Help! First aid for the Nagoya Protocol

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The Nagoya Protocol, an international agreement concerning the utilization of genetic resources, entered into force more than a year ago. However, the compliance obligations and even the existence of the protocol are not yet generally known. In this article, representatives from ABS-int, a service provider dedicated to helping organizations comply with the Nagoya requirements, discuss some of the biggest hurdles and misunderstandings life science actors face when trying to meet their access and benefit-sharing (ABS) obligations.

The basic principle of the legal framework on ABS for genetic resources is simple: the country in which a genetic resource is accessed has the sovereign right to determine under which conditions these genetic resources can be used. The Nagoya Protocol adds a compliance element, meaning that the country in which the genetic resource is used must formally verify whether the obligations in the country of access have been fulfilled. To understand how unique this is, consider this scenario. If you drive too fast in a foreign country, then you can be fined in that country. In some cases, that fine will end up in your mailbox, and you will have to respond to the authority of the foreign country. If the ABS rules were applied to this situation, the authorities of your country would also have a role; they would be obliged to setup a system to enable monitoring and formal compliance checks with the relevant traffic laws in the foreign country.

Click here to learn more about the Nagoya Protocol in general.

A note to all life sciences actors

Last year, ABS-int experts provided a series of workshops, contracted by the European Commission, addressing the regulations on ABS compliance, after the Nagoya Protocol was adopted in the European Union. Thomas Vanagt, ABS-int’s Senior Scientific Advisor, says: “Despite the long period preceding the entry into force of the Nagoya Protocol and related legal instruments, many life science actors in academia and in industry seem to have discovered its impact only recently. One of the common misunderstandings relates to ‘utilization’. Within the ABS context, this refers to the entire R&D process, and therefore it impacts everyone involved in the pre-market phase.”

Ignorance is no excuse

Many life science actors still might not be fully aware of how ABS impacts their activities. One of the reasons could be that the legal instruments were negotiated and agreed upon mainly in international fora, far away from their daily practice. In addition, ABS is a multi-layered issue, which makes it difficult to define who should take ownership for this matter within an organization. However, with the implementation of European Regulation (EU) No 511/2014 on compliance with ABS obligations, and with more and more national laws that regulate ABS coming into existence, compliance with ABS obligations must now be firmly integrated into the routine handling of genetic resources. Dominic Muyldermans, Senior Legal Advisor to ABS-int, says: “Since the entry into force of the Nagoya Protocol, organizations have investigated its effect on how they use biological material. Although some aspects still require clarification, these organizations must urgently establish compliance mechanisms to avoid possible infringements and even the prohibition of the use of their material.” This is indeed one of the most dreaded consequences of the EU Regulation: If uncertainties exist related to full compliance with the relevant ABS obligations, then the use of the biological material must be discontinued.

The formalization of the legal framework creates a completely new regulatory field at the borderline between science, intellectual property, contractual arrangements, and regulatory affairs. It is a complex picture, due in part to the international dimensions and the diversity of positions between different countries, and it might take time to fully comprehend its intricacies. However, Patrick Rüdelsheim, Senior Regulatory Advisor to ABS-int, says that uncertainties cannot be used as a reason for non-compliance: “On the contrary, we are in a period during which the EU Commission and the national competent authorities are seeking advice on implementing the legislation. For example, the Commission’s Guidance Document on scope will be an essential tool, and Sectorial Guidance Documents are expected later in 2016. ABS-int experts are contributing to their development. Feedback from our 2015 workshops was welcomed by the EU Commission, but it remains critical that life science actors continue to make sure their concerns are being understood and addressed.”

Based in Ghent, ABS-int offers support to organizations that need help understanding and meeting their ABS obligations. Their activities include awareness raising, training, conducting audits and inspections, customizing track and trace systems, assisting with contract drafting and negotiation, managing documentation, and providing legal and scientific advice. Thomas Vanagt explains: “Everyone involved in R&D who is using genetic resources, from a university researcher to a scientist at a multinational company, has to comply with the new regulations. Our aim is to work together with organizations to create a workable system for their specific needs that results in the unlocking of the desired genetic resources.”