Biology Reference
In-Depth Information
Regarding the access to health care: In the end of the study, all the participating patients
must have been ensured the access to the best proven prophylactic, diagnostic and thera-
peutic methods identified by the study (National Health Council
2008
).
Resolution 304/00, issued in 2000 (National Health Council
2000
), covers
research involving indigenous peoples. Combining requirements in the CBD about
free, prior informed consent from local and indigenous communities with the
mechanisms available through ethics review, Article IV of this resolution requires
research protocols to describe the following items:
(1) a commitment to obtain the consent of the communities involved and a description of
the process of obtaining this consent;
(2) a description of the process of obtaining and recording the Terms of Free and
Enlightened Consent, demonstrating the adequacy [of the process] to the cultural and
linguistic particularities of those involved (Albert
2005
: 167).
However, instead of combining free prior and informed consent with strict
requirements for benefit sharing that may arise from the utilization of resources
(often involving patenting), the Brazilian National Health Council opted to forbid
patenting in research involving indigenous populations.
It will be considered ethically unacceptable to patent, by somebody else, chemical prod-
ucts and biological material of any kind, obtained from researches with indigenous peo-
ples (National Health Council
2000
: article III(4)).
In this way, the Brazilian government pre-empts the difficulties described above
about making the CBD compatible with the TRIPS Agreement by forbidding any
patenting at all.
3.8 Conclusion
On the basis of this chapter one might argue that benefit sharing for human genetic
resources is an under-regulated area. Legal documents are often categorized as to
whether they are binding or non-binding. On such a simplified appraisal, only the
CBD (
1992
) and the Brazilian government's national guidelines on post-trial obliga-
tions (National Health Council
1996
,
1997
,
1999
,
2000
,
2008
) fall into the binding
category. All other key legal instruments presented in this chapter - the Declaration of
Helsinki (WMA
2008
), the CIOMS International Ethical Guidelines for Biomedical
Research Involving Human Subjects (
2002
), the HUGO Ethics Committee's
Statement on Benefit Sharing (
2000a
), UNESCO's Universal Declaration on the
Human Genome and Human Rights (
1997
) and the same organization's Universal
Declaration on Bioethics and Human Rights (
2005
) - are non-binding.
As we have seen, however, international ethics guidelines are regarded as cus-
tomary international law when they have been used generally and consistently in
support of prescribed practices. For example, the practice of obtaining informed
consent prior to involvement in medical research is widely accepted on the basis
of non-binding ethical guidelines.
