United States: Restrictions Governing International Trade In Genetic Resources Enter Into Force

Last Updated: October 17 2014
Article by Bruce S. Manheim

Nagoya Protocol Spurs New and More Stringent Requirements for Prior Informed Consent and Benefit Sharing for Research and Commercial Activities Involving Genetic Resources from Plants, Animals and Microorganisms
On October 12, 2014, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization (Nagoya Protocol or Protocol) entered into international force. The Protocol establishes a new legal framework to govern access to and utilization of genetic resources, including genetic material and any naturally occurring derivative compound. With entry into force of the Protocol, a number of countries have adopted new laws and regulations that will impact the development of, and intellectual property rights (IPR) surrounding, an array of products. Such products include pharmaceuticals, biotech products, agricultural products, nutritionals, supplements, cosmetics, perfumes and fragrances, and industrial enzymes. Although the United States has not signed or ratified the Nagoya Protocol, US companies and universities that utilize genetic resources from other countries for scientific research or commercial purposes will be subjected to these new requirements and restrictions. 
Indeed, companies and universities utilizing genetic resources from plants, animals, bacteria and other organisms must be especially mindful of these new and emerging international and domestic requirements. The same is true for scientific and commercial activities relating to the use of traditional knowledge held by indigenous and local communities. With many countries already vigorously enforcing such restrictions, the consequences of not fully complying may be draconian. In addition to being tarred in the international media as a "biopirate," those who allegedly fail to comply may be subject to enforcement actions brought by a government authority challenging the right to study and commercialize a product. Governmental authorities may also threaten criminal prosecutions. And, in certain countries, patent applications that non-complying researchers and companies file for products derived from genetic resources or traditional knowledge may be jeopardized if they do not comply with applicable "disclosure of origin" provisions.

Background—The Biodiversity Convention

The Convention on Biological Diversity (CBD) was opened for signature during the Earth Summit in 1992. To date, the treaty has been ratified by 194 countries. The CBD marked a dramatic shift in the way that genetic resources are treated from a legal perspective. Previously, such resources were considered the "common heritage of mankind" and, therefore, available for everyone's access, use and benefit. The CBD, however, established that each nation maintains sovereign rights over genetic resources occurring within its geopolitical borders. And, with that sovereignty, each party was authorized to control access to and share in any benefits arising out of the utilization and commercialization of its genetic resources-a term that is broadly defined to include any genetic material of actual or potential value.1 These access and benefit sharing, or ABS, provisions broke new ground in international law, and fundamentally altered the manner in which countries regulate access to and utilization of their genetic resources by companies and researchers.
Following adoption of the CBD, the parties struggled with implementation and enforcement of the agreement's ABS provisions. In 2002, the parties adopted voluntary guidelines (Bonn Guidelines) to assist with the development of legislative, administrative or policy measures on ABS and negotiation of contractual arrangements with users. While these guidelines were an important first step, they fell short of spurring implementation of the CBD's ABS provisions. Accordingly, in 2004, the parties agreed to elaborate and negotiate an international regime on access to genetic resources and benefit sharing with the aim of effectively implementing the ABS provisions of the CBD. Six years of intense negotiations later, that regime-the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits from their Utilization-was adopted. To date, the Protocol has been signed by 92 countries and 54 nations have ratified or acceded to the agreement. 

The Nagoya Protocol 

The Nagoya Protocol reaffirms the fundamental principle from the CBD that each state maintains sovereign rights over its genetic resources. In exercising that authority, each country must adhere to the following core obligations under the Protocol:

Access Obligations: Each party must take measures to ensure that access to its genetic resources is subject to its prior informed consent (PIC). To that end, parties must establish fair and non-arbitrary rules and procedures that establish legal certainty, clarity and transparency. Those procedures must indicate how to apply for prior informed consent and they must provide for a clear and transparent written decision by a competent national authority, in a cost-effective manner and within a reasonable period of time. When access is granted, these procedures must provide for the issuance of a permit or the equivalent thereof.

Benefit-Sharing Obligations: Each party must adopt measures requiring that the benefits arising from utilization of its genetic resources are shared in a fair and equitable manner and on the basis of mutually agreed terms (MAT). Utilization is broadly defined to include research and development involving the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology. Biotechnology is, in turn, defined to mean any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use.
Compliance Obligations: Each party is obligated to support compliance with its domestic legislation and the regulatory requirements of other parties that provide genetic resources. To that end, parties must, among other things, cooperate in cases of alleged violations of another party's requirements. They must also take measures to monitor the utilization of genetic resources after they leave the country by, for example, designating effective checkpoints at any stage of the value-chain: research, development, innovation, pre-commercialization or commercialization.
Institutional Obligations: Each party is required to designate a national focal point (NFP) and competent national authority (CNA) to serve as a contact for information, grant access or cooperate on issues of compliance. At the same time, each party must make certain information available to an ABS Clearing-House established by the Protocol. Such information includes legislative, administrative and policy measures on ABS, information on the NFP and CNAs, and permits that have been issued allowing access to genetic resources.

The Protocol also calls on each party to take measures, in accordance with domestic law, to ensure that traditional knowledge (TK) associated with genetic resources held by indigenous and local communities is only accessed with the prior approval and involvement of such communities and that such access is based on mutually agreed terms. To these ends, the access, benefit-sharing and compliance obligations set forth above also apply to utilization of traditional knowledge. While the Protocol does not itself define the term "traditional knowledge," the CBD refers to TK as the knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity.

National Implementation of the Protocol's ABS Requirements

  Many nations and jurisdictions have adopted new regulatory measures or taken other steps to implement the foregoing provisions of the Nagoya Protocol.2 For example, in April 2014, the European Parliament and the Council of the European Union adopted a new Regulation (Regulation No 511/2014) to regulate access to and utilization of genetic resources. It obliges all users to exercise due diligence to ascertain that genetic resources and associated traditional knowledge have been accessed in accordance with all applicable legal requirements, and that any benefits are fairly and equitably shared in accordance with mutually agreed terms. The regulation applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources that are accessed after the entry into force of the Nagoya Protocol. The EU regulation became effective with entry into force of the Protocol, but several key provisions will enter into force a year later.
Elsewhere, India and Brazil have moved to implement the Protocol by supplementing existing legislation. Those efforts are being watched closely by other biologically rich nations as they too consider measures to ratify the Protocol. India ratified the Protocol in 2012 on the basis of its National Biodiversity Act. Under that act, failure to gain approval from the country's National Biodiversity Authority for the use or transfer of genetic resources may result in imprisonment for up to five years, fines, benefit-sharing fees, and royalties. Although Brazil has not yet ratified the Protocol, it is relying on a Provisional Measure (MP 2.186-16) and other authorities to govern access to its genetic resources. Failure to comply with this MP may result in fines, confiscation of samples and products, suspension of the sale of products, closing down establishments, and suspension or cancellation of the registry, patent, license or authorization. Revisions of Brazil's ABS legislation are reportedly underway.
Still other nations have adopted regulations that broadly construe the scope of genetic resources subject to ABS requirements. For example, under its National Environmental Management Biodiversity Act, South Africa regulates all "indigenous biological resources," which are defined to include any chemical compounds and products obtained through the use of biotechnology that have been altered with genetic material or chemical compounds found in indigenous species." Moreover, some countries and non-governmental organizations are taking the position that the Protocol's ABS obligations apply to the utilization of genetic resources and biological materials that were collected long before the Protocol was adopted or entered into force. This has become a key issue because many genetic resources from source countries have already been collected and are currently housed ex situ in collections around the world.  

Enforcement of ABS Requirements

  With the adoption of these laws, many countries are vigorously enforcing their PIC and ABS requirements. In July 2012, for example, Brazil reportedly fined 35 companies a total of $44 million based on claims that they violated the country's ABS requirements. India's National Biodiversity Authority and non-governmental groups have repeatedly alleged that a large US company violated that country's ABS laws. Still other non-governmental organizations have alleged that a large nutritional products company improperly sought patents on South African plants without first obtaining consent from that government. Elsewhere, indigenous groups along with several organizations have sought to invalidate patents involving a drug product, claiming that the applications were based on illegal misappropriation of traditional knowledge involving the use of two plant species. 
Another way in which parties are enforcing ABS requirements is through their patent laws. Indeed, certain countries have amended their laws to forbid the issuance of patents for inventions relying on illegally acquired genetic resources or associated traditional knowledge. China's patent law, for example, requires an applicant to disclose "the direct source and the original source of the genetic resources." If the applicant cannot document that such resources were accessed properly, the patent may not be granted. Similarly, South Africa's patent law provides that patents will not be issued unless the patent applicant "furnishes proof" of title or authority to make use of indigenous biological resources or traditional knowledge. Similar disclosure requirements can be found in the laws of other countries, including Brazil and India.
At the same time, a number of these countries are pressing for an amendment to the TRIPS Agreement that would establish an international requirement compelling the disclosure of the origin of genetic resources and/or associated traditional knowledge in patent applications. This initiative is also being pursued within the World Intellectual Property Organization (WIPO), where negotiations are underway to develop a new international instrument establishing a disclosure of origin requirement for all parties. A draft of the agreement would require each party to require patent applicants to disclose the source and country of origin of the claimed genetic resource and traditional knowledge and to provide relevant information regarding compliance with ABS and PIC requirements of the source country. In the event that an applicant fails to do so, its application may not be further processed or may be declined.


With entry into force of the Nagoya Protocol, companies and researchers utilizing genetic resources occurring in foreign countries are subject to new requirements governing access and benefit sharing. These restrictions raise an array of legal questions cutting across several distinct areas, including compliance, international trade, international litigation, transactional and licensing arrangements, and protection of intellectual property rights. WilmerHale attorneys have access to many of the foreign laws adopted by countries to implement the Protocol and the firm has assisted clients on matters arising under this new framework, both at the international and domestic levels. Attorneys at the firm have conducted biodiversity compliance assessments, worked closely with local counsel on ABS matters in foreign jurisdictions confronting US companies and universities, and are very actively involved in international fora on trade issues (including TRIPS and the WIPO). They have also focused on issues surrounding the protection of intellectual property, disclosure of origin provisions, and adoption of ABS agreements.

1 The term "genetic resources" used in the CBD does not include human genetic material.

2 To date, the following countries have ratified or acceded to the Nagoya Protocol: Albania, Belarus, Benin, Bhutan, Botswana, Burkina Faso, Burundi, Comoros, Côte D'Ivoire, Denmark, Egypt, Ethiopia, European Union, Fiji, Gabon, Gambia, Guatemala, Guinea, Guinea Bissau, Guyana, Honduras, Hungary, India, Indonesia, Jordan, Kenya, Lao People's Democratic Republic, Madagascar, Malawi, Mauritius, Mexico, the Federated States of Micronesia, Mongolia, Mozambique, Myanmar, Namibia, Niger, Norway, Panama, Peru, Rwanda, Samoa, Seychelles, South Africa, Spain, Sudan, Switzerland, Syrian Arab Republic, Tajikistan, Uganda, United Arab Emirates, Uruguay, Vanuatu, and Vietnam.

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 Mondaq.com.

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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (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 www.mondaq.com

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 Mondaq.com’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 unsubscribe@mondaq.com 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 webmaster@mondaq.com.

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 EditorialAdvisor@mondaq.com.

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 enquiries@mondaq.com.

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