The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are warning the public about the risks of unregulated advanced therapy medical products (ATMPs) available to patients in the European Union.
ATMPs are medications that are derived from genes, tissues, or cells. When these drugs are regulated (i.e., allowed by the EMA or approved by a national body), they can provide significant benefits to patients. The European Union has created rules to guarantee that ATMPs meet strict safety and efficacy requirements.
However, a number of individuals, companies, and clinics have been offering unregulated ATMPs directly to patients, frequently with little or no evidence that the products work or are safe. Some unregulated products in the EU are marketed as dendritic cell therapies, which utilize a type of immune cell that targets cancer cells. Authorities warn the public that unregulated products may endanger patients by creating major adverse effects while providing no advantages. Furthermore, unregulated ATMPs pose major quality hazards due to a lack of rigid oversight and regulatory compliance during the manufacturing process, which can result in contamination, irregular product composition, and incorrect storage. Patients may also experience significant financial and emotional distress as a result of poor or dangerous therapies.
It is critical that patients only get ATMPs, including dendritic cell treatments, that have been authorized or approved by a regulator. Authorities across the EU are working together to break down on individuals who offer unregulated ATMPs. The public is asked to report any suspicious cases to their national competent authorities.
Important information for patients and their families
The products are usually sold on websites or social media channels as a last hope, exploiting the worries of patients and their families. National authorities are taking action to stop the sale of such products and, in some cases, are involving the police.
While there is usually little or no evidence that these products are effective, they may pose the risk of severe side effects.
If you or a family member has been offered an ATMP (a medicine based on cells, tissues or genes), consult official and reliable sources, such as the European Medicines Agency (EMA) or your national competent authority (NCA) to confirm its use has been approved for the intended therapeutic indication.
Beware of treatments advertised online and on social media. Always discuss potential treatments with qualified medical practitioners. You should seek a second opinion about any treatment you are considering.
Contact your national competent authority or EMA if you have any questions or suspicions.
