{"id":74047,"date":"2021-03-18T10:02:47","date_gmt":"2021-03-18T08:02:47","guid":{"rendered":"https:\/\/sfee.gr\/?p=74047"},"modified":"2021-03-17T12:30:03","modified_gmt":"2021-03-17T09:30:03","slug":"ip-and-covid-part-of-the-solution-not-part-of-the-problem","status":"publish","type":"post","link":"https:\/\/www.sfee.gr\/en\/ip-and-covid-part-of-the-solution-not-part-of-the-problem\/","title":{"rendered":"IP and COVID \u2013 part of the solution not part of the problem"},"content":{"rendered":"<p>Fostering a research eco-system that can deliver that innovation rather than undermining it through challenges to IP like compulsory licensing, is the best way to protect citizens across Europe and around the world<\/p>\n<p>by <strong>Nathalie Moll, EFPIA Director-General<\/strong><\/p>\n<p>24.02.2021<\/p>\n<div><span class=\"rte-paragraph\">Witnessing millions of Europeans getting their vaccines just 12 months on from the first discovery of COVID-19, is an incredible collaborative, scientific, manufacturing and logistical achievement involving the\u202fglobal research community working in lock-step with the research-based pharmaceutical industry,\u00a0EU institutions, governments,\u00a0regulators and\u00a0health-systems.<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Over 30 million doses have been delivered to the EU since the first COVID-19 vaccine approval by the EMA, just two months ago.<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">We understand and share the frustration caused by temporary reductions to the quantities\u202fof COVID-19 vaccines\u202fbeing delivered.\u00a0Manufacturing billions of doses for people across Europe and around the world is an unprecedented challenge involving multiple partners, working around the clock without ever compromising on the quality or safety of the vaccines. Fluctuations in the supply of doses, however frustrating,\u202fis a feature of manufacturing such complex biological products.\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">This pandemic affects us all. We all want the same thing; to provide access to as many vaccines as possible in as short a time as possible.\u00a0<em>How<\/em>\u00a0we achieve that aim is understandably the focus of intense debate as companies, governments and the EU institutions work nonstop to protect citizens from COVID-19 as quickly as possible.\u00a0When considering\u00a0<em>how<\/em>\u00a0to continue to increase the supply of vaccines to citizens across Europe and around the world, we have to avoid considerations, however well-intended they may be,\u00a0that\u00a0in practice would impede or delay the supply of COVID-19 vaccines.\u00a0\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">One such consideration is to negate patents on COVID-19 vaccines\u00a0and issue compulsory licenses.\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\"><strong>First of all, it doesn\u2019t fix the problem<\/strong><strong>.<\/strong><\/span><\/div>\n<div><span class=\"rte-paragraph\">The World Health Organisation as well as the European Commission have publicly recognized that IP is not a barrier to increased capacity to produce COVID-19 vaccines.\u00a0It is skills, infrastructure and\u00a0technical know-how that are key to\u00a0increasing capacity and\u00a0producing the billions of doses needed. Just issuing a compulsory license, while the challenge is a lack of capacity,\u00a0does not mean factories across Europe could\u00a0suddenly\u00a0start producing COVID-19 vaccines.<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Establishing a new manufacturing plant requires significant financial investment\u00a0($500-700m),\u00a0usually taking between 5 to 10 years to be built, validated\u00a0and certified. Building\u00a0new manufacturing sites\u00a0is\u00a0not a quick\u00a0fix.\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Currently, there are only 5 or 6 pharmaceutical groups capable of manufacturing COVID-19 vaccines at the pace, scale and quality needed. Globally, there are around 60 manufacturing sites equipped to produce COVID-19 vaccines.<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">The experience of the last months and weeks has shown us that increasing capacity requires the skills and technical know-how of the vaccine developer\u00a0to bring on-board partner manufacturing organizations through tech-transfer agreements under voluntary licensing arrangements.\u00a0Capacity extension is therefore mostly dependent on investments in upgrades or adaptations of existing facilities and through partnerships with CMOs and other companies.\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\"><br \/>\nThis process has been moving ahead at an unprecedented pace, some examples\u00a0announced in the last few weeks\u00a0are:\u00a0<\/span><\/div>\n<div><\/div>\n<div>\n<ul>\n<li><span class=\"rte-paragraph\"><strong>GSK\u00a0<\/strong>working with\u00a0<strong>CureVac<\/strong>\u00a0to\u00a0fill\u00a0and\u00a0finish up to 100 million doses in 2021 in\u00a0Wavre, Belgium\u00a0as well continued work to address variants<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>Bayer\u00a0<\/strong>working with\u00a0<strong>CureVac<\/strong>\u00a0to produce\u00a0160 million doses in 2022, in Wuppertal, Germany, first commercial product expected to be made available at the end of 2021; in\u00a0addition<u>,<\/u>\u00a0Bayer will aid in R&amp;D, regulatory affairs, supply chain management and potential marketing operations\u00a0<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>Sanofi\u00a0<\/strong>working with\u00a0<strong>Pfizer\/BioNTech<\/strong>\u00a0to\u00a0fill\u00a0and\u00a0finish 125 million doses starting summer 2021, in Frankfurt, Germany\u00a0<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>Rovi\u00a0<\/strong>working with\u00a0<strong>Moderna<\/strong>\u00a0to\u00a0fill\u00a0and\u00a0finish \u201chundreds of millions of doses\u201d\u00a0<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>Novartis\u00a0<\/strong>working with\u00a0<strong>Pfizer\/BioNTech<\/strong>\u00a0to\u00a0fill\u00a0and\u00a0finish\u00a0doses\u00a0starting Q2 2021 in Stein, Switzerland\u00a0<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>Moderna\u00a0<\/strong>working with\u00a0<strong>Lonza<\/strong>\u00a0to\u00a0produce\u00a0capacity for 400 million doses a year &#8211; 300 million from three production lines in\u00a0Visp, Switzerland, and 100 million in New Hampshire, US.\u00a0<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>Novavax\u00a0<\/strong>working with\u00a0<strong>Baxter<\/strong>\u00a0\u2013 production in Halle\/Westfalen, Germany\u00a0<\/span><\/li>\n<li><span class=\"rte-paragraph\"><strong>AstraZeneca\u00a0<\/strong>has\u00a0built more than a dozen regional supply chains, collaborating with over 20 supply partners in more than 15 countries\u00a0<\/span><\/li>\n<\/ul>\n<\/div>\n<div><\/div>\n<div><span class=\"rte-paragraph\">You\u00a0simply\u00a0cannot achieve this kind of\u00a0capacity expansion through compulsory licensing. It is only achievable through\u00a0voluntary, collaborative partnerships between the innovators behind each vaccine and expert\u00a0manufacturing partners. This reality was clearly articulated by Thierry\u00a0Breton, European Commissioner for Internal Market, who when speaking to the media recently said. \u201cIt is not an intellectual property subject; it is a matter of having factories, (\u2026)\u00a0Just because I give a patent to a company in India for example it would not change\u00a0anything.\u201d\u00a0\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Secondly,\u00a0the only reason we have vaccines and therapeutics to tackle COVID-19 is because of\u00a0the\u00a0intellectual property protection that has fostered innovation\u00a0in\u00a0recent years.\u00a0Take\u00a0messenger RNA,\u00a0used in\u00a0the first\u00a0COVID-19 vaccine\u00a0approved by EMA, mRNA has,\u00a0in recent months,\u00a0become\u00a0the poster child for medical innovation. But the development of\u00a0mRNA\u00a0has\u00a0spanned the last 20 years or more, long before\u00a0companies like\u00a0Moderna,\u00a0BioNtech, Pfizer and\u00a0CureVac\u00a0began applying the science to\u00a0COVID-19 vaccines.\u00a0\u00a0Its development\u00a0relied on\u00a0private\u00a0investors\u00a0supporting the research\u00a0on the basis that their investment was protected by\u00a0IP. These decisions, made over the past 20 years, help us to be agile and fast in the face of the COVID-19\u00a0crisis.\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Stopping this pandemic, including new variants, will require a number of diagnostics, treatments and vaccines. Compulsory licensing negates any incentive to invest in medical innovation for COVID-19 at a time when citizens across Europe, across the world, are looking to the life-science community to find the answers to the coronavirus crisis.\u00a0It is\u00a0not just about COVID-19, compulsory licensing would remove any incentive for investing in new technologies that could be used to fight future pandemics.<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\"><strong>So\u00a0what can be done to continue to increase capacity and achieve what we all want \u2013 more doses to more people, more quickly?\u00a0<\/strong><\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">We support the creation of a sustained high-level dialogue and collaboration between industry and the European Commission services to support efforts to increase manufacturing capacity in Europe.\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Vaccines\u00a0manufacturing involves dozens of ingredients\u00a0and disposables. Access to sufficient quantities of both may create bottlenecks in the production of COVID-19 vaccines. With\u00a0manufacturing sites running 24 hours a day, any shortage of raw material\u00a0can halt production and greatly impact production.\u00a0Today, there are\u00a0signals that\u00a0the\u00a0lead time for procurement of\u00a0some\u00a0disposables\u00a0is\u00a0increasing, which could be an indicator for future shortages.\u00a0\u00a0The first priority is to support global, resilient vaccine supply chains, allowing the uninterrupted flow of raw materials, components, consumables, clinical trial samples, batches for testing and finished vaccines.\u00a0\u00a0\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">\u00a0<\/span><\/div>\n<div><span class=\"rte-paragraph\">Like many health emergencies of the past, only medical innovation can stem the devastating human and economic cost of this pandemic. Fostering a research eco-system that can deliver that innovation rather than undermining it through challenges to IP like compulsory licensing, is the best way to protect citizens across Europe and around the world.\u00a0<\/span><\/div>\n","protected":false},"excerpt":{"rendered":"<p>by Nathalie Moll, EFPIA Director-General, EFPIA News &#8211; 24\/02\/2021<\/p>\n","protected":false},"author":78,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[429,173,97],"tags":[],"class_list":["post-74047","post","type-post","status-publish","format-standard","hentry","category-news","category-arthra-sinentefxis-omilies","category-diafora","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>IP and COVID \u2013 part of the solution not part of the problem | 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