criminal group as ” a structured group of three or more persons, existing for a period of time and acting in concert with the aim of committing one or more serious crimes or offences (…) in order to obtain, directly or indirectly, a financial or other material benefits”. When translated into national law, these provisions are applicable only when the pending penalty is greater than or equal to 4 years of imprisonment.
  • The Council of Europe’s Convention on the counterfeiting of medical products and similar crimes involving threats to public health (the Medicrime Convention) is described by the Council of Europe as a convention “which constitutes, for the first time, a binding international instrument in the criminal law field”, criminalizing counterfeiting but also the manufacture and distribution of medical products on the market without authorization or in violation of safety standards. Signed by 12 States in Moscow on 28 October 2011, it will have to be translated into national law.

The will to punish, the means to sanction
Even though laws and regulations are necessary prerequisites, alone, they are not sufficient for a repression policy to become effective: the legal apparatus must be accompanied by political determination and the material and human means to enforce the laws.
In most countries around the world, the manufacturing and marketing of drugs are indeed subject to authorizations and rigorous regulation. But the magnitude of current international trafficking of fake medicines points to many loopholes in these instruments of regulation and control.
For example, the United States, which may have one of the most highly regulated pharmaceutical markets in the world, has seen its investigations concerning counterfeit drugs increase by 20% per year since the year 2000 (Source: FDA).
Legislation, organization, means: it is urgent to fill the gaps.
The following steps summarize the provisions recommended by the WHO (“Guidelines for the development of measures to combat counterfeit medicines “) IMPACT Group (“Principles and Elements for National Legislation against Counterfeit Medical Products “) and by numerous international experts.
The broad and efficient implementation of all of these measures relies on national and/or international political determination.
Wherever such commitments have been made unambiguously and followed by clear actions, fake drug trafficking has decreased.

In the fight against crime, countries are sovereign and the authorities responsible for law enforcement (police, customs and justice) are obliged to apply the laws of their country.

  • In France, since 2007, a law (2007-1544 of 29 Oct 2007) strengthens criminal penalties applied to counterfeiting offences whenever these affect peoples’ health and safety. The extent of sanctions has been increased from 3 to 5 years imprisonment, and from 300 000€ to 500 000€ when the acts have been committed by an organized band or when they relate to goods that are dangerous for human or animal health and safety.
  • The United States recommend in a “White Paper” dedicated to the improvement of intellectual property rights, published by the White House in March 2011, to increase the penalties related to drug trafficking and in particular drug counterfeiting offences.
  • China has passed legislation that is specific to industrial property infringement. Criminal proceedings may be opened when the value of the seized and/or sold products is greater than 100,000 RMB (11 000€) for natural persons, and 500,000 RMB (55 000€) for legal persons. Regarding the production or marketing of fake medicines, article 141 of the Chinese Penal code provides a penalty of 3 to 10 years’ imprisonment. In the hypothesis where fake drugs have resulted in death or in particularly serious harm to human health, the penalty may even include a death sentence.
  • “The problem of counterfeit medical products should be managed beyond health sectors, as it is an action requiring the involvement of all parties in the criminal justice system such as police, courts, customs and national regulatory agencies” Dr. Kustantinah, Chief of the Indonesian National Agency for medicines and food

As with all fraudulent activities perpetrated by large criminal organizations, trafficking in fake medicines knows no borders. Traffickers benefit from both defects in national legislations that allow their activities to take root locally and the many disparities between national legal frameworks and administrative weaknesses in transnational cooperation. However, since 1988 and the first discussion of counterfeit drugs at the World Health Assembly, major international treaties, partnership agreements and statements of intent signed between countries have, little by little, contributed to an international consensus on the subject.

  • In 1988, the World Health Assembly adopted resolution WHA41.16, requesting the Director-General of the WHO to institute programs to prevent and detect the export, import and smuggling, among others, of counterfeit drugs.
  • In 1994, a second resolution of the World Health Assembly, WHA47.13, strengthened the first. It requested the Director-General to support Member States in their efforts to ensure the good quality of available drugs and to fight against the use of counterfeits.

This progressive unanimity allows for broader, more effective international law enforcement.

Historically, all major threats to the security of goods and persons have lead to international consensus.

  • “one of the main objectives is to get countries to admit that counterfeiting is a crime against human safety, and to get them to introduce this principle into their laws. It is through legislation, regulation and prosecution that we must attack the sale of counterfeit medicine on the Internet”. Dr Howard Zucker, the WHO
  • “Obstacles to effective action include the lack of a clear worldwide consensus on what constitutes a counterfeit drug and the fact that activities that are illegal in one country may be legal in another,” Graham Jackson, International Journal of Clinical Practice.

“Pangea” operations coordinated by INTERPOL are international weeks of actions targeting the sale of counterfeit and illicit drugs on the internet. These annual actions bring together customs authorities, health agencies, national policies and private sector players from several countries in the world.

From 30 May to 7 June 2016, 103 countries worked together on the most recent operation, “Pangea IX”. The operation led to 393 arrests worldwide, thesuspension of 4,932 illegal websites and the seizure of over 12 million counterfeit and illicit medicines with an approximate value of $53 million.

Battles won in an ongoing war.
National customs and police services of countries around the world have carried out countless seizures during the last 10 years, and major operations for the suppression of the traffic of fake medicines continue to be regularly conducted with success.

Operations Storm 1 and 2: in South East Asia
Conducted respectively in 2008 and 2009, these operations focused on South East Asia, a geographical area identified as the first supplier of counterfeit drugs in the world.
Coordinated by Interpol and under the auspices of the Impact group and the WCO, Storm 1 targeted individuals and groups involved in the production and marketing via internet sites of particularly dangerous fake medicines. 8 countries contributed to the success of the operation: China, Cambodia, Indonesia, Laos, Singapore, Thailand, Viet Nam, and Burma.
Storm 2 has led to at least 33 arrests, as well as to the closure of more than 100 illegal pharmacies and points of sale. More than 12 million tablets of illicit drugs and medical products (tablets, vials, sachets) were seized, as well as 8 million tablets of other illicit drugs (obsolete, non-registered or diverted medical products).

Operations Mamba 1, 2 and 3: in East Africa
“The purpose of the Mamba operations is to disrupt the activities of transnational networks of organized criminals involved in the trafficking of counterfeit medical products in East Africa. They also allow us to raise awareness and educate populations.”
Conducted in 2008 by Impact and Interpol, operation Mamba 1 took place in Tanzania and Uganda in collaboration with local authorities. In the two countries, this operation targeted more than 250 points of sale (pharmacies, warehouses, markets).
During summer 2010, operation Mamba 3 brought together the customs services, police forces and drug regulation authorities of Burundi, Kenya, Rwanda, Tanzania, Uganda and Zanzibar. The operation also benefited from the support of the World Organization of Customs (WCO) and the expertise of the laboratories of the Singaporean health authorities (Heath Science Authority) for scientific analyses.
All these operations have allowed the seizure of several thousands of forged drugs belonging to a hundred types of pharmaceutical products (antimalarial, antifungal, hormonal …).

Operations Pangea 1, 2, 3 and 4: in developed countries.
Since 2008, Pangea Operations are dedicated to dismantling the hidden networks engaged in the online sale of fake medicines. They are carried out on several continents and target developed countries (Germany, Australia, Canada, United States, France, Ireland, Israel….).
Pangea II obtained the cooperation of the authorities of 24 countries, Plangea III, 45 countries and Pangea 4, 81 countries.
Also participating in the latest Pangea operations were Internet access providers, companies specialized in payment systems, and e-mail companies.
Reinforced by this growing support, Pangea operations are meeting with ever-growing success and the seizures, arrests and dismantled networks are more numerous each time.

Operation Cobra: in West Africa
This was a multi-country operation run in West Africa by Interpol with the aim to investigate, identify and dismantle the networks involved in drug crime: counterfeiting, illicit production, unauthorized sale of drugs.
Organized from September 26 to October 02, 2011, this action led to the seizure of 10 tons of illegal or falsified drugs and to the arrest of more than 100 people.

MEDI-FAKE: a European operation
Conducted end 2008, the operation “MEDI-FAKE” is the first coordinated EU action. It concentrated customs controls on the illegal and counterfeit drugs entering the European Union.
During two months and using a risk profile issued by the Commission, the customs administrations of the 27 Member States focused particularly on leading a coordinated action to intercept illegal drugs entering the European Union.
The intercepted goods included antibiotics, drugs against cancer, malaria and cholesterol, as well as painkillers, Viagra and drug precursors.
This first action produced excellent results, with more than 34 million illegal drugs seized.
It has also highlighted several ways to improve the fight against the trafficking of illegal, dangerous or counterfeit goods.