AUSTRIA Trends and Developments Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
bursement of such DTx is only possible if such reimbursement complies with the ASVG in its current version. According to Section 133 (1) ASVG, medical treatment which must be pro- vided to the insured needing such treatment includes:
force on 20th of April 2025 and remains effective for three years. Conclusion Austria’s life sciences sector stands as a key driver of innovation, economic growth, and scientific progress. The sector continues to grow and evolve with public funding, a thriving research environment, and increasing business activity. It also holds many opportunities for busi- ness development. However, challenges such as pharmaceutical reimbursement, efficient and high-quality conduct of clinical trials, and regu- latory compliance must be addressed to ensure Austria remains an attractive location for life sci- ences undertakings. On an individual level, the appropriate business and legal strategy naturally plays a crucial role in profiting from Austria’s life sciences economic environment. European initiatives, including the AI Act, NIS-2 Directive, and the European Health Data Space, are set to shape the sector’s future by foster- ing digitalisation, security, and innovation. At the national level, recent legislative developments, such as amendments to the Austrian Health Telematics Act and discussions on digital thera- peutics reimbursement, highlight ongoing efforts to modernise healthcare and research infrastruc- ture. Looking ahead, Austria’s ability to navigate regu- latory challenges, leverage European opportu- nities, and support innovation through funding and collaboration among research institutions and private-sector enterprises will be crucial in maintaining its position as a leading life sciences location.
• medical assistance (“ ärztliche Hilfe ”); • medicinal remedies (“ Heilmittel ”); and • medical aids (“ Heilbehelfe ”).
The literature suggests that the current provi- sions of the ASVG also allow for reimbursement of DTx. However, it would be desirable for all stakeholders and patients that the respective provisions in the ASVG be adapted to clarify and facilitate reimbursement of DTx in Austria. Ordinance on the stockpiling of “critical medicines” The Austrian Federal Minister of Social Affairs, Health, Care, and Consumer Protection has issued an ordinance regarding the requirement for the stockpiling of (prescription requiring, not patent protected) medicinal products critical for the supply of patients in Austria (Verordnung: Bevorratung von Humanarzneispezialitäten, BGBl II 161/2024). The actual medicines con- cerned are listed in an annex to the ordinance. Marketing authorization holders are required to keep sufficient stocks of these medicinal prod- ucts in Austria. These stock levels are based on the previous year’s numbers and must be main- tained either directly by the marketing authori- zation holders or through authorized facilities. Exemptions apply in case of increased demand, force majeure, unforeseen circumstances or reg- ulatory restrictions. The ordinance comes into
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