Safety first: How packaging ensures greater safety

• Counterfeit medicines, food or cosmetic products often pose a considerable risk to the health of consumers.
• The market for counterfeit drugs in particular is lucrative and correspondingly large - as is the need for security measures to protect customers.
• Packaging is therefore subject to strict regulations designed to ensure security. To this end, manufacturing companies are constantly improving their options for protecting packaging and products against counterfeiting and attempted copying.

EXAMPLE OF COUNTERFEIT DRUGS: WHY PROTECTION IS SO IMPORTANT

Counterfeit medicines are mainly distributed illegally via the Internet, and in individual cases they enter the legal supply chain and reach patients - often with devastating consequences for the health of those affected. One example:

Danger from counterfeit drugs: The Heparin Scandal of 2008

Between January 2007 and June 2008, there were a large number of incidents involving the administration of heparin, particularly in the USA. The anticoagulant has been used for several decades in the prevention and treatment of thrombosis and in the treatment of occlusive diseases and arteries.

In the case of inpatient stays in hospitals or intravenous administration of medication over a longer period of time, it is extremely likely that heparin will be administered as a supportive measure. This is because the drug is actually considered to be well tolerated.

The reports from various hospitals in the period mentioned therefore came as a surprise. Patients who had been treated with heparin subsequently showed rapid drops in blood pressure and unusual, because extremely rare, allergy-like reactions - from hot flushes to breathing difficulties to fainting.

In 2006, 55 people in the USA alone succumbed to the consequences, and by the summer of 2008, 246 more had died. Extensive investigations proved that the heparin had been contaminated by a similar molecule (OSCS). This has a comparable effect, but causes dangerous side effects much more frequently. Since 2006, counterfeiters in China had started to mix OSCS in ever larger doses with crude heparin.

By 2008, the contaminated heparin had been seized by authorities in twelve countries, including the United States, Germany, Japan and Australia.

Not all counterfeiting is the same

Counterfeiting is not the same as medication Counterfeit medications come in different forms, and that is precisely what makes them so dangerous. A health hazard is by no means always to be expected, but the risk of this is nevertheless high:Counterfeiting

• Counterfeit packaging and falsified package inserts give the impression of holding an original preparation in one's hands. In the case of good-quality medicines, this primarily results in economic damage for the manufacturers, while patients do not notice any difference.
• If the drugs contain less active ingredient than they are supposed to according to the packaging, patients can be harmed by underdosing. Inadequately dosed antibiotics, for example, lead to faster development of resistance.
• Other active ingredients than those specified either render drugs ineffective or - as the example of heparin shows - cause undesirable or even dangerous reactions.
• However, the majority of counterfeits do not contain any active ingredient at all. Accordingly, they have no therapeutic effect whatsoever and therefore pose an increased health risk to patients.

The lucrative business with counterfeit medicines

This danger from counterfeiting is now present in an ever-increasing number of cases. This is because counterfeiters have been expanding their range of products for years. Common lifestyle drugs that are supposed to help with erectile dysfunction, hair loss or obesity, for example, are no longer among the most common counterfeits.

Vital medicines used for cardiovascular diseases or cancer are also circulating as counterfeits. This applies in the same way to antibiotics, antiviral medicines or even AIDS preparations. Especially during shortages, there is a greater risk of falling for a counterfeit.

They are distributed very unevenly internationally, as the World Health Organization (WHO) estimates. Worldwide, the proportion of counterfeit drugs is up to 10 percent, in Europe up to one percent. The situation is completely different in Africa, where up to 80 percent of medicines are counterfeit. In particular, drugs that are otherwise too expensive to treat malaria or HIV circulate there as counterfeits.

Action against medicines counterfeiters

Europol, das Amt der Europäischen Union für geistiges Eigentum (EUIPO) und die WHO – sie alle warnen vor einer immer weiteren Verbreitung des Handels mit gefälschten Medikamenten. Die sind inzwischen weltweit in Umlauf, der illegale Handel läuft professionell ab, neben oder abseits der legalen Vertriebswege. Vor allem der Parallelhandel über illegale Online-Apotheken macht es den Kriminellen leicht, ihre Fälschungen in Umlauf zu bringen.Europol, the European Union Intellectual Property Office (EUIPO) and the WHO - they all warn of an ever-increasing trade in counterfeit medicines. These are now circulating worldwide, and the illegal trade is taking place professionally, alongside or apart from the legal distribution channels. Above all, parallel trade via illegal online pharmacies makes it easy for criminals to get their counterfeits into circulation.

In the EU alone, this results in economic damage of around 10.2 billion euros; the estimates only take manufacturing into account. Added to this is the damage to the retail sector, for example pharmacies.

Cracking down on counterfeiters is difficult for a number of reasons, including the increasing number of pharmaceutical shipments distributed through parcel and postal services. In addition, the authorities are fighting against the increasing import of raw materials that serve as the basis for local production. This includes not only the necessary substances, but also the equipment, from tablet presses to labels.  

Protective measures against counterfeit drugs

Since February 2019, the EU's Anti-Counterfeiting Directive (Directive 2011/62/EU) has once again provided stricter regulatory requirements to ensure that medicines cannot be counterfeited. Together with Delegated Regulation(EU) 2016/161, it provides for additional security features and devices that make possible tampering easier to detect.

For packaging, the main issues are mandatory safety features on the outer packaging and the common logo that will identify legal mail-order and online pharmacies across the EU. The envisaged safety features are:

A first-opening protection or tamper-evident seal is intended to serve alongside this as a device against possible tampering. Adhesive dots, adhesive seals or perforated opening flaps for sealed pharmaceutical packages are intended to indicate whether a box has already been opened in advance.c

Suitable adhesive labels can be used especially for packaging that makes it difficult to print security features - i.e. glass and plastic, a cellophane coating or if the outer wrapping is missing altogether.

THIS IS HOW PACKAGING BECOMES TAMPER-PROOF

Even before the introduction of the Counterfeiting Directive, the packaging industry used a variety of means to prevent counterfeit products. By necessity, security features continue to evolve.

"Conventional" security features for packaging

Incidentally, counterfeit protection does not only apply to pharmaceuticals; cosmetic products and foodstuffs can also be manipulated to the detriment of consumers. For this reason, customers place a correspondingly high value on counterfeit protection. Our security labels work with holograms, among other things, and offer outstanding protection against attempts at manipulation and fraud.

To prevent such criminal acts, the manufacturing companies also rely on various options. Both overt and covert security features are used.

• Serialization by code:
  Encrypted coding is a comparatively simple yet effective means of providing quality assurance, traceability and, together with tamper-evident features, anti-counterfeiting protection. Serialization also makes it easier to distinguish between products packaged within the same order or batch. Open or encrypted numbering supplements the otherwise usual information (article number, manufacturing number, expiration date, etc.) and thus makes individual identification of the products possible.


• Track & Trace:
  Serialisierung braucht dennoch Echtheitsmerkmale, um Fälschungen gänzlich ausschließen zu können – die Codierung selbst kann nämlich durchaus auch gefälscht werden. Tracing-Systeme mit Barcodes, die sich per Smartphone-App auslesen lassen, können den Kund*innen in Bezug auf die Originalität der Produkte mehr Sicherheit bieten. Angebracht werden können die Codes linear, als 2D-Code oder mittels eines NFC-Chips.


• Variable code information as protection against counterfeiting:
  The variable codes are also suitable for being combined with counterfeiting features. "Static" features in the form of holograms or customer logos in security tipping color are just as conceivable as security paper with mottling fibers, printed random patterns, pixels or air bubbles enclosed in synthetic resin.
  In the course of an online comparison of the features applied in this way, additional information (product information, advertising, etc.) could theoretically even be stored for consumers.

The Fraunhofer Institute for Secure Information Technology SIT has also developed the JAB code. Unlike the usual black-and-white barcodes, the JAB code is made up of different colours. This makes it possible to store much more information in the code than barcodes have been able to do up to now.

The high data density is also the basis for improved counterfeit protection - because this is the task for which the JAB code was originally developed. It serves as proof of authenticity for documents and products.

Innovations for counterfeit-proof packaging

Nevertheless, the disadvantage of overt security features often remains: they can be copied by professional counterfeiters. For this reason, they are increasingly being supplemented by hidden and digital features.

New technologies are also used for this purpose, for example from the field of high-security printing. Features such as odourless and colourless taggants, i.e. microscopically small particles that are incorporated into the printing ink, or synthetically generated DNA codes are among the possible variants for more tamper-evident protection.

They can only be made visible with special readers or test pens and cannot otherwise be detected. Digital technologies also offer a variety of other options, for example

• computer-generated codes with high encryption as plain text number,
• 2D codes in the form of QR or data matrix codes,
• Noise patterns for authenticity verification via mobile devices.

Tiny indentations on printed surfaces work in a similar way. These are invisible to the human eye but can be read with a smartphone camera, for example. In this way, QR codes on the packaging of medicines, among other things, can be provided with an additional security feature. A particularly practical aspect of this approach is that it can be implemented using all standard printing processes.

More transparency through serialized labels and packaging

In addition to counterfeit protection, the improved security measures also offer advantages in terms of transparency. Serialized labels and packaging can be tracked much more easily on their way from production to retail and to the end consumer. Counterfeit or defective goods can thus be traced back to their point of origin.

This is another important aspect when it comes to consumer safety, as it can improve anti-counterfeiting protection at various levels, and not just for consumers.

LABELPRINT24 ENSURES SECURE PACKAGING

As a leading European system manufacturer of digitally printed packaging materials for numerous applications, Labelprint24 naturally offers a range of different security features for packaging and labels. They guarantee optimum closure and tamper protection.

Safety labels for protection in all situations

Security stickers help in many situations: As a protective measure against tampering attempts, as a seal for high-value products or as a marker for the ownership of certain products. The requirements vary depending on the intended use, which is why we at Labelprint24 develop specific solutions for our customers' needs.

This applies, for example, to our warranty seals. By using the void effect and holograms, these combine a high-quality appearance with efficient protection against the unlawful opening of packaging. If the labels are damaged or someone tries to peel them off, the hologram lettering changes - it then shows the indications "Void", "Opened" or similar. This makes it clear at first glance that the packaging is no longer in its original condition.

More protection through hidden security features

In order to be able to offer even more security in the future, Labelprint24 is working on new solutions for hidden originality protection. Individual codes and markings are to be inserted into the printed image of the labels - invisible to the human eye, but readable with the appropriate app support. In this way, the authenticity of the packaged products can be verified.