The Right to Share in the Benefits of Science IP, Human Rights and Licensing Michael Curtotti ANU...

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The Right to Share in the Benefits of Science IP, Human Rights and Licensing Michael Curtotti ANU Legal Office Slide 2 Outline Point 9 of Nine Points to Consider in Licensing University Technology The Human Rights Context: Right to Share in the Benefits of Science Development Context: operationalising human rights: what do benefits mean? Case Studies Example Contract Provisions Slide 3 Nine Points to Consider In the Public Interest: Nine Points to Consider in Licensing University Technology available at The principles have been endorsed by the ANU. 63+ endorsing organisations e.g. Assn of American Medical Colleges; California Inst of Technology; Cornell; Harvard; MIT; Stanford; Univ of California; Univ of Illinois Chicago; Univ of Illinois, Urbana-Champaign; Univ of Washington; Yale; AUTM; Duke Univ; Univ of Michigan; Univ of North Carolina Chapel Hill; Vanderbilt Univ; Lehigh Univ; Univ of Texas Medical Branch; Auburn Univ; Carleton Univ Not rigid rules - capture IP negotiating objectives. Slide 4 Some of the Nine Points (1) Reserve the right to practice inventions and research materials for public research and educational uses (any non-profit purpose). Right to publish any and all data resulting from research Right of academic publication (2) Exclusive Licenses should foster development and application of technology and not result in technology lock down. Limit to specified field Diligent development of technology Compulsory sub-licensing for unmet needs Consider non-exclusive alternative (3) Minimize licensing of future improvements. (5) Ensure broad access to research tools Slide 5 Point 9 Nine Points to Consider Consider including provisions that address unmet needs, such as those of neglected patient populations or geographic areas, giving particular attention to improved therapeutics, diagnostics and agricultural technologies for the developing world Universities have a social compact with society. As educational and research institutions, it is our responsibility to generate and transmit knowledge, both to our students and the wider society. Around the world millions of people are suffering and dying from preventable or curable diseases. The failure to prevent or treat disease has many causes. We have a responsibility to try to alleviate it, including finding a way to share the fruits of what we learn globally, at sustainable and affordable prices, for the benefit of the worlds poor. There is an increased awareness that responsible licensing includes consideration of the needs of people in developing countries and members of other underserved populations. Slide 6 The Human Rights Context Human Rights as ideas, laws and institutions Slide 7 The Right to Share in the Benefits of Science UDHR 1948 27(1) Everyone has the right to share in scientific advancement and its benefits ICESCR 1966 15.1 The States Parties to the present Covenant recognise the right of everyone: (b) To enjoy the benefits of scientific progress and its applications Slide 8 ICCPR ratifn and signature Slide 9 ICESCR ratifn and signature Slide 10 Human Rights & IP Rights: Comparison Human Rights fundamental to human person: e.g. inalienable (e.g. cant sell yourself into slavery), indivisible, may not be limited except to protect the rights of others. (see. ICESCR Committee General Comment 17) Human rights seek to define minimum standards of conduct to protect human dignity About how people treat each other Aspirational goal oriented hortatory (particularly ESC rights) IP rights: tradable, divisible, time bound, an exchange between society and creator etc. About property real static Slide 11 Human Needs Trump IP Protection Human Rights View:It is incumbent upon developed States, and other actors in a position to assist, to develop international intellectual property regimes that enable developing states to fulfil at least their core obligations to individuals and groups within their jurisdictions. (Statement of CESCR 14 Dec 2001) An IP View (WTO Members): Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition. TRIPS agreement, Can and should be interpreted and implemented in a manner supportive of WTO Members right to protect public health and, in particular, to promote access to medicine for all. WTO Member statement A small number of both developing and developed countries have issued compulsory licences under these provisions (Zimbabwe, Mozambique, Canadian Patent Act allows issue of compulsory licence for supply to developing countries to meet basic needs) Also private members Bill before US Congress with same aim. ANU recommended to ACIP that provisions similar to Canadas be considered here. Slide 12 AAAS: Science and Human Rights From AAAS Poster for the 60 th Anniversary of the Universal Declaration of Human Rights Slide 13 AAAS Science & HR Program 1.Scientists for Human Rights 2.Science for Human Rights 3.Human Rights and the Conduct of Science 4.Science as a Human Right Slide 14 Right to Share in the Benefits of Science An additional complication is that Article 15 of the ICESCR can be characterized as the most neglected set of provisions within an international human rights instrument Audrey Chapman, AAAS The right to health is closely linked to the right of everyone to enjoy the benefits of scientific progress and its applications The right to enjoy the benefits of scientific progress gives rise to national and international obligations. Paul Hunt (fmr) Special Rapporteur on the Right to Health How do we give the right content? Slide 15 Violated Rights (UDHR) Right to life (3) Right to an adequate standard of living for health and well-being including food, medical care, social services (25(1)) Motherhood and childhood are entitled to special care and assistance (25(2)) Right to share in the benefits of science (27) Slide 16 Not Sharing the Benefits UNICEF identifies the following preventable causes as the primary reasons for under 5 mortality: malaria, pneumonia, diarrhoea, neonatal infection, preterm delivery, lack of oxygen at birth Slide 17 Slide 18 Citizenship in Western liberal democracies is the equivalent of inherited feudal privilege an inherited privilege that greatly ones life chances. The exclusion of billions of desperately poor and uprooted people out there becomes morally more scandalous the harder one thinks about it. Veit Bader 1997 Others have described it as global apartheid Slide 19 AIDs & IP AIDs deaths now stabilized at 2,000,000 per annum. In 2001 39 pharmaceutical companies took the SA govt to court for using compulsory licences for HIV drugs in response to health emergency. AIDs drugs were priced at US$10,000 for a years supply. After protest dropped to price affordable for aid agencies c. $160 per year. AIDs drugs delivery in developing countries primarily publicly funded Slide 20 AIDs and universities We have seen firsthand the effects of university patenting and licensing decisions. In February 2001, Doctors Without Borders sought Yale's permission to use a generic version of stavudine in South Africa. This prompted global attention and intense discussions between the university and Bristol-Myers Squibb (to whom it had exclusively licensed the drug). The result was the first patent concession on an AIDS drug and a 30-fold reduction in the price of the patented drug in South Africa. This action was taken without negative consequences to the university, financial or otherwise. Recently, a local company began selling generic stavudine in South Africa at up to 40% less than the reduced patented price. Global Health AND UNIVERSITY Patents Amy Kapcyznski et al Science AAAS Slide 21 The Global Development Context Relevance: Provides a useful and widely adopted framework for thinking about operationalising the right to share in the benefits of science In language of Point 9 what are unmet needs Slide 22 World Leaders September 2000 Millennium Development Declaration As leaders we have a duty therefore to all the worlds people, especially the most vulnerable and, in particular, the children of the world, to whom the future belongs. We will spare no effort to free our fellow men, women and children from the abject and dehumanizing conditions of extreme poverty, to which more than a billion of them are currently subjected. We are committed to freeing the entire human race from want. Slide 23 Millennium Development Goals 1.Eradicate Extreme Poverty and Hunger 2.Achieve universal primary education 3.Promote gender equality and empower women 4.Reduce child mortality 5.Improve Maternal Health 6.Combat HIV/AIDs, malaria and other diseases 7.Ensure environmental sustainability 8.Develop a global partnership for development Slide 24 Some Targets by 2015 1. proportion of people: living on less than $1 a day Suffering hunger 2.All boys and girls complete primary education 3.Eliminate gender disparity in education 4.Reduce by 2/3 under 5 mortality 5.Reduce by maternal mortality 6.Halt and reverse: spread of HIV/AIDS Incidence of malaria and other major diseases Slide 25 Case Studies Golden Rice MoodGYM Socially Responsible Licensing (Berkeley) Universities Allied for Essential Medicines Clauses Implementing Point 9 Slide 26 Golden Rice Slide 27 View A: Solve Vitaman A Deficiency Golden Rice is part of the solution: Biofortified rice as a contribution to the alleviation of life-threatening micronutrient deficiencies in developing countries. from Science: add beta-carotine to rice grain by inserting appropriate genes (GM) Slide 28 View B: Greenpeace Golden Rice: All glitter, no gold: Amsterdam, Netherlands It was a great sales pitch: adopt this genetically engineered rice, and it'll save milli