Orphan Drug Designation: Key differences between Switzerland and the EU

Michael Zürcher
Oct 14
2 min read

Switzerland is not part of the EU, and its pathway for orphan drug designation (ODD) comes with relevant differences that can be of significantly benefit biotech and pharma companies.

Key differences in the ODD pathway (simplified)

In the EU, if another orphan drug already exists for the same indication, a “significant benefit” over existing therapies must be demonstrated.
In Switzerland, this requirement does not apply. The only requirement for an ODD in Switzerland is a prevalence of not more than 5 in 10’000 people (Art. 4 Abs. 1 Bst. a^decies HMG corresponds to Art. 4 VAZV). This makes ODD more easily accessible for second-in-class medicinal drug products.
Once Swissmedic grants ODD, there is no need to reconfirm eligibility at the time of marketing authorization (ODS maintenance), unlike in the EU.

Advantages from Switzerland’s perspective

Usually, easier access to ODD for second-in-class medicinal drug products, especially when comparative data are limited or do not show significant benefit.
Simplified (Art. 13 TPA possible) and cost-efficient process (including fee waivers in regulatory approval marketing authorisation application process for ODD medicinal products), with the potential for faster regulatory timelines.
15 years of data protection, enhancing commercial attractiveness.
The confirmation of Orphan Drug Designation for a medicinal drug product can act as a catalyst in Switzerland to initiate an Early Access Pathway under Art. 69a KVV in conjunction with Art. 31d KLV.

Limitation

With respect to reimbursement, orphan drugs in Switzerland are not incentivized in the same way as in Germany, for example through the presumption of additional benefit (Zusatznutzenfingierung).

Why a local partner matters

Understanding and leveraging these advantages and differences requires in-depth knowledge of Swiss regulation and practice.Swizzard Pharma guides biotech and pharma companies through every step of the Swiss market access process — from strategy to submission.

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About Swizzard

Swizzard Pharma AG supports biotech and pharma companies in successfully entering and thriving in the Swiss market. Committed to bringing innovation to Switzerland, Swizzard helps clients maximize the value of their medical breakthroughs through expert market entry, preparation, commercialization and access strategies. With deep industry expertise, hands-on experience and an extensive network, Swizzard delivers fast, efficient, and tailored solutions. The company is led by CEO Michael Zürcher, a seasoned life sciences executive with a strong track record in the industry.