This article has been written by Ms. Manisha Rahman , a LL.B. 3 years student of J.B. Law College, Guwahati ,Assam.

INTRODUCTION

Ancient Egyptian and Chinese  writings  had  describe herbal medicinal uses for plants as early as 3,000 BC.  Medicinal herbs Plants had been used for different purposes long before recorded history. Indigenous cultures such as in Africa and Native American ,middle eastern etc used herbs in their healing rituals, while others developed traditional medical systems such as Traditional Chinese Medicine and Siddha, Ayurveda, Unani  in which herbal therapies were used.” The consumption of plant-based medicines and other botanicals in the West has increased manifold in recent years. About centuries ago, our medicinal practices were largely dominated by plant-based medicines. However, the herbs which are medicinal  went into a rapid decline in the West  countries when more predictable synthetic drugs were made commonly available. In contrast, many developing nations continued to benefit from the rich knowledge of medicinal herbalism. For example, Siddha & Ayurveda medicines in India, Kampo Medicine in Japan and Unani medicine in the Middle East and South Asia etc. are still used by a  majority of people. In this article, we will explore Protection of traditional herbal knowledge in the Pharmaceutical industry- An Overview

Traditional  Herbal Medicine 

Traditional Herbal medicine refers to health practices, knowledge and beliefs incorporating plant, animal and mineral based medicines, spiritual therapies, manual techniques and exercises, applied singularly or in combination to treat, diagnose and prevent illnesses or maintain well-being. In industrialized countries, adaptations of traditional herbal medicine are termed “Complementary” or “Alternative” .

Recently there has been  seen a shift in universal trend from synthetic to traditional herbal medicine. These Medicinal plants have been known for millennia and are highly esteemed all over the world as a rich source of therapeutic agents for the prevention of diseases . Nature has bestowed our country with an enormous wealth of medicinal herbal plants. An India has often been referred to as the Medicinal Garden of the world. Countries with ancient civilizations such as  India, china, South America, Egypt, etc. are still using plant remedies for various conditions. In this regard India has a unique position in the world, where a number of recognized indigenous systems of medicine such as Ayurveda, Siddha, Unani, Homeopathy etc. are being utilized for the health care of people.  The herbal drugs are popular among urban as well as rural community of India. The only reason for this acceptability is belief that all natural products are safe. The demand for plant based medicines plants made products, food supplement etc are increasing in both developing and developed countries, due to the growing recognition that the natural products are non-toxic, have no side effects and easily available at affordable prices.

Herbal medicine is still in used about 55-80%of the population of the world, in the various developing countries, for primary health care.” This is because of the general belief that herbal drugs are without any side effects besides being locally available and cheap. According to the World Health Organization  report the use of herbal remedies throughout the world exceeds that of the conventional drugs by two to three times. The use of plants herbs for healing purposes predates human history and forms the origin of much modern medicine. Many conventional drugs originated from plant sources such examples include aspirin (willow bark), dioxin (from foxglove), quinine (from cinchona bark), and morphine (from the opium poppy).

Traditional Herbal Medicinal Plants and Its Market

Products derived from traditional knowledge have benefited the pharmaceutical industry greatly, and indigenous knowledge of plants has played a significant role. It nearly needs 15 years to be experienced and also very expensive as it costs $800 million for a single drug to be developed. Globally, almost 121 prescription drugs are made from plants almost half come from tropical countries. These Tropical countries are valuable for the richness of their  climatic conditions. 

The plant chemicals that have evolved to increase plants resistance may also provide protection and be therapeutically useful for human health . In the past, industries from the more developed north have taken the knowledge of the indigenous peoples of the less developed, but biologically diverse tropical countries and converted medicinal herbs into pharmaceutical products without providing any payment to the providers of the knowledge.

The global market for plant based drugs has been estimated at USD 178.23 million in 2023. There is an increasing number of  trend for the use of herbal medicines globally . Traditional herbal medicine has a dual meaning in Third World nations and  western- countries. Traditional herbal medicine in the developing countries and especially in the third world is not an alternative but is an essential component of their health systems because of its cost and easy access. When dealing with traditional herbal medicine, one is dealing with the  issues related to biodiversity preservation, conservation, protection, and promotion of cultural heritage and transfer of technology .

Traditional herbal medicines represent an alternative, an option, for people in modern countries. As well as forming the basis of modern medicine, in Europe, North America and Asia there is a growing need  annually for the popular and efficient herbal species . However, in Germany which has a strong traditional herbal medicine use and they used phyto-pharmaceutical (herbal medicine) preparations sold as over-the counter .

Agreement on Trade Related Intellectual Property Systems (TRIPS)

Since its inception, the Agreement on Trade Related Intellectual Property Systems (TRIPS), which imposes uniform standards for intellectual property protection, has raised considerable controversy, due to fears that its implementation may entail price increases for pharmaceuticals, which would reduce peoples’s access to the medicines they need, notably in developing countries.

So far, much of the discussion has focused on modern medicines. From a developing country’s perspective, when looking into the issue of IPR for modern medicines, the objectives are clear, and the strategies that can be used to achieve those objectives are known, though their implementation may be difficult. The same cannot be said with regard to traditional herbal medicine. TRIPS makes no reference to the protection of traditional knowledge; does not acknowledge or distinguish between indigenous, community-based knowledge and that of  industry. Traditional herbal medicine is intertwined with access to biological and genetic resources, and with the knowledge of local and indigenous communities regarding their therapeutic properties. Thus, at the national level, a careful assessment of the objectives and possible implications of Intellectual Property Right  protection of traditional herbal medicine should be cheak.

Protection of Traditional Herbal Medicinal Knowledge

 Protection of Traditional Herbal medicinal knowledge, it can mean the following:

(i) Preservation;

(ii) Promotion of its dissemination and use;

(iii) Control of its use (avoiding misuse);

(iv) Benefit sharing with its originators or holder.

Need for Protection

Realizing the advantages in this area,  pharmaceutical companies are behind acquiring this traditional herbal medicinal knowledge in a very  easiest manner. Traditional herbal  medicinal knowledge is treated as knowledge in the public domain for free exploitation without showing any respect or concern for the efforts taken by the communities to preserve and promote the same. So its high

 time that we should think  about protecting of the valuable traditional herbal knowledge associated with medicine.

Protection under Intellectual Property laws 

Recently, international attention has turned out to be  intellectual property laws to preserve, protect and promote traditional herbal  knowledge. The reasons for this are complex. In 1992, the Convention on Biological Diversity  recognized the value of traditional  herbal knowledge in protecting species, ecosystems and landscapes, and incorporated language regulating access to it and its use.

The international standards emerging out of the World Intellectual Property Organization and the Convention on Biological Diversity  are that firstly the development of any policies, laws or rules regarding traditional herbal knowledge and associated resources must involve the full and effective participation of indigenous and local communities; secondly access to traditional herbal knowledge and resources can only be obtained through the free, prior informed consent  of indigenous and local communities and thirdly  local communities and indigenous  have the right  to determine the form of benefit sharing, and use by others can only proceed on the basis of mutually agreeable terms between the custodians or holders of knowledge and resources and external parties resources and benefit sharing whether by explicit laws introduced nationally or regionally in response to the Convention on Biological Diversity  . Access,  in this context, means permission to use traditional herbal medicinal knowledge for research, industrial application or commercial exploitation. This was considered to be a safeguard against exploitation.

Access and Benefit Sharing

Benefit sharing was originally seen as a way to bring justice and equity to the holders of traditional herbal medicinal knowledge. In 1990’s it became one of the important pillars of the Convention on Biological Diversity which calls for fair and equitable sharing of benefits arising out of the utilization of genetic resources. But now it is moving in the different direction. Governments and corporate lawyers negotiate benefit-sharing agreements while the local communities are not aware of this. The best-known case relating to benefit sharing is worth mentioning. It relates to a medicine that is based on the active ingredient in a plant, Trichopus zeylanicus, found in the tropical forests of southwestern part of India or western ghats  and collected by the Kani tribal people who reside there. Scientists at the Tropical Botanic Garden and Research Institute  in Kerala learned of the plant, which is claimed to be good for  the immune system and provide additional energy. These scientists isolated and tested the ingredient and incorporated it into a compound, which they call  Jeevani’, the giver of life. The tonic is now being manufactured by a various  Ayurvedic  drug company in Kerala. In 1995, an agreement was struck to share the license fee and 2% of sales of the product as of the product as royalty, that was receivable by Tropical Botanic Garden and Research Institute , will be shared on a fifty-fifty basis with the tribe. This marks perhaps the first time that for Intellectual Property  held by a tribe, compensation in the form of cash benefits has gone directly to the source of the holders. This case has become  one of the important case study related to traditional herbal knowledge.

Role of Geographical Indications in protection of traditional herbal knowledge

 Traditional herbal products often have specific geographical origins that contribute to their quality and reputation. Geographical indication can protect these  identities of the region and prevent unauthorized use. Dishonest use of Geographical indications by fake parties is detrimental to consumers and legitimate producers. Geographical indications are part and parcel of the culture and traditions of a nations. Unlike patents or copyrights, which have limited terms of protection and therefore would not be suitable for the protection of traditional herbal knowledge, geographical indications may be capable of protecting some forms of traditional knowledge and if properly regulated. Most products falling under geographical indications enjoy an  premium owing to their quality or other features which creates a demand for them in the market. The same principle holds good for traditional herbal knowledge as well. Rapid Industrializations and technological advancement have little role in the production of these goods. Considering the low technology and low-cost methods of production, there is an assured higher stream of income for the producers. Such income derived from the geographical indications can eventually be given back into the traditional communities for putting in place systems for better organizing themselves and providing legal and statutory protection to the geographical indications.

Conclusion 

The growing awareness of the various traditional herbal medicinal systems of the world has led the powerful and wealthier Pharmaceutical companies of the world to go on for Patenting various traditional herbal medicine in there own name and brand in a wrongful manner through fake documents. Therefore in order to protect the traditional herbal knowledge and the natural resources of the entire world from unethical practices, we need to properly formulate and implement the Intellectual Property Rights to protect and increase the production of traditional herbal medicines including the Ayurvedic ,Unani, siddha etc. medicines developed from medicinal herbs in the developing and underdeveloped countries of the world to eradicate poverty and help them to maintain a  balanced life. The traditional herbal medicinal knowledge which is not yet in the public domain can be protected as trade secrets. But the most essential thing which is needed is compatibility between the  Customary laws and legislations. Intellectual Property rights are not the only way to of protecting traditional herbal medicinal knowledge. Also awareness of the people related to these traditional herbal medicines.

References

https://www.academia.edu/10177228/TRADITIONAL MEDICINE

https://www.sciencedirect.com/science/article/abs/pii/S0277953602004252 

https://herbni.com/eng/herbal_medicine_history/

https://www.krushilakshmi.com/service/ayurvedicherbal

https://www.researchgate.net/publication/289791244_Side_effects_of_some_medicinal_plants

https://legalservicesindia.com