SRI LANKA: ACCESS TO GENETIC RESOURCES IN ADVANCE OF

UNCLAS COLOMBO 000231


NEW DELHI FOR USPTO
OES/ENRC FOR SEZANEH SEYMOUR

E.O. 12958: N/A
TAGS: EAGR EAID SENV TBIO CE
SUBJECT: SRI LANKA: ACCESS TO GENETIC RESOURCES IN ADVANCE OF
NEGOTIATIONS

REF: (A) STATE 9667 (NOTAL)
(B) 2-6-09 SANJIT-WITMER EMAIL


1. Per ref A request, the following information concerning Sri
Lanka's regulations governing access to genetic resources and
benefit sharing is keyed below to ref A, para 20. Additional
questions raised by AmEmb New Delhi (ref B) are not relevant at
present as Sri Lanka's patent law does not provide for the
disclosure of traditional knowledge (TK) or genetic resources (GR)
in patent applications.

Legislation and regulation of research
and collection of biological resources
--------------


2. Sri Lanka does not have a unified set of laws that cover all
aspects of research and specimen collection on biological and
genetic resources. Several articles and provisions of legislation
address research aspects, including specimen collection of
biological and genetic resources. These include the following:
Fauna and Flora Protection Ordinance; Forest Ordinance; Fisheries
and Aquatic Resources Act; National Heritage and Wilderness Act;
National Aquatic Research Agency Act; and Acts of all research
institutes, such as the Coconut Research Institute (CRI),the Tea
Research Institute (TRI),the Rice Research & Development Institute
(RRDI),and the Rubber Research Institute (RRI).


3. Relevant institutions issue permits for all aspects related to
research including collection of biological specimens. This is
carried out at national and provincial levels. Research proposals
must be submitted to the relevant institution, at which time the
research committee of that institute evaluates the proposal. In Sri
Lanka, the Department of Forest and the Department of Wildlife
manage protected areas. To conduct research activities and collect
specimens in designated protected forests and wildlife parks,
researchers (local or foreign) must obtain permits from these
institutes. Research in fisheries and aquatic resources require
approval from the Fisheries and Aquatic Resources Agency prior to
collection of specimens.


4. The following government agencies are responsible for issuing
research/collection permits for their respective biological/genetic
resources:
- Wild Fauna and Flora: Department of Wildlife Conservation
(DWLC);
- Domesticated Animals: Department of Animal Production and Health
(DAPH);
- Forest products & biological resources of forest reserves:
Department of Forest Conservation;
- Aquatic Resources: Department of Fisheries & Aquatic Resources
(with concurrent permission from DWLC);
- Agricultural Crops: Relevant Research Institute (CRI,TRI, RRDI,
RRI).


5. Terms and conditions addressing the concept of Mutually Agreed
Terms (MAT) are formulated by respective research committees and
agencies under the respective laws and included in research
application guidelines.

Permits for Collection of Biological Specimens
-------------- ---


6. In general, all collection of biological resources, especially
for research, is regulated under the respective Acts of the above
named institutions. Permits can be obtained from these authorities,
unless specimens are prohibited according to relevant Acts.
Specific terms and conditions are provided, depending on the use of
the specimens, when permits are issued.

Movement of Biological Specimens
--------------


7. Collection and export of non-CITES samples for research requires
a Memorandum of Understanding (MOU) with the custodial institute of
the biological/genetic resource and the local counterpart of the
research institute. Permits for import of non-CITES biological
specimens are provided by the relevant local counterpart agency
after approval is provided by the relevant custodian of the
specimen.


8. The Plant Protection Act and Animal Disease Act have provisions
on phyto- or zoo-sanitary requirements needed for movement of
species and products.


Mutually-Agreed Terms (MAT)
--------------


9. Under present legislation, MAT are agreed to with approval by the
relevant research institution. The respective agencies negotiate
and review applications for access and use of genetic resources.
The committees of these agencies determine protocol for the
different applications and use of genetic resources. The Acts of
respective agencies are equipped to deal with the issue of access to
genetic resources and the fair and equitable sharing of benefits.
Use of resources (commercial or non-commercial) is evaluated prior
to granting permission. Terms and conditions for in-country and
non-commercial use of genetic resources is basic and uncomplicated,
according to officials at the Biodiversity Secretariat in the
Ministry of Environment.

Status of MAT and
Prior-Informed Consent (PIC)
--------------


10. Presently, coordination between relevant institutes for the
development of MAT and PIC issues is handled by the Biodiversity
Secretariat of the Ministry of Environment and Natural Resources on
a case by case basis, as requested by the national partner of the
collaborative research. The proposed policy on access to genetic
resources, which is currently being drafted, addresses the issue of
fair and equitable sharing of benefits, with the biodiversity
secretariat being nominated as the coordinating institute.


11. In short, the respective local counterpart researcher negotiates
specific contracts for providing access to genetic resources with
the approving committee of the relevant government institute. The
Biodiversity Secretariat makes arrangements to sign MAT's between
local research counterparts and the appropriate government
institute.


12. National authorities responsible for receiving financial
benefits arising from biological/genetic resources are identified in
the MAT.


13. A code of ethics for biological diversity research involving
access to genetic resources is published by the Biodiversity
Secretariat of the Ministry of Environment. It states:

a) Research on the biological diversity of Sri Lanka shall, as far
as possible, be carried out in Sri Lanka, and by Sri Lankans or with
the active participation of Sri Lankans

b) The researcher shall inform the Biodiversity Secretariat of the
Ministry in charge of the subject of environment of the nature of
the proposed research, and specifically (a) whether foreign
nationals or foreign institutions will be involved and if so the
nature and extent of such involvement, and (b) full details of the
genetic material or metabolites or other extracts of organisms that
will be sent out of the country. In either case the purpose must be
disclosed fully; failure to do so will be tantamount to a breach of
this code.

c) Having regard to the facts as stated by the researcher, if the
Biodiversity Secretariat is of the view that the research may give
rise to discoveries leading to the development of commercial
products or processes, an agreement in a form approved by the
Ministry in charge of the subject of environment acting on the
advice of the National Science Foundation and any other government
institution shall be signed by the party abroad; such agreement
shall inter alia embody clauses, as appropriate, for ensuring that
Sri Lanka receives an equitable share of the benefits from the
proposed research and development.

d) If the Biodiversity Secretariat is of the view that the research
would not give rise to discoveries leading to the development of
commercial products or processes, the Biodiversity Secretariat shall
inform the researcher that no agreement in the form specified in
Section 3 need be signed.

e) If, in the course of the research work, there are changes in the
research protocol (from that reported earlier) or in the scope of
foreign collaboration, details of such changes shall forthwith be
reported to the Biodiversity Secretariat for a fresh determination
of whether an agreement in terms of Section 3 has to be signed, or,
if an agreement has already been signed, whether any amendments to
the agreement would have to be made.

f) This Code does not obviate the requirements under existing laws,
rules and regulations, of the researcher obtaining the approval of
the appropriate institutions for carrying out the proposed research;
using any particular site; collecting biological material; or
exporting genetic material, metabolites or other extracts of
organisms.

g) Notwithstanding the provisions of Articles 3,4 and 5 of this
Code, in cases where foreign nationals and/or institutions are
involved in research on biodiversity, the collaborating Sri Lankan
researcher and/or the institution to which he is attached shall,
where considered appropriate by the Ministry, through an agreement,
exchange of letters, or other suitable instrument, with regard to
the sharing of information, publication of results, lodging of
samples and other relevant matters, ensure that Sri Lanka shares
equitably in the results of the research.


14. Post's contact person for further inquiries on this issue is
ECON - Adrian Mendis.

BLAKE