» Access and Benefit Sharing
 
 
    Access - to genetic resources means to obtain samples of biological and/or genetic material from areas within national jurisdiction for purposes of research, on conservation, commercial application or industrial use.
 
     Benefit Sharing - refers to equitable sharing of benefits, on agreed terms, arising from the use of biological and/or genetic material with the providers of the material.

    While concerns for the environment were expressed in history but sincere efforts started in 1987 by the World Commission on Environment and Development Programmes. The efforts by UNEP culminated in the largest ever meeting of the world leaders commonly known as Convention on Biological Diversity in 1992 at Rio de janeiro, Brazil. It was the first time when the need for environmentally sound economic development was recognized globally. A historic set of agreements were signed during the convention.

    Convention on Biological diversity is the first international legal instrument that brought out a radical change from the then prevailing common perception on genetic resources as common heritage of mankind to a legally binding regime that confers sovereign rights to the states over their own biological resources including genetic resources and traditional knowledge. Following are the three core objectives of the Convention-
  • Conservation of Biodiversity.
  • Sustainable use of the Components.
  • Sharing of the benefits arising from the commercial and other utilization of genetic resources in a fair and equitable way.
     Showing its concern for the conservation and to fulfill the commitments to CBD India enacted Biological Diversity Act in the year 2002 and Biological Diversity Rules in 2004.

    The main intent of this legislation is to protect India’s rich biodiversity and associated knowledge against their use by individuals and organizations without sharing the benefits arising out of such use and check bio-piracy. The act has created a three tier institutional mechanism-
  • National Biodiversity Authority at the apex based at Chennai
  • State Biodiversity Boards in all the states
  • Biodiversity management committees at the level of all local bodies.
    The BD Act 2002 stipulates norms for access to biological resources and traditional knowledge based on three ways-
  • Access to biological resources and traditional knowledge to foreign citizens companies and NRIs based on prior approval of NBA Chennai.
  • Access permits to Indian citizens, Companies Associations and other organizations registered in India on the basis of prior intimation to the State Biodiversity Board concerned (Section 7).
  • Exemption of prior approval or intimation for local people and communities including growers cultivators of biodiversity, vaids and hakims who have been practising indigenous medicines (Section 7).
    Before this legislation, access to biological resources for research, commercial use and taking IPR was an unregulated domain. Historically, plant genetic resources were used for commercial purpose outside their region of origin. Bio-prospectors searched for natural substances to develop new commercial products. Often the products would be sold and protected by the patents by IPR without any sharing with the source container.

     Considering the national sovereignty over the genetic resources, the Act empowers NBA, SBBs and BMCs to regulate access to the biological resources within their jurisdiction. .It also says that access to valuable genetic resources be carried out on mutually agreed terms and subject to the prior informed consent of the BMC of the place/area of its origin. Industries and the commercial users of the bio-resources should share the benefits/profits again on mutually agreed terms and conditions
Access and Benefit Sharing includes-
  • Prior informed consent
  • Mutually agreed terms
  • Benefit sharing agreements through monetary and non monetary means.
Prior informed Consent
    It is a set of administrative procedures for deciding on whether to grant access to genetic resources on defined terms.
Getting a prior informed consent (PIC)
  • PIC has to be sought from the owners of the resources.
  • In accordance with article 15, paragraph 5 of CBD access to genetic resource shall be subject toPIC of the contracting party providing such resources.
  • There must be legal clarity and certainty.
  • There must be consent of the relevant competent authority as well as the local community.
  • There must be timings and deadlines.
  • Specification of uses.
  • Mechanism for consultation of relevant stake holders.
Information to be provided for obtaining prior informed consent-
An application for access could require the following information to be provided in order for the competent authority to determine whether or not access to genetic resources should be granted:-
  • Legal entity and affiliation of the applicant and/or collector and contact person when the applicant is an institution.
  • Type and quantity of genetic resources to which access is sought.
  • Starting date and duration of the activity.
  • Geographical prospecting area.
  • Evolution of how the access activity may impact on conservation and sustainable use of biodiversity to determine the relative costs and benefit of granting access.
  • Accurate information regarding intended use (e.g. taxonomy, collection, research, commercialization).
  • Identification of where the research and development will take place.
  • Information on how the research and development is to be carried out.
  • Possible third party involvement.
  • Purpose of the collection, research and expected results.
  • Kinds/types of benefit that could come by obtaining access to the resource, including benefit from derivatives and products arising from the commercial and other utilization of the genetic resources.
  • Indication of benefit-sharing arrangements.
  • Budget.
  • Treatment of confidential information.
Permission to access genetic resources does not necessarily imply permission to use associated knowledge and vice versa.
Mutually agreed terms-

    In accordance with Article 15, Paragraph 7 of the Convention on Biological Diversity, each contracting party shall “ take legislative , administrative or policy measures, as appropriate with the aim of sharing in a fair and equitable way the results of research and development and the benefit arising from the commercial and other utilization of genetic resources with the contracting party providing such resources. Such sharing shall be upon mutually agreed terms”.

Basic requirements for mutually agreed terms -
Following could be considered for development of mutually agreed terms-
  • Legal certainty and clarity regarding terms and conditions.
  • Provision on user and provider obligation.
  • Contractual arrangements for different resources and for different uses and development of modal agreements.
  • Mutually agreed terms should be negotiated efficiently and within a reasonable period of time.
  • Mutually agreed terms should be set out in a written agreement.
  • Regulating the use of resources in order to take into account ethical concerns of the particular parties and stakeholders, in particular indigenous and local communities concerned.
  • Provision to ensure the continued customary use of genetic resources and related knowledge.
  • Provision for the use of intellectual property rights include joint research, obligation to implement rights obtained on inventions and to provide licenses by mutual consent.
  • The possibility of joint ownership of intellectual property rights according to the degree of contribution.
  • Type and quantity of genetic resources, and the geographical/ecological area of activity.
  • Any limitations on the possible use of the material.
  • Recognition of the sovereign rights of the country of origin.
  • Capacity-building in various areas to be identified in the agreement.
  • A clause on whether the terms of the agreement in certain circumstances (e.g. change of use) can be renegotiated.
  • Whether the genetic resources can be transferred to third parties and conditions to be imposed in such cases, e.g. whether or not to pass genetic resources to third parties without ensuring that the third parties enter into similar agreements except for taxonomic and systematic research that is not related to commercialization.
  • Whether the knowledge, innovations and practices of indigenous and local communities have been respected , preserved and maintained, and whether the customary use of biological resources in accordance with traditional practices has been protected and encouraged.
  • Treatment of confidential information.
  • Provision regarding sharing of benefits arising from the commercial and other utilization of genetic resources and their derivatives and products.
Benefit-Sharing
  • Mutually agreed terms could cover the conditions, obligations, procedures, type, times, distribution and mechanisms of benefits to be shared. These will vary depending on what is regarded as fair and equitable in light of the circumstances.
  • Types of benefit - Monetary and non-monetary benefits.
  • Timing of benefits- Near- term, medium-term and long-term benefits should be considered, including up-front payments, milestone payments and royalties. The time- frame of benefit-sharing should be definitely stipulated. Furthermore, the balance among near-term, medium-term and long term benefit should be considered on a case-by-case basis.
  • Distribution of benefit-Pursuant to mutually agreed terms established following prior informed consent, benefits should be shared fairly and equitably with all those who have been identified as having contributed to the resource management, scientific and /or commercial process. The latter may include governmental, non-governmental or academic institutions indigenous and local communities. Benefit should be directed in such a way as to promote conservation and sustainable use of biological diversity.
  • Mechanisms for benefit sharing – Mechanisms for benefit-sharing may vary depending upon the type of benefits, specific conditions in the country and the stakeholders involved. The benefit sharing mechanism should be flexible as it should be determined by the partners involved in benefit sharing and will vary on a case-by-case basis.
  • Mechanisms for sharing benefit should include full cooperation scientific research and technology development, as well as those that derive from commercial products including trust funds, joint ventures and licenses with preferential terms.
IPR over the Bio-resource
BD Law and IP Law
Section 6 of the BD Act:
  • No person shall apply for any IP right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the NBA before making such application:
    Provided that if a person applies for a patent, permission of the NBA may be obtained after the acceptance of the patent but before the sealing of the patent by the patent authority concerned:
    Provided further that the NBA shall dispose of the application for permission made to it within a period of ninety days from the date of receipt thereof.
  • The NBA may, while granting the approval under this section, impose benefit sharing fee or royalty or both or impose conditions including the sharing of financial benefits arising out of the commercial utilization of such rights.
  • The provisions of this section shall not apply to any person making an application for any right under any law relating to protection of plant varieties enacted by Parliament.
  • Where any right is granted under law referred to in sub-section (3), the concerned authority granting such right shall endorse a copy of such document granting the right to the National Biodiversity Authority
 
 
 
 
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