Origin of samples
It is important to think about how and why the samples and associated data were taken and from whom.
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Contents of samples
Samples taken during a public health emergency will likely include more than just the pathogen of interest.
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Value of samples
Not all samples are equally valuable. Value may be determined by sample type or the amount of associated data.
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Provenance of samples
It is increasingly important to be able to trace what samples have been used and for what purpose.
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Origin of samples and associated data
It is important to think about how and why the samples and associated data were taken and from whom.
In a public health emergency, samples may have originally been taken from patients for diagnosis and treatment. Informed consent may not have been explicitly obtained for the samples’ use or for future use. There are practical challenges in being able to meet requirements for informed consent during a public health emergency, for example, given the psychological impact of an individual fearing that they are infected. Furthermore, obtaining informed consent retroactively would be difficult and costly – recent experiences suggest that samples can become disassociated from patient identifiers or clinical records. Attempting to obtain retroactive consent from individuals may therefore be unfeasible, especially in outbreaks with high levels of mortality. Governments and the public health community, on the other hand, do have obligations to carry out research that might save lives during future Ebola outbreaks. This research could be significantly aided by making use of these samples. The original of the sample and the conditions under which they are taken might also influence thinking about benefit sharing. There are existing good practices on dealing with such situations included in the Helsinki Declaration.
Contents of samples and associated data
The likely contents of samples and associated data must also be considered. Many samples and associated data generated during a public health emergency are unlikely to be isolated pathogens. As a result, relevant samples and associated data will often include elements associated with the host or patient. In the longer run, such material might be of greater value than the pathogen as it could provide insights into the host’s reaction, offering important markers for diagnostics, vaccines or therapeutics.
Furthermore, pathogens are not static. They will continue to mutate and evolve. It will be important to consider in an MTA the possibility of changes in the materials they cover and the scope of the agreement – thereby preventing the need to renegotiate an MTA unnecessarily.
Value of samples and associated data
Not all samples are equally valuable - a human sample alone is useful, but a sample linked to clinical data, or part of a series of samples over time, or which is linked with epidemiological data, can be more useful and therefore potentially more valuable. The MTA process should ensure that the greater the cost to the donor, the more benefit they receive. Samples and associated data can also be used in different ways. There is a need to differentiate between different types of outputs which could be generated from the movement of samples and associated data. These include: papers or other academic output; testing or quality assurance (QA) for a product already under development; or use in an unforeseen product, perhaps some time after the material was transferred or in subsequent technical developments. It might not be possible to know the value of a sample and associated data at the outset. This may warrant including provisions to negotiate further use should a sample and associated data prove particularly valuable.
It is important that concepts of value of samples are explicitly addressed and shared amongst those involved with developing an MTA. Some initial thinking on the identification of valuable samples during a public health emergency was undertaken by WHO at its Second Informal Consultation on Biobanking in Sierra Leone in 2015 Leaving notions of cost and value of samples undefined can create ambiguity, specifically during a public health emergency, and can lead to protracted discussions and delay or hinder the development of vital diagnostics.
It is possible that perceptions of value of samples and associated data can complicate access. It is important samples and associated data can be rapidly accessed, transferred and used for public health purposes. As a result, from a public health perspective, it might be advisable not to limit access to samples and associated data on the basis of value during a public health emergency. Discussions over the value of the sample and associated data and any benefits that might therefore need to be shared could be delayed until the emergency has receded. An MTA can be a useful tool for protecting the interest of both parties and for capturing the intent to return to this issue in good faith after the emergency is over.
As one responder during the public consultation on this tool noted, attaching value to medical samples “risks promoting a view that biological materials necessary for public health responses are commodities that can and should be bargained for. Further, such competition may result in uncertain and unequal outcomes depending on the scarcity of the samples. For materials in short supply, affected countries may be incentivized to “hold out for a better deal.” For widely available materials, affected countries may be forced into a “race to the bottom” to accept less generous terms for fear of getting no benefit at all.”
Provenance of samples and associated data
The increasing importance of knowing and demonstrating the chain-of-custody or provenance of material used for commercial development is also important. A well-documented process for the acquisition of material makes commercial sense by demonstrating due diligence and insulating those developing products from later claims contesting ownership.