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The Right to Share in the Benefits of Science

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1 The Right to Share in the Benefits of Science
IP, Human Rights and Licensing Michael Curtotti ANU Legal Office Skate over surface Really no more than an exploration of the issues Now that lowered expectations I can safely get on with it Views my own not necessarily to be attributed to any other organisation etc etc

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

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”.

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

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 world’s 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.”

6 The Human Rights Context
Human Rights as ideas, laws and institutions

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

8 ICCPR ratif’n and signature

9 ICESCR ratif’n and signature

10 Human “Rights” & IP “Rights”: Comparison
Human Rights fundamental to human person: e.g. “inalienable” (e.g. can’t 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

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 Canada’s be considered here.

12 AAAS: Science and Human Rights
Really captures the different world views of science and human rights and highlights that linking the two together is not straight forward. So when it says in Article 1 of the Universal Declaration of Human Rights “All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in the spirit of brotherhood” really this is a definition of the human person. It is a completely different vision of “humanness” from the idea that we are the sum or expression of our genetic code. Long established science and human rights program recently extended by addition of AAAS Science and Human Rights Coalition which brings together human rights NGOs and scientists “We are going to beat these pro bono lawyers.” Mona Younis AAAS Science and Human Rights Program Director From AAAS Poster for the 60th Anniversary of the Universal Declaration of Human Rights

13 AAAS Science & HR Program
Scientists for Human Rights Science for Human Rights Human Rights and the Conduct of Science Science as a Human Right  

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?

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)

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


18 “Citizenship in Western liberal democracies is the equivalent of inherited feudal privilege – an inherited privilege that greatly one’s 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”

19 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 year’s supply. After protest dropped to price affordable for aid agencies c. $160 per year. AIDs drugs delivery in developing countries primarily publicly funded The global politics of pharmaceutical monopoly power p 26 A controversy over the cost of the drug stavudine (also known as d4T) came to a head on the Yale University campus in March Stavudine was an important drug used to treat HIV/AIDS. It was developed by researchers at Yale University, which held the patent on the drug. Yale licensed the patent to BMS, and it had been a great commercial success for both BMS and Yale. In 2000, Yale earned over 40 million USD in royalties from the stavudine license (Yale University Office of Cooperative Research 2000). In March 2001, researchers and students campaigned on the Yale campus, demanding that Yale not enforce its stavudine patent in South Africa so that generic versions of the drug could be used. At that time, the price of the generic version of stavudine in South Africa was thirty-four times less than the price of the BMS brand-name product. Yale Professor William Prusoff, who, together with the late Dr. Tai-Shun Lin, demonstrated the value of stavudine in treating AIDS, stated publicly, ‘People shouldn’t die for economic reasons, because they can’t afford the drug’ (as quoted in Demenet 2002). Under pressure from researchers, students, and access advocates, Yale renegotiated its license with BMS to ensure the availability of generic versions of stavudine in developing countries (‘t Hoen 2003). Ibid The campus erupts The High Cost of Living: Yale Shares Profits from AIDS Drugs Yale passed the matter to BMS, who passed it back to Yale. At the end of February, when 39 pharmaceuticals companies took the South African government to court for allowing the use of "compulsory licences" in health emergencies, the Yale campus boiled over. Backed by the Graduate, Employees and Students Organisation (GESO), Amy Kapczynski, a law student, circulated a petition in support of the MSF request. Six hundred students, technicians and researchers signed the petition. Among them was Dr William Prusoff, 81, who with the late Dr Tai-Shun Lin had shown the value of stavudine in treating Aids (7). "People shouldn’t die for economic reasons, because they can’t afford the drug," he said. "If Aids was completely solved and no royalties came in, I would be very happy." Yale gives its inventors 30% of the fees it collects. Prusoff calculated that his share - about half the total - came to $5.5m or $6m a year, just for doing his job as a researcher. "Why shouldn’t universities get part of the money the pharmaceuticals firms are making lots of?" he said. Like most Yale Medical School researchers, Prusoff played down the importance of his investment and his influence over the company exploiting his discovery. "They would listen, but they don’t have to accept," he joked. But BMS gave way even before the students handed Soderstrom their petition. On 14 March the New York-based company announced a massive reduction in prices in South Africa and promised not to prosecute any generics producer. This outcome did not satisfy the Yale activists. The university has not given up its stavudine patent in South Africa or broken its licence agreement with BMS. "In South Africa we use stavudine from BMS because, thanks to Amy Kapczynski among others, their prices have plummeted," Eric Goemaere told me. Aspen Pharmacare, a South African generics manufacturer, wanted to make a copy. "But no agreement has been signed between Aspen and BMS and, from the start, Aspen has complained that BMS is dragging its feet," Groemaere went on. "The South African company was given no information about the molecule, no technology transfer. Unlike others, BMS seems to have made a lot of concessions. But this dramatic price cut has discouraged competition and so far has prevented the emergence of generic products." "The power still lies in the US," Amy Kapczynski laments. "That’s not really what we were fighting for. What we really wanted is a shift in the whole balance of power about the issue, until the decision-making process about health care is really in the hands of people who need that health care. They don’t actually give up the patent itself in South Africa. Anything that affects the relationship between the university and a drug company is a very touchy subject because the university made a big amount of money out of there." On this as on everything else, BMS refuses to comment, but Soderstrom agrees. "We never had an argument with BMS. The question was what is the right thing to do? Yale couldn’t act unilaterally. We’ve got a licence agreement with BMS and we’ve had several research programmes running with them for years."

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

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”

22 World Leaders September 2000 Millennium Development Declaration
“As leaders we have a duty therefore to all the world’s 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.”

23 Millennium Development Goals
Eradicate Extreme Poverty and Hunger Achieve universal primary education Promote gender equality and empower women Reduce child mortality Improve Maternal Health Combat HIV/AIDs, malaria and other diseases Ensure environmental sustainability Develop a global partnership for development

24 Some Targets by 2015 ½ proportion of people:
living on less than $1 a day Suffering hunger All boys and girls complete primary education Eliminate gender disparity in education Reduce by 2/3 under 5 mortality Reduce by ¾ maternal mortality Halt and reverse: spread of HIV/AIDS Incidence of malaria and other major diseases

25 Case Studies Golden Rice MoodGYM
Socially Responsible Licensing (Berkeley) Universities Allied for Essential Medicines Clauses Implementing Point 9

26 Golden Rice From wikipedia

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)

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 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.’ Golden Rice was presented in 2000 as a rice variety that was genetically engineered in a laboratory to produce pro-vitamin A (beta-carotene). The media hype was more robust than the science, however, and our analysis revealed that people would need to consume 12 times more rice than normal to satisfy the minimum daily adult requirements of Vitamin A. Subsequent studies have questioned the very notion that Golden Rice would be effective in addressing Vitamin A deficiency. "Industry tries to sell Golden Rice as a magic solution. Their strategy is misleading the public, they are oversimplifying the actual problems in combating vitamin A deficiency and try to turn down other, more effective solutions," says Christoph Then, Greenpeace International GE campaigner. "The Golden Rice project simply aims to help industry to gain support for their controversial GE-food in markets such as India and Europe".

29 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.  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. We wish to remind you that the variety of Golden Rice used in these experiments (GR2) is inadequately described in terms of biological and biochemical characterisation on the Clinical Trials web site and indeed anywhere else in the publicly available literature, and has  woefully inadequate pre-clinical evaluation.  It is a genetically modified product which has not been shown to be distinctive, uniform and stable over time.  It has never been through a regulatory /approvals process anywhere in the world.  There is now a large body of evidence that shows that GM crop/food production is highly prone to inadvertent and unpredictable pleiotropic effects, which can result in health damaging effects when GM food products are fed to animals (for reviews see Pusztai and Bardocz , 2006; Schubert, 2008; Dona and Arvanitoyannis, 2009).  More specifically, our greatest concern is that this rice, which is engineered to overproduce beta carotene, has never been tested in animals, and there is an extensive medical literature showing that retinoids that can be derived from beta carotene are both toxic and cause birth defects. In these circumstances the use of human subjects (including children who are already suffering illness as a result of Vitamin A deficiency) for GM feeding experiments is completely unacceptable.  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.  They should not be resumed unless and until the researchers can demonstrate that a full range of laboratory and animal feeding trials have been completed and published for the Golden Rice strain being used, and unless and until appropriate regulatory bodies have had an opportunity to come to a view on the health and safety issues about which we are very concerned. We can assure you that such trials would not have been approved within the European Union in the absence of safety information, which highlights yet again the flaw of the USDA and FDA regulatory system in considering GM crops/foods as hypothetically “generally recognised as safe – GRAS” in the absence of hard experimental data. recently released on the US Clinical Trials web site confirms that Chinese children suffering from varying degrees of Vitamin A deficiency have been used in feeding trials, contrary to the Nuremberg Code (1) which underpins modern medical ethics. In three press releases (2) (3) (4)  GM Free Cymru has drawn attention to the cynical attempts by the Syngenta Foundation and the Golden Rice Project to promote this GM variety as  part of a grand humanitarian gesture which will solve the apparently intractable problem of Vitamin A deficiency in many of the poorer nations. Syngenta boasts that it has donated the patents for Golden Rice to the world, whereas it has done nothing of the sort (5).

30 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 If we are going to promote science as a solution for development problems – it’ll be important for scientists to be aware of that context. The best development is that grounded in people themselves Seeing people as human as decision makers and part of the solution Not assuming we’re the experts and they have nothing to contribute to the process etc NOTE ON ENHANCING STAKEHOLDER PARTICIPATION IN AID ACTIVITIES OVERSEAS DEVELOPMENT ADMINISTRATION Social Development Department Department for International Development (UK) April 1995 Participatory development is the process through which people, including the poor or the marginalized, shape projects, programmes and policies that affect their lives. It contributes, and responds, to poverty reduction, empowerment, gender equality, social inclusion, respect for human rights, and sustainability. It is an essential component of good governance. It grounds development in people’s cultures and priorities.

31 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. The essence of the Sublicensing Agreement The inventors have assigned their exclusive rights to the Golden Rice technology to Syngenta. Syngenta added some further technologies, and arranged licences with other companies for some additional technologies to be included in the original Golden Rice. Syngenta, in turn, has given the inventors a humanitarian licence with the right to sublicense public research institutions and low-income farmers in developing countries, to the full set of necessary technologies. Syngenta retains commercial rights, although it has no plans to commercialize Golden Rice. ’Humanitarian Use’ means (and includes research leading to): Use in developing countries (low-income, food-deficit countries as defined by FAO) Resource-poor farmer use (earning less than US$10,000 per year from farming) The technology must be introduced into public germplasm ( = seed) only (see below). No surcharge may be charged for the technology (i.e. the seed may cost only as much as a seed without the trait) National sales are allowed by such farmers (in this way urban needs can also be covered) Reusing the harvested seed in the following planting season is allowed (the farmer is the owner of his seeds Regulatory imperative and national sovereignty, i.e. Golden Rice may not be released in a country lacking biosafety regulations, and the decision to adopt the technology is a national matter. No export allowed (except for research to other licensees): this is a humanitarian project, i.e. the seeds are meant to cover the daily requirements of the poor populations that are deficient in vitamin A. Improvements to licensed technology: Commercial rights of improvements to the technology go to Syngenta, but Humanitarian Use of such improvements is guaranteed under the same terms of the original agreement (in this way any improvements to the technology will serve the humanitarian purpose). No warranties are given by licensor(s) (this is also related the fact that every receiving country will determine what biosafety and agronomic requirements to impose before approval of a Golden Rice variety. Liabilities and costs — each party is responsible for what it controls (this follows also from the fact that this is a humanitarian project and not a commercial enterprise).

32 “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) IP issues Keeping the IP all in one place so it could continue to be made available free of cost Working with researchers in NZ, Norway, Mexico ANU holds all software and web IP. Difficulty of finding a model that fits for a commercial partner which wants to commercialise essentially the same service Extrapolation of model to developing country needs

33 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 Berkeley’s Socially Responsible Licensing Program (Assistant VC for IP and Industry Research Alliances)

34 Product Development Partnership with Gates Foundation to produce low cost version of existing malaria drug $ applied regulatory approval and distbn $ for research One World Health (non-P pharma) Berkeley Licence for Dvlp Cntry Distbn Licence to supply OWH + right to sell for profit in dvlpd wrld (application to fragrances/energy) supply $ $ $ for research Gates Foundation Amyris (Berkeley Start up) Creates pathway for dissemination where market doesn’t exist

35 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 See eg P TIP report on innovation in Canadian universities

36 Philadelphia Consensus Statement
Promote Equal Access to University Research Inclusion of terms for low-cost access for developing world Develop transparent case by case global access strategies where licensing insufficient Promote R&D for Neglected Diseases Policies to promote in-house ND research Engage with non-traditional partners to create opportunities for ND drug development Carve out ND research exemptions Measure Research success according to impact on human welfare Collect and publish statistics on university practice relating to global health access Collaborate with universities/consortia to develop robust technology transfer metrics to gauge access (references article 25 of the Universal Declaration of Human Rights)


38 ANU Policy

39 Piloted Contract Provisions
Contract Type Provision 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/A Defining “unmet needs” – Millennium Development Goals With support of Office of Commercialisation and other offices.

40 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 AUTM working on a project at the moment so shortly should see these kind of provisions made public. Acknowledgements

41 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.”

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