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WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION Date: 27 July 2023 ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ REGIONAL OFFICE FOR EUROPE Ms Elen Ohov BUREAU RÉGIONAL DE L’EUROPE REGIONALBÜRO FÜR EUROPA Adviser ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО European Union Affairs and International Co- Head office: operation Department UN City, Marmorvej 51, Ministry of Social Affairs DK-2100 Copenhagen Ø, Denmark Suur-Ameerika 1 Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Email: [email protected] 10122 Tallinn Website: https://www.who.int/europe Estonia Our reference: Your reference: Notre référence: Votre référence: Unser Zeichen: Ihr Zeichen: См. наш номер: На Ваш номер: Dear Ms Ohov, WHO Updated National Influenza Centre (NIC) Terms of Reference (TOR) for seasonal influenza viruses – Global launch (virtual meeting), 4 and 14 September 2023 I have the honour to inform you that the World Health Organization will be organizing the above- mentioned virtual meeting with a purpose to update the NIC TOR for seasonal influenza viruses to bring clarity to the purpose of sharing seasonal influenza viruses or clinical specimens positive for seasonal influenza with WHO Collaborating Centres (CCs) and to inform NICs and national authorities of the benefits available and provided to them as members of Global Influenza Surveillance and Response System (GISRS). The objectives of the virtual meeting are: 1) to inform NICs and national authorities on the process for reviewing and approving the updated NIC TOR for seasonal influenza viruses; 2) to clarify the NIC TOR guidelines on the process and purpose of seasonal influenza virus sharing with WHO CCs; 3) to provide NICs and national authorities with a better understanding of the process of CVV development and selection for use in seasonal influenza vaccine production; and 4) to document the perspectives of national authorities on the processes of seasonal influenza virus sharing from their countries or clinical specimens positive for influenza with WHO CCs, the development of CVVs and where applicable, use of CVVs in vaccine production. A copy of the scope and purpose of the workshop is enclosed for your information. I have the pleasure of inviting you to nominate four to five participants to attend the virtual meeting. The participants should be as follows: • one representative from the Ministry of Health responsible for the influenza surveillance and NIC operations; • one representative from a line ministry that is responsible for the implementation of the Nagoya Protocol; • one National Focal Person for the Nagoya Protocol and/or Access and Benefit Sharing; UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: https://www.who.int/europe Denmark  • Director of the National Influenza Centre; • Head of National Laboratory contributing to the GISRS network, if applicable. The working language of the meeting will be English; simultaneous interpretation into Russian will be provided. I look forward to receiving your nominations giving the names, functional titles, and addresses (including email addresses) of the nominated participants at your earliest convenience but no later than 11 August 2023. We will then communicate with the participants directly providing the necessary documentation and administrative information. Dr Karen Nahapetyan, Technical Officer (Laboratories), Infectious Hazard Management, is responsible for this activity, and it would be appreciated if you could address your reply to Ms Halyna Borysyuk, Programme Assistant, Infectious Hazard Management at tel. +4545336850, email: [email protected]. I avail myself of this opportunity to thank you for your collaboration. Sincerely yours, Dr Gerald Rockenschaub Regional Emergency Director Encls: Scope and purpose Copy for information to: Ms Triin Uusberg, Head, European Union Affairs and International Co-operation Department, Ministry of Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia H.E. Ms Katrin Saarsalu-Layachi, Ambassador Extraordinary and Plenipotentiary, Permanent Representative, Permanent Mission of the Republic of Estonia to the United Nations Office and other international organizations in Geneva, Chemin du Petit-Saconnex 28A, CH-1209 Genève, Switzerland H.E. Mr William Mart Laanemäe, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia, Frederiksgade 19, 4th floor, 1265 Copenhagen K, Denmark Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, 10617 Tallinn, Estonia –2– Virtual Workshop on the updated National Influenza Centre (NIC) Terms of Reference (TOR) for Seasonal Influenza Viruses WHO Headquarters, Geneva 4 and 14 September 2023 A Virtual Meeting SCOPE AND PURPOSE 1. Background: National Influenza Centres (NICs) form the backbone of the Global Influenza Surveillance and Response System (GISRS) and function under national authorities with recognition from the WHO Global Influenza Programme (GIP) and in collaboration with WHO Collaborating Centres (CCs) for Reference and Research on Influenza. The sharing of information and influenza viruses or clinical specimens positive for influenza with WHO CCs is an essential criterion for all NICs. Since the last update of the NIC TOR in 2017, some countries have proceeded with the implementation of the Nagoya Protocol (NP) and applicable arrangements regarding Access and Benefit Sharing (ABS). For this reason, the WHO GIP has updated the NIC TOR for seasonal influenza viruses to include existing benefits available and provided to GISRS countries and to clarify the purpose of virus sharing with WHO CCs and where applicable with vaccine manufacturers within the context of the NP and ABS. Most of the viruses shared with the WHO Influenza Collaborating Centers (CCs) of GISRS contributes towards the continuous monitoring of the evolution of influenza viruses globally. Analysis of such viruses by WHO CCs generates data in the interest of public health which allows for risk assessments and recommendations for risk management measures. Importantly, the WHO coordinates through WHO CCs, recommendations for influenza candidate vaccine viruses (CVVs) from viruses shared by countries. In the work up for the development of a suitable vaccine, an estimated I in 4,000 to 1 in 2,000 viruses shared with WHO CCs are developed as CVV s by WHO CCs. These CVV s may be shared with influenza vaccine manufacturers on request for "seed lot" production and quality control. The CVV "seed lot" is the first step towards timely vaccine production and a recommendation by WHO CCs of a CVV does not necessarily imply the inclusion of that CVV in a vaccine. The eventual inclusion of a CVV in a vaccine is based on the assessment of public health risk and need. Over the past 8 months extensive consultations regarding the updating of the NIC TOR for seasonal influenza viruses have been completed with the WHO Legal Department, the PIP Secretariat, WHO Regional Offices, WHO CCs, ERLs and NICs of GISRS. These consultations have resulted in the finalization of the updated NIC TOR for seasonal influenza viruses with the plan to roll-out the updated TOR in 2023. The strategy for the roll-out of the updated NIC TOR includes promoting awareness and understanding of the updated NIC TOR through virtual information sessions in June 2023, followed hosting virtual workshops for NICs and other relevant national authorities in September. These virtual workshops are planned on the 4, 6 and 14th September 2023. On completion of the virtual workshops the updated NIC TOR will be rolled-out to all GISRS laboratories. Until the implementation of the updated NIC TOR, the current NIC TOR (2017) will remain valid officially for all NICs. 2|Page 2. Objectives The overall aim is to update the NIC TOR for seasonal influenza viruses to bring clarity to the purpose of sharing seasonal influenza viruses or clinical specimens positive for seasonal influenza with WHO CCs and, to inform NICs and national authorities of the benefits available and provided to them as members of GISRS. Specific objectives include: • to inform NICs and national authorities on the process for reviewing and approving the updated NIC TOR for seasonal influenza viruses; • to clarify the NIC TOR guidelines on the process and purpose of seasonal influenza virus sharing with WHO CCs; • to provide NICs and national authorities with a better understanding of the process of CVV development and selection for use in seasonal influenza vaccine production; and • to document the perspectives of national authorities on the process of; seasonal influenza virus sharing from their countries or clinical specimens positive for influenza with WHO CCs, the development of CVV s and where applicable, use of CVV s in vaccine production. 3. Expected outcomes • Documentation from NICs and national authorities on their acknowledgment and acceptance of the updated NIC TOR for seasonal influenza viruses including benefits described, available and provided to GISRS countries. • Documentation from national authorities of their approval of the development of CVV s from select viruses shared with WHO CCs for vaccine seed lot development and quality control by manufacturers. • Documentation from national authorities of their approval of the development and sharing of CVV s with vaccine manufacturers for vaccine production under the NIC TOR for seasonal influenza viruses. • Documentation from national authorities of their approval of the development and sharing of CVVs with vaccine manufacturers for vaccine production under the NIC TOR for seasonal influenza viruses and where applicable, with separate agreement with vaccine manufacturers should the country desire to seek additional benefits to those already provided by GISRS. • Launch of the roll-out for the implementation of the updated NIC TOR for seasonal influenza viruses for all GISRS laboratories. Saatja: ANDERSEN, Anne-Marie <[email protected]> Saadetud: 27.07.2023 14:39 Adressaat: <"Elen Ohov"> Koopia: <"Triin Uusberg">; <"SM Info">; Ms K. Saarsalu-Layachi <[email protected]>; <[email protected]>; Kaisa.Mitt-Alvarez <[email protected]>; <[email protected]>; <[email protected]>; KÖHLER, Kristina <[email protected]> Teema: WHO Updated National Influenza Centre (NIC) Terms of Reference (TOR) for seasonal influenza viruses – Global launch (virtual meeting), 4 and 14 September 2023 Dear Ms Ohov, WHO Updated National Influenza Centre (NIC) Terms of Reference (TOR) for seasonal influenza viruses Global launch (virtual meeting), 4 and 14 September 2023 I have the honour of sharing this invitation to the above-mentioned virtual meeting. You are invited to nominate four to five participants to attend and you will find the detailed description of the profiles of the participants in the attached letter. We are looking forward to receiving your nominations, giving the names, functional titles and addresses (including email addresses) of the nominated participants at your earliest convenience and no later than 11 August 2023. Yours sincerely, Regional Emergency Director