Potential risks of advanced therapy products promoted online

The HPRA wishes to highlight the recent joint statement from the European Heads of Medicines Agency (HMA) and the European Medicines Agency (EMA). This statement highlights the potential risks of advanced therapy medicinal products (ATMPs) promoted online for therapeutic benefit but which may not be authorised in Ireland.

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. Currently, the HPRA is not aware of any patients in Ireland receiving these treatments. However, we encourage anyone who has engaged with such providers to share their experience with us. We can be contacted at confidential@hpra.ie. Any information shared with us will be treated sympathetically and in confidence.

We recommend patients always discuss potential treatments with their healthcare team. Examples of authorised ATMPs include somatic-cell therapy medicines, tissue-engineered medicines or gene therapy medicines. The HPRA has published general advice to support patients considering cell-based therapies.

We will continue to engage with other regulatory authorities, the Department of Health and the European Commission on this matter.