Probed
From left to right: Daniel Leuenberger, Claus Bolte, Karoline Mathys, Raimund Bruhin, Helga Horisberger, Barbara Schütz, Philippe Girard, Jörg Schläpfer
Swissmedic's strategic objectives “Swissmedic has political significance for Switzerland.”
In January, Swissmedic presented its new strategic direction and the seven associated objectives. Visible interviewed members of the Agency’s Management Board and discussed the developments and visions with Executive Director Raimund Bruhin.
“As a therapeutic products authority, Swissmedic is of systemic importance for Switzerland’s healthcare system. Scientific autonomy and political neutrality are two key factors here. Not only have we gained broader general recognition, we are also noticing a higher level of acceptance among political bodies. In recent years, we have opened up and become a more accessible, vibrant and present organisation. Part of that is because we have become more open in our communications. This is an area where we’ve stepped up activities hugely in recent years, and not only in response to the pandemic. One of the things we’ve learnt from the experience is to set boundaries as a regulator when engaging in the dialogue that is needed from time to time and in open discussions.
“Our strategy for 2023 to 2026 focuses on innovation, digitalisation and organisational development.”
We have taken a step forward in our relations with the government and our dialogue with the industry. We pursue an ever more active dialogue with stakeholders and take the initiative when we think it makes sense to do so. One of the results of this is that we have been able to undertake a lot of information work, particularly with political committees, and this has made us a more tangible presence. Moreover, we have been able to acquire important experience and build valuable bridges, including during the COVID pandemic.
Our strategy for 2023 to 2026 focuses on innovation, digitalisation and organisational development. In addition, we intend to further strengthen our position in the therapeutic products sector at both national and international level.
We plan to provide scientific and regulatory support for innovations created by start-ups, research and universities from an even earlier stage and are specifically seeking cooperation with a wide variety of institutions for this purpose. Our aim is to contribute our wide-ranging regulatory affairs expertise. The primary aim of digitalisation is to roll out and establish new technologies while simultaneously optimising internal and outward-facing business processes. As we do so, we will strengthen market surveillance and improve its efficacy – something that will require the necessary resources and skills.
At the end of the day, our goal is to ensure that we can fulfil our legal mandate and to optimise our functionality as the Swiss therapeutic products authority in future too. As always, everything will revolve around the quality, safety and efficacy of medical devices and medicinal products, and thus around the safety of patients in Switzerland. By doing so, Swissmedic will be making a key contribution to healthcare and to the health market.”
Raimund Bruhin, Executive Director, Swissmedic
Objective 1 Swissmedic has stepped up its supervisory and surveillance activities in the therapeutic products market.
Karoline Mathys, what is Swissmedic doing to guarantee the safety of medicinal products and medical devices in the Swiss therapeutic products market?
“Swissmedic guarantees an orderly supply of perfect-quality, safe medicinal products and medical devices to the Swiss population by undertaking effective surveillance activities and implementing corrective actions in the marketplace.
Ensuring the Swiss population can be supplied with safe therapeutic products means everyone with a stake in the therapeutic products market – from manufacturers, importers and wholesalers to users – assuming their responsibility. This is something that Swissmedic is increasingly demanding and policing.”
Helga Horisberger, what scope does Swissmedic have for stepping up its supervisory and surveillance activities in the therapeutic products market?
“The starting point is our decisions and the measures that have to be implemented quickly and rigorously. To achieve this, we are firstly improving our internal processes and secondly working to further improve our public profile. This is an area where we’ve made very pleasing progress – we have a good level of visibility and recognition – but we can still improve and intend to do so. Dialogue with the various stakeholders – who, in addition to professionals, include other federal or cantonal authorities, for example – also plays an important role.”
Objective 2 Swissmedic is known to the public as a trustworthy authority.
Jörg Schläpfer, how do the Swiss public perceive Swissmedic?
“The pandemic highlighted Swissmedic's position as a systemically important healthcare player once again. It raised our public profile and we are now known for consistent, prompt and transparent communication. As a result, we were able to consolidate and further develop public trust in our agency. Our focus on the safety, efficacy and quality of all the therapeutic products we authorise and monitor is another contributory factor.”
Barbara Schütz, what channels can Swissmedic use to increase its visibility?
“My feeling is that we are making good progress using our current channels. I think the greatest potential lies in direct contact with patient and consumer organisations because we have the same interests – to protect the health of humans and animals. That means keeping our communications up and continuing to make careful use of all our existing channels, including social media, where we can engage in and encourage direct, one-to-one dialogue.”
Objective 3 In specific areas, Swissmedic works together with other authorities and medical professionals.
Claus Bolte, what can be done to promote even greater dialogue with other authorities, companies and specialist medical authorities?
“We need to partner with other agencies such as SECO, the FOPH or FSVO to identify and define shared goals. Working with our partners, we identify a way forward to achieving our shared goals.
Just as crucial is goal-driven dialogue with various professionals, from medical professionals and vets to alternative practitioners. They all need to know what we can do and are doing – and, conversely, what we cannot do and are not doing.”
Jörg Schläpfer, is there a particular priority target group?
“From our perspective, all stakeholders are important. We have to constantly think about how we can keep improving by engaging in dialogue with other authorities at home and abroad and working together even more closely. The first focus area here is ensuring an unimpeded information flow and actively contributing to the development of harmonised international standards. The second is continuing and developing our extremely important partnerships with patient and consumer organisations and with professionals. Because we conduct regular stakeholder surveys, we know where there is still room for improvement. We will systematically exploit this potential during the new strategy period.”
Objective 4 Swissmedic supports the development of novel therapeutic products and helps ensure swift access to innovative therapies.
Philippe Girard, how can Swissmedic provide alternative access to novel therapeutic products?
“We have to eliminate unnecessary barriers for innovative medicinal products. We can successfully do so if we start our dialogue with researchers, start-ups and pharmaceutical companies that are developing such products as soon as possible. That way, we can work together to remove regulatory obstacles and speed up processes. Regular dialogue with all stakeholders is essential here so we can map out the correct course early in the development of innovative medicinal products and avoid mistakes that might delay or prevent authorisation.”
Claus Bolte, how much knowledge of novel, innovative forms of treatment does Swissmedic have?
“An astonishingly broad amount, not least because we are involved in ongoing research and development projects via the scientific advice meetings that we offer. As a result, we can support our stakeholders – ranging from small research groups (including start-ups and spin-offs) to universities and the big pharmaceutical companies – and assist them in making sure their good ideas meet regulatory requirements and are developed in a target-driven way. We have a strong international network too, working with our partner authorities, the WHO and research companies to design international standards for the future.”
Objective 5 Swissmedic implements Swiss medical device regulations on an internationally networked basis.
Helga Horisberger, what are the challenges facing Swissmedic as regards medical devices regulation?
“It is a fact that we have to put in place our own medical devices regulation that is compatible internationally and also offers an equivalent level of protection to that provided by the EU. Following the failure to update the medical devices section of the bilateral agreements (MRA) with the EU, it is now particularly crucial for Switzerland to drive forward networking with other authorities and organisations. The major challenge stems from the fact that unlike medicinal products, medical devices do not need official authorisation under current regulations. That means that if devices are imported from abroad, we have to make sure that we always have a contact person who is responsible for Switzerland. While that’s not a problem with Swiss manufacturers, foreign manufacturers have to appoint a Swiss-based authorised representative. The important thing is finding the right balance between ensuring that medical devices sold on the Swiss market are safe and guaranteeing security of supply.”
Karoline Mathys, how hard is it for a relatively small therapeutic products authority to find its place among the ‘big boys’?
“By independently implementing the new, stricter regulation for medical devices and in vitro diagnostic devices, Swissmedic is making a key contribution to patient safety in Switzerland. As members of the International Medical Device Regulators Forum, we help work towards internationally harmonised regulations. In addition, we are continuing to expand our international network for our monitoring activities, thereby guaranteeing a high level of protection for the Swiss population.”
Objective 6 Swissmedic uses state-of-the-art digital technologies.
Daniel Leuenberger, what has Swissmedic done as regards digital technologies and what successes has it flagged up already?
“We started implementing our new functional strategy on IT last year and have already made good progress. The IT organisation has been switched over to a modern, digital operating model. As a result of the changeover, an adaptable, scalable IT organisation that meets individual business areas’ needs is gradually evolving. The structure that has been chosen and the development of digital skills are key to providing new technologies securely and quickly within Swissmedic. In parallel to this, various specialists have also put the procurement law and technical aspects of our public cloud in place. In addition to smaller, innovative data analytics projects, our first major software development project conducted using modern techniques in a multi-team partnership between Software Development and IT Operations (DevOps) is being transferred to the live environment.”
Philippe Girard, how difficult is it to keep up with the leaders in digital transformation and not lose touch?
“We must succeed in preparing key information more effectively for our employees.
That requires systems that display relevant information for business cases straight away. As a result, employees will be able to find their bearings quicker and make decisions more efficiently. The system will therefore add value. The major challenge is cultural change, kindling the flame of innovation and keeping it burning, as well as persuading people that there is no need to be afraid of the process. Quite the opposite in fact. We want to harness enthusiasm to create a firm foundation for our work going forward.”
Objective 7 Swissmedic is an agile and data-focused authority.
Barbara Schütz, what does Swissmedic mean by an agile authority?
“We’ve focused on three core elements. The first is lean management, which we will use to simplify processes and make them clear and transparent. Secondly, we must deliver what is asked of us, and that means filtering the appropriate information and data out of the vast amount at our disposal. And thirdly, we support collaboration at all levels. We are firmly convinced that an authority can be agile too, despite the boundaries that the political and legal framework imposes on us. Agility is a question of mindset. We have to keep developing as well as thinking about how we can view things from a different perspective.”
Daniel Leuenberger, where does Swissmedic stand compared with other authorities?
“Digital transformation isn’t a competition between federal agencies. The transformation process we’re pursuing isn’t an end in itself, but is geared to the needs of international and national cooperation. As a public institution and legal entity in its own right, Swissmedic has full autonomy to decide how it organises and manages itself. It operates in much the same way as an expert organisation. The Agency Council and Management Board are equally committed to the ongoing digitalisation of business capabilities. Swissmedic’s position and the way it operates simplify many things about our digital transformation and make it easier to take small, rapid steps forward. We successfully completed the first important groundwork last year. The upgrading of our existing IT platform, which began last year, will continue to be a challenge over the next few years. All the major therapeutic products authorities are currently working on the further digitalisation of their business capabilities. We certainly have no need to feel shy compared with them. Systematically implementing our business goals will enable us to remain one of the world’s leading therapeutic product agencies when it comes to digital technology too.”
Swissmedic's three locations in Bern
