EXEC CUTIVE BO OARD 134th session Prov visional age enda item 10.2
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Pa andemi ic influenza pr repared dness: sharing s g of influ uenza viruses and access to vacc cines an nd other r benef fits Pandem mic Influenza Prep paredness s Framew work Report by the Dire ector-Gene eral 1. The Pandem mic Influenz za Preparedn ness (PIP) Fra amework for r the sharing of influenza a viruses and d acces ss to vaccine es and other r benefits es stablished an n annual par rtnership con ntribution to o be paid to o WHO O by manuf facturers of influenza v vaccines, dia agnostics and d pharmaceu uticals using g the WHO O 1 Globa al Influenza Surveillanc ce and Respo onse System m. The distr ribution of P Partnership Contribution C n resou urces among companies was w to be bas sed on transp parency and equity, acco ording to thei ir nature and d capac cities. The PIP P Framew work specifie es that the Director-General in con nsultation with w the PIP P Advisory Group will w further define d the sp pecific amoun nts to be con ntributed by e each compan ny and, in so o doing g, will collab borate with industry. i The e Framework k further spe ecifies that th he Director-G General will l repor rt annually on n the outcom me to the Exe ecutive Board d. 2. Between October O 2012 2 and March h 2013, the WHO Secre etariat collab borated with h industry to o devel lop a metho odology and d formula to o distribute the partnership contribu ution among g companies s identi ified as con ntributors. The T methodo ology and fo ormula are contained c in n the docum ment entitled d “Dist tribution of Partnership p Contributio on among companies” posted on the WHO website on n 8 Ma ay 2013.2 For 2013, the Secreta 3. ariat identifie ed 37 comp panies that were w to con ntribute the total annual l Partn nership Cont tribution of US$ 28 mi llion. The amount a to be paid by e each compan ny has been n determ mined by usi ing the appro oved method dology and fo ormula. 4. As annexes to this rep port, the Dir rector-Gener ral has the honour h to tra ansmit to th he Executive e Board d, for its inf formation, a summary of f key points discussed by y the PIP Ad dvisory Grou up at its last t meeti ing (Geneva, 7–9 Octobe er 2013) (An nnex 1) and a synopsis of f its second a annual repor rt (Annex 2), , the a annual repor rt being pro oduced in ac ccordance with w section 7.2.5 of th he PIP Fram mework. The e Direc ctor-General has accepted d the reports and the reco ommendation ns and findin ngs contained d therein.
ACT TION BY THE T EXEC CUTIVE BO OARD 5. The Board is invited to note this rep port.
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Document WHA64/2011/R W REC/1, Annex 2 2, section 6.14.3. http://www. .who.int/influen nza/pip/benefit_ _sharing/pc_dis stribution_may_ _2013.pdf (acce essed 30 October 2013).
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AN NNEX 1 PANDEM MIC INFL LUENZA PR REPARED DNESS FRA AMEWOR RK ADVISO ORY GRO OUP MEETING (GENEV VA, 7–9 OC CTOBER 2013) 2 S SUMMARY Y OF KEY POINTS OF O DISCUSSION Standard Material Transfer T Ag greement 2 2: Update on current negotiation n ns 1. The P PIP secretariat provided an a update on n the status of o Standard Material M Tran nsfer Agreem ment 2 (SMTA 2) negotiations. An SMTA A 2 was conc cluded on 1 October 201 13 with the S Serum Instit tute of India (SII), a developin ng country vaccine v man nufacturer an nd also a gra antee under the WHO Global G pandemic i influenza ac ction plan to o increase v vaccine sup pply. An SM MTA 2 had d previously been concluded w with Glaxo Group Limi ited (GSK). Negotiations are under way with S Sanofi, Baxte er and China Natio onal Biotec Group, and pre-negotiat tion discussions are bein ng held with MedImmun ne and Novartis. A SMTA 2 co oncluded in October O 2012 2 with the Un niversity of Florida F was a also discusse ed and noted. Discu 2. ussions and negotiations are proving g to be time consuming, and reachin ng agreement with vaccine man nufacturers on o the terms of benefit sh haring is ofte en a lengthy process. The e Secretariat t plans to initiate d discussions with w additional manufactu urers with le egal support from a consu ultant lawye er who will begin s shortly. 3. The Advisory Group G provid ded the follo owing advic ce to the Director-Gene D eral on SM MTA 2 negotiations s: The A Advisory Gr roup welcom med the seco ond SMTA 2 that has be een conclude ed with a va accine manu ufacturer. The A Advisory Gr roup recogn nized, howev ver, that the ere have be een difficulti ies in concl luding addit tional agreem ments: • The e Advisory Group recom mmended th hat WHO sh howcase the successful conclusion of o the SM MTA 2s with h GSK and SII S as an in ncentive to conclude ag greements w with other va accine ma anufacturers as quickly as s is feasible. • In situations where w discuss sions with m anufacturers s would bene efit from hig gh level exch hanges bet tween the Or rganization and a the man nufacturer, th he Advisory Group stron ngly recommended tha at such excha anges be mad de.
Handling genetic seq quence data a in the con ntext of the e PIP Framework iating the Gr 4. The S Secretariat pr rovided an overview o of s synthetic bio ology with a view to initi roup’s discussion o on the best process p to handle h the us se of influen nza virus gen netic sequen nce data und der the Framework. 5. Advisory Gr roup agreed that develop pments in sy ynthetic biolo ogy raise com mplex issues s with The A legal, techn nical, publi ic health and biosecur rity implica ations that require car reful review w and consideratio on.
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6. To assist th he Advisory y Group in d developing gu uidance for the Director r-General on n this matter, , techn nical support t from a tech hnical exper rt working group g would be beneficia al. The Adv visory Group p devel loped Terms of Reference for such an n expert grou up.
Part tnership Co ontribution n: review of f 2013 results 7. The Secret tariat provide ed an update e on the process to colle ect the partn nership contributions due e for 2 2013. The Secretariat, th hrough the “ “PIP PC 20 013 Question nnaire”, iden ntified 37 co ompanies as s contr ributors. Foll lowing an ex xtensive proc cess to receiv ve Band Selection and C Certification Forms from m all 37 7 companies, , four Band Selection S and d Certificatio on Forms were outstandin ng as at 7 Oc ctober 2013. 8. Using pub blically avail lable financ cial and other informati ion, the Sec cretariat has s placed the e outsta anding comp panies into bands. b Invoic ces will be se ent to the 37 7 companies in mid-Octo ober to allow w time for processin ng before the e end of 2013 3. 9. The Advisory Group concurred c wi ith the Secre etariat’s appr roach to gen nerating invo oices so that t partn nership contri ibution paym ments for 201 13 are receiv ved in a timel ly fashion. If f the estimat tion of bands s for th he four comp panies subseq quently need ds revision, ad djustments could be mad de in 2014.
Part tnership Co ontribution ns: gap ana lysis and im mplementation plans 10. The Secret tariat present ted the draft t Partnership p Contributio on implemen ntation plan: 2013–2016, , includ ding the proc cess for iden ntifying and a analysing ga aps and needs s. The Advis sory Group discussed d the e plan a as well as a document d on n the Regiona al Office Rec commended Country Rec cipients. 11. The Advis sory Group met represe entatives of industry ass sociations, m manufacturer rs and other r stakeholders to di iscuss the dra aft plan. 12. The Adviso ory Group di iscussed the views and comments of industry and d other stakeholders. The e Secre etariat will revise r the im mplementatio on plan to ta ake into account these d discussions. The revised d imple ementation plan p and the e results of t the gap ana alyses will be shared wi ith the Advi isory Group, , indus stry and other stakeholders. 13. The Adviso ory Group provided the following ad dvice to the Director-Gen neral on imp plementation n of act tivities under r the Partner rship Contrib bution. To avoid th he risk of pe erceived conf flict of intere est in selection of countr ries, the Adv visory Group p wished to clearly artic culate the p rocess to de evelop the draft d Regiona al Office Re ecommended d Country Re ecipients doc cument. The f following wa as noted: • The role of the Advisory Group w was limited to o providing criteria c for co country selection: ountry develo opment statu us; – Co – IH HR core capa acities; – Co ountry needs s for influenza za epidemiolo ogical and la aboratory sur rveillance; and a – H5 5N1 vulnerab bility.
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• The ese factors were w compile ed into a data abase by the PIP Secreta ariat and sha ared with Reg gional Off ffices for the eir use in identifying i p priority cou untries for strengthening s g laboratory y and sur rveillance cap apacities. • Reg gions further r refined thei ir gap analys ses with add ditional eleme ents includin ng: – Political l situation in countries, no otably wheth her a country y is in a comp plex emergen ncy; g donor fundi ing and inves stments in a country; – Ongoing – Absorptive capacity of o the countr ry; p size; s – Country population – Geograp phical locati ion of the c country in the t region/subregion (n notably for island states); o the countr ry/Ministry of Health to work w in influe enza; and – Interest of – Ability of countries to build on existing cap pacities to produce influ uenza surveillance data whi ich could be shared s with neighbourin ng countries. • Using all the fa actors above, , Regional Of Offices recom mmended countries in prio ority order. In the eir review of f the list, the Advisory A Gr roup: • Noted the work k of selection n which has b been made among a the nu umerous poss sible recipie ents by the e WHO Regio onal Offices for this first t phase of th he implement tation plan a and acknowl ledged the e need for sup pporting rati ionales. • Noted the impo ortance of providing PC C resources to t countries that need ba basic capacit ties as well as to coun ntries that ha ave existing c capacities bu ut where add ditional supp port can serv ve as a reg gional resour rce to other countries. c The A Advisory Gr roup recomm mended that implementa ation of activities under r the PC beg gin in Janua ary 2014. They Th noted th hat the PIP implementation plan sh hould be con nsidered a “living “ docum ment” that can c be revised d over time.
Annual re eport 14. The A Advisory Gr roup adopted d its annual report to the Director-G General (see Annex 2). It I was agreed that future repor rts will cover r the period b beginning 1 October and d ending 30 S September of each year.
Election of the new Chair C and Vice-Chair V r of the Adv visory Grou up 15. After r an inform mal consultat tion, the Ad dvisory Gro oup reached consensus that Dr William W Kwabena A Ampofo (Ghana) and Professor Raja ae El Aouad d (Morocco) would be i its new Chai ir and Vice-Chair, , respectively y.
Next meet ting of the Advisory A Group G 16. 4
The n next meeting g of the Advisory Group w will take plac ce in Geneva a on 9–11 Ap pril 2014.
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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 20132 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 reserve2 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 the 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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