Legal Obstacles to Stem Cell Therapy in the EU

Stem cell therapies are legally severely limited in Europe at present. For example, treatment with donor stem cells or the body’s own (autologous) stem cells that are not injected immediately after removal is currently prohibited in in the EU and in Switzerland.

Therefore such therapies must be carried out abroad. In addition, hospitals in most countries of the world are allowed to perform “approved” therapies only. However, stem cell therapies are considered “novel” and “experimental”.

Stem cell treatment in a patient with advanced amyotrophic lateral sclerosis (ALS), for example, can be performed in a specialized hospital with all-round support in the intensive care unit only for legal, medical, and ethical reasons. If such a patient desires to undergo stem cell therapy, he/she is exposed to challenges: The patient has to travel to a country in which this therapy is generally allowed and there find a hospital where it can be performed.

These mentioned legal restrictions allegedly exist for reasons of “patient safety”. In fact they were – as other standards and restrictions in the EU – imposed because of the activity of lobbyists from the relevant industry. The industry wanted to establish a monopoly on (patented) stem cell drugs, which are currently in the planning stage. It’s more about financial interests than about patient safety.

How do doctors and affected patients think about that?

DDr. Heinrich, MD

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