For the half-year to 30 June 2014, the IPKat's regular team is supplemented by contributions from guest bloggers Alberto Bellan, Darren Meale and Nadia Zegze.

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Friday, 17 January 2014

A hideously deformed chimera that not even its mother could love - Nagoya V

In the IP profession we are used to legislative instruments emanating from the EU that are unlovely, unnecessarily obscure, difficult to interpret, hard to apply in real world situations, and … [Merpel sits on the IPKat's paws to stop him going on].  Just look at the SPC Regulation and the innumerable CJEU referrals that have been required to (so far unsuccessfully) elucidate what the law actually is.  Well, the current draft of the Nagoya implementing regulation is a worthy inheritor of this lamented heritage.

Did somebody say "Badger"?
Earlier this week, this Kat wrote a post on the draft which is the result of the trilogue, pointing out that it bore the scars of apparently being hammered out as a compromise between opposed positions - presumably the Commission and the Parliament, judging by the previous drafts of the Regulation, as reported in this Kat's original piece on the subject.  Merpel has been reading the current draft (which, under usual circumstances, will be the form that is finally enacted, so at this stage it kind of matters), and has been badgering the IPKat about Article 4 ("Obligations of Users") in particular.  The main import of Article 4 is to define the due diligence that users (=researchers) must exercise "to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and that benefits are fairly and equitably shared upon mutually agreed terms", as paragraph 1 states.

Paragraph 1a is unlovely:

Genetic resources and traditional knowledge associated with genetic resources shall only be transferred and utilised in accordance with mutually agreed terms if they are required by applicable legislation or regulatory requirements.

The IPKat thinks it is capable of only one sensible interpretation, but is left scratching his head as to why it is drafted so oddly, particularly the final clause with the hanging "if they".

Paragraphs 2 and 3 set out the due diligence requirements of users of genetic resources (remembering that "user" actually means "someone who conducts research into").  Para 2 was dealt with in the previous blogpost, but it needs reproducing here in its entirety:

For the purposes of paragraph 1, users shall seek, keep and transfer to subsequent users:
(a) the internationally recognised certificate of compliance, as well as information on the content of the mutually agreed terms relevant for subsequent users; or
(b) where no internationally recognised certificate of compliance is available, 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.

And para 3 simply says:

Users shall keep the information relevant for access and benefit-sharing for twenty years after the end of the period of utilisation.

But the real issue, that Merpel cannot understand and the IPKat cannot get his head around either, is paragraph 5.

Users acquiring a genetic resource that is determined to be the causing pathogen or likely to be the causing pathogen of a present or imminent public health emergency of international concern, in the sense of the International Health Regulations (2005) or of a serious cross-border threat to health as defined in the Decision of the European Parliament and of the Council on serious cross-border threats to health, for the purpose of public health emergency preparedness in not yet affected countries and response in affected countries, shall fulfil the obligations listed in paragraph 2 or 3 at the latest
(a) one month after the imminent or present threat for public health is terminated or
(b) three months after commencement of utilisation of the genetic resource
or discontinue utilisation.
The condition that is fulfilled first will apply.
[there is more but this is the important bit]

This is not just unlovely, it is very odd indeed.  What it seems to say is that in the case of a severe public health emergency (the IPKat is thinking SARS or the like) someone conducting research into the pathogen concerned (who is likely therefore to want to be devoting their entire efforts into the health disaster at hand) has only at most three months to complete all of the paperwork of paragraph 2(b) (since 2(a) will certainly not apply because it will be too early for an "internationally recognised certificate of compliance")… or …

all research must stop ("discontinue utilisation").  When the world is in the midst of a public health crisis.

Oh, and if the research does not stop, then Article 11 provides that, for such an infringement of Article 4, Member States must provide "penalties [that] shall be effective, proportionate and dissuasive."

This cannot possibly be correct, cries Merpel.  But what else can it possibly mean, retorts the IPKat.

The fictional felines are at a loss.  So they turn to our dear readers for help.  Are researchers in a public health emergency really subject to such a rigid and draconian timetable?



9 comments:

patently said...

Am I right in thinking that paragraph 1a is a draft of a law that says people must observe the law?

Darren Smyth said...

Thanks Patently, I think that is indeed what paragraph 1a says - if there is a law, you must comply with it.

Actually, in fairness, I don't think it is quite as otiose as it may initially appear, because, particularly in combination with Article 11, I believe that the effect is to make it an offence within the EU to breach legislation or regulatory requirement outside the EU.

So actually, as well as being ugly, it is quite scary.

Tim Roberts said...

The IPKat has form on this topic. He has been accused before of being a 'biopiracy denier'. Now he makes matters worse by attempting to construe the proposed Regulation with inappropriate literalism.

Obviously the Articles quoted are not intended to be taken au pied de la lettre. In the event of a major epidemic, they will be disregarded. Purposive construction requires first that the intention of the legislation be taken fully into account. A major objective of the Regulation is to make the EU (and its member states) look good. To impede research on a major biological threat with bureaucratic obstacles would have the opposite effect. So the requirement cannot be interpreted so as to do this - it will not be so applied. How this will come about is more difficult to work out: my guess would be that the CJEU, some years after the issue has arisen, will decide that it has power to extend the period of three months retrospectively.

A more difficult question is how and to what extent purposive construction is to be applied to other impractical requirements of the Regulation.

Darren Smyth said...

Dear Tim

Thank you for your comment. You omit to remind readers that it was you yourself who kindly accused this Kat of being a biopiracy denier, thus teaching this Kat about himself.

This Kat will construe EU legislation purposively when he learns precisely what "teleological" means.

Darren

Norman said...

Is it possible that 4(1a) actually means the opposite – that compliance with mutually agreed terms is necessary _only_ if applicable legislation so requires? Suppose that genetic resources which are accessed and developed into a product in a country which is not signatory to Nagoya, and so has no benefit sharing legislation (eg the US), and the products are then exploited in the EU (eg the resulting drugs are sold in the EU). It seems reasonable to me that the EU regulations should not require EU states to return money to the US to compensate the US for the use of its genetic resources, and the definition of “illegally accessed” Art 1(8a) seems to support that. Is it possible that this is what 4(1a) is saying? I must admit I haven’t read the entire draft.

Darren Smyth said...

Dear Norman

Thank you for your comment. It could indeed mean what you say, or even both in an "if and only if" sense.

However, if a country has no ABS legislation, then surely the expectation is that there would be no mutually agreed terms to comply with, so this provision seems hardly useful.

So still scratching my head.

Darren

Tim Roberts said...

A further thought about how to cope with the Regulation in the case of epidemics. The Regulation may be nonsense, and maybe those drafting it have totally failed to appreciate the perverse effects it may have (and – perhaps – we critics are over-reacting a bit – time will tell) but it is going to be the law. So we need workarounds. Here's one for epidemics.
Back to first (CBD) principles. Nagoya says that permission is required from the 'country of origin'. 'Country of origin', and other terms, are defined in the CBD.
"Country of origin of genetic resources" means the country which possesses those genetic resources in in-situ conditions.”
"In-situ conditions" means conditions where genetic resources exist within ecosystems and natural habitats, and, in the case of domesticated or cultivated species, in the surroundings where they have developed their distinctive properties.
"Habitat" means the place or type of site where an organism or population naturally occurs.


It will be observed (it has often been a source of complaint) that genetic resources typically do not have a unique 'country of origin'.

Now, what is the 'natural habitat' of a pathogen? It is the host it infests. So when a pathogen is infecting a population (whether human, animal or vegetable) the country containing that population 'possesses' the GR of the pathogen 'in in situ conditions'. That it is not the first country to do so is neither here nor there. So any such country will have Nagoya rights over the pathogen and be able to allow research on it. All researchers will have to do is to ensure they get samples from countries (such as most EU countries) who are not fussed about asserting their Nagoya rights. Tedious but practicable?

Tulpa said...

The onerous, impossible paperwork listed consists of:

"(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 benefit sharing including rights and obligations regarding subsequent applications and commercialisation;
(v) access permits, where applicable;
(vi) mutually agreed terms, including benefit-sharing arrangements, where applicable."

In other words, the only real paperwork required are terms for the benefit sharing agreement and access permits, which should both be very available within three months.

Is it possible the Kat has got his fur in a state over a total non issue?

Tim Roberts said...

Tulpa, I'm not convinced by your timeline. Isn't it likely that agreeing terms on access to an important and valuable resource might take more than three months - perhaps a lot more? Other delays are also possible - in determining which country you need to negotiate with, for example.

Further, the Regulation may not say so specifically, but aren't you supposed to have agreement before you access the genetic resource? It's Prior Informed Consent that is required. I believe this will be spelt out in the laws of donor countries - which the Regulation requires you to respect.

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