Interview with Raimund Bruhin, Executive Director of Swissmedic

The Swiss Agency for Therapeutic Products, Swissmedic, is an autonomous organisational unit of the Swiss Confederation and performs its legal mandate independently. Swissmedic takes oversight and regulatory decisions at a remove from day-to-day political business. How is this autonomy with respect to politics and other stakeholders faring during the COVID-19 pandemic? Is Swissmedic able to perform its tasks relating to the entities it oversees without yielding to pressures, and to take decisions purely on the basis of scientific principles?

Raimund Bruhin
Raimund Bruhin
Raimund Bruhin
Raimund Bruhin
Raimund Bruhin
Raimund Bruhin
Raimund Bruhin
Suddenly Swissmedic is in the spotlight. Were you surprised by how rapidly the Swiss Agency for Therapeutic Products became the focus of public attention?

The public takes the authorisation of safe, effective and high-quality medicinal products for granted. The many and varied functions performed by Swissmedic therefore usually attract little attention as long as they are done correctly.
It became clear at an early stage that new vaccines would be a way out of the crisis. So I expected us to become a central player in many respects (authorisation, establishment licences, market surveillance) and, sooner or later, to be in the spotlight – particularly with respect to the authorisation of vaccines. Against this background, the public attention came as no surprise. What I couldn’t have foreseen, though, was the speed at which vaccines were developed and made ready for authorisation in the last quarter of 2020. There was no way such a tempo could have been predicted on the basis of previous vaccine development times.

There is great pressure not only to authorise vaccines but to do it properly. Do you get the feeling that the employees are subject to particular stresses in this respect?

The precarious situation created by the pandemic is exerting great pressure on all medicines authorities to authorise safe and effective COVID-19 vaccines rapidly so that they can be administered. It's very difficult to find the right balance between speed and diligence. Employees who are directly involved with authorisation, in particular, have had an enormous workload since the COVID-19 crisis began.
But experts with many years of experience are used to drug companies’ expectations in terms of authorisation – it's part of their everyday working life, and they cope with it in a professional manner. Specific preparations over the past year, established efficient processes, regulatory standards and the employees’ own expertise make their demanding work easier. I’m impressed by the way people have coped so far with the challenges of working from home, and how well digital collaboration is working.

Swissmedic’s decisions and expert opinions must be informed solely by scientific criteria. How do you and the employees manage to remain impartial when people in Switzerland are falling ill and the healthcare system is up against to its limits?

We are all aware of the importance of our task of protecting the population, and of the responsibility that goes with it. Safety, efficacy and quality are mandated by the legislation. This creates the basis and the scope of action that we require to take decisions according to scientific criteria – and in the light of data that are adequate in terms of both quality and quantity. Medicinal products and vaccines that don’t fulfil these criteria, and therefore don’t have a positive benefit-risk ratio, endanger the safety of patients and public health. If we are guided by these principles, our actions won’t conflict with the environment in which we operate – and then we can decide impartially.

The former President of the USA put the American regulatory agency under a lot of pressure. Was Swissmedic also pressured by the country’s politicians?

We were under no direct pressure. On the contrary, the Federal Council and Parliament repeatedly stressed the importance of independent assessment by Swissmedic. But the high expectations of all stakeholders are tangible. However, the system in Switzerland is different from that in the USA. The legislation, as well as the governance and compliance provisions at federal level, ensure that Swissmedic – as a safety and economic oversight authority – is independent in political, scientific, organisational and financial terms. Swissmedic is associated with the FDHA, not subordinate to it, and is not bound by directives in its business activities. The central objective of the legislator in creating decentralised units of this kind was – and still is – to depoliticise the business transactions and tasks performed by these units. Given the overriding aim of protecting patients’ safety and public health, this prevents various interest groups from exerting influence on Swissmedic.

How come the two vaccines that were authorised first were the ones that the federal government had procured in large quantities?

A positive authorisation decision is determined solely by a careful scientific assessment. This is dependent on the applicant submitting sufficient data of sufficiently high quality. The two mRNA vaccines that were authorised first were quite simply those for which adequate data were available first to permit a reliable assessment of the benefit-risk profile – and thus enable a decision on authorisation to be made. In concluding reservation and supply contracts, the federal government was seeking to spread the risks across three different technological platforms. Selecting two manufacturers per technology platform – and thus six candidate vaccines in total – increased the likelihood of having chosen a successful vaccine.

How do you ensure that employees, managers and members of the external advisory committees are impartial?

All Swissmedic employees, the members of external advisory committees and the Agency Council are required to observe a code of conduct. Potential conflicts of interest must be disclosed at regular intervals or reported spontaneously if they arise during the year. There are requirements governing abstention and incompatibility. The tasks and competencies of the Swissmedic bodies are defined in the legislation, so responsibilities are also clearly regulated. We regularly check compliance with the requirements and repeatedly remind everyone concerned how important impartiality is in reaching knowledge-based decisions.

“One of the outstanding strengths of Swissmedic is its legally embedded political, organisational and financial autonomy – along with its scientific autonomy.”

Swissmedic’s work is not done once a product has been authorised; the safety of the vaccines will continue to be monitored very carefully. What are the findings so far?

The reports of undesirable effects of the vaccines that have been received from Switzerland and evaluated to date show no unknown signals; the safety profile of the vaccines is positive so far. The authorities in other countries with which we exchange information at frequent intervals are drawing the same conclusion. The side effects reported from practical use correspond to those identified in clinical trials. Moreover, the authorisation holders (manufacturers) are also required to monitor the safety of their vaccines on an ongoing basis and internationally, i.e. wherever the vaccines are being used. This means that the companies must have an established pharmacovigilance system managed by trained employees, and must promptly inform Swissmedic of any new findings concerning side effects that are still unknown or insufficiently known.

Is Swissmedic independent of the pharmaceutical industry in its market surveillance activities?

As with authorisations, a positive benefit-risk relationship is the key aspect of market surveillance. As the national pharmacovigilance centre, Swissmedic also determines safety measures independently and solely on the basis of scientific findings. The strict code of conduct and an established quality assurance system ensure that evaluations are impartial and are performed in light of the most recent safety signals. Necessary actions are defined solely by the need to protect patients and users, and not by manufacturers’ needs.

Raimund Bruhin
Interview with Raimund Bruhin Swissmedic's director
Wouldn’t it be a good idea to create a strict separation between authorisation and market surveillance?

Swissmedic has a number of separate divisions with highly professional skills which are applied to the tasks of authorisation, market surveillance, licensing and inspections. The two areas mentioned are already separate within the organisation. At the same time, many market surveillance processes dovetail into each other. Findings from market surveillance, for example, may lead to an authorisation being modified, or may trigger an inspection. As a comparison with other countries also shows, it is both usual and technically advantageous for national authorities which regulate therapeutic products to perform tasks relating both to authorisation and to drug safety.
A more stringent separation, with the functions being incorporated into a different organisation, would be counterproductive: it would be less efficient, and the new interface it would create would increase bureaucracy. And in any case, there are no conflicts of interest and no interdependencies between these divisions. Each division benefits from the proximity to and the availability of the other’s expertise – for example in the established expert groups, where cooperation is particularly close.

What are the outstanding strengths of Swissmedic now and in the future?

One of the outstanding strengths of Swissmedic is its legally embedded political, organisational and financial autonomy; that also applies to planning matters, because the organisation’s responsibility for strategy is likewise embedded in the legislation. The legislator’s interest is in an independent organisation managed according to business principles in which independent decisions are taken on the basis of science and data in the interest of patient safety – even in the sort of difficult situation we are seeing right now with the authorisation of vaccines.

This is what makes us different from regulatory agencies in other countries which are part of the political hierarchy and are thus more exposed to political – and, indirectly, also to economic – interests. Apart from the possible disadvantages it may have for patient safety, this situation generates opportunity costs which are not in the public health interest.
Another major advantage is the progress that has been made in digitalising processes, plus a highly motivated workforce that identifies very closely with the mandate and tasks conferred on Swissmedic. In the future we will continue to invest not only in digital solutions but also in our personnel. Job satisfaction, a high level of skills, efficient processes, a lean, agile organisation and receptiveness to new ideas and innovations are all factors that will ensure our organisation's future sustainability.

And last but not least, there is an established willingness to collaborate: Swissmedic is powerfully networked on every level both nationally and internationally, and it draws on this network in performing its mandate. Our intention is to retain, nurture and further develop all these strengths so that we can overcome the challenges posed by constant change.