Healthcare & Life Sciences, Austria updates

Assessing demand for public pharmacies – a never-ending story
Preslmayr Attorneys at Law
  • Austria
  • October 04 2017

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.

New price cap for medicinal products
Preslmayr Attorneys at Law
  • Austria
  • July 19 2017

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.

Nepafenac – no SPC for composition medicines
Preslmayr Attorneys at Law
  • Austria
  • April 12 2017

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".

Medicinal products by presentation
Preslmayr Attorneys at Law
  • Austria
  • January 25 2017

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.

Recommendations: line between providing information and advertising
Preslmayr Attorneys at Law
  • Austria
  • November 16 2016

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).

Shear victory: patient wins compensation for lost surgical scissors
Preslmayr Attorneys at Law
  • Austria
  • August 10 2016

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.

Calculating SPC application period based on variation of existing marketing authorisation
Preslmayr Attorneys at Law
  • Austria
  • May 25 2016

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.

Liability of apparent manufacturer of a medical device
Preslmayr Attorneys at Law
  • Austria
  • March 09 2016

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.

ECJ rules on date of first authorisation
Preslmayr Attorneys at Law
  • Austria
  • January 13 2016

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.

Supreme Court rules on advertising of dentist's mobile surgery
Preslmayr Attorneys at Law
  • Austria
  • December 02 2015

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.

Cranberry tablets – food or medicine?
Preslmayr Attorneys at Law
  • Austria
  • September 30 2015

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.

Supplementary protection certificate for carrier protein?
Preslmayr Attorneys at Law
  • Austria
  • August 05 2015

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.

Supreme Court rules on nutritional advice by 'bioenergeticians'
Preslmayr Attorneys at Law
  • Austria
  • June 03 2015

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.

New rules on reproductive medicine
Preslmayr Attorneys at Law
  • Austria
  • April 01 2015

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.

Pneumococci vaccination campaign
Preslmayr Attorneys at Law
  • Austria
  • January 14 2015

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.

Can patients receive refund for alternative medical treatment abroad?
Preslmayr Attorneys at Law
  • Austria
  • November 19 2014

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.

New practical training concept for trainee doctors
Preslmayr Attorneys at Law
  • Austria
  • August 27 2014

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.

Demand assessment for public pharmacies
Preslmayr Attorneys at Law
  • Austria
  • July 02 2014

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.

Device or product? Court examines photodynamic oncology therapy
Preslmayr Attorneys at Law
  • Austria
  • May 14 2014

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.

Teeth bleaching can be carried out only by dentists
Preslmayr Attorneys at Law
  • Austria
  • February 26 2014

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'.

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