Clinical studies
Swissmedic is simplifying processes and reducing obstacles
Horizon Scanning at Swissmedic
Anticipating the future
What are the changes, trends and innovations awaiting Swissmedic? This is the question that keeps horizon scanning process leader Daniel Hürlimann busy. He explains how he tracks down the unknown, when the therapeutic products agency responds and how the public benefits.
"Horizon scanning" is an expression that evokes images of a ship's lookout peering through a telescope in search of icebergs or uncharted islands. Although Daniel Hürlimann admits with a laugh that he would feel quite at home on a ship, he is generally to be found in front of a computer. "But my virtual telescope is in constant use." His job is to identify changes, trends, innovations, opportunities and risks early on, so that Swissmedic can respond promptly. "The aim is to future-proof our agency", the 44-year-old emphasises.
Horizon scanning is a technique for making the future more tangible. Swissmedic has been using it systematically since 2016. Daniel Hürlimann coordinates the work with the support of a group of specialists covering all sectors of the agency. Together, they monitor five key parameters: What regulatory, scientific and technological, political, economic and social developments could impact Swissmedic some day?
Innovative strategies and proactive measures
Daniel Hürlimann sifts through sources, reads reports and studies, tracks the work of international partner authorities and talks to researchers and market players. He particularly appreciates tip-offs from colleagues who spot trends at congresses. When an innovation emerges, he and the specialists assess it using fixed criteria: Does Swissmedic need to take regulatory action? Are the internal processes prepared for it? Does the authority have the necessary expertise? "If we identify a need for action on one of these points, we classify the development as relevant and respond proactively", Daniel Hürlimann explains.
He uses the example of medicinal product manufacturing to illustrate the benefits to the public. To save time, pharmaceutical companies are increasingly changing over to continuous rather than batch production. Swissmedic responded by issuing a guideline to ensure that quality and safety standards – particularly traceability in the event of production errors – are maintained. Daniel Hürlimann also turned his attention to the EU's reform of its medicinal products legislation at an early stage. Although the reform will not take effect for a few years yet, Swissmedic wants to be ready – for example if there is a chance that shorter authorisation times in the EU could diminish Switzerland's locational appeal.
"I look for things that I don't know exist".
Breakneck development
No matter how carefully the team work, there are still limitations. It is not possible to anticipate everything. "For example, artificial intelligence has been on my radar for a long time now, but the breakneck speed at which large language models have developed still caught me by surprise", says Daniel Hürlimann. Swissmedic uses this type of AI to track down illegal medicinal products, for instance. The man who is always looking ahead took a first degree in molecular biology, worked in industry and then studied futures research.
"I look for things that I don't know exist", he says, describing his work. It is exciting, instructive and sometimes frustrating. That makes it all the more rewarding when he discovers a "real gem". Up until now the results of horizon scanning have remained within Swissmedic, but there are now plans to publish them online in newsletter form and invite dialogue.
