Promoting an Inclusive Approach to Benefit Sharing: Expanding the Scope of the CBD? - Benefit Sharing - page 164

Take the case of Herceptin, which is indicated for metastatic breast cancer, and
also gained approval in the UK for early-stage breast cancer in 2006. Herceptin
treatment is seriously considered only when a patient scores within a particular
range on a diagnostic test that selectively identifies a subgroup of breast cancer
patients who may maximally benefit from Herceptin and, equally importantly,
those for whom Herceptin will not be useful. Herceptin is the epitome of personal-
ized medicine in its fundamental approach, providing the appropriate drug to the
appropriate patient and at the appropriate dosage - thus improving considerably
the safety and well-being of the patient (Madsen 2004 ).
This is an area where sequence data from the Human Genome Project, and the
subsequent Human Proteome Project, is making an enormous impact. As long as
there is a demand in discovery research for the identification of key genes involved
in common disease aetiology, this area of the market is likely to grow. Information
on key genes involved in drug metabolism or transport has also been exploited for
pharmacogenomic studies. This is an area where pharmaceutical companies, in
their quest for safer, more efficacious and more cost-effective medicines, require
indicative answers as to how subjects are metabolizing or excreting drugs to dis-
cover if there may be genetic reasons for medicinal effects on humans. Again, the
indications are that tools for pharmacogenetics will potentially provide rich pick-
ings for the diagnostic market.
Hence human genetics and genomic studies have resulted in widespread global
collaborative studies (see also Majengo sex worker case in Chap. 5 ) , with the
transportation of human biological materials across continents and between aca-
demic institutions and commercial organizations underlining the ongoing ethical
debates over the ownership of material, informed consent, material transfer agree-
ments, and ABS. A number of instances have surfaced in which the collection of
such material has been undertaken without informed consent, and these are barely
the tip of the ABS iceberg, as we show below.
7.3.1 Developing Country Experiences
India
Being a country rich in biodiversity, India attracts global interest in the genetic
diversity of its anthropologically well-defined populations, including a number of
tribal groups. This has not only global evolutionary implications, but also poten-
tial applications in pharmacogenetics for personalized medicine . India's strength in
the area of drug development complicates the situation, especially with the exist-
ence of Indian biobanks as national repositories of biological samples, which gives
rise to issues of privacy protection and confidentiality. When international col-
laborative studies are conducted, the main concerns are exploitation, stigmatiza-
tion, ownership, MTAs and benefit sharing, especially when a gene-based product