If a draft protocol on access and benefit-sharing of genetic resources is adopted in Japan in October, there will finally be an international law to prevent corporations from commandeering biological resources and traditional knowledge for their own profit, without sharing it with the community that holds the knowledge
In July 2010, the Convention on Biological Diversity’s Ad Hoc Open-ended Working Group on Access and Benefit-sharing, with representatives of governments, industry and community organisations, will meet in Montreal, Canada. The working group will be going through the text of a draft protocol with legally binding rules on access and benefit-sharing of traditional knowledge and genetic resources. If the protocol is finalised, it will be put up for adoption at a meeting in Nagoya, Japan, in October.
This could be of great importance to developing countries like India which are rich in biological resources and traditional knowledge and must wage a constant battle against their appropriation.
Take the example of the Ashwagandha plant that has been used for centuries in Ayurveda, Siddha and Unani medicine to treat various conditions including stress, heart problems, diabetes and depression.
On March 25, 2010, the European Patent Office dismissed an application from the US-based Natreon on the medicinal properties of the plant Withania somnifera. That’s the Latin name for Ashwagandha. Natreon had submitted the application in 2006 claiming that it had developed a “novel method” to treat or manage a number of stress-related conditions.
The patent application for Ashwagandha may have failed in Europe but the United States Patent Office has already granted Natreon a patent on a number of Withania-based products, including Sensoril, an extract of Withania somnifera, for stress-related disorders. On its website, Natreon advertises that it uses Ayurvedic medicine to offer “unique, patented ingredients created after exhaustive research, trial and development”. It claims to have “a broad portfolio of products and technologies, with compelling, intellectual property, that can serve unmet nutritional supplement, functional food, and pharmaceutical market needs.”
From India alone, more than 2,000 formulations based on our traditional medicine systems have been awarded patents in the United States or in the European Union. They have included the use of brahmi for memory, ginger for obesity, citrus peel extract for skin diseases, and mustard for the stomach – home remedies that are part of our kitchen medicine cabinets and our cuisines.
The government managed to get some patents revoked, such as on neem and haldi, but it took many years and millions of dollars.
In some cases the medicinal use of plants is public knowledge in the community where the plant grows. It may be incorporated into diets and home remedies. In other cases, this knowledge is controlled by a family or other group in the community and passed on to those designated to receive it. In general, unwritten guidelines exist for the use of certain natural resources and the related traditional knowledge: they are meant to be utilised for the benefit of the community. These guidelines have also ensured that resources such as, for example, medicinal plants, are nurtured and harvested wisely.
Such an understanding is fast becoming meaningless as “biopirates” -- corporations, mostly in developed countries -- appropriate traditional knowledge and genetic resources related to this knowledge, mostly in developing countries or poor communities within rich countries, for commercial gain.
The assault is manifold. Traditional knowledge has been used to develop drugs and other formulations without the awareness and consent of the community where this knowledge originated. The intellectual property rights system has been challenged for giving monopoly control over knowledge of public importance. In the case of traditional knowledge, business interests seek exclusive rights to knowledge that is not “novel”. Though novelty is a criterion for patentability, much of traditional knowledge is not documented, so the holders of traditional knowledge may lack proof that it is, in fact, “nothing new”. This deprives those who developed the knowledge in the first place. Finally, once a plant or other natural resource is found to have commercial value, companies have taken control away from those who used that resource, sometimes exploiting it to the point of extinction.
To take just one example, the cancer drug paclitaxel is based on an extract from the Pacific yew. Now, the Pacific yew has been used for centuries by the native north Americans for medicinal and other purposes but some years ago it shot into the news as a wonder anti-cancer drug. The US government’s National Cancer Institute apparently identified its anti-cancer properties through “random screening”. Once paclitaxel was developed, the tree was harvested in such large amounts that it came close to extinction before an alternative source was found for the drug’s active ingredient.
When a biological resource – whether it is the Pacific yew, Ashwagandha or any other of the thousands of sources of medicines – is identified, corporations move in to take control. For example, the US company Maypro is “one of the leading international resources of raw materials” whose “premium quality, competitive pricing, research/marketing and worldwide access” enables it “to meet the changing demands of our customers and the global marketplace”. Maypro provides raw materials for companies like Natreon.
Convention on Biological Diversity
The stated aims of the Convention on Biological Diversity (CBD) are the conservation of biological resources, their sustainable use and fair sharing of the benefits. Since it was put forward in 1992, the CBD has been adopted by 193 countries.
One of the tools described in the CBD is the access and benefit-sharing agreement. The principle behind this agreement: countries and communities have rights over the knowledge they have produced and the resources they nurture. So these resources and this knowledge may be used by others only with the community’s “free and prior informed consent”. That means the terms and conditions of access to, and use of, these resources, and the plans for benefit-sharing, must be agreed upon in advance.
However, while the CBD calls for such agreements, they are not at present legally binding at the international level.
If the draft protocol is adopted in Japan in October, we will finally have an international law to prevent corporations from swooping into countries rich in biological resources and traditional knowledge in order to commandeer these resources for their own profit.
This has been a long-standing demand of developing countries from Africa, Asia and Latin America, all rich in biologically diverse resources and traditional knowledge and all vulnerable to biopiracy. An international, legally-binding document is necessary because national laws are of little use once knowledge and/or resources are taken out of the country. Incidentally, Gopakumar of the Third World Network notes that though the US is not party to the CBD, it is part of these negotiations, possibly to influence them and ensure that standards for benefit-sharing are acceptable to them.
So it will not be easy to finalise the protocol. But even if the meeting produces a flawless document, the actual application of this principle is shaped by social and economic inequities at the national and international levels, and by the vagaries of the market.
India’s response to biopiracy
The government of countries like India and China have taken action to stop the growing number of patents derived from traditional knowledge.
In 2001, the Indian Centre for Scientific and Industrial Research set up a traditional knowledge digital library and started documenting the use and method of preparation for more than 220,000 formulas based on translations from texts of ayurveda, unani, siddha and yoga. These formulas are licensed as “public knowledge” that by definition cannot be patented. The digital library can also be used to challenge patents and this has led to the withdrawal of some 10 patent claims for products or processes that already existed in traditional medicines.
This comprehensive response is possible because ayurveda, siddha, unani and yoga have government support – teaching institutions, professional associations, regulatory bodies, services such as hospitals, and manufacturing facilities for their products. Government money will be spent on such projects.
TC James of the Delhi-based Research and Information System for Developing Countries pointed this out when he spoke on India’s actions to prevent biopiracy. He was addressing a meeting at the University of Melbourne, in March, on pharmaceutical innovation and access to lifesaving medicines.
Experiments in benefit-sharing
India is also where the Kani tribals in Kerala negotiated what is described as a pioneering benefit-sharing agreement in traditional knowledge.
The Kani people, numbering about 17,000, live in small settlements inside the forests of Kerala and make a living selling crafts and certain forest produce, with occasional employment. Knowledge of traditional medicine is held by certain families within the tribes and passed down within these families.
In 1987, a group of Indian scientists, with the government’s Tropical Botanic Gardens and Research Institute (TBGRI) and other organisations, hired Kani guides for a botanical expedition in the forest. They noticed that the guides were able to walk for much longer periods without becoming exhausted and were curious to find out why this was so. After much persuasion the guides divulged their secret: the fruit of a plant, trichopus zeylanicus or arogyapacha. Arogyapacha grew wild deep in the forest and was used by the Kani tribe for various health purposes including staving off fatigue.
After obtaining this information from their Kani guides, scientists at the TBGRI developed ‘Jeewani’. This was a standardised formulation based on the Kanis’ traditional knowledge using the leaves (rather than the fruit) of arogyappacha in combination with other ingredients. In 1995, the TBGRI obtained a process patent on Jeewani. It gave a seven-year license to a private company, Arya Vaidya Pharmacy, to produce the drug in exchange for a license fee of Rs 10 lakh and a 2% royalty on profits.
The TBGRI chose to share these benefits equally with the Kani. But they had no legal obligation to do this, as the agreement was made before India enacted the Forest Rights Act in 2006 and the Biological Diversities Act in 2002; these recognise the rights of forestdwellers to community knowledge and the related natural resources such as forest produce. A registered trust called the Kerala Kani Samudaya Kshema Trust was formed and the fees and royalties were deposited in the trust’s bank account. TBGRI also trained the Kani to cultivate the plant for sale to the Pharmacy and they were given small grants for this purpose. The institute received an award for its benefit-sharing agreement and a portion of this money went to the trust. Production started on the new drug and the Kani got what seems to be a very fair deal for sharing their knowledge.
Problems cropped up following this landmark agreement. Some of the Kani tribe felt that the negotiations had not involved all its members and the benefits of the agreement were not shared equally. (For reasons unclear, the Trust made large payments to the three informants who revealed the plant’s special qualities to the scientists. It would be interesting to know more about what motivated three Kani guides to reveal a secret known only to a few within their community to outsiders.) The actual gains were a few lakh rupees and the trust soon used up this money. The forest department disputed the right of the Kani to cultivate and harvest the plant, and the supply of raw materials slowed down. Meanwhile arogyapacha plants were smuggled out of the forest, possibly for cultivation elsewhere. TBGRI did not seek a product patent on the formulation. Eventually, a US-based company obtained trademark rights to a similar name, Jeewani Jolt, and started marketing a product with the same ingredients as Jeewani. The Arya Vaidya Pharmacy has reportedly stopped production after its licensing agreement with TBGRI expired, one reason being the shortage of raw materials. This also put an end to royalties for the Kani trust. Negotiations are reportedly on with a government unit to restart production and marketing under a new agreement with an increased license fee.
An assault on those who cannot fight back
Still, the Kani-TBGRI agreement is viewed as fair. It was initiated by the scientists, and the benefits were shared equally. This is at least partly because it had government support. But it is more often the case that communities with traditional knowledge of value to the pharmaceutical industry are so impoverished and otherwise marginalised that they are unable to fight for their rights. Moreover, government agencies may actually collaborate with private parties in the theft of knowledge.
At the Melbourne meeting, speakers from Australia, New Zealand and South Africa reported on the assault on the medicine systems and resources of communities in their countries by the pharmaceutical industry. This is often with the support of the government.
Australian activist Jack Beetson spoke on how the indigenous people all over the world “have been marginalised, had their knowledge exploited and generally been ripped off of their inherent native title rights for the financial and health benefit of others.” Ethical guidelines for research and the commercial exploitation of research findings have been violated. Communities that have already been impoverished economically and in every other way do not have the resources to do anything but watch helplessly as drug companies profit from the knowledge that has been theirs for centuries. But sometimes agreements are made, with or without prior informed consent.
Access and benefit-sharing agreements
The San people in southern Africa negotiated an agreement with the South African government’s Centre for Scientific and Industrial Research for a share of the benefits from an appetite suppressant developed from their traditional knowledge of the Hoodia cactus. While the stories of the San and the Kani have been told differently – the Kani agreement is spoken of as a landmark and the San agreement in terms of its challenges – many of the problems highlighted in the story of the San people and the Hoodia cactus also resonate in the case of the Kani tribes and arogyapacha.
The San “occupy an unchallenged niche as the poorest of the poor” in southern Africa, according to Roger Chennells, a South Africa-based lawyer who spoke on the San Hoodia case at the Melbourne meeting. Some 300,000 of these nomadic hunters and gatherers once lived across central and southern Africa. They have been hunted down and killed, and their land and means of survival have been taken away from them. Today barely 100,000 survive in settlements in the region.
As hunters and gatherers, the San had knowledge of the plants in the region. One of these is leaves of the Hoodia cactus. The thirst and appetite suppressing properties of this cactus were among its many uses that were common knowledge among the San.
Starting in the 1960s, the South African government’s Centre for Scientific and Industrial Research worked on developing a formulation extracted from the Hoodia cactus for use as an appetite suppressant. This research was conducted in secrecy.
In 1995, the CSIR applied for and received a patent for the appetite suppressing qualities of the cactus. In 1998 it signed a deal with a drug company, Phytopharm, to develop and market an anti-obesity product, and the company sublicensed this to Pfizer for commercialisation.
In 2001, it became known that the drug was in clinical trials and this was reported widely in the media. When asked why the San had not been consulted and informed of the research, and their consent taken, the CSIR initially stated that the San were not approached because they were extinct. It was eventually compelled to negotiate a benefit-sharing agreement with the San.
The matter was taken up by the Working Group of Indigenous Minorities in Southern Africa, an organisation fighting for indigenous people’s rights in the region. WIMSA assigned to the South African San Council the responsibility of negotiating with the CSIR.
At the conclusion of negotiations, the CSIR had acknowledged publicly that the knowledge for the appetite suppressing properties of the Hoodia came from the San. The CSIR agreed to pay 6% of its royalties and 8% of “milestone payments” to a trust formed by the San Council. The San Council also signed deals with growers’ associations to control the sale of the plant and ensure that the San benefited from all such sales.
An appetite suppressant has unlimited commercial potential on the international market. It was entirely possible that the San would go from extreme poverty to relative prosperity, due to their knowledge of the Hoodia cactus.
But these negotiations were taking place in a larger market environment. The publicity about Hoodia’s properties led to a mini industry of nutritional supplements labelled as containing the cactus. A black market in Hoodia sprung up and the cactus was harvested and smuggled out of the country in large quantities. Someone was making money, but not the San. Pfizer withdrew from the agreement with CSIR. Another drug company, Unilever, was approached but then dropped out.
By this time, the San trust received a total payment of 569,000 Rand (about Rs 36 lakh).
Lessons from the San Hoodia case
The challenges of benefit sharing agreements are discussed in Indigenous peoples, consent and benefit sharing: lessons from the San Hoodia case. The papers in this book are edited by, Rachel Wynberg, Doris Schroeder and Roger Chennells, social scientist, philosopher and lawyer, respectively. The San Hoodia case is compared to others in Namibia, Botswana, India, the Philippines, Australia, Canada and Mexico, by academicians and activists in these countries. The writers describe the interactions between indigenous people, industry and the government, in various settings, and discuss the concerns that need to be addressed in order that benefit sharing agreements truly share benefits.
The case studies highlight the complexities of implementing benefit-sharing agreements, the grey areas and the questions that will not be easily resolved. Who has rights over the knowledge and resources? Whose consent should be sought, and who should be involved in negotiations, when the knowledge is held by some people within a group, or by a large and dispersed group, or possibly many groups in different countries? How are agreements to be made involving many countries, possibly with conflicting laws and policies on the issue? What can be done to help representatives of small, impoverished communities negotiate fairly with powerful companies? Will the benefits of such agreements reach all those with a right to them? What should be done to ensure that communities have the skills to administer trusts and distribute the benefits in a fair manner?
The stories also highlight the fact that negotiations for access and benefit-sharing are conducted between unequal parties. The communities from whom knowledge and resources are taken do not have the material resources and the necessary skills to strike a fair bargain. Their opponents are wealthy corporations which are going to get what they want – the only question is when and for how much. The pace of negotiation is set by the companies and the community is always under pressure to arrive at an agreement fast. They may see negotiation as an opportunity to receive some payment for what is going to be taken away from them anyway. In any case, they live in conditions that rule out “free and prior informed consent”.
In some of the case studies in this book, the countries had laws preventing the takeover of indigenous people’s land without their consent – but the government has not enforced the law, forcing people to organise and protest. Elsewhere, innumerable benefit-sharing agreements have had no impact on the conditions of indigenous people.
Benefit-sharing agreements are sometimes viewed as an opportunity to improve the conditions of a community through “welfare schemes” such as health services, education trusts and other community development projects. But this ends up absolving the state of its responsibility –to use public resources and provide its people with education, healthcare and opportunities for a livelihood – a responsibility that it does not fulfil. No benefit-sharing agreement can relieve the government of this responsibility. Nor can they compensate communities who have suffered decades of injustice, who have been impoverished and marginalised with state support.
In any case, the benefit-sharing agreements have yielded small amounts so far. And once the benefit-sharing agreement ends, or the patent expires, the community is back to where it was.
One of the most important questions is whether a community’s traditional knowledge should be treated as a commodity that can be sold, bought and controlled. Can knowledge be owned? Can something that is not “owned” be sold?
Some have argued that by signing an agreement with TBRGI, the Kani accepted the notion that traditional knowledge could be patented. Some of the Kani reportedly questioned the patenting of their knowledge.
The same question faced the San. Should they challenge the CSIR’s patent application? Or should they fight for a share in the profits? There were different opinions on this matter and some discussion went into arriving at a decision, said Roger Chennells who represented the San Council in negotiations with the CSIR. Interviews with members of the community revealed that while most men were opposed to patenting common knowledge, women were more likely to state that the money from a benefit-sharing agreement could be used to educate their children and give the community a better future. The benefit-sharing agreement was viewed to some extent as a way for the San to pull themselves out of extreme poverty. Another view might be that it would be impossible to stop the patent application; the best one could do is to get a share of the profits.
In fact, the comments in the interviews seem to sum it all up. Whatever happens at the July and October meetings on access and benefit-sharing, communities like the San and the Kani are negotiating “benefit-sharing agreements” with their backs to the wall.
Acknowledgments: The Melbourne meeting was part of a project on pharmaceutical innovation and access to life-saving medicines. The project is supported by a grant from the Commonwealth of Australia under the International Science Linkages Programme. Sandhya Srinivasan attended the meeting at the invitation of the organisers who paid for her travel and stay.
Infochange News & Features, June 2010