Biology Reference
In-Depth Information
provisions of the CBD have been incorporated into national law in many coun-
tries world-wide, but success stories are still hard to find. It is hoped that the 2010
Nagoya Protocol to the CBD will address this shortfall for non-human biologi-
cal resources. An example from Brazilian national legislation, which is discussed
here, is encouraging in terms of achieving benefit sharing with those providing
access to human biological resources. However at the global level, benefit sharing
for human biological resources remains an unresolved and often contentious issue.
Keywords
Benefit sharing • Post-study access • Convention on Biological
Diversity • Declaration of Helsinki
3.1 Introduction
As benefit sharing is a relatively new philosophical and legal concept, it is impor-
tant to understand its use in legal frameworks. This chapter provides an overview
of the key international instruments and guidelines that make provision for benefit
sharing. By doing so, the chapter serves as the basis for discussions of how current
challenges in benefit sharing can be addressed.
'Benefit sharing' is a technical term that was popularized by the Convention on
Biological Diversity (CBD) adopted at the 1992 Earth Summit in Rio de Janeiro,
Brazil. The CBD was the first international treaty to recognize that the conserva-
tion of biodiversity is a 'common concern of humankind'. Today, its 193 parties
cooperate to stop the destruction of biodiversity by attempting to ensure its sus-
tainable use, and by requiring users of this natural wealth to share the benefits with
those who provide access to biological resources. The resources covered by the
CBD are animals, plants, micro-organisms and traditional knowledge.
The concept of benefit sharing is less established in the area of human
biological/genetic research. It has made a cautious entry into international debates
through the Declaration of Helsinki (2000), which aims to act against exploita-
tion by prescribing a duty to assure research participants of access to successfully
tested drugs or services after a clinical trial has been concluded. This approach
avoids a situation in which research participants in developing countries have no
access to a medical product they helped bring to market. The most recent revision
of the Declaration of Helsinki (WMA
2008
) has opened the possibility of benefit
sharing through routes other than access to successfully tested interventions.
This chapter provides an outline of the main benefit-sharing provisions of the
following instruments:
• The Convention on Biological Diversity (CBD
1992
)
• The Declaration of Helsinki (WMA
2008
)
• The Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Biomedical Research Involving Human
Subjects (CIOMS
2002
)
