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.
A recent Cartel Court decision demonstrates how a long-term relationship between Semperit and a group of Thai companies turned into an equally lengthy disagreement, which came to a decisive turning point in the courts. The final blow landed with a decision by the Federal Cartel Authority, which imposed a fine of €1.6 million on Semperit for violating the Austrian Cartel Act and Article 101 of the Treaty on the Functioning of the European Union.
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 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".