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TRIPS Agreement to remain essentially technical, and faithfully reflect what was agreed to in the Decision.548 In other words, the amendment process should not reopen issues for further discussion. For this reason the EC proposal appears to support its American counterpart as regards the content of the amendment, and the EC was accordingly unable to support the proposals from the Africa Group.549
The EC was, however, consistent in requiring that the process should be rapid and comply with the timeframe set out in paragraph 11 of WT/L/540.
6.12 The Protocol Amending the TRIPS Agreement
Paragraph 11 of the implementation decision provides that the Paragraph-6 Decision is only temporary and will terminate when an amendment to the TRIPS Agreement is agreed upon.550 Moreover, it states that the work on such an amendment shall be initiated by the end of 2003 with a view to adopting an amendment within six months.
Amending a WTO Agreement is very difficult. It involves two aspects: the legal process; and achieving consensus on how to amend the agreement. After the Ministerial Conference has received a proposal from either a member or one of the councils, it has 90 days 551 to decide to submit the proposed amendments to the members. This decision must be taken by consensus552 553 and serves as a guard against surprise proposals. If consensus is not reached within the period determined,554 the Ministerial Conference must decide by two-thirds majority, whether or not to submit the proposed amendment. Taking past negotiations into consideration and the highly divergent views of the members of the WTO, it came as come as no surprise that the process of amending the TRIPS Agreement took as long as it did.
548 IP/C/W/416 para 15
549 See Sarah Hedelund Skove ‘The new regime of compulsory patents licensing’ n XX above 52.
550 Waivers are subject to annual review, after which they may be extended, modified or terminated, Agreement Establishing the WTO art IX 4.
551 Unless a longer period is agreed upon.
552 Agreement Establishing the World Trade Organisation art X 1.
553 Consensus differs from unanimity- id art IX 1.
554 Which in the case of amending the TRIPS Agreement regarding the granting of compulsory licences will most probably be the case.
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In fact, the Protocol amending the TRIPS Agreement adopted by the General Council in 2005 (‘the Protocol’), is the first amendment of the WTO agreed to by WTO members since the WTO Agreement came into force in 1995. The General Council adopted the Protocol and submitted it to WTO members for acceptance. In substance, the Protocol closely tracks the Paragraph-6 Decision’s August 2003 text. The decision on the amendment was also taken in the light of a re-reading by the General Council Chairman of his August 2003 statement.
The amendment was to take effect in accordance with article X(3) of the WTO Agreement.555 Under article X(3), two-thirds of WTO members must accept the amendment in order for the it to take effect.
The Protocol will be formally built into the TRIPS Agreement once two-thirds of WTO members have accepted the change. The original deadline for this was 1 December 2007.
The Protocol has not yet been approved by the required two-thirds of member states and the deadline for ratification has been extended on three occasions, most recently expiring at the end of 2011. The General Council extended the deadline to 31 December 2009; 31 December 2011;
and 31 December 2013 by decisions on December 2007; 17 December 2009; and 30 November 2011.
Once two-thirds of members have formally accepted it, the Protocol will take effect in those members and will replace the 2003 waiver for them. For each of the remaining members, the waiver will continue to apply until that member accepts the Protocol and it takes effect. As at 5 November 2012, only 45 countries had ratified the Protocol.
6.12.1 Contents of the Protocol
No significant changes were made to the original paragraph 6 system implemented by the Paragraph-6 Decision 2003 Waiver Decision. The Protocol introduces three new elements to the
555 Id para 3.
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TRIPS Agreement: a new article 31bis; an annex setting out the terms and conditions for the use of additional flexibilities; and an appendix to the annex dealing with the assessment of manufacturing capacities.
The new article 31bis (following on article 31 of the TRIPS Agreement), reiterates the non-application of non-violation complaints against any measures taken in conformity with the system and the need for existing flexibilities under the TRIPS Agreement to be preserved. It introduces two additional flexibilities in subsections 1 and 2.
Article 31bis.1 exempts exporting members from complying with article 31(f) of the TRIPS Agreement when granting compulsory licences to the extent necessary for the production of a pharmaceutical product(s) and their export to an eligible importing member. These undertakings must be in accordance with the conditions set out in paragraph 2 of the Annex to the TRIPS Agreement.
Article 31bis.2 restates the article 31(h) waiver rule contained in the Paragraph-6?? 2003 Decision under which the patent holder only receives compensation from the exporting member where both exporters and importers have to grant compulsory licences for the export of a product. Article 31bis.3 transposes the waiver of article 31(f) within the RTA.
6.12.2 Shortcomings in the Protocol to the TRIPS Agreement
Since the Protocol is based on the TRIPS Council Decision of 2003 the same criticisms levelled at the Decision identified above, apply to the Protocol. In fact, MSF has noted that it is disappointing, and almost unbelievable, that the Council adopted an amendment based on the unworkable and cumbersome Paragraph-6 Decision.556
556 MSF ‘Neither Expeditious, Nor a Solution: The WTO August 2003 Decision is Unworkable’ (2006) 6. Available at
www.msfaccess.org/sites/default/files/msf_assets/Access/Docs/ACCESS_briefing_NeitherExpeditiousNorSolution_
WTO_ENG_2006.pdf
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Gathi adds that ‘in reality the practicability of the so-called amendment may prove illusory for poor countries due to the implausibility of the several conditions attached to it.’557 Since the 2003 Paragraph-6 Decision which has now given birth to the Protocol was adopted, only one country has been able to use it successfully. 558
While it is conceded that this amendment to the TRIPS Agreement strives to resolve the Paragraph-6 problem of the Doha Declaration, it is doubtful whether it will achieve this aim.
This is because the several hurdles to be overcome before a DC can invoke the use of compulsory licences under it, are a betrayal of the spirit of Doha Declaration. The Protocol does not serve the interest of DCs and is also not consistent with realising the right to health for the vulnerable and marginalised people most affected by life-threatening diseases.
6.13 Conclusion
The Doha Declaration has attempted to address real and urgent problems facing many DCs and LDCs in the area of public health. The Declaration did not intend to amend the TRIPS Agreement to any substantial extent, but rather sought to clarify the relationship between the TRIPS Agreement and the public health policies of member countries, and to confirm the rights that members have retained under the Agreement, particularly by defining the flexibilities allowed in certain important areas.
The Declaration addressed the concerns of DCs on the issue of public health. The Declaration makes it clear that in the event of a conflict between the TRIPS Agreement-standard and public health, the members – DCs and LDCs in particular – can take measures to protect public health.
The Declaration sets the standard for a differentiation of IP policies when necessary to protect public health.
557 See J Gathi ‘How necessity may preclude state responsibility for the compulsory licensing under the TRIPS Agreement’ (2006) 31 North Carolina Journal of International Law and Commercial Regulation 956.
558 Rwanda being an LDC notified the Council for TRIPS in accordance with para 2(a) of the 30 August 2003 Decision to import triple combination Triavir from Canada. In the same way Canada also notified the Council in October 2007 to export the same drugs to Rwanda in line with para 2(c) of the 2003 Decision. The whole exercise took too long and was a bitter lesson for the two parties involved in the transaction.
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As the mandate given in paragraphs 6 and 7 illustrates, the Declaration represents an initial step for rethinking the TRIPS Agreement in the light of public interest rather than the end of a process. The aim of paragraph 6 was to solve the problem created by the TRIPS Agreements’
extension of patent protection for pharmaceutical products to all WTO members, irrespective of their level of development or their pharmaceutical manufacturing capacity. Furthermore, article 31(f) the TRIPS Agreement stipulates that production under a compulsory licence must be
‘predominantly for the supply of the domestic market’. This restriction limits the quantity that can be produced for export. The Declaration elected to postpone a resolution of this problem to a later date, but called for an expeditious solution.
After more than two years of protracted and difficult negotiation, this solution was finally approved and initially embodied in a waiver, known as the Paragraph-6 Decision. This waiver is expected to be rendered permanent by virtue of a pending amendment to the TRIPS Agreement, known as article 31bis. The waiver remains in effect while governments take steps to ratify the Protocol. The Paragraph-6 Decision appears to provide solutions to most of the problems identified under paragraph 6. It is up to the country facing the national emergency not only to determine what constitutes a national emergency or other extreme urgencies, but whether the country lacks manufacturing capacity in the pharmaceutical sector.
However, even though there is now legal framework in place, and a mechanism to allow DCs and LDCs with insufficient manufacturing capacity to make effective use of compulsory licensing, the practical effect remains uncertain. As of 2009, the waiver had only been used once due, in part, to the cumbersome nature of the process. To date only one country has successful made use of the process.
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