Urs Bühler is Deputy Head of the Infrastructure Division. He discusses the significance and potential of the digital transformation that is taking place within Swissmedic, and the associated opportunities and challenges.

What does digitalisation mean for Swissmedic?

“We view digitalisation as a long-term, technology- induced process of development, which is changing the economic, social and political framework and behaviour patterns. More powerful technologies, smart applications and the growing amount of available data are facilitating this development process. This is influencing both policy and law-making processes and, by extension, Swissmedic as the body responsible for enforcing therapeutic products legislation.”

What are the challenges facing Swissmedic as a result of digital transformation?

“The challenge is shifting from automating administrative processes to reviewing the evidence in machine- prepared scientific information and extending machine information analysis to public data sources. Current machine learning methods and artificial intelligence will change the way market operators deal with scientific findings. Accordingly, Swissmedic needs new methods and additional professional skills to validate the evidence in this information. For example, it makes a difference whether clinical trials are conducted with physical substances and living people or simulated virtually with the aid of digital solutions.

However, the fundamental challenge for Swissmedic is to enforce market regulation in the period between market operators starting to use innovative digital solutions and the enactment of the associated legal provisions, which generally occurs later.”

What fresh potential does digitalisation open up for Swissmedic?

“We have already harnessed much of the potential of digitalisation in our administrative processes. The vast majority of reports, applications, scientific documentation and official decisions are already exchanged with market operators in digital formats, and we process them the same way. Five years ago, for example, a market access submission involved supplying up to 2,500 binders full of scientific documentation. These days the documentation is submitted in digital format.

Machine-learning methods and artificial intelligence represent a further source of fresh potential for us. Our goal here is to be able to reduce the amount of time our highly qualified experts have to spend looking for, analysing and validating scientific documentation or identifying patterns in adverse reaction reports. We are currently gaining knowledge and experience of the benefits and risks of these technologies by means of initial machine learning-based prototype applications, which we are testing on clinical trial reviews. The initial results are highly promising.

potential as a way of intensifying communication with the public.”

Urs Bühler, Swissmedic
What specific opportunities arise from the digital processes?

“We intend to increase internal efficiency and effectiveness. We have a mandate to provide our services as quickly as possible, yet as safely as necessary, and this is what we aim to do. The new digital technologies I have mentioned provide a specific opportunity to further reduce the time we need to process applications, to identify adverse reactions even faster and to intensify our dialogue with the public. Shorter processing times increase the likelihood of applications for new innovative therapeutic products being submitted for the Swiss market first. Identifying adverse reactions quickly helps make therapeutic products safer to use. Engaging in dialogue with the public enhances our competence and credibility in their eyes. Digital processes at Swissmedic thus ultimately benefit the people who rely on therapeutic products, as well as the doctors who prescribe them.

What risks does digital transformation present for Swissmedic?

“The risks associated with digitalisation concern information security and data protection. They primarily affect the medical devices sector. Classical medical devices are being joined by a growing number of products that are monitored and controlled with the aid of digital assistants. Imagine if someone were able to manipulate the app that controls an insulin pump with criminal intent. This scenario is one that presents a particular challenge for us as the market regulator. We have to create transparency on application-related and liability risks and make sure the public are fully aware of them. Increasing digitalisation also creates operational risks. The complexity of IT infrastructures and business applications is growing all the time. To an increasing extent, maintaining the operational availability of these applications for internal and external users means greater expertise and more outlay for operations, maintenance and support.”

What does digital transformation mean for Swissmedic employees’ personal development?

“Nowadays, interdisciplinary collaboration between experts from different scientific backgrounds is a key factor in the high quality of Swissmedic's decisions. Digital transformation is expanding the existing range of disciplines. The primary focus is on expertise in mathematical disciplines, IT and project management, which will further increase the technological and organisational complexity of our knowledge organisation. This is forcing us – in a positive sense – to review organisational structures and development processes at ever shorter intervals and to adapt them as necessary. Such technology-induced developments can also trigger anxiety and fear in various groups, including consumers, the public or our own staff. Nevertheless, this trend is irreversible. We need to face up to this development with confidence, but without losing sight of the operational risks or of Swissmedic's greatest asset: the acknowledged high quality, credibility, transparency and clarity of our services.”