PRESCRIBING GUIDELINES AND ESTABLISHING A REGULATORY FRAMEWORK FOR THE PROSPECTING OF BIOLOGICAL AND GENETIC RESOURCES, THEIR BY-PRODUCTS AND DERIVATIVES, FOR SCIENTIFIC AND COM…

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WHEREAS, Section 16, Article II of the Philippine Constitution, vests in the
State the ultimate responsibility to preserve and protect the environment; and
Section 2 Article XII, provides that wildlife, flora and fauna, among others,
are owned by the State and the disposition, development and utilization thereof
are under its full control and supervision;

WHEREAS, it is in the interest of the State’s conservation efforts to ensure
that the research, collection, and use of species, genes and their products be
regulated; and to identify and recognize the rights of indigenous cultural
communities and other Philippine communities to their traditional knowledge and
practices when this information is directly and indirectly put to commercial
use;

WHEREAS, under Article 16 of the Convention on Biological Diversity of which
the Philippines is a party, each contracting party is mandated to take
legislative, administrative or policy measures, as appropriate, with the aim
that contracting parties, in particular those that are developing countries,
which provide genetic resources are provided access to and transfer of
technology which makes use of those resources, on mutually agreed terms,
including technology protected by patents and other intellectual property
rights;

WHEREAS, the Department on Environment and Natural Resources (DENR) is the
primary government agency responsible for the conservation, management,
development, and sustainable use of the country’s environment and natural
resources; the Department of Science and Technology (DOST), the primary agency
mandated to promote local capability in science and technology to achieve
technological self-reliance in selected areas vital to national development;
the Department of Agriculture (DA), the agency responsible for the promotion of
sustainable agriculture and aquatic resource development; the Department of
Health (DOH), the agency responsible for the formulation, planning,
implementation, and coordination of policies and programs in the field of
health, including the research, regulation, and development of drugs and
medicine; the Department of Foreign Affairs (DFA), the agency responsible for
promoting international relations;

WHEREAS, an inter-agency approach is the most appropriate way of regulating
the research, collection, exploitation and use of biological and genetic
resources;

NOW, THEREFORE, I, FIDEL
V. RAMOS, President of the Republic of the
Philippines, by virtue of the powers vested in me by Law and the Constitution,
do hereby order:

SECTION 1. Policy of the State. It shall be the policy of the State to
regulate the prospecting of biological and genetic resources so that these
resources are protected and conserved, are developed and put to the sustainable
use and benefit of the national interest. Further, it shall promote the
development of local capability in science and technology to achieve
technological self-reliance in selected areas.

SECTION 2. Consent of Indigenous Cultural Communities.

a. Prospecting of biological and
genetic resources shall be allowed within the ancestral lands and domains of
indigenous cultural communities only with the prior informed consent of such
communities; obtained in accordance with the customary laws of the concerned
community.

b. Prospecting of biological and
genetic resources shall be allowed only with the prior informed consent of the
concerned local communities.

SECTION 3. When Research Agreement Is Necessary.
The prospecting of biological and genetic resources shall be allowed when the
person, entity or corporation, foreign or domestic, undertaking such
activities, on recommendation of the Inter-Agency Committee on Biological and
Genetic Resources, has entered into a Research Agreement with the Philippine
government, represented by the DENR, DOH, DA, or DOST, depending on the nature
and character of the prospecting activity. For purposes of this Executive
Order, traditional uses of biological resources by indigenous and local
communities shall not require a Research Agreement.

If the research and collection
of biological and genetic resources is intended, directly or indirectly, for
commercial purposes, the agreement must be a Commercial Research Agreement. For
purposes of this Executive Order, all Research Agreements with private persons
and corporations, including all agreements with foreign or international
entities, shall conform with the minimum requirements of a Commercial Research
Agreement.

If the prospecting of biological
and genetic materials is intended primarily for academic purposes, the
agreement shall be an Academic Research Agreement. Only duly-recognized
Philippine universities and academic institutions, domestic governmental
entities, and intergovernmental entities may apply for an Academic Research
Agreement.

Where the Commercial or Academic
Collector is merely an agent or merely collecting for another person or entity,
the agreement between the Commercial Collector and the Principal must be
reviewed by the Inter-Agency Body to determine the latter agreement does not
undermine the substantive requirements of this Executive Order.

SECTION 4. Application for Academic Research Agreement and Commercial Research
Agreement The applicant shall first submit an
application for a Research Agreement to the Inter-Agency Committee on
Biological and Genetic Resources through the Protected Areas and Wildlife
Bureau (PAWB). It must include a research proposal stating the purpose, source
of funds, duration, and a list of biological and genetic materials and the
amount to be taken. The requisites for research agreements are in Appendix B.

For Academic Research Agreement,
the proposal may be broader and more general in character as provided in
Section 5 (m).

A copy of the proposal must be
submitted to the recognized head of the local or indigenous cultural community
or communities that may be affected. Action on the proposal shall be made only
after 60 days has lapsed after a copy of the proposal is received by the
persons concerned.

SECTION 5. Minimum Terms of the Commercial Research Agreement and Academic
Research Agreement.

The Minimum Terms of the
Commercial Research Agreement and Academic Research Agreement are as follows:

(a) There must be a limit on
samples that the Commercial/Academic Collector may obtain and export and that
the approved list and amount of the samples taken from the area must be
followed strictly;

(b) A complete set of all
specimens collected shall be deposited by the Commercial/Academic Collector
with the National Museum or a duly designated governmental entity; Provided
that holotypes designated by the author must be maintained at the National
Museum;

(c) Access to collected
specimens and relevant data shall be allowed to all Filipino citizens and the
Philippine governmental entities whenever these specimens are deposited in
depositories abroad;

(d) The Commercial/Academic
Collector, or in appropriate cases, its Principal, must inform the Philippine
Government, as well as the affected local and indigenous cultural communities
all discoveries from the activity conducted in the Philippines, if a commercial
product is derived from such activity.

(e) The agreement shall include
a provision for the payment of royalties to the National Government, local or
indigenous cultural community and individual person or designated beneficiary
in case commercial use is derived from the biological and genetic resources
taken. Where appropriate and applicable, other forms of compensation may be
negotiated;

(f) There shall be a provision
allowing the Philippine government to unilaterally terminate the agreement
whenever the Commercial/Academic Collector has violated any of its terms. The
Agreement may also be revoked on the basis of public interest and welfare;

(g) A status report of the
research and the ecological state of the area and/or species concerned shall be
submitted to the Inter-Agency Committee regularly as agreed upon;

(h) If the Commercial Collector
or its Principal is a foreign person or entity, it must be stipulated that
scientists who are citizens of the Philippines must be actively involved in the
research and collection process and, where applicable and appropriate as
determined by the Inter-Agency Committee, in the technological development of a
product derived from the biological and/or genetic resources taken from any area
in the Philippines. This involvement shall be at the cost of the Commercial
Collector;

(i) The Commercial Collector
and/or its Principal shall be encouraged to avail of the services of Philippine
universities and academic institutions. Where applicable and appropriate, the
Commercial Collector and/or its Principal shall be required to transfer
equipment to a Philippine institution or entity.

(j) A fixed fee must be paid to
the DENR in accordance with a schedule of fees formulated by the Inter-Agency
Committee;

(k) The maximum term for a
Commercial Research Agreement shall be for three years and renewable upon
review by the Inter-Agency Committee; and

(l) In case of endemic species,
there must be a statement that the technology must be made available to a designated
Philippine institution and can be used commercially and locally without paying
royalty to a Collector or Principal. Provided, however, that where appropriate
and applicable, other agreements may be negotiated.

Provided, further, that the
following terms shall be considered in an Academic Research Agreement;

(m) The Academic Research
Agreement may be comprehensive in scope and cover as many areas as may be
projected. It may stipulate that all scientists and researchers affiliated with
a duly-recognized university, academic institution, governmental and
intergovernmental entity need not apply for a different Research Agreement but
may conduct research and collection activities in accordance with an existing
Academic Research Agreement. In such cases, the university, academic
institution and governmental entity shall ensure that all the terms and
conditions of the government are complied with by the affiliated scientist or
researcher. In all cases, the university institution or governmental entity must
ensure that affected communities have given their prior informed consent to the
activities to be undertaken;

(n) There must be a provision
requiring the Academic Collector to apply for a commercial research agreement
when it becomes clear that the research and collection being done has
commercial prospects.

(o) A minimal fee must be paid
to the Philippine government in accordance with a schedule of fees by the
Inter-Agency Committee; and

(p) The maximum term for an
Academic Research Agreement shall be for five years and renewable upon review
by the Inter-Agency Committee.

SECTION 6. Composition and Functions of the Inter-Agency Committee on
Biological and Genetic Resources. An Inter-Agency
Committee on Biological and Genetic Resources attached to the DENR is hereby
created as the regulatory body to ensure that the provisions of this Executive
Order are enforced and implemented. The Inter-Agency Committee shall be
composed of the following:

1. An Undersecretary of the
Department of Environment and Natural Resources designated by the DENR
Secretary who shall be the Chairperson of the Committee.

2. An Undersecretary of the
Department of Science and Technology (DOST) designated by the DOST Secretary
who shall be Co-Chairperson of the Committee.

3. A permanent representative of
the Secretary of the Department of Agriculture, who must be knowledgeable about
biodiversity or biotechnology.

4. Two permanent representatives
of the Philippine science community from the academe and who must be experts in
any of the following fields: biodiversity, biotechnology, genetics, natural
products chemistry or similar disciplines, shall be appointed by the DOST
Secretary after nominations from and consultation with the science community.

5. A permanent representative of
the Secretary of the Department of Health who must be knowledgeable about
pharmaceutical research and development.

6. A permanent representative of
the Department of Foreign Affairs who has to facilitate international linkage
relative to bioprospecting.

7. A permanent representative of
the National Museum who has expertise on natural history and/or biological
diversity.

8. A representative from a
Non-Government Organization (NGO) active in biodiversity protection to be
selected by the NGO community through a process designed by themselves and
later endorsed by the Philippine Council of Sustainable Development.

9. A representative from a
People’s Organization (PO) with membership consisting of indigenous cultural
communities and/or their organizations to be selected by the PO community
through a process designed by themselves and through the endorsement of the
Philippine Council for Sustainable Development.

All members of the Inter-Agency
Committee shall serve for a period of three years which may be renewed for
another three years. In case of death, resignation, removal or other
circumstance which requires the replacement of a member, said member may be
succeeded by another person with the same qualifications and appointed in a
similar process. The replacement shall serve the unexpired term of the member
replaced.

A Technical Secretariat, to be
headed by the PAWB, shall be created to support the work of the Inter-Agency
Committee. The Technical Secretariat shall be staffed with personnel from the
PAWB and other agencies who shall be designated by the members of the
Inter-Agency Committee.

SECTION 7. Powers and Functions of the Inter-Agency Committee.

The Inter-Agency Committee shall
meet at least once every quarter and shall have the following functions:

(a) Process applications for
Research Agreements and recommend for approval thereof to the Secretary of
DENR, DOH, DA or DOST depending on the nature and character of the prospecting
activity;

(b) Ensure that the conditions
for the Research Agreements are strictly observed;

(c) Determine the list and
amount of biological and genetic materials that may be taken from the area and
ensure that these are complied with;

(d) Deputize and train
appropriate agencies so as to ensure that no biological and genetic materials
are taken from the Philippines and exported abroad except under a valid
Research Agreement. It shall also be ensured that the specimens collected have
been deposited in the Philippines;

(e) Ensure that the rights of
the indigenous and local communities wherein the collection or researches are
being conducted are protected, including the verification that the consent
requirements in Sections 3 and 4 are complied with. The Inter-Agency Committee,
after consultations with the affected sectors, shall formulate and issue guidelines
implementing the provision on prior informed consent;

(f) Study and recommend to the
President and the Congress appropriate laws on the utilization of biological
and genetic resources including new laws on intellectual property rights;

(g) Involve local scientists in
the decision making process by creating a Multi-Disciplinary Advisory Body and
other entities as may facilitate local involvement in the research, collection
and utilization of biological and genetic resources;

(h) Develop a conceptual
framework, using the research agreements entered into as well as other data as
basis, for significantly increasing knowledge of Philippine biodiversity. The
Inter-Agency Committee shall establish mechanisms to ensure the integration and
dissemination of the information generated from research, collection and
utilization activities;

(i) Coordinate with the National
Committee on Biosafety when necessary or appropriate;

(j) Issue rules and regulations
to effectively carry out the provisions of this Executive Order; and

(k) Perform such other functions
as may be necessary to implement this Executive Order.

All decisions of the
Inter-Agency Committee must be by a majority of all its members.

SECTION 8. Monitoring Implementation of the Research Agreement. The Protected Areas and Wildlife Bureau (PAWB) of the DENR shall be
the lead agency in monitoring the implementation of the research agreement. The
regional offices of the DENR shall also participate in the monitoring.

SECTION 9. Appeals Decisions of the Secretary (DENR, DA, DOH, or DOST)
may be appealed to the Office of the President. Recourse to the courts shall be
allowed after exhaustion of all administrative remedies.

SECTION 10. Sanctions and Penalties. Undertaking activities in violation
of this Executive Order shall be subject to such criminal penalties as may be
proper under existing laws including the National Integrated Protected Areas
System Act of 1992 and the Revised Forestry Code. Failure to comply with the
provisions of the Research Agreements entered into under Sections 3, 4 and 5
shall be a valid cause of immediate termination of the Agreement and the
imposition of a perpetual ban on undertaking prospecting of biological and
genetic resources in the Philippines.

SECTION 11. Existing Researches, Contracts and Agreements. All existing research projects, where allowed under existing law,
may proceed pending the negotiation and entry into force of appropriate
research agreement. All valid and existing contracts and agreements entered
into by the PAWB, the National Museum or other governmental entities shall
remain valid and effective; Provided, that the parties shall be required to
enter into a new agreement conforming to this Executive Order.

SECTION 12. Official Depository. The official
depository of all original and official documents such as agreements and
minutes of the meeting is the PAWB.

SECTION 13. Funding. The activities of the Inter-Agency Committee on
Biological and Genetic resources shall be funded in accordance with law. Such
funding, where allowed by law, may include savings coming from the appropriate
and concerned Departments and proceeds from the fees imposed on the Research
Agreements.

SECTION 14. Effectivity. This Executive Order and Rules and Regulations
takes effect immediately upon publication in two newspapers of general
circulation and upon filing of three certified copies with the U.P. Law Center.

SECTION 15. Implementing Rules and Regulations. The
implementing rules and regulations shall be formulated by the Inter-Agency
Committee and signed by the Secretary of DENR not later than three months after
effectivity of the Executive Order.

DONE in the City of Manila, on this 18^th day of May in the
year of Our Lord, Nineteen Hundred and Ninety-Five.

(Sgd.) FIDEL
V. RAMOS
President of the Philippines

By the President:

(Sgd.) TEOFISTO T. GUINGONA, JR.
Executive Secretary

 

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