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.