Biology Reference
In-Depth Information
sharing with profit sharing, the latter is only a minor component of the former and
could be replaced with broader measures to avoid undue inducement (see below)
without major difficulties.
The most comprehensive mechanism for the sharing of benefits from research
is the access and benefit-sharing agreement in the framework of the Convention on
Biological Diversity (CBD) now formalized as the Nagoya Protocol.
11
The proto-
col itself does not explicitly exclude human genetic materials from its scope, but
such materials are already excluded by a prior agreement of the Conference of the
not apply to medical or human genetics research directly.
12
Still, through its refer-
ence to human pathogens and relevant WHO regulations (see
Chap. 3
,
Sect. 3.2.5
),
the Nagoya Protocol, together with the 2011 WHO Pandemic Influenza Pandemic
Preparedness Framework (World Health Assembly
2011
), could contribute to
future discussions of benefit sharing in human medical research (see
Chap. 8
).
The principle for benefit sharing in the Nagoya Protocol is that
benefits arising from the utilization of genetic resources as well as subsequent applica-
tions and commercialization shall be shared in a fair and equitable way with the Party
providing such resources that is the country of origin of such resources or a Party that has
acquired the genetic resources in accordance with the Convention. Such sharing shall be
upon mutually agreed terms (CBD
2010a
, article 5.1).
The protocol includes the following extensive, but not exclusive, list of poten-
tial benefits (CBD
2010a
, annex):
1. Monetary benefits may include, but not be limited to:
(a) Access fees/fee per sample collected or otherwise acquired;
(b) Up-front payments;
(c) Milestone payments;
(d) Payment of royalties;
(e) Licence fees in case of commercialization;
(f) Special fees to be paid to trust funds supporting conservation and sustain-
able use of biodiversity;
(g) Salaries and preferential terms where mutually agreed;
11
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of
Benefits Arising from their Utilization to the Convention on Biological Diversity (CBD
2010a
)
was adopted at the tenth meeting of the Conference of the Parties to the CBD on 29 October
2010, in Nagoya, Japan. The access and benefit-sharing scheme formalized in the Nagoya pro-
tocol replaced the voluntary Bonn Guidelines on Access to Genetic Resources and the Fair and
Equitable Sharing of the Benefits Arising out of their Utilization.
12
The exclusion of human genetic resources is explicitly stated in the Bonn Guidelines (
2002
:
paragraph 9), but not mentioned in the Nagoya Protocol itself. When the Nagoya Protocol was
adopted, it was made clear that 'genetic resources' did not include 'human genetic resources' in
decision I/5: 'The Conference of the Parties … [a]grees, bearing in mind decision II/11, para-
graph 2, and without prejudice to the further consideration of this issue by the Conference of the
Parties serving as the meeting of the Parties to the Protocol, that human genetic resources are not
included within the framework of the Protocol' (CBD
2010b
).
