complained about burdensome paperwork, precautions out of proportion to the risk, long delays to obtain permission, and multiple levels of bureaucracy that could block a transfer. They noted that some countries will not allow the import of drug-resistant TB strains while in other cases intellectual property restrictions block pathogen export. One mentioned that most African countries will not allow samples to be transported by air. Another person recounted that even when regulations permit transfer of samples awaiting diagnostics, inadequate transportation infrastructure in some regions may cause life-threatening delays. One person did acknowledge, however, that sample transport, particularly for pathogen collections, does present risks.
Various participants also identified consequences of the current situation:
• Labs that aspire to become international reference labs, which must be able to receive unknown samples, typically need to engage in detailed conversations with regulators to put transfer agreements in place. Additionally, regulations effectively bar some labs from ever serving as reference labs.
• Difficulty in obtaining samples when needed encourages facilities to create or retain their own reference collections.
• An inability to ship samples for timely diagnostics encourages countries and localities to build their own laboratories.
• Particularly burdensome transport regulations, such as the United States Select Agent rules that require individuals who ship select agents within or into the United States to obtain a United States security clearance, discourages potential, foreign collaborators.
To ameliorate some of these problems, several participants suggested continuing to engage the International Air Transport Association (IATA), the U.N. Committee on Dangerous Goods Transport, and national governments in a dialog to better define the requirements for safe transport and to accurately characterize the associated risks. One suggested that TB, due to the large potential number of samples and the comparatively well-characterized risks might be an ideal starting point for a conversation, particularly as transporting TB samples is much less risky than transporting TB patients.
One person indicated that countries are increasingly relying on in-country DNA sequencing capabilities rather than sample export for diagnoses. While valuable for public health independence and IHR compliance, the individual worried that such a model might stymie international characterization of emerging threat pathogens.
As reference collections present security risks, participants discussed both the demand for pathogen collections as well as the ethics of destroying collections. Many indicated that research, particularly pathogenesis studies, almost always requires viable organisms that are typically obtained from collections. In contrast, many felt that diagnostics, particularly for organisms like TB where the tests are standardized and use internal controls, created much less demand.
Opinions were mixed concerning whether pathogen collections should ever be destroyed, and one person cited that the recent eradication of rinderpest and the accompanying debate over whether or not to destroy all samples as a topical example. One viewpoint maintained that dangerous pathogens are inherently interesting and that we should retain and study them to understand the source of the pathogenicity. Another viewpoint argued for destroying samples when transporting them to more secure, centralized locations represented an unacceptably high risk, particularly when the samples are unlabeled or without context.