EU CBRN Risk Mitigation Centres of Excellence  

Jointly implemented by European Commission and UNICRI

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Funded by the European Union  

Sonia Drobysz, Programme Director for National Implementation

Harmoniza*on  of  na*onal  legal  frameworks  for  biosafety  and  biosecurity  

Regional Workshop for Central Asian States Parties to the Biological Weapons Convention on scientific and practical implementation issues 23 – 24 October, Almaty, Kazakhstan

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Outline

   

•  About  VERTIC  and  the  Na3onal  Implementa3on  Measures  Programme    •  Biosafety  and  biosecurity    •  Interna3onal  framework  for  biosafety  and  biosecurity    •  Na3onal  framework  for  biosafety  and  biosecurity    •  Assessment   and   revision   of   na3onal   frameworks   for   biosafety   and  

biosecurity:  the  example  of  EU  CBRN  CoE  Project  53      •  Useful  tools  and  publica3ons  

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About  VERTIC

   

VERTIC  •  Status:  independent,  non-­‐profit  making  charitable  

organiza3on  based  in  London,  United  Kingdom  •  Mission:   supports   the   development,   implementa3on   and  

verifica3on  of  interna3onal  agreements  as  well  as  ini3a3ves  in  related  areas  

 Na*onal  Implementa*on  Measures  Programme  •  Advises  States  on  na3onal  implementa3on  of  the  obliga3ons  

in   interna3onal   instruments,   including   the   BTWC,   CWC,  nuclear   security   instruments,   IHR,   Codex   Alimentarius   and  UNSCR  1540  

•  Mul3lingual  team  of  common  and  civil  law  lawyers  •  No  ins3tu3onal  mandate  restric3ons:  one-­‐stop  shopping  for  

States    

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Biosafety and Biosecurity

   

Natural  disease  outbreak  

Deliberate  use  of  BTW  

Unintended  consequences  

Accidents  

Vandalism  sabotage  

Negligence  

 

Biosafety:   protec3on   of   people   and   the   environment  from   the   effects   of   poten3ally   dangerous   biological  agents;  requires  procedures  and  prac3ces  to  prevent  the  risk  of  infec3on  in  the  workplace      Biosecurity:   protec3on   from   losses,   theY,   spillage   or  inten3onal   improper   use   of   microbial   agents,   toxins   or  informa3on  connected  with  an   inves3ga3on;  directed  at  guaranteeing   the   protec3on   of   biological   materials   and  corresponding  secret  informa3on  

See  defini(ons  in  WHO  Laboratory  Biosafety  Manual  –  IHR  Joint  External  Evalua(on  Mission  Reports  

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Interna*onal  framework  for  biosafety  and  biosecurity

   

“We  must  look  at  [the  BTWC]  as  part  of  an  interlinked  array  of  tools,  designed  to  deal  with  an  interlinked  array  of  problems”  –  Kofi  Annan,  BTWC  Sixth  RevCon  

One  Health:  collabora3ve  and  mul3sectoral  approach  to  designing  and  implemen3ng  programmes,  policies,  legisla3on  and  research  to  achieve  be_er  public  health  outcome  

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 Interna*onal  framework  for  biosafety  and  biosecurity

   

1972   Biological   and   Toxin   Weapons   Conven*on:   prohibits   development,  produc3on,   stockpiling,   acquisi3on,   reten3on  or   transfer   of   BTW  –   requires  states  par3es  to  adopt  measures  to  prevent  such  ac3vi3es  

 2004   UN   Security   Council   Resolu*on   1540:   requires   all   states   to   take  measures   to   prevent   the   prolifera3on   of   nuclear,   chemical   and   biological  weapons  including  controls  over  related  materials  

 2005  Interna*onal  Health  Regula*ons:  prevent,  protect  against,  control  and  provide  a  public  health  response  to  the  interna3onal  spread  of  disease    Codex   Alimentarius:   collec3on   of   interna3onally   adopted   food   standards,  guidelines,   codes   of   prac3ce   aiming   at   protec3ng   consumers’   health   and  ensuring  fair  prac3ces  in  the  food  trade    

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Na*onal  framework  for  biosafety  and  biosecurity  (1/3)

   

Na*onal   implementa*on:  process  by  which  a  State  adopts  appropriate  and  effec3ve   na3onal   legisla3ve   and   regulatory   measures   to   carry   out   and  enforce   the   obliga3ons   to   which   it   has   commi_ed   in   an   interna3onal  instrument    •  Ar3cle  IV  of  the  BWC  •  OP  2  and  3  of  UNSCR  1540  •  IHR  Ar3cle  3(4)  •  CAC/GL  82-­‐2013,  principle  11  para.  22  

 Tailored   approach:   cons3tu3onal   processes,   legal   and   technical   na3onal  specifici3es    

Credit: Carlton Stoiber

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Na*onal  framework  for  biosafety  and  biosecurity  (2/3)

   

Relevant  areas  of  na*onal  law:    •  Export-­‐import,  strategic  and  dangerous  goods,  customs  laws  •  Regulatory  systems  for  dual-­‐use  materials,  including  measures  to  account  

for  and  physically  protect  relevant  materials  •  Banking  laws,  financing  of  terrorism  •  Health  laws  (public,  animal,  plant),  food  and  sanita3on  laws  •  Related  enforcement  measures:  criminal  procedure  laws,  etc.  •  Related  measures  to  coordinate  emergency  response  •  Criminal  law    

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Na*onal  framework  for  biosafety  and  biosecurity  (3/3)

   

Types  of  measures:    •  Defini3ons    •  Offences  and  penal3es    •  Measures  to  control  authorized  ac3vi3es  with  biological  agents  and  toxins    •  Transfers  controls    •  Emergency  preparedness    •  Enforcement  

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Assessment  and  revision  of  na*onal  frameworks:  P53  (1/4)

   

EU   CBRN   CoE   Project   53:   Strengthening   the   na3onal   legal   framework   and  provision  of  specialized  training  on  biosafety  and  biosecurity  in  Central  Asian  Countries    Work   Package   1:   Objec3ve:   assessment   and   revision   of   the   na3onal  legisla3on   and   best   prac3ces   in   the   area   of   biosafety   and   biosecurity,   and  harmoniza3on  with     appropriate   interna3onal   regula3ons   such   as   the   IHR,  BTWC   and   Codex   Alimentarius   including   the   area   of   regional   emergency  response  with  the  aim  of  coming  to  a  "One  Health"  system    VERTIC:  leading  consor3um  partner  (key  expert)  

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Assessment  and  revision  of  na*onal  frameworks:  P53  (2/4)

   

Ac*vi*es:  legisla*on  surveys    •  comprehensive   analysis   of   a   State’s   exis3ng   legisla3on   for   the  

implementa3on  of  the  BTWC,  IHR,  Codex    •  BTWC,  IHR  and  Codex  survey  templates  developed  by  VERTIC,  taking  into  

account  WHO,  FAO  and  other  relevant  material    •  Relevant  na3onal  legisla3on  and  regula3ons  reviewed    •  Legisla3on   survey   overview:   summary   of   the   findings   and  

recommenda3ons  to  address  gaps  and  strengthen  implementa3on    

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Assessment  and  revision  of  na*onal  frameworks:  P53  (3/4)

   

Addi*onal  ac*vi*es:    •  Review  of  draY  legisla3on  on  biosafety  and  biosecurity    •  A   report   sta3ng   na3onal   and   regional   strategies   based   on   the  

formulated   recommenda3ons   for   legisla3ve   improvement   will   be  prepared  

 •  Report   on     Emergency   Response   Planning     in   Central   Asia:   Common  

Challenges  and  Opportuni3es  for  Coopera3on  –  published  in  September  2018  

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Assessment  and  revision  of  na*onal  frameworks:  P53  (4/4)

   

Collabora*ve  approach  

•  Team  of  Interna3onal  Experts:  consor3um  of  implemen3ng  organisa3ons  

   •  WP1:   Team   of   Interna3onal   Experts   and   Na3onal   Teams   of   Experts:  

surveys  prepared  by  na3onal   legisla3ve  experts  and   reviewed  by  VERTIC  experts  

 •  Collabora3on   with   relevant   interna3onal   organisa3ons,   ini3a3ves   and  

tools:  WHO,  FAO,  BWC  ISU  and  UNODA,  etc.  

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Useful  tools  and  publica*ons

   

•  Fact  sheets  on  the  BTWC    •  Survey  templates  (not  publicly  available)    •  Model   legisla3on:   VERTIC’s   BTWC   Sample  

Act  and  online  Legisla3on  DraYing  Assistant    •  VERTIC’s    BTWC  Legisla3on  Database   •  Report  on    Emergency  Response  Planning    in  

Central  Asia:  h_p://coe-­‐project53.istc.int/    

EU CBRN Risk Mitigation Centres of Excellence  

Jointly implemented by European Commission and UNICRI

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Funded by the European Union  

Thank you for your attention! www.coe-project53.istc.int

Sonia Drobysz sonia.drobysz@vertic.org