From the Executive Director Swissmedic: Communication – the cornerstone of therapeutic product safety

Strategically and operationally, communication is a key factor in fulfilling our mandate. Today, listening and talking to people as equals is more important than ever as a way of promoting acceptance and creating trust.

Communicating transparently and in an audience-appropriate style

To reach our target groups more effectively, we have adopted a more proactive communication strategy since 2019 and use various social media channels in addition to ‘Visible’. To date we have gained around 45,000 followers on LinkedIn, and today Swissmedic is perceived by a wider audience as being more open and having a stronger presence.

At national level, we maintain an active dialogue with our stakeholders, organise round tables and answer over 9,000 inquiries from companies, health specialists, the public and the media each year. Our Innovation Office supports and advises start-ups, research institutes and universities on scientific and regulatory issues so that patients in Switzerland can access new, promising medicines quickly.

In this era of fake news and half-truths, science-based but comprehensible information is more important than ever. That’s why we published the first issue of ‘Visible’ in June 2020, just at the start of the coronavirus pandemic. The rapid authorisation of COVID-19 vaccines raised Swissmedic’s profile dramatically.

Making Swissmedic’s comprehensive duties visible

It has been and continues to be all the more important to me to show that, in addition to the authorisation of medicinal products, Swissmedic plays a key role in safeguarding the safety and health of humans and animals in Switzerland in other core areas too. We approve and monitor clinical trials of medicinal products and medical devices, issue establishment licences for medicinal product manufacturing and wholesale trading, inspect hospitals, oversee safety and quality in the marketplace, work with national and international partners to combat illegal trade, and prosecute violations of therapeutic products legislation. By undertaking this comprehensive supervisory activity, Switzerland accommodates the public’s strong awareness of the importance of health and their need for safety.

“In this era of fake news, science-based comprehensible information is more important than ever.”

Contributing at international level

International links are essential for these activities. That’s why we are in close contact with sister authorities around the world and actively help draft international standards and guidelines for the pharmaceutical industry and medical technology in global organisations such as the International Council for Harmonisation (ICH) or International Medical Device Regulators Forum (IMDRF). New technologies such as advanced therapy medicinal products (ATMPs), software with a medical intended use or artificial intelligence in medicinal product development are raising new regulatory questions around the world. Swissmedic is addressing these complex challenges and remaining fit for the future by integrating these developments into our activities and recruiting experienced staff with the appropriate specialist skills.

This tenth issue of ‘Visible’ provides information on all this – comprehensibly and in a public-friendly, exciting way. It also clears up misunderstandings. Swissmedic is responsible for the safety, quality and efficacy of therapeutic products, but not for pricing, reimbursement by health insurers or supplies of medicinal products and medical devices to the domestic market.

Political neutrality and scientific autonomy

Swissmedic is part of the decentralised federal administration. This was a deliberate choice by Parliament to guarantee the therapeutic products agency’s independence, political neutrality and scientific autonomy. This status proved its value during the coronavirus pandemic, when we were able to take a leading role globally in the authorisation of vaccines.

Contrary to popular belief, Swissmedic is one of the six fastest therapeutic products authorities in the world, as various benchmarking studies and the audit report produced by the Federal Audit Office in January 2024 attest. While the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) may occasionally be faster in authorising products than Swissmedic, this is generally because they have received the applications earlier too. In spring 2024, our Swissmedic was one of the first three authorities in the world to be recognised and designated as a “WHO Listed Authority” (WLA). The WHO thus confirmed Swissmedic’s high quality standards and excellent international benchmarking results.

Health – our most important asset

Swissmedic is responsible for supervising a market that accounts for more than eight percent of Switzerland’s gross domestic product and some 300,000 jobs (including positions that depend on the sector). By guaranteeing the safety, quality and efficacy of therapeutic products, we make a crucial contribution to the high quality of medical care in Switzerland and prevent severe disability, invalidity and death as a result of defective products. Everything that Swissmedic does serves patient safety because health is our most important asset.