SIXTY-SEVENTH WORLD HEALTH ASSEMBLY Provisional agenda item 16.2
A67/36 14 March 2014
Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits Pandemic Influenza Preparedness Framework Report by the Director-General
1. An earlier version of document EB134/33 was considered and noted by the Executive Board at its 134th session.1 Paragraphs 8 and 9 of Annex 1 below have been updated.
ACTION BY THE HEALTH ASSEMBLY 2. The Health Assembly is requested to note the report.
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See the summary records of the Executive Board at its 134th session, tenth meeting, section 1.
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EXECUTIVE BOARD 134th session Provisional agenda item 10.2
EB134/33 22 November 2013
Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits Pandemic Influenza Preparedness Framework Report by the Director-General 1. The Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza viruses and access to vaccines and other benefits established an annual partnership contribution to be paid to WHO by manufacturers of influenza vaccines, diagnostics and pharmaceuticals using the WHO Global Influenza Surveillance and Response System. 1 The distribution of Partnership Contribution resources among companies was to be based on transparency and equity, according to their nature and capacities. The PIP Framework specifies that the Director-General in consultation with the PIP Advisory Group will further define the specific amounts to be contributed by each company and, in so doing, will collaborate with industry. The Framework further specifies that the Director-General will report annually on the outcome to the Executive Board. 2. Between October 2012 and March 2013, the WHO Secretariat collaborated with industry to develop a methodology and formula to distribute the partnership contribution among companies identified as contributors. The methodology and formula are contained in the document entitled “Distribution of Partnership Contribution among companies” posted on the WHO website on 8 May 2013.2 3. For 2013, the Secretariat identified 37 companies that were to contribute the total annual Partnership Contribution of US$ 28 million. The amount to be paid by each company has been determined by using the approved methodology and formula. 4. As annexes to this report, the Director-General has the honour to transmit to the Executive Board, for its information, a summary of key points discussed by the PIP Advisory Group at its last meeting (Geneva, 7–9 October 2013) (Annex 1) and a synopsis of its second annual report (Annex 2), the annual
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Document WHA64/2011/REC/1, Annex 2, section 6.14.3. http://www.who.int/influenza/pip/benefit_sharing/pc_distribution_may_2013.pdf (accessed 30 October 2013).
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report being produced in accordance with section 7.2.5 of the PIP Framework. The Director-General has accepted the reports and the recommendations and findings contained therein.
ACTION BY THE EXECUTIVE BOARD 5. The Board is invited to note this report.
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ANNEX 1 PANDEMIC INFLUENZA PREPAREDNESS FRAMEWORK ADVISORY GROUP MEETING (GENEVA, 7–9 OCTOBER 2013) SUMMARY OF KEY POINTS OF DISCUSSION Standard Material Transfer Agreement 2: Update on current negotiations 1. The PIP secretariat provided an update on the status of Standard Material Transfer Agreement 2 (SMTA 2) negotiations. An SMTA 2 was concluded on 1 October 2013 with the Serum Institute of India (SII), a developing country vaccine manufacturer and also a grantee under the WHO Global pandemic influenza action plan to increase vaccine supply. An SMTA 2 had previously been concluded with Glaxo Group Limited (GSK). Negotiations are under way with Sanofi, Baxter and China National Biotec Group, and pre-negotiation discussions are being held with MedImmune and Novartis. A SMTA 2 concluded in October 2012 with the University of Florida was also discussed and noted. 2. Discussions and negotiations are proving to be time consuming, and reaching agreement with vaccine manufacturers on the terms of benefit sharing is often a lengthy process. The Secretariat plans to initiate discussions with additional manufacturers with legal support from a consultant lawyer who will begin shortly. 3. The Advisory Group provided the following advice to the Director-General on SMTA 2 negotiations: The Advisory Group welcomed the second SMTA 2 that has been concluded with a vaccine manufacturer. The Advisory Group recognized, however, that there have been difficulties in concluding additional agreements: • The Advisory Group recommended that WHO showcase the successful conclusion of the SMTA 2s with GSK and SII as an incentive to conclude agreements with other vaccine manufacturers as quickly as is feasible. • In situations where discussions with manufacturers would benefit from high level exchanges between the Organization and the manufacturer, the Advisory Group strongly recommended that such exchanges be made.
Handling genetic sequence data in the context of the PIP Framework 4. The Secretariat provided an overview of synthetic biology with a view to initiating the Group’s discussion on the best process to handle the use of influenza virus genetic sequence data under the Framework. 5. The Advisory Group agreed that developments in synthetic biology raise complex issues with legal, technical, public health and biosecurity implications that require careful review and consideration.
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6. To assist the Advisory Group in developing guidance for the Director-General on this matter, technical support from a technical expert working group would be beneficial. The Advisory Group developed Terms of Reference for such an expert group.
Partnership Contribution: review of 2013 results 7. The Secretariat provided an update on the process to collect the partnership contributions due for 2013. The Secretariat, through the “PIP PC 2013 Questionnaire”, identified 37 companies as contributors. Following an extensive process to receive Band Selection and Certification Forms from all 37 companies, four Band Selection and Certification Forms were outstanding as at 7 October 2013. 8. Using publically available financial and other information, the Secretariat has placed the outstanding companies into bands. Invoices were sent to the 37 companies in mid-October to allow time for processing before the end of 2013. 9. The Advisory Group concurred with the Secretariat’s approach to generating invoices so that partnership contribution payments for 2013 would be received in a timely fashion. If the estimation of bands for the four companies subsequently needs revision, adjustments could be made in 2014.
Partnership Contributions: gap analysis and implementation plans 10. The Secretariat presented the draft Partnership Contribution implementation plan: 2013–2016, including the process for identifying and analysing gaps and needs. The Advisory Group discussed the plan as well as a document on the Regional Office Recommended Country Recipients. 11. The Advisory Group met representatives of industry associations, manufacturers and other stakeholders to discuss the draft plan. 12. The Advisory Group discussed the views and comments of industry and other stakeholders. The Secretariat will revise the implementation plan to take into account these discussions. The revised implementation plan and the results of the gap analyses will be shared with the Advisory Group, industry and other stakeholders. 13. The Advisory Group provided the following advice to the Director-General on implementation of activities under the Partnership Contribution. To avoid the risk of perceived conflict of interest in selection of countries, the Advisory Group wished to clearly articulate the process to develop the draft Regional Office Recommended Country Recipients document. The following was noted: • The role of the Advisory Group was limited to providing criteria for country selection: – Country development status; – IHR core capacities; – Country needs for influenza epidemiological and laboratory surveillance; and – H5N1 vulnerability.
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• These factors were compiled into a database by the PIP Secretariat and shared with Regional Offices for their use in identifying priority countries for strengthening laboratory and surveillance capacities. • Regions further refined their gap analyses with additional elements including: – Political situation in countries, notably whether a country is in a complex emergency; – Ongoing donor funding and investments in a country; – Absorptive capacity of the country; – Country population size; – Geographical location of the country in the region/subregion (notably for island states); – Interest of the country/Ministry of Health to work in influenza; and – Ability of countries to build on existing capacities to produce influenza surveillance data which could be shared with neighbouring countries. • Using all the factors above, Regional Offices recommended countries in priority order. In their review of the list, the Advisory Group: • Noted the work of selection which has been made among the numerous possible recipients by the WHO Regional Offices for this first phase of the implementation plan and acknowledged the need for supporting rationales. • Noted the importance of providing PC resources to countries that need basic capacities as well as to countries that have existing capacities but where additional support can serve as a regional resource to other countries. The Advisory Group recommended that implementation of activities under the PC begin in January 2014. They noted that the PIP implementation plan should be considered a “living document” that can be revised over time.
Annual report 14. The Advisory Group adopted its annual report to the Director-General (see Annex 2). It was agreed that future reports will cover the period beginning 1 October and ending 30 September of each year.
Election of the new Chair and Vice-Chair of the Advisory Group 15. After an informal consultation, the Advisory Group reached consensus that Dr William Kwabena Ampofo (Ghana) and Professor Rajae El Aouad (Morocco) would be its new Chair and Vice-Chair, respectively.
Next meeting of the Advisory Group 16. The next meeting of the Advisory Group will take place in Geneva on 9 –11 April 2014. 7
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ANNEX 2 PANDEMIC INFLUENZA PREPAREDNESS (PIP) FRAMEWORK SECOND ANNUAL REPORT OF THE ADVISORY GROUP TO THE DIRECTOR-GENERAL
SYNOPSIS OF KEY DEVELOPMENTS
1.
INTRODUCTION
This document provides a synopsis of the second Annual Report of the Advisory Group to the Director-General on its evaluation of the implementation of the Framework. 1 It focuses on the main developments during the 17-month period beginning 1 May 2012 to 30 September 2013 2 and covers the seven areas specified in the Framework. 3
2. 2.1
VIRUS SHARING Sharing of influenza viruses with pandemic potential
Human cases of disease due to avian influenza A(H7N9) virus were detected in China beginning in early 2013. Rapid sharing of viruses and information was essential to the development of candidate vaccine viruses and reference reagents, diagnostic tests, guidance and dissemination of information on risk assessment and pandemic preparedness actions. 4 Genetic sequence data for influenza A(H7N9) and other influenza viruses with human pandemic potential (i.e. influenza A(H5N1), A(H3N2)v, A(H1N1)v, A(H1N2)v and A(H6N1)) were shared through public-access databases, as required by the Terms of Reference of laboratories of the WHO’s Global Influenza Surveillance and Response System (GISRS).
2.2
Influenza Virus Traceability Mechanism
The transparency of the activities of the Global Influenza Surveillance and Response System was enhanced through use of the Influenza Virus Traceability Mechanism to track the movement of PIP biological materials. Between May 2012 and July 2013, 499 shipments of such materials were recorded in the Traceability Mechanism; 342 (69%) of these were sent to 113 laboratories not belonging to the Global Influenza Surveillance and Response System. 5 During this same period, six
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In accordance with section 7.2.5 of the PIP Framework section. In some instances data were truncated before October 2013 to allow time for tabulation and analysis.
The seven areas specified in the PIP Framework, section 7.2 5 and Annex 3, section 2 are: necessary technical capacities of the WHO GISRS; operational functioning of WHO GISRS; WHO GISRS influenza pandemic preparedness priorities, guidelines and best practices (e.g. vaccine stockpiles, capacity-building); increasing and enhancing surveillance for H5N1 and other influenza viruses with human pandemic potential; the Influenza Virus Traceability Mechanism; the sharing of influenza viruses and access to vaccines and other benefits; and the use of financial and non-financial contributions. Available at: http://www.who.int/influenza/human_animal_interface/influenza_h7n9/WHO_H7N9_review_ 31May13.pdf (accessed 30 October 2013). 5 4
Some shipments included more than one PIP biological material.
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countries recorded 164 human viruses with pandemic potential (i.e. A(H5N1), A(H7N9), A(H7N7), A(H7N2) and A(H7N3) viruses) in the Traceability Mechanism.
2.3
Definition of PIP biological materials
The directors of WHO Collaborating Centres and Essential Regulatory Laboratories informed the Advisory Group during its meeting in October 2012 of concerns related to the application of the definition of PIP biological materials,1 based on their discussions with representatives of the animal health sector. A less strict application of the definition could mean that all wild type viruses obtained from infected animals are also covered under the definition of PIP biological materials. The Advisory Group expressed a view that a strict application of the definition met the intent of Member States during the PIP Framework negotiations and would be least likely to dampen collaboration between human and animal sector laboratories.
3. 3.1
BENEFIT SHARING Standard Material Transfer Agreement 2
During SMTA 2 negotiations two developing-country vaccine manufacturers indicated that they were ready to commit to both a donation and a reserve 2 of pandemic vaccine for a total of 10% of their realtime pandemic vaccine production. Given that WHO is required to pay for the reserve, the Secretariat has sought to keep that portion of the overall 10% as low as possible and to increase the donation amount. This would mean, however, that the 5% minimum indicated in the model SMTA 2 in Annex 2 of the PIP Framework would not be respected. The Advisory Group recommended that manufacturers be permitted to commit to reserve less than 5% if there was a concomitant increase in their donation so that their total commitment under the SMTA 2 would be at least 10%.
3.2
Contributors to the Partnership Contribution
Through the voluntary contributions of six manufacturers, WHO received US$ 18.121 million in 2012 for the Partnership Contribution. In May 2013, the PIP Secretariat published a methodology for the distribution of the Partnership Contribution among vaccine, diagnostic and pharmaceutical manufacturers that use the Global Influenza Surveillance and Response System. 3 Standard operating procedures for the Partnership Contribution were also published. 4 In 2013, a questionnaire was sent to 193 companies identified as potential contributors; 89 companies responded, of which 37 were determined to be contributors.
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See PIP Framework, section 4.1 for the definition of PIP biological materials.
See PIP Framework, Annex 2 Article 4.1.1 for a list of the options available under SMTA 2 for manufacturers of vaccines and/or antiviral medicines. 3 Pandemic Influenza Preparedness Framework Distribution of Partnership Contribution among companies is available at: http://www.who.int/influenza/pip/benefit_sharing/pc_distribution_may_2013.pdf (accessed 30 October 2013).
Partnership Contribution Standard Operating Procedures is available at: http://www.who.int/influenza/pip/benefit_sharing/pc_sop_may_2013.pdf (accessed 30 October 2013).
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3.3
Use of Partnership Contribution resources
Based on the Advisory Group’s recommendations, 70% of the Partnership Contribution is to be used for pandemic preparedness and 30% as a reserve for pandemic response activities. The DirectorGeneral accepted the Advisory Group’s subsequent recommendation that 70% of preparedness resources be used for surveillance and laboratory capacity-building and that disease burden studies, regulatory capacity-building and risk communications each be allocated 10%. In March 2013, the Advisory Group, industry and other stakeholders reviewed a high-level, draft implementation plan for pandemic preparedness. The Advisory Group supported the overall approach and requested that the Secretariat develop a more detailed plan including a time-phased project design, budget, risk analysis and indicators. The Director-General accepted the Advisory Group’s recommendation in March 2013 that a portion of the Partnership Contribution funds, not exceeding 10% averaged over the period 2013 –2016, be directed to the PIP secretariat to enable it to make progress in its work to implement the PIP Framework.
3.4 Identification of countries for receipt of Partnership Contribution resources for laboratory and surveillance capacity-building At its meeting in October 2012, the Advisory Group concurred with th e Secretariat’s gap analysisbased methodology to identity countries for receipt of Partnership Contribution resources to strengthen influenza laboratory and surveillance capacities. The Advisory Group also noted the desirability of having at least one country from each WHO region receive Partnership Contribution funds for this purpose, while retaining a primary focus on countries with the greatest need. The Secretariat conducted a regional-based gap assessment. WHO regional offices further refined the gap analyses and recommended countries eligible for receipt of Partnership Contribution funds; this draft document was shared with the Advisory Group in August 2013.
4.
GOVERNANCE
The Advisory Group met twice in Geneva (3–5 October 20121 and 20–22 March 20132) and held one meeting by teleconference (12 June 2013). Regular collaboration and interaction with industry and other stakeholders have benefited the advancement of plans for the implementation of the PIP Framework. Information sessions in Geneva for representatives of the Permanent Missions to the United Nations in Geneva were held on 18 October 2012 and 15 April 2013, led by the Chair of the Advisory Group, with a telephone briefing for members of civil society on 22 October 2012.
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For meeting see document EB132/16, Annex 2. For meeting report see document A66/17 Add.1.
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SIXTY-SEVENTH WORLD HEALTH ASSEMBLY Provisional agenda item 16.2
A67/36 Add.1 9 May 2014
Pandemic influenza preparedness: sharing of influenza viruses and access to vaccines and other benefits Report of the meeting of the Pandemic Influenza Preparedness Framework Advisory Group Report by the Director-General
The Director-General has the honour to transmit to the Sixty-seventh World Health Assembly a summary report of the Pandemic Influenza Preparedness Framework Advisory Group, which reflects its deliberations during its meeting in April 2014 (see Annex). The Health Assembly is invited to note this report.
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ANNEX MEETING OF THE PANDEMIC INFLUENZA PREPAREDNESS (PIP) FRAMEWORK ADVISORY GROUP 9–11 APRIL 2014, GENEVA, SWITZERLAND Summary of the report to the Director-General 1. The Advisory Group met 9–11 April 2014 and discussed the following as per its adopted agenda.
Preliminary report of the Technical Expert Working Group on genetic sequence data 2. The matter under review arises in connection with PIP Framework Section 5.2.4 which directs the Director-General to “consult the Advisory Group on the best process for further discussion and resolution of issues relating to the handling of genetic sequence data from H5N1 and other influenza viruses with human pandemic potential as part of the PIP Framework.” 3. A few manufacturers are using genetic sequence data to make vaccines and other influenzarelated products, a trend that is anticipated to increase. During its October 2013 meeting, the Advisory Group agreed that this raised a number of complex issues in relation to benefit sharing. To assist the Advisory Group in developing guidance for the Director-General on this matter, a Technical Expert Working Group was established. 4. The Chair of the Technical Expert Working Group presented the Group ’s method of work and summarized the key elements of the preliminary report (use of genetic sequence data, regulatory and intellectual property issues, monitoring and tracing of genetic sequence data, and biosecurity and biosafety issues). The ensuing discussion noted that: • Genetic sequence data are covered by the PIP Framework. There were different perspectives on whether genetic sequence data are included in the definition of PIP biological materials. • As genetic sequence data fall within the PIP Framework (e.g. Section 5.2; Annex 4, Point 9; Annex 5 “Guiding Principles”), the spirit of the Framework and the importance of maintaining equal footing for the sharing of viruses and benefits derived therefrom must be kept in mind in considering issues related to the handling of genetic sequence data for H5N1 and other influenza viruses with pandemic potential. • Given the many ways that genetic sequence data may be disseminated, it is likely that WHO will not be aware of all instances of the use of genetic sequence data arising out of the WHO Global Influenza Surveillance and Response System. The PIP Framework ’s objective of benefit sharing, however, must be met. Different approaches are available, including the monitoring and/or tracing of genetic sequence data through electronic databases (e.g. – the Global Initiative on Sharing All Influenza Data or GenBank) or through regulatory approval files and patent applications for influenza-related products. The utility of monitoring to maximize benefit sharing, as well as the feasibility and costs of possible monitoring methods, deserve further investigation.
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5. Advice to the Director-General upon the finalization of the report of the Technical Expert Working Group. The Advisory Group reaffirmed the spirit of the Framework and the importance of maintaining equal footing for the sharing of viruses and benefits derived therefrom. It noted that genetic sequence data is a rendering of virus material and its use could accelerate the development of pandemic influenza vaccines. The Advisory Group thanked the Technical Expert Working Group for its work and noted that upon submission of its final report it will have concluded its work. The Advisory Group recommended that the Director-General: • post the final report of the Technical Expert Working Group on the WHO website for informational purposes with an attached cover note describing the process; • inform Members States, industry and other stakeholders about the posting of the report; and • inform the World Health Assembly about progress on the issue of genetic sequence data. 6. The Advisory Group will meet with electronic database managers for genetic sequence data as well as industry and other stakeholders during its meeting in October 2014 to gather further information with a view to developing advice to the Director-General on genetic sequence data-related issues.
Partnership Contribution: update on collection of funds for 2013 7. Through the PIP PC 2013 Questionnaire, the Secretariat identified 37 companies as partnership contributors. This extensive process to invoice and follow-up is ongoing and has resulted to date in a total of more than US$ 26 million for 2013 from 24 contributors. The Secretariat will pursue collection of the remaining funds. 8. Advice to the Director-General on the collection of Partnership Contribution funds. The Advisory Group expressed appreciation for the enhanced efforts and success of the Secretariat to secure PIP Partnership Contribution funds in 2013 from all identified contributors. The Advisory Group noted, however, that efforts to collect Partnership Contribution funds continue to be time-consuming and have not been successful in all instances. This is a concern as Partnership Contribution resources are needed to fully implement planned preparedness and response activities. The Advisory Group recommended that the Director-General consider additional methods to improve the completeness of Partnership Contribution funds. These could include: • better communication of the purpose and reasons for benefit sharing; • more specific targeting to encourage partnership contributions by entities that use Global Influenza Surveillance and Response System;
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• increasing visibility about participation in the Partnership Contribution collection process; • providing companies with an estimate (based on prior contributions) of their annual contribution early in the fiscal year to facilitate budgetary planning; and • feedback on achievements in preparedness activities made possible through the Partnership Contribution.
Partnership contribution: draft guiding principles for use of Partnership Contribution response funds 9. The Advisory Group reviewed the draft guiding principles and provided a number of comments, including the identification of a clear trigger for the release of funds. 10. The Advisory Group agreed that the draft guiding principles, as revised, should be shared with industry and other stakeholders in accordance with PIP Framework Section 6.14.6, with a view to finalizing them at the October 2014 meeting for submission, as a recommendation, to the Director-General.
Partnership Contribution: overview of implementation of preparedness activities 11. The Secretariat provided an update on the implementation of preparedness activities in the five areas of work: laboratory and surveillance capacity building; burden of disease; risk communications; regulatory capacity building; and planning for deployment of pandemic supplies. 12. Advice to the Director-General on the implementation of preparedness activities. The Advisory Group welcomed the significant progress made in developing detailed activity plans by areas of work. The Advisory Group recommended that the Director-General build on this progress by: • actively promoting the Partnership Contribution implementation plan; • immediately releasing funds and implementing activities at the regional and country levels; • assuring added value through synergy with related programmes and activities; • using the Partnership Contribution implementation plan to leverage additional funds, particularly from Member States and other donors; and • regularly communicating achievements and successes to encourage continued flow of Partnership Contribution contributions.
Consultation with industry and other stakeholders 13. The Advisory Group met representatives of industry associations, manufacturers and other stakeholders in a joint session. Industry and other stakeholder representatives expressed a favourable opinion of the progress achieved. Three main topics were discussed:
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(a) Partnership Contribution Implementation Plan: The Secretariat provided an update on the implementation of preparedness activities. A number of comments were expressed, inter alia: • Progress has been achieved in the development of detailed implementation plans; however, industry and other stakeholders felt that it would have been beneficial to have been regularly informed. • Established synergies among the PIP, the Global Action Plan for Influenza Vaccines, the International Health Regulations (2005) and other relevant WHO programmes need to be ensured. • Industry requested that an increased proportion of Partnership Contribution funds and emphasis be directed to regulatory capacity building, risk communications, and planning for deployment, which are critical to deployment of vaccines and antivirals during a pandemic. • Guidance and training in laboratory biosafety/biosecurity is an essential part of building capacity to produce vaccine and antivirals. (b) Technical Expert Working Group on genetic sequence data: The Chair of the Technical Expert Working Group summarized the key elements of the preliminary report. A number of comments were expressed, inter alia: • Other stakeholders noted that excluding genetic sequence data from benefit sharing would undermine the objective of the Framework and create inequity within the Global Influenza Surveillance and Response System. • Industry stated its concern that placing restrictions on the access/use of genetic sequence data would delay development of pandemic products. • Industry indicated that assuring the sharing of benefits associated with the use of genetic sequence data might be better approached through the monitoring of products derived from the use of genetic sequence data. • Industry and other stakeholders raised the issue of potential biosecurity/biosafety risks related to use of genetic sequence data. (c) Enhancing communications: Industry representatives and other stakeholders commented on the importance of communications and transparency and how this might be improved, inter alia: • Industry and other stakeholders raised the issue of emphasizing the objectives and spirit of the PIP Framework. • Industry and other stakeholders indicated that it is beneficial to be regularly informed about the implementation of the PIP Framework using a range of platforms, including annual meetings and conferences. • Industry requested that the Director-General remind Member States of their responsibilities under the PIP Framework, inter alia:
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– strengthening regulatory capacity; and – ensuring that pandemic products produced on their territories during a pandemic be made available to WHO as per the PIP Framework. 14. Advice to the Director-General on Partnership Contribution resources. The Advisory Group recommended that the Director-General consider: • industry’s request to increase the priority of regulatory capacity-building, risk communications and planning for deployment. This could be approached in a number of ways for these three areas, including: – an increase in the Partnership Contribution resources allocated to these areas of work; – earlier roll-out of implementation; – focused outreach and communication to industry on achievements and progress; and – identification of synergies with Global Action Plan for Influenza Vaccines and the International Health Regulations (2005) capacity-building activities • other stakeholders’ request that the Director-General increase efforts to ensure that all manufacturers using the Global Influenza Surveillance and Response System contribute to the Partnership Contribution and conclude SMTA 2s as appropriate. 15. Advice to the Director-General on enhancing communications. Regular and effective communication with Member States, industry and other stakeholders and between WHO headquarters, and regional and country offices is essential to the successful implementation of the PIP Framework. Communication of planned implementation activities, spending of Partnership Contribution funds, and achievement of measureable outcomes will facilitate an uninterrupted flow of Partnership Contributions. The Advisory Group was encouraged to learn that the Secretariat is considering options such as a web portal to provide real-time information on implementation of Partnership Contribution activities. The Advisory Group recommended that the Director-General: • increase communication, emphasizing the spirit and objectives of the PIP Framework; • develop a comprehensive communications strategy for the PIP Framework, with particular attention to implementation of Partnership Contribution preparedness activities; and • continue to encourage Member States to support the PIP Framework, including through the provision of resources to supplement the Partnership Contribution.
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16.
Advice to the Director-General on strengthening the PIP Secretariat. The Advisory Group noted that the Director-General’s decision to reinforce the Secretariat has resulted, inter alia, in demonstrable improvements in the collection of Partnership Contribution resources, the development of detailed implementation plans for Partnership Contribution preparedness plans, and the successful conclusion of an additional SMTA 2. The Advisory Group recommended that the Director-General provide for further strengthening of the Secretariat as needed to ensure that the work of implementing the PIP Framework moves forward unimpeded.
Preparations for the 2016 review of the PIP Framework 17. The Secretariat proposed objectives and a general process for the review. It will take into account developments in science and pandemic preparedness that have affected operationalization of the Framework. The Advisory Group will continue to consider the scope and modalities of the review.
Update on SMTA 2s 18. The Secretariat provided an update on the status of SMTA 2 negotiations. • Category A: three SMTA 2 agreements have been concluded: – Glaxo Group Limited – Serum Institute of India – Sanofi Pasteur • Category B: discussions have been initiated with five manufacturers • Category C: two SMTA 2 agreements have been concluded (University of Florida and Harvard College). 19. The Advisory Group reviewed and noted the recent Sanofi Pasteur agreement under a Supplementary Confidentiality Undertaking, as the agreement included certain propriety information. The Advisory Group welcomed the conclusion of this agreement and emphasized the importance of showcasing such agreements in an appropriate manner. 20. The Advisory Group noted industry’s continued concerns about their ability to export vaccines/antivirals from the country of production during a pandemic. The Advisory Group recommended that the Director-General seek periodic assurances from Member States that SMTA 2 agreements would be honoured and products delivered to WHO to be made available to countries in need. The Secretariat proposed that they review this with the Director-General and update the Advisory Group at its next meeting. 21. The Advisory Group noted industry’s request for greater clarity on what would trigger pandemic vaccine production.
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Technical matters 22. Global Action Plan for Influenza Vaccines update: The Advisory Group welcomed the update on the Global Action Plan for Influenza Vaccines and noted that the end of the Global Action Plan for Influenza Vaccines initiative in 2016 may present an opportunity to explore the PIP Framework and Partnership Contributions as possible mechanisms to help sustain Global Action Plan-related progress in global influenza vaccine production. 23. Global Influenza Surveillance and Response System self-assessment: The Advisory Group welcomed the preliminary report and provided a number of comments; further discussion is planned upon completion of data collection and finalization of the report.
Review and approval of meeting report 24. The Advisory Group adopted the Meeting Report after providing comments.
Next steps 25. Next meeting: The Advisory Group will meet in Geneva on 21–24 October 2014. Agenda items include: • consultation with genetic sequence data databank representatives, industry and other stakeholders • review of final Global Influenza Surveillance and Response System self-assessment report • update on SMTA 2 • update on Partnership Contribution implementation • update on Global Action Plan for Influenza Vaccines. 26. Process to renew Advisory Group members: The Secretariat outlined a process to renew one third of the members during the October 2014 meeting as required in the PIP Framework (Annex 3, Section 3.2).
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