Worldwide: The Nagoya Protocol Two Years Later

Last Updated: October 14 2016
Article by Bruce S. Manheim

Two years ago today, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization to the Convention on Biological Diversity ("Protocol") entered into international force. To date, 87 countries have ratified or acceded to the agreement, and that number is expected to reach 100 by the end of this year. With its entry into force, the Protocol is ushering in a new international system to govern research, development and intellectual property rights surrounding a potentially vast array of products derived from non-human genetic resources. Those products include, among others, pharmaceuticals, products of synthetic biology and biotechnology, seeds, biocides, horticultural and microbiome products, nutritionals, supplements, cosmetics, perfumes, fragrances and industrial enzymes.

In December 2016, the Parties to the Protocol will meet in Mexico for their second biennial meeting to further implement the agreement. As the Protocol's requirements take hold and various nations more vigorously enforce these provisions, any company or research organization that utilizes genetic resources (or genetic information derived from such materials) for research and development should take measures to ensure full compliance. Indeed, proactive compliance measures will be key to reducing the risk of legal liability and reputational harm stemming from alleged violations of the Protocol. Such measures are also needed to ensure the freedom to operate and secure protection of intellectual property rights for a product or process involving the use of genetic material or genetic information accessed from another country.

The Nagoya Protocol

The Nagoya Protocol seeks to create a transparent international legal framework to govern access to and utilization of non-human genetic resources, derivatives thereof and associated traditional knowledge. Each Party must ensure that access to its genetic resources is subject to prior informed consent in a clear and transparent manner and pursuant to fair and non-arbitrary rules. In exchange for allowing such access, the country with sovereignty over the genetic resources may require fair and equitable sharing of any monetary and non-monetary benefits arising from utilization of such resources. This access and benefit-sharing ("ABS") quid pro quo is typically achieved through an agreement spelling out detailed contractual terms between the provider country and the user company or research entity.

To establish an effective international ABS legal system, the Protocol calls upon each Party to adopt domestic-level provider measures and user measures that govern access to and utilization of genetic resources. "Provider measures" require those seeking to access genetic resources to do so only with prior informed consent of the country (and local indigenous community) and in accordance with mutually agreed terms for benefit-sharing. "User measures" must ensure that any genetic resources utilized in a country for research or development were accessed in accordance with provider measures of the country from which the genetic resources were originally obtained. User measures may include, among other requirements, mandatory due diligence reporting requirements and compliance checkpoints.

During the past two years, as various nations have adopted new provider and user measures, the Protocol's legal framework has begun to coalesce into an international regulatory scheme governing access to and use of genetic resources for research and development. To be sure, many Parties have not yet adopted laws to implement the Protocol, and others are relying on existing laws to implement the Protocol. Nevertheless, some of the leading Parties—both on the provider side and user side—have adopted new measures to bring this international system into force. These measures signal the direction forward and serve as important precedents for other countries as they too adopt measures to implement the Protocol. A brief summary of several of these provider and user measures follows below.

Provider Measures

Brazil: On November 17, 2015, Brazil's new Biodiversity Law (Federal Law 13.123) entered into force. It seeks to simplify the process for scientific research and to facilitate commercial development by mandating development and implementation of an electronic registration system for users. The Biodiversity Law also created a mechanism for regularization and reduction of penalties and sanctions of up to 90% for violations of the country's earlier ABS requirements. This regularization scheme, however, expires one year from the date on which Brazil's electronic registration becomes available.

India: In November 2014, India's National Biodiversity Authority issued new "Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations." The guidelines outline financial obligations of users for particular types of activities that must be in ABS agreements and indicate how benefits are to be shared with the government and communities. Under India's ABS provisions, any party that applies for any intellectual property right relating to use of genetic resources within or outside of India must first obtain permission. The failure to do so is punishable by imprisonment for up to five years.

South Africa: In May 2015, the Department of Environmental Affairs issued revised ABS regulations requiring a "bioprospecting permit" and an executed benefit-sharing agreement for commercialization of the country's "indigenous biological resources." The revisions are designed to harmonize international and domestic permitting requirements, and provide for more transparent provisions to govern the discovery phase of non-commercial research and administration of the country's Bioprospecting Trust Fund. The new regulations set forth penalties for any person convicted of a violation and they provide for imprisonment for up to 10 years.

Mexico: In October 2014, Mexico declared that the Nagoya Protocol constitutes legally binding law in the nation. Since issuance of this decree, government authorities within the Secretariat of Environment and Natural Resources ("SEMARNAT") have been working on new legislation and regulations to implement the Protocol. Until these measures are adopted, Mexico will operate under both the Protocol and earlier legislative measures establishing ABS requirements. Those measures include the Ecological and Environmental Protection General Act, which authorizes SEMARNAT to require consent and benefit-sharing before users may access biological resources.

User Measures

European Union: On April 16, 2014, the European Union adopted Regulation No. 511/2014. It requires all users in the EU to exercise "due diligence" to ensure that genetic resources have been accessed in accordance with the ABS requirements of the provider country. Moreover, any user who receives research funding or seeks to market a product derived from genetic resources must make a compliance declaration to the relevant authorities. Each EU Member State must establish checkpoints to verify compliance, and adopt penalties for non-compliance. On October 13, 2015, the European Commission issued detailed rules to implement Regulation 511/2014.

United Kingdom: In March 2015, the United Kingdom adopted the "Nagoya Protocol (Compliance) Regulations 2015" (Statutory Instrument 2015 No. 821) to implement EU Regulation No. 511/2014. The UK Regulations empower an inspector to enforce the EU Regulation, and they establish civil sanctions for non-compliance with the EU Regulation's provisions governing due diligence, record-keeping, and a declaration of due diligence and compliance. Any person guilty of such an offense may, on conviction on indictment, be subject to a fine or a term of imprisonment not exceeding two years, or both.

Germany: Germany became a Party to the Protocol on July 20, 2016. In support of its ratification of the Protocol and to comply with EU Regulation 511/2014, the German parliament enacted DS 18.5219 on October 15, 2015. The new law empowers the Federal Ministry for Nature Conservation to impose fines for intentional or negligent violations of the EU Regulation, which may reach EUR 50,000 for each regulatory offense. The legislation also amended the German Patent Act to require any patent application involving an invention that is based on, or involves the use of, biological material to include information on the geographical origin of that biological material.

Switzerland: In December 2015, the Federal Council adopted the "Nagoya Ordinance" to further implement user measures in the country. These measures require users to establish, through due diligence, that access to genetic resources was in accordance with a provider country's ABS regulatory requirements. Users must also notify the Federal Office of Environment of their compliance with this due diligence requirement when a product developed from genetic resources is commercialized or receives market authorization. Users who violate these provisions are subject to fines of up to 100,000 Swiss Francs and their products may not be authorized.

Compliance Is Critical

With the emergence of an international ABS system, any company, university, or research organization that accesses and utilizes non-human genetic resources for research and development should take actions to ensure full compliance. Indeed, the consequences of not fully complying may be draconian and should not be underestimated. In addition to being tarred in the international media as "biopirates," those who have allegedly failed to comply with ABS requirements have been subject to civil and criminal enforcement actions brought by foreign government authorities. In July 2012, for example, Brazil reportedly fined 35 companies (including US companies) a total of $44 million based on claims that they violated the country's ABS requirements.

Government authorities and non-governmental organizations have also sought to invalidate patents arising from collection activities alleged to violate ABS provisions. To that end, a number of countries have adopted disclosure of origin requirements governing intellectual property rights to strengthen compliance with ABS requirements. At the same time, certain countries have been working within the World Intellectual Property Organization for many years to establish a new international agreement that would require, among other things, all patent applicants to disclose the origin of any genetic resources used in development of an invention and to provide evidence of compliance with the provider country's ABS requirements.

Although the United States has not signed or ratified the Nagoya Protocol, US companies and research organizations seeking to access and utilize genetic resources from other countries are subject to both provider and user measures adopted by the Parties to the Protocol. Accordingly, any company or research entity utilizing genetic resources should fully understand the ABS legal system and the extent to which it may impact their freedom to operate when researching, commercializing, and seeking protection of intellectual property rights for a product or process. And they should implement proactive compliance programs that adhere to a number of key operating principles to ensure compliance with the rapidly emerging global ABS regulatory system.

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.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
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
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions