Traditional Medicine in Asia

Traditional Medicine in Asia
provides that anybody seeking any kind of
IPR on a research based upon biological
resource or knowledge obtained from India
needs to obtain prior approval of the NBA,
which will impose benefit-sharing conditions.
Section 18 (iv) stipulates that one of the
functions of NBA is to take measures to
oppose the grant of IPRs in any country
outside India on any biological resource
obtained from India or knowledge
associated with such biological resource.
In the Patent (Second Amendment) Bill
1999, the grounds for rejection of the
patent application, as well as revocation
of the patent, include non-disclosure or
wrongful disclosure of the source of origin
of biological resource. It has also been
made incumbent upon patent applications
to disclose the source of origin of the
biological material used in the invention in
their patent applications.
The Andean Group Decision 391 has
already established that any IPR or other
claims to resources shall not be considered
valid, if they were obtained or used in
violation of the terms of a permit for access
to biological resources residing in any of
such countries, as regulated under that
Decision.
Improving access to TM
A possible negative impact on the access
to health care of the strengthening of IPRs
in developing countries has been stressed
in recent analyses, including some studies
by the World Health Organization. (31) The
recognition or establishment of new types
of IPRs on TM may reduce, rather than
enhance, access to medicines and health
treatment, particularly by the poor. In
dealing with TM, developing countries
should, therefore, very carefully balance the
expected benefits from a possible IPRs-like
protection of TM, with the costs that are
likely to arise from the limitations on access
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to TM treatments that the exercise of such
rights would entail.
While an option to deal with TM is to
work within the sphere of IPRs,
governments should aim to promote the
use of TM for preventive and curative health
care rather than to protect it under rights
that may restrict its diffusion. An example
is provided by Act No. 8423 (1997) of the
Philippines, which aims “to accelerate the
development of traditional and alternative
health care” by improving the manufacture,
quality control and marketing of
traditional health care materials
(Section 3.d).
This promotional approach may be
combined with a misappropriation regime
aimed at avoiding the monopolization of
TM and related biological materials. Such
a regime – just as in the case of trade
secrets – would not be based on the
granting of exclusive rights (i.e, on a ius
prohibendi) but only on the right to prevent
or require a compensation for the use of
traditional knowledge when it has been
acquired, for instance, in a manner contrary
to legitimate rules and practices on
access. 13
The promotion of TM requires much
more than defining the appropriate
framework for IPRs protection. Attention
should be paid to research and development
(R&D) and to the condition for the
use of such knowledge.
Developing countries only account for
a minor part (around 4 per cent) of world
R&D, 32 and a significant part of the scarce
resources devoted thereto are applied to
issues that have been defined by and are
of primary interest to developed
countries. 33 Though the technical capacity
to undertake clinical trials in order to
establish the safety and efficacy of TM
products exists in many developing
countries, this is a costly endeavour for