Intellectual Property

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</div> </a> </li> </ul> </div> </section> <section id="content" class="content__wrapper"> <header class=" site__header"> <div class="header__burger mobile"> <i class="icon-menu"></i> </div> <div class="header__logo"> <a href="https://efpia.eu/"> </a> </div> <div class="header__breadcrumb"> <div class="breadcrumb__link"> <a href="https://efpia.eu/about-medicines/"> About medicines</a> </div> <div class="breadcrumb__link"> <a href="https://efpia.eu/about-medicines/development-of-medicines/"> Development of medicines</a> </div>  <span class="truncated-breadcrumb"> Intellectual Property... </span>  <span class="untruncated-breadcrumb"> Intellectual Property </span> </div> <div class="header__search"> <div class="search__container"> <form action="https://efpia.eu/search-results/"> <input type="text" name="query" id="header-search" class="search__input" placeholder="Search" /> <span class="fa fa-search desktop-search"></span> </form> </div> <div class="opensearch__mobile"> <span class="fa fa-search"></span> </div> </div> </header> <div class="searchbar__mobile"> <form action="https://efpia.eu/search-results/"> <i class="material-icons searchbar__close">close</i> <input type="text" placeholder="" name="query" /> <span class="fa fa-search submit-search-mob"></span> </form> </div> <div class="content__section"> <header role="banner" style="background-image:url('/media/589627/banner-ip-webpage.jpg?rxy=0.5,0.4375&width=1140&height=400')" id="banner-image"> <div class="text__wrapper"> <div class="header__blurb"> <h2>Intellectual Property</h2> <p>Europe’s framework of incentives and rewards for discovering and developing new treatments deliver access to today’s medicines and investment into tomorrow’s cures for patients who need them.</p> </div> </div> </header> <section class="content__container content__container--no-padding-m"> <div class="umb-grid"> <div class="grid-section"> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <span class="rte-paragraph"><span class="rte-paragraph"><span class="rte-paragraph"><span class="rte-paragraph"><span class="rte-paragraph"><strong>Intellectual property is the key driver of medical innovation. <br /></strong></span></span></span></span></span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div > <span class="rte-paragraph">It has enabled unprecedented collaborations between biopharmaceutical innovators and governments, universities and other research partners to speed up progress on hundreds of potential COVID-19 treatments, diagnostics and vaccines for patients. It is only because of intellectual property protection that we have over 30o treatments and more than 200 vaccines currently being explored for use against COVID-19. <br /><br />Fostering a research eco-system that can deliver that innovation rather than undermining it through challenges to IP, is the <a href="/media/636418/getting-the-world-vaccinated-against-covid.pdf" target="_blank">best way to protect citizens across Europe and around the world.</a></span><br /><span class="rte-paragraph"><br /><br /></span> </div> </div> <div class="col-md-6 column"> <div > <div class="umb-loader" style="height: 10px; margin: 10px 0px;"><iframe width="500" height="330" src="https://www.youtube.com/embed/EH584LL8bYI?feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen=""></iframe></div> </div> </div> </div> </div> </div> <div class="intellecttext"> <div class="container"> <div class="row clearfix"> <div class="col-md-4 column"> <div > <p><span class="rte-paragraph">Every new treatment or cure starts with the spark of an idea. Protecting that spark can involve ensuring funding for early-stage development of a new therapy, it can be creating the right environment for collaboration between research partners, it can be evolving the regulatory framework to keep pace with rapidly advancing science and protecting the spark means having a strong and effective intellectual property framework.</span></p> <p><span class="rte-paragraph">Pharmaceutical intellectual property (IP) – incentives and rewards are the foundation on which innovation is built: they encourage and protect innovation, driving research and development investments into areas of unmet medical need.</span></p> </div> </div> <div class="col-md-8 column"> <div > <h3><span class="Subheading">INTELLECTUAL PROPERTY DELIVERS ACCESS TO TODAY’S MEDICINES AND INVESTMENT INTO TOMORROW’S CURES</span></h3> <div id="lottie" class="wpbdmv-animation align-center renderer-svg"></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="rte-paragraph">The framework provides companies researching and developing new medicines the certainty that if a medicine makes it to the market, it will be protected from unfair competition for a limited period time. This is what they need to invest in the long, complex, risky and costly process of delivering new medicines to patients, to healthcare systems and to society.</span></p> <p><span class="rte-paragraph">It helps companies turn ideas into assets that address unmet medical needs, improve the lives of patients and their families, create value and also jobs. This, in turn, attracts investment which helps to protect the company’s ideas, retain the knowhow required to convert ideas into therapies, and support further research into the next generation of treatments to improve people’s lives.</span></p> <p><span class="rte-paragraph">With over 7000 medicines in development, the system of basic & overarching or targeted incentives is working: it enables a pipeline of this scale despite the high risk of failure.</span></p> </div> </div> </div> </div> </div> <div class="greyback greentitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div style="text-align: left;"><span class="Subheading">EUROPEAN PHARMACEUTICAL INCENTIVES FRAMEWORK</span></div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p><span class="rte-paragraph">With the number of new medicines approved every year, the system is working: it enables a pipeline of currently over 7000 medicines in development despite the high risk of failure.</span></p> <div class="et_pb_module image_hotspot_parent image_hotspot_parent_0"> <div class="et_pb_module_inner"> <div class="dih_wrapper"> <img src="https://efpia.eu/Images/EFPIA-Framework.svg" alt="" class="hotspot_image"> <div class="et_pb_module image_hotspot_child image_hotspot_child_0"> <div class="et_pb_module_inner"> <div class="hotspot-tooltip"> <div class="dih-tooltip-hover dih-container"> <span class="pointer_icon et-pb-icon et-pb-icon-circle">[</span> <div class="dih-tooltip dih-arrow dih-left"> <h3>PATENT:</h3> <div class="dih-content"><p>protects inventions for a limited term of 20 years</p></div> <div class="et_pb_button_module_wrapper"> <a class="et_pb_button" href="#patents">Read More</a> </div> </div> </div> </div> <script> (function ($) { $(window).bind("resize", function () { // Desktop if ($(this).width() > 980) { $(".image_hotspot_child_0 .dih-tooltip").addClass("dih-left"); } else { $(".image_hotspot_child_0 .dih-tooltip").removeClass("dih-left"); } // Tablet if ($(this).width() > 767 && $(this).width() < 980) { $(".image_hotspot_child_0 .dih-tooltip").addClass("dih-tablet-left"); } else { $(".image_hotspot_child_0 .dih-tooltip").removeClass("dih-tablet-left"); } // Mobile if ($(this).width() < 767) { $(".image_hotspot_child_0 .dih-tooltip").addClass("dih-mobile-top"); } else { $(".image_hotspot_child_0 .dih-tooltip").removeClass("dih-mobile-top"); } }).trigger("resize"); })(jQuery); </script> </div> </div><div class="et_pb_module image_hotspot_child image_hotspot_child_1"> <div class="et_pb_module_inner"> <div class="hotspot-tooltip"> <div class="dih-tooltip-hover dih-container"> <span class="pointer_icon et-pb-icon et-pb-icon-circle">[</span> <div class="dih-tooltip dih-arrow dih-top"> <h3>SPC: </h3> <div class="dih-content"><p>introduced to offset some of the effective patent term lost during the development of medicine due to increasing regulatory approval requirements</p></div> <div class="et_pb_button_module_wrapper"> <a class="et_pb_button" href="#spc">Read more</a> </div> </div> </div> </div> <script> (function ($) { $(window).bind("resize", function () { // Desktop if ($(this).width() > 980) { $(".image_hotspot_child_1 .dih-tooltip").addClass("dih-top"); } else { $(".image_hotspot_child_1 .dih-tooltip").removeClass("dih-top"); } // Tablet if ($(this).width() > 767 && $(this).width() < 980) { $(".image_hotspot_child_1 .dih-tooltip").addClass("dih-tablet-top"); } else { $(".image_hotspot_child_1 .dih-tooltip").removeClass("dih-tablet-top"); } // Mobile if ($(this).width() < 767) { $(".image_hotspot_child_1 .dih-tooltip").addClass("dih-mobile-top"); } else { $(".image_hotspot_child_1 .dih-tooltip").removeClass("dih-mobile-top"); } }).trigger("resize"); })(jQuery); </script> </div> </div><div class="et_pb_module image_hotspot_child image_hotspot_child_2"> <div class="et_pb_module_inner"> <div class="hotspot-tooltip"> <div class="dih-tooltip-hover dih-container"> <span class="pointer_icon et-pb-icon et-pb-icon-circle">[</span> <div class="dih-tooltip dih-arrow dih-top"> <h3>RDP: </h3> <div class="dih-content"><p>protects data relating to preclinical and clinical trials of a medicine</p></div> <div class="et_pb_button_module_wrapper"> <a class="et_pb_button" href="#rdp">Read More</a> </div> </div> </div> </div> <script> (function ($) { $(window).bind("resize", function () { // Desktop if ($(this).width() > 980) { $(".image_hotspot_child_2 .dih-tooltip").addClass("dih-top"); } else { $(".image_hotspot_child_2 .dih-tooltip").removeClass("dih-top"); } // Tablet if ($(this).width() > 767 && $(this).width() < 980) { $(".image_hotspot_child_2 .dih-tooltip").addClass("dih-tablet-top"); } else { $(".image_hotspot_child_2 .dih-tooltip").removeClass("dih-tablet-top"); } // Mobile if ($(this).width() < 767) { $(".image_hotspot_child_2 .dih-tooltip").addClass("dih-mobile-top"); } else { $(".image_hotspot_child_2 .dih-tooltip").removeClass("dih-mobile-top"); } }).trigger("resize"); })(jQuery); </script> </div> </div><div class="et_pb_module image_hotspot_child image_hotspot_child_3"> <div class="et_pb_module_inner"> <div class="hotspot-tooltip"> <div class="dih-tooltip-hover dih-container"> <span class="pointer_icon et-pb-icon et-pb-icon-circle">[</span> <div class="dih-tooltip dih-arrow dih-left"> <h3>Orphan Designation:</h3> <div class="dih-content"><p>supports research into the next generation of treatments for rare disease.</p></div> <div class="et_pb_button_module_wrapper"> <a class="et_pb_button" href="#incentives">Read More</a> </div> </div> </div> </div> <script> (function ($) { $(window).bind("resize", function () { // Desktop if ($(this).width() > 980) { $(".image_hotspot_child_3 .dih-tooltip").addClass("dih-left"); } else { $(".image_hotspot_child_3 .dih-tooltip").removeClass("dih-left"); } // Tablet if ($(this).width() > 767 && $(this).width() < 980) { $(".image_hotspot_child_3 .dih-tooltip").addClass("dih-tablet-left"); } else { $(".image_hotspot_child_3 .dih-tooltip").removeClass("dih-tablet-left"); } // Mobile if ($(this).width() < 767) { $(".image_hotspot_child_3 .dih-tooltip").addClass("dih-mobile-bottom"); } else { $(".image_hotspot_child_3 .dih-tooltip").removeClass("dih-mobile-bottom"); } }).trigger("resize"); })(jQuery); </script> </div> </div><div class="et_pb_module image_hotspot_child image_hotspot_child_4"> <div class="et_pb_module_inner"> <div class="hotspot-tooltip"> <div class="dih-tooltip-hover dih-container"> <span class="pointer_icon et-pb-icon et-pb-icon-circle">[</span> <div class="dih-tooltip dih-arrow dih-left"> <h3>Paediatric extension:</h3> <div class="dih-content"> <p> stimulates the development of new medicines for children<br> </p> </div> <div class="et_pb_button_module_wrapper"> <a class="et_pb_button" href="#paediatric">Read more</a> </div> </div> </div> </div> <script> (function ($) { $(window).bind("resize", function () { // Desktop if ($(this).width() > 980) { $(".image_hotspot_child_4 .dih-tooltip").addClass("dih-left"); } else { $(".image_hotspot_child_4 .dih-tooltip").removeClass("dih-left"); } // Tablet if ($(this).width() > 767 && $(this).width() < 980) { $(".image_hotspot_child_4 .dih-tooltip").addClass("dih-tablet-left"); } else { $(".image_hotspot_child_4 .dih-tooltip").removeClass("dih-tablet-left"); } // Mobile if ($(this).width() < 767) { $(".image_hotspot_child_4 .dih-tooltip").addClass("dih-mobile-left"); } else { $(".image_hotspot_child_4 .dih-tooltip").removeClass("dih-mobile-left"); } }).trigger("resize"); })(jQuery); </script> </div> </div> </div> </div> </div> </div> </div> </div> </div> </div> <div class="greyback greentitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <h3><span class="Subheading">BASIC AND OVERARCHING INCENTIVES</span></h3> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div class="orangetitle"> <a id="patents"></a> <h2><span class="Subheading">PATENTS</span></h2> <p><span class="rte-paragraph">Patents are the basic incentive supporting research into new medicines. It was designed to provide a limited period of exclusivity to all inventors to commercialise their innovations irrespective of the field of technology, thereby encouraging investment into the progress of science and technology. Patents are only granted to inventions & creations that are new, involve an inventive step and that are capable of industrial application.</span></p> <p><span class="rte-paragraph">A patent grants the right to exclude others from commercially exploiting their invention for a limited term of 20 years from filing date – i.e., as soon as research shows potential. As a <em>quid pro quo</em> for exclusivity, the inventor has to disclose the details of the invention, thereby contributing to the dissemination of scientific and technical knowledge, thus helping accelerate follow-on innovation.</span></p> <p style="text-align: right;"><a href="#top">Back to top</a></p> <p style="text-align: right;"> </p> <p style="text-align: right;"> </p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div class="bluetitle"> <a id="spc"></a> <h2><span class="Subheading">SUPPLEMENTARY PROTECTION CERTIFICATES (SPCS) </span></h2> <p><span class="rte-paragraph">Unlike in most other industries, around half of the standard 20-year patent term in the pharmaceutical product is spent on rigorous clinical trials to demonstrate the safety and efficacy of the medicine before it can be made available to patients. Recognising this disadvantage, the EU introduced supplementary protection certificates (SPCs) to offset part of the lost patent term and ensure sufficient protection is available to continue encouraging sustainable and appropriate funding for the next wave of biopharmaceutical research and development. In practice, the SPC restores part of the patent protection at a maximum of 5 years (to be determined case by case). The combined/total patent and SPC protection period from marketing authorisation, however, cannot exceed 15 years.</span></p> <p> </p> <p style="text-align: right;"><a href="#top">Back to top</a></p> <p style="text-align: right;"> </p> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div class="greentitle"> <a id="rdp"></a> <h2><span class="Subheading">REGULATORY DATA PROTECTION (RDP)</span></h2> <p><span class="rte-paragraph">In order to obtain a marketing authorisation, pharmaceutical companies need to submit extensive data relating to preclinical and clinical trials to demonstrate the quality, efficacy and safety of the medicine to be approved. Regulatory data protection (RDP) protects innovative companies’ investment in generating this extensive body of data through a limited period of exclusivity on the data, starting from marketing authorisation.</span></p> <p><span class="rte-paragraph">After the RDP period, generics are permitted to rely upon the originator’s data to obtain approval for their products through an “abbreviated” application. Such time limited protection is crucial to incentivize the significant investment necessary to demonstrate the safety and efficacy of new medicines, while nevertheless enabling other companies to eventually register their products on the basis of this data.</span></p> <p><span class="rte-paragraph">Specifically, the European legislator designed RDP in the following way:</span></p> <ul> <li><span class="rte-paragraph">8 years of data exclusivity during which the marketing-authorisation holder benefits from the exclusive rights to the data. This means that a generic or biosimilar applicant cannot cross-refer to this data in support of its own marketing authorization. After this period, anyone can rely on the innovator’s data in the “abbreviated” application for a marketing authorization. This is followed by 2 years of market protection during which a generic or biosimilar cannot be placed on the market. A generic or biosimilar company, can however rely on the data body to prepare its own marketing authorisation dossier.</span></li> <li><span class="rte-paragraph">1 year of additional market protection may be available in a case of a new therapeutic indication which brings significant clinical benefit in comparison with existing therapies. As per above, a marketing authorisation dossier can be prepared but the generic or biosimilar product cannot be placed on the market.<br /></span></li> </ul> <div class="et_pb_module et_pb_text et_pb_text_14 et_pb_text_align_left et_pb_bg_layout_light"> <div class="et_pb_text_inner"> <p><img class="wp-image-31501 alignleft size-medium" src="/images/Lightbulb.svg" alt="" width="70px" height="auto" /><strong>Did you know? A patent protects inventions, RDP protects data</strong></p> </div> </div> </div> </div> </div> </div> </div> <div class="greentitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <p style="text-align: right;"><a href="#top">Back to top</a></p> </div> </div> </div> </div> </div> <div class="greyback greentitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <h3><span class="Subheading">TARGETED INCENTIVES FOR RARE AND PAEDIATRIC DISEASES</span></h3> <span class="rte-paragraph">The EU has further sought to encourage the research and development of safe medicines for people living with rare diseases and children.</span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div class="lightbluetitle"> <a id="incentives"></a> <h2><span class="Subheading">ORPHAN INCENTIVES</span></h2> <br /><span class="rte-paragraph">To ensure that patients suffering from rare conditions have the same quality of treatment as any other patient in the EU, the EU Orphan Regulation was adopted in 2000. It introduced the definition of Orphan Medicinal Product (OMP), an orphan designation and a specific committee in charge of OMP at the EMA as well as a series of incentives to stimulate the development of treatments for rare diseases.</span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div class="orangea"> <p><span class="rte-paragraph"><strong>The Orphan Regulation</strong> is central to the EU’s strategy of promoting innovation that meets the needs of patients suffering from rare diseases. To qualify for orphan designation and thereby benefit from the framework of the Orphan Regulation, a medicine must meet a number of criteria:</span></p> <ul> <li><span class="rte-paragraph">it must be intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating;</span></li> <li><span class="rte-paragraph">the prevalence of the condition in the EU must not be more than 5 in 10,000, OR it must be unlikely that without incentives marketing of the medicine would generate sufficient returns to justify the investment needed for its development;</span></li> <li><span class="rte-paragraph">no satisfactory method of diagnosis, prevention or treatment of the condition concerned can be authorised, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition.</span></li> </ul> <p><span class="rte-paragraph">Pharmaceutical companies investing in R&D for orphan medicines have to <strong>prove at two distinct points in time</strong> (at the time of application for orphan designation and at the time of marketing authorisation) that the <strong>medicine fulfils the strict requirements for obtaining an orphan designation</strong>.</span></p> <p><span class="rte-paragraph">Once a product has been approved for a specific indication, any <strong>new, additional indication or extension of the existing orphan indication</strong>, requires <strong>a separate assessment by the EMA and marketing authorisation decision by the European Commission</strong> (following the same strict criteria).</span><a data-id="1074" href="/" target="_top" title="Home"></a> </p> </div> </div> <div class="col-md-6 column"> <div class="orangea"> <p><span class="rte-paragraph">It is not a simple or quick process and in fact, only a few – <strong>around 11%</strong> – medicines have more than one orphan indication or treat a larger number of (rare disease) patients.<sup><a name="_ednref1" href="#_edn1">1</a></sup></span></p> <p><span class="rte-paragraph">The EU Orphan Regulation<sup><a name="_ftnref2" href="#_ftn2">2</a></sup> provides protocol assistance, reduced fees for regulatory activities, additional incentives for SMEs, and 10 years of market exclusivity. During that period, the European Medicines Agency (EMA) and the Member States shall not accept another application for an MA for a similar product. It is also worth noting that this exclusivity is not absolute as medicines showing clinical superiority can be approved and marketed during the 10-year period. As a result, there can be multiple treatment options for some rare diseases.</span></p> <p><span class="rte-paragraph">The introduction of the EU Orphan Regulation, along with scientific advances, led to a wave of new treatment options for rare disease patients. Since the adoption of the Orphan Medicinal Products regulation in 2000, more than 160 OMPs had been approved by the European Medicines Agency EMA by 2018.</span></p> <p><span class="rte-paragraph">Despite the considerable success so far, there is still high unmet medical need in rare diseases: only 5% of rare diseases are estimated to have an approved treatment and much work remains to be done. Maintaining the right regulatory, scientific and economic environment for orphan medicine development is therefore imperative if the public health challenge of rare diseases is to be met in future.</span></p> <div id="gtx-trans" style="position: absolute; left: 67px; top: 593px;"> <div class="gtx-trans-icon"></div> </div> </div> </div> </div> </div> </div> <div class="lightbluetitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div class="boxlink"> <div style="text-align: right;"><span class="rte-paragraph"><a href="/about-medicines/development-of-medicines/intellectual-property/help-us-make-rare-disease-even-rarer/">Read more</a></span></div> <div id="gtx-trans" style="position: absolute; left: 645px; top: 22px;"> <div class="gtx-trans-icon"></div> </div> </div> </div> <div class="col-md-6 column"> <div > <span class="rte-paragraph"><a href="#top">Back to top</a></span> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div class="purpletitle"> <a id="paediatric"></a> <h2><span class="Subheading">PAEDIATRIC INCENTIVES</span></h2> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div class="orangea"> <p><span class="rte-paragraph"><strong>The Paediatric Regulation</strong> was adopted in 2007 to facilitate the development and availability of high-quality medicines suitable for children. The Regulation has contributed to make paediatric research an integral part of general medicines development, introducing obligations on pharmaceutical companies to research and develop their products in children as well as adults.</span></p> <p><span class="rte-paragraph">When a company completes a Paediatric Investigation Plan (PIP), the rewards can take two alternative forms:</span></p> <ul> <li><span class="rte-paragraph">A 6-month extension to the supplementary protection certificate (SPC), which protects the product OR</span></li> <li><span class="rte-paragraph">When the product which is the subject of the completed PIP is an orphan medicinal product, the 10 years of market exclusivity provided by the Orphan Regulation can be extended by a further 2 years.</span></li> </ul> <p><span class="rte-paragraph">Rewards are intended to support the industry by helping to offset the additional costs of conducting paediatric research. They are only available when a company has successfully completed its paediatric research as required by the EMA and updated the product labelling to reflect the results.<sup><a name="_ftnref3" href="#_ftn3">3</a></sup></span></p> </div> </div> <div class="col-md-6 column"> <div class="orangea"> <p><span class="rte-paragraph">The Regulation also provides for incentives for companies to develop off-patent compounds for paediatric indications, through the concept of Paediatric use marketing authorisations (PUMAs).<sup><a name="_ftnref4" href="#_ftn4">4</a></sup> A PUMA will only cover the paediatric indication(s) and will benefit from a separate 8+2 year period of data and market protection.</span></p> <p><span class="rte-paragraph">Rewards can be valuable but are far from certain to be achieved for all products for which PIPs are completed. According to the 2015 EMA report to the EC, out of the 113 PIPs completed, only 33 products had benefited from the 6-month SPC extension and 3 products obtained the 2-year orphan market exclusivity extension. Until July 2018; only 3 PUMAs have been authorized.</span></p> <p><span class="rte-paragraph">In the period 2007-2016, over 260 new medicines for use by children (new marketing authorisations and new indications) were authorised. Prior to the Regulation, 50% of medicines had not been tested and developed for children. In the past decade, the proportion of paediatric clinical trials has increased by 50% (from 8.25% to 12.4% of all trials conducted in the EU).<sup><a name="_ftnref5" href="#_ftn5">5</a></sup></span></p> </div> </div> </div> </div> </div> <div class="purpletitle"> <div class="container"> <div class="row clearfix"> <div class="col-md-6 column"> <div class="boxlink purple"> <div style="text-align: right;"><span class="rte-paragraph"><a href="/about-medicines/development-of-medicines/regulations-safety-supply/stimulating-the-development-of-new-medicines-for-children/">Read more</a><br /><br /><br /><br /></span></div> </div> </div> <div class="col-md-6 column"> <div > <span class="rte-paragraph"><a href="#top">Back to top</a><br /><br /><br /><br /></span> <div id="gtx-trans" style="position: absolute; left: 91px; top: -18px;"> <div class="gtx-trans-icon"></div> </div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <div class="download-list__container"> <h2 class="section__header">Downloads</h2> <ul class="download-list__list"> <li class="download-list__item"> <a href="/media/412469/future-proofing-eu-competitiveness-by-limiting-the-negative-impact-of-the-spc-manufacturing-waiver.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Future-proofing EU competitiveness by limiting the negative impact of the SPC manufacturing waiver</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/361669/ohe-consulting-report-cra-review-final.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Review of CRA’s Report “Assessing the economic impacts of changing exemption provisions during patent and SPC protection in Europe"</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/288516/efpia-spc-report_120917_v3_10217-002.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Assessing the impact of proposals for a Supplementary Protection Certificate (SPC) Manufacturing Exemption in the EU</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/15425/new-indications-cross-label-dispensing-november-2015.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">New indications & cross-label dispensing</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> <li class="download-list__item"> <a href="/media/15439/consultation-on-the-respect-of-intellectual-property-in-public-procurement-procedures-july-2015.pdf" class-="download" target="_blank"> <span class="fa download-list__type fa-file-pdf-o"></span> <span class="download-list__name">Consultation on the respect of intellectual property in public procurement procedures</span> <i class="material-icons download-list__icon">get_app</i> </a> </li> </ul> </div> </div> </div> </div> </div> </div> <div > <div class="container"> <div class="row clearfix"> <div class="col-md-12 column"> <div > <span class="rte-heading">Related blogs</span> <div class="article-list__container"> <ul class="article-list__list"> <li class="article-list__item"> <a href="/news-events/the-efpia-view/blog-articles/rd-why-the-eu-bank-invests-in-patented-ideas-guest-blog/"> <h4 class="article-list__title">R&D: Why the EU bank invests in (patented) ideas (Guest blog)</h4> <div class="article-list__description">A favourable IP environment is essential to compensate for the disadvantages that life sciences companies face when seeking investor support. 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The 10-year period of data and market protection it provides is necessarily specific to the paediatric data/indication on which the PUMA is based, and therefore restrains generic applications for that particular indication and their reliance on that particular data only. In other words, generics may not then be authorised for the paediatric indication in question, during the exclusivity period.</span></p> <p><sup><a name="_ftn5" href="#_ftnref5">5</a></sup> <a href="https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf">https://ec.europa.eu/health/sites/health/files/files/paediatrics/docs/2017_childrensmedicines_report_en.pdf</a></p> </div> </div> </div> </div> </div> </div> </div> </section> <script type='text/javascript'> var animationData = 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