Status of UNEP Negotiations Status of UNEP Negotiations affecting vaccine affecting vaccine

preservative Thiomersalpreservative ThiomersalJulia HillJulia Hill

CSO SC MeetingCSO SC MeetingDhaka, BangladeshDhaka, Bangladesh

11/11/1111/11/11Julia.hill@geneva.msf.orgJulia.hill@geneva.msf.org

OverviewOverview

Background on ThiomersalBackground on Thiomersal Ongoing UNEP negotiations & Ongoing UNEP negotiations &

possible effect on thiomersalpossible effect on thiomersal Update from UNEP INC3 in NairobiUpdate from UNEP INC3 in Nairobi Next stepsNext steps Further resourcesFurther resources

ThiomersalThiomersal

WHO-approved vaccine preservative, prevents WHO-approved vaccine preservative, prevents contamination of multi-dose vialscontamination of multi-dose vials

Used in multi-dose presentations of: DTP, DT, TT, Used in multi-dose presentations of: DTP, DT, TT, HepB, Hib, influenza, Men A conjugate, (theoretically HepB, Hib, influenza, Men A conjugate, (theoretically PCV)PCV)

NOT used in live vaccines: MMR, polio, yellow fever, NOT used in live vaccines: MMR, polio, yellow fever, BCGBCG

Thiomersal-containing vaccines used in over 120 Thiomersal-containing vaccines used in over 120 countries, averted >1,400,000 child deaths in 2010countries, averted >1,400,000 child deaths in 2010

Contains ethyl mercury. The WHO, U.S. and European Contains ethyl mercury. The WHO, U.S. and European regulatory authorities have found no evidence that regulatory authorities have found no evidence that thiomersal’s use in vaccines poses a health threatthiomersal’s use in vaccines poses a health threat

UNEP Negotiations: legally UNEP Negotiations: legally binding instrument on the use binding instrument on the use

of mercuryof mercury Goal:Goal: limit exposure to and effects of limit exposure to and effects of

anthropogenic mercury releases in the interests anthropogenic mercury releases in the interests of health and the environmentof health and the environment

Negotiators typically sit in Ministries of Negotiators typically sit in Ministries of Environment or FinanceEnvironment or Finance

Last week in Nairobi: 3Last week in Nairobi: 3rdrd Session of Session of Intergovernmental Negotiating Committee (INC3) Intergovernmental Negotiating Committee (INC3) convenedconvened

Current draft lists thiomersal on list of potential Current draft lists thiomersal on list of potential products that could be bannedproducts that could be banned

An outright ban would mean multi-dose vials of An outright ban would mean multi-dose vials of affected vaccines could no longer be produced by affected vaccines could no longer be produced by or sold to country signatoriesor sold to country signatories

What would a ban on What would a ban on thiomersal likely mean in thiomersal likely mean in

practical terms?practical terms? LIMITED ACCESS TO VACCINES!LIMITED ACCESS TO VACCINES!

Worst case scenario: Suppliers switch to single-Worst case scenario: Suppliers switch to single-dose vials of affected vaccinesdose vials of affected vaccines prices rise prices rise cold cold chain requirements increasechain requirements increase suppliers may be suppliers may be unable to maintain current production volumes unable to maintain current production volumes (prices rise more)(prices rise more) some developing countries some developing countries can’t afford cost or cold chain expansion, or can’t afford cost or cold chain expansion, or vaccines are not availablevaccines are not available

Testing or developing other vaccine preservatives Testing or developing other vaccine preservatives would require WHO to re-prequalify new multi-would require WHO to re-prequalify new multi-dose formulations (years-long process)dose formulations (years-long process)

INC3 Nairobi: Oct. 31-Nov. 4, 2011INC3 Nairobi: Oct. 31-Nov. 4, 2011 WHO does MoH outreach in INC3 run-up, provides WHO does MoH outreach in INC3 run-up, provides

technical advice at INC3technical advice at INC3 Where do various actors stand?Where do various actors stand?

Anti-ban:Anti-ban: WHO, GAVI, CSO SC (released statements)WHO, GAVI, CSO SC (released statements) USA, EU, Norway, Canada (flu vaccine)USA, EU, Norway, Canada (flu vaccine) China (traditional medicines containing mercury)China (traditional medicines containing mercury) Brazil, Korea, Cuba, Mali, Togo, Madagascar, CAR, Kenya, Brazil, Korea, Cuba, Mali, Togo, Madagascar, CAR, Kenya,

Tanzania, Cote d’Ivoire, many othersTanzania, Cote d’Ivoire, many others Wavering/Uncertain/Need more information:Wavering/Uncertain/Need more information:

Nigeria (want to switch to non-mercury preservative)Nigeria (want to switch to non-mercury preservative) AFRO (want phase-out of thiomersal over time)AFRO (want phase-out of thiomersal over time) Mexico, Honduras, Pakistan (need more information)Mexico, Honduras, Pakistan (need more information)

Pro-banPro-ban Chile (autism activist), South Africa (anti-vaccine Env. Chile (autism activist), South Africa (anti-vaccine Env.

Minister)—causing uncertainty amongst some African and Minister)—causing uncertainty amongst some African and Latin American repsLatin American reps

CoMed, SafeMinds (anti-thiomersal activists)CoMed, SafeMinds (anti-thiomersal activists)

INC3 Nairobi: Oct. 31-Nov. 4, INC3 Nairobi: Oct. 31-Nov. 4, 2011, cont.2011, cont.

Contact group set up to discuss “products and Contact group set up to discuss “products and processes”; met twice at INC3processes”; met twice at INC3

Potential options for solutions:Potential options for solutions: Positive list (exemptions)Positive list (exemptions) Negative list (prohibited)Negative list (prohibited) Hybrid +/- : list prohibited products but allow for Hybrid +/- : list prohibited products but allow for

temporary exemption periodtemporary exemption period Voluntary by country—no regulationVoluntary by country—no regulation

Many countries want to move to mercury-free Many countries want to move to mercury-free products, provided these alternatives are:products, provided these alternatives are: EconomicEconomic Technically feasibleTechnically feasible Available without interruption in supply during transitionAvailable without interruption in supply during transition (Note: this is closest to the hybrid solution)(Note: this is closest to the hybrid solution)

Next StepsNext Steps Negotiation rounds will continue: INC4, 25-29 June 2012Negotiation rounds will continue: INC4, 25-29 June 2012

WHO actions: this week SAGE endorsed proposal for WHO actions: this week SAGE endorsed proposal for scientific meeting on thiomersal alternatives, and review of scientific meeting on thiomersal alternatives, and review of policy implications prior to INC4; need to develop country-policy implications prior to INC4; need to develop country-level action plan with Regional Advisorslevel action plan with Regional Advisors

Before INC4, need to provide authoritative evidence to Before INC4, need to provide authoritative evidence to countries on:countries on: Alternative preservatives (2 phenoxy-ethanol)Alternative preservatives (2 phenoxy-ethanol) Economic, programmatic, manufacturing implications of Economic, programmatic, manufacturing implications of

moving to single-dose preservative-free vaccinesmoving to single-dose preservative-free vaccines

Call next week between WHO, PATH, CSOSC rep, others Call next week between WHO, PATH, CSOSC rep, others involved, to discuss next stepsinvolved, to discuss next steps

CSO SC thoughts or suggestions for possible solutions, next CSO SC thoughts or suggestions for possible solutions, next steps? Lobbying capacity in key countries?steps? Lobbying capacity in key countries?

Further ResourcesFurther Resources

UNEP INC3 texts:UNEP INC3 texts: http://www.unep.org/hazardoussubstances/Mercury/http://www.unep.org/hazardoussubstances/Mercury/

Negotiations/INC3/INC3MeetingDocuments/tabid/3487/Negotiations/INC3/INC3MeetingDocuments/tabid/3487/Default.aspxDefault.aspx

CSO Submissions to UNEP (including PATH submission CSO CSO Submissions to UNEP (including PATH submission CSO SC supported): SC supported): http://www.unep.org/hazardoussubstances/Mercury/http://www.unep.org/hazardoussubstances/Mercury/

Negotiations/INC2/Informationforcivilsociety/Negotiations/INC2/Informationforcivilsociety/NGOSubmissionpage/tabid/29782/Default.aspxNGOSubmissionpage/tabid/29782/Default.aspx

Technical info from WHO:Technical info from WHO: http://www.who.int/immunization/newsroom/thiomersal_informhttp://www.who.int/immunization/newsroom/thiomersal_inform

ation_sheet/en/index.htmlation_sheet/en/index.html http://www.who.int/immunization/newsroom/http://www.who.int/immunization/newsroom/

thiomersal_questions_and_answers/en/index.htmlthiomersal_questions_and_answers/en/index.html