Covid-19 and the rising tide of falsified medicines worldwide
There is no doubt that the Coronavirus outbreak presents one of the greatest recent challenges to the entire world and to the European Union with it. National, regional and local communities everywhere are on the front lines fighting this pandemic.
Patients are often unaware of the rising tide of fake medicines even as they are increasingly relying on the Internet and online services because of expanding quarantines.
Global illicit drug sales remain the most lucrative component of illicit trade, surpassing arms dealing and human trafficking. All types of medicines are being purchased online, without the need of a prescription, including antibiotics (which is very concerning when linked to the rise of antimicrobial resistance), anti-cancer treatments, and medicines that lower blood pressure, to name just three.
The “quality” of falsified medicines varies from containing too much, too little or even no active ingredient at all. Medicines may also contain toxic substances such as poisons, paint thinners and other potentially harmful or deadly substances. They can also be made in unsanitary or non-sterile environments with unsafe conditions.
The Coronavirus outbreak has regrettably offered new opportunities for criminals to take advantage of high market demand for personal protection and hygiene products. In Uganda, people were arrested for having distributed fake coronavirus vaccines, and in Iran at least 44 people have died from alcohol poisoning and hundreds have been hospitalised after consuming bootleg alcohol in an effort to treat the coronavirus.
The European Anti-Fraud Office (OLAF) has opened a case in relation to the imports of fake products used in the fight against the COVID-19 infection such as non-compliant masks, medical devices, disinfectants, sanitisers and test kits. The seizure of more than 34,000 counterfeit and substandard masks, “corona spray”, “coronavirus packages” or “coronavirus medicine” probably only represents the tip of the iceberg regarding this new trend in counterfeiting. Overall, authorities seized around 4.4 million units of illicit pharmaceuticals worldwide.
The scale of trade in fake medicines has no borders. India and China are the primary producers of counterfeit medicines. The United Arab Emirates, Singapore and Hong Kong are the key transit countries. Criminals mainly target African countries, Europe and the United States. This counterfeit trade is facilitated by the growth in small package shipments by parcel post or letter packets, which are more difficult for customs officers to detect. Between 2014-2016, 96% of all customs seizures of counterfeit pharmaceuticals were of postal or express courier deliveries.
According to a study by the Alliance for Safe Online Pharmacy in the EU (ASOP EU), a longstanding client of Instinctif Partners Brussels, there are more than 35,000 websites selling medicines at any time but the startling fact is that 96% of them are operating illegally. As ASOP EU Director Mike Isles notes, “The ability of sellers to hide their identity and misrepresent their products is particularly attractive to counterfeiters and so it provides criminals with a very easy point of entry into all countries in the world. These criminals are placing profits ahead of patient safety each and every time with reckless disregard for the consequences”.
The extent of this growing public health threat is fittingly reported in a newly released OECD/EUIPO report whose results are enlightening as well as frightening. The study estimates the total value of counterfeit pharmaceuticals traded worldwide to be as high as 4.03 billion euros and highlights the issues and challenges that the trade in falsified medicines brings to governments, businesses and society. It also examines a unique international set of customs seizure data to quantify the value, scope and trends in illicit trade in medicines worldwide.
Such illicit trade not only represents a direct threat to people’s health and safety, including costs of treating patients who have suffered adverse health consequences as a result of consuming counterfeit medicines, it also negatively impacts the environment, the job market and innovation, increasing inequalities, raising additional costs and depriving governments of tax revenues while undermining the businesses and reputations of legitimate producers.
How can we combat this criminality when consumers and patients in search of deals are driving the market?
Education is the most critical success factor. The unwitting public should have a better understanding of the dangers of buying medicines online and so EU governments should keep developing educational campaigns to raise awareness. Robust research and education are necessary to assist health care professionals, law enforcement authorities and policymakers as they help patients stay safe online.
In Europe, the Falsified Medicines Directive requires every prescription pack to be uniquely identified with a barcode that is verified at the point of sale. The pack also has a seal that reveals any tampering. This Directive greatly enhances the security and integrity of the legitimate supply chain. In addition, legitimate pharmacy websites must display a logo, known as the Common Logo, which, when clicked, links to the website of the national competent authority that lists all legally operating online pharmacies and retailers.
Many other players, such as registries, registrars and registrants, also play a vital part in the Internet governance. Search engines and e-commerce platforms and social media platforms must accelerate proactive actions to raise governance standards and adopt good practices.
Finally, there is the MEDICRIME Convention, the only binding international criminal instrument on the counterfeiting of medical products and similar crimes involving threats to public health. The Council of Europe sees it as a common responsibility for the global community to eradicate this scourge and invites all countries to sign the Convention.
The scale of illicit trade in fake pharmaceuticals is massive and so is the rise of fake medical products related to COVID-19.
Last week, the European Commission set up a scheme to gather medical equipment (through rescEU) so that the necessary supplies to combat COVID-19 can quickly get to member states facing shortages of equipment needed to treat infected patients, protect health care workers and help slow the spread of the virus.
The European Parliament is working with EU governments to swiftly approve 40-50 million euros for intensive care medical equipment, such as ventilators and personal protective equipment.
While there is currently no European Medicines Agency-approved vaccine or cure for COVID-19, we can help prevent the epidemic of misinformation about this virus and raise public awareness of the dangers of buying pharmaceuticals from unregulated online sources. This will also help mitigate the considerable knock-on effects on our economies.
COVID-19 has brought significant changes to many of our lives and will continue to do so for some time. Solidarity and responsibility across our societies and between Member States are critical to overcome the pandemic and mitigate its effects.
The new OECD/EUIPO report is another milestone in the fight against counterfeit pharmaceutical products. Please raise awareness and share the report on your social media platforms and within your network, and do get in touch with us if you wish to know more about the activities of ASOP EU.