OCTOBER 2021

ABS IN PERU
OVERVIEW OF LEGAL REQUIREMENTS
PROCEDURES AND RELEVANT AUTHORITIES

Recent studies show that Peruvian biodiversity is even greater than

previously known. In its latest report to the Convention on Biological Andean regime on ABS
Diversity (CBD), Peru increased the estimate of animal, algae and
Peru, as part of the Andean Community of Nations, is
fungi species found in the country. The report also highlighted the
bound by the Andean common regime on access to genetic
range of goods and services provided by Peruvian biodiversity.
resources, established in 1996. This regime, adopted by
Forests, for example, which occupy most of the territory, provide
Decision 391 of the Andean Community, outlines ABS
ecosystem services, as well as fruits, medicinal plants, and other
concepts, principles, and requirements, which are then
products consumed locally and around the world.
refined in national regulations and put into practice by
competent national authorities.
In 2021, Peru revised rules for governing how its biodiversity is used
in research and development. New rules now translate the Andean
regime on genetic resources into specific requirements. Main
changes include a clarification of the scope of access and benefit
ABS in national laws and regulations
sharing (ABS) requirements; a distinct, simpler procedure for access
for non-commercial purposes; and pre-established parameters for In Peru, ABS requirements and procedures are established through
monetary and non-monetary benefit sharing. two main instruments:

„ Regulation on access to genetic resources and their derivatives,

International agreements
adopted by Supreme Decree Nº 019-2021-MINAM, which was
Peru is a Party to the following ABS-related treaties: adopted on 22 July 2021, published on 24 July 2021, and enters
into force six months after the publication date.
„ Convention on Biological Diversity (CBD) - ratified 1993.
„ Law 27811 on the Collective Knowledge of Indigenous
„ Nagoya Protocol on ABS - ratified 2014.
Peoples derived from Biological Resources, which was
„ International Treaty on Plant Genetic Resources for Food and adopted on 8 August 2002 and entered into force on 11 August
Agriculture (ITPGRFA) - ratified 2003. 2002.

Disclaimer: This document is for information purposes only. The information provided is not legal advice. UEBT aims to ensure its accuracy, but it provides no guarantees in this
regard. Official information on laws and regulations on ABS is available through national focal points, competent authorities or the ABS Clearing House (https://absch.cbd.int/countries).

WHAT IS THE SCOPE OF ABS REQUIREMENTS?
The 2021 regulation covers “access to genetic resources and their derivatives.” These terms, as well as the specific resources and activities subject
to ABS requirements, are further outlined in provisions on scope and definitions.
What resources are covered?
ABS requirements in Peru cover only genetic resources and derivatives
from plant and other biological species for which Peru is a country of
origin or those migratory species that are naturally found in the country.
Both cultivated and wild native species are covered.
„ For example, acquiring samples of the Sacha inchi essential oil
(Plukenetia volubilis) for research purposes would be covered
by ABS requirements In Peru. However, acquiring samples of
Chamomile essential oil (Matricaria recutita), which is not native to
Peru, even if for research purposes, would not be covered.
„ There is no official list or source to identify native species.
However, the National Institute of the Defense of Competition
and Intellectual Property Protection (INDECOPI) has conducted
work to identify native species commonly used in research and
development.
„ ABS rules in Peru exclude plant genetic resources for food and
agriculture, listed in Annex I of the International Treaty of Plant
Genetic Resources for Food and Agriculture (ITPGRFA), for the
purpose of activities in the food and agriculture context, as well as
those plant genetic resources not listed in Annex I but collected
prior to the entry into force of the ITPGRFA and held in Consultative
Group on Agricultural Research International (CGIAR) centres.
„ Access requirements expressly extend to derivatives, which are
the naturally occurring biochemical compounds in plants and
other biological resources. That is, securing samples of fruit juice
from the Aguaje juice from the Aguaje palm for research into
its bioactive compounds would be considered and regulated as
“access to genetic resources.”
„ Access requirements also extend to information on genetic or
biochemical components of plants and other biological resources.
For example, obtaining information on the molecular structure
of any of 165 plants native to Peru in the Collective Molecular
Activities of Useful Plants (CMAUP) database, for the purposes of
research, would be considered “access.”
OCTOBER 2021
Who owns genetic resources?
The Peruvian Constitution establishes that natural resources,
which include genetic resources, are part of the country’s
national heritage. As set out in the 2021 ABS regulation,
competent national authorities are responsible for granting
access to genetic resources and their derivatives for the
purpose of their utilisation. Nevertheless, ABS rules also
recognise the rights of the providers of biological resources,
defined as the persons, entities, or communities that own or
manage the plant or other material accessed for the purpose
of utilising their genetic resources or derivatives. For access
applications to be considered by the authorities, applicants
must have an accessory contract with the providers of
biological resources, which includes consent and agreed
terms, including on benefit sharing.
What activities are covered?
Access to genetic resources is defined as obtaining and utilising
genetic resources and their derivatives for activities with or without
commercial purposes. That is, it is access to genetic resources
for the purpose of their utilisation that is regulated. Activities such
as purchasing the fruit of the Aguaje palm (Mauritia flexuosa) for
consumption or processing for juice would not have an element of
utilisation of genetic resources and would thus not be considered as
“access”(see box below).
„ Utilisation of genetic resources is defined, also as in the Nagoya
Protocol, as conducting research and development on the genetic
or biochemical composition of genetic resources.
„ Basic research related to identification, delimitation, and
classification of species, for taxonomic, evolutionary, molecular
ecology and conservation genetics and other such projects, is not
covered by the 2021 regulation if it does not have commercial
purposes.

Concept of “access to genetic resources” in Peru
OBTAINING
Genetic resources or derivatives
Extracting genetic material or derivatives
contained in biological resources, including
information held in digital repositories.
UTILISING
Genetic resources or derivatives
Conducting R&D on the genetic or biochemical
components of genetic resources.
ACCESS TO GENETIC RESOURCES
Obtaining and utilising genetic resources
and their derivatives
What are rules on
traditional knowledge?
Traditional knowledge associated to genetic resources is not
covered by the 2021 regulation. Rather, it is Law No. 27.811,
adopted in 2002, that remains the regime governing the
collective knowledge of indigenous peoples associated with
biological resources. It establishes separate requirements and
procedures for access and benefit sharing.
WHAT ARE ACCESS REQUIREMENTS?
Under the 2021 Peruvian ABS rules, there are two ways in which
competent authorities may grant access to genetic resources and their
derivatives in the country:
„ An “authorisation” is granted for cases of access for non-commercial
purposes.
„ A “contract” is granted for cases of access for commercial purposes.
OCTOBER 2021
Wild collection
Cultivation and harvest
Ex situ collection
Through all the following phases:
Bioprospecting
Phytochemical characterisation
Isolation of metabolites
Formulation of natural ingredients
Manufacturing
Source: Ministry of Environment, Peru
National competent authorities
In Peru, different government entities are charged with managing
applications for access and negotiating benefit sharing contracts,
depending on the type of resources involved:
„ The National Forest and Wildlife Service (SERFOR) is the national
competent authority for forest and wildlife genetic resources
and derivatives, including associated microorganisms and wild
relatives of cultivated species
„ The National Institute of Agrarian Innovation (INIA) is the national
competent authority for genetic resources and derivatives
of cultivated or domesticated species cultivated, including
associated microorganisms
„ The Ministry of Production (PRODUCE) is the national competent
authority for genetic resources and derivatives from species
found in marine and continental waters, including associated
microorganisms
„ The National Service of Natural Areas Protected by the State
(SERNANP) is the national competent authority for forest and
wildlife genetic resources and derivatives, as well as associated
microorganisms, found in national protected areas.

Access authorisation
An “authorisation” to access genetic resources and their derivatives
is granted by the relevant competent authorities for scientific research
and/or non-commercial technological development - that is, activities
not leading to or including commercialisation of a product or process.
„ Scientific research includes basic or applied research.
„ “Technological development” is defined as the application of
research results of research or other scientific knowledge,
to design new or substantially improved materials, products,
methods, processes, or systems.
„ Such early-stage research into new properties or new
applications of genetic resources or derivatives may be
undertaken by research institutions or companies.
Authorisations are granted through contracts signed with the relevant
competent national authority. These contracts include terms and
conditions, including on confidentiality, transfer to third parties, and
non-monetary benefit sharing.
National support institution
Applications presented by foreign companies for access
to genetic resources in Peru, whether for commercial or
non-commercial purposes, must always be endorsed by a
“national support institution.” This term refers to a national
entity involved in scientific or technical research that is
involved in project activities and is charged with ensuring
such activities are undertaken in line with the contract or
authorisation. Applicants engage with national support
institutions through an accessory contract, which may involve
provisions on benefit sharing.
OCTOBER 2021
Access contract
A “contract” for access to genetic resources and their derivatives
is signed by the relevant competent national authority and thereby
authorises research and development activities leading to the pre-
commercialisation or commercialisation of a product, whether as a
consumer good or for further processing. These contracts include the
terms and conditions for access, establish the rights and obligations of
parties and define monetary and non-monetary benefits.
WHAT ARE ACCESS PROCEDURES?
Procedures are similar for access for commercial and non-commercial
purposes.The starting point is an application submitted to the relevant
competent national authority, following a template available in the
2021 regulation. This application must be accompanied by supporting
documentation, including:
„ Detailed project description, including for commercial access, market
projections
„ Accessory contract with provider of the biological resources
„ Accessory contract with national support institutions
„ Proposal for benefit sharing
„ Request for any information to be treated as confidential.
The application is then subject to formal and substantive assessments.
According to the regulation, the assessment process should take no
more than 30 working days for applications for access authorisation
and 90 working days for applications for access contracts. If no official
response is given within these dates, access is considered to be
denied.
For access for commercial purposes, once the application has been
approved, two rounds of negotiations take place, in person or through
video conference. These negotiations, between the applicant and the
relevant competent national authority, define the benefits derived from
the utilisation of genetic resources or derivatives that must be shared.
For access for non-commercial purposes, the relevant competent
authority reviews the proposed benefit sharing and approves or
suggests changes. Templates for access contracts and access
authorisations are expected to be developed. A complete overview of
the access procedures is provided in the illustration on the following
page.
 OCTOBER 2021

Access procedure in Peru

Information gathering
Contract with provider
Contract with support institution
Application
Acceptance
Annex I for non-commercial
Formal review, with a single
Annex II for commercial projects
opportunity for the applicant to fix
A request for confidentiality may
problems
be presented

5
working
Non-commercial
days

30
working
15
working
days Assessment days
Negotiation Publication
Substantive review considers
For commercial access only Name of applicant, resource,
accessory contracts, benefit
Two virtual or in-person negotiation project and location published for
sharing proposal and confidentiality
sessions public comments
request
25
working
days

Commercial

Resolution Signature of contract International certificate

Official document communicates Templates being developed, with International certificate of
decision to issue authorisation or simplified text for non-commercial compliance published in
conclude contract for access projects the ABS Clearing House

10
working
15
working
days days
Applicant
Authorities
Both parties

WHAT ARE BENEFIT SHARING
REQUIREMENTS?
In line with the Nagoya Protocol, fair and equitable sharing of benefits
in the Peruvian ABS framework is established through mutually agreed
terms. The 2021 rules, however, introduce certain mandatory benefits
and parameters for benefit sharing.
For access authorisations (that is, for scientific research or non-
commercial technological development), the applicant must agree to
certain non-monetary benefits:
„ Dissemination of research results and research collaboration or
training are considered “mandatory” non-monetary benefits and
must always be provided.
„ At least one additional non-monetary benefit must be provided, such
as access to scientific information or databases used in the project,
transfer of technology to local actors, and actions to promote local
livelihoods.
Although there are no requirements for immediate sharing of monetary
benefits, applicants for access authorisations must commit to sharing
any benefits that could eventually derive from intellectual property
rights resulting from the project.
In access contracts (that is, for commercial research and technological
development), both monetary and non-monetary benefits must be
shared:
„ Monetary benefits must take the form of annual payments of no
less than 1% of the net sales of the product, whether intermediate
or final, resulting from the utilisation of genetic resources or
derivatives. Nevertheless, is possible for the applicant to deduct
from such payments any funds invested in projects linked to
research and conservation and sustainable use of biodiversity.
„ If patents and plant variety certificates are obtained through the
utilisation of genetic resources or derivatives, monetary benefits
must also include annual payments of at least 1% of their
commercial value.
„ Non-monetary benefits must include at least the dissemination of
research results and research collaboration or training.
Competent national authorities are obliged to allocate monetary and
non-monetary benefits received to activities that create knowledge
or promote conservation and sustainable use of the plant or other
biological species involved in the access application.
REFERENCES
Photo credits: Rainbow Mountain, Cusco, Peru (©McKayla Crump, Unsplash), Physalis (©AndreasGoellner, Pixavbay), Oreocallis grandiflora (© McKay Savage, Wikicommons), Drosera Peruensis (©Pixabay), Women walking, Peru
(©persnicketyprints, unsplash),
® Union for Ethical BioTrade Registered Trademark owner.
UNION FOR ETHICAL BIOTRADE
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Representation in Bélem, Brazil | Ghaziabad, India | Antananarivo, Madagascar | Hanoi, Vietnam
OCTOBER 2021
ARE THERE COMPLIANCE
PROVISIONS?
The 2021 ABS regulations establish two checkpoints to monitor
and ensure compliance with Peruvian and other countries’ ABS
requirements. The two checkpoints are the National Institute for
the Defense of Competition and Protection of Intellectual Property
(INDECOPI) and the National Commission for the Protection of Access
to Peruvian Biological Diversity and to the Collective Knowledge of
Indigenous Peoples. These entities monitor whether activities within
their purview comply with any applicable ABS requirements and
notify any unauthorised activities. For activities involving Peruvian
biodiversity, competent national authorities are informed. For activities
involving another country’s genetic resources, the Peruvian Ministry of
Environment is notified and communicates with the country’s ABS focal
point.
Regularisation of past activities
The new ABS rules in Peru foresee the regularisation of
past activities involving utilisation of genetic resources
undertaken without the required contracts or authorisation.
Such regularisation is possible for a period of three hundred
and sixty (360) days, counted from the date of entry into
force of the regulation. Applicants would need to use a form
included in Annex 4 of the regulation and comply with similar
requirements as for the application of an access contract,
ABS national focal point for Peru
José Álvarez Alonso
Director General for Biological Diversity
Ministry of the Environment of Peru
alvarez@minam.gob.pe
Tel:  +51 1 611 6000 extension 1002