The Swizzard research team analyzed the drugs approved by the FDA in 2018 to assess the availability of those new treatment options in Switzerland and measure the delay to regulatory availability in the country.
The vast majority of approvals (88%; 52 approvals) were authorized by the FDA before Swissmedic, whereas Switzerland was faster in seven cases (12%). For those treatments approved, but with delay, the process took over a year for more than half of those medicines
(64%; 16 approvals). A remarkable 46% of pharmaceuticals are yet to be authorized in Switzerland.
Download our three-pager containing a visualization of our research.
Swizzard’s founder and CEO Michael Zürcher explains possible reasons for the results of our
research and shares his views on accelerating medical breakthroughs for the Swiss market.
Michael, those results are quite astonishing. Is Swissmedic to blame?
Not at all! Swissmedic did a fabulous job as we can see from the latest report on newly approved substances. An impressive 45 new products were approved in 2021 (42 in 2020). For the three fast tracks in 2021, only 207 days were required to get the regulator's green light. And the median number of calendar days until approval for new dossiers improved from 482 days in 2020 to 396 days in 2021. For the first time in its history, Swissmedic beat EMA by four days in terms of average speed. For a small country like Switzerland, the performance of Swissmedic is remarkable in my opinion.
So where is this gap coming from and what are the biggest hurdles to overcome?
We have to distinguish between big pharma, which has established functions and more resources, and the typical small biotech/pharma world. The bigger companies have a much easier time commercializing their assets in smaller countries such as Switzerland, while small biotechs have less resources and have to prioritize where to launch first. Small biotechs are often based in the US and start commercialization in their home country, which happens to be the biggest market worldwide. When those smaller companies (often with only 200-300 employees) are ready to expand into Europe, for example, it is not surprising that they prefer to start in countries like Germany or France and serve smaller countries later. Sometimes, smaller companies do not yet have the required insights and network to comfortably navigate a rather unique healthcare market like Switzerland. So there is hesitation to enter the unknown.
Swizzard’s purpose is to “sow and grow medical breakthroughs in Switzerland”.
Why is this important to you?
Switzerland is one of the richest countries in the world. And we also have one of the best healthcare systems. Swiss per capita spending on medicine is above USD 1,000, just shy of the US level of USD 1,200. There is a mandatory health insurance for all Swiss residents. And we have physicians who embrace innovation and are willing to prescribe breakthrough therapies for patients in need, as anchored in the famous article 71 of the Swiss Health Insurance Ordinance.
As an immunologist, I'm intrigued by the many medical breakthroughs. As a potential patient, I welcome as many options as possible in Switzerland as well. And we all have a family member who could benefit one day. Gaps or delays in the availability of cutting-edge therapies in Switzerland touches the core purpose of Swizzard and inspires us to bring those to the market here. It's a pleasure to support young biotechs and pharma companies in their mission to gain a foothold in Switzerland and ramp up for successful launch.
I also think those companies very much appreciate our services. Since Swizzard’s inception in early 2021, we've seen strong demand for our solution packages and just signed our 13th client. We are supporting several NASDAQ-listed biotech in setting up the Swiss infrastructure needed to prepare for successful launch in multiple indications.
How does Swizzard support companies who wish to commercialize medical breakthroughs in Switzerland?
I think it's important to have Switzerland on the radar and start the strategic thinking process early on. Mostly, discussions circle around timing and priorities as well as internal and financial resources. However, we observe that companies usually overestimate the effort and cost needed to set up in Switzerland. Our goals is to provide all-inclusive, one-stop-shop packages that take most of the workload off the shoulders of our clients. We deliver these based largely on our own expertise and experience, but we're also well connected in the industry and work with trusted partners where it makes sense. Our core strengths include our ability to deliver fast and efficient
market entry, strategic go-to-market, access/reimbursement and commercialization services. But we also minimize the risk of costly mistakes and endless searches for reliable partners such as the responsible person, an experienced regulatory vendor or an efficient Swiss distributor.
Thanks so much for this Interview!
About Swizzard Pharma AG
Swizzard Pharma AG provides a range of support services for biotech and pharma companies. Headquartered in Zug (Switzerland), Swizzard focuses on helping customers maximize the value of their medical breakthroughs in the small but highly attractive Swiss market. From setting up a smart affiliate structure and building a trusted brand to accelerating time-to-market and maximizing peak sales – four specially designed solution packages bundle Swizzard’s knowledge, experience and network to help biotech and pharma companies thrive in the Swiss market.
For further expertise on the topic, please contact us:
Swizzard Pharma AG
Corporate Competence Center
Luc Heller
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