6.4 Analysis of the Doha Declaration
6.4.5 Paragraphs Five, Six and Seven
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This paragraph provides no clear-cut answers as the wording is open to different interpretations of the Declaration, which must be seen as a major problem. It seems that this paragraph aims at creating a solution to the conflict, but does not succeed in doing so as it merely states that the TRIPS Agreement should be interpreted so as to be supportive of access to medicines.
Although at first glance the impression is created that patients’ rights prevail over patent rights, no clear-cut solution is offered.
6.4.4.3 Solutions
This paragraph affirms that public health should take precedence over patent rights, and thereby confirms that the TRIPS Agreement allows flexibility in support of members’ rights to protect public health and access to medicines. Moreover it states that the TRIPS Agreement should be interpreted in a manner supportive of promoting access to medicines for all which, if interpreted similarly by members, would seem to provide a solution to the conflict.470
6.4.5 Paragraphs Five, Six and Seven
Paragraphs Five, Six and Seven are the substantive sections of the Declaration.
Paragraph Five lays out the key measures and flexibilities within the TRIPS Agreement, such as compulsory licensing, that can be used to overcome intellectual property barriers to access to medicines. It reads:
‘Accordingly and in the light of paragraph 4 above, while maintaining our commitments in the TRIPS Agreement, we recognize that these flexibilities include:
a) In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.
470 This opinion is shared by the TRIPS Council on their webpage (www.wto.org).
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b) Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.
c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.
d) The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.’
6.4.5.1 Comments
The use of the term ‘include’ in the first sentence of this paragraph makes it clear that the flexibilities in implementing the TRIPS Agreement are not limited to those listed in the Doha Declaration.471 It is clear from the provisions that a country can grant compulsory licences to deal with national emergencies and other situations of extreme emergency.
6.4.5.2 Problems
On the whole this paragraph offers solutions. However, there are several problems attached to it.
First of all, patent laws are territorial, the right to import does not amount to the right to export unless the law in the country where production for export takes place authorises such use. In other words, a country may declare a state of national emergency and alone decide what constitutes one, but if the country lacks domestic production capacity, this independence does
471 See Correa n 2 above 90 where he states that: ‘TRIPS Agreement does not limit the members’ right to establish compulsory licenses on other grounds not explicitly mentioned therein, for instance, to protect the environment or for reasons of “public health” ’.
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not lead to results.472 Moreover, when read with the other paragraphs of the Declaration, I find it;
questionable whether DCs and LDCs will be able to make use of their right to grant compulsory licences.
6.4.5.3 Solutions
The biggest victory for the DCs and LDCs appears to be the right to decide independently and without approval what constitutes a national emergency and the grounds upon which a compulsory licence may be issued. This was the weakness in the TRIPS Agreement as regards access to medicines473 as the existing paragraphs 30 and 31 of the TRIPS Agreement require members to obtain authorisation from the right-holder before granting a compulsory licence.
Read independently this paragraph can be seen as a solution to the ongoing conflict surrounding patent rights, as it should prevent retaliation and trade sanctions from other countries. The practical effects, however, remain to be seen.
Paragraph 6, which deals with production for export under a compulsory licence is discussed separately in paragraph 5.5 below.
Paragraph 7 reads:
‘We reaffirm the commitment of developed-country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to developed country Members pursuant to Article 66.2. We also agree that the least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016, without prejudice to the right of least-developed country Members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council
472 Which is of course recognised by the Ministerial Declaration on TRIPS and Public Health para 6.
473 Arvind Panagariya, Developing Countries at Doha: A Political Economic Analysis (September, 2002). Published in the World Economy Volume 25, Issue 9 pages 1205-1233 at p. 1206.
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for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.’
6.4.5.4 First Comment
The first part of paragraph 7 reaffirms ‘the commitment of developed-country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country Members pursuant to Article 66.2 of the TRIPS Agreement.’
LDCs have repeatedly raised concerns at the Council for TRIPS about the lack of effective action by developed countries to comply with article 66.2 of the TRIPS Agreement.474 Though some developed countries provide different forms of technical assistance on IP rights-related issues, LDCs have repeatedly noted that no or little action has been taken by developed countries specifically to implement their obligations under article 66. 2
6.4.5.5 Problems
The problem is that this re-affirmation by the Doha Declaration of such obligations has had no positive practical impact on developed countries’ actions in this area.
6.4.5.6 Solution
Only an improved production capacity in certain LDCs in Africa and elsewhere will constitute positive implementation. The USA has provided funding for the study of transfer of technology options for the pharmaceutical sector in Latin America.475
474 Paragraph 11.2 of the Implementation Decision adopted on 14 November 2001 states the following: ‘Reaffirming that provisions of Article 66.2 of the TRIPS Agreement are mandatory, it is agreed that the TRIPS Council shall put in place a mechanism for ensuring the monitoring and full implementation of the obligations in question. To this end, developed-country members shall submit prior to the end of 2002 detailed reports on the functioning in practice of the incentives provided to their enterprises for the transfer of technology in pursuance of their commitments under Article 66.2. These submissions shall be subject to a review in the TRIPS Council and information shall be updated by Members annually’. For information on home country measures encouraging transfer of technology, see IP/C/W/132, ADD. 1-7.
475 Frederick Abbott has served as technical expert for a project funded by USAID regarding transfer of technology in the pharmaceutical sector with respect to Colombia, which project has also involved extensive consultations in Brazil. Such projects are over and above the requirements of Art 66.2, which addresses LDCs.
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These initiatives suggest that there are concrete mechanisms by which technologically advanced countries might support the improvement of pharmaceutical research, development, and production capacity in DCs.476
6.4.5.7 Second Comment
For LDC members the second part of Paragraph Seven extends the transition period for the implementation of pharmaceutical product patents and the protection of undisclosed test data from 2006 to at least 2016. As many LDCs had already granted those rights, it also allows them not to enforce such rights until at least 2016.
While Paragraph Five provides an interpretation of existing rights under TRIPS, paragraph Seven creates new rights for LDCs. This was incorporated in the WTO rules by a decision of 8 July 2002.477
6.4.5.8 Problems
The major problem with the extension of the transitional period of patent protection with regard to pharmaceutical products is that the Doha Declaration provides the greatest benefits to countries already providing patent protection. Extending the transition period to 2016 does not appear to be linked with meaningful benefits for public health. Rather it appears that the benefits implied by the Declaration may only be realised after patent protection has been provided.
The problem is that countries which do not provide patent protection have no basis on which to issue a compulsory licence. In other words, the extended transition period can turn out to be a burden to the LDCs, as they would need to forego the benefits associated with the extended period in order to access the benefits from the Declaration and the solution of the
paragraph 6 problem.
476 See Frederick M Abbott and Jerome H Reichman ‘ The Doha Round’s public health legacy: Strategies for the production and diffusion of patented medicines under the amended TRIPS provisions’ (2007) 10/4 Journal of Int’l Economic Law 946.
477 WT/L/478.
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6.4.5.9 Solutions
The extension given in paragraph 7 must be seen as an opportunity for DCs and LDCs to take advantage of the Declaration and implement new national legislation for pharmaceuticals and patents.