EU’s Nagoya Protocol Ratification: How It Works

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The European Union Council of Ministers on 14 April adopted a decision approving the ratification of a protocol meant to facilitate access to genetic resources and to provide the fair sharing of commercial benefits with provider countries. The target date for ratification is July 2014, according to the EU.

The Council adopted two texts related to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. One was a decision approving its ratification, and the other was a regulation (referred to as the “EU access and benefit-sharing regulation”), which modify the EU legislation in order to be in line with the requirements of the Protocol.

The Nagoya Protocol of the UN Convention on Biological Diversity (CBD) was adopted on 29 October 2010. Its purpose is to set minimal requirements on access and benefit-sharing (ABS) for the use of genetic resources (GR) and associated traditional knowledge (TK), including those belonging to indigenous people. It sets several principles such as prior and informed consent of the country of origin of the resource, or of the indigenous peoples through mutually agreed terms.

The protocol will enter into force three months after the 50th ratification. At press time, the text had been ratified by 29 states [corrected]. The ongoing process of ratification by the EU and likely its member states is closely followed as it would lead to the number of 50 ratifications needed.

If the Nagoya Protocol is ratified in time, it could lead to an entry into force of the Protocol by the next planned biennial high-level meeting of the CBD. That meeting, the Conference of the Parties serving as the first Meeting of the Parties to the Protocol (COP/MOP), is scheduled for October 2014 in Seoul, South Korea.

Otherwise, the next opportunity to hold the first meeting of parties would be the next CBD Conference of Parties in 2016.

As an additional impetus, parties to the CBD agreed in the Aïchi targets, which are part of the CBD parties’ strategic plan for biodiversity for 2011-2020, that the Nagoya Protocol should enter into force before the end of 2015 (Target 16).

Why Now?

The EU signed the Nagoya Protocol in July 2011. An analysis of the text by the European Commission in October 2011 concluded that the ratification would have economic impact and that “additional legislation is needed for the EU to fulfil its obligations as a Party to the ABS Protocol.” It was thus decided to adopt a legislation prior to a ratification.

The EU legislative process was lengthy, including an online consultation and an impact assessment study (documents here), which led to a draft regulation analysed and modified both by the European Parliament and the European Council. The full legislative procedure is here.

Both texts still have to be published in the Official Journal of the European Union, which might take a few weeks, according to Joe Hennon, spokesperson for Janez Potočnik, the European Commissioner for Environment.

“The deposition of the ratification is envisaged ahead of July 2014,” Hennon told Intellectual Property Watch, which meets the objective to hold the first COP/MOP in October 2014, as the Nagoya Protocol will enter into force three months after the 50th ratification.

Draft Regulation in Question

The EU draft regulation has already been presented as insufficient to comply with all the objectives of the Nagoya Protocol, in particular regarding the protection of the rights of indigenous peoples over their genetic resources and associated traditional knowledge.

In an article entitled “European Union Draft Law Threatens Indigenous Peoples’ Rights over their Traditional Knowledge and Genetic Resources,” published in the European Intellectual Property Review, Brendan Tobin, research fellow at the Australian Centre for Intellectual Property in Agriculture (ACIPA), argues that the scope of the draft regulation undermines the rights of indigenous peoples.

First, the draft regulation defines traditional knowledge “for the purpose of protection” as “described in the mutually agreed terms applying to the use of genetic resources.” This “excludes all traditional knowledge that is not the subject of an access agreement,” Tobin said.

In other words, this leads to exclusion of “all traditional knowledge accessed without prior informed consent and mutually agreed terms.” That in turns means that situations where there is no contract relating to access would be out of the scope of the EU protection against biopiracy.

Second, Article 4(1) of the EU draft regulation states that users shall “exercise due diligence” to ensure that GR and associated TK are accessed and that “benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.”

Thus, the EU legislation only applies “where relevant national legislation exists in the countries in which the relevant genetic resources and traditional knowledge are obtained,” which is non-compliant with articles 6 and 7 of the Nagoya Protocol, Tobin argues in his paper.

The office of Sandrine Bélier, member of the EU Parliament and rapporteur of the EU draft regulation on ABS, told Intellectual Property Watch that there are some insufficiencies in the text. These concern the scope as well as controls on the use of genetic resources, as it requires reporting only during the research step and final steps of development of the product.

“Member states did not have a constructive attitude during the negotiations and it was clear that many countries would have preferred that there is no regulation,” her office added.

Bélier, during the vote on the text, also stated that “the negotiation with the Council was difficult, but its result, if less ambitious than the position adopted by the European Parliament in July 2013, is its regulation which enables the European Union to ratify the Nagoya Protocol and to be a stakeholder at the next UN conference for biodiversity” [translated]. [link to the video here.]

Two-Tiered Ratification Process

As the Nagoya Protocol concerns several domains of competence shared between the EU and its member states (See the Treaty on the Functioning of the European Union, articles 2-5), the EU does not have the exclusive competence to negotiate and ratify it. Thus, the upcoming ratification of the Nagoya Protocol by the EU would not lead to an automatic ratification by all member states.

[corrected] According to Article 33 of the Nagoya Protocol, “any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization.” In consequence, the EU ratification will not be counted as one if at least one of the EU member States ratify it after. So the 28 member states have to individually ratify it.

Some 23 member states have signed the protocol (those which have not signed it are Croatia, Estonia, Latvia, Malta, and Slovakia) but none of them have yet ratified it.

The fact that those countries did not ratify the protocol can be explained by the injunction of the European Commission to member states to not ratify the Nagoya Protocol before EU did it. Indeed, the European Commission in the document 15191/11 in 2011 considered that it was “excluded that individual EU [member States] would ratify unilaterally, prior to a ratification by the EU,” considering it would “be in conflict with the EU Treaty.”

Still, the question remains whether all EU member states that signed the Nagoya Protocol intend to ratify it before July. As the EU draft regulation leaves a lot of issues to be settled by member states, these should have already prepared a national legislation and passed it before July, which remains uncertain.

Hennon told Intellectual Property Watch that “The vast majority of EU member states has signed the Nagoya Protocol and have therewith expressed their commitment to ratify it and will do so either jointly with the EU ratification or in the months thereafter if the national requirements for ratification of international instruments require more time.”

Bélier’s office expressed its hope that the adoption of the EU ABS regulation “will create a dynamic of ratification within member states,” underlying that France for example will adopt this year a “framework” law on biodiversity that includes the ratification and implementation of the Nagoya Protocol.

A few weeks after the adoption of the EU regulation on 26 March, the French Ministry of Environment presented a draft bill on biodiversity, of which Title IV implements the draft EU ABS regulation and the Nagoya Protocol.

However, the explanatory statements of the law on page 10 state that, “Like most European countries, France could make the choice not to regulate the access to its GR and associated TK.” Moreover, considering the legislative process time, the French government does not expect the entry into force of its legislation before 1 January 2015 (see draft bill, Article 17).

The United Kingdom recently closed a consultation on the implementation of the Nagoya Protocol in the UK.

In sum, there appears to been little chance that all EU member states will ratify the Nagoya Protocol before July 2014. Thus, the EU and its member states may not be among those by which the Nagoya Protocol has reached the 50 ratifications before the Seoul conference in October. But they could help to meet the Aïchi target, which states the Nagoya Protocol should enter into force before the end of 2015.

Maëli ASTRUC is an intern at Intellectual Property Watch. She has a Master’s Degree in International Law from Aix-en-Provence University and a LL.M from Ottawa University. During her studies, she developed a high interest in intellectual property issues in particular related to agriculture and traditional knowledge.


Maëli Astruc may be reached at

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