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.
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.
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.