Legal Frameworks for Benefit Sharing: From Biodiversity to Human Genomics - Benefit Sharing - page 33

• The HUGO Ethics Committee's Statement on Beneit Sharing ( 2000a )
• The UN Educational, Scientiic and Cultural Organization's (UNESCO's)
Universal Declaration on the Human Genome and Human Rights (UNESCO
1997 ) and Universal Declaration on Bioethics and Human Rights (UNESCO 2005 )
• The Brazilian national guidelines on post-trial obligations (National Health
Council 1996 , 1997 , 1999 , 2000 , 2008 ) as an example of national law.
It is generally understood that ethical guidelines have no legal status, but it is
important to note that in terms of the current legal literature, ethics guidelines are
regarded as customary international law. To qualify as customary international law,
an ethics guideline must be supported by the consistency and generality of being
widely accepted as a practice (Brownlie 2003 : 7). David Fidler's observation that
government funding of national and international clinical trials reveals some gen-
eral and consistent state practices which support the basic principles of ethical
codes such as the Declaration of Helsinki and CIOMS guidelines supports this point
(Fidler 2001 : 326). In practice, however, there is still a considerable vacuum when
it comes to the power and bite of international as well as national ethics guidelines.
It has been argued that global bioethics has to contend with a regulatory crisis in
terms of 'the persisting national public law silences and health inequities, especially
in low-to middle income countries' (Merali et al. 2004 : 692). Complications are
often indicated by abstentions and protests by a number of states in the face of a
practice that is followed by others (Brownlie 2003 : 8). Most pertinent to the topic of
this topic is the withdrawal of the United States of America (USA) from the beneit-
sharing clauses of the Declaration of Helsinki (more in Chap. 8 ) . And, of course,
persistent objectors cannot be made to comply with voluntary guidelines, which
raises issues relating to the binding nature of customary international law.
We shall therefore start our discussion with the one international instrument on
benefit sharing that is legally binding, namely the CBD.
3.2 The Convention on Biological Diversity
3.2.1 History
Until the late twentieth century, access to biological resources was generally
regarded as a free-for-all (Schroeder and Pogge 2009 ). Typically, botanists or
researchers from the North would obtain biological samples from countries in the
South and use this biodiversity in scientific studies and product development. They
were thus able to take resources out of their natural habitats without obtaining
consent from, or sharing benefits with, states or local communities.
From the early 1970s, this approach to resource use across international bor-
ders was criticized heavily by activists around the world, Vandana Shiva ( 1991 :
257), Pat Mooney ( 1969 ), Gurdial Singh Nijar ( 1996 ) and Tewolde Berhan Gebre
Egziabher ( 1994 ) being among the most prominent. They criticized not only the