Common use of Overarching Principles Clause in Contracts

Overarching Principles. ‌ It may be useful to start the MTA with a short section acknowledging the overarching principles governing the transfer. This can help to frame the agreement and provide context for the specific terms covered in later sections. It could prove useful in ensuring both parties interpret the document in a similar manner. These overarching principles can also act as a reference during the negotiation process – helping to ensure the result meets the original aims. They can also be useful should it be necessary to return to the MTA at a later date, for example to reach an agreement on further uses for the transferred samples and associated data. A common set of overarching principles would also assist in developing good practice in the transfer of samples and associated data during public health emergencies. Principles that might be addressed in the opening section of an MTA associated with a public health emergency might include: • Speed - in a public health emergency rapid action can be critical, making it important that as soon as possible samples and associated data are shared with a suitable reference laboratory and the results made available to those that need to know; • Sustainability - 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; • Capacity building - 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; • Maximal preservation - avoiding destruction of potentially useful samples and associated data. These are im- portant biological resources. In some cases, they may be irreplaceable; • Trust - 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 ▇▇▇▇▇- derstanding research and pushing back; and to prevent stigmatisation of communities. Issues around stigma, violence cannot be ignored. • Good faith - prompt responses necessitated by public health emergencies are often not conducive to detailed negotiations, or focus on considerations beyond immediate needs. Addressing longer term arrangements for the samples and associated data may need to happen after the original transfer has been completed. Both parties will need to continue to work towards the broader public good, including through the commensurate sharing of any benefits accrued from sharing samples and associated data; • Good practices - 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; and • Consistency with applicable national and international laws - For example, 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 Interna- tional 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. During the public consultation on this tool, the difficulties in balancing the need for a prompt public health response against the need to protect the interests of all parties was raised on several occasions. Different respondees believed

Overarching Principles. ‌ It may be useful to start the MTA with Past discussions have highlighted a short section acknowledging the overarching principles governing the transfer. This can help to frame the agreement and provide context for the specific terms covered in later sections. It could prove useful in ensuring both parties interpret the document in a similar manner. These overarching principles can also act as a reference during the negotiation process – helping to ensure the result meets the original aims. They can also be useful should it be necessary to return to the MTA at a later date, for example to reach an agreement on further uses for the transferred samples and associated data. A common set number of overarching principles would also assist that could usefully be codified in developing good practice in the transfer of samples and associated data during public health emergencies. Principles that might be addressed in the opening section of an MTA associated with a public health emergency might includeincluding: • Speed - in a public health emergency rapid action can be critical, making it important that as soon as possible samples and associated data are shared with a suitable reference laboratory and the results made available to those that need to know; • Sustainability - 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; • Capacity building - public health emergencies pose a collective threat, there . 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; • Maximal preservation - avoiding destruction of potentially useful samples and associated data. These are im- portant biological resources. In some cases, they may be irreplaceable; • Trust - 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 ▇▇▇▇▇- derstanding research and pushing back; and to prevent stigmatisation of communities. Issues around stigma, violence cannot be ignored. • Good faith - prompt responses necessitated by public health emergencies are often not conducive to detailed negotiations, or focus on considerations beyond immediate needs. Addressing longer term arrangements for the samples and associated data may need to happen after the original transfer has been completed. Both parties will need to continue to work towards the broader public good, including through the commensurate sharing of any benefits accrued from sharing samples and associated data; • Good practices - 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. resources Exactly which good practices are relevant will likely be context specific; and • Consistency with applicable national and international laws - For example, 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 Interna- tional 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. During the public consultation on this tool, the difficulties in balancing the need for a prompt public health response against the need to protect the interests of all parties was raised on several occasions. Different respondees believed.