Life Sciences Horizons Brochure 2025 - Flipbook - Page 91
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU (continued)
France
In France, clinical trials involving investigational
medicinal products containing GMOs are subject to a
complex set of various regulations involving European
and French rules applicable to clinical trials and
European and French rules applicable to GMOs.
With regards to the national applicable regulations,
the French Public Health Code is applicable, as well
as the French Environment code.
The use of medicinal products containing GMOs in the context of
a clinical trial in France is mainly considered as a contained use of
GMOs. However, in some cases, notably in the context of early
access stages, the use of investigational medicinal products
containing GMOs can fall under the classification of deliberate
release. In both cases, specific regimes apply to the rules
applicable to GMOs to take into consideration the specific health
context in which the investigational medicinal product is used.
A specific expert committee has been created within the Ministry
of Research to provide assistance in the classification of the
GMOs, to determine the level of risks for public health or
environment. Even if the criteria are provided in the regulation,
sponsors can reach out to this dedicated expert committee to
receive assistance on the applicable classification and the related
protection measures to be implemented.
Two procedures apply for the contained use of GMOs in the
context of a clinical trial, depending on the level of risk for public
health and environment:
an authorization procedure for contained use with low or high
risk must be submitted by the sponsor before the French
National Agency for Healthcare Products and Medicines Safety
(ANSM), which provides its decision upon the prior opinion of
the expert committee. The authorization request must be
based on a technical file including a risk assessment.
a simplified declaration procedure for contained use with
no or negligible risk, which has been available since 1 June
2022. The sponsor must submit a prior declaration to the
ANSM, including a technical file containing a risk assessment.
The ANSM may consult the experts committee if it has any
doubts or questions on the level of risk entailed by the use
of GMOs in the context of the clinical trial.
In some limited cases, the use of GMOs in the context of clinical
trial may rather fall under the definition of deliberate release. In
such case, the above procedures are not available to the sponsors,
which should rather comply with legal obligations applicable to
the deliberate release of GMOs. Under this regime, the sponsor
must request an authorization before the French Ministry
of Environment.
The ANSM has detailed the relevant procedures on its website,
and has released simplified forms to accelerate the formalities
which must be fulfilled by sponsors launching a new clinical trial
in France involving medicinal products containing GMOs.
Joséphine Pour
Senior Associate
Paris
