Dannemann Siemsen Institute promotes debate on the manufacture of compounded medications based on third-party patents and their legal, regulatory, and health impacts.

Dannemann Siemsen Institute promotes debate on the manufacture of compounded medications based on third-party patents and their legal, regulatory, and health impacts.

On July 28, the Dannemann Siemsen Institute (IDS) hosted another edition of Agenda IDS, featuring an in-depth debate on the indiscriminate manufacturing and use of compounded medications involving patented substances, their associated health risks, and the resulting legal challenges. The virtual event was opened by Patrícia Porto, academic coordinator of IDS, and moderated by Bernardo Marinho Fontes Alexandre, partner at IDS and member of the Institute’s board. It brought together experts Ana Amélia Araripe Montenegro, senior intellectual property manager at Novo Nordisk, and Sônia Gu, the company’s senior regulatory affairs manager.

Bernardo opened the discussion by framing it around the exception provided in Article 43, item III of the Brazilian Industrial Property Law (Law No. 9,279/96 – IPL), which permits, under restrictive conditions, the use of patented substances by third parties for the compounding of medications for individualized use. He cautioned that, in practice, there is evidence that this legal exception has been improperly used by compounding pharmacies to produce and sell medications on an industrial scale—circumventing patent infringement accusations and regulatory requirements.

Next, Sônia Gu presented the regulatory aspects, emphasizing that compounded medications follow much less stringent health and safety standards. She explained the fundamental difference between the pharmaceutical industry—which is subject to strict pharmacovigilance and quality requirements—and compounding pharmacies, which lack equivalent control structures. She warned that these pharmacies, by producing large-scale compounded drugs without regulatory agency approval, expose patients to high contamination risks and to the use of unregulated substances that lack proper quality analysis. Sônia shared striking data: over the past 27 months, approximately 6 million semaglutide pens were released into the Brazilian market by compounding pharmacies, whereas the pharmaceutical industry supplied just over 1 million pens in the same period.

Following this, Ana Amélia added a legal perspective, warning against the abusive conduct of compounding pharmacies that act as competitors to the pharmaceutical industry by mass-producing still-patented substances without scientific or technical support. She stressed the misuse of Article 43, III exception, which applies strictly to individualized cases with a medical prescription. She noted that deviation from this rule constitutes patent infringement, unfair competition, and public health risks. Such practices may also harm the reputation of patent holders, as patients often confuse compounded products with original ones—especially when commercial strategies blur the lines of therapeutic personalization, such as products marketed as “compounded Ozempic.”

The speakers also discussed international precedents, such as Australia’s decision to ban the compounding of semaglutide due to significant health risks. The debate included several audience questions, including the potential legal liability of compounding pharmacies and raw material importers who distort the proper application of the legal exception.

In closing, the experts emphasized that the solution does not lie in delegitimizing compounding pharmacies or the application of Article 43, III of the IPL, but rather in ensuring that such pharmacies operate within legal boundaries, with patient safety and respect for innovation as guiding principles.

The event recording will soon be available on the IDS website.

Note: For quick release, this English version is provided by automated translation without human review.