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How do patients actually get the right therapies, how are they paid for and what is the healthcare system doing to remain (financially) sustainable? These are important questions that concern the Austrian legislator, the local supreme courts, and even the EU legislator.
Behind this lies an issue that has long been causing headaches for healthcare system partners: More and more expensive and highly specialized drug therapies are coming onto the market, leading to higher costs within the system. For example, gene therapies require extensive treatment in a hospital and cost six or seven-figure sums. However, all services provided by hospitals are deemed to be covered by lump sum payments from the state health funds, even when additional costs arise due to medical advances. Therefore, if hospitals incur higher expenses due to such therapies, they may end up having to absorb those costs themselves.
patients in some federal states being denied treatment or being “referred” to another hospital in the hope that the other hospital operator will take care of the issue. Both “practices” have been ruled inadmissible by the Supreme Court of Justice: In the decision of April 29th, 2021, 2 Ob 49/21a, the Supreme Court of Justice held that from the treatment contract, which is determined by section 8 para. 2 in conjunction with section 2a KAKuG, an obligation to carry out a specific treatment, in this case, medication, can be derived in certain instances. Central hospitals must provide all state-of-the-art therapies. In the decision of July 25th, 2023, 2 Ob 125/23f, the Supreme Court of Justice also ruled that it is unlawful for a patient to be referred to another hospital if the hospital of residence can also provide the treatment required by law (because it has free capacities) and the treatment also falls within its range of services.
The key point here is that those affected can assert their right to treatment against the hospital operator through civil law (in some cases even by means of an interim injunction). This is an important clarification of the long unclear legal protection situation in this area.
The “special fund”, which has existed in a smaller form since 2017, is an instrument in which funds from a separate financing pot are earmarked for the “financing of supra-regional care services” by resolution of the Federal Target Control Commission (“Bundeszielsteuerungskommission”) (section 59g para. 1 KAKuG). It serves to relieve hospital operators of the therapy costs of particularly expensive treatments. Up to EUR 40 million is available annually for this purpose.
Since this only makes sense if these funds are used in a targeted manner to meet current and future challenges, a “horizon scanning” mechanism has been provided for since the 2024 healthcare reform [section 59f para. 5(1) KAKuG]. It is therefore methodically “screened” which new health technologies will enter the market and what financial impact they will have.
Somewhat unflatteringly dubbed the “death commission,” the 2024 healthcare reform also provided for a new “Evaluation Board” in the KAKuG (sections 62d et seq.). However, to suggest that it was the intention of the legislator to create legitimacy for withholding expensive therapies, as this term implies, is certainly misleading. According to the explanatory notes, it is intended to serve the “needs-based supply of medicinal products […] while maintaining sustainable financial viability” (ErläutRV 2310 BlgNR 27. GP 8).
The exact process and the steps involved are not yet fully clear from the law, as key elements of the process are to be regulated in rules of procedure that have not yet been established. However, the law indicates that initially, negotiations with the company authorized to distribute the product take place, followed by an evaluation process (HTA – Health Technology Assessment). The product will then be assigned to a therapeutic setting (intramural or the interface between intramural and extramural), and finally, a “recommendation” is to be made on whether or not to use the product.
The process is complex not only from a statutory perspective but also from a competency-based and constitutional standpoint, raising many questions regarding the responsibilities for process steps, the selection of products to be evaluated, and the relevance of the recommendations. We will see what comes of it and whether the “Board” can be brought to life before the elections.
This regulation deals with the evaluation of medicinal products. From 2025, benefit assessments for certain medicinal products will be harmonized at EU level in order to reduce market barriers. This will initially affect oncology drugs and medicinal products with new active ingredients, and later also medicinal products for orphan diseases. The regulation provides for a joint clinical evaluation procedure, the results of which will require member states to engage with them but not strictly adhere to them (see Ernst/Stöger, EJHL 2024). If member states have not yet established corresponding evaluation procedures (HTA), the regulation does not obligate them to do so. Some processes in Austria, such as the HTA processes that precede the future “recommendations of the Evaluation Board,” also fall under this.
This article was published in the specialist journal Recht der Medizin (3/2024). You can read it here. Our expert Gisela Ernst from the Life Sciences & Health team will be happy to answer any further questions you may have on this topic.
This article is for general information only and does not replace legal advice. Haslinger / Nagele Rechtsanwälte GmbH assumes no liability for the content and correctness of this article.
1. July 2024