Unproven cell interventions in Poland and the exploitation of European Union law on advanced therapy medicinal products.

Abstract

The global threat of unproven "stem cell therapies" develops despite the repeated statements of scientific organizations and regulatory agencies warning about the improper rationale, lack of effectiveness, and potential health risks of such commercial activities. Here, this problem is discussed from Poland's perspective, where unjustified "stem cell medical experiments" have raised the concern of responsible scientists and physicians. The paper describes how the European Union law on advanced therapy medicinal products and the hospital exemption rule have been used improperly and unlawfully on a mass scale. The article indicates serious scientific, medical, legal, and social issues of these activities.