EU Warns Against Unregulated Advanced Therapy Products

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a communication last week warning consumers about the dangers of unregulated advanced therapy medicinal products (ATMPs) being offered to patients in the European Union. 

In the statement, EMA and HMA stated that ATMPs, which include gene, tissue and cellular therapy treatments, are being marketed directly to patients, often without evidence of safety or efficacy. The agencies specifically cited concerns around unauthorized dendritic cell therapies, which are being marketed as cancer treatments, and emphasized that these unregulated therapies pose serious risks, including potential contamination, inconsistent product quality and severe side effects. Patients may also experience financial and emotional distress from ineffective and/or potentially harmful treatments.

To ensure safety, the agencies encouraged patients to only receive ATMPs that have been approved by regulators. EMA also urged the public to report any suspicious ATMP offerings to national competent authorities.