E-DRUG: Open letter to the WTO from M�decins sans Fronti�res
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Paris, 8 February 2003
Dear Sir, Madam,
On Monday the Chair of the TRIPS Council is expected to propose to the WTO
General Council to adopt the "Motta December 16 text" and to make the
following statement:
Before proposing the adoption of the text of 16 December 2002,1 would
like to put on record a number of understandings which have emerged from
the discussions leading up to the formulation of this text.
The first is that all delegations have reconfirmed their commitment
to the provisions of the Doha Declaration on the TRIPS Agreement and Public
Health and to the need to respect fully its provisions.
Secondly, delegations have made it clear that they see the system
that we are establishing under paragraph 6 of that Declaration as being
essentially designed to address national emergencies or other circumstances
of extreme urgency.
Third, delegations have recognized the need to avoid undermining the
importance of intellectual property protection for the development of new
medicines and have also reaffirmed that the TRIPS Agreement does not and
should not prevent Members from taking measures to protect public health.
Having put on record these understandings, I would propose the adoption of
the draft decision contained in ...
We urgently call upon the WTO Members to reject this statement for the
following reasons:
1. Paragraph 6 was never meant to only address national emergencies or
other circumstances of extreme urgency, whether "essentially" or otherwise.
The objective of paragraph 6 was to ensure that countries without
production capacity could make effective use of compulsory licensing which
is a key TRIPS safeguard. Anyone who claims otherwise is re-writing the
history of the Doha negotiations.
The Motta text has no limitation to emergency situations, either in the
"main" solution or in the regional trade area solution. The fact that
Members were prepared to accept the Motta text save for the disease scope
limitation indicates that they were well aware that the paragraph 6
solution was not limited to emergency situations.
If the Motta text is accepted to apply to any public health problem, any
Member subsequently pressing for the adoption of the Motta text with an
understanding to limit the use of the paragraph 6 solution to emergency
situations indicates extreme bad faith and a desire to cripple the solution
by any means possible.
2. The adoption of this text would mean that countries without the
possibility to produce medicines are at a major disadvantage over countries
that do have the capacity. The Doha declaration confirms the right of
countries to issue compulsory licenses in paragraph 5 (b):
Each Member has the right to grant compulsory licences and the freedom to
determine the grounds upon which such licences are granted.
Whenever such a compulsory licence is granted the safeguards already
provided for in Art 31 TRIPS will have to be observed, so the interests of
patent holders are already preserved. Paragraph 6 is about effective supply
of a compulsory licence, not whether or not that compulsory licence can be
given in the first place. And yet that is exactly the effect the Chair's
note will have.
The proposed Chairman's statement would entrench a system with "Second
class" Members whose possibilities to exercise their rights under the TRIPS
Agreement and the Doha declaration will be limited compared to countries
that have the capacity to produce. It needs no mention that it will be the
people in the most disadvantaged countries who will suffer
disproportionably from this.
In effect these two different classes of Members will be constituted as
follows:
First class Members with manufacturing capacity will be able to use
compulsory licensing to address whichever public health problems they have
identified.
Second class Members without manufacturing capacity will be able to use
compulsory licensing to address public health problems only in case of a
national emergency or other circumstances of extreme urgency. In theory,
they can issue a compulsory licence to address any public health problem;
in practice they can only get supplies of the medicines they need under a
compulsory licence in an emergency situation.
Also, in terms of the use of compulsory licensing in the public sector, the
TRIPS Agreement places "public non-commercial use" ("government use") on
the same footing as emergencies and yet the Chairs text would exclude this
situation as well.
As far as the WTO, the TRIPS Agreement, the Doha Declaration and the
solution to paragraph 6 are concerned, there aren't supposed to be first
class Members and second class Members. Adopting this Chair's note would
result in the progress that was made at Doha being utterly reversed.
3. The proposed text would indicate that the 'solution' cannot be used for
the production and purchase of products meant for the prevention of an
emergency. Even in an urgent situation the solution could not be used to
prepare, only when the urgency was extreme. For example how long would a
country have to wait that attempts to prevent an outbreak of an infectious
disease by vaccinating or a country that wants to stock medicines they may
need in the future (for example to treat people suffering from a possible
anthrax outbreak). It is unacceptable that a subset of developing countries
may only provide pharmaceutical care after a public health situation has
gone out of control.
4. Limiting the operation of the paragraph 6 solution to emergency
situations would be taken by some Members as "proof" that compulsory
licensing in general is only designed to address national emergencies or
other circumstances of extreme urgency. This was a battle fought time and
time again before Doha and despite the crystal clear paragraph 5(b) of the
Doha Declaration, will have to be fought again if this text is adopted. An
obvious consequence of adopting this note will be pressure in the future
for countries to narrow their options under TRIPS to issue compulsory
licenses on public health grounds.
5. The third paragraph of the proposed text is superfluous. At numerous
occasions Members have confirmed their commitment to the TRIPS agreement
including in the Doha declaration itself. No country has ever proposed to
undermine intellectual property. However WTO members have recognised in the
Doha declaration the concerns about the effects of patents on medicines
prices. A concern the Chair does choose not to reiterate in his statement.
To highlight "patents" and not "prices" in itself is rewriting the Doha
declaration on TRIPS and Public Health.
6. There is a near absence of innovation for diseases that affect people in
developing countries. It is an illusion to think that this market failure
will be remedied through the IP system. The financing of the research and
development of new medicines for neglected diseases will require additional
and alternative global approaches. To therefore hail the importance of the
IP system for the development of new drugs for people in developing
countries might not be entirely appropriate in this context.
7. Let no delegation be under the illusion that a Chair's note, reflecting
an agreement amongst all negotiating parties, can have no legal effect. The
Chair would not be making the note if it had no legal effect and there are
grave grounds to worry that under the Vienna Convention it could be held to
have legal effect. As a result if the Motta text were used outside
emergency situations, the exporting Member would open itself to dispute
settlement for breach of its obligations under Art 31(f) TRIPS.
In conclusion an agreement to this text would be a disastrous final chapter
in the 2 year old history of the Doha declaration on TRIPS and Public
Health.
If Members agree to this text it will no longer be possible to maintain
that the TRIPS "Agreement can and should be interpreted and implemented in
a manner supportive of WTO Members' right to protect public health and, in
particular, to promote access to medicines for all." This was the main
objective and achievement of the Doha process which the Chair's statement
will undo.
We therefore propose that the Members of the WTO take into consideration
the following alternative wording for the Chair's statement:
Delegations have made it clear that they see the system that is being
established under this proposed solution as being designed to promote
access to effective treatments to address public health problems
afflicting countries with insufficient or no manufacturing capacities in
the pharmaceutical sector as called for in paragraph 6 of the Doha
Declaration on the TRlPS Agreement and Public Health.
Regardless of any accompanying statement, Chairman Motta's 16th December
text is a compromise that is far from ideal because it fails the test of
being simple, workable and economically viable. It falls far short of what
the World Health Organization's proposal of 17 September 2002 could have
delivered or still could deliver. We maintain our position that it is not
too late to reject the proposals and explore alternative ways to achieve
what the Doha declaration set out to do: access to medicines for all.
Sincerely Yours,
Ellen 't Hoen
MSF Campaign for Access to Essential Medicines
For information contact:
Ellen 't Hoen: + 33 6 22375871
Christopher Garrison: + 44 7720470622