Genetic resources

Genetic resources

Authorisation to utilize genetic resources

The Plant Protection Directorate is the appointed national competent authority that oversees the implementation of the Nagoya Protocol to the Convention on Biological Diversity​ . The Nagoya Protocol implies that public or private entities that utilize genetic resources in their research or development projects are obliged to seek the consent of national authorities to enter in possession of those resources and must establish mutual agreements that lay down the terms of utilization and sharing of the benefits arising out of such utilization. Those obligations are only applicable provided that such genetic resources originate from a country that is a Party to the same Protocol and Access And Benefit Sharing measures are institutionalised in such country. The Plant Protection Directorate is therefore the national regulator of the EU ABS Regulation applicable within the European Union for the Maltese Islands.

Genetic resources constitute biological organisms, living or dead, whole or in part, including their biochemical derivatives, that are of natural or semi-natural origin (e.g. farmer’s varieties and landraces), of actual or potential value provided various exclusions, and accessed from in situ or ex situ sources. These resources are typically used by a wide range of sectors in nature-based research and development as a basis for innovation, such as for new medicines, flavourings, chemicals or cosmetics. Within the scope of the regulations, a user of genetic resources is a natural or legal person accessing the genetic resource for the scope of research and/or development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology.

In order to be granted access to genetic resources over which Malta has sovereign rights or to be permitted to utilise traditional knowledge associated with genetic resources held by local communities, users are required to:

Obtain Prior Informed Consent (PIC) from the Plant Protection Directorate;

Enter an agreement with the provider of genetic resources based on Mutually Agreed Terms (MAT) with the involvement of the Directorate;

Obtain an Internationally Recognized Certificate of Compliance (IRCC) as evidence that PIC and MAT requirements have been fulfilled.

Users of genetic resources accessed from a country that is a Party to the Nagoya Protocol that enforces Access And Benefit Sharing laws, are required to be in possession of an Internationally Recognized Certificate Of Compliance. Moreover, if the country from which the genetic resource is accessed is a European Union country, due diligence declarations are to be made available to regulatory authorities of the country where utilization takes place within the EU and to the EU country of origin of the genetic resource.

The aim of this service is to grant access to genetic resources for research and commercial purposes, by users.

The service is provided through the Conversation of Genetic Resources Unit (GRU) of the Plant Protection Directorate as the entity responsible for genetic resources, access and benefit sharing, the national gene bank, the Plant Tissue Culture Laboratory and St Vincent de Paul nursery.

More information is available on the Access and Benefit Sharing Clearing House​  of the CBD.

Customers can make use of this service by using the application form for authorisation to access and use genetic resources, which may be obtained using any of the following options:

Requested by phone by calling freephone 80072310 or number 22926535.
Requested by e-mail on:  
Collected in person from 110, Annibale Preca Street, Lija.

You can also download from here the user guidance, and the checklist ​for authorisation to access and use genetic resources.