European Risk Forum – Monograph
Scientific Evidence and the Management Of Risk October 2016
European Risk Forum
European Risk Forum
European Risk Forum Rue de la Loi 227, B 1040 Brussels Belgium Telephone +32 2 613 28 28 Facsimile +32 2 613 28 29 email
[email protected] www.riskforum.eu
Scientific Evidence and the Management Of Risk
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Foreword Ten years ago, the Risk Forum published a ground-breaking study, ‘Enhancing the Role of Science in the Decision-Making of the European Union’. It has structured and informed the policy agenda in this critical area ever since. This new study, produced by the European Risk Forum (ERF), revisits and up-dates those igina findings ts timing is t ne t is a c nt i ti n t the eme ging de ate a t how to improve the quality of the EU’s governance, in the wake of Brexit and in the face of other powerful challenges to the Union. It recognises that progress has been made, and that the e a e g d e am es at E eve f the se f scientific evidence t make high a it eg at decisi ns t n tes h eve that im tant fai ings identified in the earlier work have not been resolved and that new problems have emerged that challenge the e f scientific evidence in decisi n making On t man ccasi ns E e s eade s have hesitated t affi m thei hist ic c mmitments t se the est avai a e scientific evidence hen making isk management decisions. Instead, there has emerged a degree of deference to relativism, accompanied by a ack f t st in science and scientific e e ts ithin the E s instit ti ns c mm n e i ements f the c ecti n and se f scientific evidence are lacking.This has contributed to an undue emphasis on who produces science, rather than on the excellence of the quality of the evidence itself. It has resulted in a failure t define and enf ce standa ds f evidence f the se in decisi n making ased n the characteristics of the best available science. Simi a ems a e esent hen ec iting scientific e e ts t s t eg at decision-making. Selection procedures, based on out-of-date assumptions about the funding of research and the causes of bias, place the greatest emphasis on identifying tentia financia c n icts f inte est his inc easing events the est e e ts eing ch sen imiting the a it f scientific assessments nd it ign es e f f ms f ias that es t f m the c m e c n icts f inte est inc ding stat s am iti n e e ience values and ideologies, undermining perceptions of impartiality.
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In this monograph, the ERF explains why science remains the pre-eminent knowledge input when the EU makes risk management decisions. It highlights the importance for the EU institutions, in an era of economic and political crisis, of reinforcing commitments to basing decisions on the best available science. It shows how, by doing this, proportionality, accountability, predictability, effectiveness, and legitimacy can be enhanced. Delivering reforms that ensure risk management decisions are based on the best available science is a natural complement to the EU’s Better Regulation strategy. It is one of the most important ways of ensuring high standards of protection for Europe’s people and environment, whilst at the same time helping to stimulate risk-takers to invest in the innovations needed to restore growth and prosperity. Finally, the ERF would like to warmly thank the members of the project Steering Group for their insights, advice, and help. Veronique Steukers (Nickel Institute) chaired the Steering Group. Its members were Esther g eman d E fess Si in e R a nd n Medica Sch Rache nfante hev n ean ie e sna d nt Rick a t n E e e nd a ing a e R di ie sche acatech ati na cadem f Science and Enginee ing e man a e na d S icia Ma tin astics E e atha ina Ma e fess iet van de Mee hent nive sit ee nive sit f sse s and Michae R ge s visiting fess k nive sit The ERF is also grateful to the experts who agreed to be interviewed - academics from the E and the S ega sch a s eminent scientists scientific advise s and g ve nment fficia s in Mem e States seni fficia s f m seve a ic di ect ates f the E ean mmissi n and f m E isk assessment agencies mem e s f the sec eta iat f the E ean a iament and seni manage s f m c m anies and siness ganisati ns in the E and the S Our thanks go as well to those experts who critically reviewed earlier drafts of the manuscript.
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e e ieve that this m n g a h i ve t e as in entia as its edecess as in 2005, and that it will contribute constructively to a debate about the role of the best available science in decision-making. Implementation of its recommendations will, we believe, help strengthen the governance of the EU, resolving immediate problems and providing a basis for new opportunities. Howard Chase hai man European Risk Forum
Dirk Hudig Secretary General European Risk Forum
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Executive Summary Background When making decisions about the best way to manage risks to citizens and the envi nment scientific evidence vides ni e insights n ike ini ns va es it ena es g ve nments t identif the e istence f ha a ds and thei ca ses t dete mine hich ha a ds se the g eatest isks t ed ce nce tainties t cha acte ise isks and eca se it is ften a e t identif the tentia enefits f acti n t a cate es ces rationally. t E eve the e is an inc easing e i ement f scientific evidence Rising demands from citizens for protection against risks and the emergence of new and more complex tentia th eats t hea th and the envi nment se cha enges t eg at s t the same time iving standa ds de end inc easing n investment in and e itati n f scientific knowledge. et this is n t eas t achieve Significant n m e s f citi ens have itt e t st in science experts, or politicians. There are also intellectually-based concerns that challenge the view that the best available science should be the pre-eminent form of evidence relied on by governments when they make risk management decisions. Overcoming these challenges, and meeting the needs of citizens for both protection and s e it is a tic a diffic t at E eve he e scientific advis cesses have developed in a piecemeal fashion since the 1950s.
Objective This ERF monograph sets out a comprehensive and internally consistent framework of political commitments, institutional and legal ‘architecture’, and policies that, taken together, ensure that the best available science is the key input to the legislative, regulatory, and administrative decisions made by the EU institutions when they assess and manage risks to citizens and the environment.
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he st d e amines the a in hich the E s instit ti ns se scientific evidence t make decisions about the best way to manage risks to humans and the environment. It assesses the ems ass ciated ith the inc eased se f a it and n n scientific evidence t e amines the actices icies cesses and st ct es f the E s scientific advis s stem nd it high ights g d actices a ng ith eaknesses and fai ings he nat e f science and f the scientific meth d is e ained in the st d a ng ith an e anati n f the e that scientific evidence a s in the diffe ent a ts f the ic c ce ic f m ati n and egis ati n tend t se science as a ivi eged in t t ase fina decisi ns n a ange f fact s inc ding itics n c nt ast im ementati n decisi ns tend t e ased n science hi st ec gnising the imitati ns f scientific evidence the st d high ights the enefits f managing isks n the asis f the est avai a e science The study focuses on natural and physical sciences and engineering because of their importance for understanding the potential risks posed by the production and use of modern technologies. It also distinguishes between “science advisers” and “science experts”. Science advisers mediate between politicians and regulators and the processes designed t gene ate scientific evidence he a e a t f the cess f eg at management n c nt ast scientific e e ts s e vide evidence
Weaknesses of the EU’s Structural Framework Ove the ast t decades significant im vements have een made in the a in hich the E s instit ti ns c ect and se scientific evidence t assess and manage the isks t humans and the environment posed by technologies and lifestyle choices. In some policy areas, this has stimulated the development of policies and processes that deliver widelyes ected high a it scientific assessments n a eg a asis eve the cess f reform remains incomplete. It lacks powerful horizontal institutions, policies, and guidance designed t ens e that scientific evidence and advice is f the highest a it that cesses f scientific assessment a e c nsistent and that standa ds f g d administ ati n a e met Major ‘horizontal’ weaknesses include:
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itica c mmitments t ase isk management decisi ns n the est avai a e scientific evidence a e imited am ig s and inc nsistent
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No central oversight mechanism exists, with the institutional power to establish, and enf ce c mm n standa ds f the a it c ecti n and se f scientific evidence
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c mm n icies and standa ds f the c ecti n and se f scientific evidence se ecti n f scientific e e ts f ncti ning f scientific c mmittees and isk ana sis have een deve ed and ad ted and
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itica h i nta g ide ines dea ing ith iss es s ch as the cha acte istics f est available science or the best practices for Systematic Evidence Review, are missing.
eaknesses f the O e ati n f the E s Scientific ssessment cess Man f the scientific assessments ca ied t the E instit ti ns a e f high a it and a number of good practices have been developed to improve consistency and utility, as well as t sha e ideas ac ss diffe ent a ts f the mmissi n eve the e emains a c ea gene a ack f c nsistenc t ans a enc and edicta i it n t man cases scientific assessments d n t meet d eading standa ds S ecific ems inc de
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nade
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Exclusion of experts with links to industry and a failure to ensure impartiality of all scientific e e ts
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nd e in ence f a it nscientific st dies inc ding a fai st dies that have een disc edited et acted
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ate e
e tise f s me echnica
n edicta i it and inc nsistenc
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na
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iate a
icati n f the
iticisati n f mandates f ini n n se ecti n and inte
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ack f a 8
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f test e eca ti na
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i ements inci e in scientific assessments
scientific c mmittees and nd e in etati n f scientific evidence i ement
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ence
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isk c mm nicati n c nt i nta i it and
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ins fficient t ans a enc
and
eak
Failure of regulators to defend science and scientists
Recommendations he m n g a h identifies m e than t ent ef ms he i d n the man g d practices already present within the EU’s institutions. Taken together, they target the underlying causes of the failings of the current EU-level system, along with the weaknesses in actices st ct es icies and cesses identified the ER s esea ch he ef ms have been designed as a comprehensive, internally consistent programme, targeting political commitment, institutional architecture, policies, and guidance, and should be implemented as a whole. In the short-term (1-3 years), the following actions should be taken:
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The Council of EU Ministers sh d affi m the e i ement t se f the est available science as the pre-eminent input to inform and guide risk management decisions to protect human health, public safety, and the environment by, for instance, ad ting dedicated nc si ns
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itica es nsi i it ithin the European Commission for the quality and effectiveness f the ve a cess f c ecting and sing scientific evidence t make isk management decisi ns sh d est ith the i st ice esident in cha ge f ette Reg ati n
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The European Commission should set up a central oversight body with responsibility f the a it ti it and integ it f scientific evidence and advice sed t g ide and inf m isk management decisi ns his c d e ased f e am e n the Scientific dvis Mechanism
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European Commission should develop and adopt minimum standards for the a it c ecti n va idati n and se f scientific evidence that a di ect ates and agencies m st es ect hese c d e set t f instance in a ne ecisi n 9
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The European Commission sh d set t ssi in a ne mmissi n ecisi n the ke inci es f the se ecti n f scientific e e ts and f the e ati n f scientific c mmittees hese sh d e minim m standa ds and sh d a t a f ms f scientific c mmittee inc ding echnica king s
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The European Commission sh d iss e s ementa g idance that c a ifies the e f the eca ti na inci e in eg at decisi n making t sh d ased n the e i ements f the e isting mm nicati n make it c ea that the eca ti na inci e sh d n t e sed t in ence di ect indi ect scientific assessments that f m a t f the cess f nde standing ha a ds isks
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The European Parliament sh d e and the f c s f the S O ane t m te de ate am ngst ME s a t the enefits f sing the est avai a e science enhance the standa ds f scientific evidence vided t egis at s the E RS and vide additi na es ces t s t the k f the E n Risk
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The Scientific Community sh d deve s ecific sa s t define meth d gica g ide ines f im ved scientific assessment his sh d inc de a cata g e f cha acte istics f est avai a e science S stematic Evidence Revie se and inte etati n f e idemi gica evidence and statistica ana sis and inte etati n
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Businesses sh d a tici ate financia in t ans a ent g ammes int ith EU institutions, to improve regulatory science in areas of importance including meth d gies f scientific assessments ne techn gies and c m e ha a ds
European Risk Forum October 2016
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1. Introduction 1.1.
Background
At EU-level, there is an ever increasing requirement from policy-makers for scientific evidence. Rising demands from citizens for protection against risks and the emergence of new and more complex potential threats to human health and the envi nment se cha enges t g ve nments that scientific evidence can he define and resolve effectively. t the same time iving standa ds de end inc easing n investment in and e itati n f scientific kn edge ste ing the e ansi n f this kn edge ased ec n m is a ma ective f ic ic in the E as e as in the OE ec n mies Yet despite (or perhaps because of) the rising importance of science for achieving economic and social objectives, there has emerged a debate about the appropriate role of scientific evidence in guiding the outcome of policy, legislative and regulatory decisions. On the ne hand significant n m e s f citi ens have little trust in science or in politicians. There are also intellectually-based concerns that challenge the view that the best available science should be the pre-eminent form of evidence relied on by governments when they make decisions about the best way to manage technological risks to human health, public safety, and the environment (Exhibit 1).
Exhibit 1 CURRENT PUBLIC DEBATE ABOUT THE ROLE OF SCIENCE IN DECISION-MAKING
The current debate, and the accompanying scepticism about the value of relying on scientific evidence is the es t f a n m e f fact s hese inc de
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g essive changes in ic making m de s sed in E Mem e States a a from traditional, technocratic, consensual models dominated by experts and t a ds m e en and in s me cases m e adve sa ia m de s
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ist ic eg at fai es m st n ta isks t h man hea th inked t SE dioxin, and contaminated blood, that undermined public trust in regulators and eg at science in the E in the s and s
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de gica c n icts a isks f m ne techn
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iticisms f scientific evidence as a ke kn edge in t f ic make s because of its inability to provide certainty. Some commentators also claim that the t aditi na scientific meth d is c nce t a inade ate hen faced ith the complexity of multi-factorial health and ecological problems created by mankind and ec n mic activit
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ic disag eements am ngst scientists es ecia in a eas inked t th eats t human health and the environment from new technologies, such as biotechnology, nan techn g and s nthetic i g
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e ce ti ns am ngst s me citi ens and stakeh de s that in the ast E ic make s and decisi n take s have a sed scientific evidence and sed it t stif decisi ns that e e made in ea it n the asis f n n scientific fact s his has nde mined ic c nfidence in the decisi n making meth ds sed the European Union.
t the m st effective and a iate gies and t tect the envi nment
a t manage
One consequence of this debate has been the increased reliance by governments in some OE ec n mies inc ding the E ean ni n n a it st dies and n n scientific evidence when making decisions about the best way in which to manage technological risks to public safety, human health and the environment. Where this has happened, it has significant inc eased the isk f eg at fai e he e egis ative and regulatory decisions are taken, additional risks to citizens and the environment are created, and incentives to invest in innovation are blunted. Urgent and systematic reform is needed to overcome these failings. Britain’s decision to seek its own path (‘Brexit’) and the failure of Europe’s economy to generate growth exacerbates the impact of these governance weaknesses, posing further challenges to the EU. In response, the EU’s institutions need to demonstrate that they can stimulate innovatory activity, whilst at the same time protecting citizens and meeting world-class standards of governance. One way to do this is to ensure that the best available science is the key input to the legislative, regulatory, and administrative decisions used to manage risk. 12
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1.2.
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Objective
his m n g a h e amines the a in hich the E s instit ti ns se scientific evidence to make decisions about the best way to manage risks to humans and the environment. It assesses the ems ass ciated ith the inc eased se f a it and n n scientific evidence t e amines the actices icies cesses and st ct es f the E s scientific advisory system. It highlights good practices, along with weaknesses and failings. Its principal aim is to set out a comprehensive and consistent framework of political commitments, institutional and legal ‘architecture’, and policies that, taken together, ensure that the best available science is the key input to the legislative, regulatory, and administrative decisions made by the EU institutions when they assess and manage risks to citizens and the environment posed by technologies.The monograph also highlights the importance for innovation of basing risk management decisions on the best available science. If implemented fully the recommendations will assist the EU institutions in realising the ectives set t in the ette Reg ati n ic 1. Finally, the monograph builds on and complements work carried out by the European Risk m ER team ve the ast decade inc ding the findings and c nc si ns f the study ‘Enhancing the role of science in the decision-making of the European Union’2.
1.3.
Scope
Re ecting the ide g a s f the E ean Risk m this m n g a h f c ses n the se f scientific evidence ithin the cess f managing isks sed the d cti n and use of technologies and by lifestyle choices, to human health, public safety, and the environment.
E ean (2015)) 2
mmissi n ette Reg ati n f
ette Res ts
nE
genda
mmissi n
mm nicati n
OM
Ballantine B. ‘Enhancing the Role of Science in the Decision-Making of the European Union’ (2005)
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It focuses primarily on evidence derived from natural and physical sciences and engineering because of their importance for understanding and managing risks posed by the production and use of technologies3. ina it c nside s the se f the est avai a e science and scientific assessments4 at a stages f the ic c c e ic f m ati n egis ati n and im ementati n th gh regulations, and substantive guidance5.
1.4.
Methodology and Report Structure
he findings c nc si ns and ec mmendati ns set f an e tensive g amme f esea ch ca ied t half of 2016.
t in this m n g a h a e the es t the ER ect team in the fi st
he g amme f esea ch inc des m e than c nfidentia in de th inte vie s ith academic e e ts f m the E and the S ega sch a s eminent scientists scientific advise s and g ve nment fficia s in Mem e States seni fficia s f m seve a ic di ect ates f the E ean mmissi n and f m E isk assessment agencies mem e s f the sec eta iat f the E ean a iament and e e ts f m c m anies and siness ganisati ns in the E and the S n e tensive desk esea ch e e cise as a s ca ied t t evie ed academic ite at e OE icati ns g ve nment icies and g ide ines th gh t the OE a ea and E Mem e States and E icies and guidance.
simi a em hasis n e ce ence s ted standa ds f evidentia a it ve sight mechanisms and advis standards, should apply to evidence generated by social science to support government decision-making. Scientific assessments a e eva ati ns f a d f scientific fact a in ts data m de s ass m ti ns and est fessi inf mati n hese assessments inc de t a e n t imited t evidence ana ses meta ana ses hea th safet ec gica integ ated assessment m de s ha a d dete minati ns e the S Office f Management and dget 5
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technica kn edge that t ica s nthesises m ti e na dgements t idge nce tainties in the avai a e state f science e ts techn g assessments eight f isk assessments t ic gica cha acte isati ns f s stances s e assessments S ce de ived f m a definiti n sed
Derived through administrative processes, substantive guidance decisions are a form of ‘soft’ law. These non-binding decisi ns a e made the E ec tive f ncti n hen im ementing c m e egis ati n he define technica scientific regulatory requirements needed to meet statutory obligations. Substantive guidance also includes detailed interpretations f stat t es fficia s he tend t have gene a a ica i it and t a in the f t e m st sinesses affected s stantive g idance the vide in actice a detai ed definiti n f the ega e i ement ai e t adhere to substantive guidance is, all too often, seen to be ‘prima facie’ evidence of non-compliance with the law. Most OE g ve nments and the E ean mmissi n make e tensive se f them a tic a hen im ementing isk management laws.
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he k f the ect team enefitted f m the e e t in t f m mem e s f a dedicated Steering Group and from the work carried out by the European Risk Forum team over more than two decades. he m n g a h is st ct ed in a n m e
f ha te s
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n the fi st a t ha te the e that scientific evidence a s in managing isk is c nside ed t identifies h decisi ns have t aditi na een ased n the est avai a e science and c nside s h scientific evidence is sed at diffe ent stages f the ic c c e t finishes e amining s me f the cha enges facing decisi n make s hen the seek t se scientific evidence t g ide isk management decisi ns
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ha te sets t a g d actice f ame k ased n a detai ed evie f initiatives taken the OE g ve nments and the E instit ti ns it sets t a f ame k of political commitments, institutional and legal architecture, and policies that, taken together, ensure that the best available science plays a pre-eminent role in the effective management of risk. It provides a set of benchmarks against which to compare the EU’s scientific advis s stem
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ha te assesses the E s scientific advis cess and the st ct a f ame k of politics, law, institutions, and policies that underpins and guides it. The assessment makes e tensive se f the g d actice f ame k a detai ed evie f c ent icies g ide ines and instit ti na st ct es and the findings f m the g amme f inte vie s t vides a ief desc i ti n f the E s s stem f viding scientific advice for risk management throughout the policy cycle. It highlights good practices and strengths. It assesses, and comments on, the structural dimensions (political commitments, institutions, policies, and guidance) of the EU’s system, as well as a aising its e ati n eaknesses and iss es a e identified
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n the fina a ts f the m n g a h c nc si ns a e set ec mmendati ns f ef m ha te
t
ha te
a ng
ith
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2. Governments, Risk Management and Excellent Science 2.1.
Governments and the Management of Risk
m e than ea s eginning ith fact egis ati n in the fi st ha f f the th ent ic management f isks t h man hea th ic safet and the envi nment posed by technologies has been one of the core functions of government. Over time, moreover, governments have recognised that this is best achieved when measures recognise the importance of economic vibrancy for longevity, improved health, and greater freedoms. This requires governments to develop and implement risk management strategies that deliver a high standard of protection whilst at the same time sustaining incentives to innovate. achieve these t in g a s m st OE g ve nments seek t ase isk management meas es n the findings f e e t s stematic assessments f isk that se evidence derived from the best available science, and that are informed by credible knowledge of real world exposures. da th sands f e e t scientific assessments a e ca ied t each ea M st are undertaken, as part of the executive function of government, to implement the requirements of complex risk management laws that often encompass production or usage of technologies. They include actions by companies to ensure compliance with d ct standa ds mandat evie s f eg ated techn gies g ve nment advise s and advice n eme ging iss es vided t fficia s ane s f eminent scientists Scientific assessments, including risk assessments, are one of a large number of expert processes used by the executive function to implement laws and as such form part of the so-called “administrative state”. nce t a the a e simi a in nature to the expert processes used to make decisions about welfare and education provision or market competition, for example. At their best and as part of the process of implementing laws, scientific assessments bring together evidence derived from the best available science and expert risk assessment knowledge from within the scientific community 16
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to provide high quality, predictable advice on which risk management decisions are based. This includes regulation, as well as the complex substantive guidance needed to interpret legislative requirements. ndeed ve the ast ea s g ve nments have made inc easing se f scientific evidence when managing technological risks to human health and the environment. Growth in the se f scientific evidence f decisi n making has cc ed f a n m e f eas ns These include:
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g essive e
ansi n in the isk management es
nsi i ities f g ve nments
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The emergence of new, complex threats to human health and the environment, identified th gh scientific esea ch
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The increased importance of the knowledge-based economy based on investments in science and technology as one of the principal drivers of growth in jobs and im vements in iving standa ds and a it f ife s a es t m de n ec n mies a e d minated d cts and cesses de ived f m scientific esea ch Science provides the principal mechanism for understanding the potential impacts of these d cts and cesses n h man hea th ic safet and the envi nment and
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ina scientific evidence and the scientific meth d have een high effective in providing theories with explanatory and predictive power. These reveal links between human health or the environment and technological hazards, and enable decisiontakers to anticipate problems and develop effective solutions. Basing risk management decisions on the best available science helps governments meet the needs of citizens for high standards of protection, without blunting incentives to innovate.
Science he
e Eminent n
edge n
t
2.2.1. Scientific Evidence When making decisions about the best way to manage risks to human health, public safety, and the environment, scientific evidence provides decisionmakers with unique insights. 17
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‘Science’ is a way of looking at the world through the testing of hypothetical explanations of the behaviour of natural or man-made systems. It is based on rationality. Through inductive and deductive reasoning science seeks to establish causeand-effect relationships based on evidence rather than dogma, beliefs, values, opinions, common sense, or superstition. t is a cess f en i the scientific meth d t is designed t e ective and t imit ias t is g ve ned a ig s meth d g and inci es f ve ifia i it e d ci i it and scientific integ it indings f m ne set f e e iments m st e d c mented e d ced the inde endent and simi a a ified scientists and s ect t independent peer review, before they become accepted as part of the existing body of kn edge he m st a s meet tests f meth d gica s ndness and f fa sifia i it Scientific findings m e ve emain visi na and s ect t cha enge h gh science is n t an enc c aedia f facts e esta ished scientific meth ds and theories have proven to be highly effective in identifying risks posed by technologies and in developing ways to mitigate them, without damaging economic activity. Uniquely, it enables governments to:
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dentif the e istence f ha a ds and thei ca ses ete mine hich ha a ds
se the g eatest isks t h man hea th
Red ce nce tainties in decisi n making ha acte ise isks Identify the existence of new, unintended risks that might be created through g ve nment acti n eve
techn
gica
effective st ategies t manage isks
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dentif f t e and eme ging ha a ds
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dentif the enefits f g ve nment acti n
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the envi nment
Scientific Evidence and the Management Of Risk
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v id ta geting inc nse
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cate es
entia
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ems hi st ign ing g eate
isks and
ces efficient
2.2.2. Managing Risks – The Benefits of Using Best Available Science E e ience f g ve nments th gh t the OE it ve m e than ea s suggests that basing risk management decisions on the best available science and expert assessment f isk eads t a se ies f eneficia tc mes E hi it
Exhibit 26 BENEFITS OF USING THE BEST AVAILABLE SCIENCE FOR THE PUBLIC MANAGEMENT OF RISK
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Regulatory quality – the best available science provides decision-takers with the opportunity to base decisions on credible evidence derived from widelyaccepted rational processes. This leads, over time, to increased regulatory quality. It is also consistent with commitments made by all members of the OE eginning in t ase eg at meas es n evidence6.
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Legitimacy - risk management decisions based on science improve public c nfidence in the ca acit f g ve nments t tect citi ens f m techn gica risks. It provides a transparent “intervention logic”, based on evidence, to stif the se f state e ic c nfidence and t a esse e tent t st is enhanced because decisions based on science, unlike those based on emotion or values, are also more likely to be effective, more rational, and more transparent.
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Protection sing the findings f e e t isk assessment de ived f m the best available science, enables risk managers to design highly effective measures that limit risks to citizens and the environment without creating unintended additional risks or damaging economic activity. Over time, this approach has contributed to increased longevity, health, environmental quality, and wealth. It a s ena es meas es t ev ve in es nse t scientific and technica g ess facilitating even higher levels of protection.
he m st im tant c mmitments a e set t in OE Rec mmendati n f the ve nment Reg ati n OE iding inci es f Reg at a it f the nci f the OE n Reg at ic and ve nance
nci
n m ving the a it f and OE Rec mmendati n
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Efficiency scientific evidence ith its ig s f c s n identif ing ca sati n he s isk assess s t deve estimates f tentia enefits f isk management measures. By combining this with estimates of the costs of proposed actions, g ve nments a e a e t ens e that enefits stif c sts and that s cieta es ces a e efficient a cated
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Risk-taking – when governments base risk management measures on the best available science and expert assessment of risk, it sends strong positive signals to entrepreneurs and risk-takers. It demonstrates that government decisions will be rational, guided by evidence and will deliver predictable regulatory outcomes. It recognises that a risk-free world is neither possible nor desirable. It supports a culture of risk acceptance. By achieving these things, incentives to develop and use new technologies are strengthened.
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Trade – global trade is based on rules that are, in turn, anchored in the best available science and expert risk assessment. WTO membership requires adherence to these rules. Trade frictions occur when countries design risk management meas es that fai t e ect these e i ements O enness t trade expands markets, strengthens competitive intensity and facilitates the spread of world-leading ideas, as well as improving internal productivity through specialisation and comparative advantage..
If these benefits are to be achieved, then scientific assessments must be undertaken by leading experts and utilise the best available science.Yet this does not always occur. On too many occasions regulators fail to accept that not all science is of an equal standard of quality. Many studies are erroneous or fail to meet the demanding e i ements f the scientific meth d a e ased n t f date scientific kn edge nd s metimes the findings f m ic c ns tati ns a e t eated as eing a f m f scientific kn edge Interventions based on poor quality evidence are more likely to result in regulatory failure, creating welfare losses, reducing protection, and undermining trust in the effectiveness of government and, ultimately, in its legitimacy.
2.3.
Science, Risk Management, and Innovation
In mature economies, higher living standards primarily depend on improvements in productivity fuelled by investments in innovation. Most are 20
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made by the private sector, and many involve large-scale expenditures on cutting-edge science to develop understanding, to exploit ideas, and to demonstrate safety, quality, and efficac Simi a investments a e made t ens e that e isting s stances and techn gies meet modern safety standards. When making investments in excellent science, companies assume that governments will assess risks using evidence of a similar standard and follow world leading risk assessment processes, leading to predictable outcomes. Regulatory decisions based on the best available scientific evidence and expert risk assessments establish a context within which businesses can innovate effectively and invest in new processes needed to up-grade productivity. By basing decisions on the best available science, regulators provide investors and managers with regulatory predictability: one of the most important ways of reducing uncertainty and expanding the potential value of investment opportunities. Lack of regulatory predictability undermines the value of potential investments and erodes incentives to innovate. Utilisation of the best available scientific knowledge, as a means to assess and demonstrate safety and to design risk management rules, also plays a critical role in creating incentives to invest in developing and adopting new technologies. Good practice acknowledges the need for governments to invest heavily, alongside experts in industry, in safety research and regulatory science7, and to design risk management a s ased n s ecific a icati ns athe than techn gies if investment in new technologies is to be promoted. “Upstream engagement”, whereby governments promote early public debates about technologies and risks can help too, so long as its weaknesses are recognised. It is a process of discourse. It is not a substitute for representative government and has no itica egitimac nd hen s ch disc se takes ace it is a t easi d minated vested interests or it becomes subject to “ideological capture”, leading, in turn, to distorted outcomes.
7
Regulatory science is the science of developing new tools, standards, and approaches to assess the safety (and sometimes the a it and efficac as e f eg ated d cts S ce de ived f m the definiti n sed the S
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Scientific Evidence and he
ic
ce
Governments use scientific assessments at different stages of the policy cycle, when developing measures to protect human health, public safety, and the environment. n s me stages scientific evidence acts t inf m decisi n make s hi st in the a ts f the cycle, most notably during the implementation of laws, decisions tend to be based on science S ecifica
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During the preparation of policy scientific evidence he s a ngside the insights to inform and shape options, helping policy-makers to understand threats and design isk management st ategies that a e ike t e effective hi st scientific evidence because of its unique characteristics, enjoys a privileged position as a source of knowledge, its role, alongside other factors, is to inform policy-makers. Scientific advice is vided th gh a ange f mechanisms inc ding ane s f eminent scientists, foresight programmes, consultancy studies, and government scientists.
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In the legislative phase isk assessments ased n the est avai a e scientific evidence, are a critical input and provide the basis of a robust “intervention logic”, justifying the use of the powers of the state. They provide the only credible means of identif ing ems and thei ca ses and hence the tentia enefits f acti n ina risk management decisions are, however, formed through political processes that take int acc nt a ange f fact s scientific evidence inf ms t d es n t a a s decide Whilst it is the role of politicians to mediate between different values within society, risk management decisions based on robust rationales derived from evidence deliver better outcomes and greater accountability. n this stage s ces f scientific evidence inc de isk assessment agencies g ve nment scientists, consultancy studies, and research programmes.
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Most national governments base implementation decisions on the outcomes of science-based risk assessments, recognising the importance of predictable, high quality decisions for achieving protection and sustaining incentives to innovate. Decisions are science-based in this stage of the cycle. They include regulatory decisions such as pre-
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market approvals for new pharmaceuticals and limit values for emissions, as well as s stantive g idance e i ed t inte et and define the technica e i ements f risk management legislation. Scientific evidence n ma f ms a t f f ma isk assessment cesses nde taken by government agencies or permanent committees of independent scientists. In this stage, evidence generated by scientists with close links to industry is likely to be one of the most important sources of knowledge.
▪
ina scientific evidence f ms an essentia in t int the evie hase regulatory cycle: ex post evaluation indings f m ne scientific esea ch important insights into the need for and effectiveness of legislative decisions.
f the vide
imitati ns n the se f Scientific Evidence s an in t int the eg at c c e science a ng ith a the f ms f evidence sed by policy-makers and decision-takers, has its limitations (Exhibit 3).
Exhibit 38 MOST IMPORTANT LIMITATIONS ON THE USE OF SCIENTIFIC EVIDENCE8
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Structural limitations of scientific evidence – it cannot resolve “valuesased esti ns it cann t dem nst ate a s te safet nce tainties a e ften esent and findings a e f e ent visi na hese a e cha acte istics f the scientific meth d as e as s me f its st engths nc easing h eve the are used, to manufacture controversies, providing a mechanism to obfuscate debates about values.
S me f the c iti es f scientific evidence a g e that eca se f these and the imitati ns it sh d e vie ed as sim another opinion, and hence should have no more weight than any other opinion in the legislative and regulatory process. his a g ment fai s t ec gni e the cess th gh hich scientific evidence is gene ated the scientific meth d t is this powerful and well-established process, and the nature and quality of the evidence generated by it, that makes the best avai a e science a ivi eged in t in isk management decisi ns in m st OE c nt ies
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▪
Lack of capability of policy-makers and decision-takers to make use of scientific evidence s me ic make s and fficia s ack scientific ite ac eading t a fai e t nde stand the st engths and imitati ns f scientific evidence. There is a lack of understanding of methodological principles and of the c nce ts that nde in scientific evidence and its assessment S ch ga s in knowledge contribute to a lack of understanding of the differences between ‘correlation’ and ‘causation’ or between ‘hazard’ and ‘risk’, as well as a growing failure to recognise that not all studies are of good quality.
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Lack of public confidence in the utility of scientific evidence – there has been a noticeable decline in public trust in government institutions over the ast th ee decades e ecting a gene a dec ine in s cia defe ence his ide shift in public attitudes, along with a series of regulatory failures in the 1980s and s has he ed nde mine the c nfidence f citi ens in the a i it f g ve nments t se scientific evidence t tect h man hea th ic safet and the environment.
▪
Technological threats and scientific uncertainty – the type of risks that governments focus on is changing. There is increased emphasis on trying to nde stand c m e diseases and dis de s s ch as ehavi a diffic ties fe ti it ems ifest e im acts m ti fact ia ha a ds m ti e e s es and very low-level exposures. Many of these pose challenges for traditional scientific nda ies s me a e ve sma isks detecta e n th gh advances in meas ement techn gies and the s e ect s cia c nce ns athe than scientific kn edge ndeed s me f these ic iss es s ch as those surrounding lifestyle choices, may prove to be debates about values that cann t e es ved scientific evidence
▪
Ideologically based concerns about the appropriateness of using scientific evidence to resolve “values-based” issues – this is a cha acte istic f af ent s cieties t d a s t gethe a ide ange f diffe ent critiques of modernism, industrialisation, and capitalism.
ha enges t
sing
igh
a it Scientific Evidence
Not all of the scientific evidence used by regulators is of an equal standard of quality M ch fai s t meet the demanding e i ements f the scientific meth d f example. Basing risk management decisions solely on scientific evidence that
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meets the highest standards of quality is, however, difficult. Governments must overcome a number of problems. These include:
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Challenges intrinsic to scientific progress scientific kn edge has advanced d amatica in the ast t decades in a eas s ch as genetic in ences n cance s and allergens, making old studies redundant and questioning some of the traditional methodologies used to understand hazards and risks.
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The negative impact of low quality studies - a succession of alleged hazards, e agge ated nce tainties and a a ent scientific c nt ve sies have eme ged ased on low quality studies or misinterpretations of evidence or poor quality hypothesisforming science.
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Gaps in reproducibility and verifiability - recent research across all branches of natural, physical, and social science suggests that there are problems of reproducibility and ve ifia i it a cent a feat e f the scientific meth d he em is m st ac te in social science, an area of knowledge increasingly important for understanding usage ehavi as a t f the isk assessment cess n ess the findings f scientific st dies can e e icated then thei va e f scientific assessments and hence f tecting citizens, is questionable. New initiatives, most notably the movement towards “open science” publishing, have een esta ished t t and s eed the avai a i it f findings f m scientific esea ch t its est this ma make m e high a it st dies avai a e m e ick at its st because it by-passes traditional peer review processes, it could trigger a wave of alleged hazards based on low quality or misleading studies that have not been reviewed independently or replicated.
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Complex, multi-causal risks - understanding complex, multi-causal risks poses challenges to regulators. One way of achieving this is to widen the range of disciplines inv ved in isk assessment hen c m ementa scientific disci ines a e ght together, as has occurred in recent work to exploit mathematical modelling knowledge to improve understanding of allergens, then this approach is effective. In contrast, when it involves integrating lay knowledge or social science with natural and physical sciences, then the ti it f scientific evidence isks eing nde mined 25
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▪
Inconsistent standards of assessment scientific assessments a e inc easing provided to risk managers by a variety of national and international institutions. In s me cases the e tent t hich s ch evie s meet g d actices f scientific assessments or are properly informed by “real world’ knowledge or by modern scientific nde standing is inc easing c ntested e e t isk assessment agencies and eminent scientists nce ns have a s een aised a t the im a tia it f s me c nc si ns eca se f a a ent fai es t identif and high ight f c n icts f interest and ideological biases of contributors.
▪
Restricted access to knowledge - access to the best available science and excellent scientific e e ts is in s me cases est icted eca se scientists h k ith industry are prevented from providing advice to governments. This poses a serious isk t the f t e ti it f scientific assessments sed g ve nments ndeed in the a eas eg ated m de n isk management a s a m st a ma scientific advances take ace ima i ithin ind st his inc des m st safet esea ch e ecting ega requirements. If scientists are excluded from advising governments because they work ith ind st then scientific assessment is eakened citi ens a e n t tected and there is regulatory failure.This is an emerging, but clear, trend and its impact will worsen over time, as leading scientists are forced to choose between working, alongside the private sector, at the cutting edge of science, or advising government institutions.
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Expert criticism et s ective ana sis e e t scientists f scientific assessments has identified a n m e f ems ith s me f the evidence sed and its inte etati n ems inc de citati n ias icati n ias tc me shifting ve in ence f d st dies ased n t f date scientific kn edge s se ent fa sified neve e d ced statistica ana sis a it e idemi gica st dies given ina iate minence and c nf si n et een c e ati n and ca sati n9.
In the light of these concerns, it is increasingly important for governments to establish robust quality standards to ensure that scientific assessments are based solely on the best available scientific evidence. he ch ane a ati n has d c mented man f these fai ings the insights can e f nd in e Re ativism eg ati n and the dange s f indiffe ent science he Si R ame n ect e t the R a ege f ath gists ic g e Re d ci i it in e e imentati n the im icati ns f eg at t ic g R a S ciet f hemist ic g Resea ch and R Statistica E s va es the g d standa d f statistical validity, are not as reliable as many scientists assume’ (Nature,Vol. 506, 2014)
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Evidence from a detailed review of reforms undertaken, suggests that many governments in the OE a ea have eg n t take ste s t ens e this ndeed these ef ms hen taken together, provide the basis for the development of a framework of good practices that link political commitments, institutions, policies and guidance. Used appropriately, such a framework provides a benchmark, alongside other sources of evidence, against which the c ent scientific advis s stem f the E s instit ti ns can e assessed viding a means to identify potential gaps and recommendations.
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3. A Good Practice Framework 3.1.
Overall Structure
It is the collective behaviour of policy-makers and officials that determines whether the best available science guides risk management decisions designed to protect human health, public safety, and the environment from technological risks. Behaviour is the result, in part, of shared attitudes and values, as well as custom, practice, and organisational incentives. Shaping behaviours in complex organisations is not easy and there is no single, or simple, right way of ensuring that the best available science plays a pre-eminent role in the effective management of risk. eve ve m e than t decades g ve nments have nde taken ef ms in the face f c mm n ems and in s it f simi a g a s na sis f these inte nati na activities, complemented by insights from experts and detailed long-term work by the ERF, highlights a framework of good practices that underpin the effective use of the best available science for regulatory decision-making10. Rather than providing a rigid and prescriptive approach, the framework provides a benchmark model, derived from actions by governments, against which to assess current activities at EU-level and to highlight areas of possible reform. The practices are interlinked and are designed to change behaviours and the attitudes that underpin them. They are grouped into four main categories, so as to high ight thei st ategic c m ehensive and inte na c nsistent nat e S ecifica
▪
itica c mmitments in dem c atic s cieties sha e the e ected ehavi g ve nment fficia s and make e ected e esentatives acc nta e f es ts
10
he f ame k is de ived f m a evie f initiatives nde taken in st a ia anada the E ean ni n in and ance e man ta a an e ea and S it e and S th ea nited ingd m and the nited States f me ica t is also informed by more than two decades of research by the ERF team, and expert contributions by the ERF’s academic advisers, and participants in Risk Forum meetings.
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s
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▪
ega changes
he e a
iate einf ce this
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ens ing c a it and c nsistenc
▪
Institutional structures allocate authority and power, establishing accountability, a cating es ces c eating ve sight and ens ing c m iance
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icies vide a detai ed f ame k defining ectives inci es and standa ds in ke a eas a tic a the a it c ecti n and se f evidence scientific e e ts and c mmittees and isk ana sis gethe ith ega e i ements the a e essentia f ens ing ng n adhe ence t itica c mmitments and
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Finally, operational guidelines describe, in detail, the new processes that must be followed, including interpreting and complementing legislation.They allow processes to es nd e i t advances in scientific and technica kn edge nd the eass e citizens that action is being taken.
The framework also distinguishes between “science advisers” and “science experts”. Science advise s mediate et een the cesses designed t gene ate scientific evidence and politicians and regulators. They form part of the wider structure responsible for eg at cess management n c nt ast scientific e e ts s e vide evidence
d
actices
igh ights
The practices include:
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iticians at the highest eve f g ve nment make f ma ic c mmitments t se the best available science as the pre-eminent knowledge input to inform and guide risk management decisi ns ec gnising its ni e insights
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There is a central oversight body, reporting directly to the head of government. It is es nsi e f the effective g ve nance f the cess f c ecting and sing scientific evidence
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Legislative requirements include a law of administrative procedures that establishes due process standards for the implementation of laws by the executive
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function that can be subject to judicial review and which embed the major principles f g d administ ati n
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There is a well-resourced, long-term programme of investment in the development of regulatory science
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c ea g ve nment ide ic e i es g ve nment decisi n making t e g ided by the best available science. It sets out the objectives and principles that describe the a it f scientific evidence as e as its se and c ecti n t ec gnises the ni e cha acte istics f scientific evidence and states e icit that e ce ence and relevance, regardless of the source of funding, are the sole criteria for determining hethe n t scientific evidence is inc ded ithin a scientific assessment
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ea h i nta icies a e a s d a n f the selection of scientific experts and for the operation of scientific committees. Selection processes for participation focus primarily on ‘excellence’ and ‘relevance’, and take account of different challenges t im a tia it m st n ta c ent financia c n icts f inte est and ide gica ias
m e e tensive desc i ti n f the f ame A.
30
k fg
d
actices is inc ded as Appendix
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4. Scientific Evidence and EU Management of Risk nde stand and desc i e the E s scientific assessment s stem and t identif its strengths and weaknesses, it is necessary to utilise a range of different forms of evidence. nte vie s ith fficia s academics and e e ts f m c m anies and siness ganisati ns vide im tant insights m a is ns ith the f ame k f g d actices high ight ga s and t nities f ef m nd a detai ed evie f e isting activities cesses policies, and structures provides additional ideas. his ha te sets
t the findings f this evie
▪
Secti n desc i es the main cha acte istics f the E s scientific assessment s stem f c sing n its h i nta dimensi ns
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In Section 4.2, the structural framework is assessed, covering political commitments, instit ti na a chitect e ega e i ements and ic f ame k and
▪
n Secti n
the
e ati n f the E scientific assessment
cess is e amined
E Scientific ssessment S stem At EU-level, the system of scientific advice used to support decision-making has developed progressively since the Union’s inception. Since the1980s, there has een a ife ati n f scientific advis cesses e ecting a shift in ic i ities away from facilitating trade and towards acting as a public risk manager. To support policy-making inc ding meas es t manage isk fficia s d a n a ide ange f instit ti na s ces f scientific evidence hese inc de ini ns and e ts f m E agencies ini ns f m f ma scientific c mmittees and e e t g s managed ic di ect ates e e t st dies and advice f m the int Resea ch ent e R es ke c ns tanc e ts c mmissi ned di ect ates agencies e ts f m scientific advis dies in the E Mem e States in h se ana ses fficia s and e ts f the E ean a iament vided the Science and echn g ssessment ane S O and the E ean a iament Resea ch Se vice E RS
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n c nt ast a m e imited ange f s ces f scientific evidence is sed t s t the implementation of risk management laws. Broadly, these can be grouped into three categories:
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nde endent scientific c mmittees c nt ed S E S S and S EER c mmittees E S and EM S OE c mmittee hese dies a e made f experts appointed in their personal capacities, following self-application to public calls f inte est
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Scientific assessments Mem e States s ca ed efe ence Mem e State then ve seen end sed a echnica king mmittee f the e e ts d a n f m Mem e States EM and E a ach f e am e and
▪
mit g c mmittees set the egis at a ne t assist the mmissi n in ic a eas legislation.
a
te Scientific se this
nci and a iament nci he e it is em e ed t im ement
In most cases, legislation prescribes the process by which risk management laws are im emented inc ding he e a iate the need f and s ces f scientific advice This further strengthens tendencies towards fragmentation and a lack of consistency. ngside these agencies and c mmittees the int Resea ch ent e R the E ean mmissi n s in h se scientific se vice vides additi na scientific and technica e e tise t the mmissi n s hi st the igh eve f Scientific dvise s f the ne Scientific dvice Mechanism S M vides scientific advice t the ege f mmissi ne s n s ecific ic iss es he e s ch advice is c itica t the deve ment of Union policies or legislation. In overall terms, the structure and nature of the scientific advisory system supporting the EU’s institutions primarily reflects the specific decisions of a series of different risk management laws and their disparate political considerations, combined with the bureaucratic practices of different parts of the European Commission.
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4.2.
European Risk F
Structural Framework
4.2.1. Political Commitment ic s tf m iticians at the highest eve is an essentia e c nditi n f the se of the best available science as the pre-eminent knowledge input for the management of risk. At EU-level, these commitments are unsystematic, ambiguous, fragmented, and limited. he e is f e am e n f ma c mmitment f m the nci ec gnising the e f the best available science in regulatory decision-making, nor is this included in the 2016 Internstit ti na g eement n ette a Making11. f the em is that ecent ic statements the E ean mmissi n a ea to express a preference for basing controversial risk management decisions on politics athe than the est avai a e scientific evidence12. This ambiguity towards the importance of science for the management of risk is further demonstrated by the cessation of the mandate f the hief Scientific dvise a inted esident a s 13, and a series of high fi e decisi ns t ve t n evise the findings f high a it scientific assessments carried out by the EU’s risk assessment agencies14. In contrast, the European Commission has recognised elsewhere, the importance of robust high quality scientific evidence for policy-making. S ecific e am es inc de the mmissi n s ette Reg ati n ic and the mmissi n ecisi n esta ishing the ne Scientific dvice Mechanism15 Statements a s M edas the 11
he nci has iss ed nc si ns n esea ch integ it to guide risk management decisions.
12
See statements inc ded in
13
The creation of this position represented a major step forward in the creation of institutional structures that could, with additi na ef ms ve see the a it f scientific evidence sed t inf m decisi n making eve the st c eated as eak st ct a it acked h man and financia es ces it as n t integ ated int the mmissi n s ced es it had n ega asis the e as n instit ti na ink t the R t R and timate it did n t en s fficient itica s t f the em as the est icti n n t ans a enc
14
m tant ecent e am es inc de est icti ns n the se f is hen and the fai e t ene f the icense to use Glyphosate, a crop protection substance. Both cases involved implementation decisions, working within frameworks defined egis ati n nd in th instances the findings f high a it scientific assessments ca ied t E S ee n t acce ted fina decisi ns e e n t ased n est avai a e science
15
E
ean
mmissi n
esident
mmissi n
ncke s
itica
ecem e ide ines f
ecisi n esta ishing the
t n t n the need f his
igh eve
est avai a e science
mmissi n
f Scientific dvise s
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mmissi ne f Resea ch Science and nn vati n have einf ced these c mmitments16. These comments and commitments, whilst important, need to be consolidated and supported by all of the EU’s institutions.
4.2.2. Institutional Architecture cha acte istic f the m st effective scientific advis s stems is the esence f a st ng central oversight body equipped with the authority and institutional power to establish and enf ce c mm n standa ds f the a it c ecti n and se f scientific evidence inc ding the f ncti ning f scientific c mmittees he e sh d a s e f ma mechanisms for sharing good practice. No such powerful, horizontal institutions exist at EUlevel. he e is h eve s me evidence f g ess nde the a s esidenc a hief Scientific dvis as a inted c eating the ssi i it f deve ing an instit ti na st ct e and aising the fi e f the need f the est avai a e science ega d ess of its origin, to guide risk management decisions17. This initiative, and attendant political momentum, was lost, however, when the current presidency did not renew the post. In its ace a mmissi n ecisi n esta ished in the Scientific Advice Mechanism (SAM). ith the aim f viding scientific advice inde endent f instit ti na itica inte ests t the ege f mmissi ne s the S M has t main feat es i st the e is a igh eve f Scientific dvise s a inted t im ve the inte acti n ith the scientific c mm nit and t ens e inde endence t ans a enc and scientific integ it f the advice vided t the mmissi n th gh the S M cess dvice sh d f e am e e ased n the est ssi e scientific evidence he sec nd feat e is a c se king e ati nshi ith E e s science academies n initia ste t a ds achieving this as the Mem and m f nde standing signed in et een the five main ass ciati ns cademia E ea E E S E SE and E M f m e than egi na and national academies and learned societies. 16
See for example his speech in May 2015
17
esident a s in his s eech t the E scientific advice th gh t a stages f in 2012.
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ean a iament in high ighted the im tance f this e f de ive ing ic deve ment and de ive he st f hief Scientific dvise as c eated
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eati n f the S M ma ks a ma ste f a d in the deve ment f cent a h i nta instit ti ns designed t ens e the a it and c nsistenc f scientific evidence sed th gh t the E ean mmissi n and its agencies es ite this m e needs t e d ne t e and significant the instit ti na a th it and e s f the S M t is n t responsible, for example, for developing, overseeing, and steering ‘horizontal’ policies for scientific evidence and scientific c mmittees f the instit ti na ef m t k ace in ith the c eati n f the EU Agencies Network for Scientific Advice (EU-ANSA). Established under the direction of the eads f E gencies this inf ma and a t time g m tes c e ati n et een agencies n iss es f c mm n inte est e ated t the visi n f scientific and technica advice ts k is ec ming g essive m e in entia n f e am e it c nside ed the e that ee evie f scientific assessments an esta ished g d actice in the a ts f the OE a ea c d a in im ving the a it f evidence sed t guide regulatory decisions. More needs to be done, however, if this nascent institution is to th ive dditi na es ces a ide mandate and instit ti na e manence a e a needed ina an nde ing st ength f the mmissi n s scientific advis cess is its in h se scientific di ect ate the Joint Research Centre (JRC). This powerful body, with its dee technica and scientific es ces vides the mmissi n ith an instit ti na mechanism for rapidly strengthening the role of best available science in risk management decisions. Its recent strategy review demonstrates a commitment to achieving new goals, inc ding a st ategic f c s as a kn edge manage f the mmissi n18 cti n is needed h eve t em ed the R in a ide set f ef ms s as t take f advantage f its instit ti na scientific and technica st engths
4.2.3. Legal Requirements One f the m st im tant cha acte istics f the est scientific advis s stems is the presence, within the legal framework, of laws of administrative procedure that require the executive function to adhere to standards of good administration when implementing laws, including those designed to manage risk. No such law has currently been adopted at EUlevel, despite the presence, in the Treaty, of legal bases enabling its establishment. 18
E ean mmissi n 2030’ (2016)
int Resea ch ent e he E
ean
mmissi n s Science and n
edge Se vice
R St ateg
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Instead, the EU legal framework lacks clarity and consistency th gh va i s provisions of the Treaty, most notably those dealing with approximation of laws and ith envi nmenta tecti n e i e scientific evidence t e taken int acc nt the e i ements a e inc m ete a it th esh ds a e n t set t the E eaties and there is no attempt to establish a hierarchy of importance of different sources of evidence to be used in decision-making. Instead, these issues are dealt with, albeit unsystematically, in sec nda egis ati n g idance d c ments and in E case a The European Courts have engaged e eated ith the e that scientific assessments should play in regulatory decisions. When considering actions by Member States that d imit t ade ithin the Sing e Ma ket the ts have tended t e i e est icti ns to be based on assessments of risk, supported by the best available science. In contrast, ve the ast t ent ea s the ts have sh n g eate defe ence t acti ns f the EU executive, in part because the Treaties do not provide an indication of the standard of evie that sh d e a ied t scientific evidence he have ef ained f m esta ishing st ng ced a s stantia c nst aints n the se the E s instit ti ns f scientific evidence to guide risk management decisions. Secondary EU legislation, designed to manage specific risks, establishes, in some instances, clearer quality thresholds and procedural requirements for scientific evidence. The EU General Food Law of 2002, for instance, requires the European Food Safet genc E S t vide the est ssi e scientific ini ns19. Evaluation of the a it safet and efficac f medicina d cts f h man vete ina se E ean Medicines genc EM sh d acc ding t the stat te e ased n the est available science20 nd the RE eg ati n e i es the E ean hemica s genc E the agenc es nsi e f assessing isks sed chemica s and thei se t f c s n viding the est ssi e scientific and technica advice21. Whilst these are all c ea e i ements the a e e evant n f each s ecific a ea f egis ati n22. They are n t h i nta standa ds M e ve the need f the definiti n inc ding f e am e 19
E Reg ati n
20
E Reg ati n
21
E Reg ati n
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f the c nce n is that the e emains m f im vement in man f these ve tica isk management a s th gh RE f e am e sets t e i ements f the a it f scientific evidence im tant as ects a e n t add essed in a clear and transparent way.
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g idance that sets t the cha acte istics f the est avai a e science i nta g idance dealing with this and similar critical technical issues does not exist at EU-level.
4.2.4. Policy Framework e f mandat h i nta icies and g ide ines a e a c mm n feat e f the m st effective scientific advis s stems he a e designed t ens e that advice and evidence a e f the highest a it that cesses f scientific assessment a e c nsistent and that standards of good administration are met. There are weaknesses and major gaps in the EU’s policy framework that make it difficult to achieve this standard.There are, for example, no common requirements for scientific evidence (covering issues, for instance, such as the characteristics of best available science, Systematic Evidence Reviews or interpretation of complex forms of evidence including modelling and epidemiology), selection of scientific experts, rules of procedure for the functioning of scientific committees, and risk analysis. he stead ife ati n f scientific advis cesses at E eve has e ace ated the inade acies f the mmissi n s eak h i nta instit ti ns icies and g idance f ens ing the a it and c nsistenc f scientific advice n t n this has ed t c iticisms the E Om dsman f the fai e f s me a ts f the scientific advis s stem t meet expected standards of good administration. he e a e a n m e f s ecific ems egin ith the e is n h i nta isk ana sis policy. The nearest equivalent is included in the 2002 General Food Law. This sets out the general principles of risk analysis, but its focus is on food safety only and it is not a mandatory requirement for the management of other risks. f the em is the f agmented and inc m ete ic f ame k f the a it c ecti n and se f scientific evidence mmissi n mm nicati n in c ve s the collection and use of expertise, and includes some general principles such as independence, excellence and transparency23 t is n t h eve f c sed s ecifica n scientific evidence and its requirements are not binding. They take the form primarily of practical tips and general advice.
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he mmissi n s ette Reg ati n ide ines in ma ked an im vement24.Whilst the d n t f c s s ecifica n scientific evidence the d c mmit the mmissi n t using the best available evidence in a transparent manner to support decision-making. hese e i ements a e c a ified f the in the s ting technica g idance that advises eg at s t ase meas es n the est evidence inc ding scientific advice ite ia f quality standards are not, however, provided and measures to manage risks to human health, public safety and the environment do not require explicitly the support of a scientific assessment he intenti n t se the est avai a e science t s t scientific assessments is f the einf ced in the mmissi n ecisi n t est ct e S E s inde endent 25 scientific c mmittees . From this range of different policy statements, requirements for the quality, collection, and use of scientific evidence can be pieced together. The next step is to build on this and establish a single, horizontal policy, supported by technical guidance. he fina em is the lack of a consolidated horizontal policy setting out common requirements for the selection of scientific experts and the functioning of scientific committees t esent e i ements a e f agmented and in some instances, problematic. There are, for example, no common standards for the se ecti n f scientific e e ts the than a e i ement in es nse t an en i the E ean Om dsman t disc se financia c n icts f inte est26. This has now been einf ced a mmissi n e i ement c ve ing the c eati n and e ati n f e e t g s f a f ms f ec n mic c n icts t e disc sed27 ndeed this f c s n financia links as the primary challenge to impartiality of experts is one of the few common themes in this a ea and it ses ma ems f the a it f scientific assessments
24
E
25
E
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n the E ean Om dsman c nd cted an groups. Recommendations were made in 2016.
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Evidence from international good practice identifies, historically, two types of ‘interest’ that might challenge impartiality: current financial links and ideological bias. Both should be assessed when considering the suitability of scientists to support regulatory decision-making28. This does not, in general, form a t f the E ean mmissi n s a ach t the se ecti n f scientific advise s nstead the f c s is a m st enti e n financia c n icts n actice this has the effect f ta geting and e c ding scientists ith inks t ind st his e des the a it f scientific assessments because of the importance of industry support for R&D in general and the role of industry knowledge in understanding many of the risks managed by EU laws. There are, however, some good practice examples at EU-level that could serve as a framework for the development of a future horizontal policy. DG S E s inde endent scientific c mmittees ad ted in f e am e c mm n es of procedure that emphasise the importance of relevance, excellence and balance in the se ecti n f scientific advise s and ec gnise that va es a ng ith itica and ide gica stances, threaten independence29.
O e ati n f E Scientific ssessment
cess
Many of the scientific assessments carried out by the EU institutions are of high quality, and a number of good practices have been developed to try and improve consistency and utility, as well as, in a number of cases, to share ideas across different parts of the Commission and its EU agencies. Examples include:
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EM s ig g idance
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k EM t t and im d g deve ment ith t
28
cademic esea ch in this a ea has advanced ecent and s ggests that iased ehavi he e im a tia it is cha enged es ts f m a ide ange f c n icts f inte est hese inc de ec n mic fact s as e as n n mate ia factors including ideology, values, experience, status, power, personal commitments, and professional ambitions. This suggests that the causes of bias may be more widespread than has been considered traditionally, and that future policies f the se ecti n f scientific e e ts sh d e ect this See f e am e Sha vi S in a kan R and a S Se f se ving stificati ns ing ng and fee ing m a ent i ecti ns in s ch gica Science
29
S E R es f ced e f the Scientific Eme ging and e dentified ea th Risks
s science ased
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ve the att activeness f investment ec n mics f ne e ing standa ds f tecti n
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ea th and Envi nmenta Risks and
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▪
se f ee medicines
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se E g idance
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Eas t nde stand science fact sheets S E and
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Emerging network of national science advisers.
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he isk c mm nicati n nde taken E S in afte its scientific assessment f the hea th isks sed is hen is a s seen t e an e am e f g d actice Indeed the study concluded that there was no health risk at current exposure levels, and this was extensively explained to citizens using a variety of communication techniques. f these initiatives and e am es dem nst ate the tentia f and for achieving excellence that lies within the EU institutions.
ad
ting est
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Whilst there are clear examples of excellent scientific assessments, and of the adoption of best practices by parts of the Commission, there remains a clear lack of consistency, transparency, and predictability. In too many cases, scientific assessments do not meet world-leading standards. S ecific ems inc de
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Inadequate expertise of some Technical Working Groups and Scientific Committees as a means f taking advantage f the scientific e e tise ithin the
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Mem e States and f inc easing itica s t f diffic t technica decisi ns the E instit ti ns se echnica king s s and Scientific mmittees t nde take scientific assessments in s me a eas s and Scientific mmittees comprise representatives, with relevant expertise, from each Member State government. n s me cases these g s f ncti n e viding edicta e high a it scientific assessments. In other cases, however, assessments do not meet world-leading standards or are inconsistent or are based on poor quality science. hese ems a e d e a dive se ange f fact s inc ding ine a ities f scientific kn edge et een Mem e States fai e t a int eminent e e ts s it f nati na itica g a s athe than assessment f scientific evidence ack f e evant t date scientific kn edge and ve am iti s mandates that st etch e e tise t thin eading t ma ga s in scientific and technica kn edge
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Lack of expertise of some independent scientific assessment committees – in s me ic a eas c mmittees f inde endent scientists a e sed t vide scientific assessments. This enables the EU institutions to make use of the expertise that lies ithin the E s ide scientific c mm nit t its est this a ach has he ed t im ve the a it f scientific assessments sed t g ide isk management decisi ns Increasingly, however, important weaknesses have become apparent. These include a lack of understanding of risk assessment practices in industry or of real world uses f s stances and techn gies ack f c tting edge scientific kn edge in ne a eas s ch as mathematica m de ing and a ack f scientific eminence These weaknesses are the result of a range of factors: low rewards for participation as an inde endent scientist a intment n the asis f c ite ia the than e ce ence and ‘ad hominem’ criticisms of independent scientists. It is also a direct result of the a in hich c n ict f inte est es a e a ied the mmissi n and its agencies leading to the exclusion of many leading experts because of their work with industry.
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Exclusion of experts with links to industry – in most of the areas regulated E isk management a s scientific advances and acc m an ing safet esea ch take place primarily within industry. Today, over 85% of all of R&D carried in the EU inv ves ind st f nding e ecting the g a s f ide inn vati n m ti n icies 41
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a tne shi s et een the ivate sect and esea ch instit tes nive sities ccess t this kn edge is essentia if scientific assessments a e t e f the highest a it thereby protecting citizens and avoiding regulatory failure. Too often, this knowledge is not available to decision-makers because scientists are excluded from advising EU institutions because they currently work with industry or have ked ith siness in the ast a e e ceived t have financia the inks with the private sector. This is an emerging, but clear, trend and its impact will worsen over time, as leading scientists are forced to choose between working alongside the private sector, at the cutting edge of science, or advising EU institutions. his em has its igins in the es nse f fficia s t ic c nce n a t tentia c n icts f inte est nde mining the a it and c edi i it f scientific assessments n es nse the E ean mmissi n s ted the E Om dsman has im emented icies f the se ecti n f scientific e e ts that f c s ima i n financia c n icts as a cha enge t im a tia it nd t achieve this it c n ates academic employment with ‘independence’. This has the effect of focusing on who produces scientific evidence athe than the cess th gh hich it is d ced and the a it of the evidence itself. It is, moreover, anachronistic because it fails to recognise the nature of modern relationships between academia and business.
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Failure to ensure impartiality of all scientific experts – good practice requires th ide gica ias and financia c n ict f inte est t e c nside ed ef e a inting scientists to expert groups. The purpose is to highlight all potential factors that might undermine the capacity of an individual to act impartially and in the public interest. his acts t inc ease ic t st in the ti it f scientific assessments and t inc ease c nfidence in the c m etence f ic isk management instit ti ns t
esent tests f ide gica ias a ea n t e a ied s stematica and ig s t s ective scientific e e ts the E instit ti ns n ess this is d ne ide gica em ti na na atives athe than the a it f scientific evidence ma nd in ence the tc mes f scientific assessments his ed ces the effectiveness f isk management rules and, if such failings are revealed publicly, erodes trust.
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Undue influence of old or low quality or unscientific studies – most EU risk management legislation requires companies to demonstrate the safety (and sometimes efficac and a it t f ne and e isting techn gies sing inte nati na ec gnised standa ds n s me instances the a s e i e scientific assessments t consider all known studies. Good practice suggests that this provision should not, h eve e i e a it st dies t in ence the fina tc me f an assessment athe that the e sh d e a ati na and scientific cess f c nside ing and he e appropriate, excluding such studies. ina scientific assessments the E s scientific advis cesses h eve a e n t a a s ased s e n scientific st dies f the same a it n a n m e f cases the tc mes f scientific assessments a ea t have een sha ed st dies that n nge e ect scientific kn edge a e ina iate inte eted d n t meet the standa ds f the scientific meth d s a es t f this the e have een n t man ccasi ns inc nsistencies in evidentia standa ds eading t a it scientific assessments. E am es f a it evidence inc de t f date st dies that fai t e ect m de n scientific nde standing have een disc edited even et acted envi nmenta im act m de s ith t ic avai a e data ass m ti ns eak e idemi gica st dies that fai t meet e esta ished standa ds f a it and ti it inacc ate statistica ana sis fai es t diffe entiate ade ate et een c e ati n and ca sati n and h thesis f ming ass m ti ns ith t st scientific stificati n
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Unpredictability of test requirements – substantive guidance, determined by EU risk assessment agencies and other advisory mechanisms, prescribes the tests that companies must perform to demonstrate that new or existing technologies meet ag eed standa ds f safet dea s ch e i ements e ect the tc me f a high a it scientific assessment and emain sta e ve time viding ce taint and edicta i it f invest s n ess the e is significant scientific technica g ess This standard of good practice is not always met by the EU institutions, leading to rapid evisi ns f g idance n t stified scientific evidence and c eating data ga s that c m anies cann t fi ith t significant nantici ated additi na e ense hen this occurs it erodes incentives to invest in innovation. 43
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Inappropriate application of the Precautionary Principle – EU institutions ec gnise f ma that the eca ti na inci e sh d n e a ied d ing the risk management phase of the overall process of risk analysis. It should not be used within the process of assessing risk30. Scientific assessments nde taken at E eve d n t a a s dem nst ate that this requirement is respected fully. Instead, there is evidence of a creeping, inappropriate a icati n f the c nce t f s stematic eca ti n n stified ng esta ished a aches f t ic g ithin the cess f scientific assessment Examples include “cherry picking” data or studies that support precautionary acti n nscientific e iance n a it st dies fai e t ens e that scientific assessments are based on the weight-of-evidence derived from modern Systematic Evidence Revie fai e t ank st dies sing inte nati na acce ted standa ds n the asis f a it and e evance fai e t e c de a it st dies n stified se f st case and h thetica e s es e c si n f high a it ni effect st dies e iance n m de s and academic st dies n e ated t ea d e e ience and the application of excessively conservative defaults and other bridging assumptions not stified scientific evidence
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Undue influence of public opinion on selection and interpretation of scientific evidence – when implementing risk management laws, evidence from throughout the OE a ea s ggests that the m st effective decisi ns a e ased n the tc mes f scientific assessments de ived f m the est avai a e science Risk manage s se this evidence t design effective s ti ns t ens e that enefits stif c sts Risk management decisions at EU-level do not always meet this standard. On too many occasions, the selection and interpretation of evidence by risk managers has been in enced ic ini n and s cia c nce n athe than the findings f scientific assessments.
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Politicisation of mandates the sc e f a scientific assessment is dete mined a mandate from the risk manager. In some cases this is determined by legislation, whilst
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in the s it e ects a s ecific c ent need d actice s ggests that mandates f scientific c mmittees sh d e c nfined t esti ns that can e ans e ed s e scientific evidence and that the sh d ec de va e dgements ini ns n a n m e f cases scientific assessments f E instit ti ns have een nde taken n the asis f mandates that em ed va es that e i e the e e cise f n n scientific dgements his nde mines the c edi i it f the cess f scientific assessments
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Lack of a “public record” requirement – most EU member states require the acti ns f the e ec tive f ncti n f g ve nment t meet ega defined standa ds f good administration. This protects citizens from abuses of power, increases openness and predictability, and helps make decision-making consistent. t E eve the e is a ack f ega enf cea e standa ds f g d administ ati n hence the e is n e i ement f a ic ec d that inc des a f the scientific evidence sed t stif an im ementati n decisi n ith t this scientific assess s and risk managers are able to include, within their deliberations, low quality studies or nscientific st dies that have n t een the s ect f an e e t S stematic Evidence Review.
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Poor risk communication g d administ ati n aces significant em hasis n transparency in the exercise of executive power, including the communication of the findings f significant scientific assessments hen this is d ne e it he s t id c nfidence in the effectiveness f g ve nment and he e a iate manage ic concerns. On t man ccasi ns c mm nicati n f the es ts f scientific assessments t isk managers and to the public by EU institutions prompts stigmatisation. When results a e n t e ained c nte t a hen nd e in ence is aced n nce tainties that cannot be resolved by science, then there is scope for misunderstanding and for the s cia am ificati n f isk
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Failure to defend science and scientists – risk management decisions, even when im ementing a s d n s me ccasi ns e ect n n scientific fact s his is a itica judgement by the executive function, for which it is accountable. When this occurs, 45
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g
d actice s ggests that it sh d n t e stified nce tainties dgements ithin a scientific assessment n ess the e is manifest e nstead fficia s sh d e ain the in ence f n n scientific fact s in thei decisi n making f f e am e they are seeking to assuage ‘concerns’ then they should state this. Too often this does not occur at EU-level, thereby undermining the credibility of the ide scientific assessment cess t a s sends negative signa s t invest s in innovation. Over time, it further reduces incentives for eminent scientists to contribute t scientific assessments at E eve
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5. Conclusions Over the last two decades, significant improvements have been made in the way in which the EU institutions collect and use scientific evidence to assess and manage the risks to humans and the environment posed by technologies and lifestyle choices. In some policy areas, this has stimulated the development of icies and cesses that de ive ide es ected high a it scientific assessments n a regular basis. Despite this, the process of reform remains incomplete. Looking ‘horizontally’ across a wide range of risk management processes and programmes, standards of scientific assessment and isk management a e inc nsistent and n edicta e and t man scientific assessments fai t meet g a acce ted standa ds f e ce ence S ecific ems inc de inade ate e e tise fai e t ens e im a tia it f scientific e e ts nd e in ence f a it st dies n edicta i it f test e i ements ina iate a icati n f the eca ti na inci e ithin scientific assessments ack f t ans a enc f scientific assessment and isk management isk c mm nicati n and an n i ingness f eg at s t defend science the scientific meth d and scientists Failings such as these in the governance of one of the world’s largest trading areas are the es t f c m e ca ses M st vi s the e ect the a in hich the s stem f scientific advice sed t inf m isk management decisi n making at E eve has developed. Over more than three decades, this process has taken place on a piecemeal basis da it e ects the s ecific g a s and e i ements f a se ies f isk management laws, combined with the bureaucratic practices and cultures of different parts of the E ean mmissi n t acks as a es t e f h i nta instit ti ns icies and guidance designed to ensure that the best available science is used to inform and g ide th gh t the ic c c e and that standa ds f g d administ ati n a e met itica c mmitments t ase decisi ns n the est avai a e scientific evidence a e limited, ambiguous, and inconsistent. No central oversight mechanism exists and there a e f e am e n c mm n icies and standa ds f the c ecti n and se f scientific evidence se ecti n f scientific e e ts f ncti ning f scientific c mmittees and isk
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ana sis itica h i nta g ide ines dea ing ith iss es s ch as the cha acte istics f best available science or the best practices for Systematic Evidence Review, are missing too. There are deeper, underlying causes as well. Some, such as the structural politicisation f im ementing decisi ns the mismatch et een egis ative as i ati n scientific capability, and technical capacity, are the result of decisions taken at EU-level, whilst others e ect ide changes in the c nte t ithin hich isk management decisi ns a e made and their impact on EU-level decision-makers. st in ic instit ti ns has dec ined e ecting a shift in s cia attit des and the im act of a series of regulatory failures in the 1980s and 1990s. Governance mechanisms continue to evolve in response to this, leaving many risk management processes embryonic or over-focused on process transparency and citizen involvement rather than ensuring the excellence of inputs as well as predictable and effective outcomes. It is all too easily forgotten that ‘participatory’ regulatory processes lack legitimacy, and that public trust depends, in part, on the effectiveness of government action. ina the siti n f scientific evidence as a ivi eged kn edge in t is th eatened Some citizens have little trust in science or in politicians. Others, taking a more intellectual perspective, argue that science is just opinion because there is no such thing as truth, and that all evidence must be biased because it is the product of human judgement. Science is thus elided with scientists. Such concerns and critiques create problems for politicians and eg at s and inc easing nde mine the se f the est avai a e scientific evidence t guide risk management decisions. h gh t a f this the scientific meth d scientific en human progress is ignored or dismissed.
i
and its c nt i
ti n t
Whilst expert scientific assessments may not be able to resolve conflicts of values or to establish definitively the absence of all risks, our lifestyles depend on them, our government is based on them, and complex decisions cannot be made without them.There is, moreover, no credible alternative. The challenge facing the European Union is to recognise this and to undertake the necessary reforms to improve and strengthen scientific assessments. It is the 48
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nat a c m ement t the OE s eg at inci es that a mem e g ve nments inc ding the E ean mmissi n s t It is the next step for the Commission’s much-admired Better Regulation strategy. It is the means to deliver high standards of protection for Europe’s citizens and for the environment, whilst at the same time helping to stimulate risk-takers to invest in the innovations needed to restore growth and prosperity.
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6. Recommendations Re ecting the mandate f the E ean Risk m a g amme f ef ms has een identified that f c ses n the se f scientific evidence t g ide isk management decisi ns at all stages of the policy-cycle (policy formulation, law-making, and implementation through rules, guidance, and administrative decisions). They are a set of reforms designed to change behaviours within a complex institutional framework. As such, they target change in political commitment, institutions, policies, and guidelines, and recognise that reforms take time to develop, accept, and implement. The reforms build on the many good practices already present within the EU institutions. Taken together, they target the underlying causes of the failings of the current EU-level s stem a ng ith the eaknesses in st ct es and cesses identified the ER s research. The programme set out is ambitious. It recommends extensive improvements and changes. Implementation will take time. Some reforms can be implemented within the next 1-3 ea s the s i take nge deas f immediate ef m a e a s set t in the E ec tive Summary of this monograph. Rec mmendati ns a e inc ded f a ange f diffe ent act s E instit ti ns c ective the E ean mmissi n the E ean a iament the scientific c mm nit siness and other organisations31. If implemented fully, these recommendations provide a means for the EU institutions to id a d eading cess f c ecting and sing scientific evidence t assess and manage risk: one of the most important areas of public policy. Standards of protection will be enhanced as a result, and innovation, the single most important process for delivering the s cia and ec n mic ectives f citi ens i enefit t edicta e isk management cesses anch ed in d c ass scientific evidence vide e f incentives f investors to support innovation and hence contribute to Europe’s prosperity.
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It is important to note that responsibility for ensuring the quality of individual studies rests with the scientists who undertake the research. Governments, however, are responsible to developing structures, processes, and policies for ensuring that the best available science guides and informs risk management decision-making.
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6.1.
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EU Institutions and Risk Management
6.1.1. Political Commitments Recommendation 1: ective the E nte nstit ti na g eement n ette a
instit ti ns sh d th gh a evisi n f the Making make a f ma c mmitment t
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Make and implement laws on the basis of high quality evidence, using globally-accepted standa ds f eg at management and g d administ ati n
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Design and implement risk management measures that protect human health, public safety and the environment while promoting economic growth, innovation, and job c eati n
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Use the best available science as the pre-eminent knowledge input to inform and guide risk management decisions to protect human health, public safety, and the environment, ec gnising its ni e cha acte istics as a s ce f insights and evidence
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Re i e scientific assessments inc ding isk assessments t e ect f e e ience and n ma c nditi ns f sage and e s e and
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mm nicate f ective and in a time manne the tentia isks sed substances, technologies, and processes whilst recognising explicitly that a zero risk society is neither possible nor desirable.
ea
d
Recommendation 2: i ding n its s tf esea ch integ it the nci f E Ministe s sh d affi m the e i ement t se f the est avai a e science as the e eminent input to inform and guide risk management decisions to protect human health, ic safet and the envi nment f instance ad ting dedicated nc si ns s e as ec gnising the ni e cha acte istics f scientific evidence the nci sh d high ight the importance for innovation of using the best available science to guide risk management decisions.
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6.1.2. Legislation Recommendation 3: The EU legal framework should be reformed to include a Law of dminist ative ced es that ec gnises the cent a e that isk assessment and the f ms f e e t scientific assessment a s in the im ementati n f a s hese activities sh d fa ithin the sc e f an E t sh d esta ish standa ds f d e process for the implementation of laws by the executive function that can be subject to judicial review and which embed the major principles of good administration. These are t ans a enc and c nsistenc ic a tici ati n ic ec d and acc nta i it ina the e sh d e a s ecific e i ement f the ic ec d t inc de a f the scientific evidence relied upon by risk managers.
E
ean
mmissi n
itica
mmitments
Recommendation 4: itica es nsi i it f the a it and effectiveness f the ve a cess f c ecting and sing scientific evidence t make isk management decisi ns sh d est ith the i st ice esident in cha ge f ette Reg ati n his portfolio, which aims to improve the quality of regulatory decision-making, is a logical complement to the existing Better Regulation policy, and should be closely co-ordinated ith the mmissi ne f Resea ch Science and nn vati n and ith the mmissi ne es nsi e f the int Resea ch ent e
E
ean
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chitect e
6.3.1. Central Oversight Body – Scientific Advice Mechanism Recommendation 5: cent a ve sight d ith es nsi i it f ens ing the effective f ncti ning f the enti e scientific advis s stem sh d e set t inc des ve seeing the a it ectivit ti it and integ it f scientific evidence and advice used to guide and inform decision-making in all parts of the EU’s executive government, including agencies. It should be adequately staffed with relevant experts and be given strong powers to ensure compliance with common policies and guidelines by all directorates and agencies t m st m e ve e inde endent f the int Resea ch ent e E agencies and policy DGs.
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This could be achieved, for instance, by expanding the scope of responsibilities of the Scientific dvice Mechanism S M his sh d e a e manent h i nta f ncti n f the S M cc ding the mandate f the S M sh d e e anded s as t inc de responsibility for:
▪
viding an instit ti na mechanism t ens e that science has a v ice in decisi ns at a stages f the ic c c e
▪
ham i ning the e f the est avai a e science as the inc ding f the nde standing and management f isk
▪
e eminent kn
m ting a ance and ati na it in c nt ve sia de ates a isks sed ne and e isting techn gies
t the
edge in t
t nities and
▪
eve ing h i nta scientific advice icies c ve ing iss es s ch as the a it c ecti n and se f scientific evidence scientific c mmittees and e e ts and isk ana sis
▪
Developing the ‘horizontal’ methodological guidelines that underpin the operation f the advis s stem ane s f eminent scientists ith e evant e e ience and inde endent f the E instit ti ns sh d ca t this k
▪
Overseeing, enforcing, and steering the implementation of ‘horizontal’ policies and g ide ines th gh t the ic c c e
▪
d cing an ann a advis cess
▪ ▪
cting as a
evie
f the effectiveness
ti it and
a it
f the scientific
ic inte est adv cate hen scientific evidence m st e ke t c nfidentia
mmissi ning e i dic eva ati ns f the s stem
e ati n f the ve a scientific advis
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▪
m ting a c nst ctive a anced and inf med ic de ate a t the e f scientific evidence in managing isk and m ting inn vati n in c eating the conditions for prosperity
6.3.2. Evidence Centre – Joint Research Centre Recommendation 6: i ding n the st ateg f the int Resea ch ent e R this instit ti n sh d e and its e and ca acit as the E ean mmissi n s cent e f e ce ence f scientific evidence inc ding that sed t inf m the management f isk S ecifica
▪
the mandate f the R sh
d ee
anded s as t inc de es
viding e e t es ces advice and s t t scientific advise s and fficia s sing scientific evidence th gh t a stages f the ic c c e inc ding a making and im ementati n his ma inc de viding e e ts n sec ndment t ic s
▪
dinating a g amme f t aining t enhance the scientific ite ac mmissi n se vices inv ved in isk management decisi n making
▪
m ting the m s
▪
▪
nsi i it f
i it
f esea che s and
ic
f fficia s in
ffice s et een the R and
ic
Supporting the Regulatory Scrutiny Board by assessing the quality and relevance of scientific evidence sed t s t egis ative and eg at meas es designed t manage isks t h man hea th ic safet and the envi nment ec ming the kn
edge manage f
the E
ean
mmissi n
▪
m ting st nge inks et een the scientific c mm nit and E agencies his c d include developing programmes that enable scientists to work within EU agencies for imited e i ds
▪
Managing a ‘foresight’ process designed to examine long-term policy challenges that are ike t c ss man t aditi na de a tmenta nda ies and e i e scientific in t
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n de t achieve these ectives acti n is needed t ens e that the R has the in h se technica e e tise state f the a t a at ies inde endence and e i i it t e ate as a esea ch ganisati n ithin the mmissi n s administ ative f ame k
6.3.3. Directorate-General for Research and Innovation Recommendation 7: Working in close collaboration with the new institutional a chitect e f im ving the effectiveness ti it and a it f the scientific advis cess ithin the E ean mmissi n the i ect ate ene a f Resea ch and Innovation should be responsible for:
▪
Designing and funding an extensive investment in regulatory science that makes use of resources from EU research framework programmes’ budgets. This should be developed using panels of eminent scientists with relevant experience and independent of the EU institutions.
▪
Establishing funding conditions that require scientists involved in regulatory science ects t ca t st dies sing inte nati na acce ted standa ds s ch as and OE g ide ines Mem e States sh d e enc aged the E ean mmissi n t esta ish simi a f nding c nditi ns
6.3.4. Directorates-General and Agencies Recommendation 8: Each mmissi n ic di ect ate gene a and E agenc ith a scientific emit sh d esta ish an inte na ganisati na st ct e t ens e that scientific evidence sed t inf m and g ide decisi n making meets the standa ds set t in mmissi n ide icies and g ide ines
▪
Each ic di ect ate gene a and agenc sh d a int a seni scientific advise scientific advis ane e ting di ect t the i ect ene a E ec tive i ect es nsi e f ens ing the a it ectivit ti it and integ it f scientific evidence sed t g ide and inf m decisi n making he scientific advise ane must also be responsible for identifying future policy issues that will require access to scientific evidence and f c mmissi ning additi na esea ch as a iate
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▪
m iance ith mmissi n ide icies and g ide ines sh ann a e t d ced the scientific advise ane
▪
Officia s es nsi e f c ecting sing scientific evidence sh d eceive eg a training. This should cover the broad methodological principles and concepts that nde in scientific evidence scientific a it imitati ns and ses f scientific evidence isk assessment nde standing f scientific nce taint in scientific assessments isk c mm nicati n iefing f scientific e e ts and c m iance ith g ve nment ide policies and guidelines.
▪
isk assessment agencies sh d esta ish t ans a ent science ased cesses f the deve ment and ef m f s stantive technica and scientific g idance cesses sh d meet the standa ds set t in the mmissi n s ette Reg ati n ic he sh d e ased n the est avai a e science the sh d em ed ea and eg a c ns tati n ith stakeh de s and the sh d e inf med f a c m ehensive nde standing f c sts and enefits cesses sh d e t ans a ent
d e desc i ed in an
6.3.5. Networks Recommendation 9: E S the inf ma net k f agenc scientific advise s should be placed on a permanent basis and provided with adequate secretarial support. It should seek to ensure effective sharing of operational good practices. Ideas should also be sha ed ith Mem e State scientific advis ane s and advis s sing e isting net ks Recommendation 10: he E ean Science dvis s m ES the eme ging network of science advisors in Member States, should become the main platform for e changing est actices in scientific assessments et een Mem e States and et een the Member States and the EU institutions. In the longer-term, this network should become a f ma nci c mmittee simi a t the E ean Resea ch ea mmittee ER
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Scientific Evidence and the Management Of Risk
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ean
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icies
6.4.1. Risk Analysis Recommendation 11: he E ean mmissi n sh d deve and ad t c mm n principles and minimum detailed standards for risk analysis.This could be achieved through, f e am e the ad ti n f a ne mm nicati n t sh d
▪
eve
the ideas and c nce ts set
t in the E
d a
▪
Distinguish between risk assessments used for determining policy and designing egis ati n he e scientific evidence sh d inf m decisi n making and the cesses of implementing laws where, unless required otherwise by legislation, decisions should e ased n scientific evidence and
▪
Require all risk assessments to be informed fully by real world experience and evidence, and to be based on normal handling and usage.
m e e tensive desc i ti n f the s ggested c ve age f a in Appendix B.)
mm nicati n is set
t
6.4.2. Quality, Collection, and Use of Scientific Evidence Recommendation 12: he E ean mmissi n sh d deve and ad t in f example, a new Decision, minimum standards for the quality, collection, validation, and use f scientific evidence that a di ect ates and agencies m st es ect he ecisi n sh d
▪
Require all forms of regulatory decision-making to be guided by the best available science gathe ed sing ide acce ted c nsistent en and t ans a ent cesses
▪
Set t st a it c nt s f ens ing that scientific evidence meets this standa d inc ding a cata g e f cha acte istics f the est avai a e science e i ement t use the established methodology of Systematic Evidence Review to collect and assess evidence se f ee evie and visi n f an inde endent ight f a ea i t disseminati n f the findings f significant scientific assessment and 57
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▪
Establish ‘excellence’, regardless of funding, and relevance as the sole criteria for dete mining hethe n t scientific evidence is inc ded ithin a scientific assessment
endi detail.)
sets
t the s ggested c ve age and e
i ements f a ne
ecisi n in m e
6.4.3. Scientific Experts and Committees Recommendation 13: he E ean mmissi n sh d set t in f instance a ne ecisi n the ke inci es f the se ecti n f scientific e e ts and f the e ati n f scientific c mmittees hese sh d e minim m standa ds and sh d a t a agencies and di ect ates and a f ms f scientific c mmittee inc ding echnica king s The Decision should:
▪
Re i e scientific assessments t e ca ied t scientific e standa ds f eminence e ce ence and e evance
▪
Recognise that industry is an important, and sometimes critical, source of knowledge, expertise, and experience, and that transparent processes should be put in place to ens e that scientific e e ts have access t this
▪
a e evant scientists h meet ag eed c ite ia f eminence e ce ence and relevance to be eligible for selection.
▪
Establish transparent selection processes that take due account of and distinguish c ea et een t diffe ent cha enges t im a tia it ias and financia c n ict f inte est
▪
Re i e mem e shi f scientific c mmittees t e c nstit ted s as t ens e that decision-makers have access to a range of relevant diffe ent t es f scientific e e ts f m diffe ent scientific disci ines
▪
Esta ish standa d
58
es f
ced e f
e ts h meet ag eed
scientific c mmittees and
Scientific Evidence and the Management Of Risk
▪
imit the sc e f mandates t scientific e ans e ed sing scientific evidence
European Risk F
e ts t
esti ns that a e ca a e f eing
(The suggested coverage and requirements of a new Decision are set out in more detail in Appendix D.)
E
ean
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idance
Recommendation 14: Working under direction of the central oversight institution, inde endent c mmittees f eminent scientists sh d d a a significant technica g ide ines e i ed t s t the mmissi n ide icies f the a it f scientific evidence and risk analysis. This should ensure that guidelines are independent of political c nside ati ns that the a e ased n eading edge science that the e ect ess ns ea ned f m et s ective eva ati n f scientific evidence and that the em ed the e e tise f the scientific c mm nit mmissi n
ide g idance sh
d inc de
▪
ata g e f cha acte istics f
▪
esign and se f S stematic Evidence Revie s
▪
at e and se f e idemi
▪
ata inte
▪ ▪
Re
est avai a e science
gica evidence
etati n and statistica ana sis
ting and c mm nicati n f scientific nce tainties
at e
a it and se f s cia science evidence
▪
ced es f identif ing and managing c n icts f inte ests f a t es inc ding ide gica ias hen se ecting scientific e e ts
▪
R es f
ced e f
scientific c mmittees
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▪
Standa ds f
▪
Mechanisms and procedures for an independent right of appeal, prior to the publication f a scientific assessment
inde endent ee
evie
f scientific assessments
▪
ha acte istics f
▪
e c nce ts and definiti ns sed in science and isk assessment
E
ean
a it scientific evidence
mmissi n
ette Reg ati n
ide ines
6.6.1. Consultation Recommendation 15: Standards and processes for public consultation should be revised to recognise the difference between opinions collected through such processes and the tc mes f scientific assessments he sh d ec gnise e icit that ic c ns tati n is n t a s stit te f c ecting scientific evidence th gh f ma cesses f scientific assessment
6.6.2. Impact Assessment – Intervention Logic Recommendation 16: Guidelines for impact assessment should be expanded to recognise that the intervention logic for ex ante assessment of measures designed to manage risks posed to human health, public safety, and the environment should be based on the findings f a f ma science ased isk assessment his sh d meet the e i ements f est avai a e science and isk ana sis set t in the mmissi n ide icies t sh d vide a stificati n f g ve nment inte venti n that disting ishes evidence f hazard from assessment of risk. It should be based on credible real world experience and n ma hand ing and se s e as identif ing the enefits f g ve nment acti n it sh d provide, through a science-based analysis of cause-and-effect, a framework for the design of appropriate and effective risk management options
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6.6.3. Risk Management – Precautionary Principle Recommendation 17: Supplementary guidelines should be developed that clarify the e f the eca ti na inci e in eg at decisi n making hese sh d e in additi n t and sh d n t e ace the e isting mmissi n mm nicati n he sh d e state the e i ements f the mm nicati n em hasising that the eca ti na inci e sh d n e sed as a stificati n f isk management meas es and that it sh d n t e sed t in ence scientific assessments that f m a t f the cesses f understanding risks. It should remind all agencies and directorates of these requirements. The guidelines should highlight questionable practices that appear to use forms of the inci e in scientific assessments hese inc de asing ini ns n nkn ns quality studies or studies that are ‘outliers’ instead of the weight-of-evidence provided by e tensive data ackages changing defa ts and ass m ti ns ith t scientific stificati n and using hypothetical or unrealistic exposures.
6.6.4. Regulatory Scrutiny Board Recommendation 18: The Regulatory Scrutiny Board (RSB) should ensure that all sections of ex ante impact assessments fully meet the relevant requirements set out in the ette Reg ati n g ide ines he RS sh d a s evie sing s t f m R e e ts the scientific evidence sed t s t mmissi n initiatives designed t tect h man health, public safety, or the environment.
6.6.5. Ex Post Evaluation Recommendation 19: Measures designed to protect human life, public safety, or the envi nment sh d e e i ed t e assess the igina scientific evidence and isk assessment sed t stif inte venti n as e as e amining ne scientific evidence ithin an appropriate time horizon. Reviews should encompass legislative and implementing meas es and sh d e ca ied t in acc dance ith mmissi n ide icies f the a it f scientific evidence and isk ana sis
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6.6.6. Substantive Technical and Scientific Guidance Recommendation 20: Rec gnising the ma e that technica and scientific g idance plays in implementing measures to protect human health, public safety, and the environment, all major guidance proposals should be brought within the scope of the requirements of the mmissi n s ette Reg ati n ic
E
ean a iament
6.7.1. Science and Technology Assessment Panel (STOA) Recommendation 21: he f c s f the S O de ate am ngst ME s a t the f ing
▪ ▪
m tance making
f scientific evidence as a
ane sh
e eminent kn
d ee
anded t
edge in
t f
m te
decisi n
ha acte istics f the est avai a e science and the dange s f asing decisi ns n a it scientific st dies
▪
enefits f sing the est avai a e science hen managing isks and,
▪
ve nance ithin the E ean a iament t ens e that advice based on the best available science
sed
techn
gies
vided t ME s is
6.7.2. European Parliament Research Service (EPRS) Recommendation 22: Scientific evidence vided t egis at s the E RS sh d meet uniform standards that are directly derived from or made equivalent to relevant mmissi n ide icies and g ide ines f the a it c ecti n and se f scientific evidence and f scientific e e ts and c mmittees Standa ds sh d e t ans a ent and the sh d inc de inde endent ee evie f the findings f e ts i t thei dissemination to legislators. They should apply to research conducted using in-house resources and to outsourced studies. 62
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6.7.3. European Parliament Group on Risk Recommendation 23: dditi na es ces sh d e vided the E ean a iament t s t the k f the E n Risk he g sh d a s e encouraged to continue to seek multi-group political representation, and to seek active c a ati n ith the E inte g s s ch as th se f c sed n m ting esea ch and innovation.
Scientific
mm nit
Recommendation 24: Eminent scientists, academies of science and learned societies, research-performing organisations, and higher education institutes that promote science standards should support independent activities and institutions designed to support, m te and ve see the se f the est avai a e science the E instit ti ns S ecifica they should take action to:
▪
Engage in st ic de ate t e ain and m te the scientific meth d and its c nt i ti n t g ess t c nte c iti es f science scientific en i the scientific meth d and scientists and t ens e a m e inf med de ate a t the c nse ences for citizens of policy-makers endorsing abstract risk management goals, such as the pursuit of zero risk or a toxic free world.They should also provide evidence to citizens f the enefits f hea th safet and the envi nment f asing isk management measures on the best available science.
▪
vide e e t scientific evidence n im and media outlets.
▪
eve s ecific sa s t define meth d gica g ide ines f im ved scientific assessment.These should be drawn up independently of initiatives of the EU institutions, and should include guidelines such as a catalogue of characteristics of best available science S stematic Evidence Revie ssi d a ing n the k f the ch ane a ati n se and inte etati n f e idemi gica evidence and statistica analysis and interpretation.
tant
c nt ve sia iss es t
na ists
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▪
a tici ate in e e t c mmittees t assist the cent a ve sight instit ti n int Resea ch ent e the E s isk assessment agencies and the E ean a iament Resea ch Se vice as e as e iva ent instit ti ns at nati na eve
▪
i d e ati nshi s ith edit s f ma scientific na s s as t iden the st ck f g d scientific st dies ishing a g eate n m e f n effect st dies
▪
Work with independent institutions, including Think Tanks, to develop quality standards f the se f s cia science in isk management decisi ns sa s sh d ec gnise the structural weaknesses of much existing social science research used in regulatory cesses m st n ta the ack f ve ifia i it and e d ci i it the fai ings f ee evie designed f nat a science in these academic d mains the nat e f evidence used by the private sector when investing in understanding attitudes, intentions, and sage f c st me s and the e e tise avai a e ithin the fessi na ma ket esea ch industry.
6.9.
Business
Recommendation 25: Major businesses, trade associations, and business organisations should develop a series of programmes to build trust in the contribution of industry knowledge to the effective management of risk. This is likely to include:
▪
a tici ating financia in t ans a ent g ammes int ith the E instit ti ns to improve regulatory science in important areas, such as complex hazards and the im acts f ne techn gies
▪
Engaging ith E instit ti ns t deve assessments inc ding isk assessments
▪
ishing the tc mes f investments in eg at science in high im act ee evie ed scientific na s sing the en access g d standa d he e this d es n t c m mise c nfidentia siness inf mati n
▪
a ing c des f scientific integ it at a sect a eve and esta ishing t ans a ent a dit ced es
64
c mm n meth d
gies f
scientific
Scientific Evidence and the Management Of Risk
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▪
Investing in education and communication programmes at EU, national and communitylevel to explain more thoroughly the role the industry plays in funding R&D in general and eg at science in a tic a and
▪
Investing in socio-economic studies that demonstrate the public gains from innovation and the f ms f ec n mic activit hese sh d high ight the enefits f s cieties from products and technologies, as well as wider corporate investment in communities, research structures, and the business environment.
6.10. Other Organisations Recommendation 26: Othe ganisati ns inv ved in gene ating and assessing scientific studies, so as to participate in risk management debates, should make public commitments t maintain the highest standa ds f e ce ence t act in a manne that is c nsistent ith the e i ements f the scientific meth d t enf ce a it standa ds ig s and hen e ting findings t disting ish c ea et een scientific evidence and va e judgements. Richard Meads and Lorenzo Allio, the Rapporteur and a Senior Policy Analyst at the European Risk Forum, wrote this monograph. However, the views and opinions expressed in this monograph do not necessarily reflect or state those of the European Risk Forum or its members. European Risk Forum October 2016
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dget Risk na sis
inci es
he ansat antic Shift in ea th Safet and Envi nmenta Risk Reg ati n e sa em a e s in Reg ati n and ve nance king a e
Wagner W. ‘Science in Regulation: a study of agency decision-making approaches’ (2013) eine Risk Reg ati n and ve nance nstit ti ns in OE ic m ving the ve nance f Risk i sd n and
eda R eds
t e
i ecti ns f
i sd n en and a avets Science dvice t c mm n cha enges iefing a e f nte nati na ck and e ea and
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Appendix A d
actice
ame
k
1. Political Commitments iticians at the highest eve
f g ve nment make f ma
ic c mmitments t
▪
Make and implement laws on the basis of evidence, using globally-accepted standards of eg at management and g d administ ati n
▪
Design and implement risk management measures that protect human health, public safety and the environment while promoting economic growth, innovation, and job c eati n
▪
Use the best available science as the pre-eminent knowledge input to inform and guide risk management decisions to protect human health, public safety, and the environment, ec gnising its ni e cha acte istics as a s ce f insights and evidence
▪
Ens e that scientific assessments inc ding isk assessments e ect f e e ience and n ma c nditi ns f sage and e s e and
▪
mm nicate f en and ective the tentia isks sed techn gies whilst recognising explicitly that a zero risk society is neither possible nor desirable.
ea
d
2. Legislation he ega f ame k inc des a a f dminist ative ced es e iva ent his ec gnises the cent a e that isk assessment and the f ms f e e t scientific assessment, plays in the implementation of laws. These activities fall within its scope. The esta ishes standa ds f d e cess f the im ementati n f a s the e ec tive function that can be subject to judicial review and which embed the major principles of g d administ ati n hese a e t ans a enc and c nsistenc ic a tici ati n ic ec d and acc nta i it
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t a sect a eve egis ati n e est avai a e science and high understanding of exposures.
i es fficia s t ase isk management decisi ns n the a it isk assessments that f e ect a ea d
3. Institutional Architecture 3.1. Central Oversight Body There is a central oversight body, reporting directly to the head of government. It is es nsi e f the effective g ve nance f the cess f c ecting and sing scientific evidence and advice. This is a permanent ‘horizontal’ function with responsibility for the a it ectivit ti it and integ it f scientific evidence and advice sed t g ide and inform decision-making in all parts of government, including agencies. It is adequately staffed with relevant experts and has strong powers to ensure compliance with common policies and guidelines by all departments and agencies.
3.2. Departments and Agencies32 Each department and agency establishes an internal organisational structure to ensure that scientific evidence vided e e ts and scientific advice sed t inf m and g ide decision-making meets the standards set out in government-wide policies and guidelines.
3.3. Networks ma net ks f de a tmenta and agenc scientific advise s a e in ace s ted the cent a ve sight d hese sha e g d actice and identif scientific and technica issues that have ‘horizontal’ implications.
3.4. Investment There is a well-resourced, long-term programme of investment in the development of regulatory science.The central oversight body oversees this, working, where relevant, with 32
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he e is a c ea distincti n et een science advise s and scientific e e ts Science advis s mediate et een iticians and eg at s and the cesses designed t gene ate scientific evidence he a e a t f the st ct e f eg at cess management n c nt ast scientific e e ts vide evidence
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agencies and government departments to identify research priorities. Relevant experts from outside government are involved in the development programme.
3.5. Legislature e es ced d eithe inte na in h se t itica inde endent vides scientific evidence ased n the est avai a e science and scientific assessment t he inf m the k f the egis ative f ncti n scientific evidence vided t egis at s this body meets uniform standards that are directly derived from or made equivalent to the government-wide policies and guidelines established by the executive function.
3.6. Scientific Community Eminent scientists, academies of science and learned societies, research-performing organisations and higher education institutes contribute to independent activities and institutions designed to support, promote and oversee the use of best available science g ve nments his inc des the visi n f e e t scientific evidence n im tant c nt ve sia iss es design f technica g idance f scientific assessments s tf na ists and the media and visi n f ective inf mati n f ic make s and ini n f me s e aining science the scientific meth d scientific e ce ence and the enefits f citi ens f asing decisi ns n science
4.
Policies
4.1.
Quality, Collection and Use of Scientific Evidence
g ve nment ide ic ec gnises that science ssesses ni e cha acte istics as a form of evidence for guiding the development and implementation of measures to manage risks to human health, public safety, and the environment. To that end, it requires government decision-making to be guided by the best available science that is gathered using widely accepted, consistent, open and transparent processes, and subject to robust quality controls. he ic sets t the ectives and inci es that dete mine the a it f scientific evidence that is used to guide policy, legislative, and implementation decisions, as well as 73
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its collection and use. It states explicitly that ‘excellence’ and relevance, regardless of the s ce f nding a e the n c ite ia f dete mining hethe n t scientific evidence is inc ded ithin a scientific assessment ina the ic esta ishes that ef e the findings f a significant scientific assessment are disseminated, they are subject to an independent peer review.
4.2.
Scientific Experts and Committees
h i nta ic c ve ing a de a tments and agencies sets t ke inci es f the se ecti n f scientific e e ts and f the e ati n f scientific c mmittees t e i es scientific evidence sed t g ide the decisi ns f g ve nments t e vided g s f high a ified eminent scientific e e ts a e t ing t gethe insights f m diffe ent scientific disci ines he e this is a iate and t d a n e evant scientific e e tise f m an s ce he e is a c ea t ans a ent distincti n et een findings and c nc si ns de ived f m scientific assessments and th se f m the s ces f kn edge his ens es the integ it f scientific advice he ic states that a e evant scientific e e ts h meet ag eed c ite ia f eminence excellence, and relevance are eligible for selection.Through a transparent selection process that ses ee g n minati n and se f identificati n e e ts a e ch sen h meet agreed standards of excellence and relevance, and who are also impartial and thus able to act objectively in the public interest. Selection processes, moreover, take due account of and disting ish c ea et een t diffe ent cha enges t im a tia it ias and financia c n ict f inte est Finally, a clear process is in place to identify and highlight the potential for bias. It recognises that ias is in gene a inte ect a m tivated the es t f a c se identificati n ith a particular point of view or group. It accepts that on some occasions the group of expert scientists may be able to balance certain forms of bias but recognises that some potential sources of bias may be so substantial that they preclude committee service.
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4.3.
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Risk Analysis
g ve nment ide ic sets t c mm n inci es f isk ana sis his e i es a c ea distinction between three phases of activity: “risk assessment”, the structured process of assessing scientific evidence isk management the cess f dete mining egis ative eg at meas es g ided the findings f isk assessment and isk c mm nicati n the cess f e aining the findings f assessment and management t decisi n make s and citizens. The policy distinguishes between risk assessments used for determining policy and designing egis ati n he e scientific evidence inf ms decisi n making and the cesses of implementing laws where, unless required otherwise by legislation, decisions are based n scientific evidence
4.4.
Regulatory Process
Government-wide regulatory process principles, standards, and guidelines require the use f the est avai a e science and e e t scientific assessment f the e ante and e st evaluation of measures designed to manage potential risks to human health, public safety, or the environment. They recognise explicitly, moreover, that public consultation is not a s stit te f c ecting scientific evidence th gh f ma cesses Intervention logic for ex ante assessment of measures designed to manage risks posed t h man hea th ic safet and the envi nment is ased n the findings f a f ma science-based risk assessment. This meets the requirements for best available science and isk ana sis set t in the g ve nment ide icies t vides a stificati n for government intervention that distinguishes evidence of hazard from assessment of isk t is ased n c edi e ea d e e ience and n ma hand ing and se s e as identif ing the enefits f g ve nment acti n it vides th gh a science ased analysis of cause-and-effect, a framework for the design of appropriate and effective risk management options. a it ass ance f e ante im act assessments inc des a f ma evie f the scientific evidence and e e t isk assessment sed t stif g ve nment acti n iate
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a ified e review.
e ts a tici ating in f ma eg at
ve sight instit ti ns nde take this
Ex post evaluations of risk management measures are required to re-assess the regulatory isk management ti n ch sen in the ight f the igina scientific evidence and isk assessment sed t stif inte venti n as e as e amining ne scientific evidence his is ca ied t in acc dance ith g ve nment ide icies f the a it f scientific evidence, and risk analysis.
5.
Guidance
mmittees f eminent scientists h a e inde endent f g ve nment a e es nsi e f d a ing a significant detai ed technica g ide ines e i ed t s t the g ve nment ide icies f the a it f scientific evidence and isk ana sis his ensures that guidelines are independent of political considerations, that they are based n eading edge science that the e ect ess ns ea ned f m et s ective eva ati n f scientific evidence and that the em ed the e e tise f the scientific c mm nit
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Appendix B E
ean
mmissi n Rec mmendati n n Risk na sis
ic
ne mmissi n mm nicati n sh d set t c mm n inci es f isk ana sis This should require a clear distinction between three phases of activity: “risk assessment”, the st ct ed cess f assessing scientific evidence isk management the cess f dete mining egis ative eg at meas es g ided the findings f isk assessment and isk c mm nicati n the cess f e aining the findings f assessment and management to decision-makers and citizens. he mm nicati n sh d disting ish et een isk assessments sed f dete mining ic and designing egis ati n he e scientific evidence inf ms decisi n making and the processes of implementing laws where, unless required otherwise by legislation, decisions a e ased n scientific evidence S ecifica
it e
i es
Risk Assessment: Risk assessors only employ the best available science, which meets standards for quality, collection, and use set out in the relevant policy, to assess risks to health, safety, and the envi nment his a ies t scientific assessments ca ied t f each individ a stage f a isk assessment ha a d identificati n d se es nse e ati nshi e s e and isk cha acte isati n
▪
Risk assessments desc i e c ea the sc e f k agent techn g activit ha a d f c nce n affected entities e s e event scena i s and event c nse ence d se es nse e ati nshi f the ha a d f c nce n
▪
Risk assessments, unless required otherwise by law, encompass all appropriate hazards, and, as well as considering the full population at risk, pay attention to sub-populations that ma e a tic a s sce ti e t s ch isks ma e m e high e sed
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▪
ha acte isati n f isk and changes in the nat e magnit de f isks is ad enough to inform risk management decisions made by government. To achieve this, it is ike t e a itative and antitative c nsistent ith avai a e data
▪
Unless otherwise required by statute, assessments of exposure are informed fully by ea d evidence and ased n n ma hand ing and se
▪
dgements sed in deve ing a isk assessment s ch as ass m ti ns defa ts and uncertainties should be stated explicitly, and the rationale for these judgements, and thei in ence n the assessment sh d e e ained
▪
aches t eva ating isks
sed
ha a d
s agents
events a e c nsistent
Risk Management: Risk management decisions are guided by government-wide regulatory management principles. These cover design of legislative measures and their implementation through a mix of rules (regulatory decisions), substantive guidance, and administrative actions. Scientific evidence is sed t he fficia s ana se the dist i ti n f isks t identif the enefits f acti n t eva ate eas na e feasi e isk management st ategies and t he fficia s imit the ike ih d f eg at fai e
Risk Communication: mm nicati n f the findings f isk assessments t isk manage s is c nsistent se and is time c m ehensive inf mative and nde standa e S ecifica presentation ensures that:
ith its g d
▪
Each population addressed by any estimate of risk and each risk assessment endint is identified a ng ith the e ected and a iate e and e nd estimates f h man hea th envi nmenta isk
▪
Excellent studies and data that support, are directly relevant to, or fail to support any estimate f isk a e high ighted
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▪ ▪ ▪ ▪
m nents f the advice that de end ini n a e disting ished c ea Meth d
gies sed t
ss m ti ns
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n
ide
acce ted facts
ec nci e inc nsistencies in scientific data a e e
dgement and
ained f
ana tica meth ds n hich c nc si ns est a e desc i ed f
Significant nce tainties a e identified and e
ained
▪
e evidence that might a te c nc si ns is high ighted and
▪
a e dgements a e av ided and c mments est icted t science and scientific advice
mm nicati n f the findings f the ve a way exchange of information. It ensures that:
cess f isk ana sis t citi ens is a t
▪
Risk management g a s a e stated c ea
▪
Significant ass m ti ns data m de s and infe ences sed assessment in the isk management decisi n a e e ained f
▪
S ces e tent and magnit de f significant scientific nce tainties ass ciated ith the assessment isk management decisi n a e desc i ed c ea distincti n is d a n et een nce tainties that f the scientific evidence ma e a e t es ve and th se that a e in effect sch astic ide gica in igin e esent a c ash f va es
e ied
n in the
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Appendix C E
ean mmissi n Rec mmendati n n se f Scientific Evidence ic
a it
ecti n and
he mmissi n sh d d a and ad t a ecisi n that sets t the ectives and inci es that dete mine the a it f scientific evidence that is sed t g ide ic legislative, and implementation decisions, as well as its use and collection. S ecifica
it sh
d e
ie
Objectives:
▪
Decision-making is guided by the best available science gathered using widely accepted, consistent, open and transparent processes, and subject to robust quality controls.
General:
▪
icati n f the ic is c m ehensive t sh d c ve a scientific assessments carried out by, and on behalf of, all directorates or agencies to guide policy-making, legislation, implementation of laws (including regulation and substantive guidance), and ex post evaluation.
▪
Science is recognised as possessing unique characteristics as a form of evidence for guiding the development and implementation of measures to manage risks to human hea th ic safet and the envi nment ts enefits f effective decisi n making f protecting citizens and the environment from risks, and for promoting innovation are explained fully. Science, as a result, is the pre-eminent knowledge input in these policy a eas
▪
m tant c nce ts and definiti ns necessa f the nde standing fficia s f scientific evidence a e e ained nce t a inf mati n ackn edges f the imitati ns f the scientific meth d efiniti ns inc de est avai a e science the scientific meth d scientific nce taint ha a d isk and isk assessment e
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activities that nde in the a s desc i ed
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cess f c ecting and assessing scientific evidence a e
▪
Scientific evidence is n c ected th gh e e t t ans a ent en cesses n ess the ise e i ed stat te ns tants and the simi a ad h c s ces f scientific inf mati n sh d n t e sed he e this is nav ida e d e t the need t ac i e s ecific e e t evidence then the eas ns f d ing this sh d e d c mented and the process used should be fully transparent and subject to external scrutiny, including independent peer review. In the event that this occurs, moreover, then the e i ements f the mmissi n ecisi n n Scientific E e ts and mmittees m st a
▪
ss ance f the a it f scientific evidence is c itica f ens ing that g ve nment decisions are effective and guided by excellent science. Robust quality controls are e i ed t ens e this inc ding ee evie f significant scientific assessments
▪
t a st dies a e f e a a it s me a e a ed the s a e as et nve ified have n t een e icated and s me a e mis eading e ne s inte eted st dies a e e c ded sing e icit and t ans a ent c ite ia and cesses f m scientific assessments
Quality:
▪
‘Excellence’, regardless of the source or funding, and relevance are the sole criteria f dete mining hethe n t scientific evidence is inc ded ithin a scientific assessment
▪
etai ed g idance vides definiti ns f est avai a e science the t aditi na meaning f e ce ence in gene a f diffe ent t es f scientific evidence and f its interpretation, based on a presumption favouring studies carried out using internationally accepted and validated approaches that meet the demanding requirements of the scientific meth d
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Collection:
▪
n ess the ise e i ed stat te scientific evidence is c ected sing the e established process of Systematic Evidence Review, focusing on a “bottom up” process of assessing all relevant studies that meet tests of quality and relevance. Detailed guidance provides a description of modern requirements. In general, however, this requires ▪
▪
g eement f a t c f the and that d ena e a simi a ecti n f a
e evant
cess that is ca a e f eing ee evie ed a ified g t each the same c nc si ns
ished and n
ished evidence
▪
Se ecti n f evidence n the asis f defined and e
▪
E iminati n f evidence that is i e evant
▪
Synthesis and interpretation of evidence in an unbiased way, with a presumption fav ing a it and eight f evidence
▪
esentati n f findings in a c m ete t ans a ent and n iased consideration to their limitations
f inade
ted c ite ia ate
a it
a
ith d e
Use:
▪
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ef e the findings f a significant scientific assessment a e disseminated the a e subject to an independent peer review, unless precluded by statute. This examines the cess ca ied t and the s stance f the findings f the assessment t is undertaken whenever an assessment is based on novel or hypothesis-forming science if the findings i have a c ea and s stantia im act n im tant ic icies ivate sect decisi ns Revie s a e m e ve ca ied t inde endent f scientific c mmittees technica king g s ve seeing the f m ati n f scientific assessments
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▪
fte c m eti n f ee evie and f m ati n f d aft scientific assessment affected a ties have the ight f scientific a ea his is e e cised i t icati n of the draft assessment and focuses solely on the processes of assessment and the inte etati n f scientific evidence ea cesses a e esta ished t faci itate this
▪
Scientific evidence vided t ic make s and fficia s is ished s ect n t necessa est icti ns t tect the c nfidentia it f c mme cia sensitive data
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Appendix D E
ean mmissi n Rec mmendati n n Scientific E mmittees ic
e ts and
h i nta ecisi n c ve ing a de a tments and agencies sh d e ad ted the mmissi n that sets t ke inci es f the se ecti n f scientific e e ts and f the e ati n f scientific c mmittees t sh d a t a a ts f the ic c c e policy, legislation, implementation (rules, guidance, administrative decisions), and ex post evaluation. S ecifica
it e
i es
Objective: Scientific evidence sed t g ide the decisi ns f g ve nments is vided g s f high a ified eminent scientific e e ts a e t ing t gethe insights f m diffe ent scientific disci ines he e this is a iate and t d a n e evant scientific e e tise f m an s ce
General: Scientific c mmittees vide e e t advice t g ve nments he c m ise eading eminent scientists he a e a anced c ntaining scientists f m diffe ent scientific disci ines e s ectives he e this is a iate iding inci es f the assessment and visi n f scientific evidence a e esta ished These include rationality, excellence, impartiality, transparency, reasonableness, public duty, consistency, and proportionality. Unless otherwise guided by statute, they require assessments of exposures or usage to be informed fully by real world evidence and to be ased n n ma hand ing and se he a s e i e the se f the eca ti na inci e t e c nfined t isk management decisi ns
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Industry is an important, and sometimes critical, source of knowledge, expertise and e e ience ans a ent cesses a e in ace t ens e that scientific e e ts have access t this iate a ified scientists ith e evant e e tise h meet ag eed standa ds f e ce ence ca t scientific assessments M e ve the e is a c ea t ans a ent distincti n et een findings and c nc si ns de ived f m scientific assessments and th se f m the s ces f kn edge his ens es the integ it f scientific advice c ea distincti n is d a n et een e e t g s that vide scientific assessments and th se that vide the f ms f advice heneve g s a e asked t vide scientific assessments then membership of the group should be limited to appropriately, excellent scientists Scientific assessments d n t ec mmend s ecific eg at actices isk management options, or answer questions that involve economics, ethics, values or other matters of ic n ess s ecifica e i ed t d s in a itten mandate Scientists hen ca ing t scientific assessments a e ins ed against a f ms f ia i it e ated t thei k findings and c nc si ns
Scientific Experts:
▪
hi st a scientific e e ts m st e high a ified and ssess e evant e e tise they should also be eminent, excellent, and recognised by their peers. These are the ima c ite ia sed t se ect them
▪
e evant scientists h meet ag eed c ite ia f eminence e ce ence and e evance are eligible for selection. This includes scientists from outside the EU and those em ed king ith stakeh de s
▪
Scientific e
e ts a e n t a
inted t
e esent a a tic a
int f vie
g
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▪
Where experts are independent of government, they receive remuneration and e enses f thei k ased n ates a a e t simi a a ified c ns tants s as t att act eminent scientists
▪
Through a transparent selection process that uses peer group nomination and selfidentificati n e e ts a e ch sen h meet ag eed standa ds f e ce ence and h a e a s im a tia and th s a e t act ective in the ic inte est
▪
Selection processes take due account of and distinguish clearly between two different cha enges t im a tia it ias and financia c n ict f inte est
▪
scientific e e ts a e e i ed t c mmit themse ves f ma t act im a tia in the est inte ests f citi ens hen viding advice t g ve nment
▪
c ea cess is in ace t identif and high ight the tentia f ias t ec gnises that ias is in gene a inte ect a m tivated the es t f a c se identificati n ith a particular point of view or group. It accepts that some potential sources of bias may e s s stantia that the ec de c mmittee se vice
▪
Re evant financia c n icts f inte est a e e i ed t e disc sed hese a e c ea defined and e ate ima i t c ent activities f the s ective e e t and e evant immediate fami mem e s inancia c n icts a e ima i managed th gh disc s e but may preclude committee service if they are current, relevant, substantial, and can reasonably be shown as being likely to impair an individual’s impartiality.
and
Operation of Scientific Expert Committees:
▪
Mem e shi f scientific c mmittees is st ct ed s ch that ic make s have access t a e evant ange f diffe ent t es f a iate scientific e e ts f m diffe ent scientific disci ines
▪
Scientific c mmittees e ate n a c nsistent asis f ing t ans a ent itten rules of procedure, and the roles of committee members, secretariat, and committee chai e s n a e desc i ed f R es f ced e f ed a scientific e e t c mmittees meet the minim m standa ds set t in g idance
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▪
Meetings of committees are, if required, held in private, and comments by committee mem e s a e made in c nfidence s as t ass e ectivit and cand f advice
▪
nf mati n a t the mem e shi is vided t citi ens n a time opinions provided to policy-makers ivate c m anies in c nfidence is n
activities and t ts f scientific c mmittees asis ith a es m ti n f enness Scientific are published, although information provided by t in gene a made avai a e
Briefing and Utilisation of Scientific Experts:
▪
Scientific c mmittees e ate ithin a t ans a ent f ame k esta ished c ea terms of reference that are set by policy-makers and agreed with committee members. e ms f efe ence a e made avai a e t citi ens
▪
Officia s c ns t ide ith stakeh de s hen f aming the c ntent and sc ic e ated esti ns t e ans e ed scientific e e ts
▪ e
▪
hen dea ing ith iss es cha acte ised e ts he ic make s f ame the sc
e f
high eve s f scientific nce taint scientific e and c ntent f esti ns
se f scientific e e ts is c nfined t esti ns that a e ca a e f eing ans e ed sing scientific evidence Scientific e e ts a e n t asked t e ess va e dgements or to make policy recommendations.
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European Risk Forum he E ean Risk m ER is an e e t ed and n t f fit think tank ith the aim of promoting high quality risk assessment and risk management decisions by the EU institutions, and raising the awareness of the risk management issues at EU-level. In order to achieve this, the Forum applies the expertise of a well-established network of experts to ‘horizontal’, cross-sectoral issues. In particular, it addresses regulatory decisi n making st ct es t s and cesses as e as the isks and enefits f ne and emerging technologies, of climate change, and of lifestyle choices. The Forum believes that:
▪
igh a it isk management decisi ns sh d take ace ithin a st ct framework that emphasises a rigorous and comprehensive understanding of need for public policy action (risk assessment), and a transparent assessment of ka i it effectiveness c st enefits and egitimac f diffe ent ic ti ns management
▪
Risk management decision-making processes should ensure that outcomes are capable f meeting ag eed s cia ectives in a ti nate manne
▪
Risk management decisions should minimise negative, unintended consequences (such as new, unintended risks, economic losses, reduced personal freedoms, or restrictions n c ns me ch ice and
▪
The way in which risk management decisions are made should be structured, consistent, non-discriminatory, predictable, open, transparent, evidence-based, legitimate, accountable, and, over time, subject to review.
chieving these g a s is ike t ig s definiti n f ic assessment f ems and thei and enefits f ic ti ns and
88
ed the the isk
e i e e tensive se f evidence es ecia science ectives c ea and c m ehensive desc i ti n and nde ing ca ses ea istic nde standing f the c sts e tensive c ns tati n
Scientific Evidence and the Management Of Risk
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The Forum works with all of the EU’s institutions to promote ideas and debate. Original research is produced and is made widely available to opinion-formers and policy-makers at E eve s an e e t g the m ings t gethe m ti e s ces f evidence s ch as the e e ience f actiti ne s and ic make s n n E g d actices and academic research) to assess issues and to identify new ideas. Indeed, direct engagement with opinion-formers and policy-makers, using an extensive programme of conferences, lunches, and roundtables, is a feature of the Forum’s work. The ERF is supported principally by the private sector. The ERF does not seek to promote an s ecific set f va es ide gies inte ests nstead it c nside s high a it isk assessment and isk management decisi ns as eing in the ic inte est n advis group of leading academics supports the ERF’s work. For more information visit www.riskforum.eu or contact: ik dig Secretary-General European Risk Forum Rue de la Loi 227 B-1040, Brussels Belgium Tel: +322 613 28 28 Fax: +322 613 28 49 Mobile: +32 477 510834
[email protected]
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