{"id":4106,"date":"2026-02-25T08:25:46","date_gmt":"2026-02-25T07:25:46","guid":{"rendered":"https:\/\/iph-multisite.berta-bewegt.ch\/?page_id=4106"},"modified":"2026-02-25T08:25:46","modified_gmt":"2026-02-25T07:25:46","slug":"orphan-drugs","status":"publish","type":"page","link":"https:\/\/www.interpharma.ch\/en\/themen\/der-patient-im-mittelpunkt\/patientenzugang\/orphan-drugs\/","title":{"rendered":"Orphan drugs"},"content":{"rendered":"\n<p>A disease is considered rare if it affects fewer than five people per 10,000 inhabitants. Since 6,000 to 8,000 such diseases are known, the total number of rare diseases can be compared to a widespread disease. Pharmaceutical companies around the world are working intensively to develop new drugs and therapies for rare diseases. Despite enormous progress in recent years, many rare diseases are still untreatable. <\/p>\n\n\n\n<p>The authorities introduced incentives for the pharmaceutical\nindustry to research and develop orphan drugs to make this a more attractive\nproposition.&nbsp;As long ago as 1983, the USA introduced a law to promote the\ndevelopment of medicinal products to treat rare diseases. The EU created a\nsimilar legal foundation in 1999 in the form of Regulation (EC) No 141\/2000. It\nforesees various measures to promote the recognition and visibility of rare\ndiseases and reinforces collaboration and coordination at EU level. It supports\nthe creation of European reference networks and promotes the networking of\nspecialist centres and experts in different countries. It has also created\nincentives for more research into rare diseases. Moreover, rare diseases are\none of the priorities within the EU Framework Programme for Research and\nInnovation. These supportive measures have resulted in an increase in the\nnumber of authorised medicines for the treatment of rare diseases. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-orphan-drugs-in-switzerland\"><strong>Orphan\ndrugs in Switzerland<\/strong><\/h2>\n\n\n\n<p>In Switzerland, Art. 14 of the Therapeutic Products Act\n(TPA) provides for a simplified authorisation procedure for important medicinal\nproducts for rare diseases. The implementing provisions have been incorporated\ninto the Ordinance of the Swiss Agency for Therapeutic Products on the\nSimplified Licensing of Therapeutic Products and the Licensing of Therapeutic\nProducts by the Notification Procedure (TPLO). A distinction is made in the\nOrdinance between recognition of the status as an important medicinal product\nfor rare diseases (Art. 4 &#8211; 7 TPLO) and the authorisation of a medicinal\nproduct that has been granted Orphan Drug Status by Swissmedic (Art. 24 &#8211; 26\nTPLO).<\/p>\n\n\n\n<p>Orphan drugs are reimbursed either in accordance with the\nList of pharmaceutical specialities or in accordance with Art. 71b HIO under\nthe same conditions as for off-label use. These conditions state that the cost\nof medicinal products that are not on the List of pharmaceutical specialities\nand used outside the registered indications will also be reimbursed. However,\nthis is only the case if the disease may have a fatal outcome or lead to severe\nor chronic problems for the insured person, and there are no therapeutic\nalternatives.<\/p>\n\n\n\n<p>This decision-making process is a complex one, and patients\nwith rare diseases are frequently in a considerably worse position with respect\nto reimbursement than patients with more common disorders.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A disease is considered rare if it affects fewer than five people per 10,000 inhabitants. Since 6,000 to 8,000 such diseases are known, the total number of rare diseases can be compared to a widespread disease. Pharmaceutical companies around the world are working intensively to develop new drugs and therapies for rare diseases. Despite enormous [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4142,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4106","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Orphan drugs - Interpharma<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interpharma.ch\/en\/themen\/der-patient-im-mittelpunkt\/patientenzugang\/orphan-drugs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Orphan drugs\" \/>\n<meta property=\"og:description\" content=\"A disease is considered rare if it affects fewer than five people per 10,000 inhabitants. Since 6,000 to 8,000 such diseases are known, the total number of rare diseases can be compared to a widespread disease. Pharmaceutical companies around the world are working intensively to develop new drugs and therapies for rare diseases. 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