Transcript WHO and patenting of genes

Genetic advances will only be acceptable if their application
is carried out ethically, with due regard to autonomy, justice,
education and the beliefs and resources of each nation and
community.”
Patenting facilitates the process of product development in
genetics as in other medical fields, but patent protection
must balance the provision of necessary incentives for
invention with protection of public health interests.
Gene patenting could impede international collaboration,
especially between developed and developing nations,
to the detriment of health care and biomedical research.
2000
Authors
Prof Heng-Leng Chee, Malaysia
Prof Dan Brock, USA
Prof. Sir David Weatherall, UK (Lead Author)
Table of contents
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Genomics & genome
projects
Potential of genomics
for health care
Relevance & time scale
of advances in
genomics for global
health
Potential for health of
developing countries
Potential risks &
hazards and their
control
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Justice & resource
allocation
Ethical issues in genetic
research, screening &
testing with particular
reference to developing
countries
Education & public
policy
Recommendations to
WHO & member states
Genes and Environment:
The characteristics of all living organisms reflect the
complex interactions between their genetic make-up,
their environment and the long history of the milieu in
which they are raised
Health and Biomedicine:
It is likely that future research into diseasesusceptibility genes will help us to understand the
mechanisms…, it will allow treatment to be tailored to
individual needs and, in the longer term- generate new
approaches to preventive medicine based on genetic
susceptibility to environmental hazards
Somatic gene therapy
Currently the most promising results are being obtained for genetic
diseases in which the inserted genes does not need tight regulation
or a high level of expression
As important diseases are expressed during early development
( Brain, ZNS ) the possibility of intrauterine gene therapy needs to
be exploited
Stem cell gene therapy
Genetic engineering of cell populations to approach difficulties of
immune rejection of cell products or use of patients nuclear DNA to
create an embryo from which embryonic stem cells compatible with
the patient could be derived
Germ line therapy
It is important to distinguish whether germ line therapy is now
sufficiently safe to be permitted from whether it could become so
in the future. At present no correct removal and replacement of a
gene is possible
non-therapeutic genetic enhancements
some consider human reproductive cloning a form of nontherapeutic enhancement... where at the present time its risks are
far too great to permit
.. the greatest ethical concern.. to use genetics to significantly
enhance important normal human functions…. the unfairness of
further widening already unjust inequalities of opportunity and
well being between the rich and the poor
Patenting Summary:
Because many of the medical benefits of genomics
research may be expensive
there is the danger that these new developments
will increase the disparity in health care within and
between countries.
There are particular concerns that inequalities will
be accentuated by the current trends in the
management of intellectual property, particular the
patenting of basic genomic information
Intellectual property, sharing benefits of research
present situation is little less than chaotic….
Invention, natural occurrence:
It is argued that a gene sequence is naturally occuring which therefore
can not be patentable. The counter argument used by patent lawyers is
that DNA sequence identification is a form of purification outside the
body, such as patenting cDNA complementary to mRNA … but mRNA
also exists in nature…,it is rather like saying that the same invention
could be repeated if translated into a different language
research
The monopolies awarded by patents on genes are not in the public
interest,.. It weakens the the contribution of the global research
community . And may complicate the granting of concessional prices for
the therapeutic agents.
In addition patenting of proteins is becoming more chaotic than DNA
patenting
WHO and patenting of genes : There is a need of a clear
articulation and discussion of key questions:
• can patents on DNA sequences continue to be justified in the
context of current technology ?
•What are real thresholds for novelty, inventiveness and
utility ?
•Are such patents really necessary for successful innovation in
health care ?
•what are the duty of patent holder in licensing their
innovations ?
Role for WHO for an international policy forum