Intellectual Property Issues in Managing Clinical Trial

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Transcript Intellectual Property Issues in Managing Clinical Trial

Are Large Dams the Way to go in North
Eastern India?
PLENARY SESSION 1
Integrating sustainability into large civil
construction projects: Legal & Policy
dimensions
New Delhi
July 25, 2008
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Organized by CII-ITC Centre of Excellence for
Sustainable Development & the Society of Indian Law
Firms
Key Propositions
1. Vision of Dams should support economic and
social progress and be environmentally
sustainable. Projects should recognize
entitlements, sustain livelihoods and
environment and share benefits
2. Mega Dams should be developed in an optimal
manner and include multipurpose use. Storage
schemes is critical to India’s water needs, flood
control and drought control
3. Environment Clearance should be
comprehensive and mean more than legal
compliance. Contentious issues must be
identified and thoroughly investigated in
advance of any final commitment to the project
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Key Propositions
4.
Comprehensive Sectoral Environmental
Assessment and Basin development must be
taken in its entirity and Site Selection must
focus on identifying better dams
5. Government should take responsibility of EIA
studies and the resulting mitigation/resettlement
plans before Utility developer get involved
6. Where large dams are the only viable
proposition, they should be supported. However,
if Small Hydro Projects offer better solutions,
they should be favored over large dams.
Further, Government to take a call whether new
dams need to be built at all !
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THE CONTEXT
India is the third largest dam constructor in the
world – 3000 large dams
 45,000 large dams on the world’s rivers.
Further, 1600 are under construction in 40
countries (source: International Commission of
Large Dams)
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 Dams and Development: A New Framework for
Decision-Making, Nov 2000 by World Commission
on Dams found that “though dams have made an
important and significant contribution to human
development, in too many cases an unacceptable
and often unnecessary price has been paid to secure
those benefits, especially in social and
environmental terms.”
THE CONTEXT
Large Dams –
 15 m above the lowest portion of the general
foundation area to the crest level
 10 to 15 m may also be considered large if
 length of crest of the dam to be not less
than 500 m;
capacity of reservoir formed by dam to be
not less than 1 mn cc m;
 maximum flood discharge dealt with by
the dam to be not less than 2000 cubic
m/sec;
dam has specially difficult foundation
problems; dam is of unusual design
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Source: International Commission of Large Dams
THE CONTEXT
Hydel Projects (Classification based on
installed capacity)
Micro: up to 100 KW
Mini: up to 101 KW to 2 MW
Small: 2 MW to 25 MW
Mega: > 500 MW (350 MW for J&K,
Sikkim and NE)
More than 25 MW – Ministry of Power
Up to 25 MW – Ministry of New and Renewable Energy
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Source: NHPC India
THE CONTEXT
 Economically exploitable hydro power potential
of India is around 1, 50,000 MW (84,000 MW at
60% load factor) Present 32,326 MW (2006)1.
Only 19.9 % of this potential has been exploited 2
 The NE region has vast water resources
including tremendous hydel power potential – only
8% of its 63,257 MW potential being harnessed.
This potential is also highly concentrated, with
50,000 MW located in Arunachal Pradesh.
 The PM’s 50,000 MW Hydroelectric Initiative
2003 proposes to bring on line installed capacity of
about 50,000 MW through 162 projects in 16
states by 2017.
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Source: 1Planning Commission India
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Source: NHPC India
THE CONTEXT
 72 out of 162 schemes totaling to 31,885 mw are in
the Northeast
 With 42 schemes with 27,293 mw capacity is in
Arunachal Pradesh and has emerged as the new
centre of massive dam building in the country, being
heralded as the ‘power house’ of India.
 As of September 2007, Arunachal Pradesh has
signed 39 MOUs to generate 24,471 MW, with both
public and private sector developers that include
companies like NHPC, NEEPCO, Reliance Energy,
Jayprakash Associates, GMR Energy and several
others.
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 Most are mega projects of up to 3000 MW
THE CONTEXT
In its blue print on strategy to increase
power supply, the 123 Agreement states:
“Hydro-power is clean but not always green
because large dams can destroy our natural
habitat and displace people”
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Livemint (July 22) quotes Power sector review
panel headed by the PM “long time was taken
for environment and forest clearances and there
was a need to shorten the time frame for grant
of the clearance”. Thereafter, nodal officers
have been appointed to expedite these
clearances.
THE CONTEXT
A 2005 World Bank Report on strategic issues for the
water sector in India has given the thumbs up to this
region as "worlds most environmentally and socially
benign sites for hydro power."
The Report does not take in to account the following:
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• The social impact on vulnerable ethnic minorities
with distinct identities and customs, dependent
directly on land, forests and rivers for their
sustenance
• Ecological fragility of the region and impact on
wildlife, rich and rare flora and fauna
• seismic activity /young mountains prone to
landslides that trigger flash floods
• Impact on lower riparian people – on disruption of
natural flows, on downstream wetlands (beels),
resultant disruption of livelihoods of tribes
THE CONTEXT
At the same time given environmental concerns
about fossil fuels and volatility of oil prices,
hydro potential should be exploited:
Hydro electricity is a renewable energy
 Provides cheaper electricity – Rs. 2.50/unit
average
 Dams can be multi-purpose projects with
added benefits for irrigation and flood control
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 Hydro Projects has a very long life and can
meet sudden increases/decreases in demand for
power
THE CONTEXT
 Hydro power projects are long term, capital
intensive investments
 Several constraints – technical (inadequate
geological investigations, outdated tunneling
methods); projects in relatively young Himalayan
mountains – geological surprises; and recently
tougher EIA compliance requirements
 Against this backdrop – GOI is trying to attract
private participation in hydro projects
 Independent Power Producers (IPPs) look for
commercial viability – ability to raise funding and
generate profits
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THE CONTEXT
 Over years, environmental issues are taking
centre stage and because of pressure from anti
dam groups, international lenders and guarantee
agencies are reluctant to finance them
 IPPs resort to non recourse or project
financing and to achieve financial closure risk
allocation has to be determined
 Significant determinant for bankability and
financial closure
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 responsibility for Environmental mitigation
measures and resettlement Clearance, and
 possible late interference and unforeseen
costs or delays arising from environmental
issues, and problems with land and water rights
Legal & Regulatory Compliance
 The framework of regulatory, institutional
and technical measures should aim at
ensuring quality of assessment, predictability
and transparency
 Social and environmental impacts should
be controlled, alleviated or mitigated
 Ensuring public trust and confidence
requires that Governments, developers,
regulators and operators meet all
commitments made for the planning,
implementation and operation of dams
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Source: Dams & Development: World Commission on Dams, 2000
Legal & Regulatory
Compliance
Site Clearance: technological, geological,
seismological, topographical, archaeological and
demographical information on the project site, the
catchment and the command area.
 displacement: if a project is seen to displace
too large a population, then it is often not
considered worthy of site clearance.
 wildlife impacts: clearance from Indian
Board for Wildlife if any denotification of a
sanctuary or national park
 Cultural heritage – archaeological and
religious sites
Alternate land sites – forest lands?
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Legal & Regulatory
Compliance
Environmental Clearance
(EC)
Union MoEF Environmental Impact Assessment (EIA)
– River Valley Projects of more than 50 MW
hydroelectric power generation and 10,000 ha. Of
culturable command area (Category A)
State Environment Impact Assessment Authority
constituted by Centre – Projects of 25 to 50 MW and
10,000 ha. Of culturable command area (Category B)
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Projects specified in category B will be treated as
category A if located in whole or in part within 10 kms
from the boundary of (i) protected areas under the Wild
Life (Protection) Act, 1972; (ii) critically polluted areas
as notified by the Central Pollution control Board; (iii)
Notified Eco-sensitive areas; (iv) inter state boundaries
and international boundaries.
Legal & Regulatory
Compliance
Risk Assessment – dam break (earthquake) ; dam
induced floods; landslides. Central Electricity
Authority grants technical approval only after
adequate safeguards are in- built.
Public Health – large water bodies create breeding
ground for diseases
Environment Management Plan – all EIAs
require an Environment Management Plan (EMP)
for the formulation, implementation and
monitoring of environmental protection measures
during and after the commissioning of the project.
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Legal & Regulatory
Compliance
National Rehabilitation
& Resettlement Policy
2007 (R&R)
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Spirit of R&R should go beyond mere
compensation
Adverse impact on PAF – economic,
environmental, social and cultural – needs to be
assessed in a participatory and transparent
manner
There should be effective monitoring and
grievance redressal mechanism
 Care should be taken - Rural poor, marginal
farmers, women, indigenous and tribal peoples
suffer disproportionate levels of displacement
 Mandatory Public Hearing: EIA, EMP and the
resettlement plan should be made available to
public and opportunity given to speak
Outstanding Deficiencies
Poor environmental and social impact assessment
405 MW (68 m high dam) Ranganadi Hydro Electric
Project (RHEP) [run-of-river scheme] Stage I, in Lower
Subansiri District was commissioned in 2002
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 Ranganadi river has been reduced to a trickle
downstream of the dam – irrigation channels dried up
 Apatanis, Nishis & hill Miris
Means of livelihood gone - Pisciluture and
horticulture
 Downstream flash floods caused by release of large
quantities of water in the river without warning/
inadequate warning
 Downstream social impacts can exceed upstream
resettlement upheavals
Outstanding Deficiencies
Poor environmental and social impact assessment
When the people complained to North Eastern Electric
Power Corporation (NEEPCO, the company that has
built the dam), its response was the issuing of a circular
on 2nd June 2006 that warned:
"... the gates of Ranganadi diversion dam may require
opening from time to time ... all villages, individuals,
temporary settlers etc. residing on the banks of river
and other nearby areas ... on the downstream of the
dam to refrain from going to the river and also to
restrict their pet animals too from moving around the
river ... the corporation will not take any responsibility
for any loss of life of human, pet animals etc. and
damage of property and others ..."
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First Wave of Flash Flood: Excess Water released from
Ranganadi Dam without prior warning June 14, 2008
NEEPCO “there is no way to get prior warning in respect of increased in
flow; natural flood occurring upstream of the project cannot be absorbed
by the small reservoir and excess after has to be released.” Heavy
Siltation is causing abnormal rise in the surface of rivers such as
Ranganadi, Dikrong and Singra. This kind of flash floods regular feature
since 1998.
District North Lakhimpur: Submerged NH-52
District Lakhimpur Submerged Villages near NH-52
Flood water touches Roof of House
Local people using Banana tree for transportation
Evacuation of School children
Flood water reaches to PWD Rural Road
Outstanding Deficiencies
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Villages Affected – 347
Population Affected – 3,01,325
Area Affected – 75,195 ha
Houses damaged – 51,220
Value – 51.22 crores (Approx)
Damage to crop area – 22,225 ha
Value – 5,55,265
Human lives lost – 8
Cattle lives lost – 7525
Damage to Public Utilities – 18
Value – 83.25 lacs
Brahmaputra & its Upper Tributaries
Source: Planning Commission 2006
Outstanding Deficiencies
Poor environmental and social impact assessment
520 kms River Subansiri, a major tributary of River
Brahmaputra. Drainage area up to its confluence of
Brahmaputra is 37,000 sq. km. of which 10,000 sq. km.
lies in Assam and 19,199 sq. km in Arunachal Pradesh.
3 projects have been identified in the Subansiri river
basin. MoEF has not given site clearance for Upper
Subansiri project as while clearing the lower Subansiri
project MoEF said that ‘there will be no construction of
dam on the Subansiri river in future.’
NBWL heard NHPC in May 2008 on Cumulative
Environmental Impacts of Subansiri Lower, Middle and
Upper Projects.
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Outstanding Deficiencies
Poor environmental and social impact assessment
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NHPC 2000 MW (116 m high) [ Rs. 6285 crores] Lower
Subansiri Hydro- Electric Project, Gerukamukh, Lower
Subansiri (AP)/ Dhemaji (Assam) Districts
EIA cleared July 2003 (with changes) (EIA report
prepared by WAPCOS records landholding of PAF as
960.11 ha but surprisingly the R&R plan allocates 1 ha
land to each PAF.
 Assam Government has complained about illegal
constructions on forest lands prior to clearance under
Forest Conservation Act/dumping of debris in the river
 Though 38 families from 2 villages were displaced,
belong to the Gallong (Adis) tribe dependent on jhum
rice cultivation and the forests (medicinal plant, wild
foods) for their livelihood.
 Dam height was halved as it was found that Daporijo
and Along townships with 5000 people each were to be
submerged.
Outstanding Deficiencies
Poor environmental and social impact assessment
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Lack of meaningful and effective hearing – local
people are steamrolled in to acquiescence
 Important biodiversity hotspot, home of two Endemic
birds, huge areas Reserve Forests (in Assam and AP)
and some areas of Tale Wildlife Sanctuary will be
submerged; important elephant corridors will be
affected – EIA report glosses over these facts – no biotic
survey was done (M. Firoz Ahmed of Aaranyak)
Downstream Ecological, Social & Livelihood Impacts
ignored:
Subansiri recharges wetlands (Beels) crucial for
fishing and deep water rice cultivation (Baodhan).
Mishing tribe depend on this (Kalpavriksh)
Serious concerns of flash floods persists – Lakhimpur
district and Majuli districts.
Outstanding Deficiencies
Poor environmental and social impact assessment
NHPC’s 3000 MW (288 m high) Dibang Multipurpose project , Lower Dibang Valley District
 PM laid the Foundation stone on February, 2008
 Idu Mishmis, Adis, Mishing, Galo tribes/ Mehao
Wildlife sanctuary
 Public hearings stalled dues to local protests
 Proposal for diversion of forest land pending
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Reliance Power’s 1000 MW (188m high) Middle
Siang project
 NHPC EIA clearance on Mar 2005
Challenged before the National Environment
Appellate Authority (NEAA)
 Pending before Delhi High Court
 Fresh Assessments being done
MW
Rs. (cr)
Status
Project
Developer
Tawang I &
II
Tawang chu
NHPC
1500
6, 568
Assessments
pending
Naying
Siyom
W. Siang
DS
Construction
1000
5,000
EC
underway
Siang Lower
E. Siang
Hatung II
Lohit/Lohit
Jayprakash
Associates
Mountain
Falls India
1600
Demwe
Lohit/Anjow
Kalai I
Lohit/Lohit
Athena
Energy Ven.
3000
9, 539
EC obtained
Mountain
Falls India
1450
1250
Way Forward
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 Each dam site is unique but there is clear need for
comprehensive sectoral Environmental Assessment
and Basin development in its entirity
 infrastructural development should be integrated
with flood management, canals/command areas
development works, watershed management works
and so on
If large dams are being built, they should include
flood management cushion as well
 small, run-of-the-river dams should be a
development choice - they are free from many of the
environmental problems associated with mega dams
 Further, generation from already existing dams
with addition of upstream reservoirs should be
chosen over new constructions
Way Forward
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 EIA needs to be strengthened and process
should be made transparent, inclusive and
acceptable to local stakeholder groups
 Move away from mere legal compliance and
internalize environmental and social costs in
economic cost benefit analysis. Government
should play a key role
Conservation should receive central focus.
Embrace good mitigation measures. Hydro
Projects must invest in the source of their raw
material by catchment conservation, biodiversity,
watershed management.
 PAF must be better off promptly under R&R
schemes. Allocate a fraction of all power project
proceeds to social and environmental needs in
perpetuity – PAFs become stakeholders
Way Forward
Why Small Hydro Projects (SHP)?
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Reliable, eco-friendly, mature and proven
technology
More suited for the sensitive mountain ecology
Does not involve setting up of large dams or
problems of deforestation, submergence or
rehabilitation
Can be exploited wherever sufficient water
flows - along small streams, medium to small
rivers
Non-polluting, entails no waste or production
of toxic gases, environment friendly
Small capital investment and short gestation
period
Way Forward
NE Vision 2020 – harnessing 40% of hydel
potential; Small and mini hydel projects
(potential 2112 MW; current 267 MW ) up to 1
MW capacity for distant hill areas
Hydro Power Policy 2008 - 2% of Capacity
Addition of 1400 MW by 2012 should come
from Small Hydro Power (SHP)
 Effective and meaningful coordination and
consensus building within GOI and/bw State
Govts - DONER should taken central role in
coordinating
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Arunachal Pradesh’s potential as a ‘ power
house’ can be fully optimized through small
projects
Assam says no to mega dams in Arunachal, Gogoi to approach PM
Indian Express
July 25, 2008
Page no.6
Guwahati, July 24: The Assam Government today said a big “no” to the proposed construction of mega dams on
the Siang and several other rivers in Arunachal Pradesh, and Chief Minister Tarun Gogoi said he would take up
the matter with the Prime Minister.
“The Prime Minister, too, is not in favour of big dams. I am trying to convince my Arunachal Pradesh counterpart
of the hazards caused by big dams,” Gogoi said here on Thursday.
Gogoi’s statement comes in the wake of an allegation made by leaders in Arunachal Pradesh that the Assam
government did not properly brief new Assam Governor Shiv Charan Mathur about the need for having big dams
in the region. Within hours of taking charge earlier this month, Mathur voiced his vehement opposition to the
construction of mega dams in the Northeast.
“I am totally with the Governor on this issue. The Governor is absolutely right in opposing big dams. Big dams in
Arunachal Pradesh will not solve our flood problems. In fact, they will do more harm than good. We will have to
convince Arunachal Pradesh of this,” Gogoi said.
The Assam Chief Minister said Arunachal Pradesh must understand that the hill state would not only see the
displacement of communities but also the destruction of forests and the environment due to the construction of big
dams. “I have already set up a high-powered expert committee to look into what damage the dams already
constructed in Arunachal Pradesh have caused to Assam,” Gogoi said.
“I am for small dams that do not have any risk given the high seismicity of the Northeastern region,” Chief
Minister Gogoi said. NGOs and environmental groups in Assam and other Northeastern states have been
campaigning against big dams pointing to their adverse impact on the region’s biodiversity.
The Assam Government, last week, asked Centre to study the cumulative damage that the state was likely to suffer
if big dams were erected in the neighbouring state.
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THANK YOU
Ms. Krishna Sarma
Managing Partner
CORPORATE LAW GROUP
1106-1107, Kailash Building,
26, Kasturba Gandhi Marg,
New Delhi-110001
Tel : 91-11-43621000 (100 Lines)
Mob : 91-9811734567
Fax : 91-11-23357721
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