EMA warns of rising dangers from unregulated advanced therapies

UK—The European Medicines Agency (EMA) has expressed concerns over the increasing availability of unregulated advanced therapy medicinal products (ATMPs) in Europe, highlighting the potential risks these pose to patients.

ATMPs consist of innovative treatments developed from cells, genes, or tissues and are often utilized for rare diseases and certain types of cancer.

While the EMA has authorized several ATMPs, individuals, clinics, and companies are marketing unauthorized products, taking advantage of vulnerable patients searching for solutions.

These unregulated therapies lack solid evidence of their effectiveness and can lead to serious side effects.

The EMA noted that these products are frequently advertised online and through social media, specifically targeting patients in distress.

Additionally, the agency pointed out the dangers associated with poor manufacturing practices surrounding these therapies, including contamination, inconsistent composition, and improper storage conditions.

One notable example is dendritic cell therapy, a kind of immunotherapy designed to boost the immune system’s ability to combat cancer.

Although it shows significant promise, only one dendritic cell therapy—Provenge (sipuleucel-T)—has ever received approval from the EMA.

Provenge was authorized in 2013 but was withdrawn in 2015 due to lackluster commercial performance; it is still available in the United States.

Nevertheless, certain clinics in Europe continue to offer dendritic cell therapies without appropriate regulatory oversight.

Germany has become a hotspot for these treatments, with clinics providing dendritic cell therapies under national regulatory frameworks instead of EMA approval.

For example, IOZK in Cologne claims to manufacture personalized cancer vaccines using dendritic cells under a national manufacturing license.

However, these therapies are not regulated by the EMA and are offered under exemptions or clinical trials sanctioned at the national level.

Similarly, Booking Health connects patients with German clinics for these treatments, charging up to €38,000 (US$ 41,426) while 41,426) while ensuring compliance with local laboratory regulations, even though specific therapy approvals are absent.

The EMA has urged patients to seek out only ATMPs authorized by regulators and called on the public to report any suspicious cases to national authorities.

This warning is part of broader efforts from health agencies worldwide to tackle the issue of unregulated medical products.

For instance, the World Health Organization (WHO) recently issued an alert concerning falsified versions of the diabetes drug Ozempic (semaglutide), highlighting the global nature of this problem.

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