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Use Caution Regarding Commercial Treatment Offers of Unauthorised / Unapproved Advanced Therapy Medicinal Products

The European Medicines Agency (EMA) and the EU Member States’ Heads of Medicines Agencies (HMA) would like to call the public's attention to the potential risks posed by certain unauthorised or unapproved advanced therapy medicinal products (ATMPs). The warning comes in light of the growing number of commercially available treatments within the European Union, most recently in the field of dendritic cell therapies for cancer treatment.

CAR-T Cells Source: Meletios Verras/Shutterstock

ATMPs are highly innovative medicinal products that are based in particular on the targeted genetic modification of cells or on biotechnologically engineered cells or tissues and can have considerable medical benefits. High regulatory standards apply in the European Union (EU) to ensure the safety and efficacy of ATMPs. These medicinal products must therefore be centrally authorised by the EU Commission following a procedure at the EMA. National medicines authorities such as the Paul-Ehrlich-Institut can approve ATMPs under certain conditions. The regulations are targeted to provide the best possible protection for patients and to ensure that new therapies are both safe and effective.

Risks of Unauthorised/Unapproved ATMPs

Caution! ATMPs that have not been officially approved or authorised are currently being advertised online, on social media, and in other forums – often without reliable scientific evidence of their effectiveness or safety. Such unauthorised/unapproved products are also not subject to mandatory controls regarding their quality, composition, and storage. Using these products can lead to health risks such as serious side effects. In addition, there is a risk of financial costs and emotional disappointment for patients who hope for an effective treatment.

EMA and national authorities therefore only advise treatment with ATMPs that are authorised or are administered within the framework of approved clinical trials. Under certain conditions, an individualised treatment can also be carried out in Germany at specialised centres, e.g. university clinics and hospitals. Such individual approaches are also subject to clear legal framework conditions and are free of charge for patients.

How Can Patients Recognise a Potentially Unauthorised ATMP?

Warning signs for unauthorised/unapproved ATMPs can include:

  • Promise of a cure for serious illnesses without scientific evidence.
  • Commercial offerings of “experimental therapies” outside of approved clinical trials.
  • No confirmation of an authorisation or approval by the EMA or national authority.
  • In some cases, high costs that are not reimbursed by the health insurance companies.

What Patients and Their Relatives Should Consider:

  • Such treatment offers can often be found online or on social media and are aimed specifically at seriously ill patients.
  • Detailed advice should be given before each treatment by specialists who specialise in the treatment of the disease in question. If in doubt, consulting your health insurance company about the possibilities of obtaining a second opinion from other independent specialists is recommended.
  • You should be particularly careful regarding expensive offers that are not reimbursed by your health insurance company. It is recommended that you contact your health insurance company before starting treatment with regard to the question of possible cost reimbursement.
  • Suspected cases of side effects can be reported to national authorities. Reports can be submitted in Germany via the Paul-Ehrlich-Institut's online portal.
  • If you suspect treatment with an unauthorised/unapproved ATMP is being offered, please submit a report to the state authority responsible for the monitoring of medicinal products.
  • The Paul-Ehrlich-Institut offers information on authorised/approved ATMPs on its website.

Updated: 31.03.2025