{"id":44950,"date":"2025-06-09T20:38:48","date_gmt":"2025-06-09T15:08:48","guid":{"rendered":"https:\/\/www.nextias.com\/ca\/?p=44950"},"modified":"2025-06-10T16:38:53","modified_gmt":"2025-06-10T11:08:53","slug":"compulsory-licensing-rare-diseases-india","status":"publish","type":"post","link":"https:\/\/www.nextias.com\/ca\/current-affairs\/09-06-2025\/compulsory-licensing-rare-diseases-india","title":{"rendered":"Demand for Compulsory Licensing for Rare Disease"},"content":{"rendered":"\n<p><strong>Syllabus: GS2\/ Health<\/strong><\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Context<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A growing number of rare disease patients in India are urging the government to invoke the compulsory licensing provision under the <strong>Indian Patents Act, 1970.<\/strong><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>About<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Compulsory licensing is a legal tool under <strong>Section 84 of the Indian Patents Act, 1970<\/strong>, which allows the government or any third party to manufacture a patented product or use a patented process <strong>without the consent of the patent owner<\/strong> in certain conditions.&nbsp;<\/li>\n\n\n\n<li>It aims to protect <strong>public health and access to affordable medicines.<\/strong><\/li>\n\n\n\n<li><strong>A compulsory license in India<\/strong> can be granted <strong>three years<\/strong> after a patent is issued if:\n<ul class=\"wp-block-list\">\n<li>The patented invention is not available to the public at a reasonable price.<\/li>\n\n\n\n<li>The reasonable requirements of the public are not being satisfied.<\/li>\n\n\n\n<li>The invention is not being worked on in the territory of India.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Legal Policy Landscape<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Patent Law Amendments: <\/strong>India\u2019s 1970 Patents Act originally allowed only <strong>process patents<\/strong>, enabling generic drug manufacturing.\n<ul class=\"wp-block-list\">\n<li>Hence, India became the <strong>&#8220;pharmacy of the world&#8221;<\/strong> by producing affordable medicines.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Safeguards Against Monopoly Abuse:<\/strong> India\u2019s law includes <strong>anti-evergreening provisions (Section 3(d))<\/strong> to prevent companies from extending monopoly through minor modifications.\n<ul class=\"wp-block-list\">\n<li>It also allows for <strong>pre- and post-grant opposition<\/strong> to patents.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>TRIPS Agreement and Flexibilities<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>India became a member of the <strong><a href=\"https:\/\/www.nextias.com\/blog\/world-trade-organisation-wto\/\" data-type=\"link\" data-id=\"https:\/\/www.nextias.com\/blog\/world-trade-organisation-wto\/\">World Trade Organization (WTO)<\/a><\/strong> and was required to align its intellectual property laws with the <strong>TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights)<\/strong>, which came into effect in <strong>1995.<\/strong>\n<ul class=\"wp-block-list\">\n<li>The TRIPS Agreement provides for the compulsory licensing (CL).<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>India amended its Patents Act in 2005,<\/strong> allowing for both product and process patents in the pharmaceutical sector.\n<ul class=\"wp-block-list\">\n<li>These patents are now valid for a period of <strong>20 years <\/strong>from the date of filing.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>The Doha Declaration <\/strong>on TRIPS and Public Health (2001) further clarified that:\n<ul class=\"wp-block-list\">\n<li>Countries may issue a compulsory license in the interest of <strong>public health emergencies,<\/strong> although the presence of an emergency is <strong>not a mandatory condition.<\/strong><\/li>\n\n\n\n<li>Each country has the <strong>sovereign right to determine the grounds<\/strong> on which it can issue a compulsory license.<\/li>\n\n\n\n<li>The patent holder must be compensated through the payment of <strong>\u201cadequate remuneration,<\/strong>\u201d the amount of which is to be determined by the issuing country based on the economic value of the license.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>A waiver in 2003<\/strong>, later made permanent in <strong>2017,<\/strong> allowed countries to <strong>import affordable drugs produced under CL<\/strong> from other nations.\n<ul class=\"wp-block-list\">\n<li>This created a legal route for cross-border access to affordable medicines.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-background\" style=\"background-color:#ebecf0\"><tbody><tr><td><strong>What are Rare Diseases?<\/strong><br>&#8211; Rare diseases, also known as <strong>orphan diseases,<\/strong> are conditions that occur infrequently within a population.&nbsp;<br>1. <strong>They are characterized by three key markers: <\/strong>Total number of people with the disease, Prevalence and Availability \/Non-availability of treatment options.<br>&#8211; <strong>The World Health Organization (WHO)<\/strong> defines a rare disease as a condition that affects a small percentage of the population, typically fewer than 1 in 1,000 to 2,000 people.&nbsp;<br><strong>Initiatives taken for rare diseases in India<\/strong><br>&#8211; <strong>National Policy for Rare Diseases (NPRD), 2021: <\/strong>It was launched in <strong>2021,<\/strong> under which financial assistance up to Rs 50 lakh is provided to patients receiving treatment at an identified Centre of Excellence (CoE).<br>&#8211; The Health Ministry has opened a <strong>Digital Portal for Crowdfunding &amp; Voluntary Donations <\/strong>with information about patients and their rare diseases.&nbsp;<br>1. Donors can choose the CoE and patient treatments they wish to support.&nbsp;<br>&#8211; Each<strong> Centre of Excellence (CoE)<\/strong> also has its own <strong>Rare Disease Fund<\/strong>, which is used with approval from its governing authority.<br>&#8211; The Department of Pharmaceuticals has launched the <strong>Production Linked Incentive (PLI) Scheme<\/strong> for Pharmaceuticals, offering financial incentives to selected manufacturers for <strong>domestic production of orphan drugs.<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Source: <\/strong><a href=\"https:\/\/indianexpress.com\/article\/health-wellness\/high-costs-life-saving-drugs-patients-rare-diseases-indian-variants-10055851\/\" rel=\"nofollow noopener\" target=\"_blank\"><strong>IE<\/strong><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<h3><strong>Context<\/strong><\/h3>\n<li class=\"ms-5\">A growing number of rare disease patients in India are urging the government to invoke the compulsory licensing provision under the Indian Patents Act, 1970.<\/li>\n<p><\/p>\n<h3><strong>About<\/strong><\/h3>\n<li class=\"ms-5\">Compulsory licensing is a legal tool under Section 84 of the Indian Patents Act, 1970, which allows the government or any third party to manufacture a patented product or use a patented process without the consent of the patent owner in certain conditions.\u00a0<\/li>\n<li class=\"ms-5\">It aims to protect public health and access to affordable medicines.<\/li>\n<p><a href=\"https:\/\/www.nextias.com\/ca\/current-affairs\/09-06-2025\/compulsory-licensing-rare-diseases-india\" class=\"btn btn-primary btn-sm float-end\">Read\u00a0More<\/a><\/p>\n","protected":false},"author":15,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[21],"tags":[],"class_list":["post-44950","post","type-post","status-publish","format-standard","hentry","category-current-affairs"],"acf":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/44950","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/comments?post=44950"}],"version-history":[{"count":3,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/44950\/revisions"}],"predecessor-version":[{"id":45032,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/posts\/44950\/revisions\/45032"}],"wp:attachment":[{"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/media?parent=44950"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/categories?post=44950"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nextias.com\/ca\/wp-json\/wp\/v2\/tags?post=44950"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}