LAUSR

1 Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products, O.J. L 18, 22.1.2000. • 2 Ornstova E, Sebestianova M, Mlcoch T, Lamblova K, Dolezal T. Highly Innovative Drug Program in the Czech Republic: Description and Pharmacoeconomic Results–Cost-Effectiveness and Budget Impact Analyses. Value in Health Regional Issues. 2018 Sep;16:92–8. • 3 Act No. 48/1997 Coll., on public health insurance and on changes to certain related laws, as last amended. Available from: https:// www.zakonyprolidi.cz/cs/1997-48. • 4 Register of designated and non-active Orphan medicinal products. European commission-The Register of orphan medicinal products for human use designated and published by the EU in accordance with Article 5 of Regulation (EC) N141/2000. https://ec.europa.eu/health/documents/community-register/html/index_en.htm • 5 Supplies of medicinal products in the Czech republic. Available from: http://www.sukl.eu/dodavky-a-jina-hodnoceni • 6 List of reimbursed medicinal products. Available at: http://www.sukl.cz/sukl/ seznam-leciv-a-pzlu-hrazenych-ze-zdrav-pojisteni • 7 Price Regulation of the Ministry of Health of the Czech republic (1/2013/FAR). Available from: http://www.mzcr.cz/obsah/cenova-regulace_1953_3.html CONCLUSIONS