AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
With regard to generics, the price of the first generic successor product must be at least 50% below the price of the original branded product whose patent protection has expired. The price of the second generic successor product must be 18% lower than the price of the first succes- sor product, and the price for the third successor product must be 15% lower than that of the sec- ond successor product. The original product’s price must be reduced by at least 30% within three months of the inclusion of the first generic product in the EKO. If there is a third succes- sor product, all other providers must reduce the price to the price of the third product. Addi- tional successors must offer price reductions of at least EUR0,10 in order to be included in the EKO. With regard to biosimilars, the price of the first successor product must be at least 38% lower than the original product. The price of the sec- ond successor product must be at least 15% lower than that of the first successor product, and the price of the third successor product must be at least 10% lower than that of the second successor product. After that, the same regulation applies as for generics (ie, the origi- nal product must reduce its price by 30% within three months, etc). In principle, no legal price control mechanisms are available for medical devices and IVD devic- es. 8.2 Price Levels of Pharmaceuticals or Medical Devices The price of a medicinal product can, in principle, be freely determined by the company authorised to distribute it but is limited by the EU average price of said product (as further detailed in 8.1 Price Control for Pharmaceuticals and Medical Devices ).
In principle, no legal price-control/price-setting mechanisms are available for medical devices and IVD devices. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds The Austrian General Social Security Act ( Allge- meines Sozialversicherungsgesetz , or ASVG) states that, in case of illness, the insured per- son is entitled to health treatment comprising the provision of remedies (Heilmittel) – a term that includes medicinal products, in particular. According to the ASVG, medical treatment must be adequate and appropriate, but it should not exceed what is necessary. Austria is one of the few EU countries where the costs of reimbursable medicinal products pre- scribed by a physician are, in principle, covered in full for the patients insured in the public insur- ance system. Patients only have to pay a flat fee (“prescription fee”) in pharmacies. Exemp- tion from the prescription fee is possible under certain conditions. Medicinal products included in the EKO can be prescribed at the expense of health insurance institutions (see 8.1 Price Control for Pharma- ceuticals and Medical Devices ). Other medici- nal products are only reimbursed in medically justified individual cases. Regarding medical devices and IVD devices, no system comparable to the EKO exists. The Austrian Social Security Act does not refer to “medical devices” as such but to Heilbehelfe and Hilfsmittel (therapeutic aids), which are reimbursed – subject to a 10% deductible (or a current minimum of EUR 40,40) – if a physician prescribes them. Typically, medical device/IVD device manufacturers sign contracts with the
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