13.01 Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits

Under this item the WHA will consider the Report of the Open-Ended Working Group of Member States on Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits (A64/8). 

The issue of benefit sharing was first raised by Indonesia who asked why they should provide samples of H5N1 to WHO if they were to be given to private corporations and vaccine stocks were to be reserved for rich country use.  

The issue raises significant questions regarding intellectual property and technology transfer. There have been some political conflicts associated with the development of this item and the report of the OEWG (A64/8).

More detailed background to this item is provided in the briefing paper prepared by TWN for the EB Watch in January 2011.

See also Influenza on the WHO topics site.

See extract from the PHM letter to EB members before the January EB meeting dealing with this matter.
See EB Watch comment on this item after the January EB meeting.

See PHM statement to the OEWG

See a summary of the framework agreement by Sangeeta Sashikant.

PHM Comment

The H5N1 and H1N1 crises have shown the need for a transparent and equitable mechanism for pandemic preparedness that puts public health as a top priority.  Towards this end it was a necessity to have a Framework with contractual agreements to oblige recipients of biological material to share reasonable benefits to facilitate pandemic preparedness and response particularly in developing countries. 
In this regard, we view the recently agreed Framework and the Standard Material Transfer Agreements (SMTA) for sharing of influenza viruses and access to vaccines and other benefits as a positive step forward as it puts in place, for the first time, terms and conditions to govern the sharing of influenza viruses of pandemic potential and obliges the recipients of influenza biological materials to engage in benefit sharing.

However, we believe that the Framework has some shortcomings. In particular it does not secure from the private entities in particular the commercial industry a reasonable level of benefits nor does it contain mandatory commitments to share knowledge,  technology and know-how. For instance the monetary contributions required of the industry is  too low given the profits levels of the  industry. Further the benefit sharing option of manufacturers setting aside 10% of their production of vaccines and antivirals is not sufficient for 80% of the world population found in developing countries and LDCs, in the event of a pandemic. Additionally the  granting of non-exclusive licenses at affordable royalties or royalty free to developing countries for the production of vaccines and other products needed in a pandemic is only a voluntary benefit sharing option under the SMTA. This should instead have been listed as a stand-alone mandatory benefit to facilitate the sharing of knowledge, technology, and know-how, which developing countries need to prepare themselves to counter influenza pandemic.

In this context we would like to express our disappointment with developed countries that placed the interests of the industry and their profits and intellectual property over the interests of global public health, throughout the negotiations on Pandemic Influenza Preparedness, resulting in weak components in the Framework including diluted benefit sharing obligations.

In addition, we note with concern efforts made by some Member States to undermine the relevance of the Convention of Biological Diversity (CBD) and the  Nagoya Protocol on Access and Benefit Sharing in the context of PIP discussions.

We call on the WHO Member states and Dr. Margaret Chan, Director General of the WHO to ensure that the Framework and the SMTAs are implemented in the manner ,that protects and promotes public health and that is consistent with the objectives of the CBD and the Nagoya Protocol.

WHA64 Committee Session Report by PHM

The meeting on agenda item 13.1 Pandemic influenza preparedness began in the afternoon of 18 May and continued until midday 19 May.  40 interventions in total were made, 37 from member states, 1 from Chinese Taipei and 2 from civil society.  Australia was the first to comment by making the suggestion that all of the bracketed text in operational paragraph 5 of resolution A64/8 be deleteted.  By doing so all mention of the Nagoya protocol would be omited from the resolution.  This proposal was supported in 15 of the other state's interventions and eventually accepted into the final resolution.
Many developing nations, including Kenya and Algeria, urged other states to support their efforts to build capacity for monitoring and dealing with pandemic disease.  This was reinforced by a strong emphasis on the transfer of technology and know-how by Brazil, Thailand, Bolivia and others.  The committee also made many statements in favour of improving the availability and supply of vaccines and antivirals.  Brazil stated to need for the supply to be geographically diverse, China urged the nations with pertenent intellectual property to share it with other nations and Thailand suggested that demand for vaccines in developing countries must be increased to support their production capacity for pandemics.
Jamaica proposed an ammendment to operative paragraph 4 to urge the WHO to 'set up mechs to facilitate access to countries in need to vaccines and antiviral medicine through stockpiling and affordable access'.  This ammendment was opposed first by the USA on the grounds that it would require the committee to renegotiate a substantial protion of the text.  Germany added that the directive is already contained within the negotiated framework withing section 6.
After hearing these objections Jamaica responded that they were familiar with the content of section 6 and found that it failed to state the directive pointedly or in a manner which assigned the responsibility for implementation on to anyone.  However they had been personally approached by Dr Chan and told that she would take personal responsibility to ensure that the directive was carried out.  For some reason this satisfied the Jamaican delegation and they withdrew their request.
The importance of non exclusive lisences, which are included in the agreement as a volutary option for producers, was also stressed by manner of the memberstates.  And the ongoing negotiations of the details of the agreement were another point of concern.  Japan stressed the need for transparency and fairness in the proceeding negotiations and China reenforced this adding that special note must be made of how industry is effective the process.  India urged the WHO to expedite the process and ensure that the spirit of the agreement is maintained.  Thailand reiterated this and added that financial mechanisms need to be elaborated to aid developing nations in there efforts to build capacity.
Sao Tume and Principe ammended the resolution to include 2 yearly reporting to the WHA through the EB and the USA added a reference to WHO constitutional article 23.  Legal council informed the committee that the USA's ammendment would have no legal ramifications.
Of all the interventions only Bolivia noted that condoning the patenting of parts of organisms, as the final framework does, is problematic.  However, to allow the process to move forward they did not oppose the resolution.
Sangeeta Shashikant spoke on behalf of CMCA, PHM and TWN, click here to see the full statement.   The World organization for animal health stated their desire to cooperate with efforts to combat pandemic influenza.  
PIP_sangeeta.doc57 KB
PHM submission_14_03_edited.doc37 KB
WHA64th - PHM-TWN statement on PIP.pdf197.51 KB
WHA64.5 - Resolution on PIP.pdf9.96 KB