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The wait for applications
By international standards, Swissmedic is very good at reviewing and authorising new medicines quickly. Nevertheless, Swiss patients often have a lengthy wait for medicinal products to become available. One reason for this is the "submission gap". Switzerland's small market is insufficiently attractive to pharmaceutical companies. Swissmedic wants to change this.
New medicines have the potential to significantly improve many patients' quality of life, or perhaps even cure their disease. While patients in the USA, Germany or Austria all benefit promptly from new medicinal products, it often takes longer for the same preparation to become available in Switzerland. "Patients resent this delay", says Eveline Trachsel, Head of Swissmedic's Medicinal Product Authorisation and Vigilance Sector. She sympathises with their impatience: "Many of these preparations raise patients' hopes and they want to get access to them as quickly as possible". However, when medicines are launched in Switzerland is not only up to Swissmedic, Eveline Trachsel tells us. "The crucial factor is when pharmaceutical companies submit their applications for authorisation in Switzerland". And Switzerland's small market is generally not a priority.
The more attractive the market, the earlier the submission
In the business, this delay between submission to the first authority (often the US FDA) and Swissmedic is known as the "submission gap". Pharmaceutical companies vary the timing of their submissions for market authorisation of new medicines depending on the country and region, giving preference to individual markets and focusing first on regions where they reach the greatest possible number of patients. As a result, innovative medicinal products are available later in certain countries, very often including Switzerland. The FDA, the US regulatory authority, generally comes first, says Eveline Trachsel. Companies also reach large numbers of patients in the EU. Switzerland's turn often comes later.
Swissmedic is pursuing two strategies to reduce or even eliminate the submission gap. Firstly it is in close dialogue with industry associations to further increase the speed and transparency of processes. "Secondly, we are trying to make the Swiss market more attractive", says Eveline Trachsel. It sees international authorisation procedures as a particularly promising way of closing the submission gap.
International procedures increase attractiveness
Under the Access and Orbis authorisation procedures (see box), several countries work together to assess authorisation applications either simultaneously (Orbis) or jointly (Access). Eveline Trachsel tells us that this facilitates intensive scientific dialogue between the partner authorities. Since each country ultimately decides for itself whether or not to approve medicinal products, Switzerland's particular circumstances are always considered.
Eveline Trachsel says that companies are definitely submitting applications to Swissmedic faster because of Access and Orbis. "Through Orbis we receive applications for cancer medicines with a delay of just 30 days rather than a year". Access is reducing the average submission gap per application from 350 to 100 days. Moreover, the number of authorisation applications being submitted through these procedures is growing: In 2024, around ten percent of all applications for new substances were submitted to Swissmedic through Access. "There's still room for improvement though", says Eveline Trachsel. "I hope the international community will continue to drive digitalisation forward and make cooperation simpler and tighter in the future". However, this would require secure platforms and political provisions in each individual country that would enable use of these shared tools.
All stakeholders benefit
According to Eveline Trachsel, the important thing now is to raise awareness of these authorisation procedures. Pharmaceutical companies are showing keen interest. "They can reach many more patients in one fell swoop". Companies' workload is also reduced because the authorities in each country always submit their lists of questions about an application together. "At the end of the day, all stakeholders have to same goal – to make safe, effective and high-quality medicinal products available as quickly as possible".
Eveline Trachsel, whenever a medicine isn't available in Switzerland yet, people are quick to say that Swissmedic works too slowly. Is there anything in that?
Nothing at all. In fact, the opposite is true. When an authorisation application comes in, our efficient, transparent processes mean we're similarly fast to the European Medicines Agency, EMA. This is borne out by regular benchmarking exercises, where we're one of the six top regulatory authorities in the world.
So is the delay entirely due to the submission gap?
Not only. Once a medicine has been authorised its price and reimbursement status have to be negotiated. This can take up to two years, depending on the country. Germany is fast because it has a "day zero" reimbursement model. New medicinal products go onto the market at a provisional price immediately after they have been authorised. This option is being discussed in Switzerland for certain medicines. However, price negotiations are not Swissmedic's area of responsibility.
"We are very fast."
To what extent are international procedures helping to close the submission gap?
Let's take a 2024 success for diabetes patients as an example. We became the first authority in the world to authorise an insulin preparation that only has to be administered once a week. This was possible because we assessed the application jointly with two other countries in Access. We divided the individual modules in the dossier between us. After intensive discussions and the joint assessment, we decided to authorise the medicine. Without Access, we would not have received the application so early.
Swissmedic wants to further step up international cooperation. Will there be just one shared regulatory authority going forwards?
No, that would not be good for patient safety. Since we are committed to ensuring that circumstances in Switzerland are always considered, it is extremely important that we make our own decision even after joint assessment. What's more, as Europe's top location for pharmaceuticals, Switzerland needs an independent and professional regulatory authority that can also guarantee medicinal product safety.
