Update on Regulation Implementing Nagoya - result of Trilogue
Merpel has, as is her wont, been prowling the corridors of power, trying to find the result of the Trilogue concerning the draft Regulation implementing the Nagoya Protocol in the EU.
As the IPKat discussed in previous posts (read this one first, which focuses on the main issues of access to genetic resources, then optionally this one which publishes some comments, and then finally this one that grapples with the tricky topic of traditional knowledge), the Commission published a fairly reasonable proposal (given the circumstanding circumstances) which was then massacred by the Parliament by making the provisions retrospective and applying to practically anything that was ever naturally occurring. In this situation, there follows a Trilogue between the Commission, Parliament and Council, in which they attempt to beat out an agreement. Although apparently concluded in 6 December 2013, the compromise document was strangely elusive. But Merpel has now dropped it in the IPKat's lap. You can read it here on the website of the Convention on Biological Diversity.
And what a document it is. It still has onerous "due diligence" provisions (Article 4(2)) for users of genetic material, which seem to this Kat completely out of proportion to the issue. If no "internationally recognised certificate of compliance is available", then users are required to "seek, keep and transfer to subsequent users" "information and relevant documents on":
The document is a hideous chimera that not even its mother could love. It defines the term "illegally accessed genetic resources" (Article 3(8a)) purely for show, because the term is never used in the draft Regulation. Sensibly, the term "user" and "utilisation" of genetic resources is defined in Article 3 consistently with the Nagoya Protocol itself:
One of the few of Parliament's many odd Recitals which has survived is Recital 4a:
This Kat welcomes that the compromise document has resisted temptation to make patent application a check-point for compliance with Nagoya - instead the main check-points are receipt of research funding and product authorisation.
This Kat's understanding is that if Parliament votes to agree the compromise text, then this is what will be adopted as the Regulation. He will continue to dispatch Merpel to prowl around seeking developments, but if our dear readers have any news, the IPKat will be grateful to hear it.
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| IPKat Trilogue |
And what a document it is. It still has onerous "due diligence" provisions (Article 4(2)) for users of genetic material, which seem to this Kat completely out of proportion to the issue. If no "internationally recognised certificate of compliance is available", then users are required to "seek, keep and transfer to subsequent users" "information and relevant documents on":
(i) the date and place of access of genetic resources or of traditional knowledge associated with genetic resources;But, for this Kat, the most welcome and important thing is that the Regulation should only apply to genetic resources accessed AFTER the entry into force of the Nagoya Protocol for the EU (Article 2(1)). This means that the effects, however unwelcome, should be manageable.
(ii) the description of the genetic resources or of traditional knowledge associated with genetic resources utilised;
(iii) the source from which genetic resources or traditional knowledge associated with genetic resources were directly obtained as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources;
(iv) the presence or absence of rights and obligations related to access and benefitsharing including rights and obligations regarding subsequent applications and commercialisation;
(v) access permits, where applicable;
(vi) mutually agreed terms, including benefit-sharing arrangements, where applicable.
The document is a hideous chimera that not even its mother could love. It defines the term "illegally accessed genetic resources" (Article 3(8a)) purely for show, because the term is never used in the draft Regulation. Sensibly, the term "user" and "utilisation" of genetic resources is defined in Article 3 consistently with the Nagoya Protocol itself:
(5) "user" means a natural or legal person utilising genetic resources or traditional knowledgeBut this definition is actually very odd - where else in human discourse does "use" mean "research"? And since the fair and equitable benefit sharing with the provider of the genetic resources (which is the whole purpose of Nagoya) is clearly not limited to the benefit of the research per se, but rather to the benefit of subsequent commercialisation, the document hangs together badly. Moreover, in order presumably to resist the Parliament's attempt to define "user" more broadly, we now have to have a Recital 10d to say :
associated with genetic resources;
(6) "utilisation of genetic resources" means to conduct research and development on the
genetic and/or biochemical composition of genetic resources, including through the
application of biotechnology as defined in Article 2 of the Convention;
It is important that the new definitions contained in the Regulation, which are not included in the Convention or in the Nagoya Protocol, are consistent with the definitions of the Convention or the Nagoya Protocol. In particular the term “user” should be consistent with the Nagoya Protocol term “utilisation of genetic resources”.This really should not have to find its way into the final document.
One of the few of Parliament's many odd Recitals which has survived is Recital 4a:
Genetic resources should be preserved in situ and utilised in sustainable ways and the benefits arising from their utilisation should be shared fairly and equitably. This would contribute to poverty eradication and, thereby, to achieving the United Nations Millennium Development Goals, as acknowledged in the preamble of the Nagoya Protocol. The implementation of the Nagoya Protocol should also aim to realise that potential.This Kat suggests that anyone who considers that the Nagoya Protocol will "contribute to poverty eradication" has severely over-estimated the potential value of research based on existing genetic material. The opposite effect of the Nagoya Protocol, that "bioprospecting" will simply become economically unattractive and decrease, does not seem to have been contemplated. After all this it may turn out that there is in the end no benefit to share. That would be unfortunate and very sad indeed.
This Kat welcomes that the compromise document has resisted temptation to make patent application a check-point for compliance with Nagoya - instead the main check-points are receipt of research funding and product authorisation.
This Kat's understanding is that if Parliament votes to agree the compromise text, then this is what will be adopted as the Regulation. He will continue to dispatch Merpel to prowl around seeking developments, but if our dear readers have any news, the IPKat will be grateful to hear it.
