COUNTERFEIT PHARMACEUTICAL PRODUCTS

Pharmaceutical goods infringing IP rights are a substantial threat to the EU and affect most, if not all, Member States. The trade in counterfeit pharmaceutical products in the EU has been increasing over recent years. The number of counterfeit medicines and other goods seized by EU customs authorities reached 1 172 076 units in 2019, entering the top 10 list of seized products by number of articles. The trend was confirmed in 2020, with medicines appearing as the seventh most-seized products at the EU’s external border. Nevertheless, the number of customs procedures increased between 2019 and 2020, from 192 to 600 . China. India and Singapore were the countries of origin most commonly detected in 2019, while in 2020 Singapore and India were replaced by Turkey and, to a lesser extent, Vietnam. Iran, Switzerland and the United States are identified as transit points for fake pharmaceuticals shipped to the EU . Criminals rely primarily on post and parcel services to ship counterfeit pharmaceutical products, which are mainly traded online. Weak links in global supply chains are exploited by counterfeiters of pharmaceuticals. This is particularly so when imports involve different countries, importers, retailers and distributors. Free trade zones are also misused in the trade in counterfeit products (including pharmaceuticals) due to their lighter regulations and limited customs control . In some cases, the production of illicit pharmaceutical products takes place in illegal laboratories based in the EU, which are difficult to detect. Clandestine laboratories can be set up with relatively few resources. Furthermore, experience with chemical production is not always needed to produce counterfeit medicines. In most cases, criminal networks operate these labs and supply multiple distributors. Some individual criminals run small-scale labs on their own . Diversion of legal supplies and theft of pharmaceuticals have also been observed in the EU. Illegal diversion occurs when a genuine pharmaceutical is approved and intended for sale in one country, but is illegally intercepted and sold in another country, often with the use of false statements, declarations  and prescriptions. Some thefts are facilitated by insiders, such as employees, doctors and pharmacists . In other cases, professional thieves specifically target locations for the theft of medicines. Thefts occur anywhere along the supply chain: at the site of manufacture, during transit, in distribution centres, warehouses, pharmacies, or hospitals . The distribution of counterfeit pharmaceutical products has shifted from physical to online markets, relying on dedicated platforms, such as online pharmacies, as well as some of the most widely used social media platforms. Most trading activity is believed to take place on the surface web. Some pharmaceutical products are also distributed via dark web platforms . The dark web allows for anonymous transactions between manufacturers, distributors and consumers. Online pharmacies selling counterfeit medication online typically pose as legitimate vendors . The number of unauthorized and unregulated online pharmacies selling counterfeit pharmaceutical products is continuously growing. Counterfeit pharmaceuticals are widely advertised and offered for sale on social media platforms. These online sales typically involve prepaid credit card and cryptocurrency payments . Online trade offers criminal networks some operational security, including encrypted email traffic and instant messaging applications . Criminal groups active in pharma crime counterfeit an increasingly wide range of medicines for the treatment of various health issues. Law enforcement authorities have seized fake anti-cancer drugs , analgesics, antioestrogens, antivirals, antihistamines , anxiolytics and psychiatric drugs , erectile dysfunction medicines , anabolic substances , metabolic regulators, and self-testing kits for HIV  and other infections The COVID-19 pandemic has presented new opportunities for criminals attempting to capitalize on the high demand for certain goods and the insecurity felt in the wake of the virus’ spread. The distribution of counterfeit and substandard goods, including pharmaceutical products, has been one of the key criminal activities during the pandemic . The illicit sale of medical and personal protective equipment products has increased significantly both online and offline, utilizing various online platforms and standard door-to-door sales methods . In some cases, counterfeiters were able to infiltrate legal supply channels to introduce counterfeit and substandard goods into the supply chain. Pharma crime also targets the global vaccination effort to halt the spread of COVID-19. Falsified COVID-19 vaccines from approved distributors have been identified. The falsified products are illicitly refilled vials of used and discarded COVID-19 vaccines . Some criminals offer unlicensed pharmaceutical products for the prevention of COVID-19, particularly online. The distribution and use of counterfeit medicines and medical supplies can cause significant direct harm to the health of victims. Some fake medicines contain less/no active ingredients compared to the genuine products. In some other cases, counterfeit pharmaceuticals contain more potent ingredients or greater concentrations that can have extreme consequences for human health . In some cases this has caused death by overdose when the counterfeit medicines are laced with fentanyl. Fake pharmaceutical products are often manufactured in unsanitary or dangerous conditions. Clandestine illicit laboratories harm the environment by producing chemical waste that is not disposed of properly. Pharma crime also harms the legitimate pharmaceutical sector and reduces the funds available for research and development and product innovation.

Products

1. medicines
2. anti-cancer drugs
3. analgesics
4. antioestrogens
5. antivirals
6. antihistamines
7. anxiolytics
8. psychiatric drugs
9. erectile dysfunction medicines
10. anabolic substances
11. metabolic regulators
12. self-testing kits for HIV  and other infections
13. medical and personal protective equipment products
14. vaccines
15. pharmaceutical products for the prevention of COVID-19