TWN Info Service on Intellectual Property Issues (Feb11/01)
1 February 2011
Third World Network
 
North's positions hindering pandemic preparedness progress
Published in SUNS #7073 dated 25 January 2011
 
London, 24 Jan (Sangeeta Shashikant) -- An Executive Board meeting of the World Health Organization (WHO) saw some developing countries cautioning against complacency with regards to pandemic influenza preparedness until concrete outcomes are achieved.
 
The warning from the developing countries came during the discussion last week on the agenda item of "Pandemic Preparedness: Sharing of influenza viruses and access to vaccines and other benefits".
 
The Executive Board (EB) is currently holding its 128th session from 17 to 25 January.
 
During the discussions on the issue of pandemic preparedness, some other developing countries highlighted what they viewed as the lopsidedness of the present WHO influenza setup that focuses on virus-sharing but fails to deliver on benefit-sharing. They also called for a reform of this fundamentally-flawed system. At the same time, they rejected reform that is donor-centric.
 
A meeting of the Open-Ended Working Group on Pandemic Influenza Preparedness (PIP/OEWG) on 13-17 December 2010 saw limited progress on account of the positions taken by developed countries.
 
[The EB is composed of 34 individuals designated by Member States that elected to do so by the World Health Assembly (WHA). The main functions of the EB are to give effect to the decisions and policies of the Health Assembly, to advise it and generally, to facilitate its work].
 
The report of the PIP/OEWG that was submitted to the EB (EB128.4) notes that it "engaged in constructive discussions and negotiations" on the Pandemic Influenza Preparedness Framework and Standard Material Transfer Agreements (SMTA) for entities inside the WHO network, as well as a proposed Standard Terms and Conditions (STC)/SMTA for entities outside the WHO network.
 
However, several sources that participated in the PIP/OEWG discussions said privately that developed countries (in particular, the European Union and the United States) were reluctant to reach agreement on any of the outstanding issues. They opined that developed countries were stalling the process until the pre-WHA negotiations, which will be held on 11-15 April 2011. There were instances when the EU and the US were unwilling to accept a consensus text that had already been agreed on previous occasions, the sources further said.
 
The report of the WHO Director-General, Dr Margaret Chan, which was noted by the EB (EB128.4), contains the report of the PIP/OEWG and the Appendices attached to the report. Appendix 1 contains the Pandemic Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits, while Appendix 2 contains the various Standard Material Transfer Agreements (SMTAs) and Standard Terms and Conditions under discussion within PIP/OEWG.
 
The PIP/OEWG report lists in a non-exhaustive way the areas on which agreement was reached.
 
The list includes the following:
 
"(a) The need to finalize the Framework for Pandemic Influenza Preparedness including its annexes;
 
"(b) the implementation of multiple tools, interlinked as necessary, are needed to address the set of challenges associated with achieving pandemic influenza preparedness and response including, inter alia, as outlined in a preliminary way in the draft technical study. These may include: separate, but complementary instruments for relevant materials, such as an SMTA within the WHO network, and an STC/SMTA for transfers outside the WHO network; strengthening all measures to increase global pandemic influenza vaccine supply, including through support for WHO's Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP), and laboratory and surveillance capacity-building including that required under the International Health Regulations (2005).
 
"( c) The need for multiple sources of financing to address these challenges in the short-, medium-, and long-term, including strengthening existing sources/mechanisms of finance and examining the need for new sustainable/innovative financing mechanisms for the Pandemic Influenza Preparedness (PIP) benefit sharing system.
 
"(d) To hold, during the inter-session, consultations by the co-chairs with civil society, which will be open to all Member States and regional economic integration organizations. They will also hold consultations with industry representatives and with other key stakeholders, including scientific institutions, from developed and developing countries. The co-chairs will report back to the Open-Ended Working Group on their consultations, including through the Bureau meetings. The co-chairs will continue with informal consultations with Member States and regional economic integration organizations during the inter-session.
 
"(e) To hold informal consultations during the inter-session, including through electronic means, which will be organized by the following Member States and on the following subject matter, respectively: Australia on the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity; Brazil on dispute resolution (SMTA inside the system); and India on definitions and use of terms. The Bureau will facilitate regional participation in the aforementioned consultations.
 
"(f) Requests the Director-General to seek information from WIPO (World Intellectual Property Organization) on PIP-related patents, including patent applications, in connection with the H5N1 virus and the pandemic (H1N1) 2009. Countries are invited to help with the patent research on this matter.
 
"(g) To submit the report of the Open-Ended Working Group, the Framework and its annexes, as amended, through the Director-General to the Executive Board at its 128th session.
 
"(h) To inform deliberations at the April 2011 meeting, the Director-General will finalize the report of the technical studies prepared in accordance with resolution WHA63.1, including a realistic assessment of short-, medium-, and long-term needs for pandemic influenza preparedness and response, and possible sources/mechanisms of financing, including existing sources/mechanisms, for each set of needs."
 
The origins of the PIP/OEWG can be traced back to WHA Resolution 60.28 adopted in 2007, which came about as inequities in the present influenza virus-sharing system in WHO became apparent following the H5N1 influenza outbreak.
 
The system, known as the "Global Influenza Surveillance Network" (GISN), required countries to share influenza viruses, while failing to deliver any concrete benefit-sharing, thus leaving many developing countries without timely and affordable vaccines. On the other hand, developed countries and private entities reaped benefits, as the former gained timely access to vaccines and other supplies, while the latter gained access to influenza biological materials and generated profits without having to share any of the benefits.
 
WHA Resolution 60.28 launched the reform of the influenza virus-sharing system. Since 2007, WHO Member States have been meeting in various formats to negotiate the terms and conditions for the sharing of viruses, as well as for ensuring fair and equitable sharing of benefits.
 
The most recent negotiating format was the PIP/OEWG, which first met on 10-12 May 2010 and most recently, on 13-17 December 2010. The PIP/OEWG made limited headway, as it continued to be bogged down by differences of view between developed and developing countries, which have dominated past negotiations, and as developed countries remained unwilling participants in the negotiations.
 
[The PIP Framework is the subject of negotiation before the PIP/OEWG, which includes sections on Principles, Objectives, Scope, Definition and Use of Terms, Sharing of H5N1 and Other Influenza Viruses of Pandemic Potential, Benefit-Sharing, Governance and Review, and Terms of Reference of the Advisory Group and WHO linked centres, i. e. the National Influenza Centre, Essential Regulatory Laboratory, H5RL and WHO Collaborating Centres for Influenza (also known as WHO Network laboratories). The PIP/ OEWG is also negotiating the standard terms and conditions that will govern the sharing of influenza viruses].
 
One controversial issue that emerged during the PIP/OEWG discussions was that of the Convention on Biological Diversity and the recently-concluded Nagoya Protocol on Access and Benefit Sharing.
 
Bracketed text on this issue prior to the PIP/OEWG were:
 
"(PP11) Recognize the [sovereign right of States over their biological resources and the] importance of collective action to mitigate public health risks.
 
"[(PP12) This Framework shall not prejudice, preempt, or prejudge the outcome of Access and Benefit sharing negotiations under the Convention on Biological Diversity.]"
 
According to some sources, the EU proposed substituting the term "biological resources" with "natural resources", although the text in PP11 is consensus text from WHA Resolution 60.28.
 
In order to substitute PP12, the US proposed: "Recognizing that influenza pathogens do not fall within the scope of the Convention on Biological Diversity or the Nagoya Protocol".
 
There were also various other proposals that were presented, such as: "[(PP12) [Recognizing that this PIP Framework and the Nagoya Protocol should be implemented in a mutually supportive manner] [with a view to achieving the objectives of this framework] [and does not run counter to the objectives of the Convention on Biological Diversity and the Nagoya Protocol] [and that the Framework is in accordance with Article 3bis(4) of the Protocol.]"
 
Canada proposed specific reference to Article 3bis(4) of the Protocol.
 
[Article 3bis (4) of the Protocol states: "This Protocol is the instrument for the implementation of the access and benefit-sharing provisions of the Convention. Where a specialized international access and benefit-sharing instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialized instrument in respect of the specific genetic resource covered by and for the purpose of the specialized instrument"].
 
Existing divergences were narrowed on this issue during informal group discussions towards the end of the week.
 
PP11 was agreed to without the changes that had been proposed by the EU.
 
Textual options for PP12 were narrowed to:
 
"[(PP12) [Recognizing articles 3bis* and 6(b)* of the Nagoya Access and Benefit Sharing Protocol to the Convention on Biological Diversity;] [*Footnote: to be updated when the Nagoya protocol text is edited];
 
"Or
 
"[Recognizing that influenza pathogens do not fall within the scope of the Convention on Biological Diversity or the Nagoya Protocol]".
 
[Article 3bis pertains to the "Relationship with International Agreements and Instruments", which essentially requires that specialised access and benefit-sharing agreements should be supportive of and do not run counter to the objectives of the Convention and the Protocol. Article 6b pertains to "Special Consideration", i. e. that requests " due regard" to be paid to "cases of present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally", and "may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries".]
 
The determination of developed countries in persisting to push for a reference to Article 3bis (4) or to language that excludes pathogens from the scope of the Convention on Biological Diversity (CBD) or the Nagoya Protocol follows from failed attempts to exclude pathogens from the Protocol during the negotiations on the Protocol.
 
Some developed countries were also not agreeable (and thus proposed deletion) to the inclusion in the preambular paragraphs of the PIP Framework a reference to internationally recognized instruments, i. e. the Doha Declaration on the TRIPS Agreement and Public Health, as well as the Global Strategy on Public Health, Innovation and Intellectual Property, adopted in Resolution WHA61.21.
 
The following options remain in brackets:
 
"[(PP13) [Recognize]/[Recall] the Doha Declaration on the TRIPS Agreement and Public Health as well as the Global Strategy on Public Health, Innovation and Intellectual Property, adopted in resolution WHA61.21.];
 
"Or
 
"[Recalling the Global Strategy on Public Health, Innovation and Intellectual Property, adopted in resolution WHA61.21];
 
"Or
 
"[Delete]".
 
Differences continued to remain over the definition/scope of the term "PIP biological material", which is used throughout the text of the Framework to refer to influenza material that is transferred and developed.
 
In a bid to restrict the scope and impact of the Framework and limit the circumstances under which the terms and conditions would be binding, the developed countries want a limited definition of the term that does not include the parts of the biological material. The developing countries, on the other hand, would like to see a more encompassing definition that includes the parts of the biological material, e. g. the RNA, DNA, genes, sequences and the proteins.
 
Another point of contention during the discussion was the nature, form and content of the standard terms and conditions that would govern the transfer of influenza biological materials from Member States to WHO linked centres (WHO Collaborating Centre, Essential Regulatory Laboratories and H5RL) and from such centres to third parties (e. g. the industry).
 
Developing countries have been pressing for all transfers of influenza biological material to be subject to a binding contract in the form of a Standard Material Transfer Agreement (SMTA). It is anticipated that such an agreement would have terms and conditions for governing the transfer and use of influenza biological material, as well as for fair and equitable benefit-sharing.
 
On the other hand, developed countries have been resistant to the notion of a binding agreement that would bind their entities to certain terms and conditions, including obligating benefit-sharing.
 
The dispute over the nature, form and content of the standard terms and conditions governing the transfer of influenza biological materials persisted at the PIP/OEWG.
 
Before the PIP/OEWG were several proposals for SMTA/STC contained in document A63/48: proposed by the Co-Chairs, jointly proposed by Brazil, India and Indonesia, and proposed by the Euro region.
 
According to some sources, discussion on terms and conditions for transfers of influenza biological materials from Member States to WHO linked centres faced a setback on account of disagreement over the question of dispute settlement.
 
To give contractual effect to the SMTA, developing countries pushed for a dispute settlement mechanism that involves amicable dispute settlement, mediation and then arbitration. Several developed countries objected to this proposed method, and were instead in favour of amicable settlement, failing which the submission of the dispute to the Director-General for settlement.
 
Both options continue to be available, as some developing countries argued that the proposal by the developed countries would undermine the contractual nature of the SMTA. They argued further that amicable dispute settlement and mediation would in any case involve the good offices of the Director-General.
 
Textual negotiations on terms and conditions for transfers of influenza biological materials from WHO linked centres to third parties also made little headway, as wide divergences persisted over the form of the terms and conditions.
 
Developed countries have generally been opposed to the notion that third parties (e. g. the industry) have to share benefits arising from the use of influenza biological materials on a mandatory basis. Many of these objections were reiterated during the PIP/OEWG session.
 
The Co-Chairs proposed "Standard Terms and Conditions for Transfers of WHO Pandemic Influenza Preparedness Materials", which would be required to accompany all shipments of WHO PIP Materials. They also proposed that "No public health laboratories working within the Global Influenza Surveillance Network coordinated by the World Health Organization will be subject to dispute settlement actions relating to interpretation or implementation of these Standard Terms and Conditions."
 
The proposal also contains elements for dispute settlement, which may be initiated by the WHO or the Recipient, adding that issues of interpretation or application of these Standard Terms and Conditions would be resolved by reference to the laws of Switzerland. Other disputes would be settled by conciliation, failing which through arbitration.
 
Brazil, India and Indonesia also presented their SMTA, which had contractual effect. The Euro region proposed that recipients participate in a solidarity mechanism that would include contributing a portion of the revenue from the sale of vaccines, although the nature of the mechanism (i. e., whether it would be mandatory or voluntary) remains an open question.
 
Discussion on this aspect resulted in a chart that provided a comparison of the various proposals.
 
According to some sources, during the discussion on the issue of benefit-sharing, there were persistent calls by developed countries (supported by the Co-Chairs) to formally involve the industry in the negotiations. Hungary, on behalf of the EU, reiterated this call during the EB session.
 
Such calls were however opposed by the developing countries.
 
As a compromise, it was agreed that the Co-Chairs will formally hold consultations with industry, including scientific institutions, from both developed and developing countries, as well as with civil society representatives during the inter-sessional period.
 
The issue of intellectual property rights (IPRs) was also discussed at the PIP/OEWG session. Previous negotiating sessions have been split along broadly North-South lines on this matter.
 
Developed countries, being the major beneficiaries of the IPR system, have been resisting attempts for any language that may affect the ability of their entities to claim IPRs. On the other hand, developing countries have repeatedly argued that WHO linked centres must not be allowed to claim IPRs over the biological material received and parts thereof, as well as over the products/processes developed using the biological material that is received.
 
In relation to transfers of influenza biological material, some developing countries contend that no IPRs should be allowed to be claimed over the influenza biological material received and parts thereof. With regard to products and processes, there is a general push by developing countries that if IPR claims are allowed, it should be on the understanding that royalty-free licenses will be given to developing countries and facilitated by WHO.
 
In putting their case forward, the developing countries have argued that claims of IPRs over the biological materials are unethical and would hinder scientific innovation. Moreover, the materials have been shared on the basis of goodwill for the purpose of pandemic preparedness.
 
While many of the same arguments were reiterated during the PIP/OEWG session, sources said that some developed countries were reluctantly willing to concede that WHO linked centres that were public laboratories should not be allowed to claim IPRs.
 
According to sources, reluctance to extend the same obligation to all WHO linked centres was due to a WHO Collaborating Centre, St. Judes Children's Research Hospital based in Memphis, the United States, which actively pursues IPRs.
 
Developing countries also sought information on the extent of patent claims over H5N1 and H1N1 influenza viruses leading to the Director-General being tasked with seeking information from the World Intellectual Property Organization (WIPO) on PIP-related patents, including patent applications, in connection with the H5N1 virus and the pandemic (H1N1) 2009. +