<div dir="ltr"><div class="gmail_default" style="font-size:large"><br></div>-<br><div class="gmail_quote"><div dir="ltr" class="gmail_attr">From: <b class="gmail_sendername" dir="auto">South Centre</b> <span dir="auto"><<a href="mailto:south@southcentre.int">south@southcentre.int</a>></span><br></div><br><u></u>
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SOUTHNEWS</span></h2>
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No. 288, 16 October 2019<br>
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<p style="color:#000000;font-family:Helvetica;font-size:12px;line-height:150%;text-align:left"><span style="font-size:25px"><span style="color:#000000"><b>The WTO TRIPS Council will discuss measures to increase transparency on</b> <b>R&D costs and prices and experiences of the use of the TRIPS flexibilities that have promoted access to medicines</b></span></span><br>
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<span style="color:#000000"><span style="font-size:14px"><b>The World Trade Organization (WTO) TRIPS Council (TRIPS – Agreement on Trade-Related Aspects of Intellectual Property Rights) will discuss in its session on 17 October the need for transparency regarding research and development (R&D) costs and prices for medicines. Under the agenda item of intellectual property and the public interest, South Africa (SA) submitted a communication to inform the discussion. The SA communication calls for WTO members to commit to the full use of the flexibilities in the TRIPS Agreement to increase access to affordable, safe, effective and quality medicines. Countries are invited to share their national experiences on how TRIPS flexibilities have been used to address high prices and barriers to access to medical technologies in order to achieve public health and related national objectives. The South Centre encourages developing countries to prepare to respond in the TRIPS Council to the guiding questions in the SA communication and to actively participate in the discussion. </b></span></span></p>
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<p style="text-align:left;color:#000000;font-family:Helvetica;font-size:12px;line-height:150%"><span style="color:#000000"><span style="font-size:14px"><b>Call to share national policies and experiences to curb high prices and barriers to access to medicines</b></span></span></p>
<p style="text-align:left;color:#000000;font-family:Helvetica;font-size:12px;line-height:150%"><span style="color:#000000"><span style="font-size:14px">The communication by South Africa (SA) to the World Trade Organization (WTO) (IP/C/W/659) echoes the growing international concern about the lack of transparency regarding research and development (R&D) costs and prices for medicines, and how pharmaceutical companies and healthcare providers that hold monopolist positions can reduce public welfare by charging high prices. The communication by South Africa invites WTO members to share their national experiences to curb high prices and diminish barriers to access to medicines and medical products. For this purpose, it offers a number of guiding questions:</span></span></p>
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<li style="text-align:left"><span style="color:#000000"><span style="font-size:14px">What are countries’ experiences with escalating prices of patent medicines and their policy responses to address this trend through the use of TRIPS flexibilities? What are the TRIPS Flexibilities adopted by Members in their patent laws to ensure availability of patented medicines at reasonable prices? What are the national experiences on efforts to improve the transparency of patent landscapes to ensure that no barriers are created to generic competition?</span></span></li>
<li style="text-align:left"><span style="color:#000000"><span style="font-size:14px">What approaches have Members implemented regarding price regulation of patented medicines (e.g. combination of cost-based pricing, value-based pricing, reference pricing, and/or through tendering and negotiation, and regulating mark-up levels)? What are the results and challenges that Members face to ensure compliance and disclosure of necessary information or their effect on the prices of medicines?</span></span></li>
<li style="text-align:left"><span style="color:#000000"><span style="font-size:14px">What are the measures implemented to enhance the publicly available information on the costs of manufacturing, in particular information on grants, tax credits or any other public sector subsidies and incentives relating to the initial regulatory approval and annually on the subsequent development of a product or procedure?</span></span></li>
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<p style="text-align:left;color:#000000;font-family:Helvetica;font-size:12px;line-height:150%"><span style="color:#000000"><span style="font-size:14px"> <br>
<b>Reinforce commitment to use the TRIPS flexibilities to protect public health</b><br>
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The SA communication notes that the international legal framework requires governments to make full use of TRIPS Flexibilities to increase access to medicines for all, including the targets of the Sustainable Development Goals (SDGs) of the 2030 Agenda for Sustainable Development. It also recalls that the protection and enforcement of intellectual property (IP) is not an end in itself, and that Article 7 of the TRIPS Agreement links IP to the promotion of technological innovation and the transfer and dissemination of technology.<br>
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The SA communication further recalls the Doha Declaration on the TRIPS Agreement and Public Health´s call for countries to make full use of the Agreement´s flexibilities, as well as the report of the United Nations High-Level Panel on Access to Medicines (2016) that examined the incoherence between trade, IP, human rights and public health.<br>
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<b>IP incentives deficient for R&D in diseases that mainly affect developing countries </b><br>
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The SA communication also points to the deficiencies of the current model of R&D and medical innovation. It notes that the current model is ill-equipped to address current health burdens, particularly for developing and least developed countries. It notes that Target 3.b of the Sustainable Development Goals underscores the importance of support for R&D of vaccines and medicines for communicable and non-communicable diseases that primarily affect developing countries.<br>
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<b>Increase transparency on R&D costs and prices</b><br>
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The SA communication recalls the recently approved Resolution WHA70.12 on transparency in the pharmaceutical sector, in particular the increasing costs of new pharmaceutical products for cancer treatment in recent years.<br>
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It notes that while many WTO Members have implemented policies to deal with the pharmaceutical sector, pricing policies of private enterprises remain opaque and differ from country to country, affecting procurement and government policies. Thus, the SA communication stresses that transparency is a central component to inform decision-making, noting that <i>“the true costs of R&D for pharmaceuticals are often unknown and highly variable, while the contribution made by public and non-profit-making sectors towards the R&D of medicines is not always accounted for”. </i>The SA communication recalls that the lack of data to assess costs is also noted by the trilateral study prepared by WTO, the World Intellectual Property Organization (WIPO) and World Health Organization (WHO) on IP and Public Health, and further states that production costs of medicines can be relatively small while many of the costs are related to marketing and promotional activities.<br>
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The SA communication notes that the lack of transparency in R&D costs is also associated to various practices by companies in the health sector that may lead to market dominance, including IP strategies such as patenting of combinations and minor variations of existing products. Anticompetitive practices result in reduced general welfare caused by higher prices and less overall economic efficiency. Therefore, addressing the abuse of IP rights remains a relevant tool to ensure cheaper and effective access to medicines and health technologies, argues the SA communication.<br>
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<b>South Centre support on use of TRIPS flexibilities</b><br>
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The South Centre welcomes the initiative led by South Africa to have a substantive and informative discussion in the WTO TRIPS Council among Members, based on their own experiences, to increase their commitment to make use of the TRIPS flexibilities, as well as policies for increasing transparency of R&D costs and prices, as legitimate means to promote access to medicines and other health technologies. The South Centre provides technical assistance on the use of TRIPS Flexibilities for developing countries in order to improve access to medicines and medical technologies, and foster competition. For more information and inquiries (open to all developing countries policymakers of any agency/occupation), please refer to:</span></span> <span style="font-size:14px"><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=dabe0f98cb&e=4fac633f11" style="color:#6dc6dd;font-weight:normal;text-decoration:underline;word-wrap:break-word!important" target="_blank">https://ipaccessmeds.southcentre.int/</a>.</span><br>
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<span style="font-size:14px"><span style="color:#000000">The communication by South Africa can be found</span></span> <span style="font-size:14px"><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=833e095998&e=4fac633f11" style="color:#6dc6dd;font-weight:normal;text-decoration:underline;word-wrap:break-word!important" target="_blank">here</a>.</span><br>
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<i><b><span style="font-size:14px"><span style="color:#000000">Authors: Vitor Ido is Programme Officer and Viviana Munoz-Tellez is Programme Coordinator of the Health, Intellectual Property and Biodiversity (HIPB) Programme of the South Centre.</span></span></b></i></p>
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