Basic vs. commercial research
I see courtesy of the good folks at the Agricultural Biodiversity blog that there’s a new request for applications for International Cooperative Biodiversity Groups (ICBGs - I blogged about one of the previous ICBGs in my series of ‘Gorilla medicine’ posts starting here.)
The details of the requirements are available on the website of the U.S. National Institutes of Health (NIH). I was trying to find when the decisions on who would be awarded the grants might be made and stumbled across a section in part VI on ‘principles for accessing genetic resources, the treatment of intellectual property and the sharing of benefits associated with ICBG-sponsored research’.
Apart from requiring compliance with national and international law (including the CBD), the section includes an interesting distinction between basic and commercial research. In discussing ‘disclosure to and informed consent of host country stakeholders’, the request for applications states:
Where national governments do not have clear regulations to guide informed consent procedures, activities should follow a two phase approach to distinguish basic and commercial research. Basic research intended primarily for publication, including collecting and analyzing biodiversity, including bioassay and chemistry work, may be considered “basic” research for the purposes of this program. If, at any time, researchers intend to file a patent application based on this work or to send a sample for testing to an industrial partner, the research immediately enters the commercial realm for the purposes of this program and must follow all the requisite permit and contract standards of the host country.
There’s a lot of discussion in ABS circles about distinguishing between basic and commercial research in order to apply to different rules to each. The prior informed consent process for commercial research is often more involved as are negotiations for the sharing of benefits. There’s general agreement that basic research should not be stifled by being subject to the same requirements.
The problem, though, is how to distinguish between basic and commercial research. It looks to me like the NIH has a good approach to making this distinction - as soon as researchers intend to file a patent or send something for testing to an industrial partner it becomes commercial research. This may mean you have to go back to the country and negotiate new terms.
My only quibble is whether the distinction should be limited to the filing of patents or should also include plant breeders’ rights. This can quickly start making things very blurry again, though, as why not also include copyright or trademark protection as the threshold for entering commercial research? But does publishing a journal article and the accompanying copyright constitute commercial research? Some have already suggested that it’s biopiracy so the argument is not necessarily far-fetched.
It doesn’t help make the distinction between basic and commercial research any more clear-cut, though.
Posted on September 18th, 2007 under ABS, CBD, Intellectual property • 
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September 19th, 2007 at 12:28 am
Australia has taken the importance of distinguishing between commercial and non-commercial research even more seriously. Their policy position as stated on their ABS web site is:
“Australia recognises the importance of
encouraging access for non-commercial
scientifi c research, particularly taxonomic
research.
To that end, the requirements for
obtaining access to Commonwealth (they mean federal)
owned or managed genetic materials
for non-commercial scientifi c research is
more flexible and less involved than for
commercial scientifi c research.
In place of an access and benefit-sharing
agreement, the permit applicant is simply
required to obtain written permission from
the access provider of the resource to enter
a Commonwealth area and remove samples.
A straightforward statutory declaration
must also be made which includes
agreeing to certain obligations. These
include accepting the obligation to
negotiate a full benefit-sharing agreement
should the purpose of research and
development change, and to obtain
permission from the access provider before
passing the sample on to anyone else.”
(http://www.environment.gov.au/biodiversity/publications/access/regs/index.html page 8 of the pdf Brochure)
This arrangement protects ‘basic’ research but importantly recognises that the great driver in science is serendipitous discovery and ‘basic’ science can become commercial at any time.
Non-commercial permits are free as well, and come with free electronic online transparent evidence of lawful collection. Thus eliminating any question of ‘biopiracy’.
If only other countries would follow the Aussie example.
Geoff Burton
September 19th, 2007 at 12:35 pm
Thanks for pointing out what’s going on in Australia, Geoff.
My question is: how does the Australian system distinguish between commercial and non-commercial research?
I looked at the 2005 ABS regulations under the Australian Environment Protection and Biodiveristy Conservation Act 1999 and I see that Division 8A.2 covers access to biological resources for commercial purposes or potential commercial purposes. But what makes something a ‘commercial purpose’? I didn’t see any attempt to define the meaning of ‘commercial purpose’ as the NIH has done in its request for applications for ICBGs.
Does Australia have certain criteria against which it can judge whether access is for commercial or non-commercial purposes (e.g., the move to file a patent application constitutes commercial research in the eyes of the NIH) or is it up to the person seeking access to identify for itself whether its purpose is commercial or non-commercial?
December 15th, 2007 at 12:28 pm
Patent applications and plant variety right applications are filed at different stages in a product’s development. A patent application may be filed on an idea (don’t believe people who say it’s impossible to patent ideas), but a plant variety right is sought for a specific product, typically in the form in which it will be sold. Commercial development will have started some time before.
I think it’s a pity that filing a patent should require prior informed consent. This is not likely to be instantly forthcoming. This may mean that the opportunity to file a patent is lost, through prior publication. That in turn may mean that commercial development is no longer attractive, and the advantages of such development are lost.