Preslmayr Attorneys at Law
Preslmayr Attorneys at Law is one of Austria's leading commercial law firms. With about 20 lawyers it is also among the larger firms in a country where they are traditionally relatively small. Our offices are conveniently located opposite Vienna University on historic "Ringstraße". Our clients, both from Austria and around the world, are primarily large to medium-sized businesses in the fields of banking, manufacturing, trade, investment, food and drugs, oil, microelectronics, software development, advertising, pharmaceuticals and institutional investing.Show more
Competition & Antitrust
Amazon has offered to change its terms and conditions following a series of Federal Competition Authority (FCA) investigations regarding business practices on the 'Amazon.de' marketplace. The FCA conducted an extensive market survey in which approximately 400 of the top-selling Austrian marketplace traders on 'Amazon.de' were interviewed in writing and via telephone. The survey results showed that Amazon had market power for a representative selection of larger Austrian marketplace traders.
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 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.
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.
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.
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.
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.
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 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.
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.
Triggered by a complaint from radio station Kronehit, the Federal Competition Authority (FCA) looked into the media cooperation practices between radio broadcasters and concert and festival organisers. The investigation led to a set of FCA guidelines for media cooperation which will address the prevalent inequality between Austrian public broadcaster radio stations and private radio stations as media partners of concert and festival organisers.
The Cartel Act contains antitrust regulations on cartels, merger control and abuses of dominant market positions. It sets out the rules on what constitutes a cartel, the definition of vertical restrictions, joint dominance and mergers and establishes the conditions for when pre-merger control applies.
Following a dawn raid of the business premises of one of Austria's biggest food retailers, the company challenged the Cartel Court's order to conduct the raid and the Federal Cartel Authority's actions during the raid – in particular, due to the use of espionage software. The Supreme Administrative Court dismissed the applicant's appeal and ruled that the use of forensic software to access electronic data during a raid is unquestionably legal.
The Higher Regional Court, acting as the Cartel Court, recently imposed a fine of approximately €17.5 million on 30 forwarding agencies for infringing European competition law by agreeing on tariffs regarding collective freight transport between 2002 and 2007. The Cartel Court's decision preceded significant discussions among competition law specialists and several other Austrian and EU decisions clarifying important questions of law.
Following criticisms of an apparent lack of information and transparency in Federal Competition Authority (FCA) settlement proceedings, the FCA has issued guidelines on its settlement policy, elaborating on its legal position and practice. While it is clear that settlements provide some legal certainty for undertakings, they must be treated with caution, as settlement decisions include a binding sentence of guilt.
In the course of recent investigations the Federal Competition Authority (FCA) has found prohibited agreements between suppliers and their respective distributors, primarily in the field of consumer prices. In the wake of these findings, the FCA published its final statement on vertical restrictions – particularly resale price maintenance. The statement serves as a guide to identifying and avoiding infringements of the cartel ban.
The Supreme Court recently ruled on the scope of the Cartel Court's obligation to publish its fine decisions and highlighted the importance of transparency as the main goal of Section 37 of the Cartel Act. In its decision, the court made clear that the purpose of Section 37 is to present market participants with clear information about cases so that they may evaluate damages claims.
The Supreme Court (acting as the Higher Cartel Court) recently decided once again on the investigatory powers of the Federal Cartel Authority (FCA) with regard to house searches. The case focused on suspicions by the FCA of participation in anti-competitive agreements and/or concerted practices with regard to vertical price agreements between the applicants and retailers of daily consumer goods, among other things.
The Supreme Court (acting as the Higher Cartel Court) recently issued its decision in a case concerning a tender procedure organised by a large Austrian municipality that was subject to heated debate among practitioners. The court ruled that the consortia (if consortia at all) were so-called 'de minimis cartels' within the meaning of the Cartel Act, and therefore were in any case exempt from the cartel ban.
The Supreme Court recently considered a case in which an acquiring entity failed to notify the Austrian Federal Cartel Authority (FCA) of a share increase in relation to a Hungarian entity. The case came to light following a subsequent share increase, of which it duly notified the FCA. The acquiring entity's actions were based on legal advice that later turned out to be erroneous.
The Supreme Court referred a question to the European Court of Justice (ECJ) regarding whether an error on the legality of actions based on advice from a specialist adviser or a decision by a national competition authority would be a viable defence against fines imposed on an undertaking for infringing Article 101 of the Treaty on the Functioning of the European Union. The ECJ has now answered this question in the negative.
The Federal Cartel Authority (FCA) has published draft guidelines on vertical (pricing) restraints. The FCA described certain practices and commented on their respective illegality or legality with a view to preventing future infringements. While it remains to be seen how these guidelines will affect authority and industry practice, the FCA and national competition authorities are increasingly monitoring vertical relationships.
The long-discussed changes to the Austrian competition laws have finally become effective. These concern, among other things, the leniency programme implemented in Austria in 2006. The amended Competition Act now makes it possible for undertakings to qualify for full immunity from fines on a leniency request even after the Federal Competition Authority has gained knowledge of the reported infringement.
The Higher Cartel Court recently ruled on the obligation of dominant undertakings to contract with other market participants, including competitors, under specific circumstances. It held that they must be very careful to avoid discriminating against other undertakings by refusing to contract with them. The decision provides interesting clarifications on the applicability of the 'essential facilities' doctrine in such cases.
The Cartel Court recently rejected a Federal Cartel Authority action to fine approximately 50 Austrian plumbers for alleged collusion in a tender procedure initiated by the City of Vienna housing agency in 2007. The court ruled that all activities of the defendants - regardless of whether they had actually infringed cartel law - were exempt from the cartel ban under the Austrian de minimis regime.
Two recent Supreme Court decisions have triggered significant debate in the competition field, both in Austria and at a European level. Both cases questioned whether a justified error in law could exclude the imposition of a fine for alleged anti-competitive behaviour. One case has been referred to the European Court of Justice, as the Supreme Court considered that EU law did not provide a clear answer.
After a lengthy internal discussion process, the Ministry of Justice and the Ministry for Economic Affairs recently presented a draft bill for changes to the competition law in Austria. While fundamental changes to this draft bill are unlikely to occur, it remains to be seen how these amendments - if enacted - will affect administration, jurisdiction and advocacy for competition law in Austria.
For some time, the official guidelines of the tax authorities on income tax have included the way in which competition fines should be treated under income tax law. With the recent entry into force of the Act Changing Tax Law 2011, the deduction of competition fines as a whole is now explicitly excluded. Under the new law, undertakings hit by fines for infringing competition law may feel a double impact.
The Supreme Court has clarified that even after an entity has ceased to do business, it may remain an 'undertaking' for the purposes of the Cartel Act, since it may transfer a market share of considerable value. The decision leaves open the possibility that an acquisition of assets from an insolvent company may constitute a merger under Austrian law.
Acting on a respective application from the Federal Cartel Authority (FCA), the Higher Regional Court of Vienna, acting as cartel court, recently fined four print chemical wholesalers €1.5 million (not final). The FCA's investigations were initiated by two whistleblowers that filed consecutive applications with the FCA to be granted immunity from the fine.
In 2009 the Supreme Court authorised the search of an Austrian company's premises to investigate possible cartel law infringements relating to the German fire engine market. Recently, in dealing with the same alleged infringement, the court issued a decision on the preconditions for searching the offices of attorneys who represent possible cartel members
The Supreme Court, acting as Higher Cartel Court, recently rendered its first decision on the preconditions for the Federal Cartel Authority to conduct house searches in Austria on behalf of other EU antitrust authorities. The decision allows for the execution of house searches in Austria even in cases that do not affect the Austrian market.
In 2008 and 2009 the Supreme Court, acting as Higher Cartel Court, rendered rare decisions on the basis of the Local Supply Act. These controversial decisions may have significant consequences for the qualification of undertakings' discriminatory practices.
The Supreme Court, acting as Higher Cartel Court, recently confirmed a second Cartel Court fine decision based on the 2006 leniency programme. According to the Supreme Court's decision, in future, before filing its applications with the Cartel Court, the Federal Cartel Authority will have to examine in detail whether the preconditions for accepting an undertaking under the leniency programme have been met.
The Supreme Court, acting as the Higher Cartel Court, recently rendered a new decision on a previous infringement of antitrust law that had ongoing effects. The case involved the allegedly abusive promotion of contracts no longer available on the market by the defendant.
The Supreme Court has upheld two Higher Regional Court of Vienna (as Cartel Court) decisions and ruled on the preconditions for receiving a declaratory decision on past infringements of antitrust law. Damages claims following a fine decision in cartel matters must be filed in the civil courts under the rules of civil procedure, without additional assistance from the cartel authorities and the Cartel Court.
The Supreme Court recently ruled on the abuse of a dominant market position through promotional giveaways that conformed to the provisions of the Act against Unfair Competition. The court had to judge the legitimacy of a newspaper that held a dominant position offering promotional giveaways to potential subscribers.
The Higher Cartel Court recently redoubled a fine imposed by the Cartel Court for infringement of the obligation to provide information upon a formal information request by the Federal Cartel Authority. The decision emphasizes the importance of fulfilment of this obligation.
In a recent merger control procedure the Cartel Court had to consider whether an additional acquisition of shares by a 50% shareholder may lead to a change of control in the target company and thus result in a notifiable merger. The court stated that in connection with obtaining control in a company, there is a distinction between joint and sole exercise of control.
Court proceedings were recently initiated by a party to a contract that contained a clause which infringed antitrust law. The Higher Regional Court of Vienna, as Cartel Court, had to decide whether it had jurisdiction to declare an infringement of antitrust law if the infringement had already been terminated (ie, the illegal clause was declared inapplicable or had been removed from the contract).
The Supreme Court (as the Higher Cartel Court) recently issued a record fine of €5 million for an alleged cartel and abuse of a dominant position, thereby bringing into question the future fining policy of the Austrian cartel authorities. This update focuses on the main conclusions that can be drawn from this decision.
The delisting of Leberkäse by a large grocery retailer in 2004 led to an investigation by the Federal Competition Authority into the whole grocery sector. However, a number of retailers and suppliers refused to answer the authority's information requests on the grounds that they would have to reveal business secrets.
The Cartel Court has fined Europay Austria Zahlungsverkehrssysteme GmbH, which operates Maestro, the most widely used debit card system in Austria, a record €5 million for an alleged illegal cartel and abuse of a dominant market position. The fine is the highest set by the Cartel Court since the introduction of the fine system in 2002.
The Supreme Court has confirmed a Cartel Court decision dismissing a case brought by an overseas customer against a producer of pharmaceutical products. The customer alleged that the producer had abused its dominant position by failing to conclude a supply contract. Both courts concluded that, based on the customer's behaviour during the negotiations, the producer had legally refused to conclude a contract.
The Supreme Court recently released a decision, contradicting a 2005 ruling, that an Austrian undertaking need not notify a merger because the target was neither currently nor potentially active in the Austrian market, and the relevant markets for the transaction (banking) were national in scope.
The new Cartel Act came into force on January 1 2006. As the legislature was eager to bring Austrian cartel legislation as far as possible into line with EU cartel legislation, the act implemented the long-established EU system of not only punishing members of a cartel with high fines, but also rewarding those members of a cartel who 'blow the whistle' before the authorities know about the cartel.
The Cartel Act has traditionally been seen as a 'paper tiger' that poses little threat. However, following recent amendments to the act, this view has changed significantly. In a recent decision, the act was used by the Cartel Court to fine a company €1.5 million for illegally implementing a merger.
The new Cartel Act 2005 will take effect on January 1 2006 and will bring domestic cartel law into line with European law. Amendments include the abolition of various categories of cartels as well as the special regime for vertical distribution agreements.
The Cartel Act has traditionally been seen as a 'paper tiger' that poses little threat. However, this view has changed significantly following amendments to the act. Recently, the former state-owned telecommunications provider was heavily fined for a tariff model that had previously been explicitly permitted.
The draft Cartel Act 2005 amends existing anti-cartel provisions to reflect EU cartel legislation, for instance eliminating the special rules on vertical agreements from the current legislation. In addition, the draft act broadens certain definitions relating to mergers. It is expected to come into force on January 1 2006.
Under Section 124 of the Cartel Law, a decision by a court of general jurisdiction may be requested even where the jurisdiction of an arbitration court has been agreed in a cartel agreement. The Supreme Court recently ruled that this reasoning does not apply to vertical restrictions on distribution.
The Supreme Court has ruled that the no-fault liability for damages resulting from a preliminary injunction does not apply to cartel matters. Consequently, parties that seek a preliminary injunction before the Cartel Court need not fear any risk of no-fault liability for the resulting damages.
The Austrian Supreme Court recently prohibited a reimbursement system and emphasized that the defendant need not hold a dominant position in order for it to do so. The case was partly referred back to the court of first instance with regard to claims for damages.
The Federal Competition Authority (FCA) recently published guidelines for the notification of mergers. Its model form should be followed as closely as possible. Otherwise, the FCA may send it back to the parties in question, requesting additional information with the friendly hint that notification will be regarded as incomplete if no further information is provided.
In a significant ruling, the Supreme Court has held that abuse of a dominant market position occurs if a set-off clause is imposed by a dominant undertaking on its contractual partner to the extent that claims in connection with the contractual obligations of the dominant undertaking are excluded. No active pressure by the dominant undertaking is required.
The Austrian Supreme Court recently ruled that a film distributor did not hold a dominant market position despite being a monopolist with regard to the film Chocolat. However, the decision may well be contrary to a prior ruling. A cohesive definition of the relevant market regarding film distribution is thus required.
The Federal Competition Authority recently became operational. Its director general's main aim is to take firmer action against violations of antitrust law in terms of more rigorous punishment for illegal arrangements and abuse of market power in Austria.
Amendments to the Cartel Act and the new Act on the Establishment of a Federal Competition Authority were published on April 16 2002, to take effect on July 1 2002. The Cartel Court's controversial decision in the Formil Case appears to have expedited the reforms.
Outright prohibitions of proposed mergers are rare in Austria. The Supreme Court has revoked a recent decision of the Cartel Court to this effect, and requested it to undertake additional factual research and issue a new decision.
The Austrian Cartel Court must be notified of a merger if three separate turnover thresholds are met. Recently, the court has begun to establish a new rule whereby a merger need not be notified if it has no appreciable effect in Austria.
The Austrian Supreme Court has confirmed that a most favoured treatment clause, which guarantees equal treatment of the parties to a contract as defined in the Neighbourhood Supply Act, cannot be considered an abuse of a dominant market position.
A decision of the cartel court of first instance approved the acquisition of a competitor by a publisher that already dominated the weekly news magazine market. The subsequent media outcry has led to the reform of the cartel law.
Healthcare & Life Sciences
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.
Product Regulation & Liability
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.