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I. Intro­duc­tion

The sub­jects of bio­se­cu­ri­ty and the con­tain­ment of bio­lo- gical wea­pons remain high­ly rele­vant and important, par­ti­cu­lar­ly in times with as many insta­bi­li­ties as today. The­se insta­bi­li­ties at the natio­nal and inter­na­tio­nal level beco­me mani­fest in ter­ro­rist attacks, as in Madrid 2004, Lon­don 2005, Bos­ton 2013, Paris 2015, and Copen­ha­gen 2015, the estab­lish­ment of a ter­ro­rist regime, the so- cal­led IS (“Isla­mic Sta­te”), that con­trols are­as in the Midd­le East, the new con­fron­ta­ti­on with Rus­sia due to the annex­a­ti­on of the Cri­mea and the armed con­flict in Ukraine.

Sci­ence seems to be far apart from any secu­ri­ty con- cerns. Sci­ence is, as long as it is aimed toward peace­ful pur­po­ses, cha­rac­te­ri­zed by often fruit­ful coope­ra­ti­on bet­ween dif­fe­rent rese­ar­chers in dif­fe­rent parts of the world, sear­ching for know­ledge, stri­ving to impro­ve the living con­di­ti­ons by figh­t­ing cli­ma­te chan­ge, hun­ger, ma- jor dise­a­ses, like Ebo­la, and pan­de­mics cau­sed by an in- flu­en­za virus or other agents. Many are­as of sci­ence in the 21st cen­tu­ry try to sol­ve the major, glo­bal pro­blems of human­kind. It does not seem easy to link peace­ful sci­en- tific rese­arch to the secu­ri­ty pro­blems of our times.

But this pic­tu­re does not seem to be cor­rect. The new, threa­tening insta­bi­li­ties of the years 2014/2015 are cha- rac­te­ri­zed by blur­red lines: The­re are no clear fron­tiers, no limi­ted “battle­fiel­ds”, often no com­ba­tants that are re- cogniz­ab­le, and the­re is no clear stra­te­gy how to restore

  1. 1  „Ord­nun­gen sind unter Druck. Unord­nung greift um sich.“ Cf. the Ger­man For­eign Minis­ter Frank-Wal­ter Stein­mei­er, „Auf der Suche nach Ord­nung in der Unord­nung: euro­pä­isch-asia­ti­sche Zusam­men­ar­beit in einer unüber­sicht­li­chen Welt“, pre­sen­ta­ti­on at the ASE­AN-Secre­ta­ri­at Gene­ral in Jakar­ta, 3.11.2014, avail­ab­le at: http://www.auswaertiges-amt.de/DE/Infoservice/Presse/ Reden/2014/141103-BM_ASEAN.html.
  2. 2  Moham­mend Atta, one of the 9/11 ter­ro­rists, the hija­cker-pilot of Ame­ri­can Air­lines Flight 11, stu­di­ed for many years at the Tech- nischen Uni­ver­si­tät Ham­burg-Har­bur­g/­Ger­ma­ny; Tamer­lan Tsar- naev, one of the ter­ro­rists of the Bos­ton Mara­thon Bom­bing, stu- died at the Bun­ker Hill Com­mu­ni­ty College/Boston/U.S.; Dzok­har Tsar­na­ev, the second Bos­ton Mara­thon Bom­bing ter­ro­rist, stu­di­ed at the Uni­ver­si­ty of Massachusetts/Dartmouth/U.S. and has been an U.S.-citizen sin­ce 2012, cf. http://www.fbi.gov/news/updates- on-inves­ti­ga­ti­on-into-mul­ti­ple-explo­si­ons-in-bos­ton/­up­dates-on- inves­ti­ga­ti­on-into-mul­ti­ple-explo­si­ons-in-bos­ton and A. Ross, Der

or main­tain secu­ri­ty. It is a new world disorder.1 And it would be fal­se to assert that ter­ro­rists have no link to our wes­tern socie­ties and act far away in Sudan, Yemen, Af- gha­ni­stan etc. from our uni­ver­si­ties and rese­arch insti­tu- tes. It is striking that some of the main ter­ro­rists of the 9/11 attacks, the Bos­ton attacks, and of the IS are or were stu­dents in wes­tern coun­tries (Ger­ma­ny, U.S., and UK) befo­re or during the time they for­med part of a ter­ro­rist group.2 Tho­se ter­ro­rists did not use bio­lo­gi­cal wea­pons or bio­lo­gi­cal agents to threa­ten the popu­la­ti­on and the world com­mu­ni­ty. But their stra­te­gy has been and still is to cau­se pure hor­ror and the maxi­mum amount of ins­ta- bili­ty in the cen­ters of wes­tern civilization.3 Espe­cial­ly if one loo­ks at attacks by IS during the last mon­ths – the behea­ding and bur­ning of hos­ta­ges, the dest­ruc­tion of cul­tu­ral goods – the­re do not seem to exist any legal or moral limits.

Bio­lo­gi­cal war­fa­re and bio­ter­ro­rism have some very spe­ci­fic cha­rac­te­ris­tics that make them dif­fe­rent from other kinds of use of wea­pons: Bio­lo­gi­cal war­fa­re agents are easy to hide, dif­fi­cult to detect or pro­tect against;4 they will

“nor­mal­ly have a delay­ed effect due to an incu­ba­ti­on peri­od. The dise­a­ses cau­sed can be high­ly let­hal and may be con­ta­gious, con­se­quent­ly capa­ble of causing in- capa­ci­ta­ti­on or death of thousands. Even their use in a small sca­le, eg by releasing a very small quan­ti­ty into a water sup­ply, could cau­se exten­si­ve casu­al­ties and de-

Kör­per der Mus­li­me, Frank­fur­ter All­ge­mei­ne Zei­tung, 4.3.2015, 3. The “Isla­mic Sta­te” mili­tant known as “Jiha­di John“, who has been pic­tu­red in the vide­os of the behea­dings of Wes­tern hos­ta­ges, is
a Bri­tish natio­nal from west Lon­don who finis­hed his com­pu­ting degree at Uni­ver­si­ty of Westminster/UK in 2009, cf. BBC news, 26.2.2015 avail­ab­le at: http://www.bbc.com/news/uk-31637090.

3 It is no coin­ci­dence that the major ter­ro­rist attacks of the last de- cades occur­red in New York, Madrid, Lon­don, Bos­ton, Paris, and Copen­ha­gen, all of them eit­her capi­tal cities and/or finan­cial and cul­tu­ral metropolises.

D. Svarc, Bio­lo­gi­cal Wea­pons and War­fa­re, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 945; A. Nouri/Ch.F.Chyba, Bio­tech­nol­gy and bio­se­cu­ri­ty, in N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Cata­stro­phic Risks, 2008, 454: “Bio­lo­gi­cal wea­pons are dis­tinct from other so-cal­led wea­pons of mass destruction”.

Sil­ja Vöneky

Bio­se­cu­ri­ty – Free­dom, Respon­si­bi­li­ty, and Legi­ti­ma­cy of Research

Ord­nung der Wis­sen­schaft 2015, ISSN 2197–9197

118 ORDNUNG DER WISSENSCHAFT 2 (2015), 117–128

struc­tion. […] [B]iological wea­pons can be used for poli- tical assas­si­na­ti­ons, in order to cau­se social dis­rup­ti­on […], eco­no­mic dama­ge […], or envi­ron­men­tal prob- lems.”5

Having this in mind it is not asto­nis­hing that espe- cial­ly the bio­lo­gi­cal sci­en­ces have been for some years a focal point in regard to secu­ri­ty concerns.6 Even if the­re have been, so far, very few attacks of bio­lo­gi­cal ter­ro­rism by non-sta­te groups, the use of bio­lo­gi­cal and other agents to inten­tio­nal­ly kill “enemies” or dama­ge their en- viron­ment is a long-stan­ding technique.7 Without being an alar­mist: It might be only a ques­ti­on of time until the first major act of bio­ter­ro­rism takes place.8

If ter­ro­rists or other cri­mi­nals use sci­en­ti­fic fin­dings, it is a pro­blem of so-cal­led dual use. The noti­on of dual

  1. 5  D. Svarc, Bio­lo­gi­cal Wea­pons and War­fa­re, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 945.
  2. 6  Ano­t­her important and cur­r­ent­ly hot­ly deba­ted area is cer­tain rese­arch in the field of so-cal­led geo­en­gi­nee­ring, see for instance the two volu­me report: Cli­ma­te Inter­ven­ti­on: Reflec­ting Sun­light to Cool Earth, 2015 by the Com­mit­tee on Geo­en­gi­nee­ring Cli- mate, avail­ab­le at: http://www.nap.edu/catalog/18988/climate-in- ter­ven­ti­on-reflec­ting-sun­light-to-cool-earth. For more examp­les of glo­bal cata­stro­phic risks due to sci­ence, see N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Cata­stro­phic Risks, 2008. For uni­ver­si­ties, rese­arch insti­tu­ti­ons, and think tanks dealing with exis­ten­ti­al risks see Future of Huma­ni­ty Insti­tu­te, Oxford Mar­tin School & Facul­ty of Phi­lo­so­phy, UK; Cam­bridge Cent­re for the Stu­dy of Exis­ten­ti­al Risk (CSER), Uni­ver­si­ty of Cam­bridge, UK and Future of Life Insti­tu­te, Bos­ton, U.S.; avail­ab­le at: http://www.fhi.ox.ac. uk/, http://cser.org/ and http://futureoflife.org/home.
  3. 7  Cf. D. Svarc, Bio­lo­gi­cal Wea­pons and War­fa­re, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 945; S. Vöne­ky, Die Fort­gel­tung des Umwelt­rechts in inter­na­tio­na­len bewaff­ne­ten Kon­flik­ten, 2001, 8 et seq.
  4. 8  “The­re is clear evi­dence that some ter­ro­rist groups, such as Al Qae­da […], con­si­de­red and expe­ri­men­ted with bio­lo­gi­cal wea- pons”; For cur­rent con­cerns see The Guar­di­an, Top-secret mili­ta- ry warning on Ebo­la bio­lo­gi­cal wea­pon ter­ror thre­at, 21.2.2015, avail­ab­le at: http://www.theguardian.com/uk-news/2015/feb/21/ top-secret-ebola-biological-weapon-terror-warning-al-qaida-isis.
  5. 9  For the dif­fe­ren­tia­ti­on bet­ween dual use rese­arch and dual use rese­arch of con­cern (DURC) see below.
  6. 10  The­se are such kinds of GOF-expe­ri­ments in which the patho- genic effects of a micro­or­ga­nism are incre­a­sed eit­her direct­ly or by incre­a­sing its trans­mis­si­bi­li­ty or adap­ting it to new host organisms.
  7. 11  For details see Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, 9, avail­ab­le at: http://www.ethikrat.org/files/opinion-biosecurity.pdf.
  8. 12  For some voices from the cur­rent deba­te see: Recon­struc­tion of the 1918 Influ­en­za Virus: Unex­pec­ted Rewards from the Past (Tau­ben­ber­ger et al. — mBio 2012), avail­ab­le at: www.ipg-journal. de/­kom­men­tar/ar­ti­kel­/k­ei­ne-expe­ri­men­te-458/; Glo­ba­li­ze the dis­cus­sion (Fou­chier & Oster­haus - Natu­re 2012); Gain-of-

use means that ter­ro­rists or cri­mi­nals can misu­se fin- dings of rese­arch to do seve­re harm or even to build we- apons of mass destruction.9 Dual use is espe­cial­ly worry- ing in the field of bio­lo­gi­cal sci­en­ces as the result could be that a virus or other agent is used that spreads all over the world and cau­ses the death or dise­a­se of indi­vi­du­als, ani­mals, or the dama­ge of the envi­ron­ment. Hence it is not asto­nis­hing that after spe­cial kinds of so-cal­led gain of func­tion (GOF)10 expe­ri­ments in the Nether­lands and the U.S. were fun­ded and took place,11 an inten­se and in- ter­di­sci­pli­na­ry dis­cus­sion star­ted about the limits of the free­dom of bio­lo­gi­cal sci­ence, the respon­si­bi­li­ty of re- sear­chers and the legi­ti­ma­cy of rules regu­la­ting rese­arch in the field of bio­lo­gi­cal sci­en­ces befo­re the results were publis­hed. This deba­te has not yet ended.12 On the con- tra­ry, it has been intensified,13 sin­ce in this field of sci-

13

func­tion expe­ri­ments on H7N9 (Fou­chier et al. — Natu­re 2013); H5N1 virus: Trans­mis­si­on stu­dies resu­me for avi­an flu (Fou­chier et al. - Natu­re 2013); Cir­cu­la­ting Avi­an Influ­en­za Viru­ses Clo­se­ly Rela­ted to the 1918 Virus Have Pan­de­mic Poten­ti­al (ECDC, 2014), avail­ab­le at: http://ecdc.europa.eu/en/activities/sciadvice/_ layouts/forms/Review_DispForm.aspx?List=a3216f4c-f040-4f51- 9f77-a96046dbfd72&ID=765; COMMENTARY: The case against ‚gain-of-func­tion‘ expe­ri­ments: A reply to Fou­chier & Kawao­ka (Lip­sitch, Gal­va­ni - CIDRAP 2014), avail­ab­le at: http://www. cidrap.umn.edu/news-perspective/2014/06/commentary-case- against-gain-func­tion-expe­ri­ments-reply-fou­chier-kawao­ka; On the Need for a Natio­nal Board To Assess Dual Use Rese­arch of Con­cern (Casa­de­vall et. al — J Virol, 2014), avail­ab­le at: http://jvi. asm.org/content/88/12/6535.long; The H5N1 Mora­to­ri­um Cont- rover­sy and Deba­te (Casa­de­vall & Shenk - mBio, 2014), avail­ab­le at: http://mbio.asm.org/content/3/5/e00379-12.long; What Sci- ence Should We Fund? Ques­tio­ning New Poli­cy on H5N1 Gain- of-Func­tion Rese­arch (Evans - Sci­Am Blogs, 2013), avail­ab­le at: http://blogs.scientificamerican.com/guest-blog/2013/01/15/what- sci­ence-should-we-fund-ques­tio­ning-new-poli­cy-Feld­funk­ti­on geän­dert on-h5n1-gain-of-func­tion-rese­ar­ch/; Kei­ne Expe­ri­men- te! Das Züch­ten neu­er Krank­heits­er­re­ger ist sinn­los und gefähr- lich. Es muss auf­hö­ren (Lip­sitch - IPG, 2014), avail­ab­le at: http:// www.ipg-journal.de/kommentar/artikel/keine-experimente-458/. For the cur­rent deba­te on bio­se­cu­ri­ty and bio­safe­ty see for instance: Das Miss­brauchs­ri­si­ko in den Bio­wis­sen­schaf­ten — Bio­si­cher­heits­re­le­van­te For­schung zwi­schen Frei­heit, Fort­schritt und Ver­ant­wor­tung, Frei­burg 2014, avail­ab­le at: http://www.jura. uni-freiburg.de/institute/ioeffr2/symposien/missbrauchsrisiko; Cam­bridge Working Group, Cambridge/Boston/U.S. 2014, avai­la- ble at: http://www.cambridgeworkinggroup.org/; Mee­ting of the Working Group, Abrüs­tung und Nicht­ver­brei­tung bio­lo­gi­scher und che­mi­scher Waf­fen, Ber­lin 2014; Bio­chem­Se­cu­ri­ty­2030- Pro­ject, Bio­lo­gi­cal and Che­mi­cal Secu­ri­ty in an Age of Respon- sible Inno­va­ti­on, Lon­don 2014; Side-Event Ger­ma­ny and Tuni­sia, Bio­se­cu­ri­ty and Limits of Rese­arch, UN Mee­ting of Sta­te Par­ties, Bio­lo­gi­cal Wea­pons Con­ven­ti­on, Geneva/CH 2014; VW Stif­tung, Sym­po­si­um Dual Use on Micro­bes: Bio­safe­ty, Bio­se­cu­ri­ty, Res- pon­si­bi­li­ty, Hano­ver 2014, avail­ab­le at: http://www.volkswagenstiftung.de/dualuseresearch.html.

ence an espe­cial­ly high, perhaps even exis­ten­ti­al or glo- bal cata­stro­phic, risk14 can be pre­sent if cer­tain rese­arch is misus­ed. It was only in Octo­ber 2014 that the White House announ­ced that the U.S. government is laun­ching a deli­be­ra­ti­ve pro­cess to assess the poten­ti­al risks and be- nefits asso­cia­ted with GOF-stu­dies and that during this peri­od, the U.S. government will

“insti­tu­te a pau­se on fun­ding for any new stu­dies that inclu­de cer­tain gain-of-func­tion expe­ri­ments invol­ving influ­en­za, SARS, and MERS viru­ses, and encou­ra­ges tho- se cur­r­ent­ly con­duc­ting this type of work – whe­ther fe- der­al­ly fun­ded or not – to vol­un­ta­ri­ly pau­se their re- search while risks and bene­fits are being reassessed.”15

It can be shown, dis­cus­sing the topic of dual use of bio­lo­gi­cal sci­en­ces means dealing with essen­ti­al ques­ti- ons for our future: What respon­si­bi­li­ty do rese­ar­chers, socie­ty, the sta­te, and even the glo­bal com­mu­ni­ty have to pre­vent the misu­se of sci­en­ti­fic know­ledge? How should the free­dom of rese­arch be deter­mi­ned con­si­de­ring the risks of misu­se? How can the risks of misu­se be effec- tively mini­mi­zed without dis­pro­por­tio­na­te­ly restric­ting rese­arch and science?

In this arti­cle, I want to add a few nuan­ces to the ar- guments and insights brought for­ward up to now and I will refer to the Ger­man Ethics Council’s16 inter­di­sci­pli- nary report on bio­se­cu­ri­ty, which was released in 2014.17 In the end, it can be shown that the­re are still lar­ge gaps that should be clo­sed by the natio­nal and Euro­pean legis- lator as well as by the inter­na­tio­nal com­mu­ni­ty. By clo- sing the­se gaps the­se actors will meet their legal obliga-

  1. 14  For this noti­on see N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Cata­stro­phic Risks, 2008; A. Nouri/Ch.F.Chyba, Bio­tech­nol­gy and bio­se­cu­ri­ty, in N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Catast- rophic Risks, 2008, 450 et seq.; Ch. Phoenix/M. Tre­der, Nano­tech- nol­gy as glo­bal cata­stro­phic risk, in N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Cata­stro­phic Risks, 2008, 481 et seq.
  2. 15  Avail­ab­le at: http://www.whitehouse.gov/blog/2014/10/17/doing- dili­gence-assess-risks-and-bene­fits-life-sci­en­ces-gain-func­tion- rese­arch and http://www.phe.gov/s3/dualuse/Documents/gain-of- function.pdf.
  3. 16  The Ger­man Ethics Coun­cil was estab­lis­hed in 2007 by an act of par­lia­ment as an “inde­pen­dent coun­cil of experts”; Art. 1 Gesetz zur Ein­rich­tung des Deut­schen Ethik­rats of 16.7.2007 (Eth-
    RG), Federal Law Gazet­te I 1385. The pre­si­dent of the Ger­man Par­lia­ment appoints the mem­bers of the Ger­man Ethics Coun­cil. The Ger­man Ethics Coun­cil shall be com­po­sed of twen­ty-six mem­bers spe­cia­li­zing in sci­en­ti­fic, medi­cal, theo­lo­gi­cal, phi­lo­so- phi­cal, ethi­cal, social, eco­no­mic, and legal con­cerns. The Ger­man Ethics Coun­cil shall con­tain repre­sen­ta­ti­ves of a varie­ty of ethi­cal approa­ches and a plu­ra­list spec­trum of opi­ni­ons. The legal duties of the Coun­cil are informing the public, encou­ra­ging dis­cus­sion in socie­ty, and pre­pa­ring opi­ni­ons as well as recom­men­da­ti­ons for poli­ti­cal and legis­la­ti­ve action.

tions to suf­fi­ci­ent­ly pro­tect human rights and to be in com­pli­an­ce with the pre­cau­tio­na­ry princip­le as a nor­ma- tive stan­dard that governs low pro­ba­bi­li­ty high risk scenarios.

II. Bio­se­cu­ri­ty and dual use rese­arch of con­cern (DURC)

In order to under­stand the noti­on of bio­se­cu­ri­ty one has to, first of all, dif­fe­ren­tia­te bet­ween bio­se­cu­ri­ty and bio- safe­ty: Bio­se­cu­ri­ty aims to pre­vent the inten­tio­nal misu- se of rese­arch results; bio­safe­ty aims to pre­vent acci­den- tal release.18 The lat­ter is an area, in which risk-mini­mi- zati­on mea­su­res, like having safe labo­ra­to­ries, are in prac­ti­ce and have been exten­si­ve­ly ensh­ri­ned in the law in Germany.19 To dif­fe­ren­tia­te bet­ween bio­se­cu­ri­ty and bio­safe­ty, howe­ver, does not mean that the­re is an abso­lu- te dicho­to­my bet­ween the­se are­as. Qui­te to the con­tra­ry, it can be sta­ted that means to ensu­re bio­safe­ty can pro- mote more bio­se­cu­ri­ty and vice versa.

Addi­tio­nal­ly the con­cept of dual use rese­arch of con- cern (DURC) is important: DURC is rese­arch in the bio- logi­cal sci­en­ces that has signi­fi­cant poten­ti­al to give rise to know­ledge, pro­ducts, or tech­no­lo­gies, which could be direct­ly misap­p­lied by the rese­ar­cher or a third per­son as wea­pons of mass destruction.20 This con­cept is impor- tant, sin­ce it allows one to dis­tin­guish – by defi­ni­ti­on – from a secu­ri­ty point of view the most dan­ge­rous expe­ri- ments from other expe­ri­ments that are less dan­ge­rous: As it is a princip­le of jus­ti­ce and a duty accord­ing to con- sti­tu­tio­nal law that simi­lar cases have to be trea­ted simi- lar­ly and dif­fe­rent cases have to be trea­ted dif­fer­ent­ly, the

17 Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi- lity of Rese­arch, 2014 (Fn. 11). In 2012 the Federal Minis­tries of Rese­arch and of Health tas­ked the Ethics Coun­cil with inves­ti- gating, whe­ther we in Ger­ma­ny are suf­fi­ci­ent­ly pre­pa­red with respect to the misu­se of rese­arch from the bio­lo­gi­cal sci­en­ces. The final ver­si­on of the report was agreed on in March 2014. The aut­hor was head of this working group of the Ger­man Ethics Council.

18 Cf. M. Böcken­för­de, Bio­lo­gi­cal Safe­ty, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 937.

19 For details see Annex II, 235 et seq. of the Ger­man ver­si­on Deut- scher Ethik­rat, Bio­si­cher­heit – Frei­heit und Ver­ant­wor­tung in der Wis­sen­schaft, 2014 (Fn. 11).

20 For simi­lar defi­ni­ti­ons see: Natio­nal Sci­ence Advi­so­ry Board for Bio­se­cu­ri­ty, Pro­po­sed Frame­work for the Over­sight of Dual Use Life Sci­en­ces Rese­arch, 2007, 17, avail­ab­le at: http://fas.org/ biosecurity/resource/documents/NSABB%20draft%20guide- lines%20on%20dual%20use%20research.pdf; Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, 14; WHO, Respon­si­ble life sci­en­ces rese­arch for glo­bal health secu­ri­ty, 2010, defi­ni­ti­on VII.

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120 ORDNUNG DER WISSENSCHAFT 2 (2015), 117–128

noti­on and rea­son­ab­le defi­ni­ti­on of DURC allows us to dif­fe­ren­tia­te bet­ween groups of expe­ri­ments in the life sci­en­ces that have to be trea­ted differently.

III. Set­ting the scene

1. Can the­re be a ratio­nal assess­ment of bio­se­cu­ri­ty risks?

The assess­ment of risks in the area of bio­se­cu­ri­ty is dif- ficult and can­not be done from a natu­ral sci­ence or inter- natio­nal rela­ti­ons per­spec­ti­ve only. Insights of secu­ri­ty experts have to be taken into account as well. Risk assess- ment has to be an inter­di­sci­pli­na­ry endea­vor. Today, on the basis of natu­ral sci­ence and secu­ri­ty exper­ti­se, it seems plau­si­ble to dif­fe­ren­tia­te bet­ween various agents and bet­ween dif­fe­rent groups of experiments.21 The­re is often some kind of cri­ti­cism that lis­ting agents is sim­pli- stic and lea­ves lacu­nae but a con­vin­cing alter­na­ti­ve, a more “func­tio­n­al” approach, has not yet been developed.

Bes­i­des the neces­si­ty to dif­fe­ren­tia­te bet­ween various agents, it can be assu­med that the more com­pli­ca­ted the tech­no­lo­gy requi­red to crea­te or to modi­fy an agent is, the lower the likeli­hood that it will be misus­ed by some- body. Howe­ver, the­se are only obser­va­tions at a sin­gle point in time, sin­ce a tech­no­lo­gy that is dif­fi­cult to use and imple­ment today may be easy to imple­ment tomor- row.22 This is even more true if one thinks of future deve- lop­ments of so cal­led do-it-yourself bio­lo­gy which is done out­side of rese­arch insti­tu­ti­ons and companies.

Ano­t­her pro­blem of eva­lua­ting the risks in the area of bio­se­cu­ri­ty is that nobo­dy can quan­ti­fy the risk of a ter- rorist attack with an agent stem­ming from a labo­ra­to­ry. In the past, the­re have been suc­cess­ful and unsuc­cess­ful attacks by non-sta­te enti­ties and indi­vi­du­als with bio­lo- gical agents;23 most recent­ly, the “anthrax let­ters” which were used after the attacks of 9/11 in 2001 in order to kill and harm peop­le in the U.S.24 For­tu­n­a­te­ly the­se have

  1. 21  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, p. 43 et seq.
  2. 22  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, p. 43 et seq.
  3. 23  Fol­lo­wers of a sect released the bac­te­ri­um Sal­mo­nel­la ente­ri­ca sero­ty­pe typhi­mu­ri­um in Oregon/U.S.; 751 peop­le fell ill; in the ear­ly 1990ies a Japa­ne­se sect tried several times to deploy various bio­lo­gi­cal wea­pons; cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, p. 19 et seq.
  4. 24  Five peop­le died; six con­trac­ted infec­tions by inha­la­ti­on; the­se attacks cau­sed signi­fi­cant eco­no­mic dama­ges and widespread public anxie­ty, cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free- dom and Respon­si­bi­li­ty of Rese­arch, 2014, p. 19 et seq; A. Nouri/ Ch.F.Chyba, Bio­tech­nol­gy and bio­se­cu­ri­ty, in N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Cata­stro­phic Risks, 2008, 450 et seq.
  5. 25  Cf. N.N. Tal­eb, The Black Swan, The Impact of the High­ly Impro- bable, 2007, 44 et seq.

been very rare cases. But even if the pro­ba­bi­li­ty is very low, the risk does not equal zero for such an attack.

2. An ethic of risk

Very rare cases who­se pro­ba­bi­li­ty of occur­rence is not zero but who have (poten­ti­al­ly) huge con­se­quen­ces are some­ti­mes cal­led “Black Swans”.25 How can we ratio­nal­ly deal with “Black Swan” sce­n­a­ri­os if they might have huge nega­ti­ve impacts? It would be irra­tio­nal and not jus­ti­fied to stri­ve for zero risk in regard to every action that inclu- des risks: It is ratio­nal that we do not stri­ve for zero risk in dri­ving cars – which would mean to redu­ce the maxi- mum speed to zero miles per hour or to pro­hi­bit dri­ving cars – becau­se we gain mobi­li­ty, i.e. we, as indi­vi­du­als and socie­ties, get a direct bene­fit from dri­ving cars; and becau­se we – or at least the dri­vers and users of cars – do con­sent to take the risks cau­sed by dri­ving cars. Becau­se of the­se argu­ments (direct bene­fit and con­sent of the indi­vi­du­als) it is jus­ti­fied that a socie­ty accepts a sta­tis­ti- cal­ly deter­mi­ned num­ber of deaths cau­sed by car acci- dents every year.26 This is at least true if the socie­ty enacts laws and regu­la­ti­ons that aim to mini­mi­ze the risks in a pro­por­tio­nal way.

On the other hand, it would be irra­tio­nal to tre­at eve- ry “Black Swan” as if the­re is a zero risk. This obvious­ly does not reflect rea­li­ty. Hence, the decisi­ve ques­ti­on is: When is it ratio­nal to stri­ve for zero risks? From an eco- nomic (and uti­li­ta­ri­an) per­spec­ti­ve zero risks are hard­ly jus­ti­fia­ble; this is not true, howe­ver, if the nega­ti­ve con­se- quen­ces, the dama­ges and deaths, are huge, for instance if a dan­ge­rous virus escapes from a laboratory.27 As the misu­se of cer­tain bio­lo­gi­cal agents falls into the cate­go­ry of low pro­ba­bi­li­ty high risk sce­n­a­ri­os – one even could speak of an exis­ten­ti­al or cata­stro­phic risk28 – one should stri­ve for a zero risk in regard to bio­safe­ty con­cerns and in regard to bio­se­cu­ri­ty con­cerns. This is true if an agent, for instance cer­tain types of influ­en­za viru­ses, can cause

26 For the dif­fe­ren­tia­ti­on bet­ween clas­ses of risk and the impor­t­ance of con­sent, cf. J. Nida-Rüme­lin, B. Rath, J. Schu­len­burg, Risi­koe- thik, 2012, 29 et seq. Howe­ver, dri­ving a car is not a per­so­nal risk in the strict sen­se, as the car dri­ver is not ent­i­re­ly iso­la­ted from others who can­not be affec­ted in any way.

27 This is cer­tain­ly not asto­nis­hing and rather a no-brai­ner but nevertheless important to sta­te in order to show the limits of a (fal­se) zero risk bias very clear; see for instance R. Dobel­li, Die Kunst des kla­ren Den­kens, 8. ed., 2015, 110, who makes express­ly the dif­fe­ren­tia­ti­on bet­ween the jus­ti­fied risk if a socie­ty does not pro­hi­bit to dri­ve cars and the unju­s­ti­fied risk if a dan­ge­rous virus can escape from a labo­ra­to­ry. The lat­ter is one of the rare cases of a jus­ti­fied zero risk bias.

28 J. Nida-Rüme­lin, B. Rath, J. Schu­len­burg, Risi­koethik, 2012, 48 et seq; simi­lar R.A. Pos­ner, Cata­stro­phe. Risk and Respon­se, 2004, 141; for fur­ther refe­ren­ces see N. Bostrom/M.M. Cir­ko­vic (eds.), Glo­bal Cata­stro­phic Risks, 2008.

an ende­mic or pan­de­mic upon inten­tio­nal or unin­ten­ti- onal release. The mate­ri­al and imma­te­ri­al dama­ges cau­sed by such an ende­mic or pan­de­mic can be quan­ti- fied and the­se huge nega­ti­ve con­se­quen­ces make it ratio- nal to stri­ve for a zero risk and irra­tio­nal not to do so.

On this basis, it is pos­si­ble to rein­for­ce the so-cal­led pre­cau­tio­na­ry princip­le as a decisi­ve ethi­cal basis for de- cisi­ons in the field of low pro­ba­bi­li­ty high risk rese­arch scenarios.29 As a legal princip­le inten­ded to pro­tect the envi­ron­ment, the pre­cau­tio­na­ry princip­le is not only part of the law of the Euro­pean Uni­on, it is also laid down in several inter­na­tio­nal trea­ties, as for instance the 1991 Pro­to­col of Envi­ron­men­tal Pro­tec­tion to the An- tarc­tic Treaty30 that regu­la­tes inter alia rese­arch in An- tarc­ti­ca and the 2000 Car­ta­ge­na Pro­to­col on Bio­safe­ty to the Con­ven­ti­on on Bio­lo­gi­cal Diver­si­ty (Car­ta­ge­na Pro- tocol);31 some­ti­mes it is argued that it is part of cus­to­ma- ry inter­na­tio­nal law, already.32 A wide­ly accep­ted ver­si­on of the legal princip­le sta­tes that whe­re the­re are thre­ats of serious or irrever­si­ble dama­ge, the lack of full sci­en­ti­fic cer­tain­ty shall not be used as a rea­son for post­po­ning cost-effec­ti­ve mea­su­res to pre­vent damages.33 Hence it has to be dis­tin­guis­hed from the pre­ven­ti­ve or pro­tec­ti­ve princi­ples that pro­vi­de for an obli­ga­ti­on of Sta­tes to pre- vent known or fore­see­ab­le harm out­side their territory.34

In the field of bio­se­cu­ri­ty-rele­vant rese­arch this me- ans that, sin­ce the misu­se of cer­tain rese­arch from the bio­lo­gi­cal sci­en­ces could lead to seve­re or even cata­s­tro- phic or exis­ten­ti­al dama­ges and the­re is no zero risk of misu­se, mea­su­res to redu­ce the risk have to be taken; hence, from an ethi­cal point of view, it is not decisi­ve that one can­not quan­ti­fy the pro­ba­bi­li­ty of misu­se; howe­ver it

  1. 29  J. Nida-Rüme­lin, B. Rath, J. Schu­len­burg, Risi­koethik, 2012, 105 et seq.
  2. 30  Federal Law Gazet­te 1994 II, 2478. For details see S. Vöne­ky,
    S. Addi­son-Agy­ei, Ant­arc­ti­ca, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 426 et seq. Par­ties of the Pro­to­col are inter alia Chi­na, Fran­ce, Ger­ma­ny, India, Rus­sia, UK and the U.S.
  3. 31  Car­ta­ge­na Pro­to­col on Bio­safe­ty to the Con­ven­ti­on on Bio­lo­gi­cal Diver­si­ty of 29.1.2000, 39 ILM 1027, M. Böcken­för­de, Bio­lo­gi­cal Safe­ty, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 939.
  4. 32  For an over­view see: M. Schrö­der, Pre­cau­tio­na­ry Approach/­Prin- cip­le, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. VIII, 2012, 400 et seq.
  5. 33  Simi­lar Princip­le 15 of the Rio-Decla­ra­ti­on sta­tes: “In order to pro­tect the envi­ron­ment, the pre­cau­tio­na­ry approach shall be wide­ly app­lied by Sta­tes accord­ing to their capa­bi­li­ties. Whe­re the­re are thre­ats of serious or irrever­si­ble dama­ge, lack of full sci­en­ti­fic cer­tain­ty shall not be used as a rea­son for post­po­ning cost-effec­ti­ve mea­su­res to pre­vent envi­ron­men­tal degradation.“
  6. 34  M. Schrö­der, Pre­cau­tio­na­ry Approach/Principle, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. VIII, 2012, 401.
  7. 35  Grund­ge­setz für die Bun­des­re­pu­blik Deutsch­land (Basic Law),

is decisi­ve that one knows that the pro­ba­bi­li­ty is not equal to zero and the nega­ti­ve con­se­quen­ces might be catastrophic.

3. The frame­work of con­sti­tu­tio­nal and inter­na­tio­nal law

The same result – that mea­su­res to redu­ce the bio­se­cu­ri- ty risks in the field of bio­lo­gi­cal sci­en­ces have to be taken – can be deri­ved from legal­ly bin­ding human rights. The fun­da­men­tal rights of the rese­ar­chers – the free­dom of rese­arch – may be restric­ted in a pro­por­tio­nal man­ner for legi­ti­ma­te aims. This is even true in regard to the free- dom of rese­arch as it is laid down in the Ger­man Grund- gesetz (GG), the Ger­man Basic Law.35 Art. 5 para. 3 GG sta­tes: “Arts and sci­en­ces, rese­arch and tea­ching shall be free. […]”.

Howe­ver it would be a misun­derstan­ding to con­clu­de that every limi­ta­ti­on of the free­dom of rese­arch is a vio- lati­on of this right.36 A vio­la­ti­on of Art. 5 para. 3 GG is only given if the­re are no legi­ti­ma­te aims or the limi­ta­ti- on is not necessa­ry to reach the aim or it is dis­pro­por­tio- nal in rela­ti­on to the pro­tec­ted good.37

The pro­tec­tion of the life and health of human bein­gs are legi­ti­ma­te aims accord­ing to the Ger­man Basic Law Art. 2 para. 2 GG38 that can jus­ti­fy pro­por­tio­nal limi­ta- tions of the right of free­dom of science.39 The­re­fo­re it is – for instance – no vio­la­ti­on of Art. 5 para. 3 GG that the- re is the duty to con­sult an inter­di­sci­pli­na­ry ethics com- mis­si­on befo­re con­duc­ting rese­arch on human bein­gs in the area of drug testing.40 The duty to pro­tect life and health of indi­vi­du­als inclu­des a duty of the Sta­te organs to assess and eva­lua­te risks even if the­re are low probabi-

23.5.1949, Federal Law Gazet­te 1, http://www.gesetze-im-inter- net.de/englisch_gg/index.html; see for the inter­pre­ta­ti­on of the free­dom of rese­arch accord­ing to the Ger­man Basic Law: M. Feh- ling, Bon­ner Kom­men­tar, Grund­ge­setz, 2011, Art. 5 Abs. 3 para. 1 et seq. For the phi­lo­so­phi­cal deba­te of the free­dom of rese­arch see T. Wil­holt, Die Frei­heit der For­schung, Begrün­dun­gen und Begren­zun­gen, 2012,

36. This is only the case in regard to human digni­ty as laid down in Art. 1 para. 1 GG: “Human digni­ty shall be inviol­ab­le. To respect and pro­tect it shall be the duty of all sta­te aut­ho­ri­ty”. The­re­fo­re every limi­ta­ti­on of human digni­ty is a vio­la­ti­on; the­re are no ways to jus­ti­fy limi­ta­ti­ons of human digni­ty becau­se of legi­ti­ma­te aims; hence tor­tu­re can never be jus­ti­fied accord­ing to Ger­man con­sti- tutio­nal law even if it is done in order to pre­vent a major ter­ro­rist attack.

37 Cf. BVerfG, 1.3.1978, 1 BvR 333/75; 1 BvR 174/75; 1 BvR 178/75; 1 BvR 191/75; BVerfGE 47, 327, 369 et seq.

38 “Every per­son shall have the right to life and phy­si­cal integrity. […]”.

39 Cf. BVerfG, 18.2.2010, 2 BvR 2502/08 (CERN).
40 S. Vöne­ky, Foun­da­ti­ons and limits of an “ethi­ca­liz­a­ti­on” of law, in: F. Bat­ta­glia, N. Muker­ji, J. Nida-Rüme­lin (eds.), Rethinking

Respon­si­bi­li­ty in Sci­ence and Tech­no­lo­gy, 2014, 183 et seq., 197 et seq.

Vöne­ky · Bio­se­cu­ri­ty 1 2 1

122 ORDNUNG DER WISSENSCHAFT 2 (2015), 117–128

lity scenarios.41 The same is true if the­re is a pro­por­tio­nal limi­ta­ti­on of the free­dom of sci­ence in order to pro­tect the envi­ron­ment (Art. 20a GG);42 this is no vio­la­ti­on of Art. 5 para. 3 GG either.

The legi­ti­ma­te aims accord­ing to the 1950 Euro­pean Con­ven­ti­on on Human Rights requi­red to limit the right of free­dom of expres­si­on, which ent­ails the right of free- dom of sci­ence, are even broa­der: Art. 10 para. 2 Euro- pean Con­ven­ti­on on Human Rights (EuCHR)43 reads:

“The exer­cise of the­se free­doms, sin­ce it car­ri­es with it duties and respon­si­bi­li­ties, may be sub­ject to such for- mali­ties, con­di­ti­ons, restric­tions or pen­al­ties as are pre­scri­bed by law and are necessa­ry in a demo­cra­tic so- cie­ty, in the inte­rests of natio­nal secu­ri­ty, ter­ri­to­ri­al inte­gri- ty or public safe­ty, for the pre­ven­ti­on of dis­or­der or crime, for the pro­tec­tion of health or morals, for the pro­tec­tion of the repu­ta­ti­on or rights of others, for pre­ven­ting the dis- clo­sure of infor­ma­ti­on recei­ved in con­fi­dence, or for main­tai­ning the aut­ho­ri­ty and impar­tia­li­ty of the judi­ci- ary.”

The­re­fo­re one can con­clu­de, that a law that is pro­por- tio­nal accord­ing to Art. 5 para. 3 GG can­not be a vio­la­ti- on of the free­dom of science/freedom of expres­si­on as part of the inter­na­tio­nal human right treaties.

  1. 41  Cf. BVerfG, 18.2.2012; BvR 2502/08 (CERN); BVerfG, 8.8.1978,
    2 BvL 8/77, BVerfGE 49, 89, 142 et seq.: “Will der Gesetz­ge­ber
    die Mög­lich­keit künf­ti­ger Schä­den durch die Errich­tung oder
    den Betrieb einer Anla­ge oder durch ein tech­ni­sches Ver­fah­ren abschät­zen, ist er weit­ge­hend auf Schlüs­se aus der Beob­ach­tung ver­gan­ge­ner tat­säch­li­cher Gescheh­nis­se auf die rela­ti­ve Häu­fig­keit des Ein­tritts und den gleich­ar­ti­gen Ver­lauf gleich­ar­ti­ger Gescheh- nis­se in der Zukunft ange­wie­sen; fehlt eine hin­rei­chen­de Erfah- rungs­grund­la­ge hier­für, muß er sich auf Schlüs­se aus simu­lier­ten Ver­läu­fen beschrän­ken. Erfah­rungs­wis­sen die­ser Art, selbst wenn es sich zur Form des natur­wis­sen­schaft­li­chen Geset­zes ver­dich­tet hat, ist, solan­ge mensch­li­che Erfah­rung nicht abge­schlos­sen ist, immer nur Annä­he­rungs­wis­sen, das nicht vol­le Gewiß­heit ver- mit­telt, son­dern durch jede neue Erfah­rung kor­ri­gier­bar ist und sich inso­fern immer nur auf dem neu­es­ten Stand unwi­der­leg­ten mög­li­chen Irr­tums befindet.“
  2. 42  Cf. for an inter­pre­ta­ti­on of Art. 20a GG and the duties of the par­lia­ment to pre­vent risks BVerfG, 24.11.2010, 1 BvF 2/05, para. 118: „In legis­la­ting, the legis­la­tu­re must balan­ce not only the in- terests affec­ted by the use of gene­tic engi­nee­ring on the one hand and their regu­la­ti­on on the other hand […] But it must like­wi­se com­ply with the duty con­tai­ned in Arti­cle 20a GG also to pro­tect natu­ral resour­ces out of respon­si­bi­li­ty for future genera­ti­ons (see BVerfGE 118, 79, 110). This duty may be impo­sed both in order to avert dan­gers and also to take pre­cau­ti­ons against risks. The envi­ron­men­tal inte­rests thus pro­tec­ted by Arti­cle 20a GG also in- clu­de the pre­ser­va­ti­on of bio­lo­gi­cal varie­ty and the gua­ran­tee of a

Bes­i­des it is well estab­lis­hed that human rights obli­ge Sta­tes not only to respect, but also to pro­tect the fun­da- men­tal rights of the indi­vi­du­als and the public:44 Thus, the legis­la­tor is obli­ged by human rights to lay down ru- les to mini­mi­ze risks for pro­tec­ted goods, such as the life and health of human bein­gs. This duty exists accord­ing to the Ger­man Basic Law and for every Sta­te that is par- ty to the 1950 Euro­pean Con­ven­ti­on on Human Rights or the 1966 Inter­na­tio­nal Covenant on Civil and Poli­ti­cal Rights (ICCPR)45, like – for instance – the Nether­lands, the UK, and the U.S.

Apart from human rights, the ques­ti­ons of bio­se­cu­ri- ty-rele­vant rese­arch are cove­r­ed by other important rules of inter­na­tio­nal law, espe­cial­ly the 1972 Bio­lo­gi­cal Wea- pons Con­ven­ti­on (BWC).46 The BWC is an important trea­ty becau­se it rules out any sto­rage or use of bio­lo­gi­cal wea­pons. But it aims to pre­vent rese­arch which has no peace­ful purpose.47 The BWC, as it stands now, is not de- signed to regu­la­te or mana­ge dual use rese­arch. In the area of rese­arch regu­la­ti­on it has many lacu­nae. Bes­i­des this, it does not con­tain a veri­fi­ca­ti­on regime.48

Ano­t­her inter­na­tio­nal trea­ty, which has many lacu- nae in regard to bio­se­cu­ri­ty-rele­vant rese­arch, is the Car- tage­na Protocol.49 The pro­to­col aims to ensu­re bio­safe­ty and inclu­des only very few rules about the ille­gal cross- bor­der trans­fer of cer­tain agents if they are modi­fied li-

spe­ci­es-appro­pria­te life for end­an­ge­red ani­mal and plant spe­ci­es.“ 43 Euro­pean Con­ven­ti­on on Human Rights and Fun­da­men­tal Free-

doms, 213 UNTS 221; Federal Law Gazet­te 2002 II, 1055.
44 An obli­ga­ti­on to pro­tect, not only an obli­ga­ti­on to respect; cf.

UN Com­mis­si­on on Human Rights, Res. 2005/69, 20.4.2005, UN Doc. E/CN.4/2005/L.10/Add.17; Gene­ral Comments No 13 § 46, HRI/GEN/1/Rewv. 7, 87.

45 999 UNTS 171; Federal Law Gazet­te 1973 II, 1543.
46 Con­ven­ti­on on the Pro­hi­bi­ti­on of the Deve­lo­p­ment, Production

and Stock­pi­ling of Bac­te­rio­lo­gi­cal (Bio­lo­gi­cal) and Toxin Wea- pons and on their Dest­ruc­tion (Bio­lo­gi­cal Wea­pons Con­ven­ti­on), Federal Law Gazet­te 1983 II, 132; 1015 UNTS 163.

47 Art. 1: “Each Sta­te Par­ty to this Con­ven­ti­on under­ta­kes never
in any cir­cum­s­tance to deve­lop, pro­du­ce, stock­pi­le or other­wi­se acqui­re or retain: Micro­bi­al or other bio­lo­gi­cal agents, or toxins wha­te­ver their ori­gin or method of pro­duc­tion, of types and in quan­ti­ties that have no jus­ti­fi­ca­ti­on for pro­phyl­ac­tic, pro­tec­ti­ve or other peace­ful pur­po­ses; Wea­pons, equip­ment or means of deli- very desi­gned to use such agents or toxins for hos­ti­le pur­po­ses or in armed con­flict.” Cf. as well D. Svarc, Bio­lo­gi­cal Wea­pons and War­fa­re, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 946.

48 D. Svarc, Bio­lo­gi­cal Wea­pons and War­fa­re, in R. Wol­frum (ed.), Max Planck Ency­clo­pe­dia of Public Inter­na­tio­nal Law, Vol. I, 2012, 948.

49 Fn. 31.

ving orga­nisms (Art. 25).50 But even tho­se rules do not bind all tho­se Sta­tes, whe­re one can find signi­fi­cant bio­se­cu­ri­ty-rele­vant rese­arch; Par­ties of the Pro­to­col are – inter alia – the EU, UK, and Ger­ma­ny, but not the U.S..

The rules of the Car­ta­ge­na Pro­to­col are sup­ple­men- ted by a lia­bi­li­ty pro­to­col, the Nago­ya Pro­to­col on Liabi- lity to the Car­ta­ge­na Protocol,51 which has not yet ente- red into for­ce. It is striking that the Nago­ya Pro­to­col on Lia­bi­li­ty lays down lia­bi­li­ty for ille­gal cross­bor­der trans- fer as well (Art. 3 para. 3)52 and only pro­vi­des excep­ti­ons from lia­bi­li­ty for situa­tions that are equi­va­lent to an in- ter­na­tio­nal or non-inter­na­tio­nal armed con­flict (“[a]ct of war or civil unrest”) but not for ter­ro­rist acti­vi­ties (Art. 6). The Nago­ya Pro­to­col on Lia­bi­li­ty is rati­fied by Ger­ma­ny and the EU, and signed – inter alia – by Fran­ce and UK, but not the U.S..

4. Rules of Euro­pean and natio­nal law

Fur­ther­mo­re, one has to look at the app­li­ca­ble legal regu- lati­ons in Ger­ma­ny and Euro­pe. It is bey­ond the scope of this paper to go into details, but in a nuts­hell one can sta- te that it can be shown that the exis­ting legal rules in Ger­ma­ny and in Euro­pe that govern rese­arch in life sci- ences are neit­her suf­fi­ci­ent nor cohe­rent. They eit­her encom­pass only limi­ted are­as of bio­se­cu­ri­ty or they tar- get main­ly spe­cial ques­ti­ons of bio­safe­ty, like the Ger- man Gene­tic Engi­nee­ring Law.53

  1. 50  Art. 25: “Ille­gal Trans­bounda­ry Move­ments 1. Each Par­ty shall adopt appro­pria­te domestic mea­su­res aimed at pre­ven­ting and, if appro­pria­te, pena­li­zing trans­bounda­ry move­ments of living modi­fied orga­nisms car­ri­ed out in con­tra­ven­ti­on of its domestic mea­su­res to imple­ment this Pro­to­col. Such move­ments shall be deemed ille­gal trans­bounda­ry move­ments. 2. In the case of an ille­gal trans­bounda­ry move­ment, the affec­ted Par­ty may request the Par­ty of ori­gin to dis­po­se, at its own expen­se, of the living modi­fied orga­nism in ques­ti­on by repa­tria­ti­on or dest­ruc­tion, as appro­pria­te. 3. Each Par­ty shall make avail­ab­le to the Bio­safe­ty Clea­ring-House infor­ma­ti­on con­cer­ning cases of ille­gal trans- bounda­ry move­ments per­tai­ning to it.”
  2. 51  The Nago­ya – Kua­la Lum­pur Sup­ple­men­ta­ry Pro­to­col on Lia­bi­li­ty and Redress to the Car­ta­ge­na Pro­to­col on Bio­safe­ty, avail­ab­le at: http://bch.cbd.int/protocol/NKL_text.shtml.
  3. 52  Art. 3 para. 3: “This Sup­ple­men­ta­ry Pro­to­col also app­lies to dama­ge resul­ting from unin­ten­tio­nal trans­bounda­ry move­ments as refer­red to in Arti­cle 17 of the Pro­to­col as well as dama­ge resul­ting from ille­gal trans­bounda­ry move­ments as refer­red to in Arti­cle 25 of the Protocol.”
  4. 53  Gen­tech­nik­ge­setz (Gesetz zur Rege­lung der Gen­tech­nik, GenTG), Federal Law Gazet­te 1993 I, 2066; Federal Law Gazet­te 2013 I, 3154. For details see Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free- dom and Respon­si­bi­li­ty of Rese­arch, 2014, 96 et seq.; C. Teetz- mann, Rechts­fra­gen der Sicher­heit in der Bio­lo­gi­schen For­schung, in: S. Vöne­ky (Hrsg.), FIP 4/2014, VII et seq. 5 et seq.; avail­ab­le at: http://www.jura.uni-freiburg.de/institute/ioeffr2/online-papers/ FIP_4_2014_Rechtsfragen_Biosicherheit.pdf

That the exis­ting rules are far away from a cohe­rent sys­tem of regu­la­ti­on for bio­se­cu­ri­ty-rele­vant rese­arch can be shown sin­ce, accord­ing to EU law, a publi­ca­ti­on in the area of bio­se­cu­ri­ty-rele­vant rese­arch only needs a per­mit from the export aut­ho­ri­ties if it will be publis­hed in a jour­nal out­side the EU.54 Even the important area of rese­arch fun­ding has not been regu­la­ted with respect to bio­se­cu­ri­ty risks: Wit­hin the EU Frame­work Pro­gram- me for Rese­arch, the new Hori­zon 2020, the­re are no re- stric­tions for fun­ding this kind of rese­arch (Art. 19 Hori- zon 2020).55

In the end, one has to con­clu­de that the­re are many gaps in the area of bio­se­cu­ri­ty-rele­vant rese­arch con­cer- ning the legal frame­work at the Euro­pean and natio­nal level.

5. Codes of con­ducts for respon­si­ble research

The ques­ti­on is whe­ther the­se gaps can be fil­led in by codes of con­duct for respon­si­ble rese­arch: The­se codes are issued as an instru­ment of “self-respon­si­bi­li­ty” or “self-gover­nan­ce” by rese­arch orga­niz­a­ti­ons, like the Ger­man Rese­arch Foun­da­ti­on (DFG),56 Max Planck Socie­ty (MPG)57 and the Leopoldina.58 The­se codes are important in set­ting nor­ma­ti­ve stan­dards but they are not suf­fi­ci­ent in effec­tively regu­la­ting bio­se­cu­ri­ty-rele- vant rese­arch: 59

54 For the legal grounds and prac­ti­cal con­se­quen­ces see Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, 96 et seq. and 149.

55 Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li- ty of Rese­arch, 2014, 110 et seq.

56 Code of Con­duct: Working with high­ly patho­ge­nic micro­or­ga- nisms and toxins (2008/2013); avail­ab­le at: http://www.dfg.de/ download/pdf/dfg_im_profil/reden_stellungnahmen/ 2013/130313_verhaltenscodex_dual_use_en.pdf. Cf. H.C. Wilms, Die Unver­bind­lich­keit der Ver­ant­wor­tung, 2015, 60 et seq.

57 Gui­de­li­nes and Rules on a respon­si­ble approach to free­dom of rese­arch and rese­arch risk (2010); avail­ab­le at: https://www.mpg. de/232129/researchFreedomRisks.pdf. The aut­hor was part of the Max Planck Working Group that draf­ted the code. For fur­ther dis­cus­sion of the code see H.C. Wilms, Die Unver­bind­lich­keit der Ver­ant­wor­tung, 2015, 65 et seq.

58 The Leo­pol­di­na draf­ted, after the report of the Ger­man Ethic Coun­cil was publis­hed, a code of con­duct tog­e­ther with the DFG and mem­bers of Max Planck Socie­ty; the code is very simi­lar to the Max Planck Code of Con­duct men­tio­ned abo­ve: Sci­en­ti­fic Free­dom and Sci­en­ti­fic Respon­si­bi­li­ty Recom­men­da­ti­ons for Hand­ling Secu­ri­ty-Rele­vant Rese­arch (2014); avail­ab­le at: http:// www.leopoldina.org/uploads/tx_leopublication/2014_06_DFG- Leopoldina_Scientific_Freedom_Responsibility_EN.pdf.

59 For details see S. Vöne­ky, Foun­da­ti­ons and limits of an “ethi­ca­li- zati­on” of law, in: F. Bat­ta­glia, N. Muker­ji, J. Nida-Rüme­lin (eds.), Rethin­king Respon­si­bi­li­ty in Sci­ence and Tech­no­lo­gy, 2014, 199 et seq.

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124 ORDNUNG DER WISSENSCHAFT 2 (2015), 117–128

Why is this the case? Alt­hough the codes of con­duct men­tio­ned abo­ve often inclu­de important ele­ments of risk mini­miz­a­ti­on, the stan­dards of the codes are “ethi- cal” stan­dards. Hence the­se codes are not direct­ly legal­ly bin­ding. Their enfor­ce­ment is thus unclear. Only some codes estab­lish an ethics com­mis­si­on that is able to vote and con­sult on dif­fi­cult or “unethi­cal” cases, as for in- stance the Max Planck Code but not the new DFG/­Leo- pol­di­na Code. Moreo­ver the­se codes have a limi­ted num­ber of addres­sees sin­ce they only bind the respec­ti­ve mem­bers of the sci­en­ti­fic socie­ty, but not all rese­ar­chers in a Sta­te, in Euro­pe or world­wi­de. Last but not least the- se codes of con­duct can have some kind of out­put legi­ti- macy but no demo­cra­tic legi­ti­ma­cy. Out­put legi­ti­ma­cy is given if a regu­la­ti­on can sol­ve a pro­blem in an ade­qua­te way. Demo­cra­tic legi­ti­ma­cy is given only if the­re is a clear link to an act of parliament.60 As the codes of con- ducts men­tio­ned abo­ve lack a legal basis and even the com­mis­si­ons that draf­ted the codes were not set up on a legal basis,61 demo­cra­tic legi­ti­ma­cy is not given. Codes of con­ducts as means of self-regu­la­ti­on can pro­mo­te some kind of out­put legi­ti­ma­cy, if and only if they sol­ve the pro­blems of bio­se­cu­ri­ty; up to now, howe­ver, the­re is no empi­ri­cal data sup­por­ting the last assumption.

To sum up: legal rules as well as codes of con­duct that cover important are­as of bio­safe­ty and bio­se­cu­ri­ty do exist; but until now the­re is no cohe­rent sys­tem of rules and other mea­su­res that aims to pre­vent the risk of misu- se of bio­se­cu­ri­ty-rele­vant research.

IV. Is the­re a way for­ward? Recom­men­da­ti­ons for legi­ti­ma­te future nor­ma­ti­ve standards

As the exis­ting legal and ethi­cal rules and regu­la­ti­ons show, the­re is no easy solu­ti­on in regu­la­ting bio­se­cu­ri­ty- rele­vant rese­arch. Recom­men­da­ti­ons that shall impro­ve the cur­rent situa­ti­on have to focus on dif­fe­rent levels. The most important are the fol­lowing five:62

1. The first level aims to rai­se the level of awa­reness for ques­ti­ons of bio­se­cu­ri­ty in the sci­en­ti­fic community.

2. The second level tar­gets the ela­bo­ra­ti­on of a natio- nal bio­se­cu­ri­ty code of conduct.

3. The third level con­cerns important limits in re- search funding.

  1. 60  S. Vöne­ky, Recht, Moral und Ethik, 2010, 130–224.
  2. 61  For a dif­fe­rent examp­le see: Deut­scher Cor­po­ra­te Gover­nance­Ko­dex (cf. http://www.dcgk.de/en/home.html). Through the decla­ra­ti­on of con­for­mi­ty pur­suant to § 161 Stock Cor­po­ra­ti­on Act (Akti­en­ge­setz), this code has a link to an act of par­lia­ment and hence demo­cra­tic legitimacy.
  3. 62  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon-

4. The fourth level dis­plays recom­men­da­ti­ons for le- gis­la­ti­on in Ger­ma­ny, espe­cial­ly the legal bases for a new DURC-Commission.

5. The fifth names Euro­pean and inter­na­tio­nal initia- tives.

From this order, it howe­ver can­not be con­clu­ded that cer­tain recom­men­da­ti­ons are more important than others; all recom­men­da­ti­ons do intert­wi­ne. Bio­se­cu­ri­ty is a pro­blem that can neit­her be sol­ved by so-cal­led ethi- cal self-gover­nan­ce and pri­va­te stan­dard set­ting nor on a natio­nal level.

1. Rai­sing of awareness

The idea is to pro­mo­te a cul­tu­re of respon­si­bi­li­ty and impro­ve the know­ledge of rese­ar­chers in the life sci­en­ces with respect to bio­se­cu­ri­ty. The­re­fo­re, ques­ti­ons of bio­se- curi­ty should be inte­gra­ted into under­gra­dua­te and gra- dua­te cur­ri­cu­la, as well as into the trai­ning and con­ti­nu- ing edu­ca­ti­on of life sci­en­tists and labo­ra­to­ry per­son- nel.63

2. A natio­nal bio­se­cu­ri­ty code of conduct

Second­ly, the ela­bo­ra­ti­on of a natio­nal bio­se­cu­ri­ty code of con­duct that defi­nes the respon­si­ble man­ner of dealing with pro­blems of bio­se­cu­ri­ty can be recommended.64 Alt­hough the­re are no empi­ri­cal data, it seems pri­ma facie plau­si­ble to argue that such a code of con­duct, which is draf­ted by the main actors of the sci­en­ti­fic com- muni­ty, is a use­ful instru­ment for this com­mu­ni­ty to enhan­ce and pro­mo­te some kind of self-respon­si­bi­li­ty. In the code, stan­dards that extend bey­ond the legal obli­ga- tions should be established.

With respect to the nor­ma­ti­ve princi­ples that the code of con­duct should inclu­de, I want to men­ti­on the fol­lowing important points. Con­cre­te obli­ga­ti­ons to mi- nimi­ze risks should be ensh­ri­ned: Rese­arch pro­grams should be exami­ned in order to estab­lish whe­ther the be- nefits are suf­fi­ci­ent to jus­ti­fy taking the risks invol­ved. Bes­i­des, it is of par­ti­cu­lar impor­t­ance for the rese­ar­cher to exami­ne whe­ther the rese­arch car­ri­es unre­a­son­ab­ly high risk for pro­tec­ted goods such as the health of peop- le as well as the environment.65 Should such an exami­na- tion reve­al that the risk is not jus­ti­fia­ble, then the re- search should not be pur­sued. Gene­ral­ly, the same ap-

sibi­li­ty of Rese­arch, 2014, 176 et seq.
63 Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon-

sibi­li­ty of Rese­arch, 2014, 179.
64 Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon-

sibi­li­ty of Rese­arch, 2014, 180 et seq.
65 This is a deon­to­lo­gi­cal ele­ment and the­re­fo­re not a risk-benefit

assess­ment, only.

plies with respect to publi­ca­ti­on and rese­arch coope­ra­ti- on programs.

Bes­i­des this, it has to be argued that the code of con- duct should also con­tain a kind of addi­tio­nal bur­den of jus­ti­fi­ca­ti­on for cer­tain rese­arch pro­grams: This should be the case for tho­se expe­ri­ments for which it is fore­see- able that the patho­ge­nic effect of a micro­or­ga­nism will be enhan­ced by a sci­en­tist in such a man­ner that the dan­ger of an epi­de­mic of a seve­re dise­a­se for humans is given. This kind of GOF-expe­ri­ments should gene­ral­ly not be under­ta­ken, unless a direct, con­cre­te, and over­whel­ming bene­fit for the pro­tec­tion of humans against dan­gers to life or health is pro­bable. The rea­son for this spe­cial bur- den of jus­ti­fi­ca­ti­on for cer­tain GOF-expe­ri­ments is that the­se expe­ri­ments – in con­trast to other fiel­ds of rese­arch in the bio­lo­gi­cal sci­en­ces – crea­te new and high risks for public health. If no direct, con­cre­te, and over­whel­ming bene­fit for the pro­tec­tion of humans against dan­gers to life or health is pro­bable befo­re rese­arch begins, it must be assu­med – becau­se the patho­ge­ni­ci­ty is incre­a­sed through the action of the rese­ar­cher – that the poten­ti­al dama­ge out­weighs the poten­ti­al bene­fit of the rese­arch program.66 The­se are the cor­ner­stones of a recom­men- dati­on for a natio­nal code of con­duct for biosecurity.

3. New limits for rese­arch funding

The third recom­men­da­ti­on con­cerns the area of rese­arch funding.67 With respect to the fun­ding of dual use rese­arch of con­cern, it should be ensu­red that the sci­en- tist ent­rus­ted with pro­ject manage­ment has agreed to com­ply with the new code of con­duct on bio­se­cu­ri­ty. Rese­arch pro­grams that are not jus­ti­fia­ble in the abo­ve sen­se, should not be funded.

Howe­ver, and this is very important, whe­ther this is the case in the spe­cial area of dual use rese­arch of con- cern (DURC) can­not be deci­ded by the rese­ar­cher or the fun­ding par­ty, but should pre­vious­ly be asses­sed by a so-

  1. 66  This pro­po­sal was sup­por­ted by some mem­bers of the Ger­man Ethics Coun­cil inclu­ding the aut­hor; cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, 182.
  2. 67  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, 183.
  3. 68  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, 185 et seq.
  4. 69  Even a per­mit pro­ce­du­re inclu­ding cer­tain kinds of expe­ri­ments is not uncom­mon accord­ing to Ger­man law; a per­mit pro­ce­du­re is for instance obli­ga­to­ry accord­ing to an act of par­lia­ment if a rese­ar­cher wants to do expe­ri­ments with human bein­gs in a drug tri­al, wants to work with embryo­nic stem cells, or even wants to con­duct rese­arch in Ant­arc­ti­ca; cf. sect. 40–42 Gesetz über den Ver­kehr mit Arz­nei­mit­teln (AMG, Medi­ci­nal Pro­ducts Act (The Drug Law)), 1.12.2005; Federal Law Gazet­te I 2005, 3394, http:// www.gesetze-im-internet.de/englisch_amg/index.html; Gesetz

cal­led Dual Use Rese­arch of Con­cern Com­mis­si­on, a DURC-Com­mis­si­on, which has to be estab­lis­hed for this pur­po­se. This new com­mis­si­on shall take con­sul­ta­ti­ve vo- tes on DURC-rele­vant expe­ri­ments in Ger­ma­ny and their votes shall deci­de on the rese­arch fun­ding of DURC.68

Alt­hough the votes of com­mis­si­on shall only be con- sul­ta­ti­ve one and hence this is not a pro­po­sal of a per­mit procedure69 such a con­sul­ta­ti­ve pro­ce­du­re has decisi­ve posi­ti­ve side effects for the rese­ar­cher: if the­re is a posi­ti- ve eva­lua­ti­on of an expe­ri­ment by the com­mis­si­on the rese­ar­cher can be sure that he or she is con­duc­ting an expe- riment that is ethi­cal­ly jus­ti­fied and law­ful. In legal terms this would exempt the rese­ar­cher from any liability.70

4. A new DURC-Com­mis­si­on based on an act of parliament

The DURC-Com­mis­si­on is an important part of the fourth recom­men­da­ti­on. Here the recom­men­da­ti­ons for new legis­la­ti­on are summarized:71 The legal estab­lish- ment of the DURC-Com­mis­si­on is recom­men­ded; besi- des the sti­pu­la­ti­on of a legal obli­ga­ti­on of rese­ar­chers to con­sult the DURC-Com­mis­si­on befo­re con­duc­ting DURC is recom­men­ded. The DURC-Com­mis­si­on must be, as bio­se­cu­ri­ty ques­ti­ons and bio­se­cu­ri­ty risk assess- ment can­not be ans­we­red by natu­ral sci­en­ces alo­ne, an inter­di­sci­pli­na­ry com­mis­si­on that should inclu­de life sci­en­ces and secu­ri­ty experts as well as bio­se­cu­ri­ty exper­ti­se from civil socie­ty. It is essen­ti­al to ensu­re that the pro­po­sal of a DURC-Com­mis­si­on is a pro­po­sal for a con­sul­ta­ti­on pro­ce­du­re and no per­mit for DURC-expe- riments will be necessary.

The con­sul­ta­ti­on by the Com­mis­si­on should again refer to the cri­te­ria for risk mini­miz­a­ti­on men­tio­ned abo­ve, that is whe­ther the bene­fits are suf­fi­ci­ent to jus­ti­fy taking the risks invol­ved. Here as well, it is cohe­rent to pro­po­se an addi­tio­nal bur­den of jus­ti­fi­ca­ti­on for DURC

zur Sicher­stel­lung des Embryo­nen­schut­zes im Zusam­men­hang mit der Ein­fuhr und Ver­wen­dung mensch­li­cher embryo­na­ler Stamm­zel­len (StZG), 28.6.2002; BGBl. 2002 I, 2277, Federal Law Gazet­te 2013 I, 3154; Gesetz zur Aus­füh­rung des Umwelt­schutz- pro­to­kolls vom 4.10.1991 zum Ant­ark­tis-Ver­trag (Umwelt­schutz- pro­to­koll-Aus­füh­rungs­ge­setz, AUG), Federal Law Gazet­te 1994 I, 2593; Federal Law Gazet­te 2013 I, 3154.

70 Lia­bi­li­ty is an important point when dis­cus­sing ques­ti­ons of bio­se­cu­ri­ty and bio­safe­ty rele­vant rese­arch; one has to dif­fe­ren­tia- te bet­ween the lia­bi­li­ty of the rese­ar­cher, rese­arch insti­tu­ti­ons etc. accord­ing to the natio­nal laws of a Sta­te and the lia­bi­li­ty of a Sta­te accord­ing to public inter­na­tio­nal law: cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, 95 et seq., 104 et seq.

71 Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, 183 et seq.

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126 ORDNUNG DER WISSENSCHAFT 2 (2015), 117–128

expe­ri­ments which enhan­ce the patho­ge­nic effect of a micro­or­ga­nism and ther­eby crea­te a new risk of an epi- demic.

Fur­ther­mo­re, the DURC-Com­mis­si­on shall con­sult on fur­ther mea­su­res for redu­cing risks, shall moni­tor DURC expe­ri­ments, and shall eva­lua­te rese­arch coo­pe- rati­ons and the publi­ca­ti­on of DURC outcomes.

Con­tra­ry to some views from the sci­en­ti­fic com­mu- nity, it is not suf­fi­ci­ent to broa­den or res­hape the Zen­tra- le Kom­mis­si­on für die Bio­lo­gi­sche Sicher­heit (ZKBS, Cen­tral Com­mis­si­on on Bio­safe­ty) which is based on §§ 4 and 5 GentG.72 Cer­tain­ly it is cor­rect that the ZKBS is an important com­mis­si­on in Ger­ma­ny to assess bio­safe- ty con­cerns; bes­i­des the ZKBS is based an act of par­lia- ment and has demo­cra­tic legi­ti­ma­cy. But the focus of this bio­safe­ty com­mis­si­on is to ans­wer main­ly bio­safe­ty ques­ti­ons, not to sol­ve bio­se­cu­ri­ty pro­blems. In the com- mis­si­on one can­not find any mem­bers that have secu­ri­ty exper­ti­se. Even more import­ant­ly: the ZKBS is based on the Gene­tic Engi­nee­ring Law (GentG). This law is only app­li­ca­ble to pro­vi­de pro­tec­tion against harm­ful effects of gene­tic engi­nee­ring work and the hand­ling of gene­ti- cal­ly modi­fied pro­ducts. This howe­ver does not cover all bio­se­cu­ri­ty-rele­vant rese­arch and not all expe­ri­ments that con­sti­tu­te dual use rese­arch of con­cern (DURC). Hence the­re are major lacu­nae and struc­tu­ral draw­backs and the­se pro­blems can­not be sol­ved by broa­de­ning or enhan­cing the ZKBS.

The­se new legal rules are only pro­po­sed for DURC- expe­ri­ments. This is a cru­cial limi­ta­ti­on: Nobo­dy recom- mends legal rules of all bio­se­cu­ri­ty-rele­vant rese­arch (all bio­se­cu­ri­ty-rele­vant rese­arch shall be encom­pas­sed by the code of con­duct), but ins­tead only of dual use re- search of con­cern. DURC can be defi­ned – as a first step – as rese­arch that has signi­fi­cant poten­ti­al to give rise to know­ledge, pro­ducts, or tech­no­lo­gies, which could be direct­ly misap­p­lied as wea­pons of mass destruction.73 But sin­ce only DURC should be regu­la­ted on a legal ba- sis, a more pre­cise defi­ni­ti­on is necessa­ry. Ten groups of rese­arch expe­ri­ments can be lis­ted and defi­ned, which, con­si­de­ring the inter­na­tio­nal dis­cus­sion, fall wit­hin the area of DURC. The­se are inter alia “work inten­ded to en- han­ce the harm­ful con­se­quen­ces of lis­ted agents”.74 But, the­se expe­ri­ments are DURC if and only if they are done with cer­tain dan­ge­rous agents.

  1. 72  More infor­ma­ti­on is avail­ab­le at: http://www.bvl.bund.de/DE/06_ Gentechnik/02_Verbraucher/05_Institutionen_fuer_ biologische_Sicherheit/02_ZKBS/gentechnik_zkbs_node.html.
  2. 73  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, 184.
  3. 74  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon-

Hence it is rea­son­ab­le to recom­mend for the legal re- gula­ti­on of DURC a com­bi­na­ti­on approach: First, the DURC defi­ni­ti­on as part as an act of par­lia­ment; second, ten groups of expe­ri­ments inclu­ded in a sta­tu­to­ry ordi- nan­ce (not an act of par­lia­ment), and, third, a list of agents. For the lis­ted agents one can refer to exis­ting lists (for instance inclu­ded in the Ger­man War Wea­pons Con­trol Act, the Bio­lo­gi­cal Wea­pons Con­ven­ti­on Draft Pro­to­col, and the U.S. Over­sight Policy)75 and to the past and cur­rent sta­tus of the inter­na­tio­nal dis­cus­sion. The pro­po­sal is, that the DURC-Com­mis­si­on shall draw up a list of dan­ge­rous agents and keep the list up to date:76 It is necessa­ry that the list has to be kept up to date in ac- cordance with new know­ledge in the life sci­en­ces; the­re- fore the list shall not be part of the legis­la­ti­on but be ag- reed upon by the DURC-Com­mis­si­on so that it can chan­ged and modi­fied more easi­ly if necessary.

Sin­ce the­se recom­men­da­ti­ons con­cen­tra­te on the area of DURC, for which the new com­mis­si­on shall be imple­men­ted, this exp­lains why only one com­mis­si­on is pro­po­sed for all of Ger­ma­ny and why a pro­po­sal to have mul­ti­ple com­mis­si­ons in the respec­ti­ve facul­ties of the uni­ver­si­ties is not con­vin­cing: The­re is the esti­ma­ti­on based on cur­rent data that the­re will only be very few re- search expe­ri­ments that fall in the cate­go­ry of DURC in Ger­ma­ny each year. Accord­ing to figu­res from the U.S., one can assu­me around ten pro­grams per year in Ger­ma- ny. Every decen­tra­liz­a­ti­on thus seems to neit­her be very effec­ti­ve nor rea­son­ab­le. Moreo­ver, each decen­tra­liz­a­ti- on also has the con­se­quence that uni­form cri­te­ria for the eva­lua­ti­on of expe­ri­ments can­not be guaranteed.

After say­ing this, one has to stress as well that it would be a mis­con­cep­ti­on to assu­me that the free­dom of re- search is dis­pro­por­tio­na­te­ly restric­ted if legal rules, besi- des a code of con­duct, are laid down: codes and legal ru- les com­ple­ment each other. Codes of con­duct can be use- ful instru­ments of self-gover­nan­ce; but in the area of DURC, that is in the area of rese­arch that car­ri­es espe- cial­ly high risks, the par­lia­ment as legis­la­tor must deci­de how to balan­ce the fun­da­men­tal rights in order to gua- ran­tee the demo­cra­tic legi­ti­ma­ti­on of the rules. Legal norms do not deny the free­dom of rese­arch, but on the con­tra­ry ack­now­ledge the signi­fi­can­ce of the affec­ted fun­da­men­tal rights, i.e. the free­dom of rese­arch and the duty to pro­tect the health of the popu­la­ti­on. The­se hu-

sibi­li­ty of Rese­arch, 2014, 184.
75 For the­se lists of agents, see Ger­man Ethics Coun­cil, Biosecurity

– Free­dom and Respon­si­bi­li­ty of Rese­arch, 2014, 190 et seq.
76 Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon-

sibi­li­ty of Rese­arch, 2014, 184.

man rights are so important that the par­lia­ment must de- cide in which cir­cum­s­tan­ces and accord­ing to which cri- teria, if necessa­ry, cer­tain rese­arch pro­jects should not be fun­ded, should not be under­ta­ken and/or results should not be published.

The­re­fo­re the four essen­ti­al recom­men­da­ti­ons for the domestic area are: 1. rai­sing the awa­reness; 2. a bio­se­cu­ri- ty code of con­duct; 3. spe­cial rules for rese­arch fun­ding; and 4. the legal estab­lish­ment of a DURC-Com­mis­si­on and of a DURC con­sul­ta­ti­on procedure.

5. Euro­pean and other inter­na­tio­nal initiatives

The fifth recom­men­da­ti­on refers to Euro­pean and other inter­na­tio­nal initia­ti­ves. Even though this recom­men­da- tion is the last one, this does not mean that it is less important; rather, the­re was a con­sen­sus that uni­form stan­dards on a Euro­pean or inter­na­tio­nal level are gene- ral­ly the most appro­pria­te for sol­ving the bio­se­cu­ri­ty and bio­safe­ty pro­blems con­nec­ted to rese­arch in the life sci- ences.

For the Euro­pean and inter­na­tio­nal area, the fol- lowing is recommended:77 The dis­cus­sion wit­hin the sci- ent­i­fic com­mu­ni­ty con­cer­ning the pos­si­ble bene­fits and risks of DURC should con­ti­nue to be pur­sued in order to reach a con­sen­sus on what con­sti­tu­tes respon­si­ble rese­arch. One should also try to agree on a bio­se­cu­ri­ty code of con- duct on a Euro­pean or even inter­na­tio­nal level.

On the Euro­pean level, Sta­tes should advo­ca­te that rese­arch fun­ding only pro­ceed accord­ing to the pre­vi- ous­ly men­tio­ned cri­te­ria and that uni­form stan­dards are estab­lis­hed for DURC in the mem­ber States.

Fur­ther­mo­re, Sta­tes should stri­ve for an inter­na­tio- nal­ly bin­ding defi­ni­ti­on and clas­si­fi­ca­ti­on of DURC, in- clu­ding uni­form labo­ra­to­ry safe­ty clas­si­fi­ca­ti­ons. It is not con­vin­cing for bio­se­cu­ri­ty and bio­safe­ty if in one count- ry cer­tain high risk gain of func­tion expe­ri­ments can be per­for­med in labo­ra­to­ries with safe­ty clas­si­fi­ca­ti­on 2 or 3, but in other coun­tries they can only be per­for­med in the few labo­ra­to­ries with safe­ty clas­si­fi­ca­ti­on 4. That this kind of soft har­mo­niz­a­ti­on is pos­si­ble in the area of bio- safe­ty and bio­se­cu­ri­ty-rele­vant rese­arch can be seen in the foot and mouth dise­a­se regu­la­ti­on in the EU.78

Last­ly, the­re are lacu­nae in the cur­rent inter­na­tio­nal trea­ty regime. Inter­na­tio­nal trea­ty law does not regu­la­te in a suf­fi­ci­ent way the rese­arch spe­ci­fic dual use bio­se­cu- rity ques­ti­ons. The BWC is important but has too many

  1. 77  Cf. Ger­man Ethics Coun­cil, Bio­se­cu­ri­ty – Free­dom and Respon- sibi­li­ty of Rese­arch, 2014, 188.
  2. 78  Coun­cel Direc­ti­ve 2003/85/EC of 29.9.2003 on Com­mu­ni­ty mea­su­res for the con­trol of foot-and-mouth dise­a­se, OJ L 306, 1, 22.11.2003.
  3. 79  UNESCO, Uni­ver­sal Decla­ra­ti­on on Bio­ethics and Human

gaps, and does not con­tain cohe­rent regu­la­ti­ons to mini- mize the risk of misu­se of peace­ful rese­arch. Here Ger- many tog­e­ther with like-min­ded Sta­tes should stri­ve for the con­clu­si­on of a spe­cial trea­ty that defi­nes the fun­da- men­tal princi­ples and limi­ta­ti­ons of bio­se­cu­ri­ty-rele­vant rese­arch or – as a first step – at least an inter­na­tio­nal soft law decla­ra­ti­on. A good examp­le for a quick­ly nego­tia­ted soft law decla­ra­ti­on, which is regu­la­ting rese­arch, is the UNESCO “Uni­ver­sal Decla­ra­ti­on on Bio­ethics and Hu- man Rights” from 2005,79 which con­sists of 28 arti­cles that con­nect bio­ethi­cal princi­ples to inter­na­tio­nal hu- man rights. This decla­ra­ti­on was nego­tia­ted wit­hin 15 months.80

V. Con­clu­si­on

The goal of this arti­cle is to dis­cuss the main legal and ethi­cal rules and to pro­po­se a cohe­rent sys­tem for rea­so- nab­le stan­dards of bio­se­cu­ri­ty-rele­vant rese­arch that is open to future deve­lo­p­ments and balan­ces the free­dom and respon­si­bi­li­ty of rese­arch: the­re neit­her may be dis- pro­por­tio­nal limits to rese­arch nor shall pos­si­bi­li­ties for risk mini­miz­a­ti­on be neglected.

To sum up the decisi­ve points:

For any future stan­dard set­ting, it is decisi­ve how fun­ding of bio­se­cu­ri­ty-rele­vant rese­arch is regu­la­ted: fun­ding is decisi­ve as tho­se who fund rese­arch have the key to restrict unethi­cal and ille­gal rese­arch; the­re­fo­re the fun­ding of bio­se­cu­ri­ty-rele­vant rese­arch must be li- mit­ed accord­ing to clear rules; no Sta­te must allow unethi­cal rese­arch to be funded.

Bes­i­des, cohe­rence is decisi­ve: It is a princip­le of jus- tice and a duty accord­ing to con­sti­tu­tio­nal law that simi- lar cases have to be trea­ted simi­lar­ly and dif­fe­rent cases have to be trea­ted dif­fer­ent­ly. The­re­fo­re, if the­re are dif­fe- ren­ces bet­ween groups of expe­ri­ments in the life sci­en­ces they have to be trea­ted dif­fer­ent­ly; the same is true for agents that are dif­fe­rent (that do not have the same pa- tho­ge­ni­ty etc.). Cohe­rence also means that the same group of expe­ri­ments must be trea­ted the same at least in one coun­try. Hence it is not con­vin­cing to install so many coun­cils and com­mis­si­ons that every uni­ver­si­ty and sci­ence orga­niz­a­ti­on has its own com­mis­si­on and can deci­de about its own research.

Har­mo­niz­a­ti­on is decisi­ve: The­re is a need for coher- ent rules in Euro­pe and world wide; sci­ence and society

Rights, C/Res 24, 19.10.2005, avail­ab­le at: http://portal.unesco. org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_ SECTION=201.html . For fur­ther refe­ren­ces see H.C. Wilms, Die Unver­bind­lich­keit der Ver­ant­wor­tung, 2015, 346 et seq.;

S. Vöne­ky, Recht, Moral und Ethik, 2010, 368 et seq. 80 S. Vöne­ky, Recht, Moral und Ethik, 2010, 368 et seq.

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128 ORDNUNG DER WISSENSCHAFT 2 (2015), 117–128

need clear rules on which kind of bio­se­cu­ri­ty-rele­vant rese­arch can be done in which kind of laboratories.

Legi­ti­ma­ti­on is decisi­ve: One has to dif­fe­ren­tia­te bet- ween some kind of out­put legi­ti­ma­cy, that is whe­ther a regu­la­ti­on can sol­ve a pro­blem in an ade­qua­te way and demo­cra­tic legi­ti­ma­cy, that is whe­ther a regu­la­ti­on is based on an act of par­lia­ment. Stan­dards of self-gover- nan­ce can pro­mo­te some kind of out­put legi­ti­ma­cy; howe­ver, only an act of par­lia­ment can pro­mo­te demo- cra­tic legi­ti­ma­cy. In the area of human rights, an act of par­lia­ment is necessa­ry if the free­dom of sci­ence and the duty to pro­tect life and health are con­cer­ned. Therefore –

as in the area of rese­arch on human being in drug tri­als – in the area of bio­se­cu­ri­ty-rele­vant rese­arch at least the main ele­ments of a stan­dard set­ting and the bases of the DURC-Com­mis­si­on must be laid down in an act of par- lia­ment; details of the nor­ma­ti­ve stan­dards, like a list of agents, can be agreed on by a com­mis­si­on or other ex- perts in life sci­en­ces, if they act on a legal bases.

Sil­ja Vöne­ky ist Pro­fes­so­rin an der Albert-Lud­wigs-Uni­ver- sität Frei­burg und Direk­to­rin des Lehr­stuhls für Völ­ker- recht, Rechts­ver­glei­chung und Rechts­ethik sowie Mit- glied des Deut­schen Ethikrates.