Author:

Keywords:

European Union, Humans, Internationality, Pharmaceutical Preparations, Technology Transfer, Tissue Banks, Transplantation, Homologous, Science & Technology, Life Sciences & Biomedicine, Technology, Cell Biology, Engineering, Biomedical, Engineering, Human cells and tissues, Directive, Quality and safety, Advanced therapy medicinal products, Globalization, GLOBALIZATION, NEED, 1103 Clinical Sciences, 1109 Neurosciences, Orthopedics, 3203 Dentistry

Abstract:

With this analysis we would like to raise some issues that emerge as a result of recent evolutions in the burgeoning field of human cells, tissues, and cellular and tissue-based product (HCT/P) transplantation, and this in the light of the current EU regulatory framework. This paper is intended as an open letter addressed to the EU policy makers, who will be charged with the review and revision of the current legislation. We propose some urgent corrections or additions to cope with the rapid advances in biomedical science, an extensive commercialization of HCT/Ps, and the growing expectation of the general public regarding the ethical use of altruistically donated cells and tissues. Without a sound wake-up call, the diverging interests of this newly established 'healthcare' industry and the wellbeing of humanity will likely lead to totally unacceptable situations, like some of which we are reporting here.