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Bioaccess agreements – hot prospect or hot air?

Amanda Hawn

As biotechnology companies begin to resemble the internet companies of the 1990s in their prospects for unfettered growth, the issue of how to use that growth to benefit conservation and biodiversity is once again bubbling to the surface. Still, concepts such as "bioprospecting" and "bioaccess" agreements engender a fair share of skepticism on the part of companies, conservation groups, and communities in developing countries. As the debate once again heats up, the Ecosystem Marketplace explores a complicated and controversial issue and looks at the path ahead.

As biotechnology companies begin to resemble the internet companies of the 1990s in their prospects for unfettered growth, the issue of how to use that growth to benefit conservation and biodiversity is once again bubbling to the surface. Still, concepts such as "bioprospecting" and "bioaccess" agreements engender a fair share of skepticism on the part of companies, conservation groups, and communities in developing countries. As the debate once again heats up, the Ecosystem Marketplace explores a complicated and controversial issue and looks at the path ahead. In 1966, Thomas Brock pulled several microbial samples from a hot spring above Great Fountain Geyser in Yellowstone National Park. In his samples, Brock discovered bacteria that could tolerate higher heats than scientists previously had thought possible. Brock named his discovery Thermus aquaticus because of its affinity for hot water, but he might as well have called the microbe Thermus aurum, for – though he didn't know it at the time – Brock had mined something worth more than hot gold. In 1984 an enzyme called Taq polymerase was isolated from T. aquaticus. Taq polymerase, because of its ability to withstand the high heats at which chemical reactions take place most efficiently, has since become a staple of DNA labs everywhere. Biology, biotech, and forensic labs all use it to catalyze the polymerase chain reaction (PCR) that amplifies DNA samples so that they can be analyzed. Annual sales of Taq polymerase currently exceed $200 million every year and the number is expected to rise into the billions in the coming decades. Coulda. Shoulda. Woulda. Nothing drives home the value of an opportunity quite like the realization that it has been missed. Royalty-sharing battles are still raging in the court system over commercial rights to revenues generated by the sale of Taq polymerase, but regardless of their outcome, Yellowstone National Park won't see a lick of the profits from the enzyme's sale. In 1966, the concept of royalty sharing between natural protected areas and for-profit companies wasn't on the map. In the wake of Taq polymerase, however, conservationists have attempted to put it there. The idea of creating public-private partnerships to mine the uses of natural biota in non-invasive ways is an incredibly attractive one – at least in principle. Products derived from microbes found in the wild have already led to scientific breakthroughs in medicine; helping combat problems ranging from high blood pressure to cancer. Likewise, anti-microbials stand to provide a new line of defense against the many pathogens that are fast evolving immunities to traditional antibiotics. Currently, ten of the twenty-five best-selling drugs are derived from chemical compounds found in nature. Additionaly, some 5% of the value produced by global chemical production is already biotech-based and analysts predict that this percentage will double within the next decade. Meanwhile, in factories, newly discovered microbial enzymes could introduce significant efficiency gains and reduce pollution. In the chemical sector, scientists think that new bio-based products might soon make hazardous waste cleanup more affordable. Indeed, some advocates say that bio-based products stand to revolutionize everything from pesticides to plastics, generating billions of dollars of profits in the process. Clearly biologically-based products can be immensely profitable, but can they help support conservation and give a market value to biodiversity? These are the sorts of questions that many in biotech and in the conservation community are struggling to answer. For conservation organizations, royalty-sharing contracts on products derived from biodiversity prospecting (or "bio-prospecting") in the field represent an opportunity to raise a great deal of much-needed capital at very little cost. A prospect that -in the current era of cash-starved national parks and increasingly dire warnings about the need to conserve Earth's waning resources- sounds incredibly promising. Veterans who have waded into the field, however, warn that structuring equitable and profitable bioaccess agreements (as these agreements are now being called) is also incredibly tricky. "There is no simple formula," says Beth Burrows of the Edmonds Institute, a non-profit that has spent more than ten years looking at the issue. "It is really, really hard."

Hot prospect?

Bioprospecting has been a hot topic during the last year because of the emergence of industrial biotech, a field aimed at the manufacturing applications of bio-based enzymes. On a website that looks like something out of an adventure travel catalogue – khaki-clad, backpack-toting researchers are depicted walking into tropical forests – one biotech's tagline reads simply, "Evolving the best from nature." Further investigation, reveals that the company – San Diego based Diversa Corporation – is hoping to 'evolve' enzymes that will revolutionize the production of things like paper, textiles and petrochemicals. Could a tiny microbe capable of withstanding the incredibly intense heat of a deep-sea vent generate products to help dyed fabrics hold up better in the dryer? Might microbes found in highly acidic or basic environments generate enzymes to help clean up toxic wastes? These are the kinds of questions Eric Mather, the Vice President of Scientific Affairs at Diversa Corporation asks himself as he criss-crosses the globe – from the equatorial forests of Costa Rica to the frozen corners of Russia. The more unique an ecosystem, the more valuable it is to bio-prospectors like Mather. Which is why the Center for Reproduction of Endangered Species (CRES) at the San Diego Zoo caught the globetrotting businessman's eye. "After flying around the world, I would take my children to the San Diego Zoo when I came home, and think, 'It's all here. Hard to find things like endemic plants, endangered species…they're all right here.'" In a family trip to the zoo, an unusual partnership between a publicly traded biotech company and a non-profit zoo thus took root. As part of their collaboration, zoo veterinarians have begun taking small, non-invasive microbial samples from the endangered species under their care. Diversa's scientists then compare these samples with those collected from the same species in the wild. "Here at the San Diego Zoo," says Oliver Ryder, the PhD geneticist in charge of CRES, "we hope that this information will help us improve the health of animals in our care." For instance, the Douc Langur (a small white-cheeked monkey from Vietnam) has a sensitive stomach when raised in captivity but not, apparently, when it lives in the wild. Through a comparative study of the microbial stomach contents of captive and wild langurs, researchers are hoping to identify the 'good' bacteria that keep the digestive systems of langurs humming along happily in the wild. From the zoo's perspective, the hope is that, upon discovery, the beneficial bacteria in wild langur stomachs might be used to quiet the upset stomachs of their counterparts at the zoo. From Diversa's perspective, the hope is that it might lead to products of much broader utility; feed additives that cold be used for cattle, chickens, and maybe even to quiet the upset stomachs of a very different primate. The case of the Douc Langur represents more than a potentially happy animal story wrapped around a potentially lucrative business deal. Now that Diversa and the San Diego Zoo have signed a bioaccess agreement, it might also be a potentially important conservation model, one that allows society to assign value to biodiversity in new ways and places. The partnership is illustrative of the kind of innovative thinking that could lead to mutually beneficial relationships between conservation groups and biotechnology companies. In exchange for sampling access to the endangered species at CRES, Diversa agreed to give the zoo a slice of the pie should their research generate commercially successful products. "We expect that discoveries from our collaborative research will contribute to Diversa's product pipeline," says Diversa's President, Jay Short, "which can also provide financial support to the San Diego Zoo's conservation efforts." Diversa is not alone in its attempts to discover commercial gold in microbes collected from the far-flung corners of the globe. Genencor and Novozymes are among other big names in the emerging field and, according to a recent projection by McKinsey & Co., industrial biotech could generate total values as high as $12 billion a year by 2010. In their race to discover the next Taq polymerase, companies like Genencor, Novozymes and Diversa are anxious to structure bioaccess agreements with governments, universities and parks throughout the world. "Diversa hopes to have revenues of over one hundred million dollars by 2010, which would result in millions of dollars of annual royalties being paid toward conservation efforts," says Mather. So why aren't conservation organizations jumping at the opportunity?

Once bitten…

In fairness, some conservation organizations, CRES among them, are entering into bioaccess agreements with industrial biotech companies – Diversa has bioprospecting projects underway in places as varied as Ghana, Iceland and Australia. Many international conservation biologists, however, remain wary of bioprospecting's golden prospects. Their reticence is due, in large part, to the fact that the conservation community has danced this dance before, not with industrial biotechs, but with big pharmaceutical companies. After pharmaceutical companies hit several jackpots by betting on natural products in the 1980s (Sandimmum, an immunosuppressant, and Taq polymerase among them), international policy-makers put their heads together and came up with a framework designed to further drug-discovery in natural areas while generating conservation funds for developing countries. The results of this thinking is partly enshrined in the Convention on Biological Diversity, a document signed amid much fanfare at the 1992 Earth Summit in Rio de Janeiro. The Convention's 188 signatories had high hopes that it would pave the way for a proliferation of profitable and equitable bioprospecting deals around the world. By the millennium, however, few profitable partnerships had been formed and the last few years have seen most major drug companies – including Merck, Monsanto and Bristol Myers Squibb – scaling back their hunt for new natural products. Why didn't benefit sharing between drug companies and natural areas work better in the 1990s? This becomes an incredibly important question as local communities, commercial enterprises and natural protected areas head into what could become round two of the bioprospecting bonanza.

What Went Wrong?

Perhaps the biggest obstacle to more widespread adoption of bioprospecting deals during the last decade has been the reluctance of all parties to confront and overcome their historical mistrust of one another. As pointed out by a recent article in Nature, "The richest biodiversity is found in exotic but sometimes lawless locales. Its study requires not just scientific perseverance but the construction of an intricate web of relationships with local people, landowners and government officials." Generally speaking, most of the raw materials (i.e. biota) involved in a bioprospecting deal are located in developing regions of the world. Most of the research and technological tools required to discover and develop these raw materials, however, are located in wealthier, more developed nations. There is, needless to say, a long history concerning the appropriation of the natural resources of the tropics by colonial powers. Throughout history, Western powers have repeatedly turned raw materials from the Third World into big profits in the First, with little concern for the prosperity or human rights of people living in the areas from whence the natural resources originated. Thus, as skeptics of bioaccess agreements point out, there is a justifiable mistrust of multi-national corporations on the part of many local communities. "The concern with bio-prospecting," says Burrows, "is that the people who consider themselves to be the stewards of the biodiversity in a region often aren't considered." Relations between scientists and local communities also need to be improved. By all accounts, the huge majority of scientists (both commercial and academic) abide by rules governing the collection and exportation of specimens. "I work in Yellowstone National Park, a place where caution is applied to the issuance of research permits," says John Spear, a microbiologist at the University of Colorado. "When we sign them, we agree to notify and enter into royalty agreements with the Park Service, should we find something of commercial value. I, and every researcher I know, believes in and abides by this." Unfortunately, it is the rare exception to this rule that often leaves the strongest impression in the minds of skeptics. Three botanists, for instance, were caught trying to smuggle medicinal plants out of the Philippines in 2000. Masquerading as ecotourists, they did little to shore up the confidence of locals in the integrity of international scientists. Their exploits, while hardly representative of most researchers, are also illustrative of how difficult it can be to regulate the flow of flora and fauna across the borders of a park where multiple actors – ecotourists, researchers, bioprospectors – are engaged in similar activities at the same time. And if monitoring the traffic of plants and animals is difficult, monitoring the traffic of microbes is even tougher. "It is pretty easy to get a lot of information from microbes in any environment. Some of that, particularly with the ability of genomics, including environmental genomics, will have good commercial value. I think bioprospecting for microbes is hard to monitor, because we only need gram amounts of samples with which to pull DNA from," says Spears. The authors of the Convention on Biological Diversity (CBD) were not unaware of concerns about equity, cultural sensitivity and enforcement in the early 1990s. Indeed, the CBD outlines a broad legal framework for addressing these issues. Specifically, it establishes the sovereign rights of states over their natural resources and requires that parties respect the knowledge of local communities while encouraging the equitable sharing of any benefits derived from biodiversity. In 2002, signatories to the CBD also adopted a voluntary set of guidelines – the Bonn Guidelines on Access and Benefit-Sharing – to inform partnership agreements between bioprospectors and natural area managers. The international legal framework outlined by the CBD and the Bonn Guidelines provides an important base around which national and local institutions can begin to structure relationships with bioprospectors. To date, however, the reality for many park managers dealing with bioprospectors on the ground has been one characterized by too little direction and too little time to ensure that proper contracts are in place before sampling begins. A recent report on Access and Benefit-Sharing (ABS) policies by the United Nations University Institute of Advanced Study acknowledged that, "Over-worked, under-funded and often beleaguered protected area managers have understandably been slow in taking up ABS issues, which are not only complex but often also contentious." In the absence of clearly defined national policies regarding bioprospecting, ad hoc regulatory agreements have cropped up in a number of countries. The result is a tangle of legislation and bureaucracy that makes bioprospecting difficult for parties who want to play by the rules and be ensured of their commercial rights at the end of the day. To take but one example, the rules regulating bioprospecting in South Africa range from an absolute ban on such projects in the Western Cape Province to the systematic facilitation of them in KwaZulu-Natal. As developing nations and indigenous peoples became savvy about their rights, the demands on companies interested in bioprospecting grew during the 1990s. The clarity of national legislative policies concerning bioaccess agreements, unfortunately, failed to keep pace. As a result, the risks and the transaction costs associated with bioprospecting have remained high for pharmaceutical companies throughout the last decade, while the potential benefits of bioprospecting ventures have continually dropped. "Companies need incentives, but those incentives are being undermined," says Lila Feisee of the Biotechnology Industry Organization in Washington DC. "When risks outweigh the benefits, companies will do something else."

Looking Ahead

So what lessons does the last decade of bioprospecting hold for those looking ahead to the next suite of deals? Clearly, the answer isn't to backtrack on the rights of indigenous people or the equitable sharing of benefits between the wealthiest and poorest nations. Tinkering with the other side of the equation – the risks associated with bioprospecting – seems the better option. The task of bioprospecting advocates in the 21st century, then, will be to come up with a coherent set of laws to reduce the transaction costs and legal uncertainty of bioaccess agreements. Important progress has already been made in this area. The National Institute of Biodiversity (InBio) in Costa Rica, for instance, demands a 'conservation overhead' payment from any commercial partners with whom it works. Fifty percent of all royalties earned by commercial bioprospectors, in addition to ten percent of all bioprospecting budgets, go to the country's Ministry of Environment and Energy. Costa Rica's bioprospecting laws couldn't be much easier to interpret, and, interestingly, companies seem to be responding to them positively. Some 2.7 million dollars have been earned for conservation efforts in Costa Rica through the InBio program since 2000. Driven by such success stories, over fifty governments are now in the process of drafting or enacting legislation concerning biodiversity access agreements. Earlier this year in Kuala Lumpur, the 188 backers of the Convention on Biological Diversity agreed to talk about a binding set of international rules to govern bioprospecting. Experts culled from this group had their first meeting just a couple of weeks ago in Montreal. One attendee described the discussions as 'exciting,' and the fact that they were taking place, as 'hopeful.' The race to streamline the legal process governing bioaccess agreements has begun in earnest, and, importantly, it has begun at both the international and local levels. In the end, the reality is that if frustrated for-profit companies, skeptical conservationists and wary local communities can all be brought back to the table by a coherent framework of laws, bioprospecting partnerships still have the potential to shore-up conservation efforts throughout the world. Implementing the provisions laid out on paper will probably continue to be difficult for many of the reasons discussed, but, as Thomas Edison once observed, "Opportunity is missed by most people because it is dressed in overalls and looks like work." So perhaps the fact that interested parties have begun the uphill climb is, as much as anything, a sign that bioprospecting may yet prove a golden opportunity for all involved. By insisting on clarity and expediency as well as equity -and thereby keeping risks and transaction costs at a minimum- conservationists, captains of industry and members of local communities might yet succeed in saving priceless biodiversity by taking into account its inestimable value. Amanda Hawn is a regular contributor to The Ecosystem Marketplace. She is an evolutionary biologist and science writer currently living in Minneapolis who has written about science and the environment for a variety of publications including The Economist, Sierra Magazine, The St. Paul Pioneer Press, and others. She can be reached at athawn@alumni.princeton.edu

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