24.03.2025.
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have issued a stark warning to the public about the dangers of unregulated advanced therapy medicinal products (ATMPs) being offered to patients within the European Union.
What are ATMPs?
Advanced therapy medicinal products are innovative medicines based on genes, tissues, or cells. When properly regulated—either authorised by the EMA or approved by national health authorities—these treatments offer significant benefits to patients suffering from serious conditions. To ensure safety and efficacy, the European Union has implemented strict guidelines for ATMPs.
However, despite these regulatory measures, some companies, clinics, and individuals are marketing unregulated ATMPs directly to patients.
This is particularly concerning as many of these products, including dendritic cell therapies used in cancer treatment, lack sufficient evidence to support their safety or effectiveness.
The dangers of unregulated ATMPs
Authorities are warning that unregulated ATMPs pose serious risks to patients, including:
- Severe side effects – Without proper oversight, these products may cause harm rather than provide therapeutic benefits.
- Quality-related issues – Lack of regulatory supervision increases the likelihood of contamination, inconsistent composition, and improper storage, all of which can affect the safety of the medicine.
- Financial and emotional burdens – Patients may spend significant amounts of money on ineffective treatments while enduring emotional distress.
To protect public health, authorities are urging patients to use only authorised or approved ATMPs and to report any suspicious products to their national competent authorities.
Key information for patients and families
Unregulated ATMPs are often marketed online and through social media as a “last hope” treatment, preying on the fears of vulnerable patients and their families.
National authorities are actively working to halt the sale of such products, sometimes even involving law enforcement.
If you or a loved one is considering an ATMP, follow these guidelines to ensure safety:
- Verify authorisation – Check with official sources like the EMA or your national health authority to confirm the medicine’s approval.
- Be cautious of online advertisements – Treatments promoted on websites or social media platforms are often unregulated.
- Consult a qualified medical practitioner – Always seek professional medical advice and consider a second opinion before proceeding with treatment.
- Report suspicious cases – Contact your national competent authority or EMA if you suspect an ATMP is being illegally marketed.
How are ATMPs legally supplied in the EU?
In the European Union, ATMPs can only be legally provided if they meet one of the following conditions:
- They are centrally authorised by the EMA – This ensures they have undergone rigorous evaluation.
- They are part of an authorised clinical trial – National authorities oversee the safety of experimental treatments.
- They have received special exemption for hospital use – Under strict conditions, national authorities may allow specific ATMPs to be used in a hospital setting.
Providers who market ATMPs outside these legal pathways are not only putting patients at risk but may also be violating the law.
How to identify an unregulated ATMP
Be wary of ATMPs that exhibit the following red flags:
- The product is marketed as “experimental” but is not part of a registered clinical trial.
- The provider cannot verify its approval from the EMA or national authorities.
- The treatment is claimed to be significantly superior to currently authorised medicines without documented evidence in medical literature.
Why regulation matters
Like all medicines, ATMPs must adhere to EU regulatory standards to ensure their safety and effectiveness. Developers are required to conduct well-structured clinical trials to evaluate the risks and benefits of their products.
When they seek market authorisation, the EMA’s scientific committees, including the Committee for Advanced Therapies (CAT), thoroughly assess the data to confirm that the benefits outweigh the risks.
By upholding these strict regulations, the EU ensures that patients receive safe, high-quality, and effective treatments.
