Through online pharmacies and sophisticated operations, counterfeit medicine that can be harmful to consumer health is available and often unknowingly consumed.
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A highly regulated industry
Safety and efficacy are at the core of the highly regulated pharma industry.
National authorities review and license medications, and attempt to create a distribution system that ensures the safety of drugs.
Prescription medications require a healthcare professional, preventing consumers from self-medicating.
Medications sold outside the legitimate supply chain result in serious health concerns.
These medications may be counterfeits, placebos, recalled products or otherwise substandard medical products.
Fake medications and medical products are counterfeits labeled with false information regarding their source, identity, and/or ingredients. Unscrupulous manufacturers and sellers make and sell them under false brand names or label them as generic drugs with attractive price tags.
Such fake pharmaceuticals may contain ingredients that vary from the label.
Some have no active ingredients, whereas others may contain harmful substances such as chalk or mercury.
With greed as a motive and no oversight, there is really no knowing how a fake pill may affect your health.
As counterfeit medication and packaging become more sophisticated, both look almost identical to the genuine product, making them difficult to identify.
As a result, they are more prevalent. Although more often found on online websites and social media, counterfeit medications infiltrate the legitimate supply chain.
This is true even in the US or EU, which are known for having some of the world’s safest supply chains.
Counterfeiters exploit gaps in complex supply chains to sell prescription drugs through secondary wholesale distributors, who in turn sell them to companies that resell medicines to unsuspecting pharmacies.
The scope of the fake pharmaceuticals problem
It is estimated that the global counterfeit market for pharmaceuticals is worth between US$200 and US$432 billion.
These figures translate to pharmaceuticals being the number one illicit activity.
The World Health Organization (WHO) reported back in 2014 that counterfeit medicines potentially make up more than 50% of the global drug market, a significant proportion of which in developing countries.
In another report, it estimated that 1 in 10 medical products in low- and middle-income countries is substandard or falsified.
Since then, e-pharmacies have further increased the threat of illicit medical products in both developed and developing countries.
From North America to Europe and from Africa to Asia and South America, no country remains free of fake medicine.
Online pharmacies also increase the difficulty of understanding the scope of the problem, often examined through custom seizures.
E-pharmacies heavily rely on small parcels that are more difficult for customs authorities to intercept.
The EU has seen an increase in the trade in counterfeit pharmaceutical goods.
In 2019, the number of counterfeit medicines and other pharmaceutical goods seized by EU customs reached nearly 1,200,000 units, entering the top 10 list of most seized products by number of articles.
The illicit “units” include a wide range of pharmaceuticals, from anti-cancer drugs to analgesics and psychiatric drugs.
Europe’s 2020 Operation Shield resulted in the seizure of illicit medicines and substances worth nearly €73 million, the arrest of about 700 suspects, and the shut down of 453 websites.
Law enforcement agencies in the US report seizures of counterfeit pills and other medicines, both for life-threatening health conditions like cancer and routine care.
Recently, the Wall Street Journal reported on drugmaker Gilead alleging that a counterfeiting ring sold its HIV drugs.
The investigation revealed over 85,000 bottles of branded medications worth more than $250 million.
Online pharmacies provide counterfeiters with a large consumer base and relatively low risks.
Sellers can conceal their identity, and the dark web allows for anonymous transactions.
The online sale of medicine is not illegal in itself. There are licensed pharmacies that sell online.
Yet in spite of enforcement efforts, illegal online sales boom, the bulk of them without a prescription.
The latest EU IP Crime Threat Assessment says that most fake drugs are traded online and sent by mail or with parcel services.
The trend is reflected in a growing number of unlicensed online pharmacies.
The problem with online pharmaceuticals
Online pharmaceuticals can come from almost anywhere.
In fact, the e-commerce of pharma practically creates an unlimited number of product entry and exit points.
The online sale of pharmaceuticals also creates unclear supply chains with consumers who do not track the legitimacy of the sellers, their location, and whether or not they have a license.
Even with highly regulated products, you can go online and buy from a supplier without checking whether or not they are licensed or if they present a transaction history document known as a pedigree, as required by law.
Consumers purchasing from online pharmacies cannot know if the medicines moved through the supply chain with proper care in terms of storage conditions, shipping and handling, or temperature issues, especially for drugs that must be refrigerated.
These may cause adverse reactions in patients, and medications can lose potency.
Other issues include short expiration dates and errors, such as using the wrong concentration or a different dosage than prescribed.
The pharmacy’s website and other sales platforms may appear legitimate, but consumers should beware.
Counterfeits do not only appear on online platforms, they are openly advertised, giving them an extra sense of legitimacy.
The US Food and Drug Administration (FDA) recognizes the problem and warns consumers about the dangers of purchasing online pharmaceuticals. It explains that rogue online pharmacies may engage in unlawful activities, including:
- Offering unapproved prescription drugs.
- Offering prescription drugs without requiring a prescription.
- Offering prescription drugs without FDA-required warning to consumers regarding health risks associated with the drug.
Source of illicit pharmaceuticals
The production of illicit pharmaceuticals often takes place in illegal laboratories.
The 2022 IP Crime Threat Assessment by EUIPO (European Union Intellectual Property Office) and EUROPOL says that although most illicit pharmaceuticals continue to originate from outside the EU, production of fake pharma increasingly takes place within the EU.
Gray market pharmaceuticals
Gray pharmaceuticals, where a genuine drug is intended to sell in one country but sold in another, happens for various reasons.
The gray market allows people to buy less expensive prescription medications, mostly over the internet.
Although government pricing of drugs is a key driver for gray marketing, there are other factors at play, such as exchange-rate fluctuations and national laws.
It is sometimes the result of drug shortages and availability issues in different territories.
When gray marketing is involved, the medicine is genuine and legally produced, but later there is no oversight of issues like expiration dates and storage conditions.
Sellers don’t comply with the same regulations, products may be resold several times, and the chain of custody is unclear.
The same is true in incidents of theft of legal pharmaceuticals that are then distributed to consumers.
Counterfeit medications and gray marketing affect public health, public confidence in the system and supply chain, and consumer trust in genuine drug companies and manufacturers of medical products.
IP Online Brand Protection
With the growth in e-commerce, consumers face graver health risks, and pharmaceutical companies face economic and reputation challenges.
The regulated pharmaceutical industry has become a target for fraudsters and counterfeiters, often as part of criminal organizations.
At Wiser Market, we believe in being proactive and stopping those who damage your reputation and revenue while putting consumers’ health in danger.
We work with clients across various industries and offer a comprehensive online brand protection solution, from detection to taking down fake products.
The Wiser Market solution combines cutting-edge technology and expert eCommerce know-how.
Our advanced monitoring system and dedicated team provide you with an automatic brand protection solution designed to make the solution easy, efficient, and scalable.
We do the hard work required to safeguard your brand so that you can focus on growing your business, knowing that your customers get the real deal.
Whether you wish to fight counterfeiting, prevent intellectual property infringements, track your supply chain, or combat gray market selling – Wiser Market is your online brand protection partner.
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How can I check my online pharmacy?
To make sure you are using a legal online pharmacy, look for it online. In the US, the FDA explains how this can be done. On the FDA’s page, you can choose your state and check the pharmacy’s license database. The FDA suggests not to use an online pharmacy that you cannot confirm is licensed in the United States.
Where do illegal medications come from?
Online pharmaceuticals can come from almost anywhere. Without a safe distribution system and a license, there is no knowing what the medication you bought online really contains.
What is the origin of fake pharmaceuticals?
In 2020, the majority of fake pharmaceutical products in the EU came from China and Turkey, with Vietnam contributing but to a lesser extent, according to a EUIPO and Europol report. The report also named Iran, Switzerland and the US as key transit points for fake medications entering the EU.
How to identify fake medical products?
Counterfeit medical products can look almost identical to the genuine product and are therefore very difficult to detect. However, the World Health Organization offers some things you can look at to self-protect:
- Examine the package carefully. Look for its condition and any spelling or grammar mistakes.
- Check the name, dosage, manufacture and expiry dates.
- Make sure that the details on the outer packaging match the details on the inner one, such as batch number and dates.
- Examine the medicine itself to make sure it looks, feels and smells right. Check for issues like discoloration and smell.
- Alert your healthcare professional, doctor or pharmacy if you have any adverse reaction or if you suspect the medicine is not working as it should.