Authorities Fail to Act on Dangerous Security Vulnerability in Medicine Packaging
The tamper-evident protection on medicine packaging is designed to guard against counterfeiting. But investigations by Plusminus reveal that this protection appears to be failing on countless packages. The regulatory authorities have been aware of the risk for years.
An ordinary household iron, a few seconds of heat, and the adhesive turns liquid. The side flap of a medicine package springs open, allowing the contents of a heart medication to be swapped out. Once the adhesive cools, the box is sealed again.
Whether it is a glued flap or a security seal: both can be opened without a trace using heat. No one can detect the tampering from the outside — the package looks exactly as it did before: intact and seemingly safe. This is shown in videos obtained by the ARD programme Plusminus.
The videos were recorded by Patrick Michel, who works in the European pharmaceutical wholesale trade. While inspecting individual packages, he discovered a security vulnerability that should not exist under European anti-counterfeiting regulations. "Every time I test a package, I can open it without leaving a trace," he says. "This is just the tip of the iceberg."
Two Security Features
Countless medicines from various pharmaceutical manufacturers appear to be affected. "In my view, this is a serious security vulnerability," says Arndt Sinn, an expert in pharmaceutical crime at the University of Osnabrück. "Because there is a risk that a legitimate supply chain could be infiltrated and counterfeit medicines could enter the market."
Since 2019, medicine packaging in the EU has been required to carry two security features: a unique serial number that is scanned at the pharmacy, and a tamper-evident device that indicates whether a package has already been opened. But this protection can apparently be circumvented — and the original packaging thus becomes a gateway for criminals. According to Arndt Sinn, the potential for misuse ranges from counterfeiting and extortion of pharmaceutical companies to the sabotage of supply chains.
Wrong Contents — Real Danger
An original package with a valid serial number is particularly valuable to counterfeiters. Some medications cost more than 1,000 euros. The perpetrators sell the genuine contents on the black market, for example, and replace them with a cheap or ineffective substitute. "This way you double your profit with almost no effort," Michel explains. Because the serial number is valid, the package goes undetected in the supply chain. Pharmacies also only check the number and not whether the genuine active ingredient is actually present.
This can be life-threatening for patients. Someone taking a heart medication from which the active ingredient has been removed goes untreated without realising it. "This security vulnerability can cause a great deal of harm, from health damage to the death of a patient," warns criminal law expert Sinn.
What makes this particularly insidious is that the victims largely remain invisible. Whether someone dies from their underlying condition or from an ineffective drug is almost impossible to determine after the fact.
An Expert Report with No Consequences
Patrick Michel reported the security vulnerability to European regulatory authorities more than two years ago. A state laboratory in Germany subsequently examined whether the packaging could actually be opened under the application of heat and resealed without leaving any trace, and confirmed his discovery. There was a risk that the contents of the medication "could be manipulated with minimal effort, without any signs of external interference." The tamper protection was insufficient to prevent counterfeiting, according to the expert report obtained exclusively by Plusminus.
The findings were also forwarded to the Federal Institute for Drugs and Medical Devices, known as BfArM. However, the authority apparently did not respond with alarm.
At EU level, there were further troubling indications. As early as 2024, an EU expert group responsible for drug safety had received a study from official testing laboratories. It found that of 26 medication packages examined, 19 had insufficient tamper protection.
A year later, the European network of official testing laboratories presented new tests involving more than 250 packages. Again, deficiencies in tamper protection were found: packages could be opened without leaving any trace, "with and without the use of tools and heat." The inspectors identified adhesives with insufficient heat resistance as the problem. How many packages were affected is redacted in the document obtained by Plusminus.
Security vulnerability already exploited
Just how real the danger is becomes clear from internal email correspondence between European regulatory authorities. The Slovenian medicines authority classified the security vulnerability as serious at the end of 2025 and criticised the absence of legally binding technical requirements for tamper protection. This very absence had already been "exploited in an investigated case of counterfeiting," according to an internal email to the European Medicines Agency EMA, which collects all the information.
At the same time, Germany's BfArM reported to the EU level that it identified "no quality deficiency" in the tamper protection. More than two years without a solution, during which the authorities were accepting a health risk for patients, is criticised by Arndt Sinn: "I consider it negligent that such clear warning signs have not prompted a change of course."
Responsibility passed around
The EMA currently declines to comment when asked. The EU Commission states that it is not responsible. Manufacturers are responsible for safe packaging, and national authorities in EU member states are responsible for controls.
BfArM, for its part, states that the tamper protection used complies with currently applicable EU regulations, but concedes that these do not specify "how resistant tamper protection must be to heat." Responsibility for legislative changes, in turn, lies with the EU Commission. The pharmaceutical companies concerned point to existing standards, which they say they comply with.
Better solutions available
Packaging sealed with adhesive is widespread in the pharmaceutical industry. This weakness therefore carries a high risk. Yet secure packaging that works without adhesive has long been available. Such packaging cannot be opened on any side without the carton being visibly destroyed. However, no manufacturer is required to use such solutions. Criminal law expert Sinn therefore calls for a legal framework that compels manufacturers to make their packaging more secure.
Until then, the security vulnerability remains, and with it the danger for all those who depend on their medication.
