Transparency at Swissmedic Visibility – Creating trust
and closeness

Transparency: Sounds simple and self-evident at first sight. One reveals all and has nothing to hide. But look more closely, there are various types of transparency: for example, physical, acoustic or political transparency. And in relation to the market and the economy, transparency means that know­ledge about data and developments are disclosed and shared.

Increasing transparency was an important aim of the revision of therapeutic products legislation, which entered into force on 1 January 2019. Swissmedic is using this challenge to open itself up more and present its activities with even greater transparency. The new measures also include the publication of an official Swiss Public Assessment Report (SwissPAR). Swissmedic has created two instruments entirely designed to promote transparency: the SwissPAR and the Public Summary SwissPAR, the latter in language accessible to lay people.

For many years, the continuous improvement of transparency has been an important issue at Swissmedic. Rosa Stebler summarises the details: "Since 2015, Swissmedic has produced open evaluation reports, which transparently explain to the applicant the reasons for the result of the evaluation. With the SwissPAR, Swissmedic has now taken the next step towards a public evaluation report, which is not aimed exclusively at the parties directly involved, but also provides healthcare professionals and national and international authorities with important information on new medicinal products."

"There needs to be openness and good communication – both internally and externally."

Rosa Stebler

Since the SwissPAR is aimed at professionals, an­other publication that makes the authorisation results of Swissmedic accessible to a wider audience was also needed. This is why Swissmedic also publishes the Public Summary SwissPAR in addition to the SwissPAR. "This explains the contents of the SwissPAR in a brief summary that is understandable to lay people – it should also be intelligible to those without basic medical knowledge", explains Martina Gerber.

"Staff members from all the sections and specialist departments of Swissmedic were involved in the development of the SwissPAR", recalls Rosa Stebler. Her key principle: The SwissPAR publishes the outcome of the evaluation and the logic underpinning the decisions issued for authorisation applications for human medicines and transplant products with new active substances and their additional indications. "In the SwissPAR we focus on the transparent presentation of the benefit-risk assessment of the new medicinal product. But, as Rosa Stebler makes clear, "We do not reveal confidential information such as commercial or manufacturing secrets or personal data".

Transparency is a subject that needs to be monitored constantly, since society's need for transparency from authorities has been growing steadily in recent years. Policy makers and society also have requirements and values that they expect to be taken into account by a modern and reliable therapeutic products authority. "Transparency is a huge issue for us, and we are attempting to make our official remit and the processes of Swissmedic as a whole more transparent", explains Rosa Stebler. In publishing the SwissPAR, Swissmedic provides an insight into its review work and decision-making processes and thereby strengthens confidence in us as a competent authority. The aim of the SwissPAR is to make the scientific method and expertise of Swissmedic transparent to the outside world. "At the same time we never want - and are not allowed - to publish confidential data", says Rosa Stebler, summarising the key elements and thus the credo of Swissmedic in a nutshell. Martina Gerber adds: "We want to be visible, create trust and closeness, but also to eliminate uncertainties."

Before it was implemented, the development of the SwissPAR was reflected in a pilot phase with representatives from the pharmaceutical industry. Rosa Stebler: "Of course we are still exchanging views with industry representatives and associations and regularly sit round the table with them. The concerns of industry and the professional associations will be carefully reviewed and incorporated in the ongoing further development of the process.

The Therapeutic Products Act is the benchmark for the fundamental theme of transparency – "The Act specifies how far transparency can be implemented. In other words, we always comply with the ­legal requirements – and the same naturally applies to companies. There is very little, if any, room for man­oeuvre here", says Rosa Stebler unequivocally.

The fact remains that transparency also needs to be applied in practice. "There needs to be openness and good communication – both internally and externally", explains Rosa Stebler, adding: "Initial concerns expressed by companies and within Swissmedic about the publication of the SwissPAR had to be overcome; a certain amount of persuasion was required. But together we achieved the objective. We will also overcome any further challenges that may arise", says a convinced Rosa Stebler.

So what about the prospects for the future? Rosa Stebler, Martina Gerber and the members of the Transparency Working Group have clear ideas about this issue. Rosa Stebler is definite: "We must continue to promote trust in Swissmedic and maintain the momentum. Transparency must remain an overarching aim." Martina Gerber adds: "The pandemic itself has shown how important it is for the regulatory authorities to be transparent in respect of their processes and decision-making pathways and thereby win the trust of the public. We will work to ensure that their benefit is also visible in future." Rosa Stebler concludes: "In the end, we can use transparency to help strengthen the credibility of, and trust in, Swissmedic and demonstrate that our work benefits patients."