{"id":11236,"date":"2019-12-11T10:50:19","date_gmt":"2019-12-11T09:50:19","guid":{"rendered":"https:\/\/saludporderecho.org\/la-opacidad-en-el-mercado-de-medicamentos-es-antidemocratica\/"},"modified":"2019-12-11T14:52:20","modified_gmt":"2019-12-11T13:52:20","slug":"la-opacidad-en-el-mercado-de-medicamentos-es-antidemocratica","status":"publish","type":"post","link":"https:\/\/saludporderecho.org\/en\/la-opacidad-en-el-mercado-de-medicamentos-es-antidemocratica\/","title":{"rendered":"\u201cThe opacity in the medicine market is antidemocratic\u201d"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">On December 3, the National Assembly of France adopted the final text of the Draft Law on Social Security Financing, which included a historical amendment on transparency in public contributions to research and development (R&amp;D) of medications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For many civil society organizations that work in health and transparency, the adoption of this amendment marks an important turning point, although they remember that the road ahead is still immense.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Today we speak with Juliana Veras, (Universities Allied for Essential Medicines), and with Th\u00e9au Brigand (Doctors of the World), to understand the details of this amendment and the near and future consequences of greater transparency in R&amp;D in health.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>When and how is the origin of this amendment? <\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The whole transparency campaign began with the World Health Assembly and the<a href=\"https:\/\/saludporderecho.org\/en\/the-oms-approves-a-proposed-resolution-for-medical-price-transparency\/\"><strong> transparency resolution in May 2019<\/strong><\/a>. The French access to medicine movement (MdM, MSF, AIDES, France Assos, Sant\u00e9, UAEM, Prescrire, Act-Up Paris and so on) had called on the French government to commit to the resolution and support transparency on the drug market.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Following this commitment, we have worked to transpose\nthis international resolution into French law. We have contacted MPs and\nrelevant ministries (Ministry of Health, Ministry of Research and Ministry of\nIndustry) to work on concrete options to implement the transparency resolution.\nTransparency on public R&amp;D was one of them.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Why is this amendment \u2018historic\u2019?&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The amendment obliges companies to disclose the public funding in R&amp;D.\nWith this amendment, we want to demonstrate that public research is significant\non the development of new drugs, and that it is particularly present when the\nrisks are most significant, at the beginning of the R&amp;D cycle. The aim is\nto enhance the value of public research, and to organize a form of\naccountability, particularly on price and access.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As of today, we do not know the amount of public research on the drugs that\nare coming on the market. All we know is that states and health systems invest\na lot and strongly support scientific and biomedical research. These investments must\nbe valued.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>There is figures about the public investment in the R&amp;D in health in\nFrance?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is challenging to trace how much France invests in\nhealth R&amp;D since it involves many forms: tax credits, support for private\nresearch, investment in universities, support for foundations and associations\u2026\nThese different measures are also managed by many different institutions, which\ndoes not facilitate accurate and accessible traceability. That\u2019s also why we\nneed some new transparent tools to better monitor how the public investment in\nR&amp;D.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/juliana-vera-1024x683.jpg\" alt=\"\" class=\"wp-image-11223\" srcset=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/juliana-vera-1024x683.jpg 1024w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/juliana-vera-300x200.jpg 300w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/juliana-vera-768x512.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption>Juliana Veras, de UAEM<\/figcaption><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>And there are public investment criteria or\nconditionalities in the agreements between pharma industry and the public\nadministration during the transfer of knowledge among them?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">About the conditionalities and transfer of knowledge\nand technologies, it is an emerging debate. We already have few experiences\nabout what some good practices could be. For example, G\u00e9n\u00e9thon, a French\ncharity focused on designing gene therapies for rare diseases, funded some research\non a therapy for young children with spinal muscular atrophy (SMA) and AAV9\nvectors. It leads to the discovery of a new therapy: Zolgensma\u00ae.&nbsp; The\ncharity holds several key patents that were licensed to AveXis, a company that\ncommercialize Zolgensma\u00ae. But today, AveXis and Novartis, are asking 2 million\ndollars a person for the therapy, making it the most expensive drug in the\nworld. However, G\u00e9n\u00e9thon included a reasonable pricing clause in a licensing\ncontract that was signed with AveXis : \u201cLicensee will use Reasonable Efforts to\nmake available within France all the Licensed Products indicated for SMA at\nprices that would allow appropriate reimbursement scheme and that would not\nconstitute an obstacle for patients to have access to the therapy.\u201d Therefore,\nwe will see how this clause will impact the market access and price\nnegotiations of Zolgensma in France. How does it work? Is it effective? How\ncould we strengthen this kind of clause? There is a lot to learn from this\ncase.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Next year, the French parliament will discuss a bill\non R&amp;D policies. Some civil society organisations want to take this\nopportunity to better discuss about how this kind of conditionalities could be\nimplemented.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Which implications this amendment could have in the next years?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We will need several months to really understand the\nimplication of this amendment. We introduced a general principle in the law,\nbut we now have to work on the concrete application. A decree will define what\nis included under public research: public grants? Tax credits? French R&amp;D\nof course, but what about European R&amp;D? And what about the R&amp;D by\nforeign countries such as Spain, Germany, the US and so on. We want it to be as\nexhaustive as possible, but we will have to negotiate it with the\nadministration. And we already know that the pharma lobby will also negotiate\nto make the scope of transparency as little as possible.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">From there, there is several implication that we are\nexpecting.&nbsp;First, it can demonstrate that the traceability of public\nfundings is feasible, therefore, the same can be ask from private fundings. The\nfirms always explained that it\u2019s not possible to know how much was invested in\nthe development of a single drug. We can demonstrate that it\u2019s doable.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Second, it can help illustrate that the drugs are not\nonly developed by public firms, but also by the public sector, that will\nintervene when the risks are at the highest. And it needs to be considered in\nthe price negotiations. The public sector can\u2019t pay twice for a single drug,\nfirst to develop it, then to access it. We want to organize a form of\naccountability regarding public R&amp;D. As long as a drug is developed with\nthe help of the public sector, it should imply a sustainable access and a\nreasonable price.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Last, we see in this amendment a first step toward\nfull transparency. It is a cultural, as much as a democratic battle. Citizens\nmust have the opportunity to understand what they are paying for.&nbsp; The\nopacity on the drug market is undemocratic. The health system and the state\nmust be accountable for their use of public ressources, and accept citizen\ncontrol. This amendment will contribute to this.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" width=\"1024\" height=\"695\" src=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/JPB2018D102F0913_0043-1-e1576056592724-1024x695.jpg\" alt=\"\" class=\"wp-image-11229\" srcset=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/JPB2018D102F0913_0043-1-e1576056592724-1024x695.jpg 1024w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/JPB2018D102F0913_0043-1-e1576056592724-300x204.jpg 300w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/JPB2018D102F0913_0043-1-e1576056592724-768x522.jpg 768w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2019\/12\/JPB2018D102F0913_0043-1-e1576056592724.jpg 1315w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><figcaption>Theau Brigand, de M\u00e9dicos del Mundo<\/figcaption><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>What barriers or oppositions did you find during the way?&nbsp;<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The main barrier we faced was by the state itself. Even if we manage to get\nFrance to endorse the transparency resolution, we still have a long way to go\nto make the political and administrative stakeholders realize that it is\npossible, but also necessary. There is a strong consent to the current system,\nto the lack of transparency and high prices. This consent is both because there\nare some industrial policy issues at stake, but also because it\u2019s difficult to\nthink of a new, and more democratic system. When speaking with the CEPS (Comit\u00e9\n\u00e9conomique des produits de sant\u00e9), that negotiate the french prices, they\nreally think that the current, system, excessively&nbsp;protected by business\nsecrecy, allow them to negotiate better prices. And maybe it\u2019s true, but we\ndon\u2019t know for sure because we know nothing about the real prices.&nbsp;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"> We hope State\u2019s recognition that there is a problem regarding drug prices will help unlock the debate on responsible models of R&amp;D, one topic we have also confronted a barrier to develop with the State. In France, for instance, we have this strange paradoxe, in which, on the one hand, we have seen French actors having a major role in the creation of <a href=\"https:\/\/www.dndi.org\/\">DNDi<\/a>, an organization created 15 years ago. On the other hand, our attempts to discuss with State actors the implementation of such experience at the national level have been completely unheard. It reasserts the precedent idea, that there is something bugging in the democratic process, in the quality of the dialogue between civil society and the State. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Do you think this amendment is (or should be) \u2018exportable\u2019 to other\ncountries?<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Yes, of course. We have this growing understanding among the organisations\nthat are part of the European Alliance regarding the public benefits of R&amp;D\ntransparency. It could also help gather some more data about public and private\nfundings on R&amp;D, to better understand how the drug is developed and the\nreal costs. We also need more transparency about patents, clinical trials,\nproduction costs, real prices and so on. If some other transparency measures\nare implemented throughout the world, we will gain more knowledge about what we\npay for, and better understand what would be a fair price that could ensure\nsustainable access to real innovations.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On December 3, the National Assembly of France adopted the final text of the Draft Law on Social Security Financing, which included a historical amendment on transparency in public contributions<\/p>\n","protected":false},"author":2,"featured_media":11221,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[309],"tags":[],"class_list":["post-11236","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-slider-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>\u201cThe opacity in the 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