View of THE CHANGING PHASE OF ECOLOGY AND ECONOMY IN INDIA: EFFECTS OF LEGAL MECHANISMS ON MEDICINAL PLANTS SECTOR

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Vol.03, Issue 01, January 2018 Available Online: www.ajeee.co.in/index.php/AJEEE

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THE CHANGING PHASE OF ECOLOGY AND ECONOMY IN INDIA: EFFECTS OF LEGAL MECHANISMS ON MEDICINAL PLANTS SECTOR

Dr. L. Pushpa Kumar

Associate Professor (Environmental Law and Policy) Nalanda University, Rajgir, Bihar

Dr. V. Arivudai Nambi

Research Director, Vaigai Flora Botanical Garden Covenant Centre for Development, Madurai, Tamil Nadu

Abstract - Medicinal plants sector creates an amalgamation of ecology, economy and engineering. Biotech, health and cosmetic products derived out of medicinal plants significantly contribute to the economy of the country. Biotech industry uses medicinal plants to make new products using genetic engineering. India has enacted a few enactments that have major implications on the way the biological resources are used in the country.

This interdisciplinary research paper probes into the legal implications on the medicinal plants sector by three enactments namely, “the Geographical Indications of Goods (Registration and Protection) Act 1999, the Protection of Plant Varieties and Farmers’ Rights Act 2001 and the Biological Diversity Act 2002” from the point of view of access and ownership of biological materials from the wild, wastelands and commons and private lands and their commercial use. The paper concludes by stating that these laws will have far reaching impacts on collection and research of medicinal plants and production of drugs and preventive and curative health care products and cosmetics made out of them. All these developments will have far reaching ramifications on ecology and economy of the country including price raise due to the cost of compliance of laws.

Keywords: Medicinal Plants, Geographical Indications, Farmers’ Rights, Biological Diversity, Intellectual Property Rights.

1. INTRODUCTION

A large number of pharmaceutical and phytopharmaceutical industries directly depend on biological resources for their raw materials. With the increased health consciousness among people and their preference towards nature based medicines, the medicinal plants sector is constantly on its expansion (Karunamoorthi, K. 2013).

Traditional medicine systems use medicinal plants. Since the medicinal plants are found plenty in nature and available for affordable cost, a large number of local people in developing countries get access to affordable healthcare. According to the World Health Organization (WHO) traditional and complementary medicine (T&CM) sector “plays a significant role in the economic development of a number of countries” and with the “current global financial constraints, use of T&CM for health promotion, self-health care and disease prevention may actually reduce health-care and disease prevention may actually reduce healthcare costs” (WHO, 2013). It is estimated that about 80% of the World’s population relies on the traditional medical systems (Ekor, 2014). In India alone, about 65% of people rely on herbal and traditional medicine for primary health

care. It has been estimated that about 6000 medicinal plants are in use in India out of that about 90% are collected from the forests (UNDP, 2015). Hence, there is a strong need to conserve medicinal plants and develop the medicinal plants sector to cater to the needs of millions of people that depend on traditional medicine for health care. Recent international and national efforts to regulate and streamline the access and utilization mechanisms pertaining to biological resources have far reaching impacts on the medicinal plants sector.

This invited interdisciplinary research paper outlines the implications on the medicinal plants sector by three enactments namely, “the Geographical Indications of Goods (Registration and Protection) Act 1999, the Protection of Plant Varieties and Farmers’ Rights Act 2001 and the Biological Diversity Act 2002” from the point of view of access and ownership of biological materials from the wild, wastelands and commons and private lands and their commercial use.

2. INTERNATIONAL LEGAL DEVELOPMENTS

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At the international level a paradigm shift has occurred in the area of biological diversity. This has been largely due to the monopolistic approaches made towards biological resources and attempts to fix intellectual property rights over them. This position has been strengthened and given shape by various international agreements and conventions like Convention on Biological Diversity (CBD), International Union for the Protection of New Varieties of Plants (UPOV), Agreement on Trade Related Intellectual Property Rights (TRIPS) and other legal instruments.

The Convention on Biological Diversity (CBD, 1992) recognizes the

“sovereign rights of the States over their biological resources and provides that the authority to determine access to genetic resources would be within the control of national governments and subject to national legislation.” The CBD mandates member countries to introduce legal mechanisms to provide effective participation in biotechnological research activities and make provisions for fair and equitable access to the genetic resources based on prior informed consent (PIC) and sharing of benefits arising from biotechnologies on mutually agreed terms.

Further, the Convention creates obligations for transfer of technology while giving due regard to intellectual property rights of the rights holders. CBD mandates due respect, recognition and reward in terms of benefit sharing to the indigenous and local communities for the use of their knowledge, innovation and practices for pharmaceutical research or commercial utilization. (CBD, 1992).

The Agreement on Trade Related Intellectual Property Rights establishes firm rules for protection of intellectual property in its varying forms. The TRIPS Agreement recognizes “seven categories of intellectual property rights namely, copyrights, trademarks, geographical indications, industrial designs, patent, lay out designs of integrated circuits and protection of undisclosed information, otherwise called trade secrets” (TRIPS, 1995).

As per the TRIPS Agreement, patent protection will be provided to “all kinds of inventions, whether products or processes, in all fields of technology, provided that they are novel and involve an inventive step and are capable of industrial application.” TRIPS Agreement obligated all member countries

to provide for the protection of plant varieties “either by patents or by an effective sui generis system or by any combination” (TRIPS, 1995).

The TRIPS Agreement stipulates the member countries to protect the geographical indications by legal means, by way of preventing the misuse of indications as to the origin of goods and unfair competition. The TRIPS makes it clear that unless geographical indications are protected in the countries of its origin, there is no obligation for other countries to extend reciprocal protection. This has obligated the signatory countries to make laws for protection of geographical indications of agricultural varieties and goods available in their countries. With regard to medicinal plants, copyrights, trademarks, geographical indications and patents assume greater importance.

The UPOV Convention as revised in 1991 extended the scope of breeders’ rights and ensured the plant breeders of new plant varieties the right to a special title of protection for both “sexually and asexually reproduced plants of botanical varieties.” As a result of this Convention, “prior authorization is required for production purposes of commercial marketing, offering for sale and marketing of the reproductive or vegetative propagating material of the protected variety” (UPOV, 1991).

In order to give effect to the international agreements and conventions, India has enacted “the Geographical Indications of Goods (Registration and Protection) Act 1999, the Protection of Plant Varieties and Farmers’ Rights Act 2001 and the Biological Diversity Act 2002.” All these enactments have large scale ramifications over the functioning and future of the medicinal plants sector in India.

The bulk of medicinal plants are collected from the wild, while some are cultivated in private lands. While the Biological Diversity Act 2002 deals with access of collections from the wild, the Protection of Plant Varieties and Farmers’

Rights Act 2001 regulates new plant varieties registered under the Act and the Geographical Indications Act 1999 comes into play at the stage of marketing and trade (Fig.1).

3. THE PROTECTION OF PLANT VARIETIES AND FARMERS’ RIGHTS ACT, 2001

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The Protection of Plant Varieties and Farmers’ Rights Act (PPVFR, 2001) provides for registration of plant varieties. There are innumerable plant varieties, vegetables, fruits and grains with known medicinal values that have been identified, improved and applied by farmers for myriad of ailments from time immemorial. Foods as healers have also been well understood by people and as such many food-processing industries and health care units are using these plant varieties in making medicines, preventive and curative health care products and cosmetics. The act facilitates registration of farmers’ varieties, extant varieties and new varieties. In the case of registration of plant varieties and development of new varieties, the concept of farmers’ rights and breeders’ rights will be strongly felt in the domain of medicinal plants also.

Any person or institution developing new varieties of medicinal plants or food crops with medicinal characteristics can register such varieties under the Act and acquire the intellectual property rights called Plant Breeders’ Rights. Registration of a plant variety will grant the farmer or breeder, exclusive rights to produce, process and market the seed of the registered variety during the period of registration. Consequently no other person can produce or commercialize the seed of such variety without the permission and license from the right holder. This will control access to registered varieties and in some respect determine the quantum of movement of medicinal plants and production of medicinal products.

4. THE BIOLOGICAL DIVERSITY ACT, 2002 AND ITS IMPLICATIONS

The Biological Diversity Act is an overarching enactment that has large-scale implications on the medicinal plant sector in all stages from collection to production.

The Act created a three level regulatory authorities consisting of the National Biodiversity Authority (NBA), State Biodiversity Boards (SBB) and Biodiversity Management Committees (BMC) at the local level.

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Protection of Plant Varieties and

Farmers’ Rights Act, 2001 Biological Diversity Act, 2002

Fig.1 Three Indian Legislation and their functional structure

Central Govt.

National Bio. Authority

State Bio. Board

Bio. Mgt. Committee

National Bio. Fund

State Bio. Fund

Local Bio. Fund State Govt.

Local Body

Annual Report Recommendation to protect TK Contribution for NBA

Designate repositories Exclude some items

Contribution for SBB

Mgt. of Heritage sites

Consultation by NBA – socio eco development Punchayat / Municipality

Heritage sites in consultation with Local Bodies Rules for heritage sites in consultation with State Govt.

Contrib- utions

Annual Report

Central Govt.

National Bio. Authority

State Bio. Board

Bio. Mgt. Committee

National Bio. Fund

State Bio. Fund

Local Bio. Fund State Govt.

Local Body

Annual Report Recommendation to protect TK Contribution for NBA

Designate repositories Exclude some items

Contribution for SBB

Mgt. of Heritage sites

Consultation by NBA – socio eco development Punchayat / Municipality

Heritage sites in consultation with Local Bodies Rules for heritage sites in consultation with State Govt.

Contrib- utions

Annual Report

Geographical Indicators of Goods (Registration and Protection Act, 1999)

Central Government

Appellate Board

Registration of Authorised User Registration of G I

G I Registry

Geographical Indicators of Goods (Registration and Protection Act, 1999)

Appellate Board

G I Registry

Appellate Board

G I Registry Central Government

PPVFR Authority Plant Variety Registry Plant Variety Protection Appellate Tribunal

Farmers’ Rights Plant Breeders’ Rights

National Register of Plant Varieties Registration of;

-Farmers’ varieties -Extant varieties

-New varieties

PPVFR Authority Plant Variety Registry Plant Variety Protection Appellate Tribunal

Farmers’ Rights Plant Breeders’ Rights

National Register of Plant Varieties Registration of;

-Farmers’ varieties -Extant varieties

-New varieties

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4.1 Need for Prior Approval

The Act contains different sets of provisions for Indians and non-Indians. If a Non- Indian entity or person wants to access biological materials or traditional knowledge from India, for “research or for commercial utilisation or for bio-survey or bio- utilisation,” approval from the NBA has to be received.

Indian citizens or organizations should get approval from the SBB for obtaining any medicinal plant for commercial utilization. Even though the Act mentions that prior intimation has to be given to the SBB, many states have made rules to the effect that approvals are required. If it is merely for research purposes or collection of biological materials for non-commercial use, Indian entities need not get approval from the SBBs. Approvals ae not needed for local people and communities, including vaids and hakims, who have been practicing traditional medicine.

As most of the dealings in the medicinal plants sector involve non-Indian participation, prior approval of the NBA is essential for access, transfer, research, and commercial utilization and for obtaining patents or other kinds of intellectual property rights. It has been felt by the medicinal plants traders that cumbersome procedures and delay in granting approvals would affect research and industrial ventures in medicinal plants sector.

However, the National Biodiversity Authority and State Biodiversity Boards have established enabling mechanisms to provide access to biological resources for anyone who needs for commercial utilisation. There are many actors involved in collection, trade, research, manufacturing and commercialization medicinal plants. If the trader is an Indian, an approval from State Biodiversity Board is required as per the State Biodiversity Rules of many states. Nevertheless, it would be a daunting task for the State Biodiversity Boards to implement the Biological Diversity Act against the traders as they deal in different states. The challenging task would be to identify and differentiate the resources collected from different states.

The State Biodiversity Boards have to go by the declarations made by the traders.

Transfer of Results

Any transfer of research results relating to medicinal plants by an Indian entity to a non-Indian entity needs approval from the NBA. However, this provision will not apply to collaborative research projects.

Benefit Sharing

Any non-Indian entity intends to obtain any biological resource that includes medicinal plant varieties from India or any knowledge relating to that they have to share the benefits of profits to the NBA as decided by mutual agreement. Anyone, whether Indian or non-Indian entiry, who wants to apply for patent or any other IPR protection for the invention involving medicinal plant or knowledge should also pay benefit sharing to for the use of medicinal plant or knowledge.

The NBA will determine benefit sharing while granting approval. The Act contains detailed provisions for determination of benefit. These include These include monetary as well as non- monetary benefits such as “joint ownership of intellectual property rights to the National Biodiversity Authority, or where benefit claimers are identified, to such benefit claimers; transfer of technology;

location of production, research and development units in such areas which will facilitate better living standards to the benefit claimers; association of Indian scientists, benefit claimers and the local people with research and development in biological resources and bio-survey and bio- utilization; setting up of venture capital fund for aiding the cause of benefit claimers; payment of monetary compensation and other non-monetary benefits to the benefit claimers as decided by the National Biodiversity Authority.” On behalf of the Government of India, the NBA will take stept to oppose intellectual property rights granted outside India on any biological resource or associated knowledge originating from India. This will prevent bio- piracies in the field of medicinal plants as happened in the cases of turmeric and neem.

Access Fees

The Act envisages establishment of a Biodiversity Management Committee (BMC) in every local body. The BMCs have to take care of the medicinal plants and other biological diversity available within the local body limits. The BMC is also expected to

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document the details of biological resources and local knowledge relating to the biodiversity. The BMCs may charge collection fees from the persons taking medicinal plants with jurisdiction of the local body.

This provision will have a direct effect on medicinal plant growers, gatherers, and traders. This will have direct implications on all forms of collection of medicinal plants from wild, wastelands and commons and private lands. The Act does not mention about the mechanism involved in providing access to medicinal plants found in the forestlands that is not under the jurisdiction of any BMC. The Act is also silent about who will fix the access fees for different species of medicinal plants and the rationale behind it.

Penalties

The penalties prescribed under the Act are stringent. Offences are congnizable and non-bailable. Anyone who contravenes the provisions of law will be punishable with a maximum of 5 years of imprisonment or with a fine up to 10 lakh Indian Rupees. If the damage caused to biodiversity goes beyond 10 lakh rupees, the fine imposed will be equivalent to the damage caused.

Anyone fails to follow the direction or order passed by the NBA or SSB or by the Central or State Government, and if no punishment is prescribed in the Biological Diversity Act separately, the fine will be maximum of one lakh rupees. If there is a second or subsequent offence, the fine may extend to two lakh rupees. If there is continuous violation, an additional fine may be imposed which may extend to two lakh rupees every day during which the default continues.

5. IMPLICATIONS OF GEOGRAPHICAL

INDICATIONS OF GOODS

(REGISTRATION AND PROTECTION) ACT 1999 ON THE MEDICINAL PLANTS SECTOR

Geographical indications act as source identifiers of originating territory, region or locality and indicators of quality of agricultural and manufactured goods. Some species found or cultivated in specific geographical locations exhibit special characteristics. For example, Sanna (Cassia angustifolia) and Periwinkle (Catharanthus roseus) have a long history of cultivation in Tamil Nadu and they are considered as

traditional medicinal plants having wider acceptability the world over for their incomparable biochemical compounds. To be particular, Thirunelveli Sanna or Avuri is considered as the best only natural laxative in the whole plant kingdom and being accepted throughout the world. There are several other such examples like Bacopa moneri from West Bengal and Thirukoilur Tuthuvilai (Solanum sp) which are known for their unique medicinal properties attributed to particular geographical region.

The Geographical Indications of Goods Act provides for the registration of geographical indications of goods and authorized users. Medicinal plants and finished products having special characteristics and curative value can be registered under the Act. If such registration is obtained for a variety or a good, the same cannot be cultivated or manufactured in any other location in the same name, apart from the region they belong to. This Act will protect the interests of producers of medicinal goods and enable them to achieve their due share in the global market at the same time safeguarding the intellectual property rights of the producers.

6. IMPLICATIONS FOR THE MEDICINAL PLANTS SECTOR

The challenges posed by the CBD and the dichotomy created by TRIPs agreement have placed the trade in biological resources, more specifically, medicinal or herbal resources and related products in a critical position compelling traders and bio- prospecting industries to think in terms of social justice, equitable benefit sharing, protection of innovations and products by way of patents and other forms of intellectual property rights.

With the introduction of Geographical Indications of Goods (Registration and Protection) Act 1999, the Protection of Plant Varieties and Farmers’

Rights Act 2001 and Biological Diversity Act 2002 in India, trade and market access to biological resources and products derived out of them are experiencing a new era of transition. While the Protection of Plant Varieties and Farmers’ Rights Act will control the access and supply of a substantial quantum of varieties registered under the Act, the Biological Diversity Act will comprehensively regulate various aspects of access and benefit sharing issues

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relating to medicinal plants, research, transfer of materials and knowledge, export and import of medicinal plants and intellectual property rights. The Geographical Indications of Goods (Registration and Protection) Act, on the other hand will protect the market interests of agricultural and manufactured goods based on their geographical indication. All major players and stakeholders involved in the medicinal plants sector must be familiar with the provisions of these enactments and their implications and prepare themselves to make use of them for their benefit.

7. CONCLUSION

In this charged scenario, a change of perception is considered necessary from the perspective of the medicinal plant traders and those involved in genetic engineering.

Conservation of biological resources, prior informed consent (PIC) for access to biological resources, and fair and equitable benefit sharing for utilization of biological resources and traditional knowledge (TK) are accepted to be the norms of the day and wheels of bio-prospecting industry and trade. Medicinal plants sector is not an exception to this. Due respect for conservation efforts and TK and equitable benefit sharing will facilitate continuous and uninterrupted flow of materials for medicinal plant trade and commercial utilization. Furthermore, a fair benefit sharing process followed by a trader or a bio-prospecting industry will gain credibility points among the traditional knowledge holders and more new TK would be revealed to them for value addition and bio- prospecting. Compliance with the above laws will undoubtedly increase the cost of research and production. Natural habitats and ecological conditions of medicinal plants need to be preserved to have sustainable use of medicinal plants. This

will provide a new impetus for medicinal plant research and enable the trader/

industry to produce new drugs and products thereby promoting their business interests at the same time conserving biological resources and enhancing the livelihood conditions of rural communities.

REFERENCES

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4. Anon. 1999, The Geographical Indications of Goods (Registration and Production) Act (Act No.48 of 1999).

5. Anon. 2001, The Protection of Plant Varieties and Farmers’ Rights Act (Act 53 of 2001) 6. Anon. 1992, The Convention on Biological

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