Falsified medicines and other illegal medicinal products are a major phenomenon that has continued to grow tremendously also in recent years. This issue poses a risk not only for economic reasons but also because of the danger to public health. In addition, sales of illegal medicinal products over the internet have also exploded in recent years, making the problem extremely difficult to manage.
Bart Ceyssens of the Special Investigation Unit testifies about the problem: “It is difficult to quantify the exact extent of this phenomenon. Nevertheless, we notice that the FAMHP’s Special Investigation Unit, which fights against illegal pharmaceutical practices, has been working on large research files more frequently in recent years. That indicates that the problem is expanding. During the coronavirus crisis, the unit faced a new phenomenon: counterfeit medicinal products against COVID-19. Non-compliant antibiotics have also been on the rise in recent years. When checking for antibiotics, the Special Investigation Unit always applies zero tolerance. After all, antibiotic resistance is an acute and serious problem with major public health implications.”
Falsified medicines are a perfect copy of the authentic version, but because they enter the distribution chain without a license, illegally in other words, we do not know where or how they were manufactured.
Other illegal medicines may not contain the active ingredient of the medicinal product or in the wrong dose, and the substances added to them may be harmful or even lethal. They usually involve distribution of unlicensed medicinal products, medicines presented as dietary supplements, misuse of veterinary medicinal products, human and veterinary doping and internet fraud. Both counterfeit and other illegal medicinal products fall under pharmaceutical crime, violating medicinal products laws and representing a potential danger to public health.
One of the spearheads for tackling pharmaceutical crime is optimal cooperation between the FAMHP and other actors such as the police, customs, justice, on national, European and even global level. The inspectors of the Special Investigation Unit participate every year in various international actions in the fight against illegal medicinal and health products.
Hans Van der Meersch
“The FAMHP participated in Europol’s Shield action in 2022, for example,” explains Hans Van der Meersch, “for six months, our inspectors worked with customs to check postal packages for illegal medicinal and health products. A total of 145 054 illegal products were seized. This action shows that not only drugs, but also other dangerous products can be ordered relatively easily and delivered to your home.
In addition, several routine operations were restarted that could not be performed temporarily during the corona crisis. In October 2022, seven sex-shops in Brussels were checked for the presence of illegal medicinal products. More than 9 000 illegal medicinal products with an estimated value of 126 000 euros were seized during this operation.”
Another risk when using illegal medicinal products is underdosing or overdosing. In fact, three-quarters of illegal medicines contain the wrong dosage. This can range from small deviations of ten percent to large deviations of forty percent. When the user ingests too high a dose of a particular product, it can lead to dangerous situations. It also appears that almost all illegal medicines are contaminated with dangerous bacteria and fungi because they are manufactured in conditions with totally no hygiene standards. Illegal medicinal products therefore pose a great danger.
Moreover, some illegal products are pure quackery. They are presented as miracle products, sometimes even as the solution for serious diseases although in reality they do not have the attributed therapeutic value and may keep patients from getting the treatment they really need.
According to Bart Ceyssens, the Special Investigation Unit sees a clear trend: “Seventy percent of all seized medicinal products are lifestyle medicinal products. These can range from erectile stimulants, to doping, slimming products, sleep aids, antidepressants and cognitive stimulants such as rilatine.”
Slimming products in particular have been on the rise in recent years. They almost always contain sibutramine, a medicine against obesity and overweight that is banned in Europe for safety reasons. The products are sold in the form of tea, coffee, chocolate, jam, honey for slimming. The presence of sibutramine or similar ingredients is usually not literally stated on the package. Without knowing it, the user ingests this product. These products also do not contain a package leaflet or indications. So the risk of overdosing is high.
These phenomena prove that the fight against pharmaceutical crime requires a specific approach across borders. Due to its complex nature, in addition to a repressive approach, the FAMHP has the important task of raising awareness to patients and the general public to purchase and use medicines in a safe and appropriate manner. After all, playing with your health, is it all worth it?
Bart Ceyssens and Hans Van der Meersch are inspectors within the FAMHP’s Special Investigation Unit. Since 2019, they have been coordinating this unit that deals with medicinal products outside the legal supply chain. The inspectors of the Special Investigation Unit regularly proceed to controls or investigations in cooperation with prosecutors’ offices, police and customs. At the international level, the unit also participates in annual actions and meetings on illegal medicinal products.