Actuality of the implementation of international practice in proliferation of counterfeit medicines involving Interpol ‎

Serhii Lebed¹, Alla Nemchenko²*, Viktoria Nazarkina³

National University of Pharmacy, Department of Organization & Economics of Pharmacy, Kharkiv, Ukraine

Correspondence: Alla Nemchenko, Department of Organization & Economics of Pharmacy, National University of Pharmacy, Kharkiv, Ukraine, 4, Valentinivska Street, 61121, Ukraine. Phone: +380-067-110-15-04. E-mail: asnemchenko @ ukr.net.

Introduction  

The problem of trafficking in counterfeit medicines (CM) has ancient historical roots, however, it is still relevant today. Many international and national legislative and normative legal acts have been targeted to prevent the spread of substandard / fake / falsely marked / falsification / counterfeit pharmaceuticals. Despite the active counteraction of the CM trafficking by international organizations and national authorities, cases of their appearance on the pharmaceutical market are constantly recorded. Unfortunately, it is impossible to estimate the volume of the counterfeit drugs market due to the lack of reliable statistics.

Certainly, the scope of manifestation of these phenomena varies significantly from country to country, but the most vulnerable to counterfeit medicines are countries with low and average prosperity, areas of conflict or civil unrest, poorly developed health care systems, low level of work of the regulatory authorities, imperfect legal system or ineffective criminal justice system, high levels of corruption, irrational public access to drugs ^{[1, 2]}. According to the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP), trafficking in counterfeit medicines accounts for about 10% of the world drug market. In developing regions, the proportion of counterfeits can be as high as 70% in total drug trafficking, and in economically advanced countries, up to 1% ^{[3, 4]}. According to unofficial data, about 50% of drugs for sale on the Internet are counterfeit, about 95% of the 50,000 online pharmacies do not meet the laws and standards ^[5].

So, eventually, falsifications become more sophisticated, the risk that CM gives to patients increases. CM is a serious threat to global health and requires a comprehensive strategy at the European and international levels ^[6].

In Ukraine CM circulation issues of particular relevance, although it is a country with a strict regulatory system, created a quality assurance system for drugs, the regulatory framework is harmonized with the world and European standards ^[8].

Particular issues of counteracting crimes in the field of production and trafficking of CM in the United States, the EU and Ukraine have been studied by scientists such as H. Sammons, I. Choonara, T. Mackey, B. Liang, P. York, T. Kubic, G. Nayyar, J.Breman, J. Clark, M. Hajjou, M. Littrell, J.Herrington, P. Tinti, A. Vevera, O. Solovyov, V. Pashkov, I.A. Kovalenko, et al. However, unfortunately, comprehensive studies of this problem have not been conducted.

The purpose of the article is to analyze the international practice of counteracting and fighting against the proliferation of CM with the involvement of Interpol at the global and national levels.

Materials and Methods

The materials used in this work are the official websites of the authorized bodies on quality assurance of medicines and counteraction of the CM circulation, regulatory documents and scientific publications on the subject. The study was conducted using the methods of logical, historical, semantic, retrospective method, as well as systematic analysis.

Results and Discussion

For the first time at the international level, the problem of counterfeiting of drugs, its scope, and possible consequences were discussed at conferences of experts on the rational use of drugs (Nairobi, 1985). Following the recommendations of the WHO Conference, an information center was set up to inform Member States' governments about the nature and extent of the spread of CM. Subsequently, the World Health Assembly repeatedly adopted Resolutions (WHA41.16 1988; WHA52.19, 1991; WHA47.13 1994), which recognized the danger of CM and were given orders to prevent their circulation. In 1992 and 1997 International Symposiums on Falsification of Medicines was held under the auspices of WHO and IFPMA - The International Federation of Pharmaceutical Manufacturers' Associations, recommendations on the detection of CM in the market were formed. Realizing the magnitude of the problem of falsification of medicines in the world, in 1995, WHO developed a program to assist national health systems in combating substandard and counterfeit products: a global network (110 countries), a worldwide CM database and a methodology for detecting substandard drugs were established ^[7]. The growth of international trade in medicines and their online sales have contributed to the massive infiltration of counterfeit products on the market. The scale of the problem of counterfeiting medicines has forced the world community to become more active around it, which has led to the adoption of international legal documents on the production and circulation of counterfeit pharmaceuticals, as well as the implementation of individual programs and projects (Table 1).

According to the WHO Guidelines for Combating Counterfeiting Drugs in 1999, almost every country has established a national system of quality assurance of drugs given situation existing infrastructure, human and other resources. The processes of globalization and internationalization of the pharmaceutical market require the development of adequate mechanisms to counteract the circulation of counterfeit and substandard drugs. At the global level, the general situation analysis functions, informing and development of the general recommendations on counterfeiting of drugs is carried out by WHO, a specialized agency of the United Nations (UN) and the International Pharmaceutical Federation (FIP). The activities of the following organizations are aimed at harmonizing the quality requirements of drugs, approximation of the standards of different countries and mutual recognition: International Convention on the Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use (ICH), International Organization for Standardization (ISO), The International Pharmaceutical Inspection Cooperation Scheme (PIC/S), (Table 2). The experience and standards of their work are based on the functioning of effective systems of national inspection and testing of drugs, the exchange of information and mutual recognition of inspections based on common standards, joint learning and close cooperation ^[8]. The WHO documents, regulations and standards of the EU, the PIC/S documents, have developed and reflected mechanisms and rules, compliance with which guarantees the effectiveness of the supply and certifies the quality of the drugs.

To coordinate the efforts of national, regional and international authorized bodies on counterfeiting of drugs on the initiative of WHO, FIP, the Council of Europe, working groups on substandard, counterfeit, incorrectly labeled, falsified, counterfeit medical products have been repeatedly created. The most effective project is the International Medical Products Anti-Counterfeiting Taskforce – IMPACT, which includes representatives from more than 80 countries, as well as international, regional intergovernmental and non-governmental organizations: in particular, WHO, UN specialized agencies, the Council of Europe, Organizations of economic cooperation and development, World Customs Organization, Interpol, FIP, International Federation of Wholesale Organizations in the field of pharmaceutical products; The International Union of Patient Protection Organizations and other international organizations. According to the results of the joint work, in December 2007 the "Principles and bases of national legislation on counterfeiting drugs" were approved. The work of IMPACT found its continuation in the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (Medicrime Convention) ^[9], which was signed in December 2010 and entered into force in Ukraine in January 2016. The introduction of criminal liability for crimes related to the counterfeiting of drugs in the vast majority of countries of the world indicates an awareness of their special danger. In particular, the responsibility for the production and distribution of CM in especially large sizes in the United States ranges from 20 years in prison to life imprisonment. In the post-soviet countries provide 10 years in prison, while in China - up to the death penalty ^[10]. In other countries (Japan, Israel, Republic of Korea) legislation does not contain rules on criminal liability for the falsification of medicines. The national legislation of EU countries is very different in terms of punishment for CM. Laws of Austria, Slovenia, and Slovakia threaten imprisonment for up to 15 years with persons who manufacture or sell counterfeit drugs that cause serious harm to human health. Estonia has three years' imprisonment for such crimes, in Sweden, Finland, and Greece - one year. In addition to imprisonment, the possible imposition of a fine of 4,300 euros in Lithuania and up to 1 million euros in Spain, and is not limited by the number of fines in the UK. Overall, in the 21 EU Member States production, distribution, import, export and online sale of counterfeit medicines are grounds for criminal prosecution ^[11].

The main measure aimed at preventing the spread of СМ following the Council of Europe Medicrime Convention, identifying and confirming the criminalization of certain actions. Effectiveness in terms of identifying criminals, termination of illegal sites selling counterfeit drugs and medical products are operations of Interpol that have been conducted for over 10 years both in pharmacies and other points of sale, including through the Internet suppliers. The analytical report of Interpol, published in 2014, states that counterfeiters operate within cross-border networks, using components from different sources and major world trade routes for the import, export, production, distribution and marketing of counterfeit medicines ^[12].

Interpol is a leading international organization that thanks to its unique structure, legal framework, and technical equipment, carries out effective and rational coordination of international police cooperation. Interpol has concluded cooperation agreements with more than 35 international organizations, including Europol, Southeast European Cooperative Initiative Regional Center for Combating Trans-border Crime (SECI), UNESCO, the Council of Europe, etc. The purpose of the International Criminal Police Organization (ICPO) - Interpol is to provide the widest cooperation among concerned agencies of criminal police within the national law of the member states of Interpol.

Today, the organization includes 194 countries, which gives reason to consider Interpol as one of the largest international organizations - the global institute of cooperation of police departments of the countries of the world. The adoption of Ukraine to the ICPO - Interpol was held on 11/04/1992. In March 1993, the National Central Bureau (NCB) of Interpol in Ukraine was established. The main areas of cooperation of the Interpol NCB in Ukraine with the General Secretariat are, among other things, cooperation in the framework of Interpol projects.

Flagship operations of Interpol to prevent the spread of counterfeit drugs are Storm (events are held in Southeast Asia), Mamba (in East Africa) and Pangea (Internet crime-focused activities). Consecutive raids on the legal and illegal pharmaceutical markets have shown the best results in terms of seizure falsified and counterfeit products, the arrest of criminals and the closing of illegal websites (Table 3).

Separate consideration should be given to Interpol’s operation «Pangea» to fight the online sale of falsified and counterfeit drugs, which is held annually. Coordinated by Interpol, these operations bring together customs, regulatory agencies, health care, national police, and private sector organizations from around the world. Activities focused on three main components used by illegal websites to conduct their trade - the Internet Service Providers (ISP), payment systems and delivery services. The operation has gained significant momentum since its launch in 2008. The first stage of the operation united 10 countries. Currently, the number of countries participating has grown to more than 100 ^[15].

In 2018 Interpol has conducted an operation «Pangea XI», which covered 116 countries. Measures within the operation made it possible to remove 500 tons of counterfeit medicines sold through the Internet. These include drugs to treat cancer, painkillers, etc. During the operation, 859 arrests were made and counterfeit medicines worth $ 14 million were seized, 3,671 online resources were closed, including sites, social media pages, and online stores ^[16].

Overall, the measures implemented by Interpol for 11 years (2008-2018 years.) allowed to involve in the fight against the spread of counterfeit medicines in 123 countries, close more than 67590 illegal drug trafficking websites, arrest more than 4,000 people, remove counterfeit medicines worth more than $ 325 mln. USD. Ukraine has cooperated with the General Secretariat of Interpol within several projects, in particular, Sidrag, a project to collect information on the distribution of synthetic drugs ^[16].

Europol is an EU law enforcement agency providing analytical, technical and financial support to partner countries in the prevention and fight against serious international offenses and terrorism. Europol has some differences from other regional international law enforcement organizations. In particular, the organization provides not only the cooperation of the police of the participating States, as well as the state border protection agencies, financial, immigration, tax, customs, intelligence, and other agencies authorized to conduct investigative operations or criminal investigations. In addition to organizing international cooperation between participating countries, Europol cooperates with countries outside the EU, based on "operating agreement" (concluded with the United States, Iceland); "Strategic agreements" (concluded with Colombia, Russia, and Turkey). The EU has recognized the need for the simultaneous protection of consumers and the protection of intellectual property. In March 2013, the mandate of the Europol Coordination Center "COPY" (Anti-Counterfeiting and Copyright Infringement) to investigate cases involving counterfeiting of products has been expanded, and now the Coordination Center is authorized to investigate cases involving substandard and dangerous goods. In the report of Europol in 2013, the priority direction of activity on fighting crime is to combat crimes related to counterfeit products that violate health, safety and food quality legislation ^[17].

At the end of 2016, Ukraine signed an agreement with Europol on operational and strategic cooperation aimed to expand the format of cooperation with Europol and exchange strategic and technical information, to use the opportunities of Interpol, to participate in joint activities to investigate a wide range of offenses, to exchange operative and personal data ^[18]. As part of this cooperation, Ukraine was first associated with the Europol coordinated Operation Viribus to end the trafficking of doping substances and counterfeit drugs in 2019. The operation, conducted by Italian «NAS Carabinieri» and led by the finance department of the Greek police, was the largest event of its kind. One of the main goals of the operation was the closure of clandestine laboratories, 9 laboratories were found in Europe; thus seized almost 24 tons of powdered steroids. Similar laboratories located in unsuitable premises (often garages) usually managed by organized criminal groups, who sell doping substances online or at local sports centers, illegal street shops, and local markets. As a result of the operation, 3.8 million illegal doping substances and counterfeit drugs (including substances, drugs, dietary sports, and nutritional supplements) were seized; 17 organized groups were neutralized; 9 illegal laboratories were closed; 234 suspects were arrested; 839 court cases were opened; about a thousand people reported a suspicion of manufacture, sale or use of doping substances ^[19].

Fighting against CM requires the cooperation of all pharmaceutical market operators, as well as regulatory and law enforcement bodies at national, regional and international levels. In this context, the important role played by all existing mechanisms, such as cooperation in the WTO, Europol, MEDICRIME, and especially – operations within Interpol. According to Article 18 of the MEDICRIME Convention training of all bodies` staff, involved in anti-counterfeiting of medicinal products and similar crimes and conducting awareness campaigns among the population is provided. Interpol’s operation Pangea provides similar campaigns to raise consumer awareness of the problem.

In 2012, Ukraine has ratified the Council of Europe Convention "On the counterfeit medical products and similar crimes that threaten public health» MEDICRIME. Paragraph 2 of Article 21 of the Convention commits the parties to "the widest possible cooperation for the implementation of relevant international, regional and bilateral agreements on extradition and mutual legal assistance in criminal matters concerning crimes recognized as such under this Convention". This measure can be used as a legal basis for the activities already undertaken by states together with other organizations - Interpol, Europol, WHO, etc. Also, this provision creates the conditions for the harmonization of existing agreements and conventions on the extradition of criminals if interstate crimes and the harm caused by them occur within the territory of one country if interstate crimes and the harm caused by them occur within the territory of one country, but the ratification of the Convention was not attributed to unlawful activity in the offender's country of origin ^[12].  Some CIS countries, including the Russian Federation, in contrast to Ukraine, already have a long-standing experience of participating in Interpol's operations to prevent the spread of counterfeit medicines (Table 4).

* on the example of individual operations of "Pangea" in the Russian Federation

The examples below demonstrate the importance of adopting the MEDICRIME international convention, which ensures national and international cooperation between different government sectors, and especially cooperation in the context of Interpol Special Operations.

Conclusion

The effectiveness of providing medical and pharmaceutical care is largely determined by the quality of drugs. However, in recent times, there has been an extremely unfavorable situation in various countries in the provision of quality drugs to the population. The trend of increasing offenses in the world in this area in recent years indicates the need for close attention by the state. At the same time, the problem of preventing the spread of counterfeit medicines is a global problem that requires coordinated international cooperation to ensure the effective implementation of various international programs and projects. The institutional component of the counterfeit drug mechanism is the system of international organizations active in the field of health care, crime prevention, and other counterfeit drug activities. Ukraine, as a member of these organizations, can and should use all opportunities in this area. Organizational support, as a necessary component of this mechanism, is the direct activity of these international organizations in such major areas as the prevention of counterfeiting of pharmaceutical products, the detection of counterfeit drugs and the response to such criminal acts. However, Ukraine is not an active member of Interpol operations, which have shown to be effective in different countries, particularly operations «Pangea». To increase the effectiveness of the fight against the production and distribution of counterfeit medicines and medical products, the regulatory and law enforcement agencies of Ukraine should be more actively involved in the operations of Interpol.

Counterfeiting of medicines is a global problem, which requires effective and enhanced international coordination and cooperation to ensure more effective strategies to combat counterfeiting, including the sale of such products online. For this purpose, EU Member States should cooperate closely and support ongoing work on this subject in international fora, such as the Council of Europe, Europol, and the UN. Ukraine, working with the EU Member States, should also cooperate with authorized bodies of other countries to effectively combat international trafficking counterfeit medicines globally.

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