Questions Arise Over EU Draft Regulation To Implement Nagoya Protocol

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The European Commission has prepared a draft regulation to implement an international protocol to prevent biopiracy, leading two non-governmental organisations to publish an opinion piece voicing concerns about it. The European Parliament is scheduled to review the draft on 4 July. A key concern is whether it would cover non-European genetic resources already in European collections.

The Berne Declaration and Natural Justice published an opinion piece [pdf] on 18 June criticising the draft European Commission Regulation 2012/0278 to implement the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity in the European Union.

The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament is scheduled to vote on the draft regulation on 4 July, according to the NGOs, and a final draft is expected to be tabled in the European Parliament in October 2013.

A report [pdf] on the draft rule has been issued by the ENVI rapporteur, Sandrine Bélier, Member of European Parliament from the Group of the Greens/European Free Alliance. The report says the EU proposal constitutes a solid basis for an effective system at European level but certain mechanisms should be strengthened and several recommendations are made in the report to such effect.

One of the recommendations concerns new utilisations of genetic resources and associated traditional knowledge and progressive compliance. The rapporteur in the report proposed that “each new utilisation that has not been defined before the entry into force of this regulation should be covered by an access and benefit-sharing contract. Such a requirement would allow all genetic resources in Europe to gradually come into compliance.”

“Much of the world’s genetic resources are indeed already found in European collections. The Commission proposal does not cover these resources, and this poses several major problems. The most important problem, according to the rapporteur, is that some uses of resources that may have been acquired illegally could thus be legalised,” it says.

A number of amendments [pdf] have also been tabled in the committee.

According to the NGOs’ joint press release, the draft regulation excludes “a significant category of genetic resources,” and fails to provide for fair and equitable sharing of benefits from the utilisation of genetic resources and associated traditional knowledge.

The main incentive for developing countries to engage in the negotiation of the Nagoya Protocol, they say, was their understanding that the engagement of both provider and user countries was key to prevent misappropriation of genetic resources. In many cases, they added, “the best Access and Benefit Sharing (ABS) legal provisions in provider countries are insufficient to ensure compliance with ABS obligations.”

Contentious issues remained in the negotiations leading to the adoption of the Nagoya Protocol, and were not resolved, allowing the text of the Protocol to contain “significant gaps allowing for flexible interpretation,” according to the opinion piece (IPW, Biodiversity/Genetic Resources/Biotech, 29 October 2010).

The two NGOs conducted an investigation which they claim shows that in the draft regulation, the rules would only apply to genetic resources (GR) and associated traditional knowledge (TK) physically accessed after the entry into force of the Nagoya Protocol, and that implementation would contrast with a number of existing ABS laws in provider countries. In those countries, they say, the utilisation of GR and TK also triggers the obligation to share benefits.

The EU interpretation of the Nagoya Protocol can have “very serious consequences,” the NGOs said. In particular, because a number of GRs and associated TK used in the EU will not be covered by the regulation, and also because individual users of GRs and TK, will face legal uncertainty as “in many cases, the utilisation of GRs and TK will be legal under EU law, but illegal under the law of the provider country.”

They urge the EU Parliament, Council and Commission to “enact a regulation that is in line with the objective of the Nagoya Protocol and ensures that all utilization that takes place after the Nagoya Protocol comes into force complies with the ABS rules of provider countries.”

Catherine Saez may be reached at

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  1. Tim Roberts says

    ‘Bioprospecting’ typically involves a collector travelling to a country and seeking out new genetic resources (GR) of potentially interesting properties, in order to develop products based on them. In such circumstances, it is both reasonable and practicable to require the ‘bioprospector’ to respect local laws (governing access and benefit-sharing, or anything else). But once GR has left a country this is much more difficult.

    Nagoya assumes that the principle of national sovereignty means that all GR (human GR apart) is under the control of the ‘country of origin’ (in perpetuity, apparently). This is a remarkable extension of the idea of national sovereignty. The uncertainties (both of fact and law) to which it gives rise are likely to have a chilling effect on research into genetic resources. This is dead contrary to the Convention on Biological Diversity, which is supposed to promote access and use.

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