Preguntas y respuestas acerca de las declaraciones de diligencia debida:

1. What is a due diligence declaration?

The due diligence declaration is the statement where the user expounds that the access to the genetic resources and/or the traditional knowledge associated with genetic resources was done in accordance with the regulations established by the provider country.

2. Who must submit a due diligence declaration?

Users of either Spanish genetic resources or genetic resources and traditional knowledge associated with genetic resources from third countries in Spain, that fall within the scope of the Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union, and are in any of the following checkpoints:

1) At the stage of research funding when the research involves the utilization of genetic resources and traditional knowledge associated with genetic resources

2) At the stage of final development of a product developed via the utilization of genetic resources and traditional knowledge associated with genetic resources

3) At the stage of patent application when that patent involves the utilization of genetic resources and traditional knowledge associated with genetic resources

3. When a due diligence declaration must be submitted?

The timing for submitting a due diligence declaration depends on the different checkpoints:

1) At the stage of either public or private research funding the declaration needs to be made after the first instalment of funding has been received and all the genetic resources and traditional knowledge associated with genetic resources that are utilized in the funded project have been obtained, but in any case no later than at the time of the final report (or in absence of such report, at the project's end).

2) At the stage of final development of a product the bylaw refers to three different instances but the declaration is to be made only once, at the first (i.e. the earliest) event occurring. Those events include:

a) Market approval or authorization for a product developed via the utilization of genetic resources and traditional knowledge associated with genetic resources.
b) Placing for the first time on the European Union market is made for a product developed via the utilization of genetic resources and traditional knowledge associated with genetic resources, either if authorization or notification is required or if it not required.
c) The utilization has ended and its outcome is sold or transferred in any other way to a natural or legal person within or outside the European Union.

3) At the stage of patent application the declaration needs to be made before applying for the patent.

4. Where to submit the due diligence declaration?

The due diligence declaration may be submitted at the Ministry for Ecological Transition (MITECO)’s website:

https://sede.mapama.gob.es/portal/site/se/procedimientos-intermedio?theme_id=5

Users must own a digital certificate to do the online submission.

According to article 16.4 of the Law 39/2015, of 1 October, on the Public Administration and the Common Administrative Procedure, the due diligence declaration can be also submitted at:

a) CORREOS post office.
b) Spanish embassies and consulates abroad.
c) Registry offices.
d) Other venues established by the regulations currently in force.

5. What are the consequences of not submitting on time the due diligence declaration?

1) At the stage of research funding, the financial institution will not pay the last instalment of funding.

2) At the stage of final development of a product, the market authorization will not be processed until the due diligence declaration is submitted.

3) At the stage of patent application, if the due diligence declaration is not submitted on time, this will not prejudge the validity of the patent and neither will stop the processing of the patent application. Nevertheless, the Spanish Patents and Trademarks Office will cooperate with the Dirección General de Biodiversidad y Calidad Ambiental of MITECO on the tracking and exchanging of information.

6. What are the consequences if the user does not comply with the due diligence obligations?

1) At the stage of research funding, grant may be cancelled or paid back partially or totally.

2) At the stage of final development of a product, placing on market may be not authorized, or if the product was already commercialized it may be removed from the market.

IIn any case, the competent authority for tracking the compliance of due diligence obligations can establish corrective measures to be adopted immediately by the user, such as temporal prohibition of utilization, cancellation of research or commercialization activities, or confiscation of genetics resources.

Additionally, the punishments established on Law 42/2007, of 13 December, will be applicable. User’s non-compliance with the Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union, is considered an administrative infringement:

Very serious infringement when profits are higher than 100.000 euros. In this case, the user may be fined 200.001 to 2.000.000 euros.
Serious infringement when profits are lower than 100.000 euros. In this case, the user may be fined 3.001 to 200.000 euros.