Germany: The Implementation Of The Nagoya Protocol In Germany

Last Updated: 16 June 2016
Article by Verena Bertram

On 12 October 2014, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity ("Nagoya Protocol") entered into force. By placing the parties under obligations to establish legislative, administrative and/or political measures with regard to access to genetic resources, the Nagoya Protocol aims to prevent biopiracy (i.e. the commercial development of biological compounds or genetic sequences by a technologically advanced country or organization without obtaining consent from or providing fair compensation to the peoples or nations in whose territory the materials were discovered1) and intends to ensure the participation of the countries of origin and/or indigenous or local communities in the benefits of the use of genetic resources. The European Union ("EU") is a party to the Nagoya Protocol.

This article explains the implementation of the Nagoya Protocol in Germany.

Implementation of the Nagoya Protocol in Germany

On 15 October 2015, the German draft law regarding the Nagoya Protocol (DS 18/5219) passed the German parliament. On 1 December 2015, it was officially promulgated in the Federal Law Gazette. Therefore, Germany will become a party to the Nagoya Protocol in its own right on the ninetieth day after the date on which Germany deposits its instrument of ratification, acceptance, approval or accession to the Nagoya Protocol.

Also on 15 October 2015, the draft law for the implementation of obligations under the Nagoya Protocol and for the implementation of Regulation (EU) No 511/2014 as well as for changes with regard to the Patent Act and to the Environmental Audit Act (DS 18/5321) ("implementation act") passed the German parliament. On 2 December 2015, the implementation act has been officially promulgated in the Federal Law Gazette. With the exception of the provision regarding changes of the Environmental Audit Act that are taking effect immediately, the implementation act will enter into force on 1 July 2016.

Regulation (EU) No 511/2014 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 EU ("Reg. 511/2014") that fully entered into force on 12 October 2015 implements the Nagoya Protocol in the EU. Regulation (EU) No 2015/1866 ("Reg. 2015/1866") that entered into force on 09 November 2015 lays down detailed rules for the implementation of Reg. 511/2014 as regards the register of collections, monitoring user compliance and best practices. Constituting directly applicable law in all EU Member States, Reg. 511/2014 and Reg. 2015/1866 shall ensure a proper application of the Nagoya Protocol throughout the EU.

Reg. 511/2014 obliges users of genetic material or traditional knowledge associated with genetic resources ("traditional knowledge") within the scope of the Nagoya Protocol to exercise due diligence to ascertain that:

  • genetic resources and traditional knowledge utilised have been accessed (i.e. acquired in a party to the Nagoya Protocol) in accordance with applicable access and benefit-sharing legislation or regulatory requirements; and
  • benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.

Therefore, Reg. 511/2014 includes obligations for documentation and record keeping as well as – for users of genetic resources and traditional knowledge receiving research funding or developing a product via the utilisation of genetic resources or traditional knowledge – obligations to declare that the requirements under Reg. 511/2014 are fulfilled. Users of genetic resources and traditional knowledge developing a product via the utilisation of genetic resources or traditional knowledge must also submit information specified in Reg. 511/2014.

According to the implementation act, the Federal Agency for Nature Conservation (i.e. Bundesamt für Naturschutz "BfN") will be the competent authority for the enforcement of the provisions of the Nagoya Protocol and Reg. 511/2014 in Germany.

Furthermore, the German Patent Act will be amended. Therefore, the implementation act provides that the German Patent and Trademark Office will inform the BfN if a patent application contains information on the geographic origin of biologic material. This measure will allow future patent applications to be checked for the use of biological material from other countries and, if applicable, in regard to whether the biological material has been obtained legally. However, as currently only a non-mandatory provision which requires indicating in the patent application the geographic origin of biologic material, the practical consequences of the amendment will probably be rather limited.

According to Reg. 511/2014, the EU Member States have to lay down penalties with regard to infringement of obligations under this regulation. Therefore, the implementation act prescribes that the intentional or negligent violation of the obligations under Reg. 511/2014 is considered an administrative offence that will be punished by regulatory fine up to EUR 50.000. However, according to Art. 17(4) of the German Code of Administrative Offences, which is also applicable, the regulatory fine shall exceed the financial benefit that the perpetrator has obtained from commission of the regulatory offence. If the statutory maximum does not suffice for that purpose, it may be exceeded. Thus, the BfN is in principle able to impose fines of unlimited amount. Additionally, certain exploitation activities can be prohibited in case a user does not comply with an order of the BfN to eliminate violations of Reg. 511/2014. Although it is rather unlikely that this will be construed in a way making it impossible to file, obtain or enforce IP rights, the practical exploitation of the IP rights in such a case can be limited.

Practical Consequences

In order to meet the obligations of Reg. 511/2014, users acquiring genetic resources or traditional knowledge thereof in a country which is a party to the Nagoya Protocol have to exercise the aforementioned due diligence and comply with the said obligations for documentation and record keeping. Users of genetic resources and traditional knowledge receiving research funding or developing a product via the utilisation of genetic resources or traditional knowledge also have to comply with the obligation to declare that the requirements laid down in Reg. 511/2014 are fulfilled. Users of genetic resources and traditional knowledge developing a product via the utilisation of genetic resources or traditional knowledge must also submit information specified in Reg. 511/2014.

With regard to the application of patents, although currently it cannot be predicted whether a violation of the obligations under Reg. 511/2014 will have consequences for the grant of a patent or the possibility of exploiting a patent, or what these consequences will be, it is to be expected that competitors or other third parties will try to attack a patent for violation of these obligations. Therefore, patentees and researchers should in any event take the obligations under Reg. 511/2014 very seriously.


American Heritage® Dictionary of the English Language, Fifth Edition. (2011). Retrieved 1 December 2015 from The Free Dictionary.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.