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"?|
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[there is more but this is the important bit]
(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.
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?