WHO has posted the Chair's Text to be considered in December at the next installment of the WHO Pandemic Influenza Preparedness Intergovernmental Meeting (WHO PIP IGM). The meeting name is a mouthful; but all you need to remember is that this is the group that is trying to resolve the virus sharing controversies.
The Chair's lengthy text is exactly that, a text drafted by the Chair of the meeting, and word on the street is that the Australia's Jane Halton actually did do much of the drafting. (Often "Chair's texts" are only nominally written by the Chair.)
Too bad the text doesn't do a better job of plugging gaps in the system and reflecting the proposals of developing countries. A complete listing of problems great and small would probably explode this blog's buffer; but, in short form, here are some of the key problems in Halton's text that will have to be resolved:
• The text's definition of "Pandemic Influenza Preparedness biological materials" (i.e. the viruses and other materials given to the WHO system) is way too narrow. As presently written, the main option has got a lot of verbiage; but it would only protect donor country sovereignty over the materials as submitted (e.g. a throat swab) and not after they'd been worked on. It would not cover, for example, synthesized copies of H5N1 genes. The restricted definition is a non-starter. It will have to be expanded.
• The Chair's system would only cover viruses isolated from human cases of potentially pandemic influenza. Another non-starter. H5N1 candidate human vaccine strains have incorporated not only genes fro humans; but from animals too, and this is likely to continue throughout the prepandemic phase. H5N1 viruses isolated in animals and elsewhere (i.e. environmental samples) will have to be covered, or else the benefit sharing system will not work.
• The text proposes to place the obligation to share benefits from use of the viruses on governments and not on vaccine and pharmaceutical manufacturers. No way, Jose Sanofi. Perhaps governments like the US and in the EU will provide some benefits to developing countries; but a binding obligation to share benefits - like vaccine technologies and an international fund - must be part of the Material Transfer Agreement that companies and other researchers sign when they access PIP materials (i.e. viruses and related materials and data). It's very simple: If companies want access to H5N1 viruses to make and sell vaccines, they're going to have to make contributions to promote access to H5N1 treatments for poorer countries.
• Thre are no major restrictions made on patenting H5N1 viruses and genes. The only restriction the Chair's text would impose would be patents on viral gene sequences. This falls well short of what is needed and will have to be improved. Stopping the patent ripoffs are a requirement for the new system.
• The Chair's system for acquiring and sharing viruses is very leaky and would not stop piracy. Through a variety of means that become apparent on close analysis, in the system proposed it would be possible for companies and other labs to acquire and utilize H5N1 viruses outside the WHO system, and without agreeing to share benefits. These holes, which are many, will need to plugged. If the viruse sharing system isn't airtight, then developing.
• At one point, the text seems to suggest that a "benefit" for developing countries would be for some of their citizens to be used as guinea pigs in vaccine trials. We hope this was a misunderstanding, because it will be patently offensive to many. Being an experimental subject is not a benefit.
• The Chair's text is schizophrenic about the role of the so-called "Essential Regulatory Laboratories" (i.e. the US FDA and its UK and Australian equivalents). It can't seem to decide if the regulatory labs are fully in the WHO system or not, and if they regulate vaccines or if they develop them. Part of the confusion is perhaps understandable. Although it is the function of the WHO Collaborating Centres to develop vaccines, in fact, the US, UK, and Australia seem to have assigned some of the these duties to their regulatory labs. This can no longer fly. The regulatory laboratories are going to have to stick to regulating, not developing vaccines, and if this means that changes have to made in the US/UK/Aus organizational structures, so be it. If the ERL's want to develop vaccines, they are going to have to be treated as vaccine manufacturer.
The text can be found here:
Stay tuned to Immunocompetent for more commentary on the text and issues for the upcoming meeting, which begins in Geneva on December 8th.
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