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.

In association with
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
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 you may opt out by clicking here

    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.

    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.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    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.

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