Life Sciences Horizons Brochure 2025 - Flipbook - Page 85
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU
The clinical trials of medicinal products involving
genetically modified organisms (GMOs) present
unique regulatory challenges within the EU. GMOs,
defined under EU legislation as organisms whose
genetic material has been altered in a manner not
occurring naturally, are increasingly used in innovative
therapies, including advanced therapy medicinal
products (ATMPs) and vaccine development.
However, due to the potential risks associated with
the deliberate or unintended release of GMOs into
the environment, the EU has established a complex
regulatory framework to govern their use.
The EU’s GMO regulatory framework consists primarily of two
Directives: the Contained Use Directive 2009/41/EC (the “EU
Contained Use Directive”) and the Deliberate Release Directive
2001/18/EC (the “EU Deliberate Release Directive”). These
directives impose strict requirements to mitigate environmental
and public health risks, including the need for detailed
environmental risk assessments and authorizations. While these
rules provide essential safeguards, their application to the clinical
trials of medicinal products involving GMOs may present
challenges for sponsors, particularly due to procedural
complexities and variability across EU Member States.
In practice, the regulation of GMO medicinal products for clinical
trials requires sponsors to navigate dual application processes:
one for clinical trial authorization under the Clinical Trials
Regulation (EU) 536/2014 (the “EU CTR”) and another for
GMO-related permissions under the national implementation
of the relevant directives. This dual burden is made more
challenging by differences in how EU Member States apply the
GMO framework, resulting in varying requirements and timelines
across the EU.
In April 2023, the European Commission has proposed reforms to
simplify the regulatory process for clinical trials involving GMO
medicinal products as part of the “EU Pharmaceutical Package,”
aiming to revise the EU pharmaceutical framework. A key element
of these reforms is the introduction of a centralized application
system, allowing sponsors to submit a single application for both
clinical trial authorization and GMO-related approvals. This
approach would replace the current system, which requires
separate applications to different national authorities for clinical
trial and GMO compliance. As of January 2025, the legislative
process of the “EU Pharmaceutical Package” is still ongoing. Once
an agreement is reached between the Council and the European
Parliament, the legislation will be formally adopted and
published. Its adoption is likely to occur in 2026, with
implementation following thereafter.
The next few pages examine the existing EU regime for clinical
trials involving GMO medicinal products, highlighting the
regulatory differences among different Member States and
the challenges they can pose to sponsors. We also explore
the European Commission’s recent efforts to streamline
the processes.
Hein van den Bos
Partner
Amsterdam
Fabien Roy
Partner
Brussels
Mikael Salmela
Partner
Paris
Jörg Schickert
Partner
Munich
Giuseppe Aminzade
Counsel
Milan
