Immunocompetent

The Centers for Disease Control has a World Health Organization Collaborating Center (WHO CC) for influenza, but it may be unable to fulfill its duty to WHO because US domestic law prevents it from adequately sharing influenza viruses.  The law is US export control legislation, and it requires that labs, including CDC, obtain a license from the Department of Commerce before sharing a number of disease agents.

This means that shipments of H5N1 to other countries require a license.  For some countries, like Canada, obtaining a license is routine; but for many others, including many WHO Member States, tighter export controls apply.  These countries are indicated in a list maintained by the US Department of Commerce called the Commerce Control List Country Chart.

(“CB” type controls generally govern H5 virus exports. These range from “CB1” to "CB3”, with “CB3” being the most restrictive. The exception are the extra "special" countries in the USG's eye, like North Korea or, much less probably, Cuba, who have country-specific  - i.e. even more restrictive - export control regimes.)

Export controls have been sharply criticized by developing countries for being arbitrary and political, and for contradicting technology transfer obligations in international agreements.

The US Department of Commerce has authority to simply deny shipment of H5N1 virus to other countries, even if the virus was given to the WHO Collaborating Center at CDC by a National Influenza Center in another country. In other cases, the US Department of Commerce may insist that foreign labs comply with US-style security rules or that they even to try prove to the US government that they are not a security threat to the United States.

US domestically legislated procedures to obtain H5N1 are contained the Select Agent Rule. They include submitting the fingerprints and biographical data of researchers to the Federal Bureau of Investigation (FBI), periodic laboratory security inspections (ironically conducted by CDC itself), and a large number of mandatory physical security measures and procedures.

Other restrictions on H5N1 viruses under US law include a prohibition on foreign recipients of H5N1 viruses from US labs from transferring them to others.  So, for example, if the WHO CC at the Centers for Disease Control is able to send an H5N1 virus to a foreign National Influenza Centre for research purposes, the CDC may require the NIC to not transfer that virus to anyone else, even another WHO network laboratory.

Such strict domestic legislation may be sensible in the US because of its severe domestic bioterrorism threat (for example, the 2001 anthrax letters that were produced at US government lab and sent by a US government scientist), however, they may interfere with the ability of the Centers for Disease Control to effectively function as a WHO Collaborating Center for Influenza and to abide by its WHO Terms of Reference, which require sharing H5 viruses internationally.

The WHO Pandemic Preparedness Intergovernmental Meeting (PIP IGM) should be careful to avoid allowing national legislation to stand in the way of WHO-approved virus sharing by WHO Collaborating Centers.  Therefore the PIP IGM should ensure that WHO Collaborating Centers for influenza are not located in where domestic legislation conflicts with the Collaborating Center’s responsibilities to WHO Member States.

In the specific case of the United States, WHO Member States should seek a public assurance from the US government that the WHO CC at the Centers for Disease Control will provide H5N1 viruses and vaccine seed strains to all Member States with a WHO-recognized laboratory, without the imposition of any delays, denials, or additional requirements due to export controls or other national legislation.