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1 October 2015AfricaAline Plançon

Interpol: clamping down on pharma crime

Pharmaceutical crime is a serious public health issue which puts lives at risk, causes harm to patients, and undermines confidence in the entire health system, affecting the reputation of manufacturers, wholesalers, pharmacists, doctors, private organisations and government institutions alike.

The term ‘pharmaceutical crime’ encompasses a wide range of criminal activities, including the falsification of medical products, their packaging and associated documentation; the manufacture, trade, transport and distribution of fake or illicit medicines and medical devices; the theft, fraud, diversion, smuggling, trafficking, and illegal trade of medical products and other crimes associated with such activities.

Transnational organised crime groups have become increasingly involved in pharmaceutical crime due to intensified international commerce, the rapid expansion of the internet, the widespread use of ‘free zones’ in international trade, and easier access to sophisticated printing and manufacturing technologies. As the world’s largest international police organisation with 190 member countries, Interpol is uniquely placed to lead the fight against pharmaceutical crime and support national law enforcement and partners in the health sector to identify and locate the perpetrators.

Police in Interpol’s member countries are reporting that criminals involved in pharmaceutical crime are operating through informal networks. Nevertheless, traditional organised crime groups across the globe are also involved in pharmaceutical crime throughout the entire supply chain, from manufacturing to trafficking and distribution.

A trend in many member countries is the increase of illicit online pharmacies, operated by both informal networks and organised criminal groups. Large amounts of money are involved in these transnational criminal enterprises: one illicit online pharmacy network, which was dismantled by US authorities in 2011, managed to accumulate $55 million during two years of operation. Other crimes, such as money laundering, prostitution networks and weapons smuggling, are often linked to the criminals involved in pharmaceutical crime.

Falsification affects all branded and generic medical products—medicines, pharmaceutical ingredients, medical devices and diagnostic equipment—and occurs in all regions of the world. The consequences of the use of falsified products can be extremely dangerous: deliberately mislabelled pharmaceuticals containing a toxic substance caused more than 400 deaths in Haiti, Panama and the US in 1996, 2006 and 2008. A collaborative study conducted by Interpol, the World Health Organization, the US Pharmacopeial Convention and other stakeholders has shown that approximately half of the samples of antimalarials collected in the Greater Mekong Subregion contained no or insufficient amounts of active substances.

It is difficult to accurately determine the exact scale of the problem as it is nearly impossible to obtain a precise estimate of the amount of falsified medical products on national markets. However, more than 2,000 incidents were detected in 2013, amounting to more than five cases per day. Even the smallest cases concerned at least one production batch, which amounts to thousands of tablets. The 2013 figure represents roughly a ten-fold increase in reported cases since 2000. While this rise undoubtedly reflects improved detection and reporting capacities, it also indicates that the problem is growing in numbers and importance.

Causes of crime

Many factors contribute to creating a political and regulatory environment in which pharmaceutical crime can thrive. Their relative importance varies considerably among countries. The following factors have been identified:

  • Governments’ unwillingness to recognise the existence or gravity of the problem;
  • Inadequate legal frameworks and insufficient sanctions;
  • Weak administrative measures not focused on fighting pharmaceutical crime;
  • Ineffective control on medical products manufacturing, exportation, importation and distribution; and
  • Insufficient international collaboration and exchange of information among health authorities, police, customs and legal systems; and between the public and private sectors.

A number of factors, which can vary from country to country, contribute to making pharmaceutical crime possible: inadequate access to reliable health services and pharmaceutical supply channels; illiteracy and poverty; insufficient social protection systems; national drug policies which prioritise the economic over public health aspects of medicine manufacturing and trade; fragmented distribution channels; extraterritorial trade zones; unregulated internet trade; and unregulated third-party manufacturing.

In many countries, national legislation is not designed to deal with pharmaceutical crime, and penalties are often too lenient to act as real deterrents. Stronger legislation clearly addressing pharmaceutical crime will help to make the action of police, customs, regulatory enforcement and the legal systems more effective. The Council of Europe’s Medicrime Convention is a step towards the creation of an international criminal law framework to specifically and primarily address the public health threats of pharmaceutical crime.

Experience has shown that this crime has a broad international scope. The criminals involved are not constrained by national borders and are able to exploit the opportunities they find in selective weaknesses of national systems, the openness of international trade, and ineffective communication and collaboration at the international, regional and national levels. It is therefore vital for countries to share information on pharmaceutical crime via Interpol to help identify the networks involved to prevent further criminal activity.

Counter efforts

Interpol has made a significant contribution towards global efforts to combat pharmaceutical crime. Through regional and global operations, targeted training, raising awareness and increased international cooperation, Interpol aims to support its member countries in dismantling the organised criminal networks perpetrating these crimes.

During the past ten years, Interpol has conducted a variety of activities and initiatives to combat pharmaceutical crime. Highlights include:

  • 19 operations—12 regional and seven global—which have produced the following combined results:

o  More than 1,550 suspects arrested;

o  More than 190 million units and 496 tonnes of illicit medicines seized;

o  More than 56,250 illicit online pharmacies shut down;

o  65 Interpol notices (law enforcement alerts on wanted persons, modus operandi, public safety threats, methods used by criminals and more) published; and

o  528 cases and 276 entities registered in Interpol’s databases.

  •  38 operational training courses and two ‘train-the-trainer’ sessions for police, customs and drug regulators.
  •  Four regional and two global conferences, providing international platforms for law enforcement officers worldwide to meet and discuss challenges and solutions on how to effectively combat pharmaceutical crime.
  • The Interpol general assembly has adopted two resolutions on combating pharmaceutical crime:

o  2010: Improving international cooperation and supporting the Interpol general secretariat in combating counterfeit medical products and pharmaceutical crime; and

o  2008: Improving international cooperation to combat counterfeit medical products.

  •  Interpol has signed memorandums of understanding with Singapore’s Health and Science Authority and the Institute of Research against Counterfeit Medicines.
  •  Member countries in Africa have adopted two declarations—the Zanzibar and Addis Ababa declarations—which outline the way forward for African countries to effectively combat pharmaceutical crime.

Recent operational results highlight how collaborative action between law enforcement, regulatory agencies and the private sector is the most effective way to disrupt the activities of criminal networks involved in pharmaceutical crime.

Operation Pangea VIII

Operation Pangea is an annual Interpol initiative targeting the global online sale of illicit medicines. Participants from law enforcement, customs, health regulatory authorities and payment systems target the criminal networks behind the sale of fake medicines via illicit online pharmacies.

“Stronger legislation clearly addressing pharmaceutical crime will help to make the action of police, customs, regulatory enforcement and the legal systems more effective.”

In 2015, Operation Pangea VIII involved the participation of 115 Interpol member countries and 236 agencies from law enforcement, customs and health regulatory communities. During the operation, more than 171,304 packages were inspected, 50,852 of which were seized when found to contain counterfeit or illicit medicines. These inspections and related investigations resulted in the seizure of more than 23.5 million units of counterfeit and illicit medicines, with an estimated value of $75,322,485. This was more than double the amount of seizures during the previous year’s operation.

Online investigations revealed 8,814 websites engaged in illegal activity, and 2,700 were shut down. In addition, 53 merchant accounts were terminated by payment providers, and 546 online advertisements offering medicines were taken offline. Investigations led to 296 individuals being arrested or investigated for a range of offences including importing, selling and supplying unlicensed or prescription-only medicines; operating fraudulent websites; and manufacturing, distributing or selling counterfeit medication.

Operation Pangea VIII also continued to highlight the importance of raising public awareness of the dangers associated with buying medicines online or at unlicensed pharmacies.

Operation Giboia II

To address the growing threat of pharmaceutical crime in Africa, Interpol has conducted its second operation targeting the region. Operation Giboia II took place in August across seven countries in southern Africa: Angola, Malawi, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe. The actions resulted in the seizure of approximately 944,000 units of illicit medicines, with an estimated value of approximately $2.9 million. In addition, 551 suspects were arrested or investigated, some 38 investigations were launched and 20 illegal outlets closed down. The medicines seized were mainly antibiotics, antimalarials, analgesics, erectile dysfunction medication, steroids and antiretrovirals. The vast majority were unregistered, expired and suspected to be counterfeit.

Although health enforcement actions in multiple sectors such as the Interpol operations detailed above have been effective, there is still the need to continue to work on several enforcement areas:

  •  Continuing targeted enforcement operations aimed at disrupting criminal activities, seizing illegal products, prosecuting offenders and collecting information for further criminal analysis;
  • Researching the methods used by organised criminal networks involved in transnational pharmaceutical crime to better understand how they operate;
  • Strengthening cross-border cooperation among enforcement authorities through exchanging information, joint investigations and operations, and the expansion of the ‘single point of contact’ approach;
  • Training enforcement and drug regulatory officials on all aspects of pharmaceutical crime; and
  • Advocating the establishment of dedicated national teams specialised in pharmaceutical crime investigation.

In order for these activities to have a lasting effect on pharmaceutical crime, it is essential to have strong mechanisms for exchanging information and collaboration between law enforcement and the public and private sectors. With its global reach, Interpol will continue to lead the way forward in connecting police and health authorities in all countries and regions of the world to present a united front against pharmaceutical crime.

Aline Plançon is head of  Interpol’s medical product counterfeiting and pharmaceutical crime unit. For more information about Interpol’s work in the area of pharma crime, please visit  http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Pharmaceutical-crime