Life Sciences Horizons Brochure 2025 - Flipbook - Page 87
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2025 Horizons Life Sciences and Health Care
Complex patchwork of rules govern GMO medicine trials in the EU (continued)
Germany
The German legislator considers the use of a
medicinal product containing or consisting of GMOs
to be a “deliberate release” of such GMO pursuant
to the EU Deliberate Release Directive. Such clinical
trials, therefore, require authorizations under both
the EU CTR and GMO legislation.
Consequently, the German Medicinal Products Act
(Arzneimittelgesetz, “AMG”) stipulates that the sponsor of
a clinical trial involving a medicinal product containing or
consisting of GMOs has to submit – in addition to the
documentation to be submitted pursuant to the EU CTR –
the documentation required under Annex II and III of the EU
Deliberate Release Directive. This includes, without limitation, an
ERA of potential adverse effects of the GMO on human health and
the environment and preventive measures to be taken.
Sponsors must submit the documentation pursuant to the
EU Deliberate Release Directive to the higher federal authority
(Bundesoberbehörde, “BOB”) that is competent for the decision
on the clinical trial under the AMG and the EU CTR (the
Bundesinstitut für Arzneimittel und Medizinprodukte, “BfArM”;
or the Paul-Ehrlich-Institut, “PEI”). The BOB will then liaise
and align with the federal authority for consumer protection
and food safety (Bundesamt für Verbraucherschutz und
Lebensmittelsicherheit) on the GMO-related aspects. The
ultimate decision by the BOB on the sponsor’s clinical trial
application will comprise both the decision under the EU CTR
and the GMO legislation. For the sponsor, this means that it does
not have to deal with two different authorities, because the
competent pharma authority obtains the opinion of the GMO
authority in an internal procedure.
However, the procedures under pharmaceutical legislation and
under GMO legislation are not completely aligned. For instance,
the EU Portal for the EU-wide submission of clinical trial
applications under the EU CTR does not allow the submission of
the ERA. Therefore, the ERA has to be submitted separately on a
national level. Also, there is no harmonization of the assessment
periods under Art. 8 of the EU CTR and those under GMO
legislation. As a result, the decision under GMO legislation may
still be pending when the EU CTR decision is due. In such event,
the BOB will take an isolated decision pursuant to the EU CTR
when due; however, the sponsor must not commence the clinical
trial until it has also received the authorization under
GMO legislation.
Dr. Benjamin Goehl
Senior Associate
Munich
