Scientific collections

Nagoya Protocol

Nagoya protocol and genetic resources: regulations and implementation

The regulations on the utilization of genetic resources, which are intended to prevent biopiracy, do also apply for basic scientific research. To be able to adhere to the relevant national and international regulations, each scientist working with biological material is obliged to acquire the necessary information on these regulations for him- and herself.

Important documents and dates

Important date:

12th October 2014

EU-regulation 511/2014 applies to all specimens collected or otherwise acquired on or after this day!

EU implementing regulation 2015/1866 is fully active since 9th November 2015

The German law on implementing the EU-regulation 511/2014 became effective on 1st Juli 2016.

 

Instructions and Information

  • Senckenberg's Position concerning the Nagoya Protocol is explained in the Grundsatzstatement (at present only in German). 
  • For the practical work, information provided by the ABS Clearing House is most important and helpful. Here you find contact information for all countries that are parties to the Nagoya Protocol as well as information on the state of each country regarding the implementation of the Nagoya Protocol.
  • The website of the German Bundesamt für Naturschutz (BfN) provides information on all aspects of the application of legal regulations concerning the Nagoya Protocol. The BfN also offers advice on concrete aspects of individual projects. 

Important regulations for theapplication of the regulations concerning the Nagoya protocoll can be retrieved here:

For those working in Germany or in any other EU member country the EU regulations are the most important documents.Who works or collects specimens in another country must obey the regulations of this country. These regulations can be different from the EU regulations or the Nagoya protocol. 

 

Handling of genetic material

EU regulation 511/2014 states that you have to exercise due diligence in acquiring and using genetic resources. It also is necessary to provide documentation of this due diligence and to report to the national authority (in Germany the BfN = Bundesamt für Naturschutz).

A report has to be submitted

  1. if research on genetic resources if funded through public or private grants (Art. 7.1):
    This declaration of due diligence can be submitted at the earliest after funding for a project is granted, but it has to be submitted before the final project report is submitted to the funding agency. The BfN and the EU offer the web portal DECLARE for submitting the declaration. If you need to get access to the portal please contact Thomas Hörnschemeyer (thomas.hoernschemeyer@senckenberg.de). Information on how to use the portal can be found here.
  2. during the final phase of development of a product that is based on genetic resources (Art. 7.2)

It is necessary to provide at least the following documents if the regulations in the country, where the genetic source derives from, requires those

PIC – „prior informed consent“
MAT – „mutually agreed terms“ should, at least, contain

  1. A dispute settlement clause
  2. Terms on benefit-sharing, including in relation to intellectual property
  3. Terms on subsequent third-party use, if any
  4. Terms on changes of intent, where applicable

For specimens that will be kept in a collection points 3. and 4. are important to make later use of such specimens by other researchers possible.

A short description of the project for which material was collected and electronic copies of all relevant documents should be deposited in the Senckenberg Data & Metadata Repository. The repository provides easy accessibility for the documents and it is possible to link to these documents from within the collection management system.

The documentation has to be archived for 20 years after utilization of the genetic material has ended!

An important question here is, when utilization of genetic material ends, especially for specimens in a public collection. Eventually, the documentation will have to be archived as long as the specimen exists.

To comply with the documentation requirements, it is necessary to deposit at least copies of all documents concerning biological specimens that have been acquired on or after 12th October 2014 or that will be acquired in the future.

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