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Research and Nagoya

Where research projects involving genetic resources that fall under the scope of the Nagoya Protocol are planned, a range of aspects must be taken into account in advance.

Research involving/on a genetic resource can very quickly constitute utilisation in the meaning of the Protocol. Clarify before the start of the project whether all cumulative conditions for the application of the Nagoya Protocol and EU Regulation 511/2014 are met and you need to fulfil the stipulated requirements. Plan plenty of time for this! You are not allowed to start utilising the resource until you have received an Internationally Recognised Certificate of Compliance (IRCC) or other verifiable permit.

First you need to establish which GR should be obtained from where and which country is the provider. On the basis of the various criteria, it may be possible to establish that your particular case falls outside the scope of the Nagoya Protocol and EU Regulation 511/2014. If so, the grounds for this exclusion and any related correspondence must be documented and retained.

If your particular case does fall under this scope, you must obtain the relevant documents officially granting you permission to utilise the resource before you start doing so. The permit is mandatory for use of the GR.

A permit to use a GR is usually granted via an Internationally Recognised Certificate of Compliance (IRCC), which is published on the ABS Clearing-House website of the provider country. The certificate is issued following successful completion of the ABS process.

The ABS process varies from country to country and make take many months. You can find examples of practical cases from the past on the Nagoya HuB website Nagoya HuB website.

A so-called Due Diligence Declaration (DDD) must be submitted at the start of the research, insofar as the research is supported by third-party funding – irrespective of whether this is public or private. It must also be submitted when a product developed via the utilisation of a genetic resource under the scope of the Nagoya Protocol is commercialised.

The declarations must be submitted via a dedicated portal (DECLARE). Template declarations can be found in Annexes II and III of the Commission Implementing Regulation (EU) 2015/1866.

If a change in the utilisation of the genetic resource is planned, you cannot simply start this new utilisation without further ado. The permit is issued specifically for the utilisation stated in the process. If the utilisation changes, a permit is also required for this and benefit-sharing arrangements must be agreed. Activities which do not fall under the definition of utilisation are excluded from this.

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