Tirzepatide and semaglutide have established themselves as two of the most relevant therapeutic advances in recent years for the treatment of obesity and diabetes, which has driven growing demand for these medications and transformed them into high-value commercial assets in the pharmaceutical market.<\/p>\n
However, the economic success of these medications also attracts the interest of organized crime, which reproduces the products\u2019 formula to distribute them through social media and clinics – in addition to encouraging the irregular entry into Brazil of units manufactured in foreign countries, such as Paraguay.<\/p>\n
But why Paraguay? Well, this is mainly due to the principle of territoriality applicable to patents. In countries where the patent is not applied for, the medication is free to be commercially exploited legally, since the patent holder has no exclusivity over that innovation.<\/p>\n
Thus, in order for a patent not to be legally reproduced anywhere in the world, it is necessary to protect the patent in all territories. There is no patent with worldwide validity, and such global protection may be impractical. Therefore, companies strategically choose to protect their inventions through patents in territories that represent a relevant market for the production and commercialization of their medications.<\/p>\n
The manufacture and commercialization of products containing tirzepatide or semaglutide in Paraguay does not, therefore, constitute an infringement of the patents granted to their respective holders – Eli Lilly in the case of tirzepatide, and Novo Nordisk in the case of semaglutide – in the countries where these inventions have been protected.<\/p>\n
Upon crossing the border, however, the situation changes. What was previously produced and commercially exploited lawfully in Paraguay becomes a smuggled product in Brazilian territory, where the companies have duly protected their assets before the Brazilian Patent and Trademark Office (BPTO), and may also be classified as a crime against public health.<\/p>\n
What this means for society is that this unofficial production in Paraguay – often carried out by manufacturers who do not have sufficient knowledge of the complexity and instability of these molecules – reaches the market without the same standard of sanitary control required of the original products, posing a real risk to the health of consumers, who are predominantly Brazilian.<\/p>\n
Among the most critical risks to consumers are the lack of control over the quality and therapeutic efficacy of the product, inaccurate dosages (present in approximately 95% of products compounded irregularly), and the possibility of contamination by microbiological or chemical agents. Taken together, these factors place even greater pressure on the Brazilian healthcare system.<\/p>\n
This uncontrolled consumption is largely driven by the sales channels themselves, such as social media and digital influencers, who, whether aware or unaware of the risks involved, rarely advise consumers to seek specialized medical supervision. This factor contributes to the spread of irregular channels and products without any production control, with potentially serious consequences for those who consume them.<\/p>\n
Last but not least, products smuggled into Brazil make use of organized crime logistics channels which, attracted by the substantial financial gains in comparison with the minor penalties imposed in cases involving the smuggling of such products, generate a series of related crimes. Alongside other types of illegal markets, such as piracy, customs evasion, and counterfeiting, annual losses amounted to BRL 468 billion in 2024 (1.7% of GDP), in addition to causing indirect losses related to tax evasion and unemployment.<\/p>\n
To address this problem, coordinated action among different sectors is essential: the productive sector, health regulatory agencies, law enforcement authorities, organizations involved in intellectual property, and the Judiciary, combined with ongoing efforts to raise consumer awareness of the risks they face to their own health.<\/p>\n
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