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Vendredi
6 juillet
II:
ADPIC — Accès aux médicaments essentiels
Modérateur:
Adrian Otten, Directeur de la Division de la propriété
intellectuelle de l'OMC
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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