I would like to preserve in my collection a bacteria isolated in Reunion (France) in 2009. The strain is currently maintained in a French laboratory. Do I need to make a declaration or to apply for a permit to access to this resource? The purpose of access would be to preserve the strain and to offer it to third parties for R&D.
Dear Aurora,
first a little bit of context:
if a user want to use the French resources for research (no comercial use) the user have to declare the use.
If a user want to use them for commercial development the user have to ask for an authorisation.
And this wherever the strain is stored.
But... there is an exemption for "domestic microorganisms"
If the strains fall in this category (more or less = microorganisms isolated from environment modified for the human use) the user do not have to declare the use for research.
The exact definition is available here (in French): https://agriculture.gouv.fr/telecharger/115029
This is only for research use. For commercial use an authorization is still necessary.
To resume:
if the strains are isolated from a human-modified environement : you don't need to declare that you include them in your collection.
And if a subsequent user want to use them for research, they do not need to declare it either.
If the strains are from an environment non human-modified, you have to declare that you include them in your collection and the next users have to declare the use for research.
And in any case, all commercial use need an authorization.
If you need more info let me know, I'll try to find answers
Dear Perrine, thank you for the detailed response.
If I understand correctly, any non-commercial use (deposit, research, quality control...) of French wild-type (from non-human modified environments) strains shall be declared to the competent authority. But I have a couple of questions about dates:
Does this apply to any French strain regardless the date of sampling from the environment?
What about French strains deposited in culture collections or preserved in laboratories outside France before the entry into force of the applicable legislation?
Aurora,
the French law takes in account the date you the user has access to the resource.
Meaning that if you access a strain today, even if it was isolated 50 years ago, you have to declare the use.
In my understanding the strains preserved in collections outside France are submitted to the same rule. Even if the collection has it for a long time.
@perrine @aurora
Dear Aurora,
In agreement with Perrine, it is my understanding that a declaration is needed (and an authorisation if a commercial use is planned), even though the GR was acquired before the French ABS legislation.
According to a guideline produced in the frame of the French project ABS4BRCs ( https://projet-abs4brcs.fr/Projet-ABS4BRCs), the temporal scope of French ABS system application is:
"Temporal Scope: Plan to use the GR, with a given purpose, after July 1, 2017 (whether the GR were acquired in situ or in collection)"
"Out of temporal scope: Project for the use of GR, with a given objective (and in particular a direct objective of commercial development or not), initiated before July 1, 2017 (whether the GR were acquired in situ or in an ex situ collection )"
I hope this helps.
Mariana
Dear Perrine and Mariana,
I was asking the question because at least in Spain the regulation is quite similar and I know that it does not apply to Spanish genetic resources (GR) that left the country before the entry into force of the legislation (15 March 2017, RD 124/2017). The reason is that the regulation applies to the access to Spanish GR in the territory of Spain.
I have read the english translation of the French regulation and it reads: "Subject: Access to genetic resources and their associated traditional knowledge on French territory..."
Therefore, it could be understood that access to a French GR outside France only applies if the access to the GR in France took place after July 1, 2017. Would be good to know if the French NFP/NCA makes the same interpretation...
Dear Aurora,
I see your point, but if I understand well, that interpretation would mean that the laws from different countries might apply to the same strain.
To put it in an example, if a strain was isolated in France and deposited in a collection in France and in another collection in Germany in e.g. 2013, a user asking for the strain today in the French collection should do the declaration because the use falls under the temporal scope of the law, but if the access is intended to be done in the German collection, then the same user shouldn't do the declaration because it left France before 2017.
In my view, that would be very strange, but I honestly don't know the interpretation of the French NFP.
It is indeed strange but actually this is how it works with Spanish genetic resources. If you or other French collections have contacts with your National Authorities dealing with ABS would be great if you can make the consultation 😉
