In its response, SwedenBIO states that the government should finance systemic and structural changes associated with the transition to the new EU regulation that will enter into force after the end of the year. Subsidizing the cost of processing applications is also justified in order to enable competitive and affordable processing processes. This contributes to making Sweden an attractive country for clinical trials and to the government’s ambition to have more clinical trials located in Sweden.
– The research and production activities that fall under the authority’s supervision should not themselves bear the costs of transitioning to new regulations with requirements for new IT and case management systems, says Frida Lawenius, Vice President of SwedenBIO.
SwedenBIO’s member companies want the Swedish Medical Products Agency to be a fast-moving partner with smooth processes, short lead times and high capacity. This obviously requires adequate resources for the work of the Agency. The indirect costs resulting from inefficient processes are much higher than the fees paid to the Authority. This concerns both the processes for authorization of clinical trials and a fast and flexible supervision of sites, for example through the possibility of remote monitoring.
– There is a general perception among SwedenBIO’s member companies that quality is above cost in the relationship with the licensing authorities and that the main competitive advantage lies in fast and smooth processes, not in cost, says Frida Lawenius, Vice President of SwedenBIO.
– However, increases in charges can be justified if they result in higher capacity, improved service or shorter lead times. A reduced processing time, for example, is a real competitive advantage that justifies a higher cost, says Frida Lawenius.
However, in the proposed fee model, the fees are in some cases very high and risk leading to exclusionary effects both in the choice of location of clinical trials and for certain products.
The fee for clinical trial authorization is proposed to increase from SEK 50,000 to SEK 150,000.
– The proposed level of costs is high relative to the relevant environment. According to the Swedish Medical Products Agency, an application for a clinical trial permit costs between SEK 10 and 20,000 in the neighboring Nordic countries and slightly more, around SEK 30 to 40,000 in countries such as Germany, France and the UK. These are the costs that we compete with when choosing where to locate clinical trials,” says Frida Lawenius.
The timing of the shock increase in fees is also bad. The COVID-19 situation has already complicated the conduct of clinical trials and costs are rising as changes to study designs have to be made, trials suspended and studies postponed. The surveys conducted by SwedenBIO show that there has been a gradual build-up in the pipeline of paused projects and trials on hold. And as a consequence, the cost of studying also increases.
– Additions and changes that require renewed permits also increase costs through additional fees to the authorities. For small, young and innovative companies, these costs represent significant expenditure.
This situation affects Sweden’s ability to achieve its ambition to locate more clinical trials in the country. And without clinical trials, no new therapies for the patient.
– We are in the midst of introducing new regulations with new management of permit applications. Adequate resources are needed for the authorities to be able to offer fast and coherent procedures in this transition at a cost comparable to our competing neighboring countries.
Read the full response here
