EMA and the Heads of Medicines Agencies (HMA) are warning the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) offered to patients in the European Union.

ATMPs are medicinal products that are based on genes, tissues or cells. When these medicines are regulated (i.e. authorised via EMA or approved by a national authority), they can offer important benefits for patients. The European Union has established guidelines to ensure that ATMPs meet stringent safety and efficacy standards.

However, a number of individuals, companies and clinics have been marketing unregulated ATMPs directly to patients, often when there is little or no evidence that the products work or are safe. Some of the unregulated products in the EU are sold as dendritic cell therapies, which use a type of immune cell (dendritic cell) to attack cancer cells.

Authorities are warning the public that unregulated products could put patients at risk, causing serious side effects while not providing benefits to patients. Additionally, unregulated ATMPs present significant quality-related risks due to the lack of strict oversight and regulatory compliance in the manufacturing process, which can lead to contamination, inconsistent product composition, and improper storage. Patients may also face substantial financial costs and emotional distress from ineffective or harmful treatments.

It is important that patients are only offered ATMPs, including dendritic cell therapies, that have been authorised or approved by a regulator.

Authorities across the EU are working together to clamp down on those supplying unregulated ATMPs. The public are requested to report any suspicious cases to their national competent authorities.