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Friday,
6 July
Session
II: TRIPS — Access to essential medicines
Moderator:
Adrian Otten — Director, WTO Intellectual Property Division
This
work session was characterized by a lively and, I believe, useful
exchange of views, thanks to the active participation of a wide
range of participants, including those from health and developmental
non-governmental organizations, industry and professional
associations, and academics.
I
think it fair to say that the general starting point was that, from
a public health perspective, patents are important in providing
incentives for the generation of new drugs, but that a balance has
to be found with the need to ensure access to existing drugs,
especially in the poorest countries. There was some discussion about
the extent to which this balance has been taken into account in the
negotiation of the TRIPS Agreement and in its provisions and also
about the extent to which the provisions of human rights conventions
regarding health are taken into account. It was noted that the
objectives of the TRIPS Agreement, as set out in its Article 7,
specifically recognize the need for balance between the promotion of
new inventions and access to existing ones and that Article 8.1 of
the TRIPS Agreement makes specific reference to the protection of
public health and nutrition. As I will indicate later, much of the
discussion revolved around the extent to which the flexibility in
the TRIPS Agreement enables countries to find a proper balance that
takes into account their public health needs.
The
point was made that, in finding this balance, it is important to
assess the extent to which the patent system is delivering on its
objective of promoting research and development into new drugs and
whether there are other possible alternatives. In this connection,
different views were expressed on a range of points, including the
size of the research and development effort by the private sector,
the extent to which this is directed towards genuinely needed
therapeutic advances, in particular in regard to the diseases more
prevalent amongst poor people in developing countries, the relative
roles of the public and private contribution towards research and
development into new drugs, and whether the patent system, at least
in some countries, sets the test of the inventiveness sufficiently
high. While I believe it was generally accepted that the patent
system is important for private sector research and development, it
was recognized that, where the market for new drugs is weak, even
under patent protection, it may need to be complemented with other
measures, notably in order to ensure sufficient research and
development into the neglected diseases of the poor.
The
point was also made that the patent system plays an important role
in encouraging disclosure, and thus the dissemination, of inventions
which companies might otherwise be tempted to keep secret.
Turning
to the other side of the coin, namely the effect of the patent
system on access to existing drugs, there was a fair amount of
debate about the extent to which the patent system poses a problem
and how significant this is relative to other factors affecting
access to drugs. Different views were expressed on a number of
issues in this connection, including the extent to which patents
affect prices, the significance of patented drugs now and in the
future among drugs essential for basic health care, and the relative
role of prices compared to other factors affecting access, such as
health care supply systems and funding. Some participants believed
that it is important to assess the impact of the patent system on a
case-by-case and country-by-country basis. There was discussion
about the extent to which countries in which drugs are not patent
protected experience the same problems of access to drugs as other
countries.
With
regard to the flexibility in the TRIPS Agreement, the discussion
revolved around two main points. One was the extent to which
countries feel confident and secure in using this flexibility and
the other was the scope of the flexibility.
On
the former point, concern was expressed that countries, especially
those who have less bargaining power in international economic
relations, have felt and might still feel constrained in using the
full flexibility under the TRIPS Agreement to promote their public
health objectives, due, on the one hand, to uncertainty about the
scope of this flexibility and, on the other hand, to bilateral or
other pressures not to use it. References were made to a number of
recent legal cases and also to negotiations relating to regional and
bilateral trade arrangements. There was discussion about how these
concerns could be met, especially if the avenue of providing greater
legal certainty through court and dispute settlement interpretation
is not to be followed. In this regard, the work session was informed
of the ongoing work in the Council for TRIPS aimed at clarifying the
flexibility available in the TRIPS Agreement.
With
regard to the scope of the flexibility in the TRIPS Agreement, the
main provisions that were discussed were those relating to
compulsory licensing, parallel imports, the so-called Bolar or
regulatory exception under which generic companies can use patented
inventions for the purposes of obtaining regulatory authorization
for the prompt marketing of their generic versions after the expiry
of the patent term, and other possible exceptions covered by Article
30 of the TRIPS Agreement. One general issue that was raised in
connection with the scope of the flexibility was whether it is
sufficient to enable countries at different stages of development to
establish the optimal balance in their intellectual property system
from a public health perspective. Reference was made to the
possibility for extensions to the transition periods of
least-developed countries.
Time
did not permit for a detailed exchange of views on the relevant
provisions of the TRIPS Agreement, although a number of different
views were expressed regarding compulsory licensing and parallel
imports. On the former point, compulsory licensing, one general
issue that was discussed went to the question of differing
underlying conceptions of what is required for the patent system to
work effectively in promoting research and development. One view was
that the system is designed to provide incentives for future
research and development, not merely to enable recovery of research
and development costs already incurred, and that if this objective
is to be met, the patent right had to be viewed as essentially an
exclusive right, with compulsory licensing used as a remedy only in
cases of misuse of that exclusive right. For some other
participants, the patent system could continue to serve its
underlying purpose even with a more widespread and systematic use of
compulsory licensing where warranted by public health objectives.
Among the more specific points that were touched upon in relation to
the TRIPS provisions on compulsory licensing were the relation
between the TRIPS rule relating to non-discrimination between areas
of technology and the scope for giving compulsory licences on public
health grounds, how to ensure that countries with small markets who
give compulsory licences for importation are able to obtain the
necessary supply, and the way in which the TRIPS Agreement affects
the use of compulsory licensing to promote local domestic
production, the so-called local working requirement.
A
couple of other points which came up which I should also mention
were, first, the impact of the TRIPS rules relating to the
protection of test and other data submitted to drug regulatory
authorities in order to obtain marketing approval for new drugs and,
secondly, the question of the protection of traditional knowledge in
medicines. This latter point is, of course, highly relevant to the
second TRIPS work session on which you will be receiving a separate
report.
This
then is my report on the work session on TRIPS and Access to
Essential Medicines. I should emphasize that it is submitted on my
personal responsibility and represents my own attempt to highlight
the main points of discussion. It is a summary and thus by its very
nature not exhaustive of all the points made in what I believe was a
rich, useful and constructive exchange of views.
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