{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T08:35:01Z","timestamp":1793349301266,"version":"4.5.0"},"reference-count":41,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,1,13]],"date-time":"2019-01-13T00:00:00Z","timestamp":1547337600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100001058","name":"Australian-American Fulbright Commission","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001058","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Milbank Quarterly"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:sec><jats:label\/><jats:p><jats:boxed-text content-type=\"box\" position=\"anchor\"><jats:caption><jats:title>Policy Points<\/jats:title><\/jats:caption><jats:p><jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>Securing access to pathogen samples for research purposes is crucial for pandemic preparedness and responding to infectious disease outbreaks.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>The <jats:italic>Pandemic Influenza Preparedness Framework<\/jats:italic> (PIP Framework) is the only pathogen\u2010specific international access and benefit\u2010sharing (ABS) instrument.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>This analysis reveals that during an influenza pandemic, the PIP Framework will safeguard access to virus samples but may not be as effective in delivering the associated benefits, like vaccines and antivirals, to countries in need.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>The PIP Framework's deficiencies must be addressed before an influenza pandemic and before this ABS model is extended to other human pathogens.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:boxed-text><\/jats:p><\/jats:sec><jats:sec><jats:title>Context<\/jats:title><jats:p>The World Health Organization (WHO) adopted the <jats:italic>Pandemic Influenza Preparedness Framework<\/jats:italic> (PIP Framework) after being forced to grapple with the demands of developing countries for the fairer distribution of vaccines and antivirals created using influenza viruses isolated from within their territories. Though adopted as a nonbinding resolution, the PIP Framework has been praised for its novel legal approach to access and benefit\u2010sharing (ABS), using Standard Material Transfer Agreements (SMTAs) to create binding terms and conditions on both providers and users of PIP biological materials. The PIP Framework's SMTA1 regulates the movement of influenza viruses with human pandemic potential through the WHO's Global Influenza Surveillance and Response System (GISRS) as it operates to monitor the spread of seasonal influenza and detect the emergence of pandemic strains. Member States give consent to the WHO to transfer their materials to third parties under the terms of a negotiated SMTA2. The SMTA2 details benefits such as vaccines and antivirals to be made available to the WHO for distribution in the event of an influenza pandemic.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>I analyzed the PIP Framework, its SMTAs, and secondary sources to determine whether the PIP Framework will effectively function as an ABS instrument during an influenza pandemic.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>The SMTAs do not create any direct or binding agreements between Member States and third\u2010party recipients of influenza viruses. In the lead\u2010up to and during a pandemic, the SMTA1 secures access to influenza viruses for the WHO, and the SMTA2 secures access for commercial users of virus samples, but the SMTA2 may be ineffective in securing tangible benefits for the sovereign providers of those materials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>As the international community starts to consider how to best regulate access to nonpandemic influenza pathogen samples, it is imperative that we first address the shortcomings of the only pathogen\u2010specific international ABS instrument available, and we should do so before it is put to the ultimate test.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1468-0009.12364","type":"journal-article","created":{"date-parts":[[2019,1,14]],"date-time":"2019-01-14T07:59:55Z","timestamp":1547452795000},"page":"91-112","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":24,"title":["Access by Design, Benefits if Convenient: A Closer Look at the Pandemic Influenza Preparedness Framework's Standard Material Transfer Agreements"],"prefix":"10.1111","volume":"97","author":[{"given":"MICHELLE F.","family":"ROURKE","sequence":"first","affiliation":[{"name":"Griffith Law School Griffith University and Australian Defence Force Malaria and Infectious Disease Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,1,13]]},"reference":[{"issue":"29","key":"e_1_2_6_2_1","doi-asserted-by":"crossref","first-page":"482","DOI":"10.47102\/annals-acadmedsg.V37N6p482","article-title":"Towards mutual trust, transparency and equity in virus sharing mechanism: the avian influenza case of Indonesia","volume":"37","author":"Sedyaningsih ER","year":"2008","journal-title":"Ann Acad Med Singapore"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid1401.070700"},{"key":"e_1_2_6_4_1","volume-title":"Negotiating and Navigating Global Health: Case Studies in Global Health Diplomacy","author":"Lange JE","year":"2012"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.3201\/eid0101.950102"},{"key":"e_1_2_6_6_1","volume-title":"Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits","author":"60th World Health Assembly","year":"2007"},{"key":"e_1_2_6_7_1","volume-title":"Pandemic Influenza Preparedness: Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (PIP Framework)","author":"64th World Health Assembly","year":"2011"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/09512748.2014.909523"},{"key":"e_1_2_6_9_1","volume-title":"Global Influenza Surveillance and Response System (GISRS): Technical and Scientific Resource for WHO Public Health Policy Making","author":"World Health Organization","year":"2015"},{"key":"e_1_2_6_10_1","volume-title":"National Influenza Centers","author":"World Health Organization","year":"2017"},{"key":"e_1_2_6_11_1","unstructured":"WHO Collaborating Centers for Influenza and Essential Regulatory Laboratories.World Health Organization website.http:\/\/www.who.int\/influenza\/gisrs_laboratory\/collaborating_Centers\/list\/en\/. Last updated June 20 2018. Accessed October 22 2018."},{"key":"e_1_2_6_12_1","volume-title":"Terms of Reference for WHO H5 Reference Laboratories","author":"World Health Organization","year":"2006"},{"key":"e_1_2_6_13_1","volume-title":"Influenza Vaccines","author":"World Health Organization","year":"2016"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1314094"},{"key":"e_1_2_6_15_1","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1163\/9789004217201_006","volume-title":"The 2010 Nagoya Protocol on Access and Benefit\u2010Sharing in Perspective","author":"Wilke M","year":"2013"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.26530\/OAPEN_613388"},{"key":"e_1_2_6_17_1","first-page":"59","article-title":"Levelling the playing field? Sharing of influenza viruses and access to vaccines and other benefits","volume":"20","author":"Jefferies N","year":"2012","journal-title":"J Law Med"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.4159\/9780674369870"},{"issue":"22","key":"e_1_2_6_19_1","first-page":"1","article-title":"Establishing a national influenza sentinel surveillance system in a limited resource setting, experience of Sierra Leone","volume":"11","author":"Kebede S","year":"2013","journal-title":"Health Res Policy Syst"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1017\/CBO9781139128957"},{"key":"e_1_2_6_21_1","volume-title":"Terms of Reference for National Influenza Centers of the Global Influenza Surveillance and Response System","author":"World Health Organization","year":"2017"},{"issue":"2","key":"e_1_2_6_22_1","first-page":"79","article-title":"Viruses for sale: all viruses are subject to access and benefit\u2010sharing obligations under the Convention on Biological Diversity","volume":"39","author":"Rourke MF","year":"2017","journal-title":"Eur Intellect Prop Rev"},{"key":"e_1_2_6_23_1","volume-title":"Review of the Pandemic Influenza Preparedness Framework","author":"70th World Health Assembly","year":"2017"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.4324\/9781315754451"},{"key":"e_1_2_6_25_1","volume-title":"Category A: Manufacturers of Vaccines & Antivirals","author":"World Health Organization","year":"2017"},{"key":"e_1_2_6_26_1","volume-title":"Category B: Manufacturers of Diagnostics & Other Pandemic Related Products","author":"World Health Organization","year":"2017"},{"key":"e_1_2_6_27_1","volume-title":"Category C: Academic & Research Institutions","author":"World Health Organization","year":"2017"},{"key":"e_1_2_6_28_1","unstructured":"Agreements signed with manufacturers of vaccines and\/or antivirals.World Health Organization website.http:\/\/www.who.int\/influenza\/pip\/benefit_sharing\/SMTA2_catA\/en\/. Accessed October 22 2018."},{"key":"e_1_2_6_29_1","unstructured":"Standard Material Transfer Agreement 2 between WHO and China National Biotec Group Company Limited Concluded 23 May 2016.Geneva Switzerland:World Health Organization;2016.http:\/\/www.who.int\/influenza\/pip\/benefit_sharing\/SMTA2_CNBG.pdf?ua=1. Accessed October 22 2018."},{"key":"e_1_2_6_30_1","unstructured":"Standard Material Transfer Agreement 2 between WHO and Glaxo Group Limited Concluded 18 December 2012.Geneva Switzerland:World Health Organization;2012.http:\/\/www.who.int\/influenza\/pip\/benefit_sharing\/gsk_smta2_dec_2012.pdf?ua=1. Accessed October 22 2018."},{"key":"e_1_2_6_31_1","volume-title":"Black's Dictionary","author":"Garner BA.","year":"2014"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1177\/0968533217723683"},{"key":"e_1_2_6_33_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000247"},{"key":"e_1_2_6_34_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0033025"},{"key":"e_1_2_6_35_1","doi-asserted-by":"publisher","DOI":"10.1093\/acprof:oso\/9780199917907.001.0001"},{"issue":"2","key":"e_1_2_6_36_1","first-page":"1","article-title":"Whom do you trust? Doubt and conspiracy theories in the 2009 influenza pandemic","volume":"6","author":"Smallman S","year":"2015","journal-title":"J Int Glob Stud"},{"issue":"2","key":"e_1_2_6_37_1","first-page":"20","article-title":"Biopiracy and vaccines: Indonesia and the World Health Organization's new pandemic influenza plan","volume":"4","year":"2013","journal-title":"J Int Glob Stud"},{"key":"e_1_2_6_38_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.960"},{"key":"e_1_2_6_39_1","doi-asserted-by":"publisher","DOI":"10.1080\/14781158.2012.641292"},{"key":"e_1_2_6_40_1","doi-asserted-by":"publisher","DOI":"10.1002\/gch2.1018"},{"key":"e_1_2_6_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-802311-2.00006-0"},{"key":"e_1_2_6_42_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-9248.2011.00926.x"}],"container-title":["The Milbank Quarterly"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1468-0009.12364","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1468-0009.12364","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1468-0009.12364","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1468-0009.12364","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,24]],"date-time":"2023-08-24T04:32:32Z","timestamp":1692851552000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1468-0009.12364"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,13]]},"references-count":41,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,3]]}},"alternative-id":["10.1111\/1468-0009.12364"],"URL":"https:\/\/doi.org\/10.1111\/1468-0009.12364","archive":["Portico"],"relation":{},"ISSN":["0887-378X","1468-0009"],"issn-type":[{"value":"0887-378X","type":"print"},{"value":"1468-0009","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1,13]]},"assertion":[{"value":"2019-01-13","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}