Access to Spanish genetic
resources from wild taxa

Mari Carmen Fernández Pinos, PhD
Subdirección General de Biodiversidad
y Medio Natural
Ministerio para la Transición Ecológica

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Brief introduction
Convention on Biological Diversity• Into force on 29 December 1993
• 196 parties to the CBD• Spain ratified it on 21 December 1993

It has 3 main objectives:
1. The conservation of biological diversity
2. The sustainable use of the components of biological diversity
3. The fair and equitable sharing of the benefits arising out ofthe utilization of genetic resources

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Brief introduction
Nagoya Protocol• Into force on 12 October 2014
• 113 Parties• Spain ratified it on 3 June 2014
Article 1. OBJECTIVE
The objective of this Protocol is the fair and equitable sharing of thebenefits arising from the utilization of genetic resources, including by
appropriate access to genetic resources and by appropriate transfer ofrelevant technologies, taking into account all rights over thoseresources and to technologies, and by appropriate funding, thereby
contributing to the conservation of biological diversity and thesustainable use of its components.
Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Brief introduction
Nagoya Protocol“Utilization of genetic resources” means to
conduct research and development on the genetic
and/or biochemical composition of genetic resources,
including through the application of biotechnology as
defined in Article 2 of the Convention;

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Brief introduction
Nagoya Protocol
Access to genetic resources or to
traditional knowledge associatedto genetic resourcess

NagoyaProtocolCompliance with domestic
legislation or regulatory
requeriments on access andbenefit-sharing

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

To be decided by theParty in the exercise
of sovereign rights
over natural resources

Compulsory
for the Party

Brief introduction
European Union (EU)• Spain is a member state of the EU• The EU is Party to the CBD and to the Nagoya Protocol
EU ABS normative
Regulation (EU) No 511/2014 of the European Parliament and of the Councilof 16 April 2014 on compliance measures for users from the Nagoya Protocolon Access to Genetic Resources and the Fair and Equitable Sharing of Benefits
Arising from their Utilization in the Union.
Commission implementing Regulation (EU) 2015/1866 of 13 October 2015
laying down detailed rules for the implementation of Regulation (EU) No
511/2014 of the European Parliament and of the Council as regards theregister of collections, monitoring user compliance and best practices.

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Brief introduction
European Union (EU)
Access to genetic resources or totraditional knowledge associated togenetic resourcessEU ABSRegulation
Compliance with domestic legislation
or regulatory requeriments on accessand benefit-sharing

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Brief introduction
European Union (EU)
Scope of EU ABS Regulation
Genetics Resources

Traditional knowledges
associated to GR₊

to genetic resources over which the origin country exercises sovereign rights

₊

when the origin country is Party to the Nagoya Protocol₊

where ABS measures have been established by this Party, with thosemeasures applying to the specific genetic resource (or aTK) in question₊

to genetic resources which were accessed as of 12 October 2014

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Brief introduction
European Union (EU)
Obligations of users
Users shall exercise due diligence to ascertain that GR and aTK which theyutilise have been accessed in accordance with applicable access and benefitsharing legislation or regulatory requirements, and that benefits are fairly
and equitably shared upon mutually agreed terms, in accordance with any
applicable legislation or regulatory requirements.

Checks on user compliance• In accordance with a periodically reviewed plan developed using a riskbased approach.

• When a competent authority is in possession of relevant information
regarding a user’s non-compliance.

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Brief introduction
European Union (EU)Due diligencedeclaration
checkpoints

1) at the stage of
research funding

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 20192) at the stage of final
development of aproductSpanish ABS legislation

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Spanish biodiversity act
Natural Heritage and Biodiversity Act (Law 42/2007) amended by Law 33/2015.
Into force on 07 Oct 2015.
Access to Spanish genetic resources from wild taxa subject to PIC, MAT andaccess authorization.

Article 71 National Focal Point: Ministry for the Ecological Transition (MITECO).
Benefits arising from the utilization of Spanish genetic resources will be mainly
direct towards the conservation and sustainable use of biodiversity in Spain.

Articles Control of the utilization of genetic resources and associated traditional
72 & 74 knowledge in Spain (Compliance measures for the implementation in Spain ofEU Regulation 511/2014).

Articles
80 & 81

Infringements and penalties.

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Spanish biodiversity act
Control of the utilization of genetic resources in Spain
In accordance with the EU ABS Regulation but adding a third checkpoint:

Due diligencedeclaration
checkpoints
1) at the stage of
research funding

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 20192) at the stage offinal developmentof a product3) at the requestof a patentSpanish ABS bylaw
Laying down detailed rules forthe implementation of articles
71, 72, 74, 80 and 81 of theSpanish Biodiversity Act

Establishing rules governingcompliance in accordance with the EU
ABS Regulation and the Commission
Implementing Regulation
Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Royal Decree 124/2017, of 24
February, on access to genetic
resources from wild taxa andon control of the utilization.
Spanish access regulationentered into force on
15 March 2017

Access to Spanish genetic
resources from wild taxa

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Access to Spanish genetic resources
Scope:• Spanish and foreign users of Spanish genetic resources.
• Spanish genetic resources, in situ and ex situ, from wild taxa.

Outside of the scope :- Plant genetic resources for agriculture and food regulated by Law 30/2006.
- Fishery resources for food and aquiculture exploitation regulated by Law 3/2001.
- Zoogenetic resources for agriculture and food.
- Exclusively taxonomic purposes (definition in Art. 2.3.)

Provider Country Measures on ABS Taken by
Developed Countries, Tokyo 13 Feb 2019

Exclusively taxonomic purposes(definition in Art. 2.3. Spanish ABS bylaw)«Application of principles and methods for identification,delimitation and classification of living beings, which
requires the study of their phylogenetic relationships aswell as the evolutionary and ecological processes that havegenerated biodiversity using morphological, physiological,genetics, behavioral and environmental data».

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Access to Spanish genetic resources
Access to GR for their utilization for
non-commercial research
Two accessprocedures

Access to GR for their utilization forcommercial purposes

In both cases the user is obliged to get an access permit before accessing the GR.

The access permit is independent from other permits/authorizations.

Provider Country Measures on ABS Taken byDeveloped Countries, Tokyo 13 Feb 2019

Access for the utilization for

non-commercial research
USER
Fills the request form

Signs the declaration

COMPETENT ACCESS AUTHORITY

COMPETENT AUTHORITY FOR PIC AND MAT
Possible additional conditions

COMPETENT ACCESS AUTHORITY
2 months deadline

USER OWNING AN ACCESS AUTHORIZATION
Accesses to genetic
resources

Does not transfer the GR to unauthorized
persons or entities, and always transfers
the GR under the same terms of use

Access for the utilization for

non-commercial research
USER
Fills the request form

Signs the declaration

COMPETENT ACCESS AUTHORITY

COMPETENTAUTHORITY
FOR PICAND MATInternal process
betweenSpanishadministrations.
user doesn’t
PossibleTheadditional
conditionshave to doanything.
COMPETENT ACCESS AUTHORITY
2 months deadline

USER OWNING AN ACCESS AUTHORIZATION
Accesses to genetic
resources

Does not transfer the GR to unauthorized
persons or entities, and always trasfers
the GR under the same terms of use

Access for the utilization forcommercial purposes

COMPETENT AUTHORITY
FOR PIC AND MATUSER

Negotiates Prior Informed Consent and Mutually Agreed Terms
USER

Fills the request form

Attachs PIC and MAT

COMPETENT ACCESS AUTHORITY
6 months deadline

USER OWNING AN ACCESS AUTHORIZATIONAccesses to genetic resources

Trasfers the genetic resources
under the same terms of use

Guidelines for negotiating MATs under development.

Competent authorities
Genetic Resource

Marine genetic resources

Competent authority for PICand MAT

Competent accessauthority

Dirección General de Sostenibilidad
de la Costa y del Mar of MITECO
Authority of the General

Genetic resources in public domain Administration of the State to whichthat public domain is assigned

Genetic resources in state
institutions of ex situ conservation

Managing authority of the state
institution of ex situ conservation

Genetic resources from terrestrial
wild taxa distributed along theterritory of more than one
autonomous community

Authority established by theautonomous community where thegenetic resource is accessed

Others (e.g. endemic species in anautonomous community)

Authority established by theautonomous community where thegenetic resource is accessed

Dirección General de
Biodiversidad y Calidad
Ambiental of the Ministry forthe Ecological Transition(MITECO)

Authority established by theautonomous community
where the genetic resource isaccessed

One National Competent Authority (MITECO).
Several Regional Competent Authorities (autonomous communities).

Competent authorities
Genetic Resource

Marine genetic resources

Competent authority for PIC
and MAT

Competent accessauthority

Dirección General de Sostenibilidad
de la Costa y del Mar of MITECO
Authority of the General

Users don’t
need
to know
everyofSpanishcompetentauthority,
Administration
the State towhich
Genetic resourcesin publicdomain
DirecciónGeneral dethat public domain is assignedBiodiversidad
they just may contact
the Spanish National Focal
Point. y Calidad
Ambiental of the Ministry for
Genetic resources in state bzn-protocolonagoya@mapama.es
Managing authority of the state
the Ecological Transition
institutions of ex situ conservation institution of ex situ conservation(MITECO)Genetic resources from terrestrial
wild taxa distributed along theterritory of more than one
autonomous community

Authority established by theautonomous community where thegenetic resource is accessed

Others (e.g. endemic species in anautonomous community)

Authority established by theautonomous community where thegenetic resource is accessed

Authority established by theautonomous community
where the genetic resource isaccessed

One National Competent Authority (MITECO).
Several Regional Competent Authorities (autonomous communities).

Information
https://www.miteco.gob.es/es/biodiversidad/
temas/recursos-geneticos/

bzn-protocolonagoya@mapama.es

Thank you for yourkind attention!

bzn-protocolonagoya@mapama.es