Statement to the 148th Executive Board by the Chair of the Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response

Honorable Chair, Excellencies, Director-General, Ladies and Gentlemen

Thank you once again for the opportunity to provide you with an update on the work of the Review Committee on the Functioning of the International Health Regulations (2005) during COVID-19.

As you know, this Committee was convened by the Director-General on 8 September 2020, in line with World Health Assembly Resolution WHA73.1. The Committee is composed of experts with a wide range of expertise and with adequate gender and geographical representation. I have the honour to be the Chair of this Committee and am ably supported by our Vice-Chair, Professor Lucille Blumberg of South Africa and our Rapporteur, Professor Preben Aavitsland, from Norway.

Our mandate is to review the functioning of the International Health Regulations (2005) during the COVID-19 response and the status of implementation of the relevant recommendations of previous IHR Review Committees and to make technical recommendations to the Director-General, including any potential amendments.

We convened for 16 closed meetings so far, and we continue to work through three sub-groups: preparedness, alert, and response. I take this opportunity to reiterate my thanks to our three subgroup leads. We also convened 5 open meetings, when we provided updates on our work and listened to the submissions and questions raised by Member States, international agencies and non-governmental organizations in official relation to WHO. These open meetings continue to be attended by numerous designated representatives.

I reported on our progress to the 73rd World Health Assembly on 9 November 2020. And I continue to interact regularly with the Co-Chairs of the Independent Panel for Pandemic Preparedness and Response and the Chair of the Independent Oversight Advisory Committee.

Let me now turn to the substance of our work. I invite you to read our Interim Progress Report, document EB148/19. It details our preliminary findings as of December 2020, which were reached following numerous interviews, discussions and the review of a wealth of documentation.

Let me point out the most important ones:

  1. Member States and experts overwhelmingly support the IHR as a cornerstone of international public health and health security law, but several areas need improving if we are to be better prepared for the next pandemic. While we have not finalized our article-by-article assessment, there is a growing belief in the Committee that most of the necessary improvements can be achieved through more effective implementation of the existing provisions of the IHR, and do not require at this point changes to the design of the IHR.

     

  2. National IHR Focal Points need to be further empowered, including where necessary through national legislation. National Focal Points play a critical role in the timely sharing of information, but their limited authority and status often lead to delays in notification. The Committee noted that effective IHR implementation requires many functions that are not within the narrow mandate of the national IHR focal points, such as multisectoral coordination for preparedness and response and collaborative risk assessment. The absence of a dedicated national entity with sufficient authority and a clear mandate to take ownership and leadership is considered a significant limitation to effective implementation of the IHR at national and subnational levels. At country level, national IHR focal points need to be integrated in the national emergency plan as well as the national health committee or similar body.

     

  3. The possible need for an intermediate level of alert before a Public Health Emergency of International Concern (PHEIC) is declared, is also under consideration. The previous review committee on the Ebola response recommended such an intermediate level, but this recommendation was not taken up. The 5th open meeting of the Committee on 12 January 2021 discussed issues surrounding the possible introduction of a grading system. The different views expressed by Member States and the advantages and potential disadvantages of a new system will be further studied by the Committee. It is clear, that global preparedness, alert and response actions need to start much earlier and more decisively than they did during COVID-19. But it is far from certain, that introducing an intermediate level of alert would result in such earlier action. The Committee is considering how regular global and regional risk assessments can be used better to drive earlier and more targeted response measures at all levels. The aim, the Committee feels, should be to react early and strongly enough so as to prevent the need to declare a PHEIC.

     

  4. Compliance with IHR provisions remains a challenge in several areas, from setting up core capacities to implementing travel measures during health emergencies. The Committee is mindful of the lack of teeth in the IHR. We are therefore looking at new ways to monitoring and evaluating adherence to the IHR – both in preparedness and response – and to strengthen existing tools without overburdening countries. Considering a peer-review mechanism similar to the Universal Periodic Review used by the Human Rights Council, may be useful in improving preparedness and response. For example, the Universal Periodic Review has been shown to foster intersectoral coordination and whole-of-government approaches, to encourage good practices, and to link implementation of its recommendations with other government agendas – all of which are vital to strengthening IHR implementation. It is in this context that the Director-General has proposed the Universal Health and Preparedness Review initiative which is currently being pilot tested.

     

  5. Last but far from least, political support and resources for IHR implementation remain insufficient and irregular at all levels. In this context, the Committee is awaiting further detailed information on the funding mechanisms for IHR implementation.

I would like to clearly state my conviction that we need more meaningful cooperation during and in-between health emergencies; more transparency, more regular detailed exchange of real-time data and experiences at all levels, more reliability of interaction, and greater speed in sharing data and samples. Fortunately, digital technology supporting such developments is increasingly becoming available, from data mining to find disease outbreaks early, to next generation sequencing to follow a pathogen around the globe, to virtual conferencing that makes human interaction easier.

To come to the conclusion, the deadline for our final report is the 74th World Health Assembly in May 2021. However, as we all know, the COVID-19 pandemic will be far from over in 4 months’ time, and therefore our findings and recommendations will not necessarily be complete. Further deliberations may be needed later.

Let me reiterate what I said in November 2020 on the occasion of the 73rd Health Assembly: The IHR are your instrument, our instrument, of international public health law. Making them work requires giving WHO the tools and the resources it needs to better prepare and protect humanity against public health risks, through an effective, coordinated, multisectoral and evidence-based public health response.

Thank you again for the opportunity to speak to you today and let me also thank the Director-General for the excellent support provided by the WHO Secretariat to this Review Committee.

 

Honorable Chair, Excellencies, Director-General, Ladies and Gentlemen

Thank you once again for the opportunity to provide you with an update on the work of the Review Committee on the Functioning of the International Health Regulations (2005) during COVID-19.

As you know, this Committee was convened by the Director-General on 8 September 2020, in line with World Health Assembly Resolution WHA73.1. The Committee is composed of experts with a wide range of expertise and with adequate gender and geographical representation. I have the honour to be the Chair of this Committee and am ably supported by our Vice-Chair, Professor Lucille Blumberg of South Africa and our Rapporteur, Professor Preben Aavitsland, from Norway.

Our mandate is to review the functioning of the International Health Regulations (2005) during the COVID-19 response and the status of implementation of the relevant recommendations of previous IHR Review Committees and to make technical recommendations to the Director-General, including any potential amendments.

We convened for 16 closed meetings so far, and we continue to work through three sub-groups: preparedness, alert, and response. I take this opportunity to reiterate my thanks to our three subgroup leads. We also convened 5 open meetings, when we provided updates on our work and listened to the submissions and questions raised by Member States, international agencies and non-governmental organizations in official relation to WHO. These open meetings continue to be attended by numerous designated representatives.

I reported on our progress to the 73rd World Health Assembly on 9 November 2020. And I continue to interact regularly with the Co-Chairs of the Independent Panel for Pandemic Preparedness and Response and the Chair of the Independent Oversight Advisory Committee.

Let me now turn to the substance of our work. I invite you to read our Interim Progress Report, document EB148/19. It details our preliminary findings as of December 2020, which were reached following numerous interviews, discussions and the review of a wealth of documentation.

Let me point out the most important ones:

  1. Member States and experts overwhelmingly support the IHR as a cornerstone of international public health and health security law, but several areas need improving if we are to be better prepared for the next pandemic. While we have not finalized our article-by-article assessment, there is a growing belief in the Committee that most of the necessary improvements can be achieved through more effective implementation of the existing provisions of the IHR, and do not require at this point changes to the design of the IHR.

     

  2. National IHR Focal Points need to be further empowered, including where necessary through national legislation. National Focal Points play a critical role in the timely sharing of information, but their limited authority and status often lead to delays in notification. The Committee noted that effective IHR implementation requires many functions that are not within the narrow mandate of the national IHR focal points, such as multisectoral coordination for preparedness and response and collaborative risk assessment. The absence of a dedicated national entity with sufficient authority and a clear mandate to take ownership and leadership is considered a significant limitation to effective implementation of the IHR at national and subnational levels. At country level, national IHR focal points need to be integrated in the national emergency plan as well as the national health committee or similar body.

     

  3. The possible need for an intermediate level of alert before a Public Health Emergency of International Concern (PHEIC) is declared, is also under consideration. The previous review committee on the Ebola response recommended such an intermediate level, but this recommendation was not taken up. The 5th open meeting of the Committee on 12 January 2021 discussed issues surrounding the possible introduction of a grading system. The different views expressed by Member States and the advantages and potential disadvantages of a new system will be further studied by the Committee. It is clear, that global preparedness, alert and response actions need to start much earlier and more decisively than they did during COVID-19. But it is far from certain, that introducing an intermediate level of alert would result in such earlier action. The Committee is considering how regular global and regional risk assessments can be used better to drive earlier and more targeted response measures at all levels. The aim, the Committee feels, should be to react early and strongly enough so as to prevent the need to declare a PHEIC.

     

  4. Compliance with IHR provisions remains a challenge in several areas, from setting up core capacities to implementing travel measures during health emergencies. The Committee is mindful of the lack of teeth in the IHR. We are therefore looking at new ways to monitoring and evaluating adherence to the IHR – both in preparedness and response – and to strengthen existing tools without overburdening countries. Considering a peer-review mechanism similar to the Universal Periodic Review used by the Human Rights Council, may be useful in improving preparedness and response. For example, the Universal Periodic Review has been shown to foster intersectoral coordination and whole-of-government approaches, to encourage good practices, and to link implementation of its recommendations with other government agendas – all of which are vital to strengthening IHR implementation. It is in this context that the Director-General has proposed the Universal Health and Preparedness Review initiative which is currently being pilot tested.

     

  5. Last but far from least, political support and resources for IHR implementation remain insufficient and irregular at all levels. In this context, the Committee is awaiting further detailed information on the funding mechanisms for IHR implementation.

I would like to clearly state my conviction that we need more meaningful cooperation during and in-between health emergencies; more transparency, more regular detailed exchange of real-time data and experiences at all levels, more reliability of interaction, and greater speed in sharing data and samples. Fortunately, digital technology supporting such developments is increasingly becoming available, from data mining to find disease outbreaks early, to next generation sequencing to follow a pathogen around the globe, to virtual conferencing that makes human interaction easier.

To come to the conclusion, the deadline for our final report is the 74th World Health Assembly in May 2021. However, as we all know, the COVID-19 pandemic will be far from over in 4 months’ time, and therefore our findings and recommendations will not necessarily be complete. Further deliberations may be needed later.

Let me reiterate what I said in November 2020 on the occasion of the 73rd Health Assembly: The IHR are your instrument, our instrument, of international public health law. Making them work requires giving WHO the tools and the resources it needs to better prepare and protect humanity against public health risks, through an effective, coordinated, multisectoral and evidence-based public health response.

Thank you again for the opportunity to speak to you today and let me also thank the Director-General for the excellent support provided by the WHO Secretariat to this Review Committee.

 

Next Post

WHO Information Notice for IVD Users 2021/01

Kam Jan 21 , 2021
<p><strong></strong></p><p><strong>Product type: </strong>All in vitro diagnostic medical devices (IVDs) for detection of SARS-CoV-2 <strong></strong></p><p><strong>Date:</strong> 18 January 2021                                                                    </p><p><strong>WHO-identifier: </strong>2021/01, version 1   </p><p><strong></strong></p><div><p><strong>Target audience:</strong> Laboratory professionals and users of IVDs.  </p></div><div><p><strong>Purpose of this notice:</strong> <span>To request that IVD users monitor mutations of SARS-CoV-2 and their impact on diagnosis. </span></p></div><div><p><strong>Description of the problem: </strong></p><p><span>Following the detection of SARS-CoV-2 variants containing mutations, including SARS-CoV-2 VOC 202012/01, and SARS-CoV-2 501Y.V2, WHO reminds users of IVDs to monitor detection rates for SARS-CoV-2 at their site.  </span></p></div><div><p>IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or unreturnable result rate, etc. These variations may be early indicators of impact on the safety, quality or performance of the IVD products. Certain mutations may increase the risk of delayed diagnosis (due to inconclusive or invalid results), and misdiagnosis. </p></div><div><p>Manufacturers of IVDs listed by WHO (through Emergency Use Listing) must proactively scan literature and other sources for any documented mutations that might impact the safety, quality or performance of their product. This should be incorporated as part of their post-market surveillance plan and will be supplemented by feedback reported by IVD users in the form of unexpected results, as well as other product problems and adverse events. All gathered information must be reviewed in a timely fashion, using risk management principles to determine any necessary actions. </p></div><div><div><p><strong>Advice on action to be taken by IVD users:</strong>  </p></div><div><p>IVD users should notify the IVD manufacturer in the following circumstances: </p></div><div><ol role="list"><li data-leveltext="%1." data-font="Times New Roman" data-listid="16" data-aria-posinset="1" role="listitem" data-aria-level="1"><p>Increased discrepancies in cycle threshold (Ct) values between different gene targets. </p></li></ol></div><div><ol role="list" start="2"><li data-leveltext="%1." data-font="Times New Roman" data-listid="16" data-aria-posinset="2" role="listitem" data-aria-level="1"><p>Failure to detect specific gene targets, including those containing gene sequences that coincide with documented mutations.  </p></li></ol></div></div><div><div><ol role="list" start="3"><li data-leveltext="%1." data-font="Times New Roman" data-listid="16" data-aria-posinset="3" role="listitem" data-aria-level="1"><p>Misdiagnosis (for example, false negative).  </p></li></ol></div><div><p>See WHO website for reporting form for IVD users to give feedback to manufacturers  </p></div><div><p><a href="https://www.who.int/health-topics/substandard-and-falsified-medical-products/safety-info-medical-devices-in-vitro-diagnostics" target="_blank" rel="noopener noreferrer">https://www.who.int/health-topics/substandard-and-falsified-medical-products/safety-info-medical-devices-in-vitro-diagnostics  </a></p></div></div><div><p><strong>Contact person for further information: </strong></p></div><div><p>Anita SANDS, Regulation and Prequalification, World Health Organization,  <br>e-mail: <a href="mailto:rapidalert@who.int" target="_blank" rel="noopener noreferrer">rapidalert@who.int </a></p></div><div><p><strong>Reference: </strong></p></div><div><p><a href="https://www.who.int/publications/i/item/guidance-for-post-market-surveillance-and-market-surveillance-of-medical-devices-including-in-vitro-diagnostics" target="_blank" rel="noopener noreferrer">Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics.</a> Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.  </p></div><p><a href="mailto:sandsa@who.int"></a></p><p> </p><h2></h2><h2></h2><p><strong> </strong></p>