Indian R & D merits fair deal

The Biodiversity Bill is a serious deterrent to biological research since it mandates approvals before a research project involving biomaterials is initiated, says M. D. Nair.

THE BIOLOGICAL Diversity Bill 2000, awaiting Parliamentary sanction and Presidential approval, is a landmark legislation aimed at protecting India's bio-assets and ensuring equitable benefit sharing by the users and the owners. The Bill provides no incentives for indigenous research efforts in the area; on the other hand, it is a major deterrent in view of the proposed participation of parties in the decision-making process, some of whom are least qualified for the job. Several layers of bureaucratic intervention will slow down and make India non- competitive in research on bio-resources.

Bill No. 93 of 2000 was tabled in Parliament on May 15. Christened the Biological Diversity Bill 2000, it is intended "to provide for conservation of Biological Diversity, sustainable use of its components and equitable sharing of the benefits arising out of the use of biological resources and for matters connected therewith or incidental thereto". This preamble is the same as the objectives spelt out at the Convention on Biological Diversity (CBD) signed in 1992 at the U.N. Conference on Environment and Development (UNCED) at Rio de Janeiro, also known as the Earth Summit. While 150 countries signed the treaty, the U.S. was an exception, arguing that it will set back research efforts in biotechnology and protection of intellectual property. Subsequently, the U.S. Congress agreed to ratify the treaty in 1993 and decreed that current U.S. laws were adequate to implement the terms of the treaty.

According to the decisions taken at the CBD, every contracting state was expected to develop strategies and programmes backed by appropriate legislations to realise the general objectives of the treaty. While conservation and sustainable use are the accepted principles of the CBD, Articles 15, 16, 19, 20 and 21 deal with the sovereign rights of states over their natural resources and their transfer for research or commercial purposes to other parties based on equitable benefit sharing with the owners of the resources.

The compulsions for including the above provisions at the CBD were to protect the rich biodiversity of developing countries from exploitation by the technology-rich developed countries, and at the same time to ensure that these bio-assets were effectively utilised exclusively by the owners for reaping economic benefits and growth.

The Indian Bill and its implications

Eight years after the CBD was signed in 1992, the Biological Diversity Bill, which has undergone several reviews since it was first drafted four years back, is now ready for approval by the Indian Parliament. Apart from the basic mandates of CBD largely related to conservation and sustainable utilisation of bio- resources with equitable benefit sharing between users and owners, it says very little of the needs for incentives for the effective utilisation of and value addition to the natural and rich bio-resources available in India.

The Bill's primary focus is on control over transfer and use of Indian genetic resources by foreign parties including individuals and corporations. The two-tier approval system stipulates that all research and commercialisation projects of foreign parties, alone or in collaboration with nationally based parties, on Indian bio-materials have to be sanctioned by the apex body, the National Biodiversity Authority (NBA).

As far as approval for work on bio-resources by Indian nationals, research laboratories and corporations is concerned, the competent authority is the State Biodiversity Board (SBB). The NBA consists of the chairperson and 13 members of whom 8 are ex- officio members representing various Central Ministries and 5 non-official members drawn from specialists, scientists, industry, conservers, creators and knowledge holders of biological resources. All questions which come up before the NBA are to be decided by a majority of votes of the members present. Similarly, the SBB has, besides the chairperson, five ex-officio members to represent the departments of the State government and five experts in conservation of biological resources and equitable sharing of benefits.

IPR issues

The document is silent on the patentability or otherwise of innovations made based on the use of Indian bio-resources. However, the NBA may take steps to oppose grant of IPR in any country outside India on any biological resource or knowledge obtained from India. Applications for patents or any other form of IPR have to be cleared by the NBA prior to submission. As part of benefit-sharing, the NBA can insist on joint ownership of IPR by the users, NBA and identified benefit claimers.

State boards and management committees

The State Biodiversity Board is the authority for the grant of approvals for commercial utilisation or bio-survey and bio- utilisation of any biological resource by Indians. It is not clear whether approval of R&D projects on bio-resources belonging to a particular State is within the purview of the SBB or is vested with the NBA. It is significant that the SBB has to mandatorily consult the local bodies concerned (panchayats and municipalities), before approval is granted and the terms of benefit-sharing finalised. The local body shall be represented by a bio-diversity management committee (BMC), which will be consulted on any matter related to bio-resources occurring within its territorial jurisdiction. The BMC is empowered to levy charges from anyone accessing and using the bio-resources of the region.

As part of its objects, the Biological Diversity Bill specifies that:

This Act shall have effect notwithstanding anything inconsistent therewith contained in any other law for the time being in force.

For all collaborative research projects based on agreements entered into prior to this Act, the provisions under the same shall be void if they are inconsistent with the provisions of this Act.

The NBA is to be vested with the same powers as are vested in a Civil Court and proceedings before the NBA are to be deemed as judicial proceedings.

Contravention is punishable with imprisonment for a term up to five years and fine up to Rs. 10 lakhs.

While disputes between the NBA and the SBB can be referred to the Central Government disputes between State boards will be handled by the NBA.

The Bill proposes free access to Vaids, Hakims of bio-resources and their use by Indian citizens for research purposes.

Problem areas

The Bill is meant to be a landmark legislation intended to protect India's vast and rich bio-assets. While the Bill effectively plugs loopholes of exploitation by foreign companies of India's natural resources; it is deficient in the area of encouragement of indigenous research on biological resources. The concept of achieving conservation through R&D and commercialisation has not been appreciated. The Bill in fact, is a serious deterrent to biological research since it makes it mandatory to rely on local bodies' recommendations and approvals by the State Biotechnology Boards before a research project involving biomaterials is initiated. This stipulation is based on the rationale that local communities should have a say in ensuring that valuable bio-resources are not indiscriminately depleted and they are not denied due benefits.

Both these arrangements are untenable since accession for research purposes hardly depletes natural resources and secondly it is impossible to put a value on bio-resources at the time of imitating a research project. Monetary considerations and royalty payments can be decided only when a research product reaches the commercialisation stage. On the IPR side, conventional yardsticks for protection of IPR do not have provisions for joint patenting unless all patentees have contributed to the innovation. Benefit- sharing through forced technology transfer mechanisms, location of production and R&D units in areas to be dictated by benefits to local communities, participation of benefit claimers in R&D projects, are all not only impractical proposals, but will also throttle investments and make efforts in R&D slow, cumbersome and inefficient.

The creation of various levels of bureaucracy with approvals needed at every level, will further slow down Indian research. In modern research, which is multi-disciplinary in character, collaboration with international agencies assumes importance. While control on the utilisation and export of endangered species should be exercised, all other biological material should be readily accessible for research purposes without prior approval from the State or national authorities. Collaboration agreements based on well-laid out commercial considerations could be entered into between the partners before research projects are initiated.

On the practical side, genetic resources including germ plasms are rarely unique to one State or region or very often, even to one country. For centuries, they have been floating around the World and allocation of region or community-based benefits is going to be the biggest challenge to this whole exercise. The proposed dispute settlement mechanism is inadequate to solve the associated problems.

The Bill under Clause 63 has rightly provided for removing difficulties which may arise in giving effect to the provisions of the proposed legislation during the first two years after its implementation. It is hoped that the Government will review all the contentious clauses and arrive at a fair and enlightened piece of legislation, which will benefit the nation through improved and equitable use of its bio-resources.

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In a nutshell

Objects and reasons

Regulate access to biological resources.

Respect and protect knowledge of local communities.

Protection and rehabilitation of threatened species; and

Involve self-government institutions in implementation.

Safeguards and exemptions

Free access to Indians to use biological resources within the country for research.

Use of bio-resources by vaids and hakims.

Traditional knowledge to be protected.

Authorities

National Biodiversity Authority (NBA) to deal with requests for access from foreigners; to grant approval for seeking IPRs in or outside India for any invention pertaining to a biological resource obtained from India.

State Biodiversity Boards (SBBs) to deal with matters relating to access by Indians for commercial purposes and restrict activities violating objectives of conservation, sustainable use and equitable sharing of benefits.

Funds

Biodiversity Funds to be set up at Central, State and local levels.

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