During my hiatus for much of May, I missed stories from the 60th session of the World Health Assemby (WHA) over access to samples of H5N1, more frequently known as the avian flu virus. While it’s now August, I think the story is about to heat up again with some pending meetings and I wanted to offer a few thoughts.
I thought I had seen something about Thailand asserting that viruses fall under the scope of the CBD and so access to samples of the virus should include obligations for benefit-sharing. I can’t seem to find the source where I read this now but I’ll comment regardless. I guess the uncertainty would revolve around whether a virus can be considered a ‘living organism’ in the definition of ‘biological diversity’ in Article 2 of the Convention. I’m not going to get into grander philosophical questions of ‘what is life?’ I’ll just point out that viruses are included in the definition of ‘living organism’ in the Biosafety Protocol. As a subsidiary instrument to the Convention, the Protocol shouldn’t include stuff that the Convention doesn’t so reverse reasoning would suggest that viruses are also included in the Convention.
By way of further background, in February of this year, Thailand stopped supplying virus samples to an international network by which the spread of flu is monitored and vaccines developed. As described by Maryn McKenna, a contributing writer at the University of Minnesota’s Center for Infectious Disease Research & Policy:
The fear of a legal claim that could disrupt flu surveillance and vaccine manufacturing is the latest chapter in a dispute that began late last year when the government of Indonesia withdrew from the 55-year-old system by which flu viruses are shared around the world.
Under that system, which was developed for tracking and controlling seasonal flu and has now been extended to flu strains that could spark a pandemic, viruses are isolated in a country and analyzed to increasing levels of sophistication by a national lab, regional lab, and WHO Influenza Collaborating Centers in Tokyo, Melbourne, London, and the US Centers for Disease Control and Prevention in Atlanta. Gene sequences from the analyses are used to identify emerging strains of flu and then passed free of charge to pharmaceutical companies to be commercialized as vaccines.
Developing countries paid little heed to the system for most of its existence because they do not manufacture vaccine and typically do not vaccinate their populations against seasonal flu. However, the Southeast Asian countries where H5N1 is concentrated have a strong interest in protecting their populations against a potential pandemic—but they would be unable to afford the pandemic-flu vaccines that Northern Hemisphere manufacturers might produce.
Turning to the May negotiations, Thailand asserted that genetic resources (in the form of the avian flu virus) over which it has state sovereignty were being accessed and used to develop vaccines in developed countries. Thailand does not have the domestic manufacturing capacity to produce vaccines itself and may not be able to afford to purchase vaccines produced elsewhere so they felt that they felt that there should be some form of benefit-sharing - probably in the form of access to avian flu vaccines - in exchange for access to the avian flu genetic resources, as per the CBD.
What I haven’t seen is information on where or how avian flu ‘isolates’ are isolated from. To me, the most logical source would be birds or people that have contracted avian flu but I’m no scientist. If the isolates come from people, things could start to get tricky as in decision II/11 of the Conference of the Parties to the CBD, the Parties excluded human genetic resources from the scope of the Convention. If the isolates contain human genetic resources as well as those of the avian flu virus, the human component isn’t covered by the Convention. I suppose, though, that this needn’t stop countries from asserting that they want access and benefit-sharing rules to apply to these resources as well in their domestic context.
So at the WHA meeting in May, countries adopted resolution 28 on “Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits”. I’m not going to go through the whole thing but there are some interesting points.
Two paragraphs in the preamble state:
Recognizing the sovereign right of States over their biological resources, and the importance of collective action to mitigate public health risks;
Recognizing that intellectual property rights do not and should not prevent Member States from taking measures to protect public health …
I think this is a nice mix of CBD and WTO rules (although neither are mentioned by name) being done in a third international forum.
The first paragraph of the operative text of the resolution urges WHO Member States to continue providing virus samples to WHO’s international flu surveillance network. The second operative paragraph makes a number of requests of the Director General of WHO, largely concerning benefit-sharing. My interpretation of the paragraph is that states will not actually be paid for supplying virus samples to the surveillance network but that there will be benefit-sharing aimed, in particular, at the “support of public health”. This includes access to flu vaccines and assistance in the development of domestic manufacturing and research capacity. I like how these are examples of non-monetary benefits that can be shared in exchange for access.
The Director General is also to establish a stockpile of flu vaccines “for use in countries in need” and to convene an interdisciplinary working group to revise the terms of reference for the surveillance network and how it shares viruses between originating countries and WHO Collaborating Centres, and the latter and third parties.
Since the resolution was adopted in May, Indonesia has apparently provided a few flu isolates to the international system but is largely waiting to see the outcomes from upcoming meetings this fall at which guidelines on benefit-sharing will be developed.
Overall, I think it is unfortunate but unsurprising that this has degenerated into a bit of a tit for tat dispute. I see it as the logical consequence of the expansion of the scope of intellectual property - and patents in particular. If, in order to improve their bottom line, pharmaceutical companies in developed countries want their governments to negotiate international trade agreements that require the patentability of pharmaceutical products then they are increasingly going to have to pay one way or another for the resources from which those products are developed, in this case samples of the avian flu virus.
Free flow of information and virus samples might serve the public better and help in the development of flu vaccines but this stopped being about the public interest quite a while ago. It’s naive to expect developing countries to give something away for free when that ’something’ is going to be used to develop an income-generating product, and one that the developing countries won’t be able to afford at that.
Further resources:
- the McKenna quote above is from “Virus ownership claims could disrupt flu vaccine system”, 19 June 2007. Be forewarned, the discussion of sample sharing in this article seems pretty good but it contains a number of legal errors, e.g. the EU (or, more accurately, the EC) is most definitely a Party to the CBD.
- Tove Iren S. Gerhardsen, “WHO Moves Closer To Guidelines On Avian Flu Sharing, Access”, 25 May 2007, IP-Watch.