In a health emergency rapid action in the public health interests of the affected populations is critical. To enable effective public health response, information is required to be generated in a timely manner and communicated promptly to decision-makers in the affected countries. Some critical types of information can only be generated from samples. It is therefore important that samples and associated data are shared rapidly with a suitable reference laboratory and the results are made available as widely as possible, particularly to local decision-makers and WHO. Prompt responses necessitated by emergencies are often not conducive to lengthy negotiations or considerations beyond immediate needs. Any MTA put in place during the outbreak will need to allow for later discussion and agreement on further use and access and benefit sharing provisions.
Benefit sharing is a core principle for MTA development using this tool. In countries that are party to the Nagoya Protocol of the Convention on Biological Diversity there are legal obligations to agree terms for equitable sharing of possible benefits before samples are transferred. In the context of R&D Blueprint pathogens possible benefits include the following: access to products developed (if any), including reagents, diagnostics, therapeutics and preventives, with intellectual property management accordingly, and acknowledgement, attribution and where appropriate co-authorship for originating/provider parties. In responding to pressing public health needs, it is important to protect both the short and the longer term interests of affected populations. Furthermore, public health emergencies pose a collective threat. There remains much to be done to build the core capacities needed to address them effectively. This is an ongoing process requiring continual consideration. Successful capacity building may reduce the need to transport samples and associated data in the future.
The samples and associated data generated by a public health emergency can be important for understanding more about the disease and in developing tools to combat it. These important resources will need to be maintained and managed over the longer term. It will be important to think of how this can be realistically accomplished at the same time as addressing immediate public health needs.
Avoiding destruction of potentially useful samples and associated data. These are important biological resources. In some cases, they may be irreplaceable.
It is important that the MTA process establishes a level of trust among the participants where they feel their needs are recognised in the text. This is important also to prevent populations from fearing or misunderstanding research and pushing back; and to prevent stigmatisation of communities. Issues around stigma and violence cannot be ignored.
It is important that, despite the emergency setting, transfers of samples and associated data follow the highest possible standards, for example taking into account bioethics issues, procedures and practices for safe and secure storage, handling and shipping of materials, and principles for access to genetic resources. Exactly which good practices are relevant will likely be context specific.
Drafting an MTA will likely have to take into account a legal environment composed of both national and international laws. Applicable national laws may be contract laws, rules regarding conflicts of laws, national security laws, biosafety laws, or national access and benefit-sharing measures. Applicable international laws could be instruments such as the International Health Regulations (2005), in particular its Articles 6 and 46, the Convention on Biological Diversity, in particular Article 15 on access to genetic resources, or the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity.