Chapter 9, section 6
Table of Contents, Chapter 9: Summary
Chapter 9 Justice and Development. section 6: Commons-Based Research for Food and Medicines
Introduction
Liberal Theories of Justice and the Networked Information Economy
Commons-Based Strategies for Human Welfare and Development
Information-Embedded Goods and Tools, Information, and Knowledge
Industrial Organization of HDI-Related Information Industries
Toward Adopting Commons-Based Strategies for Development
Commons-Based Research for Food and Medicines
While computation and access to existing scientific research are important in the development of any nation, they still operate at a remove from the most basic needs of the world poor. On its face, it is far from obvious how the emergence of the networked information economy can grow rice to feed millions of malnourished children or deliver drugs to millions of HIV/AIDS patients. On closer observation, however, a tremendous proportion of the way modern societies grow food and develop medicines is based on scientific research and technical innovation. We have seen how the functions of mass media can be fulfilled by nonproprietary models of news and commentary. We have seen the potential of free and open source software and open-access publications to replace and redress some of the failures of proprietary software and scientific publication, respectively. These cases suggest that the basic choice between a system that depends on exclusive rights and business models that use exclusion to appropriate research outputs and a system that weaves together various actors-public and private, organized and individual-in a nonproprietary social network of innovation, has important implications for the direction of innovation and for access to its products. Public attention has focused mostly on the HIV/AIDS crisis in Africa and the lack of access to existing drugs because of their high costs. However, that crisis is merely the tip of the iceberg. It is the most visible to many because of the presence of the disease in rich countries and its cultural and political salience in the United States and Europe. The exclusive rights system is a poor institutional mechanism for serving the needs of those who are worst off around the globe. Its weaknesses pervade the problems of food security and agricultural research aimed at increasing the supply of nourishing food throughout the developing world, and of access to medicines in general, and to medicines for developing-world diseases in particular. Each of these areas has seen a similar shift in national and international policy toward greater reliance on exclusive rights, most important of which are patents. Each area has also begun to see the emergence of commons-based models to alleviate the problems of patents. However, they differ from each other still. Agriculture offers more immediate opportunities for improvement because of the relatively larger role of public research-national, international, and academic-and of the long practices of farmer innovation in seed associations and local and regional frameworks. I explore it first in some detail, as it offers a template for what could be a path for development in medical research as well.
Food Security: Commons-Based Agricultural Innovation
Agricultural innovation over the past century has led to a vast increase in crop yields. Since the 1960s, innovation aimed at increasing yields and improving quality has been the centerpiece of efforts to secure the supply of food to the world's poor, to avoid famine and eliminate chronic malnutrition. These efforts have produced substantial increases in the production of food and decreases in its cost, but their benefits have varied widely in different regions of the world. Now, increases in productivity are not alone a sufficient condition to prevent famine. Sen's observations that democracies have no famines-that is, that good government and accountability will force public efforts to prevent famine-are widely accepted today. The contributions of the networked information economy to democratic participation and transparency are discussed in chapters 6-8, and to the extent that those chapters correctly characterize the changes in political discourse, should help alleviate human poverty through their effects on democracy. However, the cost and quality of food available to accountable governments of poor countries, or to international aid organizations or nongovernment organizations (NGOs) that step in to try to alleviate the misery caused by ineffective or malicious governments, affect how much can be done to avoid not only catastrophic famine, but also chronic malnutrition. Improvements in agriculture make it possible for anyone addressing food security to perform better than they could have if food production had lower yields, of less nutritious food, at higher prices. Despite its potential benefits, however, agricultural innovation has been subject to an unusual degree of sustained skepticism aimed at the very project of organized scientific and scientifically based innovation. Criticism combines biological-ecological concerns with social and economic concerns. Nowhere is this criticism more strident, or more successful at moving policy, than in current European resistance to genetically modified (GM) foods. The emergence of commons-based production strategies can go some way toward allaying the biological-ecological fears by locating much of the innovation at the local level. Its primary benefit, however, is likely to be in offering a path for agricultural and biological innovation that is sustainable and low cost, and that need not result in appropriation of the food production chain by a small number of multinational businesses, as many critics fear.
Scientific plant improvement in the United States dates back to the establishment of the U.S. Department of Agriculture, the land-grant universities, and later the state agricultural experiment stations during the Civil War and in the decades that followed. Public-sector investment dominated agricultural research at the time, and with the rediscovery of Mendel's work in 1900, took a turn toward systematic selective breeding. Through crop improvement associations, seed certification programs, and open-release policies allowing anyone to breed and sell the certified new seeds, farmers were provided access to the fruits of public research in a reasonably efficient and open market. The development of hybrid corn through this system was the first major modern success that vastly increased agricultural yields. It reshaped our understanding not only of agriculture, but also more generally of the value of innovation, by comparison to efficiency, to growth. Yields in the United States doubled between the mid-1930s and the mid-1950s, and by the mid-1980s, cornfields had a yield six times greater than they had fifty years before. Beginning in the early 1960s, with funding from the Rockefeller and Ford foundations, and continuing over the following forty years, agricultural research designed to increase the supply of agricultural production and lower its cost became a central component of international and national policies aimed at securing the supply of food to the world's poor populations, avoiding famines and, ultimately, eliminating chronic malnutrition. The International Rice Research Institute (IRRI) in the Philippines was the first such institute, founded in the 1960s, followed by the International Center for Wheat and Maize Improvement (CIM-MYT) in Mexico (1966), and the two institutes for tropical agriculture in Colombia and Nigeria (1967). Together, these became the foundation for the Consultative Group for International Agricultural Research (CGIAR), which now includes sixteen centers. Over the same period, National Agricultural Research Systems (NARS) also were created around the world, focusing on research specific to local agroecological conditions. Research in these centers preceded the biotechnology revolution, and used various experimental breeding techniques to obtain high-yielding plants: for example, plants with shorter growing seasons, or more adapted to intensive fertilizer use. These efforts later introduced varieties that were resistant to local pests, diseases, and to various harsh environmental conditions.
The "Green Revolution," as the introduction of these new, scientific-research-based varieties has been called, indeed resulted in substantial increases in yields, initially in rice and wheat, in Asia and Latin America. The term "Green Revolution" is often limited to describing these changes in those regions in the 1960s and 1970s. A recent study shows, however, that the growth in yields has continued throughout the last forty years, and has, with varying degrees, occurred around the world./10 More than eight thousand modern varieties of rice, wheat, maize, other major cereals, and root and protein crops have been released over the course of this period by more than four hundred public breeding programs. One of the most interesting finds of this study was that fewer than 1 percent of these modern varieties had any crosses with public or private breeding programs in the developed world, and that private-sector contributions in general were limited to hybrid maize, sorghum, and millet. The effort, in other words, was almost entirely public sector, and almost entirely based in the developing world, with complementary efforts of the international and national programs. Yields in Asia increased sevenfold from 1961 to 2000, and fivefold in Latin America, the Middle East/North Africa, and Sub-Saharan Africa. More than 60 percent of the growth in Asia and Latin America occurred in the 1960s-1980s, while the primary growth in Sub-Saharan Africa began in the 1980s. In Latin America, most of the early-stage increases in yields came from increasing cultivated areas (~40 percent), and from other changes in cultivation-increased use of fertilizer, mechanization, and irrigation. About 15 percent of the growth in the early period was attributable to the use of modern varieties. In the latter twenty years, however, more than 40 percent of the total increase in yields was attributable to the use of new varieties. In Asia in the early period, about 19 percent of the increase came from modern varieties, but almost the entire rest of the increase came from increased use of fertilizer, mechanization, and irrigation, not from increased cultivated areas. It is trivial to see why changes of this sort would elicit both environmental and a social-economic critique of the industrialization of farm work. Again, though, in the latter twenty years, 46 percent of the increase in yields is attributable to the use of modern varieties. Modern varieties played a significantly less prominent role in the Green Revolution of the Middle East and Africa, contributing 5-6 percent of the growth in yields. In Sub-Saharan Africa, for example, early efforts to introduce varieties from Asia and Latin America failed, and local developments only began to be adopted in the 1980s. In the latter twenty-year period, however, the Middle East and North Africa did see a substantial role for modern varieties-accounting for close to 40 percent of a more than doubling of yields. In Sub-Saharan Africa, the overwhelming majority of the tripling of yields came from increasing area of cultivation, and about 16 percent came from modern varieties. Over the past forty years, then, research-based improvements in plants have come to play a larger role in increasing agricultural yields in the developing world. Their success was, however, more limited in the complex and very difficult environments of Sub-Saharan Africa. Much of the benefit has to do with local independence, as opposed to heavier dependence on food imports. Evenson and Gollin, for example, conservatively estimate that higher prices and a greater reliance on imports in the developing world in the absence of the Green Revolution would have resulted in 13-14 percent lower caloric intake in the developing world, and in a 6-8 percent higher proportion of malnourished children. While these numbers may not seem eye-popping, for populations already living on marginal nutrition, they represent significant differences in quality of life and in physical and mental development for millions of children and adults.
The agricultural research that went into much of the Green Revolution did not involve biotechnology-that is, manipulation of plant varieties at the genetic level through recombinant DNA techniques. Rather, it occurred at the level of experimental breeding. In the developed world, however, much of the research over the past twenty-five years has been focused on the use of biotechnology to achieve more targeted results than breeding can, has been more heavily based on private-sector investment, and has resulted in more private-sector ownership over the innovations. The promise of biotechnology, and particularly of genetically engineered or modified foods, has been that they could provide significant improvements in yields as well as in health effects, quality of the foods grown, and environmental effects. Plants engineered to be pest resistant could decrease the need to use pesticides, resulting in environmental benefits and health benefits to farmers. Plants engineered for ever-higher yields without increasing tilled acreage could limit the pressure for deforestation. Plants could be engineered to carry specific nutritional supplements, like golden rice with beta-carotene, so as to introduce necessarily nutritional requirements into subsistence diets. Beyond the hypothetically optimistic possibilities, there is little question that genetic engineering has already produced crops that lower the cost of production for farmers by increasing herbicide and pest tolerance. As of 2002, more than 50 percent of the world's soybean acreage was covered with genetically modified (GM) soybeans, and 20 percent with cotton. Twenty-seven percent of acreage covered with GM crops is in the developing world. This number will grow significantly now that Brazil has decided to permit the introduction of GM crops, given its growing agricultural role, and now that India, as the world's largest cotton producer, has approved the use of Bt cotton-a GM form of cotton that improves its resistance to a common pest. There are, then, substantial advantages to farmers, at least, and widespread adoption of GM crops both in the developed world outside of Europe and in the developing world.
This largely benign story of increasing yields, resistance, and quality has not been without critics, to put it mildly. The criticism predates biotechnology and the development of transgenic varieties. Its roots are in criticism of experimental breeding programs of the American agricultural sectors and the Green Revolution. However, the greatest public visibility and political success of these criticisms has been in the context of GM foods. The critique brings together odd intellectual and political bedfellows, because it includes five distinct components: social and economic critique of the industrialization of agriculture, environmental and health effects, consumer preference for "natural" or artisan production of foodstuffs, and, perhaps to a more limited extent, protectionism of domestic farm sectors.
Perhaps the oldest component of the critique is the social-economic critique. One arm of the critique focuses on how mechanization, increased use of chemicals, and ultimately the use of nonreproducing proprietary seed led to incorporation of the agricultural sector into the capitalist form of production. In the United States, even with its large "family farm" sector, purchased inputs now greatly exceed nonpurchased inputs, production is highly capital intensive, and large-scale production accounts for the majority of land tilled and the majority of revenue captured from farming./11 In 2003, 56 percent of farms had sales of less than $10,000 a year. Roughly 85 percent of farms had less than $100,000 in sales./12 These farms account for only 42 percent of the farmland. By comparison, 3.4 percent of farms have sales of more than $500,000 a year, and account for more than 21 percent of land. In the aggregate, the 7.5 percent of farms with sales over $250,000 account for 37 percent of land cultivated. Of all principal owners of farms in the United States in 2002, 42.5 percent reported something other than farming as their principal occupation, and many reported spending two hundred or more days off-farm, or even no work days at all on the farm. The growth of large-scale "agribusiness," that is, mechanized, rationalized industrial-scale production of agricultural products, and more important, of agricultural inputs, is seen as replacing the family farm and the small-scale, self-sufficient farm, and bringing farm labor into the capitalist mode of production. As scientific development of seeds and chemical applications increases, the seed as input becomes separated from the grain as output, making farmers dependent on the purchase of industrially produced seed. This further removes farmwork from traditional modes of self-sufficiency and craftlike production to an industrial mode. This basic dynamic is repeated in the critique of the Green Revolution, with the added overlay that the industrial producers of seed are seen to be multinational corporations, and the industrialization of agriculture is seen as creating dependencies in the periphery on the industrial-scientific core of the global economy.
The social-economic critique has been enmeshed, as a political matter, with environmental, health, and consumer-oriented critiques as well. The environmental critiques focus on describing the products of science as monocultures, which, lacking the genetic diversity of locally used varieties, are more susceptible to catastrophic failure. Critics also fear contamination of existing varieties, unpredictable interactions with pests, and negative effects on indigenous species. The health effects concern focused initially on how breeding for yield may have decreased nutritional content, and in the more recent GM food debates, the concern that genetically altered foods will have some unanticipated negative health reactions that would only become apparent many years from now. The consumer concerns have to do with quality and an aesthetic attraction to artisan-mode agricultural products and aversion to eating industrial outputs. These social-economic and environmental-health-consumer concerns tend also to be aligned with protectionist lobbies, not only for economic purposes, but also reflecting a strong cultural attachment to the farming landscape and human ecology, particularly in Europe.
This combination of social-economic and postcolonial critique, environmentalism, public-health concerns, consumer advocacy, and farm-sector protectionism against the relatively industrialized American agricultural sector reached a height of success in the 1999 five-year ban imposed by the European Union on all GM food sales. A recent study of a governmental Science Review Board in the United Kingdom, however, found that there was no evidence for any of the environmental or health critiques of GM foods./13 Indeed, as Peter Pringle masterfully chronicled in Food, Inc., both sides of the political debate could be described as having buffed their cases significantly. The successes and potential benefits have undoubtedly been overstated by enamored scientists and avaricious vendors. There is little doubt, too, that the near-hysterical pitch at which the failures and risks of GM foods have been trumpeted has little science to back it, and the debate has degenerated to a state that makes reasoned, evidence-based consideration difficult. In Europe in general, however, there is wide acceptance of what is called a "precautionary principle." One way of putting it is that absence of evidence of harm is not evidence of absence of harm, and caution counsels against adoption of the new and at least theoretically dangerous. It was this precautionary principle rather than evidence of harm that was at the base of the European ban. This ban has recently been lifted, in the wake of a WTO trade dispute with the United States and other major producers who challenged the ban as a trade barrier. However, the European Union retained strict labeling requirements. This battle among wealthy countries, between the conservative "Fortress Europe" mentality and the growing reliance of American agriculture on biotechnological innovation, would have little moral valence if it did not affect funding for, and availability of, biotechnological research for the populations of the developing world. Partly as a consequence of the strong European resistance to GM foods, the international agricultural research centers that led the way in the development of the Green Revolution varieties, and that released their developments freely for anyone to sell and use without proprietary constraint, were slow to develop capacity in genetic engineering and biotechnological research more generally. Rather than the public national and international efforts leading the way, a study of GM use in developing nations concluded that practically all GM acreage is sown with seed obtained in the finished form from a developed-world supplier, for a price premium or technology licensing fee./14 The seed, and its improvements, is proprietary to the vendor in this model. It is not supplied in a form or with the rights to further improve locally and independently. Because of the critique of innovation in agriculture as part of the process of globalization and industrialization, of environmental degradation, and of consumer exploitation, the political forces that would have been most likely to support public-sector investment in agricultural innovation are in opposition to such investments. The result has not been retardation of biotechnological innovation in agriculture, but its increasing privatization: primarily in the United States and now increasingly in Latin America, whose role in global agricultural production is growing.
Private-sector investment, in turn, operates within a system of patents and other breeders' exclusive rights, whose general theoretical limitations are discussed in chapter 2. In agriculture, this has two distinct but mutually reinforcing implications. The first is that, while private-sector innovation has indeed accounted for most genetically engineered crops in the developing world, research aimed at improving agricultural production in the neediest places has not been significantly pursued by the major private-sector firms. A sector based on expectation of sales of products embedding its patents will not focus its research where human welfare will be most enhanced. It will focus where human welfare can best be expressed in monetary terms. The poor are systematically underserved by such a system. It is intended to elicit investments in research in directions that investors believe will result in outputs that serve the needs of those with the highest willingness and ability to pay for their outputs. The second is that even where the products of innovation can, as a matter of biological characteristics, be taken as inputs into local research and development-by farmers or by national agricultural research systems-the international system of patents and plant breeders' rights enforcement makes it illegal to do so without a license. This again retards the ability of poor countries and their farmers and research institutes to conduct research into local adaptations of improved crops.
The central question raised by the increasing privatization of agricultural biotechnology over the past twenty years is: What can be done to employ commons-based strategies to provide a foundation for research that will be focused on the food security of developing world populations? Is there a way of managing innovation in this sector so that it will not be heavily weighted in favor of populations with a higher ability to pay, and so that its outputs allow farmers and national research efforts to improve and adapt to highly variable local agroecological environments? The continued presence of the public-sector research infrastructure-including the international and national research centers, universities, and NGOs dedicated to the problem of food security-and the potential of harnessing individual farmers and scientists to cooperative development of open biological innovation for agriculture suggest that commons-based paths for development in the area of food security and agricultural innovation are indeed feasible.
First, some of the largest and most rapidly developing nations that still have large poor populations-most prominently, China, India, and Brazil-can achieve significant advances through their own national agricultural research systems. Their research can, in turn, provide a platform for further innovation and adaptation by projects in poorer national systems, as well as in nongovernmental public and peer-production efforts. In this regard, China seems to be leading the way. The first rice genome to be sequenced was japonica, apparently sequenced in 2000 by scientists at Monsanto, but not published. The second, an independent and published sequence of japonica, was sequenced by scientists at Syngenta, and published as the first published rice genome sequence in Science in April 2002. To protect its proprietary interests, Syngenta entered a special agreement with Science, which permitted the authors not to deposit the genomic information into the public Genbank maintained by the National Institutes of Health in the United States./15 Depositing the information in GenBank makes it immediately available for other scientists to work with freely. All the major scientific publications require that such information be deposited and made publicly available as a standard condition of publication, but Science waved this requirement for the Syngenta japonica sequence. The same issue of Science, however, carried a similar publication, the sequence of Oryza sativa L.ssp. indica, the most widely cultivated subspecies in China. This was sequenced by a public Chinese effort, and its outputs were immediately deposited in GenBank. The simultaneous publication of the rice genome by a major private firm and a Chinese public effort was the first public exposure to the enormous advances that China's public sector has made in agricultural biotechnology, and its focus first and foremost on improving Chinese agriculture. While its investments are still an order of magnitude smaller than those of public and private sectors in the developed countries, China has been reported as the source of more than half of all expenditures in the developing world./16 China's longest experience with GM agriculture is with Bt cotton, which was introduced in 1997. By 2000, 20 percent of China's cotton acreage was sown to Bt cotton. One study showed that the average acreage of a farm was less than 0.5 hectare of cotton, and the trait that was most valuable to them was Bt cotton's reduced pesticide needs. Those who adopted Bt cotton used less pesticide, reducing labor for pest control and the pesticide cost per kilogram of cotton produced. This allowed an average cost savings of 28 percent. Another effect suggested by survey data-which, if confirmed over time, would be very important as a matter of public health, but also to the political economy of the agricultural biotechnology debate-is that farmers who do not use Bt cotton are four times as likely to report symptoms of a degree of toxic exposure following application of pesticides than farmers who did adopt Bt cotton./17 The point is not, of course, to sing the praises of GM cotton or the Chinese research system. China's efforts offer an example of how the larger national research systems can provide an anchor for agricultural research, providing solutions both for their own populations, and, by making the products of their research publicly and freely available, offer a foundation for the work of others.
Alongside the national efforts in developing nations, there are two major paths for commons-based research and development in agriculture that could serve the developing world more generally. The first is based on existing research institutes and programs cooperating to build a commons-based system, cleared of the barriers of patents and breeders' rights, outside and alongside the proprietary system. The second is based on the kind of loose affiliation of university scientists, nongovernmental organizations, and individuals that we saw play such a significant role in the development of free and open-source software. The most promising current efforts in the former vein are the PIPRA (Public Intellectual Property for Agriculture) coalition of public-sector universities in the United States, and, if it delivers on its theoretical promises, the Generation Challenge Program led by CGIAR (the Consultative Group on International Agricultural Research). The most promising model of the latter, and probably the most ambitious commons-based project for biological innovation currently contemplated, is BIOS (Biological Innovation for an Open Society).
PIPRA is a collaboration effort among public-sector universities and agricultural research institutes in the United States, aimed at managing their rights portfolio in a way that will give their own and other researchers freedom to operate in an institutional ecology increasingly populated by patents and other rights that make work difficult. The basic thesis and underlying problem that led to PIPRA's founding were expressed in an article in Science coauthored by fourteen university presidents./18 They underscored the centrality of public-sector, land-grant university-based research to American agriculture, and the shift over the last twenty-five years toward increased use of intellectual property rules to cover basic discoveries and tools necessary for agricultural innovation. These strategies have been adopted by both commercial firms and, increasingly, by public-sector universities as the primary mechanism for technology transfer from the scientific institute to the commercializing firms. The problem they saw was that in agricultural research, innovation was incremental. It relies on access to existing germplasm and crop varieties that, with each generation of innovation, brought with them an ever-increasing set of intellectual property claims that had to be licensed in order to obtain permission to innovate further. The universities decided to use the power that ownership over roughly 24 percent of the patents in agricultural biotechnology innovations provides them as a lever with which to unravel the patent thickets and to reduce the barriers to research that they increasingly found themselves dealing with. The main story, one might say the "founding myth" of PIPRA, was the story of golden rice. Golden rice is a variety of rice that was engineered to provide dietary vitamin A. It was developed with the hope that it could introduce vitamin A supplement to populations in which vitamin A deficiency causes roughly 500,000 cases of blindness a year and contributes to more than 2 million deaths a year. However, when it came to translating the research into deliverable plants, the developers encountered more than seventy patents in a number of countries and six materials transfer agreements that restricted the work and delayed it substantially. PIPRA was launched as an effort of public-sector universities to cooperate in achieving two core goals that would respond to this type of barrier-preserving the right to pursue applications to subsistence crops and other developing-world-related crops, and preserving their own freedom to operate vis-à-vis each other's patent portfolios.
The basic insight of PIPRA, which can serve as a model for university alliances in the context of the development of medicines as well as agriculture, is that universities are not profit-seeking enterprises, and university scientists are not primarily driven by a profit motive. In a system that offers opportunities for academic and business tracks for people with similar basic skills, academia tends to attract those who are more driven by nonmonetary motivations. While universities have invested a good deal of time and money since the Bayh-Dole Act of 1980 permitted and indeed encouraged them to patent innovations developed with public funding, patent and other exclusive-rights-based revenues have not generally emerged as an important part of the revenue scheme of universities.
Table 9.2: Selected University Gross Revenues and Patent Licensing Revenues
|
|
|||||
|
|
Total Revenues |
Licensing and Royalties |
Government Grants & Contracts |
||
|
|
(millions $) |
(millions $) |
% of total |
(millions $) |
% of total |
|
|
|||||
|
All universities |
$227,000 |
$1,270 |
0.56% |
$31,430 |
13.85% |
|
University of California |
$14,166 |
$81.3 |
0.57% |
$2,372 |
16.74% |
|
Stanford University |
$3,475 |
$43.3 |
1.25% |
$860 |
24.75% |
|
Florida State |
$2,646 |
$35.6 |
1.35% |
$238 |
8.99% |
|
Harvard |
$2,473 |
$47.9 |
1.94% |
$416 |
16.82% |
|
Columbia University |
$2,074 |
$178.4 |
8.6% |
$532 |
25.65% |
|
University of Wisconsin-Madison |
$1,696 |
$32 |
1.89% |
$417.4 |
24.61% |
|
University of Minnesota |
$1,237 |
$38.7 |
3.12% |
$323.5 |
26.15% |
|
Cal Tech |
$531 |
$26.7/e |
5.02% |
$268 |
50.47% |
|
|
|||||
|
Sources: Aggregate revenues: U.S. Dept. of Education, National Center for Education Statistics, Enrollment in Postsecondary Institutions, Fall 2001, and Financial Statistics, Fiscal Year 2001 (2003), Table F; Association of University Technology Management, Annual Survey Summary FY 2002 (AUTM 2003), Table S-12. Individual institutions: publicly available annual reports of each university and/or its technology transfer office for FY 2003. Notes:
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As table 9.2 shows, except for one or two outliers, patent revenues have been all but negligible in university budgets./19 This fact makes it fiscally feasible for universities to use their patent portfolios to maximize the global social benefit of their research, rather than trying to maximize patent revenue. In particular, universities can aim to include provisions in their technology licensing agreements that are aimed at the dual goals of (a) delivering products embedding their innovations to developing nations at reasonable prices and (b) providing researchers and plant breeders the freedom to operate that would allow them to research, develop, and ultimately produce crops that would improve food security in the developing world.
While PIPRA shows an avenue for collaboration among universities in the public interest, it is an avenue that does not specifically rely on, or benefit in great measure from, the information networks or the networked information economy. It continues to rely on the traditional model of publicly funded research. More explicit in its effort to leverage the cost savings made possible by networked information systems is the Generation Challenge Program (GCP). The GCP is an effort to bring the CGIAR into the biotechnology sphere, carefully, given the political resistance to genetically modified foods, and quickly, given the already relatively late start that the international research centers have had in this area. Its stated emphasis is on building an architecture of innovation, or network of research relationships, that will provide low-cost techniques for the basic contemporary technologies of agricultural research. The program has five primary foci, but the basic thrust is to generate improvements both in basic genomics science and in breeding and farmer education, in both cases for developing world agriculture. One early focus would be on building a communications system that allows participating institutions and scientists to move information efficiently and utilize computational resources to pursue research. There are hundreds of thousands of samples of germplasm, from "landrace" (that is, locally agriculturally developed) and wild varieties to modern varieties, located in databases around the world in international, national, and academic institutions. There are tremendous high-capacity computation resources in some of the most advanced research institutes, but not in many of the national and international programs. One of the major goals articulated for the GCP is to develop Web-based interfaces to share these data and computational resources. Another is to provide a platform for sharing new questions and directions of research among participants. The work in this network will, in turn, rely on materials that have proprietary interests attached to them, and will produce outputs that could have proprietary interests attached to them as well. Just like the universities, the GCP institutes (national, international, and nonprofit) are looking for an approach aimed to secure open access to research materials and tools and to provide humanitarian access to its products, particularly for subsistence crop development and use. As of this writing, however, the GCP is still in a formative stage, more an aspiration than a working model. Whether it will succeed in overcoming the political constraints placed on the CGIAR as well as the relative latecomer status of the international public efforts to this area of work remains to be seen. But the elements of the GCP certainly exhibit an understanding of the possibilities presented by commons-based networked collaboration, and an ambition to both build upon them and contribute to their development.
The most ambitious effort to create a commons-based framework for biological innovation in this field is BIOS. BIOS is an initiative of CAMBIA (Center for the Application of Molecular Biology to International Agriculture), a nonprofit agricultural research institute based in Australia, which was founded and is directed by Richard Jefferson, a pioneer in plant biotechnology. BIOS is based on the observation that much of contemporary agricultural research depends on access to tools and enabling technologies-such as mechanisms to identify genes or for transferring them into target plants. When these tools are appropriated by a small number of firms and available only as part of capital-intensive production techniques, they cannot serve as the basis for innovation at the local level or for research organized on nonproprietary models. One of the core insights driving the BIOS initiative is the recognition that when a subset of necessary tools is available in the public domain, but other critical tools are not, the owners of those tools appropriate the full benefits of public domain innovation without at the same time changing the basic structural barriers to use of the proprietary technology. To overcome these problems, the BIOS initiative includes both a strong informatics component and a fairly ambitious "copyleft"-like model (similar to the GPL described in chapter 3) of licensing CAMBIA's basic tools and those of other members of the BIOS initiative. The informatics component builds on a patent database that has been developed by CAMBIA for a number of years, and whose ambition is to provide as complete as possible a dataset of who owns what tools, what the contours of ownership are, and by implication, who needs to be negotiated with and where research paths might emerge that are not yet appropriated and therefore may be open to unrestricted innovation.
The licensing or pooling component is more proactive, and is likely the most significant of the project. BIOS is setting up a licensing and pooling arrangement, "primed" by CAMBIA's own significant innovations in tools, which are licensed to all of the initiative's participants on a free model, with grant-back provisions that perform an openness-binding function similar to copyleft./20 In coarse terms, this means that anyone who builds upon the contributions of others must contribute improvements back to the other participants. One aspect of this model is that it does not assume that all research comes from academic institutions or from traditional government-funded, nongovernmental, or intergovernmental research institutes. It tries to create a framework that, like the open-source development community, engages commercial and noncommercial, public and private, organized and individual participants into a cooperative research network. The platform for this collaboration is "BioForge," styled after Sourceforge, one of the major free and open-source software development platforms. The commitment to engage many different innovators is most clearly seen in the efforts of BIOS to include major international commercial providers and local potential commercial breeders alongside the more likely targets of a commons-based initiative. Central to this move is the belief that in agricultural science, the basic tools can, although this may be hard, be separated from specific applications or products. All actors, including the commercial ones, therefore have an interest in the open and efficient development of tools, leaving competition and profit making for the market in applications. At the other end of the spectrum, BIOS's focus on making tools freely available is built on the proposition that innovation for food security involves more than biotechnology alone. It involves environmental management, locale-specific adaptations, and social and economic adoption in forms that are locally and internally sustainable, as opposed to dependent on a constant inflow of commoditized seed and other inputs. The range of participants is, then, much wider than envisioned by PIPRA or the GCP. It ranges from multinational corporations through academic scientists, to farmers and local associations, pooling their efforts in a communications platform and institutional model that is very similar to the way in which the GNU/Linux operating system has been developed. As of this writing, the BIOS project is still in its early infancy, and cannot be evaluated by its outputs. However, its structure offers the crispest example of the extent to which the peer-production model in particular, and commons-based production more generally, can be transposed into other areas of innovation at the very heart of what makes for human development-the ability to feed oneself adequately.
PIPRA and the BIOS initiative are the most salient examples of, and the most significant first steps in the development of commons-based strategies to achieve food security. Their vitality and necessity challenge the conventional wisdom that ever-increasing intellectual property rights are necessary to secure greater investment in research, or that the adoption of proprietary rights is benign. Increasing appropriation of basic tools and enabling technologies creates barriers to entry for innovators-public-sector, nonprofit organizations, and the local farmers themselves-concerned with feeding those who cannot signal with their dollars that they are in need. The emergence of commons-based techniques-particularly, of an open innovation platform that can incorporate farmers and local agronomists from around the world into the development and feedback process through networked collaboration platforms-promises the most likely avenue to achieve research oriented toward increased food security in the developing world. It promises a mechanism of development that will not increase the relative weight and control of a small number of commercial firms that specialize in agricultural production. It will instead release the products of innovation into a self-binding commons-one that is institutionally designed to defend itself against appropriation. It promises an iterative collaboration platform that would be able to collect environmental and local feedback in the way that a free software development project collects bug reports-through a continuous process of networked conversation among the user-innovators themselves. In combination with public investments from national governments in the developing world, from the developed world, and from more traditional international research centers, agricultural research for food security may be on a path of development toward constructing a sustainable commons-based innovation ecology alongside the proprietary system. Whether it follows this path will be partly a function of the engagement of the actors themselves, but partly a function of the extent to which the international intellectual property/trade system will refrain from raising obstacles to the emergence of these commons-based efforts.
Access to Medicines: Commons-Based Strategies for Biomedical Research
Nothing has played a more important role in exposing the systematic problems that the international trade and patent system presents for human development than access to medicines for HIV/AIDS. This is so for a number of reasons. First, HIV/AIDS has reached pandemic proportions. One quarter of all deaths from infectious and parasitic diseases in 2002 were caused by AIDS, accounting for almost 5 percent of all deaths in the world that year./21 Second, it is a new condition, unknown to medicine a mere twenty-five years ago, is communicable, and in principle is of a type-infectious diseases-that we have come to see modern medicine as capable of solving. This makes it different from much bigger killers-like the many cancers and forms of heart disease-which account for about nine times as many deaths globally. Third, it has a significant presence in the advanced economies. Because it was perceived there as a disease primarily affecting the gay community, it had a strong and well-defined political lobby and high cultural salience. Fourth, and finally, there have indeed been enormous advances in the development of medicines for HIV/AIDS. Mortality for patients who are treated is therefore much lower than for those who are not. These treatments are new, under patent, and enormously expensive. As a result, death-as opposed to chronic illness-has become overwhelmingly a consequence of poverty. More than 75 percent of deaths caused by AIDS in 2002 were in Africa. HIV/AIDS drugs offer a vivid example of an instance where drugs exist for a disease but cannot be afforded in the poorest countries. They represent, however, only a part, and perhaps the smaller part, of the limitations that a patent-based drug development system presents for providing medicines to the poor. No less important is the absence of a market pull for drugs aimed at diseases that are solely or primarily developing-world diseases-like drugs for tropical diseases, or the still-elusive malaria vaccine.
To the extent that the United States and Europe are creating a global innovation system that relies on patents and market incentives as its primary driver of research and innovation, these wealthy democracies are, of necessity, choosing to neglect diseases that disproportionately affect the poor. There is nothing evil about a pharmaceutical company that is responsible to its shareholders deciding to invest where it expects to reap profit. It is not immoral for a firm to invest its research funds in finding a drug to treat acne, which might affect 20 million teenagers in the United States, rather than a drug that will cure African sleeping sickness, which affects 66 million Africans and kills about fifty thousand every year. If there is immorality to be found, it is in the legal and policy system that relies heavily on the patent system to induce drug discovery and development, and does not adequately fund and organize biomedical research to solve the problems that cannot be solved by relying solely on market pull. However, the politics of public response to patents for drugs are similar in structure to those that have to do with agricultural biotechnology exclusive rights. There is a very strong patent-based industry-much stronger than in any other patent-sensitive area. The rents from strong patents are enormous, and a rational monopolist will pay up to the value of its rents to maintain and improve its monopoly. The primary potential political push-back in the pharmaceutical area, which does not exist in the agricultural innovation area, is that the exorbitant costs of drugs developed under this system is hurting even the well-endowed purses of developed-world populations. The policy battles in the United States and throughout the developed world around drug cost containment may yet result in a sufficient loosening of the patent constraints to deliver positive side effects for the developing world. However, they may also work in the opposite direction. The unwillingness of the wealthy populations in the developed world to pay high rents for drugs retards the most immediate path to lower-cost drugs in the developing world-simple subsidy of below-cost sales in poor countries cross-subsidized by above-cost rents in wealthy countries.
The industrial structure of biomedical research and pharmaceutical development is different from that of agricultural science in ways that still leave a substantial potential role for commons-based strategies. However, these would be differently organized and aligned than in agriculture. First, while governments play an enormous role in funding basic biomedical science, there are no real equivalents of the national and international agricultural research institutes. In other words, there are few public-sector laboratories that actually produce finished drugs for delivery in the developing world, on the model of the International Rice Research Institute or one of the national agricultural research systems. On the other hand, there is a thriving generics industry, based in both advanced and developing economies, that stands ready to produce drugs once these are researched. The primary constraint on harnessing its capacity for low-cost drug production and delivery for poorer nations is the international intellectual property system. The other major difference is that, unlike with software, scientific publication, or farmers in agriculture, there is no existing framework for individuals to participate in research and development on drugs and treatments. The primary potential source of nongovernmental investment of effort and thought into biomedical research and development are universities as institutions and scientists, if they choose to organize themselves into effective peer-production communities.
Universities and scientists have two complementary paths open to them to pursue commons-based strategies to provide improved research on the relatively neglected diseases of the poor and improved access to existing drugs that are available in the developed world but unaffordable in the developing. The first involves leveraging existing university patent portfolios-much as the universities allied in PIPRA are exploring and as CAMBIA is doing more aggressively. The second involves work in an entirely new model-constructing collaboration platforms to allow scientists to engage in peer production, cross-cutting the traditional grant-funded lab, and aiming toward research into diseases that do not exercise a market pull on the biomedical research system in the advanced economies.
Leveraging University Patents. In February 2001, the humanitarian organization Doctors Without Borders (also known as Médecins Sans Frontières, or MSF) asked Yale University, which held the key South African patent on stavudine-one of the drugs then most commonly used in combination therapies-for permission to use generic versions in a pilot AIDS treatment program. At the time, the licensed version of the drug, sold by Bristol-Myers-Squibb (BMS), cost $1,600 per patient per year. A generic version, manufactured in India, was available for $47 per patient per year. At that point in history, thirty-nine drug manufacturers were suing the South African government to strike down a law permitting importation of generics in a health crisis, and no drug company had yet made concessions on pricing in developing nations. Within weeks of receiving MSF's request, Yale negotiated with BMS to secure the sale of stavudine for fifty-five dollars a year in South Africa. Yale, the University of California at Berkeley, and other universities have, in the years since, entered into similar ad hoc agreements with regard to developing-world applications or distribution of drugs that depend on their patented technologies. These successes provide a template for a much broader realignment of how universities use their patent portfolios to alleviate the problems of access to medicines in developing nations.
We have already seen in table 9.2 that while universities own a substantial and increasing number of patents, they do not fiscally depend in any significant way on patent revenue. These play a very small part in the overall scheme of revenues. This makes it practical for universities to reconsider how they use their patents and to reorient toward using them to maximize their beneficial effects on equitable access to pharmaceuticals developed in the advanced economies. Two distinct moves are necessary to harness publicly funded university research toward building an information commons that is easily accessible for global redistribution. The first is internal to the university process itself. The second has to do with the interface between the university and patent-dependent and similar exclusive-rights-dependent market actors.
Universities are internally conflicted about their public and market goals. Dating back to the passage of the Bayh-Dole Act, universities have increased their patenting practices for the products of publicly funded research. Technology transfer offices that have been set up to facilitate this practice are, in many cases, measured by the number of patent applications, grants, and dollars they bring in to the university. These metrics for measuring the success of these offices tend to make them function, and understand their role, in a way that is parallel to exclusive-rights-dependent market actors, instead of as public-sector, publicly funded, and publicly minded institutions. A technology transfer officer who has successfully provided a royalty-free license to a nonprofit concerned with developing nations has no obvious metric in which to record and report the magnitude of her success (saving X millions of lives or displacing Y misery), unlike her colleague who can readily report X millions of dollars from a market-oriented license, or even merely Y dozens of patents filed. Universities must consider more explicitly their special role in the global information and knowledge production system. If they recommit to a role focused on serving the improvement of the lot of humanity, rather than maximization of their revenue stream, they should adapt their patenting and licensing practices appropriately. In particular, it will be important following such a rededication to redefine the role of technology transfer offices in terms of lives saved, quality-of-life measures improved, or similar substantive measures that reflect the mission of university research, rather than the present metrics borrowed from the very different world of patent-dependent market production. While the internal process is culturally and politically difficult, it is not, in fact, analytically or technically complex. Universities have, for a very long time, seen themselves primarily as dedicated to the advancement of knowledge and human welfare through basic research, reasoned inquiry, and education. The long-standing social traditions of science have always stood apart from market incentives and orientations. The problem is therefore one of reawakening slightly dormant cultural norms and understandings, rather than creating new ones in the teeth of long-standing contrary traditions. The problem should be substantially simpler than, say, persuading companies that traditionally thought of their innovation in terms of patents granted or royalties claimed, as some technology industry participants have, to adopt free software strategies.
If universities do make the change, then the more complex problem will remain: designing an institutional interface between universities and the pharmaceutical industry that will provide sustainable significant benefits for developing-world distribution of drugs and for research opportunities into developing-world diseases. As we already saw in the context of agriculture, patents create two discrete kinds of barriers: The first is on distribution, because of the monopoly pricing power they purposefully confer on their owners. The second is on research that requires access to tools, enabling technologies, data, and materials generated by the developed-world research process, and that could be useful to research on developing-world diseases. Universities working alone will not provide access to drugs. While universities perform more than half of the basic scientific research in the United States, this effort means that more than 93 percent of university research expenditures go to basic and applied science, leaving less than 7 percent for development-the final research necessary to convert a scientific project into a usable product./22 Universities therefore cannot simply release their own patents and expect treatments based on their technologies to become accessible. Instead, a change is necessary in licensing practices that takes an approach similar to a synthesis of the general public license (GPL), of BIOS's licensing approach, and PIPRA.
Universities working together can cooperate to include in their licenses provisions that would secure freedom to operate for anyone conducting research into developing-world diseases or production for distribution in poorer nations. The institutional details of such a licensing regime are relatively complex and arcane, but efforts are, in fact, under way to develop such licenses and to have them adopted by universities./23 What is important here, for understanding the potential, is the basic idea and framework. In exchange for access to the university's patents, the pharmaceutical licensees will agree not to assert any of their own rights in drugs that require a univer- sity license against generics manufacturers who make generic versions of those drugs purely for distribution in low- and middle-income countries. An Indian or American generics manufacturer could produce patented drugs that relied on university patents and were licensed under this kind of an equitable-access license, as long as it distributed its products solely in poor countries. A government or nonprofit research institute operating in South Africa could work with patented research tools without concern that doing so would violate the patents. However, neither could then import the products of their production or research into the developed world without violating the patents of both the university and the drug company. The licenses would create a mechanism for redistribution of drug products and research tools from the developed economies to the developing. It would do so without requiring the kind of regulatory changes advocated by others, such as Jean Lanjouw, who have advocated policy changes aimed similarly to achieve differential pricing in the developing and developed worlds./24 Because this redistribution could be achieved by universities acting through licensing, instead of through changes in law, it offers a more feasible political path for achieving the desired result. Such action by universities would, of course, not solve all the problems of access to medicines. First, not all health-related products are based on university research. Second, patents do not account for all, or perhaps even most, of the reason that patients in poor nations are not treated. A lack of delivery infrastructure, public-health monitoring and care, and stable conditions to implement disease-control policy likely weigh more heavily. Nonetheless, there are successful and stable government and nonprofit programs that could treat hundreds of thousands or millions of patients more than they do now, if the cost of drugs were lower. Achieving improved access for those patients seems a goal worthy of pursuit, even if it is no magic bullet to solve all the illnesses of poverty.
Nonprofit Research. Even a successful campaign to change the licensing practices of universities in order to achieve inexpensive access to the products of pharmaceutical research would leave the problem of research into diseases that affect primarily the poor. This is because, unless universities themselves undertake the development process, the patent-based pharmaceuticals have no reason to. The "simple" answer to this problem is more funding from the public sector or foundations for both basic research and development. This avenue has made some progress, and some foundations-particularly, in recent years, the Gates Foundation-have invested enormous amounts of money in searching for cures and improving basic public-health conditions of disease in Africa and elsewhere in the developing world. It has received a particularly interesting boost since 2000, with the founding of the Institute for One World Health, a nonprofit pharmaceutical dedicated to research and development specifically into developing-world diseases. The basic model of One World Health begins by taking contributions of drug leads that are deemed unprofitable by the pharmaceutical industry-from both universities and pharmaceutical companies. The firms have no reason not to contribute their patents on leads purely for purposes they do not intend to pursue. The group then relies on foundation and public-sector funding to perform synthesis, preclinical and clinical trials, in collaboration with research centers in the United States, India, Bangladesh, and Thailand, and when the time comes around for manufacturing, the institute collaborates with manufacturers in developing nations to produce low-cost instances of the drugs, and with government and NGO public-health providers to organize distribution. This model is new, and has not yet had enough time to mature and provide measurable success. However, it is promising.
Peer Production of Drug Research and Development. Scientists, scientists-in-training, and to some extent, nonscientists can complement university licensing practices and formally organized nonprofit efforts as a third component of the ecology of commons-based producers. The initial response to the notion that peer production can be used for drug development is that the process is too complex, expensive, and time consuming to succumb to commons-based strategies. This may, at the end of the day, prove true. However, this was also thought of complex software projects or of supercomputing, until free software and distributed computing projects like SETI@Home and Folding@Home came along and proved them wrong. The basic point is to see how distributed nonmarket efforts are organized, and to see how the scientific production process can be broken up to fit a peer-production model.
First, anything that can be done through computer modeling or data analysis can, in principle, be done on a peer-production basis. Increasing portions of biomedical research are done today through modeling, computer simulation, and data analysis of the large and growing databases, including a wide range of genetic, chemical, and biological information. As more of the process of drug discovery of potential leads can be done by modeling and computational analysis, more can be organized for peer production. The relevant model here is open bioinformatics. Bioinformatics generally is the practice of pursuing solutions to biological questions using mathematics and information technology. Open bioinformatics is a movement within bioinformatics aimed at developing the tools in an open-source model, and in providing access to the tools and the outputs on a free and open basis. Projects like these include the Ensmbl Genome Browser, operated by the European Bioinformatics Institute and the Sanger Centre, or the National Center for Biotechnology Information (NCBI), both of which use computer databases to provide access to data and to run various searches on combinations, patterns, and so forth, in the data. In both cases, access to the data and the value-adding functionalities are free. The software too is developed on a free software model. These, in turn, are complemented by database policies like those of the International HapMap Project, an effort to map common variations in the human genome, whose participants have committed to releasing all the data they collect freely into the public domain. The economics of this portion of research into drugs are very similar to the economics of software and computation. The models are just software. Some models will be able to run on the ever-more-powerful basic machines that the scientists themselves use. However, anything that requires serious computation could be modeled for distributed computing. This would allow projects to harness volunteer computation resources, like Folding@Home, Genome@Home, or FightAIDS@Home-sites that already harness the computing power of hundreds of thousands of users to attack biomedical science questions. This stage of the process is the one that most directly can be translated into a peer-production model, and, in fact, there have been proposals, such as the Tropical Disease Initiative proposed by Maurer, Sali, and Rai./25
Second, and more complex, is the problem of building wet-lab science on a peer-production basis. Some efforts would have to focus on the basic science. Some might be at the phase of optimization and chemical synthesis. Some, even more ambitiously, would be at the stage of preclinical animal trials and even clinical trials. The wet lab seems to present an insurmountable obstacle for a serious role for peer production in biomedical science. Nevertheless, it is not clear that it is actually any more so than it might have seemed for the development of an operating system, or a supercomputer, before these were achieved. Laboratories have two immensely valuable resources that may be capable of being harnessed to peer production. Most important by far are postdoctoral fellows. These are the same characters who populate so many free software projects, only geeks of a different feather. They are at a similar life stage. They have the same hectic, overworked lives, and yet the same capacity to work one more hour on something else, something interesting, exciting, or career enhancing, like a special grant announced by the government. The other resources that have overcapacity might be thought of as petri dishes, or if that sounds too quaint and old-fashioned, polymerase chain reaction (PCR) machines or electrophoresis equipment. The point is simple. Laboratory funding currently is silo-based. Each lab is usually funded to have all the equipment it needs for run-of-the-mill work, except for very large machines operated on time-share principles. Those machines that are redundantly provisioned in laboratories have downtime. That downtime coupled with a postdoctoral fellow in the lab is an experiment waiting to happen. If a group that is seeking to start a project defines discrete modules of a common experiment, and provides a communications platform to allow people to download project modules, perform them, and upload results, it would be possible to harness the overcapacity that exists in laboratories. In principle, although this is a harder empirical question, the same could be done for other widely available laboratory materials and even animals for preclinical trials on the model of, "brother, can you spare a mouse?" One fascinating proposal and early experiment at the University of Indiana-Purdue University Indianapolis was suggested by William Scott, a chemistry professor. Scott proposed developing simple, low-cost kits for training undergraduate students in chemical synthesis, but which would use targets and molecules identified by computational biology as potential treatments for developing-world diseases as their output. With enough redundancy across different classrooms and institutions around the world, the results could be verified while screening and synthesizing a significant number of potential drugs. The undergraduate educational experience could actually contribute to new experiments, as opposed simply to synthesizing outputs that are not really needed by anyone. Clinical trials provide yet another level of complexity, because the problem of delivering consistent drug formulations for testing to physicians and patients stretches the imagination. One option would be that research centers in countries affected by the diseases in question could pick up the work at this point, and create and conduct clinical trials. These too could be coordinated across regions and countries among the clinicians administering the tests, so that accruing patients and obtaining sufficient information could be achieved more rapidly and at lower cost. As in the case of One World Health, production and regulatory approval, from this stage on, could be taken up by the generics manufacturers. In order to prevent the outputs from being appropriated at this stage, every stage in the process would require a public-domain-binding license that would prevent a manufacturer from taking the outputs and, by making small changes, patenting the ultimate drug.
This proposal about medicine is, at this stage, the most imaginary among the commons-based strategies for development suggested here. However, it is analytically consistent with them, and, in principle, should be attainable. In combination with the more traditional commons-based approaches, university research, and the nonprofit world, peer production could contribute to an innovation ecology that could overcome the systematic inability of a purely patent-based system to register and respond to the health needs of the world's poor.