tag:theconversation.com,2011:/us/topics/novartis-3118/articlesNovartis – The Conversation2022-12-05T13:27:20Ztag:theconversation.com,2011:article/1898682022-12-05T13:27:20Z2022-12-05T13:27:20ZPharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation<figure><img src="https://images.theconversation.com/files/498366/original/file-20221130-8007-d247y0.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/medicines-and-money-the-cost-of-treatment-and-royalty-free-image/1129305852">Andrii Zastrozhnov/iStock via Getty Images Plus</a></span></figcaption></figure><p>Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs. </p>
<p>I am an <a href="https://www.lucyxiaoluwang.com/">economist</a> who studies <a href="https://scholar.google.com/citations?user=M0QlVjcAAAAJ&hl=en">innovation and digitization</a> in health care markets. Growing up in a developing region in China with limited access to medications inspired my interest in institutional innovations that can facilitate drug access. One such innovation is a patent pool, or a “one-stop shop” where entities can pay one low price for permission to make and distribute all the treatments covered by the pool. My recent research found that a <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">patent pool geared toward public health</a> can spur not only generic drug access in LMICs but also innovation for pharmaceutical companies.</p>
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<figcaption><span class="caption">Patent pools can help increase access to expensive drugs.</span></figcaption>
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<h2>Drug patents in the global landscape</h2>
<p>Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, <a href="https://www.wipo.int/patents/en/faq_patents.html">typically 20 years</a> from the application filing date. </p>
<p>However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “<a href="https://doi.org/10.1016/j.jhealeco.2012.01.004">evergreens</a>” the company’s patent portfolio without requiring substantial new investments in research and development. </p>
<p>Furthermore, because patents are <a href="https://www.wipo.int/patents/en/faq_patents.html">jurisdiction-specific</a>, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.</p>
<p>To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 <a href="https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm">Agreement on Trade-Related Aspects of Intellectual Property Rights</a>, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.</p>
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<figcaption><span class="caption">Determining what is patentable can be complicated.</span></figcaption>
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<p>The 2001 <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">Doha Declaration</a> clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.</p>
<p>One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court <a href="https://doi.org/10.1186/1744-8603-10-3">denied Novartis’s patent application</a> for Glivec for <a href="https://www.upcounsel.com/patent-obviousness">obviousness</a>, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been <a href="https://doi.org/10.1136/bmj.f2099">patented in 40 other countries</a>. As a result of India’s landmark ruling, the price of Glivec <a href="https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/">dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88)</a> for one month of treatment.</p>
<h2>Patent challenges and pools</h2>
<p>Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain <a href="https://doi.org/10.1038/s41587-021-01137-6">multiple patented compounds</a>, each of which can be owned by different companies. Overlapping patent rights can create a “<a href="https://doi.org/10.1086/ipe.1.25056143">patent thicket</a>” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.</p>
<p>One solution to these drug access issues is <a href="https://doi.org/10.1257/0002828041464641">patent pools</a>. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization. </p>
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<a href="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of licensing markets with and without a patent pool" src="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=264&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=264&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=264&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=332&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=332&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=332&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
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<p>Patent pools were first used <a href="https://www.jstor.org/stable/43186442">in 1856 for sewing machines</a> and were once <a href="https://doi.org/10.1257/0002828041464641">ubiquitous across multiple industries</a>. Patent pools gradually disappeared after a <a href="https://supreme.justia.com/cases/federal/us/323/386/">1945 U.S. Supreme Court decision</a> that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later <a href="https://firstmonday.org/ojs/index.php/fm/article/view/1912/1794">revived in the 1990s</a> in response to licensing challenges in the information and communication technology sector.</p>
<h2>The Medicines Patent Pool</h2>
<p>Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The <a href="https://medicinespatentpool.org/">Medicines Patent Pool, or MPP</a>, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.</p>
<p>But how much has the MPP improved drug access?</p>
<p>I sought to <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">answer</a> <a href="https://dx.doi.org/10.2139/ssrn.4016897">this question</a> by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.</p>
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<a href="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of the Medicines Patent Pool licensing structure" src="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=255&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=255&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=255&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=320&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=320&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=320&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
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<p>I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.</p>
<p>I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.</p>
<p>The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.</p>
<p>Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.</p>
<h2>Technology licensing for COVID-19 and beyond</h2>
<p>Since May 2020, the Medicines Patent Pool has become a key partner of the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool">World Health Organization COVID-19 Technology Access Pool</a>, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an <a href="https://medicinespatentpool.org/covid-19/mrna-technology-transfer-hub-programme">mRNA vaccine technology transfer hub</a> in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.</p>
<p>Licensing COVID-19-related technologies can be complicated by the <a href="https://pubmed.ncbi.nlm.nih.gov/34194207">large amount of trade secrets</a> involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as <a href="https://heinonline.org/HOL/LandingPage?handle=hein.journals/ilr101&div=32&id=&page=">manufacturing details</a>. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to <a href="https://medicinespatentpool.org/partners/how-to-get-or-give-a-licence">close the licensing knowledge gap</a>. </p>
<p>Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug <a href="https://medicinespatentpool.org/news-publications-post/mpp-signs-licence-agreement-to-increase-access-to-nilotinib-for-the-treatment-of-chronic-myeloid-leukaemia">nilotinib</a> – the first time a cancer drug has come under a public health-oriented licensing agreement.</p><img src="https://counter.theconversation.com/content/189868/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lucy Xiaolu Wang receives research funding from Cornell University and the Institute for Humane Studies.</span></em></p>The Medicines Patent Pool was created to promote public health, facilitating generic licensing for patented drugs that treat diseases predominantly affecting low- and middle-income countries.Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass AmherstLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1627772021-06-17T14:28:09Z2021-06-17T14:28:09ZGender washing: seven kinds of marketing hypocrisy about empowering women<figure><img src="https://images.theconversation.com/files/407045/original/file-20210617-12-zgs0pm.jpeg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">'We're all about you.'</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/digital-art-painting-illustration-business-man-564387154">jesadaphorn</a></span></figcaption></figure><p>At a time of so much focus on how women are held back and treated unfairly, corporations spend multiple millions telling us what they are doing to empower women and girls. When this makes them seem more women-friendly than they really are, it’s known as gender washing. </p>
<p>Gender washing comes in different varieties, and some can be easier to spot than others. To help identify them, it can be useful to look at the decades of research on corporate greenwashing – that better known variant related to climate change. </p>
<p>Inspired by a <a href="https://journals.sagepub.com/doi/full/10.1177/1086026615575332?casa_token=CkZLSpkmkJEAAAAA%3A3VRqewkRzQLKk-_unLf4GtR79bhvVs_n2WQvkUOSBmkHL65U4r61f3H0Gk4lnYoXVO6zakPwuqF-">2015 paper</a> that identified seven varieties of greenwashing, I have published <a href="https://www.tandfonline.com/doi/full/10.1080/09692290.2021.1935295">a new paper</a> that classifies seven kinds of questionable corporate claims about empowering women and girls.</p>
<p><strong>1. Selective disclosure</strong></p>
<p>When corporations publicise improvements in, say, female boardroom representation, or the gender pay gap, while omitting contradictory or inconvenient information, it’s known as selective disclosure. </p>
<p>For example, pharma group Novartis frequently features on <a href="http://www.workingmother.com/frequently-asked-questions-about-working-mother-surveys">Working Mother</a> magazine’s annual list of the 100 best companies to work for, via an application highlighting the progress it has made in employment practices towards women. Novartis also proudly cites its support for Working Mother, per the tweet below. Yet as recently as 2010, <a href="https://sanfordheisler.com/case/novartis-pharmaceutical-gender-discrimination-class-action/">the corporation lost</a> the then largest gender pay, promotion and pregnancy discrimination case ever to go to trial.</p>
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<p><strong>2. Empty gender policies</strong></p>
<p>Some companies take initiatives to raise women’s voices internally which, in reality, have little impact. For example, “women’s networks” aim to increase female employees’ confidence and help them build leadership skills through networking events and mentoring schemes. But critics argue that such networks are frequently ignored, and don’t address the underlying causes of discrimination or engage men in efforts to tackle institutional sexism. </p>
<p><a href="https://www.tandfonline.com/doi/full/10.1080/13678860500100517?casa_token=M6YF6dfj4GIAAAAA%3AwdsPPMRVIE-QT5d1MYLntVdVKfhZOGc94oxNezrrjgiqznM-73LO8ydW1qe5ORZMTjw_qy0zL7db">One study</a> from 2007 found that the members of one company’s women’s network feared it might actually damage their career prospects because at the time, it was ridiculed by male colleagues as a forum for “male-bashing” and exchanging recipes. </p>
<p><strong>3. Dubious labelling</strong></p>
<p>The promotional placement of the pink breast cancer awareness ribbon by brands with products containing known carcinogens or other arguably risky ingredients is an example of this third kind of gender washing. There are examples involving <a href="https://journals.sagepub.com/doi/full/10.1177/0891243214540991?casa_token=dqmpBlAII48AAAAA%3A5JsfDEKId7AeXO38mGCyQhEjfpOrEHbz0UjdPvV4obekV7Y9SwMkV_ph_HpwraxPS684OhKm-br8">makeup</a>, <a href="https://onlinelibrary.wiley.com/doi/full/10.1111/add.13035?casa_token=o0KFdzhtj4cAAAAA%3ALae1SGdaHxKGOFJLRfSbP54SJ1MJbKoIDZUsIATvk4uN_Yev0OXNqtGI4x1W9ZGMxpCqZyDEjdCFVQ">alcoholic drinks</a> and even <a href="https://nca.tandfonline.com/doi/abs/10.1080/0033563032000160981?casa_token=PohNuVZfFXcAAAAA:wF0QhHKQjQnrYsPYDEO1aM8AcafVEytoksKjfONbNaRUAA0_QZHq3m-BP4JYu6wip1ujv8rlmrSd#.YMCIHPnduUk">pesticides</a>.</p>
<p>The pink ribbon can also gender wash the objectification of women. For example, US bar chain Hooters has built its entire brand around waitresses with voluptuous breasts and skimpy clothing. In the company logo, the two Os are replaced by the eyes of an owl, symbolising breasts to be stared at, wide-eyed. Yet, once a year for breast cancer awareness month, the eyes are replaced by pink ribbons as Hooters invites customers to “give a hoot” for breast cancer awareness. Staring is thus rebranded as caring.</p>
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<p><strong>4. Useful partnerships</strong></p>
<p>One way in which a corporation’s image could be gender-washed is to associate with a feminist, women’s or girls’ organisation through funding or some other assistance. The corporation gets to place its logo on the organisation’s marketing materials, potentially distracting from practices elsewhere. </p>
<p>For example, Dove has partnered with the World Association of Girl Guides and Girl Scouts on a <a href="https://free-being-me.com/downloads/">teaching resource</a> aimed at helping girls to question dominant beauty standards that damage their self-esteem. This is despite the beauty industry - of which Dove is part - <a href="https://www.journals.uchicago.edu/doi/10.1086/528849">perpetuating those standards</a> to sell products.</p>
<p><strong>5. Voluntary codes</strong></p>
<p>When rights abuses emerge in global supply chains – often most affecting female workers in the global south – there are often demands for tighter regulation of corporate behaviour. One way for corporations <a href="https://www.jstor.org/stable/20097949?casa_token=gcBe12TotnkAAAAA%3A6rIR07PA5rkuCE5U80VB0p6ZAOZOaIDycef6zjTJTlz52HbjeswM1n64hRwienr7SoLnpBqk0TlNOiihqLVWg0Ph25Omg-n4DLnW8OyYzp3W6huPBNo&seq=1#metadata_info_tab_contents">to respond</a> and potentially deflect such demands is by creating voluntary codes of practice. Their very voluntariness is presented by corporations as evidence of a commitment to empowering workers – particularly women.</p>
<p>Voluntary codes rarely lead to meaningful improvements. For example, when the Rana Plaza garment factory in Bangladesh collapsed in 2013, over 1,000 garment factory workers died, <a href="https://link.springer.com/article/10.1007/s10551-018-3798-1">some 80%</a> of them women. In the aftermath, the voluntary Alliance for Bangladesh Worker Safety was established and <a href="https://corporate.walmart.com/our-commitment-to-the-workers-of-bangladesh">promoted by</a> western retailers such as Walmart as improving safety and empowering female factory workers. Yet crucially, there were no <a href="https://link.springer.com/article/10.1007/s10551-018-4080-2">legally binding commitments</a> to prevent another disaster, and the alliance was <a href="https://www.theguardian.com/business/2016/may/31/rana-plaza-bangladesh-collapse-fashion-working-conditions">later criticised</a> by activists and researchers for not improving conditions quickly enough.</p>
<p><strong>6. Changing the narrative</strong></p>
<p>Corporations can position themselves as global leaders on issues where they have previously been found wanting. For example in the late 1990s and early 2000s, Nike <a href="https://journals.sagepub.com/doi/abs/10.1177/0021943610389752?casa_token=dVWU3tTcZ1EAAAAA:yvP7HaS5wP6xHUD19QyhYlB7BCBO1GmMNpa02N6DtRZYyQcfSE6wycw8-4JpQZ-LqrG1Ybnnb7R3">was dogged</a> by claims of child labour, sexual and physical abuse among workers at supplier factories, 90% of whom were female. </p>
<p><a href="https://journals.sagepub.com/doi/abs/10.1177/0021943610389752">Nike’s response</a> included establishing a division of corporate responsibility and setting up the Nike Foundation. One of the foundation’s flagship campaigns was the Girl Effect, launched in 2008 to persuade global elites to invest in girls’ education in the global south. </p>
<p>The campaign quickly went viral, and was soon partnering with the UK’s Department for International Development on programmes to empower girls in the global south. Nike had gone from a brand tarnished by accusations of child labour and exploitation to a trusted partner in international efforts to promote girls’ rights.</p>
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<p><strong>7. Reassuring branding</strong></p>
<p><a href="https://www.chiquita.com/">Chiquita Banana</a>, the famous logo of Chiquita Brands Corporation, might give shoppers in the global north the impression of buying their bananas from a happy, Latina market woman cheerfully selling her wares. </p>
<p>Yet feminist scholars <a href="https://books.google.co.uk/books?hl=en&lr=&id=16kwDwAAQBAJ&oi=fnd&pg=PR9&dq=cynthia+enloe+bananas+beaches+bases&ots=1Oyi5OdiuL&sig=ijIFpEmVipKmlHAE_t56ey2keZs&redir_esc=y#v=onepage&q=cynthia%20enloe%20bananas%20beaches%20bases&f=false">have documented</a> the long history of Chiquita – formerly the United Fruit Company – exploiting women on banana plantations in Latin America and the Caribbean. This includes past cases of <a href="https://link.springer.com/chapter/10.1057/9780230289673_3">sexual harassment, discrimination</a>, exposure to harmful chemicals, <a href="https://www.jstor.org/stable/jcorpciti.21.85?seq=1#metadata_info_tab_contents">and violations</a> of childcare and maternity rights. </p>
<p>Does all of this matter? If corporations want to take up the cause of gender equality, is that so bad? It is true that some women and girls do find ways within gender washing campaigns to make gains, but we can’t lose sight of <a href="https://theconversation.com/feminism-washing-are-multinationals-really-empowering-women-120353">the bigger picture</a>. </p>
<p>If a corporation’s employment practices, supply chains or products are harmful to women and girls, and it sells more products thanks to gender washing, then this has increased the harm done. That is why it is so important to identify and call out forms of gender washing whenever we see them.</p><img src="https://counter.theconversation.com/content/162777/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rosie Walters receives funding from the ESRC, and is a member of the Women's Equality Party. </span></em></p>How companies love to tell us all the great things they’re doing to help women.Rosie Walters, Lecturer in International Relations, Cardiff UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/488352015-10-09T09:54:43Z2015-10-09T09:54:43ZGM crops: an uneasy truce hangs over Europe<figure><img src="https://images.theconversation.com/files/97778/original/image-20151008-9659-1a3zs46.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Staple food</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/cat.mhtml?lang=en&language=en&ref_site=photo&search_source=search_form&version=llv1&anyorall=all&safesearch=1&use_local_boost=1&autocomplete_id=&searchterm=GM%20crops&show_color_wheel=1&orient=&commercial_ok=&media_type=images&search_cat=&searchtermx=&photographer_name=&people_gender=&people_age=&people_ethnicity=&people_number=&color=&page=1&inline=126284900">Solmule</a></span></figcaption></figure><p>Most EU member states <a href="https://uk.news.yahoo.com/most-eu-nations-seek-bar-gm-crops-145652899.html#mEcgCiq">have now exercised</a> a new conditional <a href="http://eulawanalysis.blogspot.ie/2015/03/choosing-to-go-gm-free-new-eu-legal.html">legal right</a> to prevent GM crops from being cultivated within their own territories. This is the first time they have been able to do so since the EU started regulating the technology more than 20 years ago. It represents a compromise attempt by the European Commission to overcome a status quo where <a href="http://www.europabio.org/which-gm-crops-can-be-cultivated-eu">only one</a> GM crop is cultivated in the EU and member states <a href="http://europa.eu/rapid/press-release_MEMO-13-952_en.htm">impose national bans</a> based on safety concerns. </p>
<p>When the deadline for exercising the right expired on October 3, it ended a transitional period where member states could take the “easy option” to restrict GM cultivation in part or all of their territories. There will be other chances later, but with more substantial hurdles. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=553&fit=crop&dpr=1 600w, https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=553&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=553&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=695&fit=crop&dpr=1 754w, https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=695&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/97786/original/image-20151008-9679-syx3zp.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=695&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<p>GM crops have been highly contentious within the EU. Once a crop <a href="http://ec.europa.eu/food/food/animalnutrition/labelling/Reg_1829_2003_en.pdf">received</a> EU <a href="http://www.biosafety.be/GB/Dir.Eur.GB/Del.Rel./2001_18/2001_18_TC.html">authorisation</a>, it automatically applied across all member states – irrespective of who voted yes or no. Indeed, crops can even be authorised where the majority of members are opposed, under rules that <a href="https://www.qub.ac.uk/schools/SchoolofPoliticsInternationalStudiesandPhilosophy/FileStore/EuropeanisationFiles/Filetoupload,38422,en.pdf">state that</a> crops permitted in one state can be grown in any (this happened with <a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31997D0098">Novartis BT176 maize</a> in the 1990s, for example). </p>
<p>Some member states and regions have resisted by establishing the <a href="http://gmofree-euroregions.regione.marche.it">GMO-Free Network</a> and invoking so-called “<a href="http://www.loc.gov/law/help/restrictions-on-gmos/eu.php">safeguard clauses</a>” that permit temporary bans on a crop at national level where new information demonstrates a risk to human health or the environment. Some members have also pushed for greater freedom to restrict cultivation at national level, while the commission has been delaying authorising new crops to avoid conflict. </p>
<p>The European Court of Justice <a href="http://curia.europa.eu/juris/document/document.jsf;jsessionid=9ea7d2dc30dd606cddbd82224367bd0ba723ef88e5a6.e34KaxiLc3qMb40Rch0SaxuRbhf0?text=&docid=142241&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=487442">condemned</a> the commission for these delays in 2013. There has also been the possibility for further action before the World Trade Organisation, as the situation mirrors a previous de facto moratorium <a href="http://www.ft.com/cms/s/0/624a88c6-97db-11da-816b-0000779e2340.html#axzz3nxpJapad">that ran</a> between 1999 and 2003 and was <a href="http://www.euractiv.com/trade/wto-panel-rules-eu-gmo-moratorium-illegal/article-152341">condemned by</a> the organisation following pressure from the US and Canada.</p>
<h2>The new approach</h2>
<p>The commission proposed the new rules back in 2010. It proposed that risk assessment and management would remain harmonised at the EU level, while members could impose post-authorisation restrictions. After much wrangling, this led to <a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_068_R_0001">Directive 2015/412</a> coming into force in April. It aims to give more sceptical states such as Austria and Italy the freedom to choose to prevent cultivation while potentially enabling more enthusiastic territories such as Spain and England to cultivate crops that have not yet been authorised. </p>
<p>The directive allows member states to request geographical restrictions while a crop is being authorised (or reauthorised) without providing reasons, subject to the applicant biotech company not objecting. In the case of crops that are already authorised, member states can unilaterally impose restrictions if they can demonstrate they are necessary to protect a “compelling ground” (the directive contains a non-exhaustive list). The company and other interested parties can raise a legal challenge, however. </p>
<p>The transitional phase that ended on October 3 enabled members to use the first option to prevent cultivation of the one GM crop with EU authorisation – Monsanto’s MON810 maize – and the eight crop applications going through the authorisation process. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=499&fit=crop&dpr=1 754w, https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=499&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/97781/original/image-20151008-9675-1dqchde.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=499&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Splice of life.</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/s/GM+crops/search.html?page=3&thumb_size=mosaic&inline=85099198">Pedrosala</a></span>
</figcaption>
</figure>
<h2>Effective compromise?</h2>
<p>Of the 19 member states which met the deadline to apply to prevent GM cultivation, the first two have already been waived through by the biotech companies in question and the remainder look likely to receive the same treatment. The hope from the companies is that these members will be willing to vote in favour of authorisations in future, or at least not attempt to block them – and that they will lift their safeguard-clause bans and not resort to new ones, since they feed wider concerns over safety. </p>
<p>The longer-term position is less clear, though. Preliminary findings from my research funded by the British Academy, involving interviews of member representatives, indicate that the opt-out will make some states less likely to create safeguard measures, but have little to no impact on votes on authorisations. It is true that crops may nonetheless be authorised either by qualified majority votes or by the commission where there is a hung vote. Where the commission was wary of forcing through authorisations in the past, it may feel the system is now sufficiently flexible to make this acceptable. </p>
<p>But even then, lack of member support lengthens the process for approving a new crop and removes the incentives for applicant companies to agree to exclude particular territories from their applications or waive their right to challenge a restriction of an existing authorisation. You can understand member states feeling that they have to be consistent in their approach to a particular crop at national and EU level, but there is a danger that applicant companies may see no reason to rubber-stamp restrictions if the same countries are going to obstruct them at the EU level anyway. </p>
<p>For members seeking restrictions who don’t get the blessing of the applicant company, if the EU grants an approval for a crop, they are then reduced to making “compelling grounds” arguments for a unilateral restriction. It may be a difficult argument to win. Justifications on grounds of environmental protection are limited under the directive. And because the rules permit local restrictions, it makes it harder to argue that an outright prohibition across a whole country is justified. </p>
<p>On the other hand, if member states are prevented from opting out, the danger swings the other way: they may fall back into their well trodden paths and resort to safeguard clauses, threaten to block authorisations and generally make the whole authorisation process tortuous. </p>
<p>So the October 3 deadline was only one step in this debate. If both the EU’s member states and the biotech companies can demonstrate flexibility, more crops might be authorised and safeguard measures might be lifted. Directive 2015/412 would then look like a workable truce. If not, it will not be long before the EU’s long conflict over GM crops resumes.</p><img src="https://counter.theconversation.com/content/48835/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Mary receives funding from the British Academy for some future research relating to genetically modified crops
</span></em></p>New EU rules on GM attempt to unblock logjam that has hung over the technology in the region for most of this century. To work, anti-GM member states and Big Biotech will need to cooperate.Mary Dobbs, Lecturer in Law, Queen's University BelfastLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/98802012-11-19T19:28:51Z2012-11-19T19:28:51ZDavid and Goliath: Novartis challenges India’s patent law<figure><img src="https://images.theconversation.com/files/17758/original/5g6p3b85-1353286379.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Pharmaceutical companies view the growing middle class in India and other emerging economies as a significant source of revenue.</span> <span class="attribution"><span class="source">Ryan/Flickr</span></span></figcaption></figure><p>India is the global focal point for legal and political struggles over patent rights and access to medicines. <a href="http://blogs.bmj.com/bmj/2012/09/27/leena-menghaney-indias-patent-law-on-trial/">Particular attention</a> is focused on the Swiss pharmaceutical giant <a href="http://www.novartis.com/">Novartis</a>, which is in battle with the Indian government. </p>
<p>For six years, Novartis has pursued litigation against the Indian government, to extend patent protection for the marginally modified anti-cancer drug, <a href="http://www.cancer.gov/clinicaltrials/conducting/gleevec/Page3">imatinib mesylate</a>, marketed in India as <a href="http://www.cancer.gov/clinicaltrials/conducting/gleevec/Page3">Glivec</a>. Novartis’ litigation is directed against a critical safeguard for public health in Indian patent law.</p>
<p>Novartis’ claim for a patent was rejected by the Chennai Patent office in 2006, then by the Madras High Court in 2009, and again by an appeals court in 2009. <a href="http://www.lawyerscollective.org/news/archived-news-a-articles/126-novartis-case-background-and-update-supreme-court-of-india-to-recommence-hearing.html">At each step</a>, Glivec was deemed to be a modified version of a pre-1995 drug for which patents cannot be issued under Indian law.</p>
<p>In September 2012, the case reached the <a href="http://supremecourtofindia.nic.in/">Supreme Court of India</a>. The outcome, expected before the end of the year, will have major implications for access to affordable medicines in India and in the developing world. See <a href="#http://www.thehindubusinessline.com/opinion/article3373972.ece?homepage=true">here</a> for Novartis’ perspective.</p>
<h2>India and patent law</h2>
<p>When a company is awarded a patent for a medicine, competitors cannot enter the market, and the supplier is able to charge a high monopoly price. Prices decline significantly when alternative generic (non-patented) brands become available after the expiry of the patent.</p>
<p>Pharmaceutical product patents were not recognised in India between 1972 and 2005. This made it possible for Indian drug firms to emerge as major suppliers of relatively affordable generic drugs to people in India and the rest of the developing world, as well as to developed countries such as the United States.</p>
<p>Most dramatically, the entry of Indian firms in the global pharmaceutical market resulted in the price of first-line triple combination antiretrovirals (ARVs), used in the treatment of HIV, to fall from as much as $15,000 per person per year in 2000 to <a href="http://utw.msfaccess.org/">less than US$120</a> in 2012.</p>
<p>In 2005, the Indian parliament amended the patent legislation for compliance with the Agreement of Trade-Related Intellectual Property Rights <a href="http://www.wto.org/english/tratop_e/trips_e/trips_e.htm">(TRIPS)</a>. Under this agreement, all member countries of the <a href="http://www.wto.org/">World Trade Organization</a> are required to allow product patents in all areas, including medicines.</p>
<p>But to protect access to medicines, the Indian legislation also incorporated several so-called TRIPS flexibilities. The 2001 <a href="http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm">Doha Declaration</a> confirmed that intellectual property rights “should not prevent members [of the World Trade Organization] from taking measures to protect public health.”</p>
<p>An important flexibility is the right of nations to define the criteria of patentability (novelty, inventive step, and industrial application). Generic competition is facilitated if patents are awarded for only genuinely innovative new drugs. In contrast, national standards that allow patenting for minor product changes will impede generic competition.</p>
<p>Patents are supposed to provide incentives for innovation but the patenting of medicines in countries such as India is undertaken mainly by foreign companies for the strategic purpose of restricting competition. Few benefits from intellectual property rights flow in the direction of the consumer.</p>
<h2>Markets and competition</h2>
<p>At issue in the Novartis case is Section 3(d) of the <a href="#http://www.wipo.int/wipolex/en/details.jsp?id=2407">Indian Patent Act 2005</a>. This section is intended to prevent the awarding of patents for new uses or slightly modified versions of known molecules, unless a “significant enhancement of efficacy” can be demonstrated. The objective is to prevent the unwarranted extension of monopoly pricing through patenting trivial modifications, so called <a href="http://www.msfaccess.org/content/evergreening-drugs-attack-access-medicines">evergreening</a>.</p>
<p>The context for Novartis’ persistence are pressures on <a href="http://www.imap.com/imap/media/resources/Pharma_Report_2012_FINAL_2F6C8ADA76680.pdf">profitability and growth</a> in established markets. Multinational pharmaceutical companies increasingly view the growing middle class in India and other emerging economies as a significant source of revenue. </p>
<p>The former CEO of India’s largest drug company <a href="http://www.ranbaxy.com/">Ranbaxy</a> (now owned by Japanese multinational Daiichi Sankyo) observed in an article in the <a href="http://jgm.sagepub.com/search/results?fulltext=tempest&x=0&y=0&submit=yes&journal_set=spjgm&src=selected&andorexactfulltext=and">Journal of Generic Medicines</a>, “Big Pharma have become intrigued by the fact that 88 per cent of the world’s pharmaceuticals is shared among only 18 per cent of the world’s population. … Here lies a business opportunity.” </p>
<p>From the perspective of these companies, full exploitation of this business opportunity requires extended intellectual property rights protection.</p>
<p>If Novartis is successful in gaining a patent for Glivec, generic competition will be delayed for many more drugs, and prices will remain much higher for longer. Consider Novartis’ price for Glivec in India – about $26,000 per patient per year; generic versions are currently available at about $2,000 per year. Novartis supplies Glivec at no cost to some patients, but health policy cannot be hostage to corporate charity.</p>
<p>A win for Novartis will have a devastating effect on access to medicines not only in India but throughout the developing world. That may be why Médecins Sans Frontières (MSF) is pursuing a global campaign to make Novartis “<a href="http://www.doctorswithoutborders.org/publications/article.cfm?id=6072&cat=briefing-documents">drop the case</a>”. </p><img src="https://counter.theconversation.com/content/9880/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hans Lofgren is a member of the People's Health Movement. He is the editor of recently published 'The Politics of the Pharmaceutical Industry and Access to Medicines: World Pharmacy and India' (Social Science Press, New Delhi, 2013).</span></em></p>India is the global focal point for legal and political struggles over patent rights and access to medicines. Particular attention is focused on the Swiss pharmaceutical giant Novartis, which is in battle…Hans Löfgren, Associate Professor Politics and Policy Studies, Deakin UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/44722012-06-05T04:23:15Z2012-06-05T04:23:15ZBig Pharma in legal battles for monopoly prices in India<figure><img src="https://images.theconversation.com/files/11348/original/4py6qb84-1338790154.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug prices reduce dramatically when large multinationals’ monopoly is broken.</span> <span class="attribution"><span class="source">m.p.3./Flickr</span></span></figcaption></figure><p>Two large multinational pharmaceutical companies are fighting for patents and monopoly pricing in Indian courts. The outcomes of the cases – involving Novartis and Bayer – are likely to determine the country’s future as a major global supplier of low-cost essential medicines.</p>
<p>About <a href="http://www.indiainbusiness.nic.in/industry-infrastructure/industrial-sectors/drug-pharma.htm">a third of all drugs</a> are produced in India.</p>
<p>The rise of domestic firms was made possible by India’s abolition of product patents for pharmaceuticals in the <a href="http://www.wipo.int/wipolex/en/details.jsp?id=2393">Patents Act of 1970</a> (which came into effect in 1972). Only patents for processes were recognised for a maximum of seven years. This was to encourage the development of a domestic drug industry and the supply of more affordable medicines. The result was a spectacular rise of Indian firms over subsequent decades. </p>
<p>Family-owned companies such as Cipla, Ranbaxy and Dr Reddy’s (often in collaboration with public sector research organisations) <a href="http://apps.who.int/medicinedocs/documents/s17761en/s17761en.pdf">developed alternative processes</a> for manufacturing a wide range of pharmaceutical raw materials and generic drugs (alternatives to the originator brands).</p>
<p>Large multinationals’ monopoly on supply of critical HIV antiretroviral drugs, for instance, was first broken by Cipla in 2001, when it <a href="http://www.hindu.com/2001/02/23/stories/0623000f.htm">commenced supply to developing countries for $350 per annum per patient</a>. The multinational drug companies had charged more than $10,000 per patient per year.</p>
<p>Today, the same drugs are available for about $150 for a year’s supply. <a href="http://www.msfaccess.org/content/how-fta-between-eu-and-india-could-threaten-access-affordable-medicines">Indian manufacturers supply</a> more than 80% of the HIV medicines used to treat millions of people in developing countries, as well as generics to treat many other diseases.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=416&fit=crop&dpr=1 600w, https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=416&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=416&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=523&fit=crop&dpr=1 754w, https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=523&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/11323/original/z5qg9d9p-1338776444.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=523&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Most people in India cannot afford expensive drugs.</span>
<span class="attribution"><span class="source">zz77</span></span>
</figcaption>
</figure>
<h2>India’s approach to TRIPS</h2>
<p>The 1995 Agreement on <a href="http://www.wto.org/english/tratop_e/trips_e/trips_e.htm">Trade Related Aspects of Intellectual Property Rights (TRIPS)</a> created a new era of globalised intellectual property rights. TRIPS gave developing countries, such as India, a ten-year transition period before patents had to be introduced in all product categories. (The least developed countries must be fully TRIPS compliant by 2016).</p>
<p>Indian firms are allowed to continue production of drugs marketed before 2005, but can no longer produce generic versions of medicines patented in India after 2005 (unless voluntarily licensed by the originator company). This will result in high monopoly prices for many more years for new products, including second- and third–line AIDS medicines, unless countermeasures are taken in the interest of public health.</p>
<p>TRIPS triggered a <a href="http://www.soros.org/initiatives/health/focus/access/articles_publications/publications/aem_20090312">global struggle</a> between public health advocates and some developing countries, and the big pharmaceutical companies backed by the United States and the European Union. Much of this conflict revolves around the public health safeguards contained in the TRIPS Agreement. These were confirmed and extended in the <a href="http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm">2001 Doha Declaration on the TRIPS Agreement and Public Health</a>.</p>
<p>Legally, <a href="http://www.wto.org/index.htm">World Trade Organisation</a> (WTO) <a href="http://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm">member countries</a> have significant leeway in their interpretation of TRIPS. But most countries don’t effectively use these options to lessen the impact of patents on affordable access to essential medicines.</p>
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<img alt="" src="https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1130&fit=crop&dpr=1 754w, https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1130&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/11345/original/3wcpkt69-1338788628.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1130&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The Norvartis case has inspired protests across the world.</span>
<span class="attribution"><span class="source">Carlos Capote</span></span>
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<p>India has used them more extensively than probably any other country with its <a href="http://www.wipo.int/wipolex/en/details.jsp?id=2407">Patents (Amendment) Act, 2005</a>. Two of the safeguards in Indian legislation relate to definition of patentability and compulsory licensing.</p>
<h2>Novartis’ challenge</h2>
<p>Now, Swiss drug multinational Novartis is spearheading a global industry campaign against India’s utilisation of its right to public health safeguards. Indian legislation contains a section intended to prevent the awarding of patents for slightly modified versions of known molecules, unless a “significant enhancement of efficacy” can be demonstrated. This measure is intended to prevent “evergreening”, the extension of monopoly pricing through patenting of trivial modifications.</p>
<p><a href="http://www.2ser.com/shows/aidworks/podcasts/aidworks-4th-april-2012-interview-with-msfs-katy-athersuch-about-the-patent-case-between-the-indian-govt-swiss-pharmaceautical-novartis">Novartis’ challenge</a> centres on the anti-leukaemia (blood cancer) drug imatinib mesylate, marketed by Novartis as Glivec (or Gleevec), which has global sales in excess of $4bn. In 2006, the Indian patent office rejected Novartis’ application for a patent on Glivec on the grounds that it’s a slightly modified version of a known molecule.</p>
<p>The original patent on imatinib mesylate dates from 1993, and the product has long been produced and marketed in India by local companies. Novartis charges Rs120,000 (about A$2,400) for a month’s supply, which makes this drug unaffordable to more than 99% of the population. Several <a href="http://bit.ly/K1mQw6">Indian manufacturers sell the same drug</a> for Rs8,000 (A$160), 1/15th of Novartis’ price.</p>
<p>Novartis has pursued its case through India’s legal system since 2006. It has now reached the Supreme Court where final arguments are set to commence on 10 July. If Novartis is successful, no other brands of imatinib mesylate can be supplied in India or exported from India.</p>
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<img alt="" src="https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=433&fit=crop&dpr=1 600w, https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=433&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=433&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=545&fit=crop&dpr=1 754w, https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=545&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/11324/original/m4cbn2v3-1338776453.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=545&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="attribution"><span class="source">Norvartis AG</span></span>
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<p>What’s more, a victory for Novartis will open the <a href="https://www.doctorswithoutborders.org/publications/article.cfm?id=5768&cat=briefing-documents">floodgates for patent extensions</a> on many well-established medicines, to the detriment of patients in India and throughout the developing world. Novartis’ stance has garnered a <a href="http://msfaccess.org/novartis-drop-the-case">strong reaction</a> from public health activists and NGOS in India and around the world.</p>
<h2>Bayer and compulsory licensing</h2>
<p>The second recent development of great importance is the granting of India’s first compulsory licence for production of a drug. A compulsory licence authorises a third party to manufacture and sell a product without the consent of the patent holder in return for adequate compensation.</p>
<p>Multinational drug companies put strong pressure on developing countries for compulsory licenses to only be considered in circumstances of national emergency.</p>
<p>It is, however, clear in Article 31 of TRIPS and in the <a href="http://www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm">2001 Doha Declaration</a> that countries are free to determine “any and all grounds upon which CLs may be issued”. In fact, there is a long history of compulsory licenses for pharmaceuticals in Canada, the United Kingdom, Italy, and more recently in developing countries, such as Brazil, Thailand and Malaysia.</p>
<p>The United States and the European Union, on behalf of their pharmaceutical companies, have brought extreme pressure to bear on developing countries, through so-called free trade agreements and in other ways, to <a href="http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001154">dissuade them from issuing compulsory licences</a>.</p>
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<img alt="" src="https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/11358/original/f6xvxzyj-1338792443.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">A compulsory licence was issued on the grounds that Bayer’s price for an anti-cancer drug was exorbitant.</span>
<span class="attribution"><span class="source">Conan</span></span>
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<p>On 12 March, 2012, the Indian generic drug company Natco Pharma was successful in gaining a licence for the production and supply of the patented anti-cancer drug sorafenib, marketed by Bayer as Nexavar. Bayer’s version of this drug costs Rs280,000 (A$5,600) a month, an astronomical figure for almost all Indian households. Natco will sell the same drug at 3% of this price, while paying a license fee – and it will still make a profit.</p>
<p>The compulsory licence was issued essentially on the grounds that Bayer’s price is exorbitant. It also doesn’t manufacture the drug in India and imports in such small volumes that only a tiny fraction of potential patients could benefit.</p>
<p>The <a href="http://www.ipindia.nic.in/">Indian Controller General of Patents, Designs and Trademarks</a> <a href="http://donttradeourlivesaway.wordpress.com/2012/03/12/kei-statement-on-india-grant-of-compulsory-license-to-patents-on-cancer-drug-sorafenib-natco-vs-bayer/">concluded</a> that the drug “was not bought by the public due to only one reason, that is, its price was not reasonably affordable to them”. This decision in favour of Natco sets a very important precedent for possible compulsory licences on other patented products sold at unaffordable prices.</p>
<p>Bayer filed an appeal against the compulsory licensing decision on May 4 to the <a href="http://www.ipab.tn.nic.in/">Intellectual Property Appellate Board</a> but observers believe it’s likely the decision will ultimately stand.</p>
<p>India is in a very special category within the global pharmaceutical sector because its domestic drug companies have unique technological capabilities. Although they are just as profit-oriented as firms in any other sector, Indian drug manufacturers have made it possible for millions of poor people to access essential medicines. For these gains not to be reversed, it’s essential that Novartis loses its Supreme Court appeal, and that India’s first compulsory licence is followed by many more.</p><img src="https://counter.theconversation.com/content/4472/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Hans Löfgren does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Two large multinational pharmaceutical companies are fighting for patents and monopoly pricing in Indian courts. The outcomes of the cases – involving Novartis and Bayer – are likely to determine the country’s…Hans Löfgren, Associate Professor Politics and Policy Studies, Deakin UniversityLicensed as Creative Commons – attribution, no derivatives.