{"id":4288,"date":"2026-02-25T08:25:55","date_gmt":"2026-02-25T07:25:55","guid":{"rendered":"https:\/\/iph-multisite.berta-bewegt.ch\/?page_id=4288"},"modified":"2026-02-25T13:12:59","modified_gmt":"2026-02-25T12:12:59","slug":"der-weg-eines-medikaments","status":"publish","type":"page","link":"https:\/\/www.interpharma.ch\/en\/themen\/fuhrend-in-forschung-entwicklung\/der-weg-eines-medikaments\/","title":{"rendered":"The lengthy process of medicine development"},"content":{"rendered":"\n<p>In any\ntype of research, major breakthroughs are the exception, while many small steps\nforward are the rule. This also applies to pharmaceutical research. It is the\nongoing, incremental innovations over many years that lead to new therapies\nproviding optimum benefit for patients. The pharmaceutical companies are in\nstiff global competition against each other to achieve small innovations in\ncommon diseases. They are competing with different substances aimed at the same\npharmacological target. Yet the therapeutic success achieved by an individual\nmedicine often does not become evident until it has been in use for some time.\nA wide variety of factors play a decisive role in success, among them efficacy,\nduration of action, interactions with other medicinal products, the existence\nof side effects, optimum availability of the active substance and optimum\ndosage forms.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-growing-development-effort\"><strong>Growing development effort<\/strong><\/h2>\n\n\n\n<p>The effort that goes into research and development has increased greatly in recent decades, not least because of the stringent safety requirements embedded in the legislation. It now takes an average of 12 years to bring a new medicinal product to market. This work involves costs of around 2.6 billion dollars. Roughly two-thirds of this amount is spent before clinical trials even begin. Just ten out of every 10,000 substances that are investigated and tested in laboratories make it as far as clinical trials. Of these, only one single substance passes all the tests and comes onto the market as a medicine. The long development time means that the time available to the pharmaceutical companies to recoup their high development costs while their patent protection is active is continually decreasing.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-important-patent-protection-for-new-active-substances\"><strong>Important patent protection for new active substances<\/strong><\/h2>\n\n\n\n<p>On a\nglobal scale, a sum equivalent to around 20 percent of a pharmaceutical\ncompany\u2019s turnover from prescription medicines is spent on research and\ndevelopment. This is one of the highest levels in any sector. Accordingly,\nresearch-based companies need to be sure that their discoveries will not be\nexploited commercially by third parties who have not shared in the cost of\nresearching the products. A new active substance is granted protection by the\nstate in the form of a patent. Statutory patent protection is limited to 20\nyears starting from the date the patent is submitted for registration, i.e.\nbefore preclinical studies in cell systems, for example, have even started. The\nusable period of patent protection has decreased as the safety requirements\nthat a new medicinal product must meet have grown. Supplementary protection\ncertificates were created to keep pace with this development. These\ncertificates enable the patent protection for new medicinal products to be\nextended for a further 5 years, giving a maximum effective exploitable period\nof protection of 15 years.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-protection-for-submitted-data-as-an-incentive\"><strong>Protection for submitted data as an incentive<\/strong><\/h2>\n\n\n\n<p>The\nhealth authorities require the pharmaceutical industry to submit extensive data\nfrom preclinical and clinical studies before a medicinal product can be\nauthorised. These data are required so that the quality, efficacy and safety of\nthe medicine can be assessed. Pharmaceutical companies invest a great deal of\ntime and money in preparing these data. The submitted data are protected (first\napplicant protection) to ensure that no other company can refer to or use them\nduring the period of protection following the marketing authorisation of the\nproduct. First applicant protection provides an incentive for companies to\nallocate resources to research and development. It is an investment incentive\nthat is independent of a product\u2019s patent status. There are a number of reasons\nwhy a patent may not exist for a certain product in a specific country. In such\ncases, first applicant protection is the primary incentive for investment. This\napplies, for example, to the growing trend for companies to develop new\nindications on the basis of established active substances.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In any type of research, major breakthroughs are the exception, while many small steps forward are the rule. This also applies to pharmaceutical research. It is the ongoing, incremental innovations over many years that lead to new therapies providing optimum benefit for patients. The pharmaceutical companies are in stiff global competition against each other to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":14774,"parent":4303,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4288","page","type-page","status-publish","has-post-thumbnail","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>The lengthy process of medicine development - 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\/fuhrend-in-forschung-entwicklung\/der-weg-eines-medikaments\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The lengthy process of medicine development\" \/>\n<meta property=\"og:description\" content=\"In any type of research, major breakthroughs are the exception, while many small steps forward are the rule. 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