The Supreme Court recently had to decide whether a lump-sum compensation for expenses must be considered profit. According to Section 8 of the Blood Safety Act (BSG) 1999, blood and plasm donors must not make a profit by donating blood or plasm. The law uses the terms "profit" and "compensation of expenses" only in Section 8(4) of the BSG. The concentration of these terms in one single paragraph shows a clear intent – namely, that profit is prohibited but the compensation of expenses is permitted.
The Act on Medicinal Products and the Trade and Industry Act set strict rules on the sale of medicinal products. The German-Austrian drugstore chain, dm, brought a constitutional complaint against these limitations. In a decision which is likely to disappoint those in favour of market liberalisation, the Constitutional Court recently dismissed the complaint.
The Supreme Court of Justice recently found that a party involved in the marketing of in vitro diagnostics devices did not infringe the Act on Medical Devices or EU Directive 98/79/EC because the devices in question bore the CE mark. The decision clarifies that only the Federal Office for Safety in Healthcare is competent to ascertain whether a CE mark is correctly affixed.
The medical information duty comprises the obligation to inform a patient of possible dangers and negative consequences of a treatment or failure to have such treatment. This information duty exists not only if the patient's consent to a medical treatment is required, but also if the patient must make an informed decision to refrain from having further medical treatment. However, as demonstrated in a recent Supreme Court case, patients must allow their doctor to provide such information.
The Supreme Court recently ruled that nursing homes can restrict residents' freedom by isolating them in their room. The resident in question had been isolated in his room in an attempt to prevent the spread of COVID-19 among the other nursing home residents. This decision shows the interaction between protecting the freedom of nursing home residents and challenges caused by the COVID-19 pandemic.
Although Austrian social security provides for a legal entitlement to benefits in kind (ie, free administration of medicines listed in the Reimbursement Code, except for a small prescription fee), the Organisation of Austrian Social Security is reluctant to reimburse the cost of medicines not listed in the Reimbursement Code. A recent Supreme Court decision shows that this restrictive approach is supported by the Austrian courts.
In March 2020 the legislature enacted the COVID-19 Measures Act, which authorised the Federal Ministry for Social Affairs, Health, Care and Consumer Protection to enact regulations prohibiting access to business premises to the extent necessary to prevent the spread of COVID-19. Based on this provision, the ministry enacted the COVID-19 Measures Regulation; however, the Constitutional Court recently overruled Sections 1, 2, 4 and 6 of the regulation.
Recent case law suggests that, although medical society and other expert committee guidelines are non-binding, they may serve as evidence to specify current medical standards. However, as they cannot be considered on the same level as medical standards, the application of such guidelines to specific cases requires an expert assessment.
A landmark Supreme Administrative Court decision concerning Onpro Kit, a medicine for treating chemotherapy-induced leucopenia, provides further clarity on the inclusion of medicines in the Main Association of Austrian Social Security Institutions' reimbursement code. The court examined the special circumstances in which a medicine is inappropriate for use in the course of medical treatment because it is designated for use predominantly in hospital treatments.
The Ministry of Health recently provided Parliament with a draft amendment to the Health Telematics Act for public consultation. The proposal aims to remedy a number of challenges relating to Austria's existing immunisation system through the introduction of electronic immunisation cards and a central register of vaccinations.
The Austrian professional rules for dentists are strict and restrictive and permit advertising only within tight limits. Recent case law suggests that the Chamber of Dentists is highly active in enforcing both the Directive on Advertising and the Dental Act. Under the directive, print media ads must not exceed quarter of a page and dentists must not use unobjective advertising (eg, ads which promise patients non-dental advantages or services).
Patients who are beyond treatment under the standards of conventional medicine often seek help from alternative medical treatments; however, these methods pose not only medical risks for patients, but also legal risks for doctors. A recent Supreme Administrative Court decision appears to favour a liberal approach to new therapies and compassionate use and enhances the possibilities for developing new therapies and alternative medicines in future.
When a generic is added to the Reimbursement Code, the product manufacturer or authorised distributor must reduce its price in order for the product to remain therein. If the Main Association of Social Security Institutions and the product manufacturer or authorised distributor cannot agree on a price, the product will be removed from the Reimbursement Code. A recent Supreme Court decision provides important considerations for maintaining original medicinal products in the Reimbursement Code.
While there are signs of greater liberalisation with respect to hemp use internationally, the Austrian government has resisted this trend. In October 2018 the Ministry of Labour, Social Affairs, Health and Consumer Protection published a decree outlining its legal opinion on product regulations which prohibit CBD use in food and cosmetics. However, rather than providing legal certainty, the decree merely reflects headlines relating to the government's narcotics programme.
The Austrian social security system has been characterised by regional and occupational fragmentation and the domination of employee representatives. However, a recent amendment to the Social Security Act proposes merging the provincial social security institutions with the company insurers into one Austrian Health Insurer, which will be the only provider of employee health insurance.
The two chambers of the Austrian Parliament recently adopted the government bill on the amendment of the Act on the Medical Profession. The amendment will enter into force following its publication in the Law Gazette, which is expected in late January 2019.
The Supreme Court recently ruled in an interesting case relating to comparative advertising. The court ultimately found that the challenged announcement was 'comparative advertising' within the meaning set out in Section 2a(1) of the Unfair Competition Act, as it directly and indirectly identified a competitor and its goods and services. The decision follows the letter of the law and perfectly summarises the legal structure regarding comparative and drug advertising in Austria.
The Supreme Court recently provided an extensive description of the principles of medical liability and held, in concrete terms, that the standard of care principle must not be overstretched. The court confirmed that the expert liability provided for in the General Civil Code is based on an objective standard and thus depends on the usual diligence of the persons who carry out the activity in question. As such, the performance standard of the occupational group concerned will be a decisive factor.
The Supreme Court recently ruled on the advertising of a product which sits in the grey zone between medicinal products, medical devices and foodstuffs. Among other things, the plaintiffs had originally requested that the defendant be prohibited from offering and distributing products containing zeolite and bentonite as medical devices if they were not authorised as such, including disease-related information in the advertising of those products and promoting the products as "vegan, lactose-free and gluten-free".
The delineation between medical treatment and quackery is not always easy to draw. A recent Supreme Administrative Court decision has brought some clarifications as to what constitutes legitimate medical treatment as opposed to illegal quackery.