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Development of Personalised Medicine within Hospitals: Myth or Reality?

Inesa Fausch

DOI https://doi.org/10.21552/stoffr/2021/2/3

Personalised medicine has become one of the major focal points in global healthcare discourse. Due to its complexity, the use of autologous human materials as well as the need for a variety of specialists, its development and manufacturing has also become an issue of rising interest for hospitals. A comparative analysis on a number of countries in and outside Europe, that looks into legal systems allowing personalised therapies to be manufactured in hospitals, reveals that some countries, such as Russia, are characterised by a strategic approach only, while others, such as Spain or Great Britain, are willing to implement suitable legal instruments and are already developing personalised medicine on site in a non-routine manner. The recent examples of personalised CAR-T cell therapies demonstrate that this can be highly successful – so despite the diversity one can see across different jurisdictions and disparate legal rules on the regulation of medicinal products, hospitals have a central role to play in the production of personalised medical therapies in the future.

Dr. Inesa Fausch is a legal adviser responsible for Central and Eastern European jurisdictions at the Swiss Institute of Comparative Law (ISDC) in Dorigny, CH-1015 Lausanne, Switzerland. She is also a member of the European Association of Health Law Interest Group on Supranational Biolaw, E-mail: inesa.fausch@isdc-dfjp.unil.ch.


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