Personalised medicine and gene therapy: understanding legal and commercial challenges in transnational contexts

A webinar presented by the IBA Healthcare and Life Sciences Law Committee and supported by the International Association of Young Lawyers (AIJA) 

Personalised medicine and gene therapy represent revolutionary frontiers in contemporary medical science, offering targeted treatments based on patients' individual genetic profiles.

However, these innovations raise complex legal issues in transnational contexts, where differences between national regulatory systems create significant regulatory challenges. On of the main issues concerns the harmonisation of regulations on data protection, as well as those concerning the regulation of human tissues, which varies considerably among different jurisdictions, so that researchers and pharmaceutical companies must navigate multiple compliance regimes for cross-border transfer of biological samples and genetic information.

An additional critical dimension of legal challenges relates to intellectual property, informed consent and medical liability in the transnational context. Finally, different market access strategies and pathways create fragmentation in the timing and cost of placing new products on the markets globally.

This regulatory fragmentation across the United States, Europe and Asia generate legal uncertainty for investors and researchers, that have to face and specifically address such topics from both a business and a contractual perspective, when they look to invest in and/or commercialise personalised medicine and gene therapy and develop the commercial applicability of such therapies.

As we are limited to 1,000 registrants, we request that you please only register for this event if you will be attending.