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<table id="m_-1427097102525729586root" width="100%" cellspacing="0" cellpadding="0" border="0"><tbody><tr><td valign="top" align="center"><table style="max-width:660px" role="presentation" width="100%" cellspacing="0" cellpadding="0" border="0"><tbody><tr><td style="background-color:#ffffff;background-position:center;background-repeat:no-repeat;background-size:cover" valign="top"><table role="presentation" width="100%" cellspacing="0" cellpadding="0" border="0" align="center"><tbody><tr><td style="background-position:center;background-repeat:no-repeat;background-size:cover" valign="top"><table role="presentation" width="100%" cellspacing="0" cellpadding="0" border="0"><tbody><tr><td style="padding-top:0;padding-bottom:0" class="m_-1427097102525729586mceColumn" colspan="12" width="100%" valign="top"><table role="presentation" width="100%" cellspacing="0" cellpadding="0" border="0"><tbody><tr><td style="padding-top:48px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top"><div class="m_-1427097102525729586mceText" id="m_-1427097102525729586dataBlockId-1" style="width:100%"><p><a href="https://mailchi.mp/southcentre/southnews-how-to-balance-competition-policies-and-intellectual-property-in-the-pharmaceutical-industry?e=4415b83dfc" target="_blank">View this email in your browser</a></p></div></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top" align="center"></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:0;padding-left:0" class="m_-1427097102525729586mceBlockContainer" valign="top" align="center"><br></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top"><div class="m_-1427097102525729586mceText" id="m_-1427097102525729586dataBlockId-3" style="width:100%"><p style="text-align:left"><i><b><span style="font-size:20px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">SouthNews No. 466, 27 October 2023</span></span></b></i></p><p><br></p><p><b><span style="font-size:25px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">How to balance competition policies and intellectual property in the pharmaceutical industry is part of debate co-organized by the South Centre and the Administrative Council for Economic Defense (CADE) in Brasília</span></span></b></p><p><br></p><p style="text-align:left"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">By Vitor Ido</span></span></b></p></div></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:0;padding-left:0" class="m_-1427097102525729586mceBlockContainer" valign="top" align="center"></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top"><div class="m_-1427097102525729586mceText" id="m_-1427097102525729586dataBlockId-28" style="width:100%"><p style="text-align:justify"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">The South Centre and the Administrative Council for Economic Defense (CADE, the competition authority of Brazil) co-organized on 18 August 2023 a public discussion on the interface between competition policies and intellectual property (IP) in the pharmaceutical industry. The event took place in CADE’s headquarters in the Brazilian capital, Brasília, and online. The discussion addressed the role of IP and how can competition law and policy be tailored to achieve access to health technologies, particularly in the context of developing countries, as well as the potential pitfalls and difficulties of such an approach.</span></span></p><p><br></p><p style="text-align:justify"><i><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">The South Centre continues to provide no-cost, tailored, and confidential technical assistance on issues related to intellectual property and public health. Beneficiaries include developing countries’ officials, including competition authorities, medicine regulatory agencies, IP offices, judicial authorities, and administrative bodies. For more information, please refer to our dedicated website: </span></span></i><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=9170122f96&e=4415b83dfc" target="_blank"><i><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">https://ipaccessmeds.southcentre.int/</span></span></i></a><i><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> . </span></span></i></p><p><br></p><p style="text-align:justify"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">The speakers represented the following institutions: CADE, the South Centre, the Ministry of Finance, the Brazilian IP office (INPI), Fiocruz (Oswaldo Cruz Foundation, Brazil’s leading public health institute affiliated to the Ministry of Health), the Ministry of Development, Industry, Trade and Services, and the National Health Surveillance Agency (Anvisa). Around 100 participants from the in-person and online audience included members of other Brazilian ministries and agencies, as well as pharmaceutical industry representatives (both originator and generics), civil servants and private attorneys. Accordingly, the session was an opportunity for a wide diversity of views to be presented on the topic of IP and competition.</span></span></p><p><br></p><p style="text-align:justify"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">There is ample policy space for all countries to make use of competition law and policy to promote access to medicines, and there is a clear emerging global trend in that regard, in both developed and developing countries. Therefore, developing countries can craft pro-health competition policies in full respect of international law requirements.  The presentations by </span></span><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Dr. Carlos Correa</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">, </span></span><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Executive Director of the South Centre</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">, and by </span></span><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Dr. Vitor Ido</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">, </span></span><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Programme Officer of the Health, Intellectual Property and Biodiversity Programme of the South Centre</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">, focused on how this can be concretely implemented (including doctrines, enactment of guidelines, pharmaceutical sector inquiries, among others), while also highlighting the important record of CADE in addressing these issues and the value of the precedents it has set for other Latin American jurisdictions and even beyond.</span></span></p><p><br></p><p style="text-align:justify"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">The session was opened by </span></span><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">CADE’s Deputy Chief Economist</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> </span></span><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> who noted that inter-institutional cooperation in the field of access to medicines is important. He commented on the interplay between competition and IP, and particularly how the debate has concrete implications to real-life situations and access to medicines of citizens. He insisted on the importance of access to databases and the need to find solutions to improve access to cheaper and high-quality medicines.</span></span></p><p><br></p><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Dr. Carlos Correa</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> made a presentation on how competition law and policy has been increasingly deployed around the world to address anti-competitive practices in the pharmaceutical sector. He insisted on the important role of Brazil, a country with a strong institutional capacity in the antitrust realm, and how countries do not need to follow the doctrines that the US and the EU have already established – while also noting that such jurisdictions have extensively made use of competition law to address anti-competitive practices in the pharmaceutical sector. The role of legal doctrines that can be adopted by competition authorities and the possibilities to scrutinize IP anti-competitive practices should be further explored to ensure access to medicines. For example, the use of the ‘essential facilities’ doctrine and the option not to follow the approach of the “Chicago School” can be beneficial to that aim.</span></span></p></div></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:0;padding-left:0" class="m_-1427097102525729586mceBlockContainer" valign="top" align="center"></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top"><div class="m_-1427097102525729586mceText" id="m_-1427097102525729586dataBlockId-34" style="width:100%"><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Dr. Vitor Ido</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> noted that given the global trend of expanded use of competition law and policy, there is further space for more institutional development. This is particularly true in light of the increased number of anti-competitive conducts identified, such as pay-for-delay agreements, patent thickets, evergreening, sham litigation and excessive pricing. By making reference to a few landmark cases, he noted the variety of remedies that can be applied, as well as other tools such as the launch of pharmaceutical sector inquiries and the adoption of guidelines which generate more legal certainty for economic actors and business relations and more consistent policy approaches. In such regard, some difficulties will need to be overcome, including problems of capacity of authorities, the disparity of power and access to data between pharmaceutical companies, civil society and authorities, as well as undue economic and political influences.</span></span></p><p><br></p><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Dr. Júlio Cesar Castelo Branco Reis Moreira, President of the INPI (Brazilian IP office),</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> focused his presentation on the recent activities by INPI in the field of patents, which have, </span></span><i><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">inter alia</span></span></i><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">, substantially reduced the backlog of patent applications, and reiterated the importance laid by the institute to IP, including to attract more foreign investments and innovation.</span></span></p><p><br></p><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> Ministry of Finance</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> noted the position the government has had on IP and its entanglements with innovation policies, as well as the need for a better regulatory environment for the pharmaceutical sector.</span></span></p><p><br></p><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> Ministry of Development, Industry, Trade and Services</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> explained the composition and the work of the Interministerial group on IP, which regularly discusses various IP issues, and the Ministry’s position on various IP topics, including avoiding TRIPS Plus measures in free trade agreements.</span></span></p><p><br></p><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> FIOCRUZ, Oswaldo Cruz Foundation,</span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> recalled the centrality of the right to health and the constitutional mandate on public health. He presented the broad international context and the importance of competition to promote access. He recalled a 2017 event organized by Fiocruz reuniting IP offices, competition authorities and Health Ministries and invited the participants of this event to envision a second round of it.</span></span></p><p><br></p><p style="text-align:justify"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"> ANVISA (Brazilian Health Regulatory Agency)<span class="gmail_default" style="font-size:large"> </span></span></span></b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">explained how ANVISA deals with marketing approvals of medicines in Brazil and exposed some of the ways it intersects with competition. One example under discussion in Brazil is the approval of skinny labeling, which could facilitate entry of generics into markets.</span></span></p><p><br></p><p style="text-align:justify"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">As a general conclusion of the session, more inter-agency cooperation was deemed to be required, including at the international level. The complex interface between IP, medicines’ regulatory approval, public health, medicine price regulation, consumer protection and competition, needs to be further explored. Institutional solutions that include further dialogues will be required. The South Centre stands ready to continue cooperating with CADE and other Brazilian institutions on this matter.</span></span></p><p><br></p><p style="text-align:justify"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"><br></span></span></p><p><br></p><p style="text-align:justify"><i><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">Author: Vitor Ido, Programme Officer of the Health, Intellectual Property and Biodiversity Programme of the South Centre.</span></span></b></i></p></div></td></tr><tr><td style="background-color:transparent;padding-top:20px;padding-bottom:20px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top"><table style="background-color:transparent" role="presentation" width="100%" cellspacing="0" cellpadding="0" border="0"><tbody><tr><td style="min-width:100%;border-top:1px solid #000000" valign="top"></td></tr></tbody></table></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top"><div class="m_-1427097102525729586mceText" id="m_-1427097102525729586dataBlockId-14" style="width:100%"><p style="text-align:left"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">SouthNews is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.<br><br>To view other articles in SouthNews, please click </span></span></b><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=c868e649e5&e=4415b83dfc" target="_blank"><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">here</span></span></b></a><b><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">.</span></span><span style="color:rgb(0,0,0)"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif"><br><br>For more information, please contact Anna Bernardo of the South Centre: Email </span></span></span></b><a href="mailto:abernardo@southcentre.int" target="_blank"><b><span style="color:#ff8019"><span style="text-decoration:underline"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">abernardo@southcentre.int</span></span></span></span></b></a><b><span style="color:rgb(0,0,0)"><span style="font-size:14px"><span style="font-family:Arial,'Helvetica Neue',Helvetica,sans-serif">.</span></span></span></b></p><p><br></p></div></td></tr><tr><td style="padding-top:12px;padding-bottom:12px;padding-right:24px;padding-left:24px" class="m_-1427097102525729586mceBlockContainer" valign="top" align="center"><table role="presentation" cellspacing="0" cellpadding="0" border="0" align="center"><tbody><tr class="m_-1427097102525729586mceStandardButton"><td style="background-color:#008246;border-radius:0;text-align:center" valign="top"><a href="https://southcentre.us5.list-manage.com/track/click?u=fa9cf38799136b5660f367ba6&id=183a7d1803&e=4415b83dfc" style="background-color:#008246;border-radius:0;border:2px solid #000000;color:#ffffff;display:block;font-family:'Helvetica Neue',Helvetica,Arial,Verdana,sans-serif;font-size:16px;font-weight:normal;font-style:normal;padding:16px 28px;text-decoration:none;min-width:30px;text-align:center;direction:ltr;letter-spacing:0px" target="_blank">Visit our website</a></td></tr><tr>

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