Abstract
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.
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