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.
A client recently sued her beautician because of an unsuccessful fat-burning injection treatment. The first-instance court granted the plaintiff two-thirds of her claim, holding that the defendant had had the same obligation as a physician to provide medical information on the risks and complications. However, as the plaintiff had been aware of the defendant's inexperience, she was responsible for the contributory fault, which reduced her claim by one-third.
In general, a healthcare professional may testify on observations made in respect of a patient only if he or she has been released from the obligation of confidentiality by the patient personally. However, there are a few limited exceptions to this general rule. The Supreme Court carefully applied these exemptions in a recent decision on the hypothetical release by a deceased person.
Providing patients with insufficient medical information may impede their ability to give informed consent to proposed medical treatments and thus may trigger the tort liability of physicians or healthcare institutions. However, a March 2017 Supreme Court decision has reduced the scope of the medical information that must be provided to patients.
Public pharmacies are heavily regulated in Austria. The opening of new (or the relocation of existing) pharmacies is subject to approval by the district authority. Approval will be granted only if there exists a viable need for the new public pharmacy. In a recent case, two courts ignored a 2016 amendment to Section 10 of the Pharmacies Act, which allowed a deviation from the strict 5,500 person limit set out therein.
After 14 months of negotiations between the Federation of Austrian Social Security Institutions and the pharmaceutical industry, and lengthy discussions within the government coalition, Parliament recently adopted a new price cap for expensive medicinal products and a new price regime for generics and biosimilars. The government, social security institutions and the legislature hope that these amendments will create further savings in relation to expenses for medicinal products.
The Vienna Higher Regional Court recently provided valuable conclusions about the interpretation of Article 3(a) of the Supplementary Protection Certificate Regulation – specifically, whether a functional identification of an active ingredient in a basic patent is sufficient to assess whether a product can be considered as "protected by a basic patent in force".
The Supreme Court recently ruled on the line between dietetic foods and medicinal products by presentation. The defendant was ultimately ordered to cease and desist from distributing its product OMNi-BiOTiC MIGRAene as a medicinal product without marketing authorisation and using the product's name. This decision is important as it keeps a close watch on the thin line between dietetic foods and medicinal products.
The Supreme Court recently ruled in a case involving a request for an ophthalmologist to cease and desist from providing recommendations for opticians to his clients. According to the court, the prohibition against advertising can be interpreted as allowing physicians to recommend a specific service provider to patients on request. Recommendations will be considered illegal only where they are based on inappropriate motives (eg, to gain a financial advantage).
The Supreme Court recently granted compensation for pain and suffering for mental strain to a patient after a piece of broken scissors was left in his body post-surgery. Although the claimant suffered no physical pain, contrary to the appellate court's opinion, the Supreme Court considered his distress and uncertainty to constitute a mental strain following a physical injury.
The Vienna Higher Regional Court recently considered whether an amendment to an existing marketing authorisation could be considered valid under EU Regulation 469/2009. The court referenced established European Court of Justice case law in holding that prior authorisations do not prevent later authorisations of a patented use from being considered as a first authorisation, as long as the earlier authorisation is not protected by the basic patent.
The Supreme Court recently clarified the rather sparse jurisprudence in relation to the liability of apparent manufacturers according to Section 3 of the Product Liability Act. This case centred on the question of whether there was an objective impression that the defendant was the manufacturer when the medical device was put into circulation.
The Vienna Higher Regional Court recently referred two questions to the European Court of Justice for a preliminary ruling. The Vienna court wanted to know whether the date of first authorisation for a supplementary protection certificate is determined according to EU law or the law of the member state in question; and if EU law applies, whether the applicable date is the date of authorisation or the date of notification.
The Chamber of Dentists recently sued a dentist's assistant to cease and desist radio advertising – in particular, in relation to information provided about the dentist's mobile surgery in a radio interview. While the Supreme Court noted that a cease and desist claim can be made based on third-party infringements, it held that the plaintiff could not rely on this remedy, as the defendant had reserved the right to approve the interview before it went live.
Defining the boundaries between medicines, food supplements, dietetic foods and foods is frequently difficult. A recent Supreme Court decision sheds some light on the differences between medicines and dietetic foods, clarifying that the marketing of medicinal products requires marketing authorisation and that products qualify as medicinal products due to their presentation as such, even in the absence of medicinal properties.
Applications for supplementary protection certificates (SPCs) often raise interesting and sometimes difficult questions. Following a preliminary ruling by the European Court of Justice, the Supreme Court recently issued a decision in which it provided the Patent Office with supplementary guidance for further proceedings regarding the grant of an SPC.
The Supreme Court recently enforced and supported the law which states that only qualified healthcare professionals can provide health-related advice and services. The case involved a 'bioenergetician' who offered services (eg, assessing an individual's nutritional type, testing for adverse food reactions and suggesting nutritional supplements) which are reserved for professionals who have completed specific education.
The Constitutional Court recently repealed parts of the Act on Reproductive Medicine which had prohibited female civil partners and female life partners from availing of all permitted methods of medically assisted reproduction. Under the amended act, homosexual and heterosexual individuals will have equal access to medically assisted reproduction. However, the amendment still permits different treatment of male and female homosexual couples.
The Supreme Court recently had to determine whether an advertising campaign regarding pneumococci aimed at the general public violated the Medicinal Products Act's restrictions on the advertising of medicinal products. The court dismissed the claim, holding that since none of the ads accessible to the public contained a direct or indirect reference to a particular medicinal product, the act was not violated.
A recent Supreme Court case considered a plaintiff's claim to obtain a refund for costs incurred from her daughter's alternative medical treatment abroad. The plaintiff's claim was denied, but the decision clarifies that social security institutions must bear the costs associated with the off-label use of medicines if an acceptable and promising treatment using medicines with marketing authorisation is unavailable or unsuccessful.
After years of negotiations, stakeholders in healthcare have agreed on a new model for postgraduate doctor training. The reform emphasises the obligation to complete nine months of basic training after the completion of medical studies in order to acquire basic clinical competences in the fields of internal medicine, surgery and emergency medicine.
The Ministry of Health recently granted an application for the establishment of a public pharmacy, based on an expert opinion which stated that even after the new pharmacy was established, a neighbouring pharmacy would have sufficient customer potential. On appeal, the Supreme Administrative Court did not consider this sufficient to quantify the customer potential and remanded the decision for further investigation.
A higher administrative court recently rejected an appeal brought in relation to a photosensitising substance for the treatment of cancer. The decision provides useful guidance on the differentiation of medical devices and medicinal products and supports the high safety standards with which medicinal products must comply by blocking off the back door to marketing medicinal products as medical devices.
Austrian law provides rather strict reservations on the services that must be rendered exclusively by physicians and dentists. Both the Chamber of Physicians and the Chamber of Dentists vigilantly monitor potential competitors. The Supreme Court recently confirmed this approach and upheld an interim injunction brought by the Austrian Chamber of Dentists against a beauty parlour offering 'cosmetic teeth bleaching'.
Two months ago, the Austrian media revealed that physicians in private practice, pharmacists and hospitals were providing IMS Health with patients' medication data. To obtain this information, IMS Health allegedly paid €360 a year to physicians in private practice and €1,700 a year to hospitals, plus value added tax. The revelation has caused an outcry among politicians, social insurance institutions and the Medical Chamber.
The Austrian Chamber of Pharmacists recently sued a Czech mail-order pharmacy for misleading advertising on the grounds that it had wrongly created the impression of being established in Austria. The Supreme Court dismissed the defendant's claim that the disclosure of its domicile in the legal notice and the general terms excluded the likelihood of consumers being misled.
In recent years the average annual growth of public expenditure for healthcare was consistently higher than the nominal growth of gross domestic product. The Ministry of Health has produced a draft bill that aims to bring the two growth rates into line with each other. In theory, the draft bill is well suited to achieve the aim of cost containment, but in practice its results are likely to be limited.
The Federal Office for Safety in Healthcare has issued new information on compassionate use programmes, which provides manufacturers of medicinal products with a useful guideline for gathering the necessary documentation for a successful application for such programmes in Austria. It also demarcates the borderline between compassionate use programmes and clinical trials.
The Austrian legislature recently amended the rules on advertising of medicinal products to professionals to bring them in line with the jurisdiction of the European Court of Justice. However, contrary to the explanatory materials mentioned in the bill, the limitation in relation to advertising to laypersons remains. The legislation as it stands is therefore not in compliance with EU law.
A recent advertisement placed by a Hungarian dentist in several Austrian newspapers, under the heading "Spring Promotion", was found by the Austrian Supreme Court to be illegal and to be in danger of bringing the dental profession into disrepute. The decision demonstrates that the Supreme Court will maintain its strict approach on advertising limits for medical professionals in Austria.
The Supreme Court recently upheld the appellate court's opinion that Section 17(1) of the Act on Medicinal Products requires the labelling of certain particulars in the case of eventual outer packaging, but does not require the outer packaging of medicinal products. This interpretation conforms with Article 54 of EU Directive 2001/83/EC, which provides that certain particulars must appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging.
A cosmetics producer launched a product series entitled '24 K-rat Deluxe Formula', which claimed to give consumers a youthful glow. A competitor argued that both the name of the product series and the defendant's claims were misleading. On appeal by the claimant, the Supreme Court in part confirmed the claim and in part remitted the case to the court of first instance.