Abstract
This research offers a critical review of the relevance and influence of the liberalization of EU law concerning the online sale of pharmaceuticals in the context of transnational criminal law.
The Internet has enabled and accelerated the distribution of a class of drugs called substandard, spurious, falsely labeled, falsified, and counterfeit medicines (SSFFC) through online sales. This situation exposes many unsuspecting individuals to enormous public health risks. Both individuals and widespread criminal networks are involved. Both the buyers and the purveyors of illicit medications and pharmaceutical ingredients contribute to this problem. The liberalization of pharmaceutical sales in the digital marketplace has contributed to the growth of pharmaceutical crime and provided expedients through which criminal groups have circumvented liability.
Several steps would help mitigate these risks at national, regional, and international levels. These include improving control and verification mechanisms for the manufacture of pharmaceuticals and raw pharmaceutical materials supplied in the EU, toughening the penalties for criminal distribution of SSFFCs, and educating the population at large about their dangers.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Abma, J. (2016). Bitter biopharmaceuticals: Biologic counterfeiting and supply chain concerns. San Diego International Law Journal, 18, 161–197.
Acri, K. (2018). They cost us billions and they can kill: Counterfeit drugs are invading Canada. Special to Financial Post.
Alarcón-Jiménez, O. (2015). The MEDICRIME convention—fighting against counterfeit medicine. Eurohealth International, 21(4), 24–27.
Attaran, A. (2015). Stopping murder by medicine: Introducing the model law on medicine crime. American Journal of Tropical Medicine and Hygiene, 92(Suppl 6), 127–132.
Attaran, A., Bate, R., & Kendall, M. (2011). Why and how to make an international crime of medicine counterfeiting. Journal of International Criminal Justice, 9(2), 1–30.
Balfour, H. (2021). Chinese police seize over 3,000 fake COVID-19 vaccines. European Pharmaceutical Review.
Bate, R. (2012). The deadly world of fake medicine. Special to CNN.
Berkot, B. (2012). Fake Avastin shows little protection of drug supply. Healthcare & Pharma.
Blackstone, E. A., Fuhr, J. P., & Pociask, S. (2014). The health and economic effects of counterfeit drugs. American Health & Drug Benefits, 7(4), 216–224.
Breman, J. G. (2019). It’s time to stop murder by counterfeit medicine. Stat.
Buckley, G. J., Gostin, L. O., & Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products, Board on Global Health & Institute of Medicine (Eds.). (2013). Counterfeiting the problem of falsified and substandard drugs (p. 1 & 313). National Academies Press (US).
Case C-322/01. (2003). Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval. ECLI:EU:C:2003:664.
Case C-171/07. (2009). Apothekerkammer des Saarlandes and Others v Saarland and DocMorris NV. ECLI:EU:C:2009:316.
Case C-369/88. (1991). Delattre. ECLI:EU:C:1991:137.
Cannon, D. T. (2015). War through pharmaceuticals: How terrorist organizations are turning to counterfeit medicine to fund their illicit activity. Case Western Reserve Journal of International Law, 47(1), 343–375.
Cockburn, R., Newton, P., Agyarko, E. K., Akunyili, D., & White, N. J. (2005). The global threat of counterfeit drugs: Why industry and governments must communicate the dangers. PLoS Medicine, 2(4), e100, 0302–e100, 0308.
Council Framework Decision (2002/584/JHA). European arrest warrant and the surrender procedures between Member States. OJ, L 190/1, 18.7.2002.
Dahl, J., Kubic, T. T., & Shepherd, M. (2015). International effort to protect patients from unsafe pharmaceuticals. European Industrial Pharmacy, 24, 4–7.
Dégardin, K., Guilleman, A., Guerreiro, N. V., & Roggo, Y. (2016). Near infrared spectroscopy for counterfeit detection using a large database of pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis, 128, 89–97.
Di Giorgio, D. (2015). Operation volcano—the herceptin case. AIFA—Agenzia Italiana del Farmaco, 3–51.
Directive 2011/62/EU of 8 June 2011 on the prevention of the entry into the legal supply chain of falsified medicinal products amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. (2011). OJ L 174/74.
EMVO. European Medicines Verification Organisation. (2023). Retrieved from https://emvo-medicines.eu/evi/. Accessed 22.03.2023.
European Alliance for Access to Safe Medicines. (2008). The counterfeiting superhighway. Medicom Group Ltd., 1–31.
European Union: European Commission. (2018). Report from the Commission to the European Parliament and the Council on the Member States’ transposition of Article 118a of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, Brussels, 26.1.2018, COM(2018) 49 final (pp. 1–9).
EUROPOL. (2020). Vaccine-related crime during the COVID-19 pandemic (pp. 1–2). Europol Public Information.
Fichera, M. (2013). Criminal law beyond the state: The European model. European Law Journal, 19(2), 174–200.
George, C. (2006). Internet pharmacies: Global threat requires a global approach to regulation. Hertfordshire Law Journal, 4(1), 12–25.
Hall, A., Koenraadt, R., & Antonopoulos, G. A. (2017). Illicit pharmaceutical networks in Europe: Organising the illicit medicine market in the United Kingdom and The Netherlands. Trends in Organized Crime, 20, 296–315.
Hamulák, O. (2018). La carta de los derechos fundamentales de la union europea y los derechos sociales. Estudios constitucionales, 16(1), 167–186.
Harris, J., Stevens, P., & Morris, J. (2009). Keeping it real. Combating the spread of fake in poor countries. International Policy Network, 1–28.
Hock, S. C., Lee, M. M. X., & Chan, L. W. (2019). Regulating online pharmacies & medicinal product E-commerce. Pharmaceutical Engineering.
INTERPOL. (2014). Pharmaceutical Crime and Organized Criminal Groups. An analysis of the involvement of organized criminal groups in pharmaceutical crime since 2008. INTERPOL, pharmaceutical crime sub-directorate (pp. 1–21).
Ivic, S., & Troitiño, D. R. (2022). Digital sovereignty and identity in the European union: A challenge for building Europe. European Studies, 9(2), 80–109. https://doi.org/10.2478/eustu-2022-0015.
Jing, M. (2016). China FDA stops online med sales. China Daily USA.
Kubic, T. T. (2008). Pharmaceutical counterfeiting: Understanding the extent of a new transnational crime. The Police Chief, 75(8), 38–43.
Lavorgna, A. (2015). The online trade in counterfeit pharmaceuticals: New criminal opportunities, trends and challenges. European Journal of Criminology, 12(2), 226–241.
Lechleiter, J. (2012). Ways to more affordable medicines: Introduction. Forbes.
LegitScript. (2016). The internet pharmacy market in 2016. Trends, challenges, and opportunities. The Center for Safe Internet Pharmacies.
Liang, B. A. (2007). A dose of reality: Promoting access to pharmaceuticals. Wake Forest Intellectual Property Law Journal, 8(3), 301–386.
Mackey, T. K., Liang, B. A., York, P., & Kubic, T. (2015). Counterfeit drug penetration into global legitimate medicine supply chains: A global assessment. American Journal of Tropical Medicine and Hygiene, 92(Suppl 6), 59–67.
Magdun, M. (2021). Trademark enforcement of counterfeit drugs: A Guardian of the rich and poor alike. Indiana Journal of Law and Social Equality, 9(2), 281–303.
Miettinen, S. (2013). Criminal law and policy in the European Union, (p. 304). Routledge Research in EU Law, Taylor & Francis Group.
Negri, S. (2016). The Medicrime convention: Combating pharmaceutical crimes through European criminal law and beyond. New Journal of European Criminal Law, 7(3), 350–367.
OECD/EUIPO. (2020). Trade in counterfeit pharmaceutical products. (pp. 1–93). Illicit Trade, OECD Publishing, Paris.
Orton, T., Omar, Z., Subramanian, P., & Adeli, N. (2019). Counterfeit drugs in the pharmaceutical industry. American University.
Power, M. (2013). Online highs are old as the net: The first e-commerce was a drugs deal. The Guardian.
Ramiro Troitiño, D., Martín de la Guardia, R., & Pérez Sánchez, G.A. (2022) The European Union and its political leaders understanding the integration process the essence of Europe: Understanding Europe through its designers. (pp 1–4). Springer International Publishing Cham.
Regulation (EC) No 726/2004 of 31 March 2004. (2004). Laying down community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. OJ L136/1.
Seelke, C. R., Wyler, L. S., Beittel, J. S., & Sullivan, M. P. (2011). Latin America and the Caribbean: Illicit drug trafficking and U.S. counterdrug programs. Congressional Research Service, 1–41.
Terry, N. P. (2017). Regulatory disruption and arbitrage in healthcare data protection. Yale Journal of Health Policy, Law, and Ethics, 17(1), 143–208.
TFEU. Consolidated Version of the Treaty on the Functioning of the European Union. (2012). OJ C321/1.
TRACIT. (2022). Illicit trade in pharmaceuticals, Transnational Alliance to Combat Illicit Trade.
Treadwell, J. (2012). From the car boot to booting it up? eBay, online counterfeit crime and the transformation of the criminal marketplace. Criminology & Criminal Justice, 12(2), 175–191.
Trenfield, S. J., Tan, H. X., Awad, A., Buanz, A., Gaisford, S., Basit, A. W., & Goyanes, A. (2019). Track-and-trace: Novel anti-counterfeit measures for 3D printed personalized drug products using smart material inks. International Journal of Pharmaceutics, 567, 1–7.
Turudić, I. (2018). Case law on the European arrest warrant. EU and Comparative Law Issues and Challenges Series, 2(2), 511–529.
United Nations. (2002). Convention against transnational organized crime. Office on Drugs and Crime.
Vander Beken, T., & Balcaen, A. (2007). Crime opportunities provided by legislation in market sectors: Mobile phones, waste disposal, banking, pharmaceuticals. European Journal on Criminal Policy and Research, 12, 299–323.
van Duyne, P. C., von Lampe, K., van Dijck, M., & Newell, J. (2005). The organised crime economy: Managing crime markets in Europe. (pp. 1–298). Wolf Legal Publishers.
Wechsler, J. (2012). Campaign mounts to curb counterfeit drugs. BioPharm International, 25(9), 40–45.
WHO. (2022). Norms and standards for pharmaceuticals. Health product and policy standards.
WHO. (2018). Substandard and falsified medical products. Fact Sheets.
WHO. (2011). Safety and security on the Internet: Challenges and advances in member states: Based on the findings of the second global survey on eHealth. Global Observatory for eHealth Series, 4, 1–92.
Wilson, B. K., Kaur, H., Allan, E. L., Lozama, A., & Bell, D. (2017). A new handheld device for the detection of falsified medicines: Demonstration on falsified artemisinin-based therapies from the field. American Journal of Tropical Medicine and Hygiene, 96(5), 1117–1123.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2023 The Author(s), under exclusive license to Springer Nature Switzerland AG
About this chapter
Cite this chapter
Sogomonjan, M., Forcht Dagi, T. (2023). Online Sale of Pharmaceuticals: Liberalization of EU Law in the Context of Transnational Criminal Law. In: Ramiro Troitiño, D., Kerikmäe, T., Hamuľák, O. (eds) Digital Development of the European Union. Springer, Cham. https://doi.org/10.1007/978-3-031-27312-4_4
Download citation
DOI: https://doi.org/10.1007/978-3-031-27312-4_4
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-031-27311-7
Online ISBN: 978-3-031-27312-4
eBook Packages: Political Science and International StudiesPolitical Science and International Studies (R0)