BIODIVERSITY AND INTELLECTUAL PROPERTY RIGHTS
IMPLICATIONS FOR INDIGENOUS PEOPLE OF SOUTH AFRICA
Herewith is a defense, raised by the traditional healers and indigenous community, in an effort to have the State re-consider the implementation of regulations pertaining to the regulation and control of African traditional medicines under the new SAMMDRA Act. We note with concern that the SAMMDRA not only infringes upon the rights of citizens under our own South African Constitution (Act 108 of 1996), but also the Declaration On The Rights Of Indigenous Peoples (1996), and the exploitation of traditional knowledge for drug patenting which is in contravention of the Bio-diversity Convention (1992)
Biopiracy and Indigenous Traditional Medicine Knowledge
The blatant plunder of indigenous knowledge and genetic resources in South Africa continues unhindered and without State monitoring. Since 1997, We have been monitoring private and public enterprises (or their intermediaries) who are actively collecting, sampling and acquiring traditional knowledge for the development of pharmaceutical products. What concerns us is that international organizations are entering South Africa to carry out this research. Not even the World Health Organization are free of scrutiny in this regard.
"Biopiracy" refers to the use of intellectual property laws (patents, plant breeders' rights) to gain exclusive monopoly control over genetic resources that are based on the knowledge and innovation of indigenous peoples. Biopiracy and bioprospecting don't just happen in the field ; biopiracy is even more likely to take place in the laboratories of industry and academia, and in patent offices in the cities not even in South Africa.
Biopiracy : The Inequitable Sharing of Benefits
We find it evident that the pharmaceutical industry have reached a sense of exhaustion in the development of synthetic drugs, and are now focusing their attention onto higher plants for potential cures. This, together with a fastest growing sector of health care, namely alternative medicine, is forcing pharmaceutical companies to re-focus their resources in medicine development.
While South Africa looks at benefits involved in using traditional resources for foreign capital, it is important to note that the handing over of some staple resources can be of detriment to the public at large. We have carried out a simple risk/benefit analysis in the sphere of traditional medicines as one example.
It is a well known fact that the World Health Organization and it's Collaborating Centers For Drug Policy and for Traditional Medicines are behind an initiative which is pushed by the pharmaceutical industry to scour our indigenous plant species and traditional healers knowledge for potential drug development. At a recent WHO conference in Italy, named "Monographs for Complimentary Medicines - 2nd WHO conference on Medicinal Plants on the 3rd and 4th of March 1999, a newly appointed official of the Medicines Control Council, Dr. Isaac Mayeng, represented South Africa.
Dr. Mayeng is known by our organization as a "biopirate", because he has been actively involved in traditional medicine research at the University of Cape Town's Traditional Medicines Research Project (TRAMED). This specialized research department have been actively screening our regions traditional plants for potential drug development, under the auspices of anti-malarial research.
It is noted that a vast amount of traditional medicine knowledge has been recorded by the department over the last thirteen years' some of it being donated to the university by Noristan Laboratories, who handed over their traditional medicine bio-prospecting data base in the early nineties. This institution is currently under the directorship of Professor Peter Folb, WHO Chairman for the Collaborating Center For Drug Policy.
Many traditional healers have been exploited for this ethno-botanical knowledge accumulation from all corners of the country with the carrot hung before their nose with offers of money and even registration.
In a recently published WHO document is states that the World Health Assembly has adopted a number of resolutions drawing attention to the fact that most of the populations in various developing countries around the world depends on traditional medicine for profits. (WHO Fact Sheet N 134 September 1996) Healers facilitate an important resource for the furtherance of primary health care, that the work force represented by practitioners of traditional medicine is a potentially important resource for the delivery of health care and that medicinal plants are of great importance to the health of individuals and communities. (WHO Fact Sheet N 134 September 1996) However they do not seem to involve the traditional healers, and the local communities in the drafting of these resolutions. This lack of representation raises serious question about the motives of the WHO in this regard.
Through its Traditional Medicine Programme, the World Health Organization (WHO) supports South Africa in it's efforts to formulate a national policy on traditional medicine and to study the potential usefulness of traditional medicine including evaluation of practices and examination of the efficacy of remedies.
We have clearly noted that Folb has been actively supporting the proposed regulatory system for complimentary medicines, including traditional medicines in his capacity of previous Chairman of the Medicines Control Council. We have noticed however that the safety issues involved with these substances are blatantly ignored, considering that up to 68% of deaths caused by acute poisoning among indigenous South Africans are directly linked to traditional medicine toxicity. Surely the WHO and the medicines regulatory authority should be evaluating not only the efficacy of these "patentable" bio-products, but should be actively supporting the communities in education about the toxicity issues involved.
The WHO state " Medicinal plants are also important for pharmacological research and drug development, not only when plant constituents are used directly as therapeutic agents, but also when they are used as basic materials for the synthesis of drugs or as models for pharmacologically active compounds." (WHO Fact Sheet N 134 September 1996) So, here we have the it, the real reason the WHO is behind the pharmaceuticalization and expropriation of traditional medicines, MONEY for drug companies.
Our South African situation is not unique however. We know that the WHO is working closely with 19 other Collaborating Centres in ten countries such as Belgium, China, Democratic People's Republic of Korea, Italy, Japan, Republic of Korea, Romania, Sudan, United States of America and Vietnam.
We have also noted that it is not only the WHO who are responsible for this bio-piracy endorcement. There is a growing amount of interest being shown of our bio-diversity by international pharmaceutical companies and their intermediary researchers. One example of a blatant bio-piracy operation in the development of an appetite suppressant drug called P57, which has been pirated by Physer Pharmaceuticals from an indigenous succulent of the Cape Karoo region. This company has sated that the financial potential of the marketing of this drug will exceed R1 000 000 000 billion. We ask how much of this will be given back to the community who led them to "their" discovery. Another recent bio-piracy situation involved the commercialization of a patented medicine soured from the African Potato. We know that the sale of this products over the last eighteen months has reached into the R 20 000 000 million mark, and will now be aggressively marketed overseas.
The pharmaceutical industry sector which is involved in traditional medicine research says that it is not patent-dependent; but it does pursue patents for many products.
Agreements often blur the lines between public (university) and private research, and between conservation and profit-seeking. Farmers and indigenous people have reason for concern about intermediaries that seek to negotiate bioprospecting deals on behalf of communities and then position themselves to receive and manage benefits earmarked for communities' sustainable use of biodiversity.
What is Bioprospecting and How Does it Relate to our Indigenous Peoples?
Recently in South Africa a genuine interest in various traditional practices exists among practitioners of modern medicine and growing numbers of practitioners of traditional, indigenous or alternative systems are beginning to accept and use some of the modern technology. This will help foster teamwork among all categories of health workers within the framework of primary health care. We truly believe that the government should primarily be using it's resources in encouraging traditional healers to become a part of the health care delivery system. However, it is noted that priority by means of financial grants and resource distribution is being focused on the bio-piracy scene and not the furtherance of the practice of traditional medicine in it's cultural form.
We believe the reasons for the inclusion of traditional healers in primary health care are manifold: the healers know the socio-cultural background of the people; they are highly respected and experienced in their work; economic considerations; the distances to be covered in some sub-regions; the strength of traditional beliefs; the shortage of health professionals, particularly in rural areas, to name just a few.
Biodiversity prospecting is the exploration, extraction and screening of biological diversity and indigenous knowledge for commercially valuable biochemical resources. While it is true that biodiversity prospecting does not always involve the use of indigenous knowledge, it is clear that valuable chemical compounds derived from plants, animals and microorganisms are more easily identified and of greatest commercial value when collected with indigenous knowledge and/or found in territories traditionally inhabited by indigenous peoples. It is a fact that bio-pirates have a 60% better chance of finding a cure with the help of a healer. (Rural Advancement Foundation International Report 1996)
On the positive side, the Convention recognizes that states have sovereign rights over their natural resources, and that terms and conditions for access to these materials are within the domain of national legislation. The Convention also recognizes the "knowledge, innovations and practices of indigenous and local communities" and specifically "encourage[s] the equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices"
The WHO states "In most countries the herbal medicines market is not adequately regulated, and the products are therefore unregistered and often not controlled by regulatory bodies. The establishment of regulation and registration procedures has become a major concern in both developed and developing countries" (WHO Fact Sheet N 134 September 1996)
As it stands, the Biodiversity Convention offers passive endorsement of bilateral contractual agreements that will pit indigenous communities and countries against one another. While multinational corporations are free to patent phyto-medicines, there are no effective guidelines and conditions defined for recognizing and rewarding the contributions of traditional healers, indigenous peoples and other informal innovators who are responsible for nurturing, using and developing natural health care worldwide.
Within the framework of the proposed and hurried regulations for the control of traditional medicines, we believe that safeguards should be imposed. Such safeguards should include active promotion of the clauses of the Biodiversity Convention and even a the writing of a local Biodiversity Section under the Department of art and Culture or Department of Trade and Industries
Scientific institutions, such as the University of Cape Town's TRAMED project seek access to traditional medicine knowledge for the primary purpose of developing profitable products. It is our contention, through a comparative study of other countries where traditional medicines are brought into the pharmaceutical arena that no matter how convincing the rhetoric, conservation and equity are secondary issues. Once indigenous peoples share traditional health information or plant material they effectively lose control over those resources, regardless of whether or not they are compensated.
Some people believe that current levels of technology will allow drug pharmaceutical companies and science-based institutions to undermine the importance of traditional medicine and respect for indigenous knowledge.
According to rough estimates, medicinal plants from the South Africa can contribute at least R2 billion a year to the pharmaceutical industry. It is conservatively estimated that the market for natural product research specimens (samples or extracts of biological materials) within the South African pharmaceutical industry alone is R20 million per annum. Not surprisingly, biological bounty hunters are in feverish pursuit. What is sad is that the money which is gained from these international bio-piarcy companies may not be plowed back into the South African economy, but siphoned out of the country to off-shore bank accounts.
We implore the State to assist in protecting intellectual integrity of indigenous and other rural peoples. It is important that South Africa stick to the principles of maintaining Biodiversity and culture. This includes the right of indigenous peoples, collectively, to benefit from their traditions and genius, and to be compensated for their ongoing role in conserving and creating useful biomaterials.
Intellectual integrity also means the right of indigenous communities to say "no" to bio-pirates, or to legitimate bio-prospectors. While it is proper and necessary to upgrade international accords related to "prior informed consent" (PIC) for the expropriation of indigenous knowledge, it is urgent that the Convention also acknowledge the right of nations and communities not to consent. Indeed, the assumption should be that communities have NO INTENTION OF CONSENTING (NIC). (Rural Advancement Foundation International)
In the absence of a convincing local and global ethic or clear intention on the part of the international community, indigenous communities and our national government have every right and reason to declare a moratorium on further resource collecting, new research agreements, and the SAMMDRA regulations regarding the sale of traditional medicines.
There is no moral reason, at any time, to permit the patenting of living products or processes. There is even less reason for South Africa to allow intellectual property over biomaterials when our own medicinal plants and indigenous knowledge lies unprotected and pirated by local and overseas corporations. Current intellectual property systems do not, and will not, protect the interests of informal community innovators.
We believe that indigenous peoples' organizations must receive financial support to ensure their full and effective participation in all decision-making for that which affects the conservation and use of indigenous medicine knowledge.
Unfortunately in the past it has been noticed that some groups positioning themselves between the pharmaceutical industry and local communities, such as academics of TRAMED, small bioprospecting companies, and even NGOs who have continued to facilitate self-serving deals.
The legislative control in respect of medicinal plants has not evolved around a structured control model. We urge the regulatory authorities to seriously re-consider their actions by bulldozing the Listing System for the registration of traditional medicines under the new South African Medicines, And Medical Devices Act.
We challenge the South African government to place a moratorium on the insidious over-regulation of traditional medicines in all their forms, and to engage in meaningful dialogue with the communities who are being exploited in this proposal. We believe that we should be aware that by following the WHO's resolutions to the last letter will alienate our people from the government and create a true sense of mistrust. Already, the traditional healers have requested a moratorium on the regulation and control of their biomaterials in the form of herbs and other traditional medicines. (Interim Coordinating Committee Of Traditional Medical Practitioners of South Africa - 27th Feb 1999) We hope that the State stops for a second, and listens to it's people in this regard.
Indigenous people have been so oppressed by the evils of the past, and now it looks like the cash king is to override the traditionalist's interest once again through non-representative groups who are calling for control without the input of the mandated healers or their communities.
Many of the traditional healers are beginning to question the motives behind the bio-piracy scam. Many bio-piarcy setups have exploited the indigenous peoples lack of recourse to legal challenge in the previous oppressive regime, but are now waking up to the reality of what has been happening and what may happen if the bio-piracy continues and is endorsed by our authorities without due regard of the people's wishes.
Many healers are now joining in a new struggle to preserve their cultural integrity and are actively canvassing for support in holting the expropriation of natural health substances by the pharmaceutical industry, the Medicines Control Authority, TRAMED, and the WHO.
We support them in their awakening and their call to strengthen South Africa's sovereignty, biodiversity, and cultural ethics. DECLARATION ON THE RIGHTS OF INDIGENOUS PEOPLES UNITED NATIONS
Indigenous individuals and peoples are free and equal to all other individuals and peoples in dignity and rights, and have the right to be free from any kind of adverse discrimination, in particular that based on their indigenous origin or identity.
Indigenous peoples have the collective and individual right not to be subjected to ethnocide and cultural genocide, including prevention of and redress for:
It is our contention that the implementation of the SAMMDRA and the expropriation of marketed traditional medicines will contribute to the ethnocide of traditional African medicine, because the healer/s will be hindered in their traditional practice by setting high fees and stringent, first world regulations over the sale and manufacture of their goods. The SAMMDRA will not allow the traditionalists to aspire to entering into the herbal market, because of financial, technical, educational, and legislative constraints set out in the SAMMDRA
a. any action which has the aim or effect of depriving them of their integrity as distinct peoples, or of their cultural values or ethnic identities;
Propaganda is clearly directed towards the indigenous healers by the SAMMDRA, by means of telling the healers that they will not be effected by the regulations. However it is still not known, by definition, what a packaged or marketed medicine is. Therefore it is considered wrong for the SAMMDRA to make such assumptions without any clear mandate being set which describes what is construed as "packed", "marketed", "labeled" or "bottled".
Indigenous peoples have the right to practice and revitalize their cultural traditions and customs. This includes the right to maintain, protect and develop the past, present and future manifestations of their cultures, such as archaeological and historical sites, artefacts, designs, ceremonies, technologies and visual and performing arts and literature, as well as the right to the restitution of cultural, intellectual, religious and spiritual property taken without their free and informed consent or in violation of their laws, traditions and customs.
It is believed that the SAMMDRA will restrict the sale of traditional medicines, which are often bartered or wholesaled throughout the country. In many cases healers use plant-based remedies which are imported from different regions. The restrictions of having herbs not being able to be packaged and wholesaled to different parts of the country will restrict the present and future manifestation of the culture. As all cultures grow, the SAMMDRA will hinder any further manifestations of the traditional healers scope of practice, which may include the entering into legitimate business by marketing his/her herbs available through health stores, pharmacies, muti stores, etc.
However, because of the social difficulties relating to low income in many cases, the regulations will make it impossible for healers and indigenous communities to develop a market which will be competitive with other forms of traditional medicines from the west, east, etc..
Indigenous peoples have the right to participate fully, if they so choose, at all levels of decision-making in matters which may affect their rights, lives and destinies through representatives chosen by themselves in accordance with their own procedures, as well as to maintain and develop their own indigenous decision-making institutions
Indigenous peoples have the right to participate fully, if they so choose, through procedures determined by them, in devising legislative or administrative measures that may affect them. States shall obtain the free and informed consent of the peoples concerned before adopting and implementing such measures.
Indigenous peoples have the right to determine and develop priorities and strategies for exercising their right to development. In particular, indigenous peoples have the right to determine and develop all health, housing and other economic and social programs affecting them and, as far as possible, to administer such programs through their own institutions.
Indigenous peoples have the right to their traditional medicines and health practices, including the right to the protection of vital medicinal plants, animals and minerals.
Indigenous peoples are entitled to the recognition of the full ownership, control and protection of their cultural and intellectual property. They have the right to special measures to control, develop and protect their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs and visual and performing arts
Indigenous peoples, as a specific form of exercising their right to self-determination, have the right to autonomy or self-government in matters relating to their internal and local affairs, including culture, religion, education, information, media, health, housing, employment, social welfare, economic activities, land and resources management, environment and entry by non-members, as well as ways and means for financing these autonomous functions.
It is noted with concern that the indigenous healers and peoples are not being offered the opportunity for self-determination in respect to the over-regulation of all natural health products, including traditional medicines. This is clearly evident with the absence of representative traditional healers on the CMC, who conceded to allowing the MCC and the Department of Health to include African traditional medicines in the SAMMDRA Act. This we believe is illegal and ill-considered , considering these members are not representative of any groupings. It is also noted that these members did not fulfill their basic function of bringing more representative people on board, nor passed on any information regarding the SAMMDRA to the indigenous communities during the two years of setting up the Listing System under the SAMMDRA. It is noted with concern that members who were supposed to be representing the indigenous community, had direct financial interests in natural health caremanufacturing, thereby allowing them and opportunity for self-interest.
Indigenous peoples have the right to have access to and prompt decision through mutually acceptable and fair procedures for the resolution of conflicts and disputes with States, as well as to effective remedies for all infringements of their individual and collective rights. Such a decision shall take into consideration the customs, traditions, rules and legal systems of the indigenous peoples concerned.
Traditional healers groupings, who represent the indigenous healers have on many occasions requested that the Ministry of Health, Department of Health, and the Medicines Control Council stop the deliberations of the CMC before the SAMMDRA was initiated in December 1998.
This has been done either by written protest or protest at meetings where such deliberation took place. Up until today, the State and it's mentioned organs have not conceded nor written back to acknowledge these grievances. This lack of just administrative action has led to the considered illegal and unenforceable SAMMDRA and it's regulations. More spurious however, was the expulsion of the indigenous healers mandated organizations, namely Health Freedom South Africa and PHARMAPACT in parliament in October 1998, when these issues, among others were to be raised.
Nothing in this Declaration may be interpreted as implying for any State, group or person any right to engage in any activity or to perform any act contrary to the Charter of the United Nations