MSF calls on WTO to refuse 'Paragaraph 6' change

Proposed statement by the Chair of the TRIPS Council to the WTO General Council "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 ..."
Open letter to the Members of the WTO from Médecins Sans Frontières 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 two 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 December 16 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 September 17 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