2023-03-26-世界卫生组织-2023_Terms_of_Reference_for_Strategic_Advisory_Group_of_Experts_on_In_Vitro_Diagnostics_SAGE_IVD_5页_82kb

Summary of Terms of Reference for SAGE IVD

The Strategic Advisory Group on In Vitro Diagnostics (SAGE IVD) functions as the World Health Organization's (WHO) principal advisory body for global policies and strategies related to in vitro diagnostics (IVDs). Its primary role is to provide expert advice to the WHO Director-General on various aspects of IVDs, with a focus on priority, essential, and neglected IVDs where no specific advisory mechanisms exist.

Key Functions

• Serve as a principal advisory group on all IVD-related matters.
• Provide technical advice on policy development, evaluation, and use of IVDs, including linkages with health interventions.
• Advise on progress toward WHO goals set in World Health Assembly resolutions.
• Recommend policies for universal health coverage and global public health security, ensuring integrated diagnostic capabilities.
• Suggest guiding principles for IVD use in national, regional, and global contexts.
• Review the pipeline of existing and innovative IVDs, including those for non-communicable diseases, rare diseases, and infectious diseases, and identify gaps.
• Advise on IVD standards, methodologies for evidence review, and alignment with WHO's Essential Diagnostics List (EDL).
• Provide input on WHO activities, partnerships, and engagements in IVD development, access, and use.

Notably, SAGE IVD accepts recommendations from established WHO mechanisms for certain diseases like HIV, TB, and malaria without further review.

Composition

• The advisory group consists of up to 15 members, appointed by WHO in their personal capacities to ensure diverse expertise, geographical representation, and gender balance.
• Members are appointed for a two-year term, eligible for reappointment once, subject to conflict of interest evaluations.
• The Chairperson is selected with similar criteria and may not serve multiple terms consecutively for the chair position.
• All members must declare conflicts of interest, and appointments are contingent on passing WHO evaluations to avoid any conflicts.

Operation

• Meetings are held at least every two years, combining in-person and virtual formats.
• Decisions are made by consensus, with minority opinions recorded in meeting reports if consensus is unachievable.
• Working groups can be established to address specific issues, with outcomes shared at AG meetings.
• Attendance is expected; missing two consecutive meetings may lead to appointment termination.
• Sessions can be open or closed, with strict adherence to confidentiality rules enforced across all participants.

Support and Resources

• WHO provides the secretariat, including scientific, technical, and administrative support, such as agendas, documents, and discussion papers.
• Members receive no remuneration; travel expenses for in-person meetings are covered by WHO in accordance with its policies.

Confidentiality and Information Handling

• SAGE IVD-related information is confidential and proprietary to WHO.
• Members must uphold confidentiality obligations, and AG documents can only be used for prescribed purposes.
• WHO retains full authority over the publication and final decisions on AG recommendations.

This summary captures the core elements of SAGE IVD's Terms of Reference, emphasizing its advisory role, membership criteria, operational procedures, and confidentiality requirements.