Olivier Negre presents on a Webinar “Developing gene therapy medicinal products: issues and opportunities in the simultaneous implementation of the EU’s GMO and ATMPs regulation” of the EU Health Policy Platform
Advanced Therapy Medicinal Products (ATMPs) have the potential to address global health problems, however, they are faced with rather strong regulatory challenges.
Consequently, only 14 ATMPs have obtained marketing authorisation (2009-2019) with more than 500 clinical trials running within Europe. In this Joint Statement, we stress that the Commission plays a critical role in ensuring access to ATMPs for patients by, inter alia, eventually revising regulatory rules and taking actions towards harmonisation of those rules among Member States.
For instance, genetically modified organism (GMO) requirements are a crucial hurdle for the ATMPs’ market access. However, complying with GMO requirements is complex and varies across the EU. The complexity and lack of harmonisation leads to delays in clinical trials with ATMPs. Not only is the EU less attractive for companies conducting clinical trials on ATMPs, but also the current position is detrimental to EU patients/trial participants whose access to ATMPs is thus delayed.
Despite that, because of the COVID-19 pandemic, the Commission granted a temporary derogation from GMO requirements for investigational COVID-19 medicinal products, so as to accelerate the development of vaccines and treatments.
Thus, one option to foster the development of ATMPs is to consider the implementation of an exemption regime or a less burdensome procedure for complying with GMO requirements for ATMPs undergoing clinical trials, depending on the risk involved.
Indeed, a simplified and centralised GMO approval process for clinical trials could reduce delays in the initiation of clinical trials and make it more likely that trial sponsors base their research in EU Member States.
