Sustainability, Benefit to the Community and Ethics

The Norwegian Biotechnology Advisory BoardContentsIntroduction 5Opinion of the Biotechnology Advisory Board 71. Decision-making structure 72. System limits 73. Danger of detrimental effects on health and the environment 84. Precautionary principle 105. Sustainable development 136. Benefit to the community 157. Other ethical and social considerations 17

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified OrganismsIntroductionThe Norwegian Act relating to theproduction and use of genetically modifiedorganisms 1strongly emphasizes that thedeliberate release of such organisms shouldhave no detrimental effects on either healthor the environment. This emphasis is fullyin line with the legislation of other nationsconcerning the regulation of geneticallymodified organisms (GMOs). In the Act’spreparatory work 2 , several references aremade to the concept of risk. One of thesereferences emphasizes that the wording“without detrimental effects on health andthe environment” in the purpose statementof the Act should not be interpretedThe Gene Technology Act,Section 10, excerpt:“The deliberate release of geneticallymodified organisms may only beapproved when there is no risk of adverseeffects on health or the environment.In deciding whether or not to grant anapplication, considerable weight shallalso be given to whether the deliberaterelease will be of benefit to societyand is likely to promote sustainabledevelopment.”Sustainable developmentThe World Commission definedsustainable development in the report“Our Common Future” (1987) as“development that meets the needs ofthe present without compromising theability of future generations to meettheir own needs”.The concept of “sustainable development”is included in the Gene Technology Actin two ways, both as part of the purposestatement of the Act and as an explicitcriteria for approval (Section 10, secondparagraph, see above).literally – but rather that the expression“without detrimental effects” has beenused to emphasize the aim of carrying outa prior assessment of the risk to healthand the environment and avoiding possibledetrimental effects, and that this should beunderpinned by the precautionary principle.It is further stated that “a strict assessmentof risk to health and the environment is inline with the views of the Government andthe Parliament 3 ” (These concepts will bediscussed further in Chapter 3).As distinct from the regulations of othernations, however, the Norwegian GeneTechnology Act also stresses that thedeliberate release of such organisms shouldrepresent a “benefit to the community” andenable “sustainable development”. Theseconcepts are used in Sections 1 and 10 of theNorwegian Gene Technology Act.The EU has since established new GMOdirectives4 that move towards the Norwegianlegislation. However, there are still differencesin the emphasis on ethics and benefit to thecommunity as the Norwegian laws demandan assessment of the GMO’s contribution tosustainable development.However, it is not self-evident how“sustainability” and “benefit to thecommunity” should be considered in termsof the practical application of the Act. In thelight of the preparatory work, consultativestatements and the political debate onthe Gene Technology Act, it is not clearwhether the provisions contained in Section10 relating to “benefit to the community”and “sustainable development” are to beconsidered as additional requirements oras a softening-up of the requirement for nodetrimental effects on either health or theenvironment. “Sustainable development” and“benefit to the community” can be understoodas either:1. For the Gene Technology Act, see www.lovdata.no2. Ot. prp. nr.8 (1992-93)3. Stortinget: The Norwegian Parliament4. Most importantly the deliberate release directive 2001/18/ECwhich in 2002 replaced directive 90/2205

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified OrganismsOpinion of the Norwegian Biotechnology Advisory Board1. Decision-making structureIn the opinion of the Norwegian BiotechnologyAdvisory Board, Section 10 of the GeneTechnology Act should be interpreted tomean that the requirements of “sustainabledevelopment”, “benefit to the community”and other “ethical and social considerations”represent prerequisites that alone couldcarry decisive weight against granting anapplication, but that should also be consideredin relation to, and weighed against the risk ofdetrimental effects, when such risk is low.Hence, an assessment of the individualapplication will have the following structure:1) Danger of detrimental effects on healthand the environment:a) what are the possible negativeconsequences?b) what is the likelihood of suchconsequences occurring?2) The precautionary principle:a) is the risk assessment associatedwith justified uncertainty?b) is there a possibility of substantialor irreversible harm?3) Is it:a) in compliance with the principle of“sustainable development”?b) of “benefit to the community”?c) “ethically and socially justifiable”?If there is a demonstrable yet minor risk ofdetrimental effects under item 1) and theprecautionary principle is not applicableaccording to item 2), then the contributionto “sustainable development” and “benefit tothe community” may be seen as significantenough to warrant that the applicationnevertheless may be recommended (theapplication is in other respects ethically andsocially defendable).The Biotechnology Advisory Board is anadvisory body and should in all cases consider“sustainable development”, “benefit to thecommunity” and other “ethical and socialconsiderations”, even though it believes theremay be a serious risk of detrimental effectsinvolved. In the event that the opinions of thedecision-making authority, the Ministry ofthe Environment, were to differ from that ofthe Biotechnology Advisory Board on the riskof the detrimental effects of an application,it is important that assessments of the othercriteria stipulated in the Act should be made.2. System limitsAn essential question is to understandthe limits of the system relating to thecases for consideration. It is particularlyimportant not to define the system limits for“sustainable development”, “benefit to thecommunity” and other “ethical and socialconsiderations” too narrowly. The GeneTechnology Act uses the terms “production”and “use” to express this broader approach.This means that assessments should notonly apply to the genetically modifiedproduct itself, but also to the productionsystem in a broader sense, which includesthe production line – from development andpilot production to processing in a productionfacility – and thereafter the marketing, salesand distribution of the finished product. Butit also covers the properties of the productitself. The Biotechnology Advisory Boardfeels, therefore, that it might be useful todistinguish between three different conceptsthat jointly determine system limits:- product characteristics- production- useThis distinction applies primarily to theassessments of “sustainable development”,“benefit to the community” and “other ethicaland social considerations”.7

The Norwegian Biotechnology Advisory Board3. Danger of detrimentaleffects on health and theenvironmentSection 10, second paragraph, of theGene Technology Act uses the wording“danger of detrimental effects on healthor the environment”. The term “risk” isnot directly used in Section 1 of the Act(purpose statement) nor in Section 10,second paragraph. However, Section 10, fifthparagraph, contains the following wording:“The authorities responsible under the presentAct, however, may still prohibit or limit suchplacing on the market if in their opinion itinvolves a risk to health or the environmentor if the placing on the market is otherwisein conflict with the purpose of this Act”.Section 11 of the Act also uses the term “risk”:“Applications for approval of deliberate releasepursuant to section 10 shall contain an impactassessment setting out the risk of detrimentaleffects on health and the environment andother consequences of the release”.In the Act’s preparatory work, severalreferences are made to the concept ofrisk. It is, for instance, emphasized thatthe wording “without detrimental effectson health and the environment” in thepurpose statement of the Act should not beinterpreted literally – but rather that theexpression “without detrimental effects” hasbeen used to emphasize the aim of carryingout a prior assessment of the risk to healthand the environment and avoiding possibledetrimental effects, and that this should beunderpinned by the precautionary principle 7 .It is further stated that “a strict assessmentof risk to health and the environment is inline with the views of the Government and theStorting 3 ”.AssessmentWhen evaluating cases pursuant to theprovisions of the Gene Technology Act, theBiotechnology Advisory Board thereforeconsiders the two concepts of “danger” and“risk” to be synonymous. When it is statedin Section 10, second paragraph, that adeliberate release of genetically modifiedorganisms may only be approved when there7. Ot. prp. nr. 8 (1992-93) p 67is no danger of detrimental effects on healthor the environment, this must be understoodas a declaration of intent to apply theprovisions of the Act in a restrictive manner.In consequence, the deliberate release ofgenetically modified organisms may only beapproved when the risk of detrimental effectson health and the environment is low.Risk is per se a complex concept. TheBiotechnology Advisory Board applies thecommonly accepted scientific and technicalunderstanding of the term as a function oftwo factors – consequence and probability –recognizing, nevertheless, that the productof these two factors does not provide anadequate understanding of risk in a decisionmakingcontext. In such a context, the riskinvolved may in fact be minor, even thoughthe negative consequences may be verysubstantial. Hence, the Board concludesthat approving a deliberate release in suchan instance would be incompatible withthe intentions of the Act, even when thereis a reasonably secure basis for probabilityassessments.It might be useful to introduce the conceptof “perceived risk”, i.e. the manner in whichrisk is perceived by individuals or societyas a whole. Perceived risk is, moreover,a commonly applied concept in recentdevelopments in the field of risk research– even in narrower scientific and technicalcontexts. Something that has seriousnegative consequences generally entailsgreater perceived risk, even if the probabilityof such consequences occurring is low. If so,it would not be acceptable to implement themeasure or the deliberate release. This callsfor an additional prerequisite linked to therequirement of low risk, namely that thedeliberate release of genetically modifiedorganisms may only be approved when thepossible detrimental effects on health and theenvironment are minor.In general, every application for a deliberaterelease should be assessed in the light of therisk with which the specific release applied formay be associated, i.e. on a case-by-case basis.However, a number of serious consequencesmay arise as the cumulative effects of severalreleases, even if the effects of the individualreleases are minor. The term “cumulativeeffects” is relevant in such contexts. It8

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified Organismsunderlines the need for a further additionalprerequisite: that the deliberate release ofgenetically modified organisms may only beapproved when the cumulative detrimentaleffects on health and the environment ofseveral releases are minor.There is a connection between theseprerequisites for deliberate release and theapplication of the precautionary principle.The recommended prerequisites apply onlywhen the knowledge base is reasonably ortotally secure. This applies to knowledge of theconsequences, as well as of the probabilities,including those related to cumulativeeffects. It also expresses another additionalprerequisite – if there is a reasonable degreeof doubt about the knowledge acquiredthrough impact assessments and the relatedrisk assessments, then the precautionaryprinciple will (under certain conditions) apply.In this respect, we refer to the assessmentof the conditions for the application of thisprinciple under the Gene Technology Act thatfollows below.CommentIf the answer to question 1 is “no”, the case willbe assessed in the light of the precautionaryprinciple. If the answer to one or more ofquestions 2 through 4 is “yes”, the applicationwill be rejected. If the answer to all questionsfrom 2 to 4 is “no”, the application will besubject to further consideration in the light ofthe precautionary principle.Checklist questions1. Does the application provide adequatedocumentation for assessing possibledetrimental effects?2. Is it reasonable to assume that majoror significant risk to health or theenvironment is involved?3. Is it reasonable to assume that majoror significant negative consequencesfor health or the environment areinvolved?4. Is it reasonable to assume that majoror significant negative cumulativeconsequences for health or theenvironment are involved?9

The Norwegian Biotechnology Advisory Board4. Precautionary principleThe precautionary principle is not mentionedin the wording of the Gene Technology Actitself. However, reference is made to thisprinciple in the Act’s legislative history.Several references are to be found in Ot. Prp. 6No. 8. It is stated that the precautionaryprinciple also applies in relation to the ethicalassessment of consequences, in addition tothe relevant impact assessments 8 .The precautionary principle is also mentionedin the discussion of the Act’s requirementof being “without detrimental effects”. It isstated that the term is used to underscorethe aim of carrying out a prior assessmentof the risk to health and the environmentwhile avoiding possible detrimental effectsand that this should be underpinned bythe precautionary principle 9 . Moreover, thestatutory proposition to the Storting outlinesthe manner in which the precautionaryprinciple is to be interpreted 10 :on sustainable development in Rio in 1992.A further confirmation and more specificformulation of its content and importanceare to be found in the White Paper to theStorting 11on “sustainable development”.There, the precautionary principle is given acentral role as an instrument to develop anenvironmental policy allowing sustainabledevelopment. This is defined as follows 12 :“If there is danger of serious or irreversibleharm, any lack of complete scientificcertainty shall not be used as groundsfor carrying out encroachments on natureor for deferring environmental policymeasures. Great importance must beattached to the possible detrimental effectswhen setting objectives.”“The Ministry emphasizes that theprecautionary principle does not meanthat all use of gene technology should beautomatically considered hazardous, butin instances where a concrete assessmentindicates that there may be reasonabledoubt about the risk, this directs againstsuch use.”Today, there is a general understandingthat the precautionary principle representsone of several principles embodied in theconcept of “sustainable development”. Thefact that the concept is emphasized in thestatutory text itself further underlinesthat the precautionary principle must betaken into account when considering casesunder the Gene Technology Act. Within theframework of the international processesrelated to “sustainable development”, theprecautionary principle is laid down in theso-called Rio Declaration and in the UNConvention on Biological Diversity – bothadopted at the UN Earth Summit (UNCED)8. Ot. prp. 8 (1992-93) p 45.9. Ot. prp. 8 (1992-93) p 67.10. Ot. prp. 8 (1992-93) p 46.11. St. meld. No. 58 (1996-97)12. St. meld. No. 58 (1996-97) concerning sustainabledevelopment, p. 1310

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified OrganismsAssessmentConsequently, the precautionary principleregulates actions associated with doubt oruncertainty. This constitutes the most centraldimension of the principle. Are we absolutelycertain – or even just reasonably certain – ofthe consequences and/or the probabilities, thenthe principle will not apply. However, in theevent of reasonable doubt, the precautionaryprinciple alone constitutes sufficient groundsfor acting in nature’s best interests, i.e. itis sufficient grounds for refraining fromcarrying out the encroachment on naturethat is the subject of the application, e.g. thedeliberate release of a genetically modifiedorganism. This latter aspect also embodiesthe precautionary principle’s other centraldimension – that nature is to have the benefitof the doubt. The position of the BiotechnologyAdvisory Board is that mankind in thiscontext, is to be perceived as a part of nature,which means that the principle also appliesin those instances where there is uncertaintyabout the consequences for human health.What then can give cause for doubt? Theprinciple does not apply to doubt aboutall types of consequences for health andthe environment. It would have to involvepotentially serious detriment. The definitionuses the terms serious or irreversible harm.The principle is, in this respect, based on adiscussion of how we must act in order to avoidunintentional, irreversible environmentalconsequences.Cumulative effects represent a crucialelement of this discussion – meaning thatthe principle should also apply when there isreasonable doubt about serious cumulativeeffects, even if there may be no doubt aboutthe serious consequences associated with theindividual encroachment or release.So, in which contexts could such doubt exist?The following elements might serve as aguide:- doubt about fundamental cause-effectrelationships- doubt about probability assessments- doubt about impact assessments- doubt about cumulative consequencesand/or- doubt as to whether moderatingand regulatory measures and policyinstruments are functioning asintended.Often, there will also be considerableuncertainty and insufficient knowledge aboutthe effects of a deliberate release of geneticallymodified organisms in relation to “sustainabledevelopment” and “benefit to the community”.It could be queried whether the precautionaryprinciple might not also apply in the face ofthis type of uncertainty as well. Uncertaintyabout the negative consequences for societymight, for instance, be perceived as a decisiveargument for opposing the deliberate releaseof a genetically modified organism. TheBiotechnology Advisory Board is of the opinionthat the precautionary principle does not11

The Norwegian Biotechnology Advisory Boardapply in this type of context, on the groundsthat it has been given a precise meaning inthe context of environmental and healthissues. The application of the precautionaryprinciple in other areas might easily lead to awatering down of the concept, resulting in itsloss of significance and impact.Thus far, the question has been what criteriashould be used for applying the precautionaryprinciple. It is important that we separatethis from the question of what strategiesand measures may then be used to deal withthis uncertainty. In the Act’s preparatorywork it is stated that application of theprinciple implies that approval will not begiven to the release of the GMO in question.In many cases this will be the case. But atthe same time it is also important to stressthat the application of the precautionaryprinciple does not necessarily lead to onlyone kind of action. There may, in principle,be many strategies and measures available.Among such strategies, the following can bementioned (see, for instance: NOU 2001: 18):1. Permanent ban.2. Moratorium (time-based, temporaryban).3. Step-by-step strategy (with welldefinedmilestones that must bereached for each step).4. Take-it-slow strategy (where limitedactivity is followed up by targetedfollow-up programs, in research, forinstance).5. Surveillance strategy (where moreextensive activities are followedup with specific surveillanceprograms and reporting systems,while preserving the principle ofreversibility).Checklist questions- Is there a reasonable degree of doubtabout existing risk assessments and isthere danger of even greater risk beinginvolved?- Is there a reasonable degree of doubtabout existing probability assessmentsand is there danger of an even greaterprobability of detrimental effects beinginvolved?- Is there a reasonable degree of doubtabout existing impact assessments andis there danger of even more seriousconsequences for health and theenvironment being involved?- Is there a reasonable degree of doubtabout possible serious, cumulativeconsequences for health and theenvironment?- Is there a reasonable degree of doubtas to whether the proposed moderatingmeasures and policy instruments arefunctioning as intended?CommentAn affirmative answer to one or more of thesequestions indicates that the precautionaryprinciple should be used. In such casesfurther assessments of which strategies andmeasures should be used to deal with therelevant uncertainty should be made.The choice of strategy must be done on thebasis of a case-by-case assessment.12

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified Organisms6. Benefit to the communityThe concept of “benefit to the community”appears in the Gene Technology Act as one ofseveral criteria for granting an application.It is a complex concept, for which neither theAct itself nor its legislative history providesany clear guidance as to how it should beunderstood. In the current context, theBiotechnology Advisory Board has optedfor a relatively pragmatic approach, aimedat expressing those aspects of the concepton which there appears to be a high level ofagreement.The majority of the Storting’s 3StandingCommittee on Municipal Affairs and theEnvironment underlined that:“…permission [for the deliberate releaseof a GMO] must be contingent on theutility value involved and the ethical,health and ecological issues that thedeliberate release raises following priorthorough trials and impact and riskassessments.” 14It is assumed that applicants will drawattention to the benefits to society of anew, genetically modified product. On theother hand, the governing bodies and theBiotechnology Advisory Board also have aresponsibility to assess the disadvantages tosociety of a new, genetically modified product.This is all part of the general concept of“benefit to the community”.The Norwegian authorities’ experience withGMO-applications so far is that they contain(surprisingly) little documentation that couldrender possible an assessment of a givenGMO’s benefit to the community. This is, afterall, the one point where the manufacturercan make a case for the positive effects of theproduct they have developed. It is the opinionof The Norwegian Biotechnology AdvisoryBoard that it is important for Norwegianauthorities to continue asking for suchinformation so that assessments can be madein line with the Gene Technology Act.AssessmentThe Board will assess both the positive and14. Recommendation to the Storting No. 155 (1990-91), p. 8the negative effects the product may haveon the community. When new antibiotics areapproved in Norway, the Norwegian MedicinesAgency (NoMA) performs an assessment of thedrug itself – whether it functions satisfactorilyand whether its side-effects are acceptable– which is, in many ways, similar to therequirements set out in the Gene TechnologyAct of avoiding detrimental effects on healthand the environment. In addition, a societalassessment is made, which goes beyond thescope of the manufacturer’s wish to sell theproduct and the patient’s wish to buy it, andwhich for instance includes an assessment ofthe risk of developing antibiotic resistance.This societal assessment could focus on thefollowing aspects:- which problem does the new drug seekto solve?- which alternatives are available forsolving the same problem?- which problems could arise if the use ofthe drug leads to increased resistance?These elements serve as a source of inspirationfor how the Biotechnology Advisory Boardwill implement the requirement of “benefit tothe community”.It should be emphasized that we areconsidering, in this context, the benefits anddisadvantages to society. Hence, it is not onlya matter of the benefits that the individualmanufacturer, consumer or applicant mayachieve. It is also very much a matter of thirdpartyconsiderations. To the extent in whichsecond-party considerations are involved, e.g.by highlighting the aspect of competition withother manufacturers already on the market,this should also be seen in a broader, societalcontext.So, what types of benefits and disadvantagesare involved? To start with, we need a negativedelimitation. It might involve purely ethicalassessments, e.g. in relation to weak parties.But in the context of the BiotechnologyAdvisory Board’s work, this is covered bythe question of “other ethical and socialconsiderations”. What then about geographicalspace, i.e. what is the spatial extent of whatwe here call the “community”? This requires,first of all, a positive delimitation. The term15

The Norwegian Biotechnology Advisory Board“community” means primarily Norway.But a negative delimitation is also needed– it does not encompass the whole world.Considerations of this type would largely becovered by aspects related to “sustainabledevelopment”. However, the term “primarily”is indication that it might be useful to assessthe situation in our part of the world – alsooutside Norway’s borders. Furthermore, itmight be relevant to consider the matterof societal changes over time, e.g. the factthat there will always be changes occurringin what is perceived as a necessity or aninconvenience. This type of assessment mayeasily develop into something comprehensiveand speculative. Other, more fundamental,long-term assessments are covered by theconsiderations of “sustainable development”.The Biotechnology Advisory Board believes,therefore, that any assessment of “benefitto the community” must primarily beundertaken in the light of the situationprevailing today or of the near future.In the opinion of the Biotechnology AdvisoryBoard, it might be useful to divide checklistquestions into two groups:- product characteristics- production and use of the productChecklist questionsProduction and use of the productAmong the relevant aspects to be consideredare:- Does the product contribute to creatingnew employment opportunitiesin general and in rural areas inparticular?- Does the product contribute to creatingnew employment opportunities inother countries?- Does the product create problems forexisting production whose existenceshould otherwise be preserved?- Does the product create problems forexisting production in other countries?(This list of questions is not meant to beexhaustive, but primarily to serve as anindication of the type of questions that shouldbe considered).CommentAny assessment of benefit to the communitymust be based on a discussion of the responsesas a whole. However, it should be emphasizedthat every question may not be equallyrelevant in all instances.Product characteristics- Is it reasonable to say that there isa need for the product in terms ofdemand or otherwise?- Is it reasonable to say that the productwill solve or possibly contribute tosolving a societal problem?- Is it reasonable to say that the productis significantly better than equivalentproducts already on the market?- Is it reasonable to say that there arealternatives that are better than theproduct in terms of solving or possiblycontributing to solving the societalproblem in question?16

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified Organisms7. Other ethical and socialconsiderationsThe Gene Technology Act aims “to ensurethat the production and use of geneticallymodified organisms takes place in an ethicallyand socially justifiable way…” (Section 1).This brings in the concept of “ethically andsocially justifiable”. Section 10 of the Act,which stipulates the criteria for approval,makes no reference to such a concept(other than what is implied by the terms“sustainable development” and “benefit to thecommunity”). Nonetheless, the BiotechnologyAdvisory Board finds that the reference to“other ethical and social considerations”constitutes an independent criterion thatmust be considered in all applications forapproval. This opinion is further corroboratedby the legislative history of the Act. It is,moreover, the type of issue that is specificallyemphasized in the Board’s mandate.According to the first paragraph of itsmandate, the Biotechnology Advisory Boardis “to assess general questions, or questions ofprinciple concerning biotechnological activity,including ethical and social questions”.AssessmentThe preparatory work of the Act providessome guidance on how the term “otherethical and social considerations” is to beunderstood, i.e. the type of considerationsthat may be included. In the propositionOt. prp 6 . No. 8, it is stated that the purposeof the Gene Technology Act is “… to ensurethat modern biotechnology is utilized for thecommon good and in keeping with the ethicalvalues on which our society is founded”. In theWhite Paper to the Storting No. 25 (1992-93)entitled “Humankind and biotechnology”, itis stated that we must “root our positions inethical principles that enjoy broad acceptancein Norwegian society”. This is expressed evenmore precisely in the Recommendation to theStorting 3 No. 155 (1990-91):”The Committee underlines thatlegislation and guidelines must befounded on fundamental norms that,in the Committee’s view, must form anethical basis for developments in the fieldof biotechnology, i.e. on the Christianhumanisticvalue base and on respectfor the value of human life, humankind’sabsolute value, human rights, the principleof equality and solidarity and on respectfor ecological balance and the integrity ofnature.”In the light of this, the Biotechnology AdvisoryBoard finds that it might be useful to make adistinction between ethical norms and valuesassociated with humankind and eco-ethical(the integrity of nature) circumstances andassessments. This provides a structure for thegrouping of checklist questions. An exampleof an eco-ethical issue would be the respectfor nature’s intrinsic value. In order for adeliberate release of genetically modifiedorganisms to be justifiable in terms of therespect for human equality, it must be likelythat sufficient consideration has been given insociety as a whole to the interests of any weakparties involved. Moreover, other aspects ofan application for approval, than merely theproduct’s characteristics or its production anduse, may also be brought in for consideration.There might, for example, be a question ofwhether the applicant can prove that thegenetic material used has been acquired inan ethically justifiable manner and underwhich (ethical) conditions the product is to bemarketed and distributed.The aim of any ethical reflection must be toenable us to make an assessment of whatis right and wrong, good or evil, in a moresystematic and reliable manner. When weask ourselves how we should act toward oneanother or how society should be organized,we must also look at the type of rules andguidelines that are commonly followed ineveryday life: how do individuals in fact actand how is society organized? These aredescriptive questions of what we call morals –our customs and practices, the norms that areknown and followed in society and the valuesthat are generally accepted. But we areconcerned not only about the way in whichpeople act in reality and the practices thathave developed in society. Generally speaking,we see that we are unable to find completeanswers to all such “should” questions bysimply ascertaining how things really are.In order to answer these questions wecannot be content with knowing which moral17

Sustainability, Benefit to the Community and Ethics in the Assessment of Genetically Modified Organismsattribute to them, and that such values implyother guiding principles for biotechnology.This means that other parties and interestsshould be included in the ethical evaluationthan just humans – for example, the survivalof (higher) animal and plant species and/or ecosystems. The justification for sucha position may be of a religious nature –Divine creation – or based on the respect forall living things in general. Some of theseviews are more controversial than others. Forthe purpose of the Biotechnology AdvisoryBoard’s work, however, it is worth noting thatany disagreement may not necessarily be soserious in practice as to give rise to difficultieswhen the Board advises whether to authorizeor prohibit.Eco-ethical considerations- Do the product or its productionconflict, by their very nature, with anyintrinsic value of animal species?- Does the production of the productcause unnecessary suffering toanimals?- Does the production of the productresult in any transgression of barriersbetween species in ways that arematerially different from whatotherwise occurs in cultivated or wildnature and that must be consideredincompatible with the value ascribedto the segregation of species?Checklist questionsEthical norms and values associated withhumans- Does the authorization/prohibition ofthe product and its production and usecomply with the ethical principles ofthe population at large?- Does the product or its productionand use conflict with ideals of humansolidarity and equality, especially inrelation to the safeguard of weakergroups of society?- Indigenous peoples, people with strongtraditional cultures and weaker groupsof society may be exposed to seriousadverse consequences of the decisionsof mainstream society. The interests ofsuch groups in being allowed to controltheir own cultural change should betaken into special consideration.- Does especially the marketing and saleof the product conflict with such normsand values?(This list of questions is not meant to beexhaustive, but primarily to serve as anindication of the type of questions that shouldbe considered).CommentAn assessment of the regard for such ethicaland social circumstances must be based ona discussion of all answers as a whole. Onceagain it must be emphasised, however, thatnot all the questions may be equally relevantin all cases.19