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The Nagoya Protocol

How to proceed in research work with biological material of foreign origin? Access to genetic resources and the sharing of benefits arising from their use are one of the three main objectives of the Convention on Biological Diversity, which entered into force in 1993 and is one of the most important international environmental conventions.

The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilizationwas negotiated as an international agreement to this Convention and entered into force on 12 October 2014. The Protocol is intended to establish transparent rules for access to genetic resources and ensure equitable benefit sharing between providers and users (in accordance with mutually agreed terms).

As a party to the Nagoya Protocol, the EU leaves the regulation of genetic resources to the individual Member States and only deals with the issue of compliance by users on EU territory.

In the Czech Republic, the rules related to the Nagoya Protocol may affect users who work with genetic material of foreign origin. Genetic resources of Czech origin are not subject to regulation and therefore do not need to reflect the Nagoya Protocol when working with them.

For users in the Czech Republic, the key issue is EU Regulation 511/2014, which sets out the obligation to exercise due diligence in the use of genetic resources acquired after 12 October 2014 from a country that is a party to the Nagoya Protocol and has adopted legislation or regulatory requirements on access and benefit sharing. Utilization means research and development on the genetic or biochemical composition of genetic material.

Nagoya Protocol and scientific institutions

Institutions that acquire genetic material from abroad for research and development purposes should familiarize themselves with the Nagoya Protocol and set up rules and processes to ensure that researchers have sufficient information and can exercise due diligence when acquiring genetic material and subsequent research. This means obtaining, maintaining and communicating to other users information demonstrating that the genetic resources used have been accessed in accordance with the applicable legislation of the providing country or that the benefits arising from the use of these resources are shared. Failure to comply risks complications, especially on the part of the providing country. The latter can seize the material when it is exported from the country, or put the scientist’s reputation at risk if, for example, he publishes the results of research using genetic material in violation of the rules.

For more details see the website and in particular the methodological guidelines for users of genetic resources in the Czech Republic, which can be found here. The Ministry of the Environment also offers consultations and lectures that can be tailored to a specific institution.

The Nagoya Protocol and the importance of biodiversity for developing countries

Many developing countries are among the world’s most biodiverse. It can therefore be assumed that their genetic wealth is being used more intensively. The aim of the Nagoya Protocol is therefore to channel the benefits arising from research and development back to the countries of origin of the genetic material under investigation. At the same time, these funds should be used for biodiversity conservation, so they can be an important (not only financial) resource, without which conservation in these countries would be more difficult.

How do you assess the impact of the Nagoya Protocol?

Although 9 years since the entry into force of the Nagoya Protocol seems like a long time, setting up legislative, administrative and technical measures at the national level is a long haul. Therefore, it can be said that we are still learning. We will have to wait until the Parties submit their first national reports for a more detailed assessment.

Today, the perception is that the Nagoya Protocol is not yet fulfilling its purpose. It set strict, and not always understandable, rules for users, and in turn failed to generate the funds that developing countries expected.

On a positive note, the Protocol has contributed significantly to spreading awareness that the sovereign right to genetic resources belongs to the countries of origin.. Users of genetic resources who do not accept and respect this principle are now the exception rather than the rule.

If we were negotiating the Nagoya Protocol today, the basic principle and objectives would remain the same, but the mechanism of rules and obligations would probably look different. It would probably accept a more flexible benefit sharing arrangement, rather than the current direct bilateral provider/user setup. Our experience of implementing the protocol in practice helped us to gain this insight.

One of the key themes of the recent UN Biodiversity Conference 2022, which adopted a new global framework for biodiversity conservation, was the issue of Digital Sequence Information – DSI). The Parties to the CBD agreed that the benefits from the use of DSI should also be shared, but the different nature of DSI and physical genetic material requires a different solution than the bilateral approach under the Nagoya Protocol. A multi-faceted mechanism is therefore proposed, which at the same time must meet important conditions such as efficiency, economic return, legal certainty or preservation of open access to data, and that the new mechanism does not jeopardise research and development. Many negotiators made no secret of the fact that they saw the new mechanism as an opportunity to correct some of the shortcomings of the Nagoya Protocol.

A question instead of a conclusion, so can we expect changes in the rules?

There are unlikely to be any changes in the Czech Republic and other EU countries in the near future. Often, non-EU countries are still working on adopting legislation on access and benefit-sharing; in other countries there may be partial adjustments based on experience with the implementation of the Protocol. A deeper reflection can only be expected in 2026, when an evaluation based on national reports will take place.

Part of this reflection is already taking place in the context of the discussion on the DSI and the setting up of the new multilateral mechanism. A significant shift from the preparation of the Nagoya Protocol is the involvement of other actors concerned with the issue (including scientific and research institutions) in the discussion. Only in this way will it be possible to design a mechanism that will effectively generate resources that will be used for the conservation and sustainable use of biodiversity, without imposing undue obstacles to science and research. Author Eliska Rolfová, National Contact Person for the Nagoya Protocol, Department of International Conventions, Department of Species Conservation and Implementation of International Obligations.
Ministry of the Environment of the Czech Republic