Interview with Swissmedic Agency Council Chair Lukas Bruhin “We do what we promise.”

Appointed Chair on 1 August 2020, Lukas Bruhin heads the seven-member Agency Council of Swissmedic. According to the Therapeutic Products Act, the Agency Council is the strategic body of Swissmedic and supervises the Management Board. Although it is not responsible for authorisation decisions, the Agency Council is well aware of the expectation that COVID-19 vaccines should be made available in Switzerland as quickly as possible. Lukas Bruhin views the Agency Council as a “sparring partner” here, too, and as both a generator and recipient of initiatives

The interview was conducted by Danièle Bersier and Lukas Jaggi

As of the start of December 2020, Swissmedic has received four authorisation applications for COVID-19 vaccines, and the pressure is building with each submission – how do you perceive the expectations of the public?

“Swissmedic is in the limelight, and opinions about COVID-19 vary considerably. Some people believe that the authorisation of a first vaccine cannot come too soon, while others have concerns about safety. The Swissmedic experts are working very quickly and single-mindedly and are managing to cope with this pressure. They are implementing the mandate conferred on us by the government: a vaccine will be authorised when it is safe, effective and of impeccable quality. Of course, Swissmedic is prioritising these applications and sharing information with foreign regulatory authorities so that their findings can also be considered in the decision-making process in Switzerland. But one thing never changes: when it comes to safety, no corners can be cut, even for the sake of speed.”

Would it not be possible to place vaccines in circulation in Switzerland ahead of schedule, as in other countries?

“In adopting the COVID-19 legislation, the Federal Council and Parliament have expressly rejected the option of placing vaccines in circulation in Switzerland prematurely, i.e. without authorisation. This is especially important for vaccines, since they are administered primarily to healthy people as a preventive measure. On the other hand, Switzerland does have the option of temporary authorisation or an authorisation with conditions. With the rolling review and the differentiated approach, Swissmedic is able to review the data packages submitted by companies on an ongoing basis and take decisions very quickly. This means that the review process is quick, but just as meticulous as usual. With these instruments, Swissmedic can reach an authorisation decision in sync with foreign authorities when the required data packages become available. But exactly when Swissmedic is able to authorise vaccines against the new coronavirus crucially depends on the quality and completeness of the authorisation studies. Authorisations will probably be issued in phases, and initially just for a specific population group for whom sufficient data are available.”

Cannot Swissmedic simply base its authorisations on foreign decisions?

“As I said, the existing therapeutic products legislation already allows Swissmedic to take the findings of comparable foreign authorities into account in reaching its decisions. And I am glad that the legislators realised at an early stage that international collaboration is becoming increasingly important and has therefore granted Swissmedic the corresponding legal options, which we are now utilising. Since Swissmedic is actively involved in an international network, the review period can also be accelerated by synergy effects. Swissmedic and its partner authorities regularly share their respective analyses and interim results. Even after COVID-19 vaccines receive market authorisation, the worldwide sharing of information on possible long-term side effects that were not yet known at the time of authorisation will further enhance drug safety.”

You were Head of the Federal Council Coronavirus Crisis Unit. What do you bring from this period?

“Generally speaking, we in Switzerland can be glad that we possess public and private institutions that are sound and that function effectively – institutions in which motivated and committed people work. In the first wave we managed, on the one hand, very quickly to introduce measures for protecting health. On the other hand, we were able to take financial measures and make resources available. I think that we’ve communicated clearly, comprehensibly and calmly while still conveying the urgency of the situation. We have taken measures that were logical and effective, and that have been accepted by the public.”

Swissmedic has set itself the goal of becoming more visible. What are your expectations and wishes concerning the public's perception?

“Swissmedic is an Agency under public law with a sovereign remit. Accordingly, it also has a duty to explain to the public how and why it fulfils its mandate. The aim of communication at Swissmedic is to strengthen the transparency of its decisions and the trust in its work, and to make the Agency more visible. But we don't want visibility just to be "seen". What we do want is for our communication to contribute towards the enforcement of the Therapeutic Products Act, ultimately for the benefit of patient safety and consumers.”

Lukas Bruhin
Lukas Bruhin
As a former FDHA Secretary General, you are already familiar with Swissmedic. How did you perceive Swissmedic in your former role?

“I viewed Swissmedic as a highly competent, independent authority that does its job very effectively – an expert organisation, but one that competes to a certain extent with other regulatory authorities.
Swissmedic is an organisation that attracts highly skilled professionals and in which the staff are keen to be involved. However, the Agency needs to raise its profile in relation to other stakeholders and government bodies in the healthcare system and to better explain its remit. The aim is for Swissmedic to be involved at an early stage wherever it is affected by the operation of the law. Let me give you an example: participants in the legislative process need to think about Swissmedic and listen to its views on the practical implications of the law. There is still potential for optimisation in this area.”

What do you see as the strengths of Swissmedic?

“The reliability and quality of its work and, at the same time, the fast rate at which it processes authorisations compared to other regulatory authorities – we do what we promise, we are efficient. The Swissmedic personnel are another of our strengths. I have visited the various departments and everywhere been struck by the pride that the staff have in being able to work for Swissmedic. They are convinced that they are doing something important and useful. That is one reason why so many staff have been working at Swissmedic for years and why, at the same time, Swissmedic is able to recruit a ­constant stream of competent new employees.”

What do you see as the greatest challenges faced by Swissmedic?

“We could talk about that for hours. Apart from the current challenges posed by the pandemic, the main challenge, on the one hand, is definitely technological development, as this also affects therapeutic products – the convergence of medicines and medical devices, the new types of treatment and transplant products. In the field of medical devices, Swissmedic will be taking on new, additional tasks, but I believe that we are making good progress with our preparatory work here.

On the other hand, there is the challenge of the digital transformation. I have the impression that Swissmedic is also progressing well here compared to other federal agencies. The dialogue with companies that submit authorisation applications is very professional. The processes are constantly being improved and accelerated without jeopardising the attention to detail or scope of the review process. Speed and exchanging views are important. This also applies to the possible authorisation of a Covid vaccine, where the importance of "rolling submission" and entering into a dialogue with the applicant at an early stage is self-evident.

Another challenge is to recruit sufficient numbers of qualified and competent personnel – an important issue for the future. At Swissmedic we have departments in which 25 percent of the staff will be retiring in the next three to five years. We must act soon so that we are able to attract new, motivated and qualified personnel and experts. We will also be needing people with other skills: a lot of what we used to do manually will be automated in future. More interdisciplinary thinking is required. The new technological developments do not respect the responsibilities as we have defined them at Swissmedic. Keeping up to date and remaining competitive in relation to other regulatory authorities is a major challenge. We want to position Switzerland as the ideal place for authorisation applications, partly also to ensure that Switzerland is well supplied with therapeutic products.

And then we have the coronavirus pandemic, of course, which is a huge challenge. Authorising a vaccine is not the only challenge. A lot needs to be done within a very short period, medicines and clinical trials must be newly assessed and authorised, establishment licences need to be issued and market surveillance – in other words, monitoring the products that are already on the market – must be ensured.”

What can you as the Chair, or the Agency Council, do to help overcome these challenges?

“The Agency Council has a mandate that is clearly defined by law. We must fulfil this mandate usefully and effectively. The Agency Council should be a sparring partner for the Management Board, it should lead the dialogue with the Management Board about the upcoming challenges. That is a key task. We must jointly consider what the technological developments that affect Swissmedic will mean for the Agency in everyday practice – what they will mean for the revision of the strategic objectives of the Agency, and what we will need to modify in order to be equipped to face the future challenges. The Agency Council has an important role to play here as a generator of initiatives. And then there are the other legal tasks of course: the appointment of Management Board members, the dialogue with the key stakeholders so that we know what requirements will apply to Swissmedic – and so that we can then incorporate and, where possible, implement these requirements. Those are the various aspects that we cover, much like a private company's board of directors.”

“The Swissmedic personnel are another of our strengths.”

What do you see as the challenge that faces Swissmedic – as a medium-sized, efficient and professional authority – in remaining successful in the international arena.

“To retain its moderate size while still carrying out its legal mandate in all areas – properly, swiftly and effectively. Squaring that circle will be extremely difficult. I believe we’ve reached a crossroads here. For example, we will intensify coordination and consultation at the international level, take seriously the information and principles of equivalent foreign authorities, and seek and establish collaborations. Swissmedic needn’t necessarily do everything alone.
Some things also depend on developments connected with the institutional framework agreement. This is another challenge, and one that is not equally present everywhere in the public sphere.

The Switzerland-EU relationship affects our remit in respect of both medical devices and medicinal products. If we at Swissmedic, particularly in respect of market surveillance, were no longer able to access the databases of our European partners – specifically for medical devices – then we would have to set up our own organisation. That would be enormously expensive. And it's doubtful whether the high level of protection can still be guaranteed.

Swissmedic is an authority that authorises medicines. But numerous medical devices are also manufactured in, or imported into, Switzerland. This is where Swissmedic plays an important role in monitoring. For example, we ensure that the conformity assessment bodies operate correctly. The industry seeks dialogue with Swissmedic and values this contact. I want to work with the Director of Swissmedic to develop this aspect and institutionalise even more our dialogue with those associations that have an interest in our work – including with patient organisations, for example.”

Areas of competence and responsibilities that do not fall within its remit are increasingly being attributed to Swissmedic. How can Swissmedic position itself so as to prevent such incorrect notions?

“You spoke before about the question of prices for medicines. Those who work in industry and politics are well aware that, while Swissmedic authorises the medicines, it does not set the prices. Of course, authorisation opens up the possibility of a medicine being included on the List of Pharmaceutical Specialities. But those who are in the know realise that Swissmedic is not primarily responsible for the prices. If there are certain misunderstandings among the general public, then we can take note of these. But we don't need to launch a major information campaign as a result. In my view at least, that is not the greatest challenge faced by Swissmedic. However, it’s definitely useful to keep explaining the whole system. Otherwise the buck will quickly be passed from one authority to the next.

Swissmedic is a part of the institutional health policy landscape with a specific remit and a specific measure of independence. But being independent doesn't mean that we are deaf to justified concerns that are brought to our attention, or that we don't see which health policy issues are looming. We are networked, and we don’t close our eyes to issues that are not in our direct line of sight.”

Where do you want to take Swissmedic? What corporate goal are you pursuing with Swissmedic?

“We have to operate within a legal framework. My feeling is that we will still be able to carry out our legal remit effectively in the next ten years with the available resources, in the interests of the health of the Swiss population. Our credo must be: quality, safety and efficacy of therapeutic products. That must remain our top priority. We need to stand by this credo whenever we authorise a medicine for Switzerland. We can constantly review and improve the way in which we achieve this, and we are also happy to be compared with other countries when it comes to efficiency.
In addition, Swissmedic will become a trailblazer in the area of digital transformation: we utilise digital instruments in all areas.
Swissmedic will remain an institution where people enjoy working. In assuming their tasks, they perform an important and meaningful role.”

Is there something that we haven't asked you, but that you would like readers of Visible to know?

“What the Financial Market Supervisory Authority (FINMA) is for the financial sector, Swissmedic is – up to a point – the same for the therapeutic products industry. And this therapeutic products industry will become increasingly important for Switzerland. That's why our remit will also become increasingly important.”

Lukas Bruhin