The Ministry of Agriculture, Food and Environment has already begun by sending companies and/or natural persosn a questionnaire to identify users of genetic resouces in order to obtain a Register of companies using genetic material. 

Once the companies are identified, it will begin with the requirement of compliance with the Nagoya Protocol.

WHAT IS THE NAGOYA PROTOCOL?

The Nagoya Protocol arises from the Convention on Biological Diversity to fulfill the third objective of the Convention: the fair and equitable distribution of the benefits derived from the use of genetic resources, thus contributing to the conservation of biological diversity and the sustainable use of its components.

The Ministry for Ecological Transition has initiated the State Plan for the control of the legality of the use of genetic resources and associated traditional knowledge in Spain, therefore, we must be clear on what affects my company and if I comply with the required regulations .

DOES MY COMPANY USE GENETIC RESOURCES?

Genetic resources are any material of plant, animal, microbial or other origin that contains functional units of inheritance, of real or potential value (Article 2 of the Convention on Biological Diversity).

Therefore, the use of genetic resources will be all research and development activities on the genetic composition and / or biochemical composition of genetic resources, including the application of biotechnology.

By traditional knowledge associated with genetic resources, we understand the traditional knowledge that an indigenous or local community possesses related to the use of genetic resources and that are described as such in the mutually agreed conditions that apply to the use of genetic resources.

WHAT PURPOSE IS THE PROTOCOL OF NAGOYA APPLIED FOR?

  1. To regulate both the access and the distribution of the benefits derived from the use of genetic resources and traditional knowledge associated with them.
  2. Conserve biological diversity.
  3. Guarantee the sustainable use of its components.

WHEN DOES IT APPLY?

  • ON the genetic resources of countries that have exercised their sovereign right to regulate access
  • Country of origin that is a part of the Nagoya Protocol.
  •  When access and use if after October 12, 2014

Not applicable:offshore genetic resources or human genetic resources *

OBLIGATIONS AS A COMPANY IF I USE GENETIC RESOURCES

To act with DUE DILIGENCE, that is, to ensure that access to genetic resources and traditional knowledge associated with those resources used is in accordance with the access regulations of the country from which those resources come.

Tendremos que comunicar al Ministerio si en el desarrollo de mis actividades mi empresa utiliza recursos genéticos o conocimientos tradicionales asociados a recursos genéticos para:

  • La Investigación con fines no comerciales.
  • La Investigación con fines comerciales.
  • El Desarrollo de productos destinados a la venta.
  • Si tiene una colección ex situ de material genético (un conjunto de muestras recogidas de recursos genéticos y la información asociada, acumuladas y almacenadas, independientemente de que estén en manos de entidades públicas o privadas).
Alfredo Sánchez-Gimeno, Agricultural Engineer Agrointec

PROCESS

The user/company must prove the due diligence whenever requested by the Ministry and which can be given at the following control points:

  1. When you are a beneficiary of research funds.
  2. In the final stage of developing a product.
  3. When a patent is requested.
  4. When the competent authorities carry out checks to verigy compliance by users a COMPLIANCE.

Definitely,

Countries in which genetic resources are used will establish at least 1 verification point before which users and companies must prove that they accessed them legally, how? Obtaining an Internationally Recognized Certificate of Compliance.

Encarnita Hervías L.
Encarnita Hervías L.Founding partner at HERCAM ABOGADOS - COMPLIANCE & PROPIEDAD INDUSTRIAL