Safety and Accident Prevention

Risk Analysis, Vol. 26, No. 1, 2006 DOI: 10.1111/j.1539-6924.2006.00731.x

Commentary

Scientific Peer Review to Inform Regulatory Decision Making: A European Perspective

Ragnar Lofstedt1∗ and Robyn Fairman1

1. INTRODUCTION

The authors, Patton and Olin, should be congrat- ulated for producing a concise “wish list” on the use of scientific peer review for regulatory decision mak- ing (Patton & Olin, 2005). As a wish list, we agree with the authors particularly with regard to defining and distinguishing review processes (which is a much talked about topic in Europe), and the need to take into account external scientific peer review seriously. We do have two specific comments on the substantive content. First, we feel that the exclusion of a discus- sion of how social scientific or economic data could be “peer reviewed” leaves this otherwise comprehensive review lacking. Such analyses are a crucial factor in en- suring the “credibility of science-based rule-making decisions” and validating these data is as important in many instances to the final regulatory decision as it is for the “harder” scientific data. Second, we would challenge the statement that “[p]eer review is one of several complementary venues for public participa- tion.” We understand the drivers for increasing pub- lic participation in regulatory decision making, but would question whether peer review should ever be a “venue” for public participation.

This brief comment attempts to shed further light on the changing scientific peer-review process in Europe. We will explore how the nature of the scien- tific advice used by U.K. food regulators has changed over the last 10 years. The bovine spongiform en- cephalopathy (BSE) crisis in the United Kingdom

1 King’s Centre for Risk Management, King’s College, London,

UK. ∗ Address correspondence to Ragnar Lofstedt, King’s College,

King’s Center for Risk Management Strand, London WC2R 2LS,

England, UK; tel: +44(0) 20-7836-5454; fax: +44-207-848-2748; [email protected].

has led to radical changes in both regulatory struc- tures and changed the “rules of the game” by which they operate. We then expand this discussion from a U.K. base to look at scientific review in the European Commission.

Our discussion is therefore based on evidence from scientific advisory groups in regulatory decision making. This is not a classical peer review of new data as would occur in the publication of journal articles. It is the examination and analysis by a group of experts of the application of peer-reviewed science to a policy- relevant problem. These two functions are conceptu- ally distinct. This analysis and critique of the chang- ing institutional arrangements and culture of review in the United Kingdom and Europe support many of the items in Patton and Olin’s wish list, although it also raises implementation issues. Through this discussion, we hope to enlighten the readers of Risk Analysis re- garding the differences between how peer review is conducted in Europe vis-à-vis the United States.

2. SETTING PEER REVIEW OF SCIENCE IN REGULATION IN CONTEXT: PUBLIC TRUST AS A DRIVER

During the period between World War II and the mid 1960s, the U.S. landscape of regulation was not significantly different from that in Europe (Brickman et al., 1985; Vogel, 1986). The American public was generally supportive of business, believing that a strong industrial sector was essential in meeting the Soviet threat and for the United States to continue to assert its authority in the world. Washington trusted industry to manage its own affairs, a decision rein- forced by a legacy of remarkable growth and expan- sion during the war. Similarly, until the late 1960s,

25 0272-4332/06/0100-0025$22.00/1 C© 2006 Society for Risk Analysis

26 Lofstedt and Fairman

regulators in Western Europe were largely seen as credible. The public and stakeholders viewed them as working on behalf of society as a whole, although the regulatory styles primarily used, corporatist and consensual, were significantly different from the ad- versarial style in the United States (O’Riordan, 1985).

The future of environmental and health regula- tion in Europe as well as in the United States were fun- damentally shaped by the environmental events of the 1960s and 1970s. Both trade blocks had their fair share of environmental disasters (Aberfan, Torry Cannon; Minimata; Love Canal) (Andrews, 1999; McCormick, 2001). These and other environmental events had profound effects in the United States and Europe. Between 1965 and 1975, according to Vogel “more legislation was enacted and more regulatory agen- cies were established (in the United States) to ad- minister them than in the entire history of the federal government” (Vogel, 1986, pp. 250–251). Similarly in Europe, these events led to establishment of environ- mental protection agencies (e.g., Sweden established its Environmental Protection Board in 1967) as well as tougher regulations (e.g., the 1974 Clean Air Act in Germany and the 1969 Swedish Environmental Protection Act). However, the levels of public and stakeholder distrust witnessed in the United States (caused by these environmental disasters as well as the prevailing climate of the Vietnam War, and the appointment of Anne Gorsuch as EPA Administrator in the first Reagan Administration) were not present in Europe. As a result, at the time American regula- tors, arguably, went further than their European coun- terparts in many cases, arguing for a separation of risk assessment from risk management (NRC, 1983), greater use of science in the policy-making process, and greater use of cost–benefit analysis (Andrews, 1999; Landy et al., 1994; Viscusi et al., 1995).

Over the past 10 years the West European reg- ulatory scene, however, has changed dramatically. Rocked by a number of regulatory scandals, rang- ing from BSE, to dioxin in Belgian chicken feed, to tainted blood in France, the public and stake- holders no longer trust their respective regulators (Lofstedt, 2005). Majone and Everson (2001) argue that the consensual style of regulation is now dead. Because of this mounting public distrust, there is ev- idence that European regulators and advisory bod- ies are in effect “Americanizing” European regula- tions (Lofstedt, 2003). In the next section, this will be illustrated by examining the impact of BSE on scientific advice for food safety regulation, first in the United Kingdom and then in Europe. Do we see

what has been part of the U.S. regulatory landscape since at least 1983 (Andrews, 1999) being exported to Europe?

3. U.K. SCIENTIFIC ADVICE FOR FOOD REGULATION

Scientific or expert advisory committees are a long-established part of British regulatory decision making. The traditional consensual approach of U.K. regulation led to expert committees playing a piv- otal role in advice and guidance. Formalized expert committees have been involved in food regulation since the early 1980s and include technical commit- tees (such as the Committee on Toxicity) or wider advisory committees that examine risk management issues (such as the Food Advisory Committee). A dis- tinction has always been made between expert advi- sory committees and scientific or technical advisory committees, with their remit being determined by his- torical precedent (Fairman, 1999).

Fundamental questions have been posed about the scientific advisory process in the United Kingdom as a result of successive food safety crises. The main is- sues have been the composition and remit of advisory boards, and how their information was used by gov- ernment. The shortcomings of the system were voiced by a former minister of the Ministry of Agriculture, Fisheries and Food (MAFF) in a House of Lords de- bate in 1997.

We set up those committees and used them in a way that

lead to many of the problems . . . , and which lead to a

breakdown in trust between the people of this country

and MAFF. (Lord Lucas, 1997)

Lord Lucas then went on to explore the expecta- tions of MAFF:

that the people on the committee should display a great

deal of level-headedness and that they should not rep-

resent extremes of opinion; that they should be able

to agree together and not produce dissenting opinions.

(Lord Lucas, 1997)

The net result was a system “strongly biased to- wards consensus.” Scientists wish to see their research funded. The two principal sources of income for re- search are the government, which tends toward con- sensus in its research funding, and industry, which tends toward research that does not undermine its own business. Lord Lucas commented that “that pro- cess has also led to committees that excludes people from participation” and that “leads to a whole process

Scientific Peer Review to Inform Regulatory Decision Making 27

of dissatisfaction, a feeling of cover-up and a lack of trust” (ENDS, 1998).

In his analysis, Lord Lucas identified the require- ment by politicians and government for a “single clear recommendation” from expert committees as a factor that ensures that only those from within the accepted middle-ground of science were invited onto commit- tees. The decisions can then be based upon consensus but they exclude extremes or innovative views. If the government’s desire for openness and the inclusion of lay people within this framework is considered in this context, then lay people on the committee would ei- ther have to represent the middle-ground of opinion or they will severely threaten consensus. An example of this has been on the Advisory Committee on Re- leases to the Environment (ACRE), which deals with the issue of genetically modified (GM) biotechnology applications. The one lay member of the committee repeatedly dissented from the consensus arrived at by the committee (ENDS, 1999). She contended that it was not up to ACRE to judge whether the spread of genes from GM crops into the environment matters or not, and that the issue needed wider debate.

The biggest shake-up to food safety regulation and scientific advice came with the BSE crisis. MAFF was replaced by the Food Standards Agency (FSA), an independent body established to explicitly “protect the public” (MAFF, 1998). The Phillips inquiry into BSE (Phillips, 2000) and the May review (May, 1997) into the handing of risk in scientific advisory com- mittees both made recommendations in line with that in Patton and Olin’s article. They focused in particu- lar on the separation of risk assessment and manage- ment; being clear about the evidence reviewed and us- ing peer-review comments in reports; the importance of lay voices; selection of reviewers; and the disclo- sure of interests. As a result of the Phillips inquiry and in line with some of the criticisms voiced by Lord Lucas, all the advisory committees (including techni- cal committees) included lay members and this has been strengthened to two lay people on all commit- tees since 1999. Partly as a result of the Phillips and May reviews, the U.K. Parliamentary Office of Sci- ence and Technology issued a Code of Practice for Scientific Advisory Committees (POST, 2000).

In their review of how expert committees oper- ated (UK FSA, 2002a), the FSA recommended “that committees should not be asked to manage risks al- though they will be asked to provide scientific ad- vice on risk management options.” This pragmatic approach to the separation of risk assessment and management in scientific committees arose as a re- sult of some members of committees expressing their

disquiet at the practical issues in attempting to sep- arate assessment from management issues, and the stilting of discussion that this may cause. In the min- utes of an FSA meeting discussing scientific review it was recorded that:

It is recognised that during discussion on risk assess-

ment it was inevitable that questions on risk manage-

ment will occur. Furthermore discussions by commit-

tees on risk management should not be suppressed as

it was useful to bring to light future research require-

ments. (UK FSA, 2002b)

To assist in the separation of risk assessment and management the minutes record that “public com- ment should be invited on the form of the questions to be put to advisory committees” (UK FSA, 2002b).

Further recommendations of the review relate to the appointment of experts. Positions have to be openly advertized (as a result of government rules on all appointments) but “efforts should be made to ensure that suitably qualified individuals from all sec- tions of the population have the opportunity to apply.” They recognize that open competition discourages some experts from applying and recommend that “the Agency should actively search for suitable candidates and encourage them to apply” (UK FSA, 2002a). Ex- perts from around the world are encouraged and some committees are served by experts from outside the United Kingdom.

The impact of BSE on the scientific advisory sys- tem in the United Kingdom has been fundamental and resulted in two driving forces, sometimes operating against each other. On the one hand, distrust by the public and the consensus nature of the views present in committee has led to the inclusion of lay people on expert groups and the public and open approach to recruiting experts. The second driver has been the attempt to reduce the consideration of the impacts of the risk assessment in the conduct of the risk assess- ment itself. The NRC (1983) called for the concep- tual separation of risk assessment and management. The response of the FSA to this driver can be seen in the operation of committees such as the Spongiform Encephalophy Advisory Committee, which is wholly and exclusively focused on the scientific assessment of risk. The example of ACRE shows that in practice some of the lay people or consumer representatives on these committees can open the debate wider than “pure” assessment issues.

This raises the question as to the function of the inclusion of the lay people on committees. Does in- clusion of two lay people on a scientific committee make it participatory? Could this be an example of

28 Lofstedt and Fairman

the “venue of public participation” identified by Pat- ton and Olin? These lay people can only ever repre- sent one of the many “publics” with a particular view on any issue. The United Kingdom has an example of a more participatory scientific review process. Theses are the scientific advisory bodies established to as- sist the Health and Safety Commission/Executive in their decision making. These expert groups, like the Commission they serve, are tripartite, consisting of experts nominated by trade unions, employers, and the Commission. For instance, the Working Group on the Assessment of Toxic Chemicals is a tripartite scientific committee serving a tripartite expert com- mittee (Advisory Committee on Toxic Substances). Here, judgments about the application of science to policy-relevant questions are made by scientists with different values representing different constituents.

The next part of the commentary will examine these issues from a European context.

4. EUROPEAN SCIENTIFIC PEER REVIEW TO INFORM REGULATORY DECISION MAKING

Since the mid 1990s, the EU institutions have taken steps to improve the quality and credibility of scientific evidence and peer review used in their decision making. Major reforms include the creation of independent scientific committees, the creation of independent risk assessment agencies for both food and medicine, and the introduction of a Commission- wide policy for the collection and use of expertise. This is not to say that scientific advice or scientific committees did not exist prior to the mid 1990s (they did—the Scientific Committee for Food was estab- lished in 1974, for example), but reforms were seen as necessary in the wake of the BSE crisis. The is- sue of the Commission’s credibility was at stake, as policymakers, regulators, and, increasingly, scientists were no longer believed. Indeed, it is interesting to note, for example, that the then President of the Eu- ropean Commission, Jacques Santer, announced in a 1997 speech to the European Parliament a new set of scientific principles for the management of food safety and consumer health at the height of the BSE scare (Koning & Jasanoff, 2001). The 1997 Communication resulting out of this restructuring noted that:

Consumer confidence in the legislative activities of the

EU is conditioned by the quality and transparency of

the scientific advice and its use on the legislative and

control process. (European Commission, 1997)

One of the primary outcomes of both the BSE (and related regulatory crisis) and the resignation of the Santer Commission on charges of corruption was the 2001 Commission’s White Paper on Governance (European Commission, 2001). This, too, discussed the role of scientific committees and scientific exper- tise. It notes, for example:

It is often unclear who is actually deciding—experts or

those with political authority. At the same time, a better-

informed public increasingly questions the content and

independence of the expert advice that is given. These

issues become more acute whenever the Union is re-

quired to apply the precautionary principle and play its

role in risk assessment and risk management.

To get around this conundrum, in the same Gov- ernance White Paper, the Commission proposed two separate solutions. First, guidelines were needed on the collection and use of expert advice, and second that a Science in Society program (situated in DG Research) should be established. The research guide- lines were put forward in a Communication in 2002 (European Commission, 2002b), and the Science and Society program was established the same year. The Commission’s research guidelines put forward three core principles, namely, that the Commission should seek advice of an appropriate high quality; it should be open in seeking and acting on advice from experts; and that it should ensure that its methods for collect- ing and using expert advice are effective. The guide- lines, which became operational on January 1, 2003, were seen as a positive step forward with regard to the use of scientific expertise and these are now being im- plemented through the various DGs in the European Commission.

With regard to the use of scientific expertise to inform regulatory decision making was the launch of the Science in Society program in 2002. The program, based on 38 Actions, aims to “pool efforts at European level to develop stronger and more harmonious rela- tions between science and society” (European Com- mission, 2002a).

Among the issues raised by the Science in Society Action Plan Document is the use of scientific expertise (European Commission, 2002a, pp. 24–26). It notes that although the community-level scientific commit- tees for food and consumer health have now been well established and that frameworks have been set up to ensure distinctions between collective more formal advice and that of solicited and unsolicited opinions and findings, that more work is needed. The report notes the following:

Scientific Peer Review to Inform Regulatory Decision Making 29

� Science is often perceived as dealing with cer-

tainty and hard facts, whereas this is rarely

the case, . . . leading to a sense of frustration

and despair when experts fail to provide sim-

ple answers to apparently simple questions. A

more coherent interface is needed between the

providers and receivers of advice, with mu-

tual understanding and clear communication

between the two;� Policy makers do not find it easy to tap into the

resource of knowledge provided by the diver-

sity of scientific cultures and range of special-

ized centers of excellence in Europe . . . . There

is a need to be a more systematic and open

approach, at national and European level, to

identify the best expertise at the right time;� Advice can appear remote if the public and

stakeholders are excluded, and are unable to

or ill equipped to contribute to the debate and

to challenge the experts and the advice they

give. There is a need to open the process by

providing opportunities for the voicing of al-

ternatives views, for scrutiny, and for construc-

tive debate.

The Commission addresses these three issues by stressing the need for guidelines (as discussed above) and by calls for improving the delivery of scientific support to policymakers, such as via creating open Internet-based networks of scientists and organisa- tions concerned with scientific issues (European Com- mission, 2002b).

Since these initiatives there have been some fur- ther changes. For example, DG SANCO now has a unit that just deals with the science and communica- tion issues that are generated by the European Food Safety Authority. In addition, the Science and Society program (88 million Euros between 2003 and 2006) has sponsored a number of workshops and research projects, including “Science Education and Careers” (3 million Euros), “Deepening the Understanding of Ethical Problems” (5 million Euros), and in August 2004, it helped coorganize the first EuroScience Open Forum meeting in Stockholm (this latter initiative is mirrored by the American Association for the Ad- vancement of Science meetings in the United States).

The question remains, however, whether the Commission has put its primary attention on what can be called “soft” areas of the scientific peer-review pro- cess. For example, to ensure that the process is trans- parent, that the process is efficient, and that it is of high quality is always useful in terms of gaining public credibility (Lofstedt, 2004, 2005). It is also clearly im- portant to ensure public “buy in” to the scientific pro- cess and rekindle public interest of science (Funtowicz et al., 2000). These issues, however, do not address the

core aspects of scientific peer review to inform regu- latory decision making. For example, in research that we have been doing on Commission scientific commit- tees over the past year one can note that quotas op- erate in the recruitment of experts. The Commission implements country quotas in many instances with re- gard to setting up scientific advisory boards. Hence, scientists may be picked because of where they come from rather than based on the scientific expertise that they can bring to the table. In addition to this, gen- der quotas operate with the expectation that no less than 40% of experts will be either male or female. In many cases only European citizens can serve on these boards even if the actual competence in certain in- stances can actually be found in Japan or the United States. The selection process of those scientists who participate is not via peer nominations (as is the case for US EPA SAB) but, rather, scientists are asked to apply via advertisements in select publications to possibly take part in the scientific committees. As a re- sult, the committees are not necessarily staffed with the most competent scientists. To complicate matters, there is, first, no real scientific oversight committee, playing the role of the National Academy of Sciences in the United States, and, second, the broad scientific community is, relative to the United States, poorly paid and funded (Lofstedt, 2005), although this lat- ter point is something that the Commission is now addressing (European Commission, 2004).

Over the past year, the first author served as the academic advisor on a European Policy Centre project examining what the European Commission should do with regard to ensuring rigorous scientific peer review of the policy-making process, thereby ad- dressing the problems noted above. Among the find- ings coming out of this document (for a full discussion, please see Ballantine, 2005) were the following.

� The Commission should publish a Decision containing a new formal and binding policy statement covering risk analysis in policy mak- ing;� The EU institutions should issue a joint Com- munication affirming that high-quality science will have a principal role in policy-making and decision-making processes;� The Commission should establish a new coher- ent policy for the collection and use of scientific advice; the policy should be applied to all in- stitutions to all stages of the regulatory cycle and to all sources of scientific advice;

30 Lofstedt and Fairman

� The Commission should establish Chief Sci- entific Advisors or Scientific Advisory Groups in all relevant services or agencies with responsibility for ensuring the integrity, qual- ity, and effective operation of the scientific ad- visory system in the service/agency concerned;� The Commission should also establish an inde- pendent Chief Scientific Advisor or Scientific Advisory Group, reporting directly to the Pres- ident of the European Commission, with re- sponsibility for ensuring the integrity, quality, and effective operation of its overall scientific advisory system;� The Commission should establish a central unit in the Secretary General’s Office in sup- port of the Chief Scientific Advisor or Scien- tific Advisory Group;� The Parliament should review the provision of independent scientific advice available to Members of the European Parliament (MEPs) and ensure that it is able to support the devel- opment and updating of technical legislation;� The creation of a “European Academy of Sci- ences” should be encouraged.

At present, European Commission officials are considering whether some of these points should be implemented in the EU.

5. CONCLUSIONS

One of the main drivers of the reforms of the sci- entific peer-review process that has been ongoing in Europe is the loss of public trust in science. This can be viewed as a part of the ongoing Americanization of European regulation. Among reforms that have been put in place to date are the development of guidelines for how scientific committees can best be used, the importance of getting society to buy into science, and the role of greater transparency. Little attention, how- ever, has been paid at a European level to improving the selection process of scientists, to develop scien- tific oversight committees with the Commission, or to establishing an equivalent to the National Academy of Sciences. Both the European Commission and the United Kingdom are going in the right direction of reforming the scientific peer-review system, but they have a long way to go to reach the standards set out in the Patton and Olin article. Maybe a useful next step would be for the two authors to travel to Europe and with the assistance of ILSI Europe hold a num-

ber of seminars based on their conclusions with the Brussels-based regulators?

ACKNOWLEDGMENTS

The research leading to this article was par- tially supported by grants from the Swedish Research Council via the Centre for Public Sector Studies (CEFOS), University of Gothenburg, where the lead author is a visiting professor, and the European Policy Centre-Risk forum program. We would like to thank the following individuals for commenting on previous drafts of this article and for bringing relevant mate- rial to our attention: Lorenzo Allio, Stanley Crossick, Baruch Fischhoff, Anna Jung, and Ortwin Renn. This commentary is dedicated to the memory of the late Bruce Ballantine.

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