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 Federal Cartel Authority (FCA) recently published for consultation draft guidelines on the good conduct of entrepreneurs. Generally, neither the practices nor the laws as described by the FCA are new. The major issue is fear: smaller and less aggressive enterprises are afraid to lose business if they stand up to their dominant contractual partners in cases where the loss of a contract could lead to their financial collapse.
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.
In 2017 an additional merger threshold was implemented to catch cases that fall below existing turnover thresholds but where the consideration for the transaction exceeds a specified amount and the target is active in the relevant country to a significant extent. While the first cases and legal discussions have shown that there is considerable uncertainty regarding the application of this legislation, new draft guidelines have been published on the application of the new, quite difficult piece of legislation.
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.
To date, the law contains no definition of 'implementation' in relation to mergers. There has been much debate in doctrine regarding whether implementation should be defined broadly as the mere possibility of influencing the target's behaviour, or more narrowly as the actual exercise of such influence. The Cartel Court's case law has followed the narrower definition. However, a recent Supreme Court decision has clarified the matter and reached a different conclusion.
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.
Following some busy years conducting dawn raids in various industries, the Federal Cartel Authority (FCA) recently published guidelines regarding such searches. Although the guidelines contain no big surprises, as they largely reflect the law and the FCA's earlier practice, there are some interesting points – particularly as some of the Austrian legal regime deviates from European law and practice.
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.
At present, the Austrian merger control regime is based on a system of turnover thresholds. Following German legislation and anticipating possible new legislation by the European Union, the new Cartel Act introduces a consideration threshold for which, at least in Europe, there is no practical experience. Due to vague criteria in the law, it is expected that more transactions than envisioned by the legislature will be caught by the new regime or at least notified by careful parties and lawyers.
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".
Although implementation of the EU Cartel Damages Directive in Austria was somewhat delayed, the Council of Ministers recently approved the bill to amend the Cartel Act and the Competition Act. The law will significantly amend Austrian cartel law, primarily facilitating private enforcement of cartel damages for consumers and enterprises alike. While Austrian law has included some of these elements since 2013, the implementation of the directive goes far beyond those implemented.
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 considered whether a special concentration had to be assessed in accordance with the EU Merger Regulation or national cartel law. The Supreme Court ultimately submitted this question to the European Court of Justice for a preliminary ruling. While an answer to this question is necessary, the interest in quick merger proceedings must also be considered.
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).
After the Supreme Court imposed a record €30 million fine on grocery chain SPAR Österreichische Warenhandels-AG and its subsidiaries, a draft to amend the Cartel Act 2005 was circulated. In addition to implementing EU Directive 2014/104/EC, the draft amends existing limitation periods, reiterates the joint and several liability of cartel members and further promotes Austria's leniency programme regarding the fine procedure.
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.