Biology Reference
In-Depth Information
What is important is
clarity
in law, whether in binding conventions or in custom-
ary international law. In this respect, the clarifications and additions regarding post-
study access that have been provided in the Declaration of Helsinki since 2000 are
commendable. The rigidity of insisting on post-trial access to drugs and services (as
in the 2000 version) considerably limited the potential for benefit sharing. In particu-
lar for the donors of genetic samples, the chances of receiving access to a success-
fully tested product were minimal, given the vagaries of medical research and the
limited possibility that any specific research would lead to a marketed product.
Yet even when the law is clear, compliance is not easily achieved. It is here, one
hopes, that the Nagoya Protocol has significantly enhanced the CBD, at least for
non-human genetic resources. Requiring greater legal certainty and transparency on
benefit sharing for providers and users of such resources was one of its main aims
(CBD
2010
: 1). To realize this aim, the protocol requires all parties to ensure, within
their jurisdictions, that users of genetic resources comply with the CBD. While
many parties have already adopted national legislation to govern access and benefit
sharing for non-human genetic resources, the following example from Brazil shows
that a tightening up of procedures and follow-up on compliance may be necessary.
Brazil implemented a comprehensive biodiversity law in 2001, nine years after
the Earth Summit in Rio de Janeiro. Yet, from 2002 to 2009, the relevant authority
obtained only 33 applications to access genetic resources (of which 15 were renew-
als) and two applications to access traditional knowledge associated with genetic
resources (Kleba
2011
). Only when the Brazilian authorities started tracking the
use of genetic resources through the application of patents or the registration of new
drugs did the extent of non-compliance become obvious. This tracking, combined
with the imposition of fines and other penalties, had an almost immediate effect. In
2010 alone, more than a hundred new applications to access genetic resources were
filed with the relevant authority (Kleba
2011
). One would hope that the Nagoya
Protocol leads to similar approaches and successes in other countries, especially
biodiversity-rich ones. Whilst the example from Brazil is encouraging in terms of
achieving benefit sharing for access to non-human resources at least in the medium
term, benefit sharing for human resources is less promising.
More detailed legal and practical challenges will become clearer in the next two
chapters, which review a number of benefit sharing cases that have come to inter-
national attention.
References
Albert B (2005) Biomedical research, ethnic labels, and anthropological responsibility: further
comments. In: Borofsky R (ed) Yanomami: the fierce controversy and what we can learn
from it. University of California Press, Berkeley and Los Angeles, pp 157-168
Andanda P (2006) The law and regulation of clinical research: interplay with public policy and
bioethics. Focus Publishers Ltd., Nairobi
Andanda P (2008) Human-tissue related inventions: ownership and intellectual property rights
in international collaborative research in developing countries. J Med Ethics 34(3):171-179
