Presentation on theme: "The Right to Share in the Benefits of Science IP, Human Rights and Licensing Michael Curtotti ANU Legal Office."— Presentation transcript:
The Right to Share in the Benefits of Science IP, Human Rights and Licensing Michael Curtotti ANU Legal Office
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
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.
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
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.
The Human Rights Context Human Rights as ideas, laws and institutions
The Right to Share in the Benefits of Science UDHR (1) Everyone has the right … to share in scientific advancement and its benefits ICESCR The States Parties to the present Covenant recognise the right of everyone: (b) To enjoy the benefits of scientific progress and its applications
ICCPR ratifn and signature
ICESCR ratifn and signature
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
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.
AAAS: Science and Human Rights From AAAS Poster for the 60 th Anniversary of the Universal Declaration of Human Rights
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
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?
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)
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
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
AIDs & IP AIDs deaths now stabilized at 2,000,000 per annum. In 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
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
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
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.
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
Some Targets by ½ 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 ¾ maternal mortality 6.Halt and reverse: spread of HIV/AIDS Incidence of malaria and other major diseases …
Case Studies Golden Rice MoodGYM Socially Responsible Licensing (Berkeley) Universities Allied for Essential Medicines Clauses Implementing Point 9
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)
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 millions of children from blindness! "Golden Rice" is a technical failure. It won't overcome malnutrition. Worse, it is drawing funding and attention away from the real solutions to combat the very real problem of vitamin A deficiency.
Scientists Protest Unethical Clinical Trials of GM Golden Rice: … The three Projects listed breach the Nuremberg Code / medical ethics code on a number of counts, and we urge you to call them to a halt immediately. GM-food-trials-unacceptable.html Other Scientists Respond: The story originates from dedicated anti-GM campaigners who will stop at nothing... It is morally reprehensible that they are willing to allow millions of humans to die or endure avoidable blindness because of Vitamin A deficiency (VAD) in order to achieve their goal of a GM free world.
What does development mean? The purpose of aid is to enhance the economic and social development and well-being of recipients. This means fully taking into account recipients' views on objectives and how they are to be achieved. It is a question both of principle and practice. The principle is that people should be fully involved in issues concerning themselves and the society in which they live. And effectiveness and sustainability depend practically, in part, on the commitment of interested parties (stakeholders). Thus participation is a central element in achieving aid objectives. Department for International Development UK
Golden Rice: IP Aspects The difficulty of dealing with the patents: –Between 0-44 patents depending on country –Significant licensing activity required to make available in developing countries –FTO necessary and never definitive The Intellectual and Technical Property Components of pro-Vitamin A Rice (Golden Rice). Kryder, Kowalksi, Krattiger The preparedness of companies involved to grant humanitarian licenses: Syngenta but also to Bayer AG, Monsanto Co, Orynova BV, and Zeneca Mogen BV – available to developing country farmers royalty free up to $10,000 return. Farmers free to use harvested rice.
Public-public partnerships: MoodGYM Model MoodGYM: ANU Centre for Mental Health Research Online depression and anxiety CBT system – provided to 200,000 + users free of charge. Fully publicly developed & funded –Public health agencies fund research into efficacy to deliver public health outcomes –Researchers develop science and advance mental health Evidence based efficacy and comparison with other alternatives to the research led solution Driven by researcher vision and determination Strong interest from public health agencies in UK/NZ and elsewhere Developing country needs public funders and private philanthropies looking for research that can increase effectiveness of aid (e.g. ausaid research program)
Berkeley: Socially Responsible Licensing Program Grew out of work of researcher on hand held diagnostic tool for dengue fever (Eva Harris) Reconceptualised metrics for tech transfer office - success to include social impact and sustainable business relationships Source: Carol Mimura article Technology Licensing for the Benefit of the Developing World: UC Berkeleys Socially Responsible Licensing Program (Assistant VC for IP and Industry Research Alliances)
Product Development Partnership with Gates Foundation to produce low cost version of existing malaria drug One World Health (non-P pharma) Amyris (Berkeley Start up) Gates Foundation Berkeley Licence for Dvlp Cntry Distbn Licence to supply OWH + right to sell for profit in dvlpd wrld (application to fragrances/energy) $ $ for research $ applied regulatory approval and distbn Creates pathway for dissemination where market doesnt exist $supply
Universities Allied for Essential Medicines Philadelphia Consensus Statement Equitable access and neglected disease license –University licensed to grant non-exclusive sub-licence to supply to any notifier who wants to use for Neglected Disease application –Fair royalty (lower percentage for low and middle income countries) –Neglected research licence right to any notifier –Pass through clause –Transparency clause Promotion of new metrics –Minimum percentage of due diligence clauses in licensing agreements –80% exclusive / 20% non-exclusive to contain such clauses University of British Columbia : adopts non-financial metrics to measure societal impacts
Philadelphia Consensus Statement 1.Promote Equal Access to University Research 1.Inclusion of terms for low-cost access for developing world 2.Develop transparent case by case global access strategies where licensing insufficient 2.Promote R&D for Neglected Diseases 1.Policies to promote in-house ND research 2.Engage with non-traditional partners to create opportunities for ND drug development 3.Carve out ND research exemptions 3.Measure Research success according to impact on human welfare 1.Collect and publish statistics on university practice relating to global health access 2.Collaborate with universities/consortia to develop robust technology transfer metrics to gauge access (references article 25 of the Universal Declaration of Human Rights)
Piloted Contract Provisions Contract TypeProvision Type Inst. Research Collab.Pursue NPCLUT in future licensing Commercially funded research Option: license terms must comply with NPCLUT Assignment/Exclusive Licence Humanitarian Licence to Univ. N/ADefining unmet needs – Millennium Development Goals
US Univ. Licence Practice Freedom to Operate (non-suit clause): for use etc in Non-suit country Reserved right for supply to humanitarian organisation for use in GAVI country – Global Alliance for Vaccines and Immunization Reserved right to supply to meet health and safety needs not meet by licensee Waiver of university royalties for developing countries Diligence requirement on commercial partner to ensure supply at affordable price. Obligation to enter good faith discussion re global health needs and humanitarian use Company within 12 months to submit plan to university for supply to developing world for univ. comment Developing country obligations to be passed on to sub-licensees
Conclusions Right to share in the benefits of science are significant and violated Removing barriers is complex –requires good interface with human rights and development worlds –Requires reflection at level of policy, research, tech transfer and licensing practice to effectively implement Fundamentally aligned with what universities are about Univ. licensing practice in leading universities is already moving in this direction MDG: 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.