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Tuesday, 14 January 2014

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.

IPKat Trilogue
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":
(i) the date and place of access of genetic resources or of traditional knowledge associated with genetic resources;
(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.
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.

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 knowledge
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;
But 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 :
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.


Tim Roberts said...

Thanks for this.

To speculate: presumably this is the final form of the Regulation. As one or two of the more ridiculous proposals of the Parliament have been taken out, the Environmental Committee is not conceding yet, but it seems improbable that the Council and Commission will give further ground.

It could be worse (yes, honestly!). It's not been made retrospective. There is no specific mention of criminal sanctions. And above all there is no requirement (yet) that every time you file a patent application mentioning a genetic resource, you have to mention its country of origin.

But the scope of the Regulation is worryingly broad. It's not just 'bioprospecting'. It covers (doesn't it?) all research on non-human genetic resources. When Nagoya comes into force (later this year) all research on such genetic resources will become prima facie unlawful. To make it lawful, you will have to show, either that you have had the GR from before Nagoya came into force, or that you have the appropriate permissions from the 'country of origin' (for which purpose you are going to have to know what the 'country of origin' is).

And patent attorneys are going to have to explain this to their clients.

Darren Smyth said...

Dear Tim

Thank you for your comments. I agree with every word. I am sorry that it seems to be just the two of us talking...

I had intended this would be my last post for a while, but I had some further thoughts last night, so watch this space.


Graham Dutfield said...

Would there be any interest in the IPKat hosting an evening discussion on the subject in London? I'd be delighted to take part and it might be rather interesting. I come at this subject from a different direction and while I broadly agree with much that is said by Darren in his various posts there are some matters about which there could be some constructive debate that might possibly interest more than the 2-3 people who have been commenting so far.

Jeremy said...

Thanks, Graham -- and I have some positive news for you. The IPKat is happy to organise just such a discussion. Kate Chapman (CGIAR) is happy to participate, as is Neil Wilkof. It would be great to involve you too. Watch this space!

Anonymous said...

Environnement committe of the eu parliament adopted the compromise text yesterday see web site of eu parliament. Not as broad as originally proposed

Charis Cook said...

Thanks for this - it is about the only article I could (easily) find on it! If the discussion event occurs, please let me know (, though I am a twitter follower so should keep up) - I would be happy to help spread the word to UK plant scientists, it is important for them to be aware of the new regulations.

Claudio Chiarolla said...

Dear all,
You may be aware that the EU draft Regulation on ABS was approved by the European Parliament’s Environment Committee on 22 January 2014. However, it is not easy to find the link to the most recent version of the text, which is why I am taking the liberty to posting it here:

This text will be voted by the EU Parliament on 11 March 2014, with a view to its adoption the same day the Nagoya Protocol will come into force.
If you are still planning to organise a discussion in London on this topic, I would be happy to contribute to it as well. I could usefully share some insights on the French experience in this regard. In particular, the Parliament is about to vote a law on access to genetic resources and associated TK which will be applicable to France and (some of) its overseers dependencies.

Best regards,
Claudio Chiarolla

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