Compulsory Licensing

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<center> ''[[PHM in Victoria|Back to PHM Vic homepage]] </center />
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''[[Intellectual Property and Pharmaceuticals|Back to IP main page]]''
 
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== Internet Workshop ==
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''Compulsory Licensing: current hot spots - Part II''
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Tuesday 20 March, 7:30pm
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To be held using Paltalk internet software: see the [[Internet Workshops]] page for how to participate.
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''' Program'''
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The workshop will follow on from our first workshop in February. Please prepare by reading [http://phmoz.org/files/Novartis_India_Upendra_2007.ppt Novartis_India_Upendra_2007.ppt Upendra's presentation] and the resources below.
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Convenor: David Legge
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Last time we discussed:
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: compulsory licensing and where it stands now (Sharon) <br />
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: report of WHO Commission on IPRs and Health (David) <br />
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: current disputes over IPRs in India (Upendra)  <br />
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: current disputes over IPRs in Thailand (Gillian).
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For '''technical assistance''' in preparing to participate, please see the [[Internet Workshops]] page.
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== Resources ==
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==== Facts about compulsory licensing ====
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WTO documents give a good overview of compulsory licensing and the key dates and documents:
 
WTO documents give a good overview of compulsory licensing and the key dates and documents:
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Report of WHO Commission on Intellectual Property Rights, Innovation and Public Health
 
Report of WHO Commission on Intellectual Property Rights, Innovation and Public Health
 
[http://www.who.int/intellectualproperty/en/ Web link] <br />
 
[http://www.who.int/intellectualproperty/en/ Web link] <br />
: Chapter six: Towards a sustainable plan to promote innovation and access (concluding chapter) [http://phmoz.org/files/CIPIHReport_Chapter6.pdf PDF file]
 
  
==== News articles ====
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Legal Framework for Compulsory License Drugs, Knowledge Ecology International, 16 March 2007 [http://www.keionline.org/misc-docs/thai16mayhandout.pdf PDF file]
  
'''India: Former Swiss President joins chorus against Novartis' patent challenge''' <br />
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'''WHO Presses Development of Cheap Drugs''' <br />
15 February 2007:
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May 23, 2007: [BRADLEY S. KLAPPER, Associated Press] The U.N. health agency approved a resolution Wednesday urging experts to find new ways of financing medicine and vaccine development to lower drug prices and improve worldwide availability. <br />
More prominent figures have joined the chorus of over 300,000 people worldwide voicing concerns about Novartis’ legal challenge against the Indian government and its impact on access to essential medicines across the globe. <br />
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[http://www.forbes.com/feeds/ap/2007/05/23/ap3752158.html Access full article]
[[TWN 15Feb07 India: Former Swiss President joins chorus against Novartis' patent challenge licenses|Read full article]]
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''' WHO DG regrets her reported remarks on Thai compulsory licenses ''' <br />
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15 February 2007: The WHO Director General Dr. Margaret Chan, has sent a letter to Thailand's Health Minister expressing regret for the embarrassment caused to his government by remarks she was reported to have made in Bangkok that were critical of the compulsory licenses granted by the government for three medicines. <br />
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[[TWN 15Feb07 WHO DG regrets her reported remarks on Thai compulsory licenses|Read full article]]
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''' Stephen Lewis Criticises Margaret Chan ''' <br />
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4 Feb 2007: Stephen Lewis, former UN Special Envoy for HIV/AIDS in Africa, calls for World Health Organization director Margaret Chan to reverse her support of drug companies over governments trying to provide medicines for their peoples. His remarks were recorded at the Global Justice student conference in Washington, DC, on February 4. <br />
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Video [http://www.youtube.com/watch?v=zOz6jIngeD8] <br />
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Fight AIDS [http://www.fightglobalaids.org/news/?p=139]
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''' WHO Chief's Stand on Generic Drugs Slammed''' <br />
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BANGKOK, Feb 2 (IPS) - Civil society and humanitarian groups slammed the new head of the World Health Organisation (WHO), on the sidelines of a meeting here, after she appeared to favour the interests of pharmaceutical giants over the plight of the sick and the poor in the developing world. <br />
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Full article available from IPS: [http://ipsnews.net/news.asp?idnews=36420]
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''' Thailand approves copycat drugs ''' <br />
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January 30, 2007: THAILAND'S army appointed government said today it had approved a cheap, copycat heart disease drug, the first time a developing country has ignored an international patent for such a treatment. <br />
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Full article available from The Australian: [http://www.theaustralian.news.com.au/story/0,20867,21140548-1702,00.html]
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''' Thailand throws down gauntlet to drug giants ''' <br />
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30 Jan 2007: IN A precedent-setting challenge to global drug companies, Thailand has become the first developing country to issue a compulsory licence to manufacture a generic drug that is not AIDS related. <br />  
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Follow link to Sydney Morning Herald article.
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[http://www.smh.com.au/news/world/thailand-throws-down-gauntlet-to-drug-giants/2007/01/30/1169919338573.html]]
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''' Thailand Invokes WTO Rule To Sell Generics For HIV And Heart Disease Drugs ''' <br />
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30 Jan 2007: Thailand has invoked a World Trade Organization (WTO) agreement on
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intellectual property rights to allow the manufacture, purchase and sale
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of generic versions of two drugs for heart disease and HIV/AIDS in the
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country.  <br />
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Full article available online [http://www.medicalnewstoday.com/healthnews.php?newsid=61863 here]
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'''US activists try to deliver coffin to Novartis over Indian patent case''' <br />
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29 Jan:  WASHINGTON (AFP) - Non-governmental groups tried to deliver a mini coffin to Swiss pharmaceuticals giant Novartis to protest legal action aiming to overturn a ban on a drug patent application in India. <br />
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http://news.yahoo.com/s/afp/20070129/hl_afp/usindiapharmacompany_070129215623
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'''WHO’s mandate on IPRs under US attack''' <br />
 
'''WHO’s mandate on IPRs under US attack''' <br />
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[[TWN Dec06 WHO’s mandate on IPRs under US attack|Read full article here]]
 
[[TWN Dec06 WHO’s mandate on IPRs under US attack|Read full article here]]
  
==== Other information ====
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'''All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines'''  <br />
 
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March  2007, Oxfam Briefing paper: The USA continues to impose TRIPS-plus rules on developing countries, thus preventing poor people from accessing inexpensive, generic medicines. Jordan was required under the terms of its WTO accession package and its free trade agreement (FTA) with the USA to introduce TRIPS-plus rules. Medicine prices have increased drastically, and TRIPS-plus rules were partly responsible for this increase. <br />
'''Rep Waxman letter to Novartis on Indian legal challenge''' <br />
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http://www.oxfam.org/en/policy/briefingpapers/bp102_jordan_us_fta
[[Rep Waxman letter to Novartis on Indian legal challenge|Read the letter here]]
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'''Open Letter to WHO/UNAIDS India re Margaret Chan's comments on Thai Compulsory License'''  <br />
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[[Open Letter re Margaret Chan's comments on Thai Compulsory License |Read the letter here]]
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''' WHO DG Chan Shocking Views Criticised by NGOs (Martin Khor, 5 Feb 07) ''' <br />
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Read a [[Comment from PHM member on Chan's visit to Bangkok re Thai Compulsory License]]
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''' MSF Petition regarding Novartis '''  <br />
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http://www.msf.org/petition_india/can_eng.html
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==== Journal articles ====
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''Please note, you will need access to the New England Journal of Medicine to read these articles. Most university libraries will provide access on site if you do not have online access.''
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'''Thailand and the Compulsory Licensing of Efavirenz''''
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Robert Steinbrook ''NEJM'' Volume 356:544-546
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Of the many medicines for human immunodeficiency virus (HIV) infection, efavirenz, a nonnucleoside reverse-transcriptase inhibitor that became available in the late 1990s, is one of the most important. For the initial treatment of adults, the combination of efavirenz and two nucleoside reverse-transcriptase inhibitors "has become a standard-of-care comparator in clinical trials," according to Hammer et al.1 Moreover, efavirenz is available in a fixed-dose combination tablet with the nucleoside analogues emtricitabine and tenofovir; this tablet is taken only once a day. Efavirenz can cause birth defects when taken during the first trimester of pregnancy, so its use is restricted in . . . .
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'''Taking TRIPS to India — Novartis, Patent Law, and Access to Medicines'''
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Janice M. Mueller ''NEJM'' Volume 356:541-543
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In August and September 2006, patients with cancer, lawyers for patient advocacy groups, and representatives of nongovernmental organizations (NGOs) converged on the offices of Novartis in Mumbai, India, to protest the company's efforts to obtain an Indian patent on Gleevec, the company's brand-name version of imatinib mesylate. Gleevec (spelled Glivec outside the United States) is used to treat chronic myeloid leukemia, and Novartis has patented the drug in 35 countries. The protesters also decried the drug's high price: Novartis sells it in India (where only 5% of people have private health insurance) for $26,000 per year; generic-drug manufacturers offer the drug at less than one tenth that price....
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'''Patents versus Patients: Five years after the Doha Declaration'''  <br />
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November 2006, Oxfam Briefing paper: Five years ago, members of the World Trade Organisation (WTO) signed a ministerial agreement to ensure that intellectual property rules would no longer obstruct developing countries’ efforts to protect public health. Since then, however, little has changed. Patented medicines continue to be priced out of reach for the world’s poorest people. Trade rules remain a major barrier to accessing affordable versions of patented medicines (generic medicines). The prevalence of debilitating and life-threatening diseases in poor countries is growing, but medicines are simply not available. Urgent action is needed.  <br />
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http://www.oxfam.org.uk/what_we_do/issues/health/bp95_patents.htm
  
  
''[[PHM in Victoria|Back to PHM Vic homepage]]''
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Return to [[Intellectual Property and Pharmaceuticals | IP Resources page]]
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[[PHM_Oz_IP_Project|IP Project Page]]

Latest revision as of 00:00, 11 July 2007

Back to IP main page

WTO documents give a good overview of compulsory licensing and the key dates and documents: Fact Sheet Sept 2006 PDF file

Technical Note on pharmaceutical patents and the TRIPS agreement Web link

MSF documents are quite illuminating in how this fits into practical usage: PDF file, Web link

Report of WHO Commission on Intellectual Property Rights, Innovation and Public Health Web link

Legal Framework for Compulsory License Drugs, Knowledge Ecology International, 16 March 2007 PDF file

WHO Presses Development of Cheap Drugs
May 23, 2007: [BRADLEY S. KLAPPER, Associated Press] The U.N. health agency approved a resolution Wednesday urging experts to find new ways of financing medicine and vaccine development to lower drug prices and improve worldwide availability.
Access full article

WHO’s mandate on IPRs under US attack
12 Dec 2006: At the recent meeting of WHO’s international working group on public health, innovation and intellectual property, the US challenged WHO’s work on the impact of Intellectual Property Rights (IPRs).
Read full article here

All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines
March 2007, Oxfam Briefing paper: The USA continues to impose TRIPS-plus rules on developing countries, thus preventing poor people from accessing inexpensive, generic medicines. Jordan was required under the terms of its WTO accession package and its free trade agreement (FTA) with the USA to introduce TRIPS-plus rules. Medicine prices have increased drastically, and TRIPS-plus rules were partly responsible for this increase.
http://www.oxfam.org/en/policy/briefingpapers/bp102_jordan_us_fta

Patents versus Patients: Five years after the Doha Declaration
November 2006, Oxfam Briefing paper: Five years ago, members of the World Trade Organisation (WTO) signed a ministerial agreement to ensure that intellectual property rules would no longer obstruct developing countries’ efforts to protect public health. Since then, however, little has changed. Patented medicines continue to be priced out of reach for the world’s poorest people. Trade rules remain a major barrier to accessing affordable versions of patented medicines (generic medicines). The prevalence of debilitating and life-threatening diseases in poor countries is growing, but medicines are simply not available. Urgent action is needed.
http://www.oxfam.org.uk/what_we_do/issues/health/bp95_patents.htm


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