EU Parliament gives Nagoya Protocol green light

18 March 2014

The European Parliament has given its overwhelming consent ­- with 647 votes in favour - for the EU to be legally bound to the Nagoya Protocol on Access and Benefit Sharing (ABS) ­to the UN Convention on Biological Diversity (CBD), which was signed by world leaders in the Japanese city in 2010.

The Protocol aims to provide a binding legal framework to determine how researchers and companies will access genetic resources and associated traditional knowledge, as well as how benefits derived from these will be shared. This implements the third pillar of the CBD, which overall is designed to promote the conservation and sustainable use of biological diversity in a fair and equitable manner.

The Parliament's vote on the 11 March marked the Nagoya Protocol's 30th ratification - the Protocol will officially enter into effect 90 days after its 50th ratification. According to the bloc's law, the EU has the legal personality to give assent to the Protocol as a whole, and the consent of the Parliament has been required since 2009 in areas that fall under ordinary legislative procedure.

Analysts suggest that the ratification by the EU is critically important because it opens the way to individual ratifications from its 28 member countries, which in turn should significantly help to achieve the entry into effect of the Protocol by CBD COP 12 in October 2014.

EU regulation on key elements

In the same March plenary sitting, the European Parliament in large numbers approved a proposal to implement mandatory elements of the Protocol ­ targeting genetic resource use within the Union. The Protocol sets out core obligations for its contracting Parties with regard to domestic-level access measures, benefits, and compliance responsibilities.

The EU's regulation will potentially bring the bloc and its member countries in line with minimum ABS requirements mutually negotiated with biodiversity-rich countries such as Brazil, South Africa, and India.

"The Parliament vote is a landmark vote that will significantly impact the way biodiversity based R&D is conducted in the food and cosmetics industry," said María Julia Oliva, Senior Coordinator for Policy and Technical Support at the Union for Ethical BioTrade (UEBT).

The new EU rules establish certain due diligence requirements based on best practices, and businesses dealing with research and development must keep and distribute information about resource access and ABS compliance. When compliance is uncertain, the ruling requires that businesses obtain the proper permit or discontinue use.

"We believe that the EU has been largely successful in striking a careful balance between competing considerations. It has proposed an innovative approach to the Protocol based on due diligence, which will encourage responsible utilization of genetic resources and promote compliance, while providing legal certainty for users of resources," the European Federation of Pharmaceutical Industries and Associations (EFPIA) said in a statement that welcomed both legislative decisions.

The industry group nevertheless warned that challenges remained in ensuring that different stakeholders worked together to ensure regulation compliance across the supply chain, in a timely manner, citing sensitive example such as access to seasonal influenza viruses.

Some commentators were more sceptical with regards to the new regulation, suggesting that it fails to protect traditional knowledge. Others pointed to the failure to disclose legal provenance in patent applications - a measure eligible as a compliance checkpoint under the Protocol.

Certain experts suggest that the due diligence system is coupled with a number of legal presumptions, that "may result in some critical gaps in monitoring compliance of users with their benefits sharing obligations," said Claudio Chiarolla, a research fellow on international governance of biodiversity at IDDRI, a non-profit research institute based in Paris, France.

ICTSD reporting; "European Parliament adopts rule that will impact biodiversity based R&D in food and cosmetics sectors," Union for Ethical BioTrade, 12 March 2014, "EU steps forward in adoption of Nagoya Protocol on genetic resources," THE PHARMALETTER, 12 March 2014.

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