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Social Science & Medicine 73 (2011) 655e662

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Social Science & Medicine

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Institutional policy learning and public consultation: The Canadianxenotransplantation experience

Mavis Jones a,c,*, Edna Einsiedel b

a Johnson-Shoyama Graduate School of Public Policy, University of Saskatchewan, Canada, Diefenbaker Centre, Saskatoon, SK, Canada S7N 5B8b Faculty of Communication and Culture, University of Calgary, Canadac Echo: Improving Women’s Health in Ontario, Canada

a r t i c l e i n f o

Article history:Available online 23 July 2011

Keywords:Institutional learningParticipatory technology assessmentXenotransplantationPublic consultationDonor organ shortagePolicyCanada

* Corresponding author. Tel.: þ1 416 597 9687x235E-mail addresses: mjones@echo-ontario.ca (M.

(E. Einsiedel).

0277-9536/$ e see front matter � 2011 Elsevier Ltd.doi:10.1016/j.socscimed.2011.06.041

a b s t r a c t

Attempts to evaluate public consultations, participatory technology assessment, and deliberativedemocracy have typically considered impacts on either policy or participants. The determination ofimpacts on policy institutions has been limited due to the challenges of tracing effects through the policyprocess, or penetrating bureaucratic walls. This paper presents findings from a retrospective studyexploring the institutional lessons learned from a 2001 Canadian national public consultation on xen-otransplantation. The consultation was conducted through an arm’s-length process and involved the useof citizen juries in six regional sites. We conducted in-depth interviews of regulatory and policy actorswho were engaged in early policy discussions and the consultation process. We reviewed evaluations ofthis process, both internal and external, which gave us richer insights into what institutional actors sawas the impacts of this consultative experience on their policy environment. Participants in our researchidentified a broader shift toward openness in policy culture which they linked specifically to the inno-vative consultation process employed for xenotransplantation. We argue that beyond input into policydecisions, a consultation may have an impact in terms of its contribution to overall shifts in institutionalculture (related to institutional learning), such as an “opening” of technological decision processes toa broader range of actors, knowledge, and values.

� 2011 Elsevier Ltd. All rights reserved.

Introduction

The use of public consultation to inform technology policydevelopment, has, in many countries, contributed to an increasinglysophisticated critique (from policy makers, citizen groups, andacademics alike) of consultative designs, processes and instruments.Aspolicymakersand regulators look forways tobuildpublic trust andto develop accountable frameworks, innovations in public consulta-tions, and the way they are evaluated, have grown. Organizers ofpolicy-linked public consultations now have access to considerablematerial on “lessons learned”, both in terms of constructive critiqueof processes and evaluation of impacts and outcomes.

Of course, the stakes for some consultations are higher thanothers, where the issue is perceived as having potential benefitsand risks not easily balanced e as in the case we present here.Xenotransplantation, the therapeutic transplantation of organs,

.Jones), einsiede@ucalgary.ca

All rights reserved.

tissues and cells from animals into humans, is a technologydesigned to solve the problem of donor organ shortages. Xeno-transplantation brought with it two significant concerns thattempered the enthusiasmwith which it was received. The first wasrejection. In transplants between humans (allotransplantation),rejection of the donormaterial can happen in days and attempts areusually made to prevent rejection through the use of immuno-suppressant drugs. In transplants across species, hyperacuterejection of the source material happens immediately. Because ofthe promise of xenotransplantation as a successful (and lucrative)therapy, the biopharmaceutical industry combined immunosup-pressant therapies with genetic engineering to create animalswhose tissues were more compatible with humans, and less likelyto be rejected. Pigs were the favored source for organs and tissues,due to their physiological similarities to humans. Although theseattempts did not lead to human trials at this stage, a secondaryconcern emerged regarding the possibility of xenozoonoses.Although the risk of disease transmission is considerably differentbetween transplants of, for example, islet cells to treat diabetes,versus the transplant of a whole organ, there were still concerns.The potential for transmission across species barriers of porcine

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endogenous retroviruses (or PERVs) to an already immune-suppressed patient, and eventually to the larger population, wasa real public health concern. Publics, policy makers and the scien-tific community were already aware of speculation in the 1990sthat the HIV virus was a mutation of Simian ImmunodeficiencyVirus, which had “jumped” from chimpanzee to human (Brown,Matthews, & Sandstrom, 1998; Weiss & Wrangham, 1999). Subse-quent research found that PERVs could indeed infect human cells(Patience, Takeuchi, & Weiss, 1997). At the same time, the potentialfor therapeutic power was suggested by porcine islet transplants inSweden to treat diabetic patients (Groth et al., 1994), and earlierbaboon-to-human liver transplants in the US (Starzl et al., 1993). Asboth the therapeutic possibilities and significant health risksassociated with xenotransplantation were revealed, health regu-lators and policy makers began to recognize the need to addressthis therapy through a policy response. It was an issue furthercomplicated by values-based public discourses related to animalrights and welfare, as well as a moral or emotional discomfort withthe transplant of animal tissues into humans (Daar, 1997).

In Canada, where our research is based, Health Canada (thefederal policy and regulatory body responsible for public health)recognized the need to engage in public consultation on xeno-transplantation. Canada has a history of public consultation on bothlarge and small scales, commissions of inquiry to ad hoc stake-holder meetings. Health Canada recognized that none of theirconventional approaches suited the issue and opted for an inno-vative, arm’s-length, socially (rather than statistically) representa-tive method of consultation.

In this paper we describe the Canadian public consultation onxenotransplantation that took place in 2001e2002. Internationally,it was the first such consultation on the issue (Health Canada, 2003,p. 10). Despite the notable lack of outcome e Canada remainswithout a policy on xenotransplantation e those we spoke with,both in Canada and the United States, indicated the Canadianconsultation was a highly regarded example of public involvementin technology assessment. We argue that this consultation’s impactgoes beyond high regard, and can be seen in terms of its contri-bution to a broader trend in institutional cultural change. Throughdocumentary and interview research we trace a narrative of policyevents from the appearance of xenotransplantation as a policyconcern, to the consultation and later activities related to publicinvolvement in health technology assessment. We look at theoverall trend toward openness and changing approaches toconsultation within Health Canada, and identify the role the xen-otransplantation consultation played in contributing to this trend,with a particular focus on two areas: expertise in consultation, andaccountability practices. Where we recognize cause and effect inlearning may be difficult to determine, we argue that this innova-tion made an important contribution to the growing favor towardopenness and innovative consultative practices within HealthCanada e a position supported by our research participants.

Participatory technology assessment: evaluating impact

Impacts in the literature

Much empirical research and theoretical development hasaddressed the impact of public consultations. Measuring impact isoften addressed in terms of outcomes (how policy reflects recom-mendations), or social learning (what participants learn from theact of participating). There have been many efforts to evaluateconsultative processes in relation to science and technology,including critiques of different models or specific events.

Rowe and Frewer (2000), for example, compare modelsaccording to evaluative criteria such as resource accessibility, cost-

effectiveness, and task definition. Deliberative exercises may berobust in terms of unpacking the nuances of an issue, but theirsmall scale may work against their strength to influence policy,described as “variable but not guaranteed” (19). Larger scaleactivities e surveys, referenda and the like e may seem represen-tative but allow the participant no opportunity to qualify answersor ask questions. In later work, the authors review scholarship onpublic participation, noting that “institutional and societalresponses to a particular exercise may be manifest months or evenyears after an exercise has finished” (2004, p. 520). This means, inturn, that researchers face the challenges of not only identifyingimpacts, but evaluating them in the long-term. Goodin and Dryzek(2006, p. 221) stress the importance of deliberative processes as“micro-political innovations” involving mini-publics, or collectionsof individuals which are not statistically representative but havesome claim to representativeness on the basis of including a rangeof demographics and perspectives on the issue. They also exploreseveral possible impacts of such processes: actual policy making;having recommendations taken up in the policy process; informingpublic debates; testing the popularity of policy ideas before they areconcretized; legitimating policy; confidence or constituencybuilding; popular oversight to ensure accountability, especially incontroversial matters; and explicitly resisting co-option byconsultation. While they note that mini-publics and their micro-political innovations can have impacts on the macro-political,they caution against limiting analysis to the content of policyalone, and emphasize the difficulty of tracing direct impact of anyinput through complex political processes. The problem is oftenhow to link micro processes to their macro impact.

We find compelling the notion that impact can be best traced byextending the scope of observation and analysis, as some impacts areonly observable over time. In the case presented in this paper, we seeevidence that the xenotransplantation consultation e throughensuring accountability, informing the public, and testing ideas e

were impacts contributing to institutional learning atHealthCanada.

Learning as institutional impact

In an analysis of Canadian public consultations on xeno-transplantation, Einsiedel (2002) observed that there is evidence ofinstitutional learning in broader policy communities as an impact.To clarify, although an objective in public policy consultation designis to produce an impact on policy e through take-up of recom-mendations, for example e the range of possible impacts ofa consultation are not limited to issue-specific policy outcomes, perse. Thus, while Canada remains without a xenotransplantationpolicy, this was not the only possible impact.

Mohr and Friedland (2008), in their introduction to a specialissue of Theory and Society on institutionalism, note there is littleconsistency to how the term ‘institution’ is defined, despite it beinga key concept of sociological theory. For the purposes of this paperwe draw elements from two useful definitions. Sociologist W.Richard Scott, a key figure in institutionalist scholarship, definesinstitutions as “social structures that have attained a high degree ofresilience”, providing stability to social life with the support ofthree pillars e culturalecognitive, normative, and regulative (Scott,2001). The regulative pillar is particularly relevant to our study, as itconcerns how rules are developed, sanctioned and enforced,particularly in regulatory structures such as the state. This is partlymaintained through carriers, or systems thatmay serve as a conduitfor institutional ideas; for example, in the regulative pillar, a tech-nology assessment protocol could be a routine carrier. Relationalsystems, referring to interpersonal or interorganizational linkages,are also important carriers as they delimit the way power circulatesamong actors in an institution (Scott, 2003). Another articulation,

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aligned with new institutionalism and specific to science policy isprovided by Frickel and Moore (2006), who define institutions as“relatively durable sets of practices and ideas that are organizedaround social activities and that in various ways shape the contourand experience of daily life” (8). In this conception, scientificknowledge systems have an embedded relationship with politicalinstitutions, in which the distribution of power is structured.

These definitions allow us to conceive of an everyday workenvironment in which organizational actors make decisions withininstitutionally-maintained (and often taken-for-granted) parame-ters. Common elements to these definitions are: a) the importanceof routines in stabilizing institutions, which allows certain ways ofthinking to remain taken-for-granted until destabilization occurs;and b) the importance of relationships between actors, in terms ofhowpower circulates. In relation to our analysis, the routineswhichcharacterize policy making as part of the regulative pillar of healthgovernance circumscribe ways of approaching policy development.The possibility of change exists in the circulation of ideas, andpower, between organizational actors.

This is where learning comes in. Institutional learning hasappeared in the literature to describe evolving designs andprocesses as connected regions, particularly in the Europeancontext, interact and draw lessons from each other (Wink, 2010). Inrelation to political institutions, policy learning (Dolowitz & Marsh,1996) refers to the tendency of governments to find solutions tocurrent intractable problems by drawing from the experience ofother settings or other times (Rose, 1993). Policy learning derivesfrom Peter Hall’s 1993 application of social learning to policychoice, with his use of the concept of paradigm change playinga particularly influential role in learning studies (Busenberg, 2001;Grin & Loeber, 2007).

By gathering the recollections of key policy actors of a particularpolicy moment in the past (i.e. the xenotransplantation consulta-tion), and observing changes in policy practices and structuressince that time, we can explore the extent to which a learningimpact can be associated with that particular moment. Institutionallearning over time is particularly relevant where public engage-ment is concerned, as for many countries, effective consultation isan ongoing learning process that becomes more sophisticated witheach attempt at engagement. With the benefit of reflection,learning may impact on routines, actors, and even organizationalvalues.

Method

The findings reported here emerge from a larger researchproject on citizen participation in xenotransplantation policy, usingseveral countries within Europe and North America as compara-tors. The authors of this manuscript were primarily responsible forthe North American context. For the purposes of this paper we arefocusing on the Canadian case, in particular the 2001 consultationon xenotransplantation initiated by Health Canada and run by theCanadian Public Health Association (CPHA). This was the largestconsultation on this issue conducted in the Canadian context andour interviewees were selected on the basis of their involvement init.

The method we used in this Canadian case began with docu-mentary research (web, policy documents, and scholarly literature)that informed the development of a semi-structured interviewguide. Two versions of the guide were developed to facilitateinterviews with either stakeholder/“consultees” (e.g. a patientadvocate), or organizers/initiators of consultations (a representa-tive of Health Canada or the CPHA). The latter group is the source ofmaterial used in this paper. This version of the guide was looselystructured to probe for participants’ perspectives on:

1) The general policy context: recollections of policy discussions,technology assessments of xenotransplantation, and relatedpolicy context and similar issues; personal questions orconcerns in this policy area

2) Public consultations: recollections of the process leading up tothe decision to consult; who was involved; what expectationswere held by organizers; the extent to which xeno-transplantationwas seen as requiring a similar approach to oneor more other issues

3) Outcomes: identification of the consultation’s impacts, if any,on policy or regulation; impacts on this issue compared toimpacts on similar issues; what, if any, lessons were learned

4) Final thoughts: open-ended additional remarks; discussion ofhow hindsight might influence the interviewee’s approach toa similar issue in future

One author (EE) was a participant in Canada’s 2001 consultationon xenotransplantation; we drew from that intimate knowledge ofthe process in building the interview participant list. We beganwith attendee and organizer lists to identify potential participantsand gained further information through web searches and snow-balling in the course of conducting interviews. University ethicsclearance was obtained prior to embarking on interview recruit-ment. Research participants e i.e., interviewees e were promisedtheir interview transcripts and recordings would remain confi-dential within the research team, and they would be given theopportunity to review and confirm the accuracy of material quotedin publication. Those quoted in this paper are identified by nameand role, with their permission; if referred to more than once, onlythe surname will appear. Eleven interviews were conductedbetween November 2009 and March 2010 with key policy actorsand organizers of the consultation. Transcripts were analysed foridentification of patterns and key themes. We establisheda detailed timeline of events (see Einsiedel, Jones, & Brierley, 2011)and focused specifically on the impacts of consultation activities. Inthis respect we were assisted through the addition of two docu-mentary sources: an evaluation of the 2001 consultation (Kishchuk,2002) conducted independently for CPHA, and the internal evalu-ation compiled by Health Canada’s Biologics and Genetic TherapiesDirectorate (Health Canada, 2003).

Canada’s public consultation process on xenotransplantation

As established, policy makers in Canada and elsewhere wereaware of both the therapeutic promise of xenotransplantation, andof its potential public health (and politicization) risks. In Canada,pharmaceutical and biotechnology companies ‘sponsor’ thera-peutic products they wish to place on the market by submitting alltesting information (including clinical trial data, study protocols,and formularies) to Health Canada’s Health Products and FoodBranch (HPFB). HPFB employs thousands of product reviewersacross multiple specializations to assess the safety, quality andefficacy of a product e based on the data provided by the productsponsore prior to approving that product for themarket. HPFB alsoapproves some pre-market processes, in particular clinical trialdesign, to protect the safety of clinical trial participants.

As part of its regulatory activities, HPFB is also vigilant ofproducts on the horizon; in the late 1990s its reviewers becameaware that some research teams were planning to submit appli-cations to Health Canada to conduct limited clinical trials for xen-otransplantation. As the turnaround time for a clinical trial reviewwas thirty days, discussion at the Branch revolved around theuncertainties related to xenotransplantation risks to public health.One individual told us the anticipation of these submissions“sparked a lot of discussion among our reviewers and also with our

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legal advisors as to what. did the Food and Drugs Act encompass”(Kim Hannah, then a scientific evaluator and policy analyst;currently a policy analyst and Public Involvement Advisor, HealthCanada). At the time HPFB did not have the appropriate expertise toaddress genetically modified animals and the potential for diseasetransmission to humans. Keith Bailey, Director of Health Canada’sBureau of Biologics and Radiopharmaceuticals at that time, told usthat Health Canada saw the need to recruit outside experts toensure Canadians were protected, as these were rapidly evolving,“contentious publicly and politically” areas of science. Theseconditions set the stage for regulators to begin investigatingoptions for public consultation on how to address this scientificallyand ethically complex technology.

The first step was a National Forum on Xenotransplantation thatbrought together regulators, scientists, legal and ethics experts, andstakeholder communities to “present information and initiatediscussion on the risks, benefits and ethics of xenotransplantation;to identify key regulatory issues; and define areas where researchand new information is required” (Health Canada, 1997). Discus-sions focused on the acceptability of the technology, the use ofanimals as sources of tissues and organs, conditions for informedconsent, and the risks to public health. This forum concluded withgeneral agreement by participants on the need for informed publicdebate and discussion before firm policy was developed (HealthCanada, 1997). Health Canada then convened an Expert WorkingGroup on Xenotransplantation Standards, which developeda Proposed Canadian Standard for Xenotransplantation and openedit to public comment in summer 1999. That same summer, IndustryCanada (theMinistry responsible for regulating industry) conveneda Planning Meeting on Ethics, Science and Governance in xeno-transplantation. While this meeting did not take the form ofa public consultation, it did highlight scientific uncertainty aroundthe technology and contributed to the understandingwithin HealthCanada that the issue required a specialized approach.

Discussions continued at Health Canada. An Expert AdvisoryCommittee on Xenograft Regulation was formed in fall 1999,mandated to include representation not only from relevant medicaland scientific backgrounds but also members of the public and anethicist. They made a case for public consultation on this issue. Itthen fell to certain actors within Health Canada to decide how toproceed. Hannah, charged with planning the consultation told usthat “there wasn’t a high climate of trust, public trust in thegovernment at that time. Because of the nature of the issue, theethical and science issues. we didn’t want the public to perceivethe process as being biased by involvement of Health Canada”. Animportant political legacy driving Health Canada’s approach toxenotransplantation was the so-called ‘tainted blood scandal’:failures to screen donated blood for HIV or Hepatitis C in the 1980sled to the infection of thousands of Canadians. Health Canada andthe Canadian Red Cross were implicated in this public healthdisaster which became the subject of a highly-visible Commissionof Inquiry (the Krever Inquiry, led by Justice Horace Krever). Thesubsequent report and related investigations led to changes in howthe organization dealt with transplants, such as the development ofthe Expert Advisory Committee on Cells, Tissues and Organs. ThisCommittee led a consultation in 2005 that repeatedly cites Kreverrecommendations as key considerations for Health Canada’s policymaking in this area (Health Canada, 2005). The politicization ofHealth Canada’s protective duties e especially in light of the logicalconnection between blood transfusion and xenotransplantation (interms of biological transfer and public health risk)emeant that theorganization was sensitive to potential future controversies. Withxenotransplantation, Health Canada was “looking to make surethey were much more pro-active in transplantation risks than inthe past” (André LaPrairie, who at the time was a consultation

organizer with CPHA and is now with the Public Health Agency ofCanada). Bailey noted “there was huge political nervousness at thattime regarding the introduction of scientific and technicaladvances, and great concern that any regulatory actions be takenwith the greatest of caution”. Wewould suggest that this sensitivitymotivated a shift in organizational culture toward a precautionaryapproach as a means to respond to mistrust in government as wellas “the internal desire to be more open and transparent.” (Hannah).

This environment of caution and concern for public trust alsoprovided an opportunity to innovate, and the decision was made tohold the consultation at arm’s-length from Health Canada. TheCanadian Public Health Association was chosen as the organizer,with a contribution of resources from Health Canada. CPHA formeda Public Advisory Group (PAG) comprised of key stakeholders withbroad-ranging expertise in the area, who helped develop questionsand lead the consultation. The consultation was conducted viamixed methods including surveys (telephone, mail-in and website)and six public fora modeled after a Calgary citizen jury process(Medlock, 2001). Juries were held in six different cities across thecountry: Halifax, Quebec City, Toronto, Saskatoon, Vancouver, andYellowknife. Juries were selected through letters of invitation sentto a representative sample of citizens in each city. Of those whoresponded expressing interest in participation, a citizen jury panelof 15e25 participants was chosen whose demographic profilereflected the census profile. They were charged with discussing thequestion, “Should Canada proceed with xenotransplantation, and ifso, under what conditions?” The process involvedmeeting over oneweek-end where panelists were provided educational informationon xenotransplantation, heard presentations from a range ofexperts including transplant surgeons and patients, animal welfarerepresentatives, veterinary experts, bioethicists (Einsiedel, 2002).After an orientation session on the first day, a question period, opento the public and media, with an expert panel was held on Day 2,after which the citizen and expert panellists went into a discussionsession. The third day involved small group deliberation witha moderator/process facilitator provided by CPHA.

Finally, the recommendation was made that Canada shouldrefrain from approving clinical trials of xenotransplantation untilcritical issues were resolved and other options to address the organshortage could be explored. Since that time the Government ofCanada has not made any definitive statements about xeno-transplantation; there have been no clinical trials, nor has thepolicy been finalized. This could be interpreted as a decision not todecide; to either preclude further controversy by leaving the issueunresolved, or return to business as usual. It is difficult to determinethis conclusively from our findings, though perhaps future researchcould attempt to investigate such ambiguities. The consultationitself was subject to a certain amount of critique. Some notedconcerns with the methodology and limitations to representa-tiveness while others queried Health Canada’s decision not toadhere to fora recommendations (Mortensen, 2005; Wright, 2002).From her own observations as a participant (and those of theindependent evaluator, Kishchuk, 2002) Einsiedel developed anevaluative framework drawing on the literature in constructivetechnology assessment and deliberative democracy. This frame-work is broken down into three areas of evaluation: institutional/organizational arrangements; process criteria; and outcomes(Einsiedel, 2002; Einsiedel & Ross, 2002). Einsiedel (2002, p. 327)identifies several generally effective aspects of the consultationeincluding the event’s independence, transparency, timeliness, andsome procedural aspects e but notes a “disjunction” betweencitizens and organizers over task definition. While organizersdefined the consultation question in narrow terms, asking whetherCanada should proceed to clinical trials, the citizen panellistsranged more broadly on issues around regulatory preparedness,

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animal issues, allocation of health care resources, and alternativesto addressing the organ shortage challenge. Although the twoevaluations conducted of this consultation both reported that citi-zens’ perceptions change upon receiving more information, theindependent evaluator (Kishchuk, 2002) found a diversity amongthe experiences of citizen panellists in terms of how their percep-tions changed after receiving more information. The HPFB reportcharacterizes the advantage to the use of deliberative methods assupporting an informed public, which in turn assures “public inputwould be credible, and therefore useful as an element in decision-making” (17).

The assessments we found most intriguing are the ones closestto the heart of government: the two ‘official’ evaluations of theconsultation. One was via an independent evaluator, NatalieKishchuk, enlisted by CPHA. The other (Health Canada, 2003) wasan evaluation conducted by the Biologics and Genetic TherapiesDirectorate, or BGTD (formerly part of the Therapeutic ProductsProgramme). The organizational position of BGTD is significant.Not only does xenotransplantation fall within its regulatorypurview as a directorate for science-based assessment, but it is thelargest of six review directorates in Health Canada’s HealthProducts and Food Branch, and as such is an influential actor inHealth Canada policy. We had the opportunity to view both thesedocuments and their summary of lessons learned. Generallyspeaking both reports present positive assessments of the way theconsultation was organized and run e particularly in terms of thearm’s-length status of CPHA, the citizen fora as the most valuablemethod to glean public input, transparency, and the capacity forindividuals without professional scientific training to quicklybecome informed on xenotransplantation. However, there weresome disparities between reports in terms of tone and emphasis.While the BGTD evaluation frequently notes the capacity formembers of the public to absorb technical knowledge andunderstand the issues, it still retains some commitment to hier-archical views of expertise. During the consultation, participantswere asked to identify what level of influence, on a 1e10 scale,they thought different stakeholders should have “in policy orregulatory decisions about xenotransplantation (or other contro-versial biomedical issues)” (53). To the stakeholder category“general public”, average levels assigned by forum participantswas 8.3; by the PAG, 6.6; and by the Expert Advisory Committee,4.3. The findings of this survey led to this “Lessons learned”statement in BGTD’s evaluation:

Relative weighting of information in policy development may ormay not result in a decision that is fully consistent of publicviews. Whether or not the final decision on xenotransplantationfully reflects “the publics’” views as derived from this consul-tation, a critical piece of this initiativewill be not only to providefeedback to the “public” on the decision itself e but also it willbe important to explain the decision-making process and therationale for the decision made. (Health Canada, 2003, p. 54)

In contrast, the independent evaluation, also emphasizing thecapability of diverse publics in understanding and speaking tocomplex policy issues, argues that “Findings from this evaluationraise questions about the role of experts and suggest that alter-natives to the expert-based model should continue to beexplored” (Kishchuk, 2002, p. 5). Interestingly, since then we canidentify a shift in the official policies and practices of HealthCanada that align more closely with the independent evaluator’sreport than with the BGTD report of that time, suggestinga destabilization of the paradigm for public consultation, despitematerial obstacles that may remain (such as the government inpower or resource limitations). We will explore these more in theAnalysis section.

Analysis: institutional learning as impact

At the time of earlier analyses of the consultation (Einsiedel,2002), it was too soon after the event to determine what long-term institutional impacts might be. At this writing it is clear tous that the xenotransplantation consultation at least contributed toan overall trend toward consultative innovation, and at most had animpact on policy culture around openness and consultation atHealth Canada. We have thus far presented a narrative of the rise ofxenotransplantation as a policy issue in Canada. Now we turn to anaccount of subsequent events and conditions, suggested by thosewe interviewed as evidence of the longer term impacts manifest incultural and structural changes within its policy organizations. Aswe stated earlier in this paper, two central themes in the concep-tualization of institutions (i.e. suggesting ways to test institutionallearning) are the importance of relationships and actors, and theimportance of accountability and engagement practices as stabi-lizing routines.

The importance of public actors and their expertise

Complex political organizations may resist outside expertise,particularly where there is a decision-making hierarchy, andparticularly in science-based organizations where the science/not-science boundary is defended. The depiction of expert and non-expert perspectives in the BGTD evaluation may have reflectedthe dominant culture at the time, but it also reflects a culture opento change in terms of how it views expertise. For example, thereport notes that despite inconsistencies in the experts and infor-mation provided at various regional fora, the final recommendationdid not differ greatly across fora in part because participants hadtime to develop both interest and a level of knowledge regardingthe issue. BGTD, a complex multidisciplinary section of an evenmore complex multidisciplinary organization (HPFB), was awarethat a monolithic expert view is not possible; “there are differingperspectives on the issues e no one set of experts can be seen asrepresenting “expert” views” (Health Canada, 2003, p. 50). Therecognition that reasoned deliberation among diverse actors canachieve a valuable outcome, despite the sometimes messy processit takes to get there, is, we feel, suggestive of a lesson learned.

Acknowledging the value of social adjudication representsa significant change for policy, and especially regulatory, practice. Itreflects a shift from an entirely ‘sound science’ based approach toone that recognizes some problems are beyond the scope of sciencealone. Consultation allows the organization to explore policyoptions for issues where a solution is not readily available. Itenables brainstorming between actors with different sets of expe-rience, allows ideas to be explored and adopted or dismissed, andhas the potential to strengthen communication between diversestakeholders. The question of how public views and broader socialvalues are accounted for in the policy process, however, remains anongoing challenge for predominantly expert-based systems. BGTDacknowledged these challenges:

Consulting with the general public was new to the Directorateand there was limited expertise or experience within theDirectorate in undertaking public involvement initiatives.Unlike today, there were no manuals, or templates to guide theinitiative and no established infrastructure through which toseek guidance, direction or approval to move the projectforward. (Health Canada, 2003, p. 10)

The temporal difference noted here e “unlike today” e isa reference primarily to the work of the Office of Consumer andPublic Involvement (OCAPI), established by Health Canada in 2000to promote an infrastructure for in-house public engagement

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expertise. Although it was a small office at the time the consultationwas run, it has since grown in terms of staff, resources, and profile,and has a horizontal responsibility to develop materials andcapacity (the manuals and templates mentioned above) acrossdirectorates to support consultation initiatives within HPFB. Asdocumented in the evaluation report, BGTD discussed the “lessonslearned” from the CPHA consultation with OCAPI (Health Canada,2003, p. 46). Those we interviewed connected to Health Canadafelt that lessons learned from the xenotransplantation consultationsupported the work of OCAPI and in this way contributed to itsgrowth (Hannah, LaPrairie). In turn, OCAPI’s cooperation withBGTD’s evaluation of the consultation contributed to some analysisin terms of how the xenotransplantation experience had broaderimplications. The following point, for example, is footnoted as“Discussion with OCAPI officials”:

In part, these lessons provide some direction as to what worked,how things might be done differently next time or what factorsneed to be considered in designing and implementing futureefforts. Some of [these] lessons reflect issues that are not uniqueto the xenotransplantation alone and have broader implicationsfor government public consultation initiatives (eg. How toencourage public input to ensure a representative response).(Health Canada, 2003, p. 57)

OCAPI was involved in organizing two citizen fora, similar to theCPHA consultation, in 2005. The topics for these fora were twopoliticized technologies: silicone gel-filled breast implants andCox-2 non-steroidal anti-inflammatory drugs. These events servedthe dual purpose of investigating the issues, and piloting an eval-uated model of consultation to be used in future. Lessons learnedfrom these evaluations were applied in the development of a Policyon Public Input, launched in 2007 and binding as guidance forregulatory review across Health Canada. This was revolutionary inthe Canadian federal regulatory context as it establishes a mecha-nism to integrate certain forms of citizen knowledge into regula-tory decision-making (Graham & Jones, 2010; Jones & Graham,2009). It further allows for a broader definition of relevant exper-tise than simply that from formal scientific training, indicating thatthe Minister may seek advice from stakeholders “with knowledgeand experience in different areas, particularly those who use ormight use the regulated product, to broaden the informationavailable to make an informed evaluation of the risk and benefitassociated with a product” (Health Canada, 2007). As Hannah toldus, “there are unknowns and uncertainties and there are timeswhen we need to involve additional citizen perspectives”. Part ofthe policy focuses on controlling for conflict of interest (see below)for participants. It uses the language of transparency and openness,particularly with regard to the basis for regulatory decisions. Thisrelates to our earlier discussion of paradigm change in policylearning. Dolowitz and Marsh (1996) suggest that learningprocesses may be driven by technological change. Xeno-transplantation may have been seen as having the (still unrealized)potential to challenge the paradigm of regenerative medicine, itsaccompanying uncertainty and risk allowed it to challenge theparadigm for science policy development. We interpret what hashappened as a shift from a science-only paradigm (as the basis fordecision-making), to a paradigm of science-at-the-center (supple-mented by other forms of expertise, knowledge, and evidence).

Accountability routines

One area of learning related to the xenotransplantationconsultation is, we argue, the establishment of new mechanismsfor government accountability. Health Canada’s internal evaluationof the CPHA consultation noted, in the context of “lessons learned”,

that in future consultations the initiating department shouldarticulate clearly at the outset its objectives, its commitment to theprocess, and exactly how findings would be used. While thisconclusion may not seem exactly fresh, it is important to recognizethis “lesson” as part of a broader expression of the need foraccountability mechanisms in government. A cumulative under-standing has emerged e from consultations and other activities e

that citizens often have no way of knowing what information istaken into account when regulatory or policy decisions are made,and as a result, see transparency and accountability as importantfeatures of government practice. In essence, how can we knowwhat factors, public input or otherwise, have gone into making anofficial decision? This is an area where we might argue that policylearning is ongoing rather than a fait accompli. Policy officialscontinue to grapple with balancing the need for in camera policyformulation with the need to operate transparently.

In the case of the CPHA consultation, the decision on the part ofthe regulator to select an arm’s-length body as organizer wasexplicitly related to accountability issues (as noted by Hannah,above). The internal BGTD evaluation makes a similar statement:

Whether or the extent to which a consultation should be carriedout at “arms length”will depend on the climate of public trust ofgovernment (at the time of xenotransplantation consultationthere was little trust in government), the government agency’strack record in handling critical issues, and the extent to whichthe subject matter is controversial. (27)

That, combined with earlier concerns about in-house expertise,set the scene. In Scott’s (2003) view, empirical research might askhow types of carriers affect the way institutional elements arereceived. Here, conventional protocols for consultation (i.e. by theregulator) were brought into question in the case of xeno-transplantation, especially as a recent history with accountabilitypractices was motivating the regulator to work differently. Thedecision was made to adjust the relational systems within theexisting protocols for consulting the public. The arm’s-lengthrelationship between Health Canada and CPHA allowed theconsultation to be structured in a way that achieved higher credi-bility than would have been possible had the regulator been incharge. The destabilization of an existing routine allowed relationalsystems to shift.

In line with institutional theory, we would argue that changingpractices around transparency, openness and consultation atHealth Canada have to an extent become new forms of routinizedpractice. The creation of a dedicated office for public consultationdoes suggest new relationships and routines, capable of serving ascarriers for further innovations in consultation and openness. Laterevents indicate that something more than cosmetic changes havebeen occurring at Health Canada.

In the years following the CPHA xenotransplantation consul-tation, Health Canada has made moves toward transparentaccountability through the creation and adoption of newinstruments. Along with the Policy on Public Input, the HealthProducts and Food Branch instituted online publication ofSummary Basis of Decision (SBD) notices, which explain regula-tory risk/benefit decisions underlying the approval of therapeuticproducts for market; and the Voluntary Statement of Information(VSI), which asks public consultation participants to reveal(primarily financial) conflicts of interest they hold related to theconsultation’s subject matter e for example, shares in a drugcompany e so this record can be made available. For some timenow, concerns about bias in the participation of industry-supported patient groups (see e.g. Batt, 2009) have led to thedevelopment of mechanisms to scrutinize the financial interestsof consultation participants.

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Conflict of interest is not only an issue of accountability forconsultation participants, however. During a planning workshop in2000, Health Canada had defined the objective of public consul-tation and policy development as being to ensure new therapeuticsreach the market in a timely manner (a concern deeply connectedto the relationship between the regulator and product sponsors) aswell as regulating the sponsors of new therapeutic products. Thisdual purpose of government, as “typically engaged in both thepromotion of technology as well as in its regulation or control”(Einsiedel, 2002, p. 319), holds potential or real conflicts that areincreasingly of concern to regulators. In 2008, Bill C-51 e An Act toamend the Food and Drugs Act and to make consequential amend-ments to other Actsewas introduced in the House of Commons, andincluded an article on confidential business information or CBI. CBIis information having “actual or potential economic value to theperson or their competitors because it is not publicly available andits disclosure would result in a material financial loss to the personor a material financial gain to their competitors” (Parliament ofCanada, 2008). Health Canada essentially enters into a contractagreeing to keep proprietary information secret so companies canensure their competitive edge. Had the Bill passed, the HealthMinister would be able to disclose CBI to outside experts (in orderto gain advice on product safety prior to approval) without consentof the ‘owner’ of this information. With the Policy on Public Input,Health Canada recognized that some perspectivese from commu-nity health physicians, patient advocates, or informal carers ofthose with specific illnesses e could complement scientificevidence about a product (e.g. through clinical trials). Input of thisnature requires detailed knowledge about the product, so a mech-anism to release this information beyond the protected confines ofthe regulatory body was put forward. Unfortunately, Bill C-51 wasin the process of second reading before Parliament dissolved in2008. It has not been resurrected, at least in its entirety. Never-theless, it represents a shift in the taken-for-granted practices andrelationships at the center of evidence-based marketed productreview.

Goodin and Dryzek (2006) note that a consultation’s impact willat least partially depend on the system in which it takes place. Itseems likely to us that the value of integrating different knowledgebases and forms of experience/expertise was part of a growingappreciation by organizational actors at Health Canada, includingthose engaged in the xenotransplantation consultation. These on-the-ground policy analysts and regulators used their influence tochange their own practices and perspectives, and lead a vanguardof change within the regulator. This is, necessarily, an incrementalchange with many contributing factors; and is the type of impactreferred to in the literature that can only be observed froma temporal distance.

Conclusion

According to those we interviewed, state-sponsored consulta-tions of publics on xenotransplantation in Canada was the result ofa “perfect storm” (LaPrairie): concerns about lack of supply oforgans, the potential of rectifying this through xenotransplants ifthe necessary research was conducted, the rise of precautionaryand ethical concerns, the imminence of clinical trial applications,combined with “a little bit of breathing room because the sciencewasn’t quite there”. In combination with the immediate climate ofdistrust fostered by the tainted blood scandal, we also heard thisdescribed as a “window of opportunity” (Hannah).

The element of serendipity suggested here is noteworthy.The CPHA consultation occurred at a time when circumstanceshad raised concerns about the accountability of health policydevelopment. One option policy makers have, when the state’s

accountability is brought into question, is to demonstrate goodfaith by being open with and engaging citizens in policy processes.In that sense, it may be difficult to attribute causation of thechanges in Health Canada’s public engagement framework to theissue of xenotransplantation itself. However, the complexity of theissue combined with the timing of its appearance on the policylandscape made it a contributor to processes of learning about howand why to run effective public consultations as part of healthtechnology assessment. The moment at which xenotransplantationbecame an experimental site for Health Canada’s public consulta-tion practices, it became linked with challenges to existing ways ofpracticing policy in the regulator. Organizational actors in theregulative functions of health governance were already aware thatpublic consultation can enhance citizens’ perceptions of the state’saccountability; this is, after all, one of the reasons consultation wasdone on the issue of xenotransplantation. The way the public wasconsulted, however, demonstrated openness to learning newlessons about how and why to engage. We begin to see changes inrelationships and the actors involved, as the use of arm’s-lengthbodies and stakeholder advisory committees teaches policymakers within Health Canada the validity of expertise outside thesanctioned regulatory offices. We also see a destabilization of theroutines associated with closed, expert-driven regulatory practices,as the organization develops its own capacity for expertise in publicengagement through OCAPI and its activities.

Without access to high-level internal decision-making docu-mentation at Health Canada, we cannot conclusively state that thexenotransplantation consultation resulted in institutional learning.However, based on the insider perspectives of those we inter-viewed, we feel there is a case to be made that it contributed tolearning at Health Canada. Moves continue to be made towardgreater transparency (including a proposed Consumer ProductSafety Bill, again affected by the calling of an election in 2011). Itremains to be seen whether transparency will work as citizensmight hope.

Acknowledgments

The authors wish to acknowledge the support of the EuropeanCommission Framework 7 study, Citizen Participation in a Knowl-edge Intensive Policy Field (CIT-PART) (SSH-CT-2008-225327),Genome Canada’s GE3LS project on Genomics and knowledgetranslation in health systems, the invaluable contribution of Mea-ghan Brierley, and the anonymous reviewers whose suggestionsgreatly improved this manuscript.

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