Providers and recipients should ensure consistency with any applicable national and international laws and many MTAs might include provisions detailing relevant commitments.
Relevant international rules can be legally binding, such as relevant provisions of the International Health Regulations (2005), in particular their Articles 6 and 46, the Convention on Biological Diversity in particular its 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. They might include international normative documents, such as the WHO Laboratory Biosafety Manual the UN Recommendations of the Transport of Dangerous Goods, or those for the protection of human and animal subjects, such as those enshrined in the Helsinki Declaration.
In this context, benefit-sharing clauses may need to take into account domestic legal requirements (e.g., those related to intellectual property or existing domestic benefit-sharing measures) and national security considerations and obstacles that may be relevant. Failure to address national requirements can potentially foster legal uncertainty and delay a public health response.
When considering relevant laws and regulations, it might be important to cover such issues as: national access and benefit-sharing measures, ethical use or oversight, laboratory biosafety, laboratory biosecurity, or good practices for handling, storage or shipping samples and associated data, or the data or results generated. It could also cover issues connected to human rights and patient confidentiality issues.
The MTA might usefully identify individuals or bodies responsible for compliance in relevant areas.