Life Sciences Horizons Brochure 2025 - Flipbook - Page 49
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2025 Horizons Life Sciences and Health Care
Germany’s Medical Research Act benefits domestic clinical trials
The Medical Research Act (“Medizinforschungsgesetz”),
passed by the German Parliament on 04 June 2024, is
part of a larger national strategy to incentivize
pharmaceutical and medical device research and
production. For clinical trials, it has three key provisions:
Standard contract clauses for CTAs:
As the conclusion of clinical trial agreements (CTAs) has been
identified as one aspect to delay commencement of clinical trials,
Germany’s Federal Government will issue standard contractual
clauses. These will cover key terms like IP and publication rights,
liability, and data privacy. The standard clauses will be mandatory
unless the sponsor and the institution agree to deviate from them.
We anticipate that deviations from these standard clauses will
require heavy negotiations with health care organizations (HCOs)
complicating sponsors’ efforts to address specific needs related to
novel technologies and therapeutic contexts. In any case, it is
highly recommended to thoroughly review the standard clauses
once published, conduct a comparative analysis with the
company’s current CTA template, and identify necessary
deviations and negotiations strategies.
Benefits for clinical trials at German sites:
Following the launch of a medicinal product (or of an existing
product in a new indication), the Federal Joint Committee (G-BA,
“Gemeinsamer Bundesausschuss”) assesses and categorizes the
benefit of a medicinal product in contrast to the comparison
therapy. This benefit assessment (the so-called “AMNOGprocess”) is then followed by price negotiations with the Head
Association of the German Sick Funds (“GKV-Spitzenverband”)
with the price already being affected by the outcome of the benefit
assessment. In the future, the G-BA will have to determine
whether a relevant part of the clinical trial has been conducted
in Germany, which is when at least 5% of the overall clinical trial
participants have been enrolled at German clinical trial sites.
This determination will have a significant impact in the price
negotiations, if the G-BA at the same time comes to the conclusion
that the medicinal product has no quantifiable or (only) a minor
additional benefit; in such event, the thresholds for the price will
be less strict.
Confidential reimbursement price for research
in Germany:
Once the reimbursement price is set, a pharmaceutical company
can make a request to the Head Association of the German Sick
Funds (GKV-Spitzenverband) for the negotiated reimbursement
price to be treated confidential. However, to receive this benefit ,
a pharmaceutical company will have to demonstrate that it has a
research department in Germany, as well as relevant preclinical or
clinical projects and cooperations with public entities in Germany
(e.g., university hospitals). If the Head Association of the German
Sick Funds acknowledges these requirements, then the
pharmaceutical company will have to grant an additional 9%
rebate on the agreed price until the end of the regulatory
exclusivity period. This provision aims to hinder the reference
pricing in other countries to the German reimbursement price
and currently applies until 30 June 2028.
Dr. Tina Welter-Birk
Counsel
Munich
Dr. Benjamin Goehl
Senior Associate
Munich
