AUSTRIA Trends and Developments Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
Current Challenges • In addition to the implementation of the numerous European directives and regula- tions in the life sciences field (see below), the new Austrian government will have to deal with the following major challenges in the life sciences sector, for example: • regarding reimbursement of medicinal prod- ucts (currently very low price level regarding off-patent medicines, on the other hand, in principle availability for reimbursement by the state sick funds of extremely expensive innovative medicines); • ensuring that Austria remains an attractive location for research and clinical trials (eg, through safeguarding efficient and high-qual- ity implementation of clinical trials in accord- ance with the Clinical Trials Regulation (CTR), optimisation of administrative processes in the operational implementation of clinical research projects and the extension of eligibil- ity for research funding to multicenter clinical trials with Austrian participation); and • public healthcare reform – guaranteeing access to healthcare by strengthening the private practice sector European Initiatives Are Drivers of Development European initiatives influence many develop- ments in the Austrian life sciences sector. Below, you will find the currently most significant regula- tions and initiatives. AI Act The European Parliament passed the AI Act on 13 March 2024, and its directly applicable provisions will likely also influence life sciences- related AI applications, machine learning, and big data projects in Austria. Inventors and found- ers will have to take different precautions, taking
into account the expected risk that emanates from the prospective AI. Both medical devices and IVD-medical devices fall under the scope of the AI Act as they are considered high-risk AI systems. Henceforth, developers and investors will need to examine whether their AI tool complies with the obliga- tions of high-risk AI systems. These obligations cover a risk management system, data govern- ance, technical documentation, transparency and information provision, robustness, accu- racy and security, human oversight, conformity assessment, post-market monitoring, CE mark- ing, registration with the EU’s database and cooperation with authorities. NIS-2-Directive The NIS-2-Directive, a legislative act intended to strengthen cybersecurity, was due to be trans- posed into national law on 17 October 2024. The most recent legislative attempt failed because of a missing majority in the Austrian parliament. Notwithstanding, compliance with its obligations should already be achieved as the draft of the transposing law ( Netz- und Informationssystem- sicherheitsgesetz 2024) already exists, and the legal act is expected to be passed soon. The NIS-2 Directive applies to a broader range of entities than its predecessor (NIS Directive), tar- geting the following. • Essential entities – larger organisations with critical roles, such as pharmaceutical com- panies, biotechnology firms, and healthcare providers. • Important entities – medium-sized enterprises that provide significant services, such as clini- cal research organisations (CROs), diagnostic labs, and supply chain partners.
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