4.4. Regulatory and legal requirements
Many governments have reporting requirements regarding AMR. When certain pathogens are found within the surveillance system, public authorities must be notified. The appearance of other less virulent pathogens might only need to be shared within the country’s reporting system.
Whatever the requirements, the introduction of WGS to a surveillance system should not adversely impact required reporting. Data should be reported in a timely and transparent manner as it was within the phenotypic surveillance system. Regulations concerning data protection and the anonymisation of patient data should also continue to be respected. When data will be shared between entities, data-sharing agreements that outline the terms and conditions for sharing data should be put in place.
Activity 8: Reflections on the requirements for conducting AMR surveillance using WGS in your context
Look at the questions in Table 5 to help you reflect on your system’s readiness for introducing WGS as part of your AMR surveillance. (You may want to use the space below to make notes.)
| Question | Reflection prompts |
|---|---|
| What national, regional or local reporting requirements exist related to AMR surveillance? | Can I meet these requirements with WGS data? If not, what policy changes would need to occur for me to continue to comply with these reporting requirements? Laboratories might have to confirm that using WGS instead of other already established methods complies with national and institutional guidance. |
| Do I have a functioning phenotypic antimicrobial susceptibility testing (AST) AMR surveillance system in my country, state or region? | In most contexts, it makes sense to establish a functioning phenotypic system before moving to WGS. A robust phenotypic AST system provides the foundational data needed to interpret and validate genomic findings. It also ensures that basic infrastructure, laboratory capacity and data management systems are in place – critical prerequisites for successfully integrating WGS into surveillance. |
| Are there authorities and agencies in the country who can act on the data produced from my WGS AMR surveillance system? | If not, how will the collected data be used? For WGS data to have a public health impact, there must be clear pathways for translating genomic findings into policy and action. This requires coordination with stakeholders – such as public health authorities, regulatory bodies and clinical networks – who understand and trust the data and have the mandate to respond. |
Discussion
You’ve taken an important step by evaluating how WGS could fit into your existing AMR surveillance framework. As you continue, consider which colleagues and stakeholders can help you to build partnerships with the relevant authorities and advocate for policy alignment to support the integration of WGS data into your surveillance efforts.
Now that you have considered the wider aspects of whether and how a new WGS facility would fit within your system, the focus shifts to considering the important aspect of the costs involved in establishing a WGS facility.
4.3 Data for action
