Kwalifikacja prawna terapii medycznych z użyciem komórek macierzystych – przyczynek do dyskusji
Legal classification of medical treatments with the use of stem cells: Contribution to the discussion

Summary/Abstract: The purpose of this article is to discuss the major legal issues that are involved in implementing innovative medical treatments based on stem cells. It contains an analysis of legal definitions of manipulated cells, non-manipulated cells and minimally-manipulated cells. It provides an outline of the administrative requirements of the European Medicinal Agency and the Polish General Pharmaceutical Inspector that apply to the authorization of medicinal products containing stem cells. It also gives an overview of the controversies over the legal character of stem cell therapies, in particular, whether they always lead to creating an advanced therapy medicinal product that requires obtaining central marketing authorization from the EMA in London, or whether there are some exceptions where possessing a manufacturing permit issued by the Polish General Pharmaceutical Inspector is sufficient to start applying stem cells therapies to patients. The articles compares various legal approaches under Polish law, European law, as well as under recent case law from the US.

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