By : Dr. N.S. Hemam
The ongoing 'Saikot Cancer Medicine' saga has raised hopes for many terminally ill patients for a new beginning and at the same time it has also raised many concerns on the management and proprietary rights of such traditional knowledge practices and bio-resources. Sandwiched between these two extremes is the lack of educated judgment or the absence of it among desperate users and a stoic silence from the state administration. A handful of individuals, researchers, intellectuals and interest groups have however begun to raise, discuss and investigate the matter at different levels, but things have not changed much and no concrete steps are visible on the ground to ameliorate the concerned issues.
The issues and concerns could be of many natures, depending upon one's interest and affiliation – to a public health administrator, it could be the process of making, quality control and legality of the 'medicine' itself; to an innocent patient, it could be a matter of well being and ill health; to a researcher, it could be a lifetime opportunity to work on a challenging prospect; to an environmentalist, the possible threat of misuse and overexploitation of the plant resources leading to extinction; to an intellectual, it could be a threat of bio-piracy and misuse and misappropriation of traditional knowledge systems; to an entrepreneur, it could be an opportunity to surge his/her business enterprise; and to the practitioner(s)/knowledge holder(s), it could be one way of serving people or earning a livelihood. Can we strike a balance among all these interrelated and interdependent but not necessarily mutually compatible factors? We are in desperate need of a common platform to make a beginning.
There is no magic bullet; we have to look for means and ways to come up with solutions acceptable to the local people and at the same time also make sure that they do not go against the established norms and guidelines at the local and state/national level. It is also high time that the first priority is given to the interest of the knowledge holder(s), for too long we have ignored and taken for granted that such knowledge as an open source (free) knowledge. Just think of the multi-billion dollar pharmaceutical industry in the world – according to WHO estimates, more than 70% of the compounds used in allopathic (modern) medicine originate from the knowledge of folk medicine or traditional knowledge systems. What have these practitioners or traditional knowledge holders received in return? NONE. In our own backyard, let's be honest and reflect upon the number of doctoral works, dissertations, research and academic papers produced every year based on such knowledge systems and generosity of such people; is there any instance where any of the knowledge holders/providers being given authorship or due share? NONE.
The 'Siakot Cancer Medicine' has given us the opportunity to discuss and deliberate on certain issues which are of prime importance and immediate concern to all of us. Irrespective of our difference of opinions, interest and affiliations, we all need to initiate a common effort to resolve these pressing issues – 1) Public health concerns and legality of the practice; 2) IPR issues Scientific validation; and 3) Benefit sharing and business opportunities. In this age of information technology and bio-piracy, these are the issues likely to come up in the near future as more and more resources (knowledge and biological) become easily accessible. If the triumphs and tribulations of 'Saikot Cancer Medicne' led to a healthy dialogue and mass public awakening on such dormant issues and formulation of a state policy towards management and scientific investigation on traditional knowledge systems, it would have served more purpose in the long run and go down as a landmark turning point in the way we look and treat traditional knowledge systems, regardless of the merit of the said medicine. (The efficacy and novelty of the medicine will not be part of this discussion).
1. Public health concerns and legality of the practice
Indeed it is of great concern and interest, based on the few reports available and personnel visits, that the open-air processing unit may not be the best and most hygienic way to manufacture the medicine. It is often reported that "the water source is also a suspect", not to speak of the primitive mortar and pestle used for grinding the leaves and other accessories used for treatment and distribution. What is more disturbing is the mushrooming of many more vendors selling the medicine in and around the village, and no one has any knowledge on how these vendors are preparing the medicine?
It is high time that an acceptable minimum quality control is maintained all across. The unfortunate part is that these methods and procedures are text-book materials; one can easily find anywhere at any time. The standardized extraction machineries wouldn't cost much and can easily be procured at any time. This would not only ensure standardized quality but also make the medicine more hygienic/safe. A conservative estimate suggests that at any given day more than 50 thousand people may be consuming the medicine; the number may be growing everyday. What if anything goes wrong? There were sporadic instances of contamination, hospitalization after consumption of the said medicine. Who would be liable in the case of an unfortunate fatality?
Other concern is that the said plant has completely been exhausted from the surroundings; therefore it is being brought in far away places like Myanmar (Burma) and other away districts of Manipur. With more than 30 similar species with minor local variations, it would be a tough call to distinguish them. Many of them have similar features and characteristics, and then there is every possibility of mixing of other plants of the same family inadvertently by innocent collectors or purposely by unscrupulous collectors to make some quick bugs. Such instances have already been reported from the village.
Is there any way out? Yes, there is. With little investment of time and money, one could easily overcome these shortcomings. Irrespective of the efficacy and high demand of the medicine, we need to get the basics right – there ought not to be any compromise on such fundamentals. If the practitioner(s) has problem in sourcing the fund locally or at the state level, which I believe is not the case, there are other possible sources at the central level. National Innovation Foundation (NIF), under Department of Science and Technology, GOI, is one of the organizations which regularly provide such support or the Science and Society Programme of Department of Science and Technology.
Can people make the medicine and distribute? The answer is 'NO' and 'YES'. There are stringent guidelines and regulations to manufacture drugs (allopathic). If one goes by the book, no one can manufacture or sell any medicine without a valid license and the Saikot medicine, in that respect, could be treated as an illegal practice or substance. Remember the controversial 'Pig Heart Surgeon', Dr. Dhani Ram Baruah of Assam, who landed in jail for transplanting a pig's heart into a human being in 1997 as the patient died after 7 days. The state authority can act and intervene to ensure that proper regulatory standards and guidelines are followed. However, there are also not so stringent guidelines and regulations for other Indian System of Medicines (like Ayurveda or Homeopathy). For instance, a qualified Ayurvedic Doctor can easily obtain an Ayurvedic drug manufacturing license, provided all the required standards and guidelines are met. Either way one has to have the basics right (processing and manufacturing part) – it is a prerequisite. This should be the first priority.
The other reality is that whether we like it or not, patients will continue to come to collect the medicine and people will continue to sell the medicine irrespective of the outcome (negative or positive) of the scientific test of the medicine – these are the insoluble facts. Given these scenarios, it is more important and pressing to have a regulatory (informal or formal) to control quality and monitor. Of course, it is a difficult thing to do, considering the huge monetary transaction likely to involve. The case of 'Hoodia' plant is a constant reminder of how indigenous knowledge can be exploited with or without the permission of indigenous people. Hoodia Gordonii is a bitter tasting succulent plant (like a cactus) that is indigenous to southern Africa. It grows wild in the Kalahari Desert of South Africa. Hoodia has been part of the diet of the South Africa's Bushmen for thousands of years. They use it in long hunting trips to stop the urge to eat and drink. Scientists have discovered that this appetite suppression quality of 'Hoodia' was due to a molecule that fools the brain into thinking you have just eaten. There are tens of thousands of internet sites selling the plant or its extract. Therefore, it is going to be a tough and uphill task to make people from misusing the Saikot plant/medicine for his/her own benefits. What if the 'Saikot medicine' becomes another Hoodia?
2. IPR issues and scientific validation
The potential use and misuse of a highly economical plant/practice brings us to the most critical issue of competing claims and IPR issues. Since the publication of the medicine in a local vernacular paper and subsequent coverage in electronic media, the demand of the medicine increased several folds so as the claims of ownership. There are at least two versions of the accidental discovery of the medicine. On the one hand, Mr. Chawlien, the cancer patient, and his group say that it was an accidental experiment that led to the discovery of the present medicine. Treating of animals, using the said plant, is believed to have known to the Hmar community for long. It was in one of Mr. Chawlien's dreams that he was asked to try out with the extract of the said plant. With no other option left, he experimented with the concoction of the said plant. To his utter surprise the pain got subsided in a few days and the lump got reduced in weeks. That's how the medicine was discovered. His treatment goes with a prayer in early morning session, before giving away or administering the medicine.
On the other, Mr. Darminglien, a school teacher, says it was his late father who first practiced the medicine. His late father, Mr. Hneira, who died in 1997, used to practice herbal medicine for years. He used to treat animals for various ailments using the said plant. Since it was very effective in animals, they thought of experimenting with the said plant to Mr. Chawlien's cancer treatment as a last resort.
Mr. Chawlien is a cousin of Mr. Darminglien and they are neighbors. Mr. Darminglien says he used to take Mr. Chawlien to hospitals for treatment as Mr. Chawlien's sons were engaged in daily labor works. After a prolonged unsuccessful treatment at different medical hospitals, including RIMS, his family gave up hope and treatment. As a last resort, Mr. Darminglien, who has known his father's medicines for years, convinced Mr.Chawlien to try out the medicine as a last resort. Fortunately, the medicine worked and led to the sudden popularity and fame.
Two organizations
The first treatment and curing happened sometime in the early part of last year. It was kept as a low profile and a non-event, while trying out with other ailments like breast cancer, piles, etc. The words spread out and it became a wonder drug in the last few months. On 29th of April 2008, one of the local dailies, carried a story on the new medicine and its curing power, then it became a sensation. At least a few thousand patients visit Mr. Chawlien's home daily to collect the medicine. The treatment goes along with a prayer by Mr. Chawlien. To meet the demands, his neighbors and community members formed a society called Chawlien Cancer Medicine Research Agency (CCMRA). They look after the collection of leaves, preparation, distribution and other business transactions of the said medicine.
Community members prepare the medicine, using traditional pestle and mortar, to make the medicine. Each member takes rotational turn for different activities like preparation, distribution and looking after the visitors, etc. By first week of May, in a short span of few weeks of distribution, numbers of visitors had crossed more than 15 thousand. The last newspaper reports suggest that more than 30 thousand people visited in a single day.
Mr. Darminglien, on the other hand, has another registered body called the 'D.Neo Life Herbarium Society'. He claims that his registered body was constituted before the formations of CCRMA. He has been experimenting with the said medicine in a low key manner for about a year. He also has been selling the medicine in Mizoram for quite some time, through his relatives. His group has put up the medicine on the web (www.dneolife.com) and has tried to explore for possible scientific investigation with other collaborators, without much success.
High commercial value and overexploitation
It is just like open source knowledge – every member of the locality knows the plant and how the medicine is prepared. As the demand grew enormously after the media coverage, many villagers have started selling the medicine on their own. Many roadside vendors also sell the medicine; some even sell the saplings of the plant. A few villagers have also started cultivating the plant in their fields.
In a matter of few weeks, the plant got exhausted from the nearby surroundings. Now they send out people as far as Burma (Myanmar) border and Thangjing range to collect the plant. A bag of plant leaves (15 kg apx) gets Rs 300. If the rate of present collection continues, the plant may get exhausted from the entire state in a short period of time.
IPR issues
Who is the rightful owner? Was it a community knowledge of the Hmar Tribe? Was it Mr. Chawlien who tested the medicine first? Was it Mr. Darminglien who tested it first? Or should (L) Mr. Neista, father of Darmienglen, have the rightful ownership as he was the one who first experimented with the plant? What was common, however, in all these was that Mr. Chawlien was the first patient who got treated and "cured".
Traditional Knowledge or any plant (life form) cannot be patented as per the provisions of Indian Patent Act, but the process of using the plant can be (in this case the medicine making process, provided there is novelty and inventiveness). However, a knowledge which is known to everyone or open source knowledge or in public domain cannot be patented. Given these limitations, it is high time that all stakeholders come together and take a common stand otherwise we all may end up in the loosing side.
If indeed the knowledge belongs to the community, then no individual could have a proprietary claim over it. There was the famous case of Kani tribe who had the knowledge of usage of an indigenous plant Arogyappach, the Kani tribe was awarded the intellectual property rights to profit from its development. The agreement enabled the Kani tribe to receive half of the $50,000 fee paid by the Arya Vaidya Pharmacy (AVP) to the Tropical Botanical Garden and Research Institute (TBGRI) for the development of Jeevani and the technology to mass produce it. Jeevani is a product of the arogyappacha plant. The Kani tribe also receives 2% royalty on all sales of Jeevani world wide. The Kani tribe cultivates and harvests the arogyappacha plants used by the AVP in the production of Jeevani.
These are the issues that need to be deliberated and shorted out. The plant is readily available, the information is easily accessible and almost anybody who has some interest in the medicine can make it by himself/herself. Being open source knowledge, there is no liability or restriction to the user. In this age of bio-piracy and extreme competition, there is no guarantee that such thing hasn't happened yet. It is highly desirable that such a matter is deliberated and works out a plan of action, in case of any eventuality. The case of Hoodia plant is a constant reminder to all of us how a traditional knowledge practice could be misused and exploited. (For free patent consultation and filing of patent for grassroots innovations and traditional knowledge practices on behalf of the innovator or practitioner/community, you may write to ipr@nifindia.org or visit www.nifindia.org)
Scientific validation process
Amidst the euphoria, we seem to have forgotten that the scientific validation process is a must and without systematic validation no claim will be sufficient and recognized. The process of scientific investigation is universal; there are standard methods, norms and criteria to be followed. A road map needs to be worked out so that role of each stake holder is defined and works can be started immediately at different levels – within or outside the state.
Preparing a road map is not difficult, but agreeing on the terms and conditions among various stake holders will be. Let's take the case of scientific validation expenses. Scientific validation process and further research investigation is an expensive exercise. Who will do and invest on such an exercise? What are the terms and conditions of the research institute involved, if there is any? There are few possibilities – 1) the most common practice is that the institute bears the expenses and shares the IPR with the innovator/knowledge holder, if anything positive comes out; 2) the knowledge holder pays everything and the research institute does a paid job, and every finding goes to the knowledge holder/provider; 3) the institute/individual does the work free/paid, and gets published their findings with or without the knowledge provider; and 4) the research institute/scientist does it everything free as a voluntary service and has no claim over IPR.
The last (4th) option should have been the ideal option for the knowledge holder, but in practice it never happens. The 1st (first) and the 3rd (third) options seem to be the preferred option for the institutes/scientific community. Therefore, the odds are staked heavily against the knowledge holder in every sense. This needs to be changed. Just think of a scenario where any of the stakeholders (mis)uses the information or findings for his/her own benefit – what mechanism do we have to protect the rights of a knowledge holder? When it is difficult to understand the basics by the knowledge holders (community) at the moment, who will care to know the outcome of a research work 10-15 years down the line, which is the usual time period to come up with a medicinal formulation? This by no means is not to suggest that research institutes/scientist are exploiting or misusing traditional knowledge systems, but we cannot guarantee that such a thing hasn't happened in the past. It is time that we propose a step through which we could reassure people that their knowledge will be safe and will not be misused.
The existence of PRIOR ART (PA) may provide some succor. The revoking of patents over Turmeric, Neem, Basmati Rice, etc. in the US was enabled because the body of literature (PA) that existed for the said plants (as open source knowledge) far outweighs the claims of the new findings. In 1995, the US Patent Office granted a patent on the wound-healing properties of turmeric. Scientists at CSIR asked for a re-examination of this patent - #5401504 - filed by two US-based Indians. In a landmark decision, United States Patent and Trademark Office revoked this patent as it was being used in India for centuries. This was the first time that a patent based on the traditional knowledge of a developing country was challenged successfully and US PTO revoked the patent. The case of the revocation of the patent granted to W.R. Grace Company and US Department of Agriculture on Neem (EPO patent No. 436257) by European Patent Office, again on the same grounds of its use having been known in India, is another example. While these examples suggest that some errors can be reversed, this comes at a high cost and after enormous effort; the US case, for example, lasted two years and cost $6 million.
Unfortunately, for any traditional knowledge system such a body of literature (PA) is not available. Therefore, the very traditions of 'keeping it secret' may itself become a liability in protecting the knowledge. There is an effort to digitize the Indian Traditional Knowledge System called Traditional Knowledge Digital Library (TDKL), under the initiative of Council of Scientific and Industrial Research (CSIR), especially for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy. With the TKDL in place, the incident like Neem, Turmeric, etc. will be more difficult. Patent offices around the world would be alerted to the existence of this database, and would need to cross-examine new claims against its knowledge. It will be mandatory for patent examiners to refer to this database before granting a patent.
But the TDKL is confined only to Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, and doesn't include the oral tradition and other un-written traditional knowledge systems. There is no such 'data base' for traditional knowledge at the National level, except the National Register of Grassroots innovations and Traditional Knowledge Practices being developed and maintained by National Innovation Foundation (NIF).
In this context, a Non Disclosure Agreement (NDA) may be signed by the participating individual(s) or expert(s) stating that the shared information will not be disclosed or used for any personnel purpose in future, without prior permission of the knowledge holder. Likewise, the knowledge provider also needs to sign a Prior Informed Consent (PIC), which provides a framework and guideline for the future course of action. The signed PIC between the parties (knowledge provider and investigating group) will be the guiding light of the proposed work. This will help reaffirm and reassure the knowledge holder about the safety and confidentiality of the knowledge. It is therefore imperative that all intellectuals, research scientists/institutes, or organizations involved also signed an NDA and PIC agreement for confidentiality and safe keeping of the knowledge. What if any of the researchers published the findings in a journal/paper and the claims of medicine were found positive, without prior consent of the knowledge holder? The loss would be enormous - the patentability of the claim would be gone forever and the credit would go to someone else. The scientific fraternity also needs to do some introspection on these issues and come out with a proactive plan and tangible solution.
The demand for Traditional knowledge for leads into the unexplored world of herbal medicine is growing leaps and bounds. In 2000, CSIR found that almost 80 per cent of the 4,896 references to individual plant based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices. In 2005 this number had grown to 35,000, which clearly demonstrates the interest of developed world in the knowledge of the developing countries. Conveniently, none of the patent examiners are from developing countries, allowing a virtual free pass to stealing indigenous knowledge from the Old World. Given the porous nature of traditional knowledge system in the state, it is high time that we also have a regulatory and management mechanism to have a protective wall around the traditional knowledge systems.
Benefit sharing and business opportunities
If not for the huge transaction or business opportunity involved, none would have noticed the Saikot Medicine – this is an inconvenient truth. There are hundreds of low profile traditional medicinal practices longing for recognition and appreciation. Except for academic interest none has been investigated and examined properly, that's where the paradox lies. On the one hand, everyone, including politicians, jumps into the 'Saikot Medicine' (just look at the number of competing individuals, RD institutes, interest groups visiting the site and courting the practitioners) and on the other there are thousands of other traditional practices craving for attention and recognition.
As of now there is no standard framework or guideline at the national/state for benefit sharing options. It is mostly done on a case to case basis, based upon the merit and nature of ownership in the given set-up. What is important, however, is that there has to be a complete clarity in the ownership of the given knowledge.
The scientific validation and investigation process is not only lengthy and expensive, but also risky and uncertain exercise. It would involve different research scientists and institutions at different levels, and may even take more 10-15 years to come up with a single formulation. The bottom line is that irrespective of our wishes and desire, we need to get involved experts at different levels to get the job done. At the moment Manipur simply doesn't have the facility, manpower and resources – we do not have even a single licensee for manufacturing Ayurvedic medicine, which any Ayurvedic doctor could have had. What then would be the compensatory mechanism for these active actors/institutions? They also need to be compensated for their time, effort and resources.
As for the community level traditional knowledge ownership, one could think of the Kani tribe model as a framework and modify to suit the local requirements and conditions. In this arrangement, the knowledge is given to the Tropical Botanical Garden and Research Institute (TBGRI) who did the research works on the said plant at their expense. The IPR on the outcome of the research work was shared between the Kani tribe (who provided the knowledge) and the TBGRI (who did the scientific investigation). The commercial and manufacturing rights of the medicine were given to Aray Vaidya Pharmacy (AVP) at a fee, which was then shared between Kani tribe and TBGRI. Also, the tribe gets the right to cultivate and harvest the said plant used by AVP and receives 2% royalty on all sales of Jeevani worldwide. One must not forget that a team of scientists spent many years to come up with the said medicine, based on Kani tribe's knowledge.
At the group level, once could think of a different benefit sharing mechanism. With the initiative of NIF/SRISTI, five traditional knowledge practitioners from different parts of the country came up with a medicinal paste by pooling their knowledge and experiences. The said medicinal paste was licensed to a pharmaceutical company for further scientific validation and product development with a benefit sharing agreement with the practitioners. All the five practitioners would receive Rs 1 (one) each on every tube sold as royalty. If the company sells 1 lakh tube a month, then each practitioner would have received Rs 1 lakh each. Such a framework could be re-modeled to suit local conditions.
Similarly, at the individual level, one could explore various possibilities of licensing the rights to a research institute or pharmaceutical company for further research and development with fair and equitable benefit sharing arrangement. Depending on the merit of the case, one could negotiate an upfront payment for the disclosed knowledge or royalty on sales once a product is developed or both. Each of the arrangements will have both pros and cons, one has to negotiate, adapt and settle as the situation demands. For details of such business linkages, without any riders, one may write or contact business development (BD) section of NIF. (bd@nifindia.org).
The other option is establishment of a state specific RD, manufacturing and business development center, which can take care of all such matters. The chances of realizing such a dream are far too remote at the moment; the state doesn't have a single RD center which is capable of undertaking all the essential works. There is not a single drug manufacturing licensee, not to speak of a manufacturing unit. Even if we did have an RD center, then the same RD process and benefit sharing arrangement would have been followed as anywhere else. Having a set up in the state doesn't guarantee a more equitable benefit sharing arrangement with the knowledge provider(s). However, having a local RD center may help in easy access and bridging the gap between the knowledge holders and scientific community.
The road ahead
The 'Saikot medicine' is an indication of the things to come in the near future. It is high time that the state takes up initiatives to systematically investigate these issues either by tying up with other institutions/organizations that have the expertise and experience in such matters or establish state level centers to facilitate such a process. It may be mentioned here that at the national level, the National Innovation Foundation (NIF), an autonomous society supported by the Department of Science and Technology (DST), GOI, maintains and National Level Register for Grassroots Innovations and Traditional Knowledge Practices with the sole objective of protecting the rights of innovators and knowledge practitioners and providing support in scientific investigation, value addition work and business development.
Let's ensure that the rights of traditional knowledge holder(s) is protected and promoted. This can only be done by proper documentation of the knowledge practices at different levels; establishment of a just and equitable benefit sharing regime; and followed up by a systematic scientific validation and investigation work. Experience tells us that as the economic importance of any resource (knowledge or natural) increases, the chances of competing claims and misuses of the said resource increases many folds. The traditional knowledge system in its present form is an open access resource; it has been misused, misinterpreted and mishandled.
It is a common practice for a knowledge holder to keep the knowledge as secret to protect to protect his/her proprietary rights. The tradition has outlived its uses; now it is time to adopt and practice a new protection regime accepted and recognized by the established institutions. One of the prerequisites of such a system is to have the knowledge well documented and systematically studied; therefore the very tradition of keeping the knowledge secret may in fact become a liability in protecting the rights of knowledge holders, in case of a misuse by another group. If the new regime protects the privacy and proprietary rights of the owner, then there is no harm in sharing the knowledge with the concerned authorities.
The onus lies on us - intellectuals, academicians, researchers, administrators, public organizations, etc – to educate and convince people that there are new means and ways of protecting the rights of knowledge holders. If people do not come out, the case of competing claims, as in the case of Saikot medicine, is bound to come sooner or later for other practices as well. To re-ensure the faith of these knowledge holders, it is time that all stakeholders also respect the sanctity of Non Discloser Agreement (NDA) in spirit and in principle, and Prior Informed Consent (PIC) is taken from the concerned knowledge holder in every step. PIC should be the guiding for subsequent steps.
The Saikot medicine has brought us out the many shortcomings in our system; having seen and learnt the drawbacks, it is time that we start taking corrective measures. We do not need to re-invent the wheel to move forward faster, there are innumerable means and ways in front of us as an open book. The long inaction of state machineries in dealing with such an important issue may further complicate the matter. With small corrective measures like proper equipments and more systematic processing methods could help a long way in resolving many of the health concerns. A proper regulatory mechanism needs to be evolved. The Saikot medicine episode, therefore, could well turn out to be the 'proverbial trigger' to initiate many more measures in safeguarding the rights of traditional knowledge holders, management and systematic investigation on such knowledge systems, and finally recognition and appreciation of those unsung heroes and heroines. National Innovation Foundation (NIF)
http://ifp.co.in/ArticleFull.asp?ArticleID=374
The ongoing 'Saikot Cancer Medicine' saga has raised hopes for many terminally ill patients for a new beginning and at the same time it has also raised many concerns on the management and proprietary rights of such traditional knowledge practices and bio-resources. Sandwiched between these two extremes is the lack of educated judgment or the absence of it among desperate users and a stoic silence from the state administration. A handful of individuals, researchers, intellectuals and interest groups have however begun to raise, discuss and investigate the matter at different levels, but things have not changed much and no concrete steps are visible on the ground to ameliorate the concerned issues.
The issues and concerns could be of many natures, depending upon one's interest and affiliation – to a public health administrator, it could be the process of making, quality control and legality of the 'medicine' itself; to an innocent patient, it could be a matter of well being and ill health; to a researcher, it could be a lifetime opportunity to work on a challenging prospect; to an environmentalist, the possible threat of misuse and overexploitation of the plant resources leading to extinction; to an intellectual, it could be a threat of bio-piracy and misuse and misappropriation of traditional knowledge systems; to an entrepreneur, it could be an opportunity to surge his/her business enterprise; and to the practitioner(s)/knowledge holder(s), it could be one way of serving people or earning a livelihood. Can we strike a balance among all these interrelated and interdependent but not necessarily mutually compatible factors? We are in desperate need of a common platform to make a beginning.
There is no magic bullet; we have to look for means and ways to come up with solutions acceptable to the local people and at the same time also make sure that they do not go against the established norms and guidelines at the local and state/national level. It is also high time that the first priority is given to the interest of the knowledge holder(s), for too long we have ignored and taken for granted that such knowledge as an open source (free) knowledge. Just think of the multi-billion dollar pharmaceutical industry in the world – according to WHO estimates, more than 70% of the compounds used in allopathic (modern) medicine originate from the knowledge of folk medicine or traditional knowledge systems. What have these practitioners or traditional knowledge holders received in return? NONE. In our own backyard, let's be honest and reflect upon the number of doctoral works, dissertations, research and academic papers produced every year based on such knowledge systems and generosity of such people; is there any instance where any of the knowledge holders/providers being given authorship or due share? NONE.
The 'Siakot Cancer Medicine' has given us the opportunity to discuss and deliberate on certain issues which are of prime importance and immediate concern to all of us. Irrespective of our difference of opinions, interest and affiliations, we all need to initiate a common effort to resolve these pressing issues – 1) Public health concerns and legality of the practice; 2) IPR issues Scientific validation; and 3) Benefit sharing and business opportunities. In this age of information technology and bio-piracy, these are the issues likely to come up in the near future as more and more resources (knowledge and biological) become easily accessible. If the triumphs and tribulations of 'Saikot Cancer Medicne' led to a healthy dialogue and mass public awakening on such dormant issues and formulation of a state policy towards management and scientific investigation on traditional knowledge systems, it would have served more purpose in the long run and go down as a landmark turning point in the way we look and treat traditional knowledge systems, regardless of the merit of the said medicine. (The efficacy and novelty of the medicine will not be part of this discussion).
1. Public health concerns and legality of the practice
Indeed it is of great concern and interest, based on the few reports available and personnel visits, that the open-air processing unit may not be the best and most hygienic way to manufacture the medicine. It is often reported that "the water source is also a suspect", not to speak of the primitive mortar and pestle used for grinding the leaves and other accessories used for treatment and distribution. What is more disturbing is the mushrooming of many more vendors selling the medicine in and around the village, and no one has any knowledge on how these vendors are preparing the medicine?
It is high time that an acceptable minimum quality control is maintained all across. The unfortunate part is that these methods and procedures are text-book materials; one can easily find anywhere at any time. The standardized extraction machineries wouldn't cost much and can easily be procured at any time. This would not only ensure standardized quality but also make the medicine more hygienic/safe. A conservative estimate suggests that at any given day more than 50 thousand people may be consuming the medicine; the number may be growing everyday. What if anything goes wrong? There were sporadic instances of contamination, hospitalization after consumption of the said medicine. Who would be liable in the case of an unfortunate fatality?
Other concern is that the said plant has completely been exhausted from the surroundings; therefore it is being brought in far away places like Myanmar (Burma) and other away districts of Manipur. With more than 30 similar species with minor local variations, it would be a tough call to distinguish them. Many of them have similar features and characteristics, and then there is every possibility of mixing of other plants of the same family inadvertently by innocent collectors or purposely by unscrupulous collectors to make some quick bugs. Such instances have already been reported from the village.
Is there any way out? Yes, there is. With little investment of time and money, one could easily overcome these shortcomings. Irrespective of the efficacy and high demand of the medicine, we need to get the basics right – there ought not to be any compromise on such fundamentals. If the practitioner(s) has problem in sourcing the fund locally or at the state level, which I believe is not the case, there are other possible sources at the central level. National Innovation Foundation (NIF), under Department of Science and Technology, GOI, is one of the organizations which regularly provide such support or the Science and Society Programme of Department of Science and Technology.
Can people make the medicine and distribute? The answer is 'NO' and 'YES'. There are stringent guidelines and regulations to manufacture drugs (allopathic). If one goes by the book, no one can manufacture or sell any medicine without a valid license and the Saikot medicine, in that respect, could be treated as an illegal practice or substance. Remember the controversial 'Pig Heart Surgeon', Dr. Dhani Ram Baruah of Assam, who landed in jail for transplanting a pig's heart into a human being in 1997 as the patient died after 7 days. The state authority can act and intervene to ensure that proper regulatory standards and guidelines are followed. However, there are also not so stringent guidelines and regulations for other Indian System of Medicines (like Ayurveda or Homeopathy). For instance, a qualified Ayurvedic Doctor can easily obtain an Ayurvedic drug manufacturing license, provided all the required standards and guidelines are met. Either way one has to have the basics right (processing and manufacturing part) – it is a prerequisite. This should be the first priority.
The other reality is that whether we like it or not, patients will continue to come to collect the medicine and people will continue to sell the medicine irrespective of the outcome (negative or positive) of the scientific test of the medicine – these are the insoluble facts. Given these scenarios, it is more important and pressing to have a regulatory (informal or formal) to control quality and monitor. Of course, it is a difficult thing to do, considering the huge monetary transaction likely to involve. The case of 'Hoodia' plant is a constant reminder of how indigenous knowledge can be exploited with or without the permission of indigenous people. Hoodia Gordonii is a bitter tasting succulent plant (like a cactus) that is indigenous to southern Africa. It grows wild in the Kalahari Desert of South Africa. Hoodia has been part of the diet of the South Africa's Bushmen for thousands of years. They use it in long hunting trips to stop the urge to eat and drink. Scientists have discovered that this appetite suppression quality of 'Hoodia' was due to a molecule that fools the brain into thinking you have just eaten. There are tens of thousands of internet sites selling the plant or its extract. Therefore, it is going to be a tough and uphill task to make people from misusing the Saikot plant/medicine for his/her own benefits. What if the 'Saikot medicine' becomes another Hoodia?
2. IPR issues and scientific validation
The potential use and misuse of a highly economical plant/practice brings us to the most critical issue of competing claims and IPR issues. Since the publication of the medicine in a local vernacular paper and subsequent coverage in electronic media, the demand of the medicine increased several folds so as the claims of ownership. There are at least two versions of the accidental discovery of the medicine. On the one hand, Mr. Chawlien, the cancer patient, and his group say that it was an accidental experiment that led to the discovery of the present medicine. Treating of animals, using the said plant, is believed to have known to the Hmar community for long. It was in one of Mr. Chawlien's dreams that he was asked to try out with the extract of the said plant. With no other option left, he experimented with the concoction of the said plant. To his utter surprise the pain got subsided in a few days and the lump got reduced in weeks. That's how the medicine was discovered. His treatment goes with a prayer in early morning session, before giving away or administering the medicine.
On the other, Mr. Darminglien, a school teacher, says it was his late father who first practiced the medicine. His late father, Mr. Hneira, who died in 1997, used to practice herbal medicine for years. He used to treat animals for various ailments using the said plant. Since it was very effective in animals, they thought of experimenting with the said plant to Mr. Chawlien's cancer treatment as a last resort.
Mr. Chawlien is a cousin of Mr. Darminglien and they are neighbors. Mr. Darminglien says he used to take Mr. Chawlien to hospitals for treatment as Mr. Chawlien's sons were engaged in daily labor works. After a prolonged unsuccessful treatment at different medical hospitals, including RIMS, his family gave up hope and treatment. As a last resort, Mr. Darminglien, who has known his father's medicines for years, convinced Mr.Chawlien to try out the medicine as a last resort. Fortunately, the medicine worked and led to the sudden popularity and fame.
Two organizations
The first treatment and curing happened sometime in the early part of last year. It was kept as a low profile and a non-event, while trying out with other ailments like breast cancer, piles, etc. The words spread out and it became a wonder drug in the last few months. On 29th of April 2008, one of the local dailies, carried a story on the new medicine and its curing power, then it became a sensation. At least a few thousand patients visit Mr. Chawlien's home daily to collect the medicine. The treatment goes along with a prayer by Mr. Chawlien. To meet the demands, his neighbors and community members formed a society called Chawlien Cancer Medicine Research Agency (CCMRA). They look after the collection of leaves, preparation, distribution and other business transactions of the said medicine.
Community members prepare the medicine, using traditional pestle and mortar, to make the medicine. Each member takes rotational turn for different activities like preparation, distribution and looking after the visitors, etc. By first week of May, in a short span of few weeks of distribution, numbers of visitors had crossed more than 15 thousand. The last newspaper reports suggest that more than 30 thousand people visited in a single day.
Mr. Darminglien, on the other hand, has another registered body called the 'D.Neo Life Herbarium Society'. He claims that his registered body was constituted before the formations of CCRMA. He has been experimenting with the said medicine in a low key manner for about a year. He also has been selling the medicine in Mizoram for quite some time, through his relatives. His group has put up the medicine on the web (www.dneolife.com) and has tried to explore for possible scientific investigation with other collaborators, without much success.
High commercial value and overexploitation
It is just like open source knowledge – every member of the locality knows the plant and how the medicine is prepared. As the demand grew enormously after the media coverage, many villagers have started selling the medicine on their own. Many roadside vendors also sell the medicine; some even sell the saplings of the plant. A few villagers have also started cultivating the plant in their fields.
In a matter of few weeks, the plant got exhausted from the nearby surroundings. Now they send out people as far as Burma (Myanmar) border and Thangjing range to collect the plant. A bag of plant leaves (15 kg apx) gets Rs 300. If the rate of present collection continues, the plant may get exhausted from the entire state in a short period of time.
IPR issues
Who is the rightful owner? Was it a community knowledge of the Hmar Tribe? Was it Mr. Chawlien who tested the medicine first? Was it Mr. Darminglien who tested it first? Or should (L) Mr. Neista, father of Darmienglen, have the rightful ownership as he was the one who first experimented with the plant? What was common, however, in all these was that Mr. Chawlien was the first patient who got treated and "cured".
Traditional Knowledge or any plant (life form) cannot be patented as per the provisions of Indian Patent Act, but the process of using the plant can be (in this case the medicine making process, provided there is novelty and inventiveness). However, a knowledge which is known to everyone or open source knowledge or in public domain cannot be patented. Given these limitations, it is high time that all stakeholders come together and take a common stand otherwise we all may end up in the loosing side.
If indeed the knowledge belongs to the community, then no individual could have a proprietary claim over it. There was the famous case of Kani tribe who had the knowledge of usage of an indigenous plant Arogyappach, the Kani tribe was awarded the intellectual property rights to profit from its development. The agreement enabled the Kani tribe to receive half of the $50,000 fee paid by the Arya Vaidya Pharmacy (AVP) to the Tropical Botanical Garden and Research Institute (TBGRI) for the development of Jeevani and the technology to mass produce it. Jeevani is a product of the arogyappacha plant. The Kani tribe also receives 2% royalty on all sales of Jeevani world wide. The Kani tribe cultivates and harvests the arogyappacha plants used by the AVP in the production of Jeevani.
These are the issues that need to be deliberated and shorted out. The plant is readily available, the information is easily accessible and almost anybody who has some interest in the medicine can make it by himself/herself. Being open source knowledge, there is no liability or restriction to the user. In this age of bio-piracy and extreme competition, there is no guarantee that such thing hasn't happened yet. It is highly desirable that such a matter is deliberated and works out a plan of action, in case of any eventuality. The case of Hoodia plant is a constant reminder to all of us how a traditional knowledge practice could be misused and exploited. (For free patent consultation and filing of patent for grassroots innovations and traditional knowledge practices on behalf of the innovator or practitioner/community, you may write to ipr@nifindia.org or visit www.nifindia.org)
Scientific validation process
Amidst the euphoria, we seem to have forgotten that the scientific validation process is a must and without systematic validation no claim will be sufficient and recognized. The process of scientific investigation is universal; there are standard methods, norms and criteria to be followed. A road map needs to be worked out so that role of each stake holder is defined and works can be started immediately at different levels – within or outside the state.
Preparing a road map is not difficult, but agreeing on the terms and conditions among various stake holders will be. Let's take the case of scientific validation expenses. Scientific validation process and further research investigation is an expensive exercise. Who will do and invest on such an exercise? What are the terms and conditions of the research institute involved, if there is any? There are few possibilities – 1) the most common practice is that the institute bears the expenses and shares the IPR with the innovator/knowledge holder, if anything positive comes out; 2) the knowledge holder pays everything and the research institute does a paid job, and every finding goes to the knowledge holder/provider; 3) the institute/individual does the work free/paid, and gets published their findings with or without the knowledge provider; and 4) the research institute/scientist does it everything free as a voluntary service and has no claim over IPR.
The last (4th) option should have been the ideal option for the knowledge holder, but in practice it never happens. The 1st (first) and the 3rd (third) options seem to be the preferred option for the institutes/scientific community. Therefore, the odds are staked heavily against the knowledge holder in every sense. This needs to be changed. Just think of a scenario where any of the stakeholders (mis)uses the information or findings for his/her own benefit – what mechanism do we have to protect the rights of a knowledge holder? When it is difficult to understand the basics by the knowledge holders (community) at the moment, who will care to know the outcome of a research work 10-15 years down the line, which is the usual time period to come up with a medicinal formulation? This by no means is not to suggest that research institutes/scientist are exploiting or misusing traditional knowledge systems, but we cannot guarantee that such a thing hasn't happened in the past. It is time that we propose a step through which we could reassure people that their knowledge will be safe and will not be misused.
The existence of PRIOR ART (PA) may provide some succor. The revoking of patents over Turmeric, Neem, Basmati Rice, etc. in the US was enabled because the body of literature (PA) that existed for the said plants (as open source knowledge) far outweighs the claims of the new findings. In 1995, the US Patent Office granted a patent on the wound-healing properties of turmeric. Scientists at CSIR asked for a re-examination of this patent - #5401504 - filed by two US-based Indians. In a landmark decision, United States Patent and Trademark Office revoked this patent as it was being used in India for centuries. This was the first time that a patent based on the traditional knowledge of a developing country was challenged successfully and US PTO revoked the patent. The case of the revocation of the patent granted to W.R. Grace Company and US Department of Agriculture on Neem (EPO patent No. 436257) by European Patent Office, again on the same grounds of its use having been known in India, is another example. While these examples suggest that some errors can be reversed, this comes at a high cost and after enormous effort; the US case, for example, lasted two years and cost $6 million.
Unfortunately, for any traditional knowledge system such a body of literature (PA) is not available. Therefore, the very traditions of 'keeping it secret' may itself become a liability in protecting the knowledge. There is an effort to digitize the Indian Traditional Knowledge System called Traditional Knowledge Digital Library (TDKL), under the initiative of Council of Scientific and Industrial Research (CSIR), especially for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy. With the TKDL in place, the incident like Neem, Turmeric, etc. will be more difficult. Patent offices around the world would be alerted to the existence of this database, and would need to cross-examine new claims against its knowledge. It will be mandatory for patent examiners to refer to this database before granting a patent.
But the TDKL is confined only to Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, and doesn't include the oral tradition and other un-written traditional knowledge systems. There is no such 'data base' for traditional knowledge at the National level, except the National Register of Grassroots innovations and Traditional Knowledge Practices being developed and maintained by National Innovation Foundation (NIF).
In this context, a Non Disclosure Agreement (NDA) may be signed by the participating individual(s) or expert(s) stating that the shared information will not be disclosed or used for any personnel purpose in future, without prior permission of the knowledge holder. Likewise, the knowledge provider also needs to sign a Prior Informed Consent (PIC), which provides a framework and guideline for the future course of action. The signed PIC between the parties (knowledge provider and investigating group) will be the guiding light of the proposed work. This will help reaffirm and reassure the knowledge holder about the safety and confidentiality of the knowledge. It is therefore imperative that all intellectuals, research scientists/institutes, or organizations involved also signed an NDA and PIC agreement for confidentiality and safe keeping of the knowledge. What if any of the researchers published the findings in a journal/paper and the claims of medicine were found positive, without prior consent of the knowledge holder? The loss would be enormous - the patentability of the claim would be gone forever and the credit would go to someone else. The scientific fraternity also needs to do some introspection on these issues and come out with a proactive plan and tangible solution.
The demand for Traditional knowledge for leads into the unexplored world of herbal medicine is growing leaps and bounds. In 2000, CSIR found that almost 80 per cent of the 4,896 references to individual plant based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices. In 2005 this number had grown to 35,000, which clearly demonstrates the interest of developed world in the knowledge of the developing countries. Conveniently, none of the patent examiners are from developing countries, allowing a virtual free pass to stealing indigenous knowledge from the Old World. Given the porous nature of traditional knowledge system in the state, it is high time that we also have a regulatory and management mechanism to have a protective wall around the traditional knowledge systems.
Benefit sharing and business opportunities
If not for the huge transaction or business opportunity involved, none would have noticed the Saikot Medicine – this is an inconvenient truth. There are hundreds of low profile traditional medicinal practices longing for recognition and appreciation. Except for academic interest none has been investigated and examined properly, that's where the paradox lies. On the one hand, everyone, including politicians, jumps into the 'Saikot Medicine' (just look at the number of competing individuals, RD institutes, interest groups visiting the site and courting the practitioners) and on the other there are thousands of other traditional practices craving for attention and recognition.
As of now there is no standard framework or guideline at the national/state for benefit sharing options. It is mostly done on a case to case basis, based upon the merit and nature of ownership in the given set-up. What is important, however, is that there has to be a complete clarity in the ownership of the given knowledge.
The scientific validation and investigation process is not only lengthy and expensive, but also risky and uncertain exercise. It would involve different research scientists and institutions at different levels, and may even take more 10-15 years to come up with a single formulation. The bottom line is that irrespective of our wishes and desire, we need to get involved experts at different levels to get the job done. At the moment Manipur simply doesn't have the facility, manpower and resources – we do not have even a single licensee for manufacturing Ayurvedic medicine, which any Ayurvedic doctor could have had. What then would be the compensatory mechanism for these active actors/institutions? They also need to be compensated for their time, effort and resources.
As for the community level traditional knowledge ownership, one could think of the Kani tribe model as a framework and modify to suit the local requirements and conditions. In this arrangement, the knowledge is given to the Tropical Botanical Garden and Research Institute (TBGRI) who did the research works on the said plant at their expense. The IPR on the outcome of the research work was shared between the Kani tribe (who provided the knowledge) and the TBGRI (who did the scientific investigation). The commercial and manufacturing rights of the medicine were given to Aray Vaidya Pharmacy (AVP) at a fee, which was then shared between Kani tribe and TBGRI. Also, the tribe gets the right to cultivate and harvest the said plant used by AVP and receives 2% royalty on all sales of Jeevani worldwide. One must not forget that a team of scientists spent many years to come up with the said medicine, based on Kani tribe's knowledge.
At the group level, once could think of a different benefit sharing mechanism. With the initiative of NIF/SRISTI, five traditional knowledge practitioners from different parts of the country came up with a medicinal paste by pooling their knowledge and experiences. The said medicinal paste was licensed to a pharmaceutical company for further scientific validation and product development with a benefit sharing agreement with the practitioners. All the five practitioners would receive Rs 1 (one) each on every tube sold as royalty. If the company sells 1 lakh tube a month, then each practitioner would have received Rs 1 lakh each. Such a framework could be re-modeled to suit local conditions.
Similarly, at the individual level, one could explore various possibilities of licensing the rights to a research institute or pharmaceutical company for further research and development with fair and equitable benefit sharing arrangement. Depending on the merit of the case, one could negotiate an upfront payment for the disclosed knowledge or royalty on sales once a product is developed or both. Each of the arrangements will have both pros and cons, one has to negotiate, adapt and settle as the situation demands. For details of such business linkages, without any riders, one may write or contact business development (BD) section of NIF. (bd@nifindia.org).
The other option is establishment of a state specific RD, manufacturing and business development center, which can take care of all such matters. The chances of realizing such a dream are far too remote at the moment; the state doesn't have a single RD center which is capable of undertaking all the essential works. There is not a single drug manufacturing licensee, not to speak of a manufacturing unit. Even if we did have an RD center, then the same RD process and benefit sharing arrangement would have been followed as anywhere else. Having a set up in the state doesn't guarantee a more equitable benefit sharing arrangement with the knowledge provider(s). However, having a local RD center may help in easy access and bridging the gap between the knowledge holders and scientific community.
The road ahead
The 'Saikot medicine' is an indication of the things to come in the near future. It is high time that the state takes up initiatives to systematically investigate these issues either by tying up with other institutions/organizations that have the expertise and experience in such matters or establish state level centers to facilitate such a process. It may be mentioned here that at the national level, the National Innovation Foundation (NIF), an autonomous society supported by the Department of Science and Technology (DST), GOI, maintains and National Level Register for Grassroots Innovations and Traditional Knowledge Practices with the sole objective of protecting the rights of innovators and knowledge practitioners and providing support in scientific investigation, value addition work and business development.
Let's ensure that the rights of traditional knowledge holder(s) is protected and promoted. This can only be done by proper documentation of the knowledge practices at different levels; establishment of a just and equitable benefit sharing regime; and followed up by a systematic scientific validation and investigation work. Experience tells us that as the economic importance of any resource (knowledge or natural) increases, the chances of competing claims and misuses of the said resource increases many folds. The traditional knowledge system in its present form is an open access resource; it has been misused, misinterpreted and mishandled.
It is a common practice for a knowledge holder to keep the knowledge as secret to protect to protect his/her proprietary rights. The tradition has outlived its uses; now it is time to adopt and practice a new protection regime accepted and recognized by the established institutions. One of the prerequisites of such a system is to have the knowledge well documented and systematically studied; therefore the very tradition of keeping the knowledge secret may in fact become a liability in protecting the rights of knowledge holders, in case of a misuse by another group. If the new regime protects the privacy and proprietary rights of the owner, then there is no harm in sharing the knowledge with the concerned authorities.
The onus lies on us - intellectuals, academicians, researchers, administrators, public organizations, etc – to educate and convince people that there are new means and ways of protecting the rights of knowledge holders. If people do not come out, the case of competing claims, as in the case of Saikot medicine, is bound to come sooner or later for other practices as well. To re-ensure the faith of these knowledge holders, it is time that all stakeholders also respect the sanctity of Non Discloser Agreement (NDA) in spirit and in principle, and Prior Informed Consent (PIC) is taken from the concerned knowledge holder in every step. PIC should be the guiding for subsequent steps.
The Saikot medicine has brought us out the many shortcomings in our system; having seen and learnt the drawbacks, it is time that we start taking corrective measures. We do not need to re-invent the wheel to move forward faster, there are innumerable means and ways in front of us as an open book. The long inaction of state machineries in dealing with such an important issue may further complicate the matter. With small corrective measures like proper equipments and more systematic processing methods could help a long way in resolving many of the health concerns. A proper regulatory mechanism needs to be evolved. The Saikot medicine episode, therefore, could well turn out to be the 'proverbial trigger' to initiate many more measures in safeguarding the rights of traditional knowledge holders, management and systematic investigation on such knowledge systems, and finally recognition and appreciation of those unsung heroes and heroines. National Innovation Foundation (NIF)
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