Environmental Engineering Reference
In-Depth Information
license to a local manufacturer. Members' freedom to do so is explicitly articulated
in article 8, which authorises members to 'adopt measures necessary to protect
public health and nutrition, and to promote the public interest in sectors of vital
importance to their socio-economic and technological development', provided that
such measures are consistent with the trIPS agreement (wto 1994).
Furthermore, article 6 does not prohibit the parallel import of drug products.
countries that have relatively high drug prices in their domestic market are free
to import a patented product from a country where it is priced lower. while these
provisions in the agreement indicate that states can adopt measures necessary to
ensure access to medicines for all, in practice many governments have not applied
these safeguard provisions (cullet 2003, 139-160). the reasons are many. they
include the lack of capacity to make use of provisions (such as in the case of
compulsory licensing, which until the 2001 Declaration on the trIPS agreement
and Public Health required a country to have manufacturing capability), restrictive
legislation not in line with international legislation, and political pressure to respect
intellectual patent law for pharmaceuticals and thus not to make use of potential
health safeguards. one case of the political pressure that can be brought to bear on
a state perceived to be non-compliant is the use of the Special 301 report by the
USTR official puts into perspective the powerful nature of this tool:
one fascinating aspect of the Special 301 process occurs just before we make our annual
determinations, when there is often a flurry of activity in those countries desiring not to
be listed or to be moved to a lower list. IP laws are suddenly passed or amended, and
enforcement activities increase significantly (Fisher 1999, cited in Drahos 2001, 3).
notwithstanding, from a purely legal perspective, the trIPS agreement has
room to move because of the imprecision of its language and its relative youth in
legal terms. There are some terms without clear definitions or without concrete legal
precision in the agreement. While these indefinite terms will be subject to certain
international interpretative principles (such as the vienna convention on the law of
treaties; see Un 1969), such principles also allow the values of the agreement to be
interpreted and applied.
Some of the trIPS articles can be used to interpret the 'objectives and principles'—
i.e., underlying values—of the agreement for future definitional impreciseness. These
include the preamble and articles 7 and 8. the preamble includes the provision that
the trIPS agreement recognises the need for 'adequate standards and principles
concerning … trade-related intellectual property rights', rather than high or very
high standards (wto 1994). another is the recognition that 'the special needs of the
least-developed country Members in respect of maximum flexibility in the domestic
implementation of laws and regulation in order to enable them to create a sound and
viable technological base'. this could be used, for example, to strengthen the case
for certain developing countries to emulate India's success with the generic drug
industry and further forgo certain trIPS obligations.
