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Zusam­men­fas­sung

Fort­schrit­te in den lebens­wis­sen­schaft­li­chen Arbei­ten haben in den ver­gan­ge­nen Jah­ren neue und ver­bes­ser­te Ansät­ze zur Bekämp­fung von Krank­hei­ten und zur Beför­de­rung von Gesund­heit im All­ge­mei­nen gebracht. Sol­che For­schun­gen sind wei­ter­hin essen­ti­ell. Gleich­zei- tig kön­nen die Ergeb­nis­se eini­ger die­ser Arbei­ten für nicht­fried­li­che Zwe­cke miss­braucht wer­den; sie sind mit einem soge­nann­ten Dual-Use-Cha­rak­ter (dop­pel­te Ver- wend­bar­keit) behaf­tet, der es beson­ders schwer macht, den Nut­zen zu ern­ten und gleich­zei­tig die damit ver­bun- denen Risi­ken zu mini­mie­ren. Die rele­van­ten Ent­wick- lun­gen bezie­hen sich vor allem auf die For­schungs­be­rei- che der Genom­for­schung, der syn­the­ti­schen Bio­lo­gie, der Sys­tem­bio­lo­gie, der Bio­in­for­ma­tik, der Nano­tech­no- logie und der Tar­ge­ted-Deli­very-Tech­no­lo­gien. Auf inter­na­tio­na­ler Ebe­ne kom­men die Bemü­hun­gen sehr schlep­pend vor­an, Risi­ko­ma­nage­ment­pro­gram­me, die die Gefah­ren des Miss­brauchs ent­schär­fen könn­ten, abzu­fas­sen und zu eta­blie­ren. Die Ent­wick­lun­gen in Wis­sen­schaft und Tech­nik stan­den stets im Mit­tel­punkt der 1972 ver­ein­bar­ten B‑Waffenkonvention (Über­ein- kom­men vom 10. April 1972 über das Ver­bot der Ent- wick­lung, Her­stel­lung und Lage­rung bak­te­rio­lo­gi­scher (bio­lo­gi­scher) Waf­fen und von Toxin­waf­fen sowie über die Ver­nich­tung sol­cher Waf­fen) und mit den rasan­ten Ent­wick­lun­gen in den Lebens­wis­sen­schaf­ten in den letz- ten Jah­ren haben die­se kon­ti­nu­ier­lich an Rele­vanz gewon­nen. Seit 2005 wer­den die Mit­glieds­staa­ten der Kon­ven­ti­on spe­zi­ell auf­ge­for­dert, ihre Akti­vi­tä­ten in Rich­tung Risi­ko­vor­sor­ge bzw. Risi­ko­ma­nage­ment bekannt zu machen, sodass opti­ma­le Ver­fah­ren (best prac­ti­ces) aus­fin­dig gemacht wer­den kön­nen. Bis jetzt haben sehr weni­ge Staa­ten dar­auf reagiert, näm­lich die Ver­ei­nig­ten Staa­ten von Ame­ri­ka (USA), deren Risi­ko- manage­ment­sys­tem schon imple­men­tiert wor­den ist und die Nie­der­lan­de, des­sen Risikovorsorgeprogramm

  1. 1  Natio­nal Human Geno­me Rese­arch Insti­tu­te, DNA Sequen­cing Cos­ts. Data from the NHGRI Geno­me Seque 1093/nar/gks546.
  2. 2  A. Prindle/J. Selimkhanov/H. Li et al., Rapid and Tun­ab­le Post-trans­la­tio­nal Cou­pling of Gene­tic Cir­cuits, 508 Natu­re (2014), 387,

zwar abge­fasst aber noch nicht imple­men­tiert ist. Jetzt hat auch Deutsch­land reagiert. In Ant­wort auf eine Anfra­ge der Bun­des­re­gie­rung an den Deut­schen Ethik- rat, hat der Ethik­rat eine Stel­lung­nah­me dazu ver­fasst, mit Emp­feh­lun­gen zu einem kohä­ren­ten Rege­lungs­sys- tem, das den Miss­brauch von For­schung und For- schungs­er­geb­nis­sen in den Lebens­wis­sen­schaf­ten mini- mie­ren und ver­hin­dern soll. Um auf der inter­na­tio­na­len Ebe­ne vor­wärts zu kom­men und bis ande­re Staa­ten die- sen Bei­spie­len fol­gen, soll­ten die Mit­glieds­staa­ten der BWC schon mit die­sen drei detail­lier­ten Risi­ko­ma­na­ge- ment­pro­gram­men in einem Arbeits­grup­pen­for­mat begin­nen, opti­ma­le Ver­fah­ren aus die­sen Sys­te­men aus- fin­dig zu machen, die mit allen Mit­glieds­staa­ten als Weg­wei­ser zur Risi­ko­vor­sor­ge dis­ku­tiert wer­den kön- nen.

I. Intro­duc­tion: life sci­en­ces work of rele­van­ce to biosecurity

Advan­ces in sci­ence and tech­no­lo­gy over the past few years have initia­ted new and impro­ved approa­ches to coun­te­ring dise­a­se and pro­mo­ting health in gene­ral. This pro­gress in the life sci­en­ces is abso­lute­ly essen­ti­al. At the same time, the rapi­di­ty with which the advan­ces occur and the pos­si­bi­li­ties for misu­se that they reve­al give us a clear indi­ca­ti­on that we have reached a cri­ti­cal point in being able to deal effec­tively with the bio­se­cu­ri­ty impli- cati­ons of the­se developments.

Pro­gress in geno­mics is enab­ling the ever incre­a­singly rapid and cost effec­ti­ve ana­ly­sis of genes and their regu- lato­ry ele­ments as well as faci­li­ta­ting high through-put nucleic acid syn­the­sis, which in turn is enab­ling the mo- difi­ca­ti­on of even very com­plex micro­or­ga­nisms to meet desi­gner specifications.1 Syn­the­tic bio­lo­gy is advan­cing bey­ond sophisti­ca­ted engi­nee­ring of micro­or­ga­nisms to per­form new tasks by out­fit­ting them with DNA-based bio­lo­gi­cal cir­cuits built from stan­dar­di­zed biological

doi: 10.1038/nature13238.
K. Adamala/J. W. Szostak, Nonen­zy­ma­tic Tem­pla­te-Direc­ted RNA

Syn­the­sis Insi­de Model Pro­to­cells 342 Sci­ence (2013), 1098, doi: 10.1126/science.1241888; D.G. Gibson/J.I. Glass/C. Lar­ti­gue et al.,

Kathryn Nix­dorff

Bio­safe­ty and Bio­se­cu­ri­ty
Rele­vant Life Sci­en­ces Work: Pro­tec­tion from Bio-War­fa­re and Bio-Terrorism

Ord­nung der Wis­sen­schaft 2015, ISSN 2197–9197

60 ORDNUNG DER WISSENSCHAFT 2 (2015), 59–64

parts.2 Sub-fiel­ds of syn­the­tic bio­lo­gy are now reaching into the realm of crea­ting arti­fi­cial life from che­mi­cal components.3

Advan­ces in sys­tems bio­lo­gy are reve­aling new poten- tial tar­gets for dis­rup­t­ing the care­ful balan­ce of vital phy- sio­lo­gi­cal functions.4 This is a field of bio­lo­gy that seeks to under­stand the working of com­plex phy­sio­lo­gi­cal sys- tems wit­hin and bet­ween cells on a mole­cu­lar level. An enor­mous amount of know­ledge is accu­mu­la­ting through this work that pin­points vital cel­lu­lar tar­gets and ways of affec­ting tho­se sys­tems; eit­her posi­tively, to- wards bet­ter health or nega­tively, towards dis­rup­ti­on of the pro­per, balan­ced func­tion of tho­se systems.

Bio­in­for­ma­tics has to do with a who­le array of enab­ling functionsformodernlifescienceswork,includingthesto- rage and recall of geno­mics data, the direc­ted design of gene seg­ments and genes on up to ent­i­re geno­mes of micro­or­ga- nisms, direc­ted design of the­ra­peu­tic drugs as well as the model­ling of the inter­ac­tions bet­ween molecules.5 Bio­in­for- matics also enab­le the glo­bal dis­tri­bu­ti­on and exchan­ge of know­ledge. Inde­ed, bio­in­for­ma­tics plays a decisi­ve role in all are­as of life sci­en­ces work today.

Nano­tech­no­lo­gy is the stu­dy of mate­ri­als on a nano sca­le (a nano­me­ter is one-bil­lion­th of a meter). It is most rele­vant for bio­se­cu­ri­ty in the crea­ti­on of nano­par­ti­cles with a size bet­ween 1–100 nano­me­ters. The­se par­ti­cles can be desi­gned to have spe­ci­fic size, form and phy­si­cal- che­mi­cal pro­per­ties that can pro­mo­te impro­ved deli­very of bio­ac­ti­ve sub­s­tan­ces such as phar­maceu­ti­cal drugs ac- ross nasal and respi­ra­to­ry pas­sa­ges as well as the blood- brain-bar­ri­er for the­ra­peu­tic purposes.6 At the same time nano­par­ti­cles cou­pled with new methods for ma-

Crea­ti­on of a Bac­te­ri­al Cell Con­trol­led by a Che­mi­cal­ly Syn­the- sized Geno­me, 329 Sci­ence (2010), 52; M. A. Bedau/E. C. Parke/U. Tangen/B. Hant­sche-Tan­gen, Social and Ethi­cal Check­points for Bot­tom-up Syn­the­tic Bio­lo­gy or Pro­to­cells, Sys­tems and Syn­the­tic Bio­lo­gy 3 (2009), 65, doi: 10.1007/s11693-009‑9039‑2.

  1. 4  K. Thiel, Sys­tems Bio­lo­gy, Incor­po­ra­ted?, 24 Natu­re Bio­tech­no­lo­gy (2006), 1055; A. Aderem/J.N. Atkins/C. Ansong et al., A Sys­tems Bio­lo­gy Approach to Infec­tious Dise­a­se Rese­arch. Inno­vat­ing the Patho­gen-Host Rese­arch Para­digm, 2 mBio (2010), e00325-10,doi: 10.1128/mBio.00325–10; B.A Kidd/L. A. Peters/E.E. Schadt/J.T. Dud­ley, Uni­fy­ing Immu­no­lo­gy with Infor­ma­tics and Mul­tis­ca­le Bio­lo­gy, 15 Natu­re Immu­no­lo­gy (2014), 118.
  2. 5  L. Yao/J.A. Evans/A. Rzhe­ts­ky, Novel Oppor­tu­nities for Com­pu- tatio­nal Bio­lo­gy and Socio­lo­gy in Drug Dis­co­very, 27 Trends in Bio­tech­no­lo­gy (2009), 531.
  3. 6  S. Suri/H. Fenniri/B. Singh, Nano­tech­no­lo­gy-Based Drug Deli­very Sys­tems, 2 Jour­nal of Occup­a­tio­nal Medi­ci­ne and Tech­no­lo­gy (2007), 16; F. Andrade/D. Rafael/M. Videi­ra et al., Nano­tech­no­lo- gy and pul­mo­na­ry deli­very to over­co­me resis­tance in infec­tious dise­a­ses, 65 Advan­ced Drug Deli­very Reviews (2013), 1816.
  4. 7  Natio­nal Rese­arch Coun­cil, Glo­ba­liz­a­ti­on, Bio­se­cu­ri­ty, and the Future of the Life Sci­en­ces, (2006), Natio­nal Aca­de­mies Press, Avail­ab­le at http://www.nap.edu/catalog/11567.html (29.8.2014);

king sub­s­tan­ces more solub­le across mucous mem­bra­nes could be used to deli­ver bio­lo­gi­cal war­fa­re agents more effec­tively, for examp­le in the form of aerosols.

Inde­ed, con­cerns about advan­ces in sci­ence and tech- nolo­gy that could lead to the crea­ti­on of novel bio­lo­gi­cal war­fa­re agents are com­po­un­ded by the reco­gni­ti­on that new and impro­ved ways of deli­vering bio­ac­ti­ve sub­stan- ces are alrea­dy at hand and will be deve­lo­ped fur­ther at a rapid pace.7 As out­lined abo­ve, nano­tech­no­lo­gy has con- tri­bu­t­ed great­ly to impro­ved deli­very of bio­ac­ti­ve subs- tan­ces over the aero­sol rou­te, the method that has always been pre­fer­red for deli­vering bio­lo­gi­cal weapons.8 How- ever, the emer­ging inte­rest over the past deca­de in deve- loping viral vec­tors to deli­ver vac­ci­nes and for use in tar- geted can­cer, drug and immunotherapy9 has cau­sed bio­se­cu­ri­ty con­cerns that this may be an effec­ti­ve way to deli­ver bio­lo­gi­cal agents as wea­pons. The stra­te­gy is to out­fit viru­ses with for­eign genes enco­ding bio­ac­ti­ve sub- stan­ces that will be deli­ve­r­ed to a host after infec­tion by the virus. The host acti­va­tes tho­se genes to direct the syn­the­sis of the encoded sub­s­tance, which then exerts its effects.

Viru­ses are very effi­ci­ent in infec­ting cells and deli­ve- ring genes, nevertheless, non-viral vec­tors (arti­fi­cial viru- ses) are being actively deve­lo­ped to over­co­me some of the dis­ad­van­ta­ges of viral vec­tors such as safe­ty, manu- fac­tu­ring pro­blems, host immu­ni­ty and limi­ted car­ry­ing capacities.10 The most recent deve­lo­p­ments in this direc- tion are the so-cal­led nanoro­bots.11 The­se are nano­par- ticles com­po­sed of a poly­mer-based frame­work enclo- sing a bio­ac­ti­ve sub­s­tance e.g. DNA or pro­te­in. They are out­fit­ted with sur­face mole­cu­les that can dock onto desi-

K. Nix­dorff, Advan­ces in Tar­ge­ted Deli­very and the Future of

Bio­wea­pons, 66 Bul­le­tin of the Ato­mic Sci­en­tists (2010), 24.
8 See GolbalSecurity.org, Wea­pons of Mass Dest­ruc­tion, Biological

War­fa­re Agent Deli­very. Avail­ab­le at http://www.globalsecurity. org/wmd/intro/bio_delivery.htm (29.8.2014); U.S. Depart­ment of Defen­se, The Mili­ta­ri­ly Cri­ti­cal Tech­no­lo­gies List. Part II: Wea­pons of Mass Dest­ruc­tion Tech­no­lo­gies, Office of the Under Secreta­ry of Defen­se for Acqui­si­ti­on and Tech­no­lo­gy (1998). Avail­ab­le at http://www.fas.org/irp/threat/mctl98‑2/mctl98‑2.pdf (29.8.2014).

P.A. Gil­bert and G. McF­ad­den, Poxvi­rus Can­cer The­ra­py 1 Recent Patents on Anti-Infec­ti­ve Drug Dis­co­very (2006), 309.

10 K.L. Dou­glas, Toward Deve­lo­p­ment of Arti­fi­cial Viru­ses for Gene The­ra­py. A Com­pa­ra­ti­ve Eva­lua­ti­on of Viral and Non-Viral Trans­fec­tion, 24 Bio­tech­no­lo­gy Pro­gress (2008), 871.

11 S.M. Douglas/I. Bachelet/G.M. Church, A Logic-Gated Nanoro­bot for Tar­ge­ted Trans­port of Mole­cu­lar Payloads; 335 Sci­ence (2012), 831; J. Elbaz/I. Will­ner, DNA Ori­ga­mi. Nanoro­bots Grab Cel­lu­lar Con­trol, 11 Natu­re Mate­ri­als (2012), 276; S.C. Lenaghan/Y. Wang/N. Xi et al., Grand Chal­len­ges in Bio­en­gi­nee­red Nano­ro- botics for Can­cer The­ra­py, 60 IEEE (Insti­tu­te of Electri­cal and Elec­tro­nic Engi­neers) Tran­sac­tions on Bio­me­di­cal Engi­nee­ring (2013), 667.

Nix­dorff · Bio­safe­ty and Bio­se­cu­ri­ty Rele­vant Life Sci­en­ces Work 6 1

gna­ted cells, signal­ling the vec­tor to open up and release its bio­ac­ti­ve payload. Some nanoro­bots are being deve­lo- ped to be taken up by cells and upon a signal, release their bio­ac­ti­ve sub­s­tan­ces insi­de the cell. Even though non-viral vec­tors have not been as effi­ci­ent as viral vec- tors in deli­vering genes to host cells,12 the­re is a gre­at deal of inte­rest in deve­lo­ping them further.

II. The Inter­na­tio­nal Gover­nan­ce Problem

Urgent atten­ti­on is nee­ded in dealing ade­qua­te­ly and res- pon­si­b­ly with the risks of misu­se that are inherent in life sci­ence work of dual use cha­rac­ter. Alt­hough the­re has been a sub­stan­ti­al amount of thought put into mini­mi- zing the risks invol­ved in this work, the gover­nan­ce pro- posals made to date are not in any way kee­ping pace with the developments.

In effect, all work with bio­lo­gi­cal agents for non- peace­ful pur­po­ses is pro­hi­bi­ted by the Bio­lo­gi­cal Wea- pons Con­ven­ti­on (BWC)13, which was agreed in 1972 and came into for­ce in 1975. In Arti­cle I of the con­ven­ti- on, each mem­ber state14 agrees never to deve­lop, stock- pile or other­wi­se acqui­re or retain bio­lo­gi­cal agents that have no jus­ti­fi­ca­ti­on for peace­ful pur­po­ses. Thus, at the same time, the con­ven­ti­on allows work with all bio­lo­gi- cal agents for peace­ful pur­po­ses. With this for­mu­la­ti­on, cal­led the gene­ral pur­po­se cri­ter­ion, the con­ven­ti­on pro- hibits bio­lo­gi­cal wea­pons, but does not hin­der sci­en­ti­fic pro­gress, and it is not a cap­ti­ve of the tech­no­lo­gi­cal deve- lop­ment of the 1970s. In this regard, all new tech­no­lo­gi- cal deve­lo­p­ments in the life sci­en­ces to date are une­qui- vocal­ly cove­r­ed by the con­ven­ti­on, as has been deter­mi- ned at all Review Con­fe­ren­ces of the BWC, inclu­ding the last one in 2011.15 This is the gre­at strength of the con­ven- tion.

At the same time, the pro­blem with the con­ven­ti­on in this con­text is that it has no effec­ti­ve way of assu­ring com­pli­an­ce. It was not poli­ti­cal­ly pos­si­ble at the time of nego­tia­ti­on of the BWC for the sta­tes par­ties to agree on

  1. 12  Fn. 10, 871.
  2. 13  United Nati­ons 1972, Con­ven­ti­on on the Pro­hi­bi­ti­on of the­De­ve­lo­p­ment, Pro­duc­tion and Stock­pi­ling of Bac­te­rio­lo­gi­cal (Bio­lo­gi­cal) and Toxin Wea­pons and on Their Dest­ruc­tion, Uni- ted Nati­ons Gene­ral Assem­bly Reso­lu­ti­on 2826 (XXVI). Avail­ab­le at http://www.unog.ch/80256EDD006B8954/(httpAssets)/C404 8678A93B6934C1257188004848D0/$file/BWC-text-English.pdf (29.8.2014)
  3. 14  As of August 2014, the­re are 170 Sta­tes Par­ties and 10 signa­to­ries. 16 sta­tes have neit­her signed nor rati­fied the con­ven­ti­on. For lists, see http://www.unog.ch/80256EE600585943/(httpPages)/7BE6CB BEA0477B52C12571860035FD5C?OpenDocument (29.8.2014).
  4. 15  United Nati­ons 2011, Final Docu­ment of the Seventh Review Con­fe­rence. The Seventh Review Con­fe­rence of the Sta­tes Par­ties to the Con­ven­ti­on on the Pro­hi­bi­ti­on of the Development,

a veri­fi­ca­ti­on regime16, and the text gives no indi­ca­ti­on of how to deal with the bio­se­cu­ri­ty risk of misu­se of ma- teri­al and know­ledge resul­ting from dual use work in the life sci­en­ces. Nego­tia­ti­ons star­ting in 1995 over a Pro­to- col to the BWC that would streng­t­hen the con­ven­ti­on with, among other mea­su­res, a detail­ed veri­fi­ca­ti­on pro- gram­me, fai­led in 2001 to be agreed upon.17 In Arti­cle IV of the con­ven­ti­on the sta­tes par­ties are char­ged not only with pro­hi­bi­t­ing bio­lo­gi­cal wea­pons but also with pre- ven­ting their (mis)use, again without pro­vi­ding any pro- cedu­re for accom­pli­shing this.

The evo­lu­ti­on of the work of the BWC has taken place at dif­fe­rent levels of under­ta­kings. At the top level, the BWC its­elf con­tains legal­ly bin­ding obli­ga­ti­ons, or the things that Sta­tes Par­ties MUST do. No new legal­ly bin- ding mea­su­res have been agreed sin­ce the trea­ty was sig- ned and came into for­ce. At the next level, the review con­fe­ren­ces, which are gene­ral­ly held every five years, reach “addi­tio­nal agree­ments” as to how to imple­ment the obli­ga­ti­ons of the BWC; the­se are con­si­de­red to be poli­ti­cal­ly (as oppo­sed to legal­ly) bin­ding obli­ga­ti­ons, or the things the Sta­tes Par­ties SHOULD do. Final­ly, the in- ter­ses­sio­nal pro­ces­ses (ISPs), year­ly mee­tings which have taken place sin­ce 2003 bet­ween the review con­fe­ren­ces, have led to the deve­lo­p­ment of “com­mon under­stan- dings” on ele­ments that might be use­ful; the­se are shared natio­nal posi­ti­ons on mecha­nisms that might streng­t­hen the imple­men­ta­ti­on of the BWC, or the things Sta­tes Par- ties COULD do.18 The­se com­mon under­stan­dings are clear­ly the wea­kest form of agree­ments reached in the BWC process.

In this regard the sta­tes par­ties to the BWC have sin­ce 2003, wit­hin the ISPs, tried to “pro­mo­te com­mon under- stan­dings and effec­ti­ve action” on spe­ci­fic topics of grea- test rele­van­ce to the BWC that could streng­t­hen the con- ven­ti­on. One topic that con­ti­nues to be taboo is, how- ever, veri­fi­ca­ti­on of the con­ven­ti­on; ins­tead, sta­tes par- ties try to reach agree­ments on other topics, which have over the years inclu­ded streng­t­he­ning the implementati-

Pro­duc­tion and Stock­pi­ling of Bac­te­rio­lo­gi­cal (Bio­lo­gi­cal) and Toxin Wea­pons and on Their Dest­ruc­tion. UN Doc. BWC/ CONF.VII/7. Avail­ab­le at http://www.un.org/ga/search/view_doc. asp?symbol=BWC/CONF.VII/7 (29.8.2014).

16 M.I. Che­vri­er, Histo­ry of BTWC Dis­ar­ma­ment, in: K. McLaughlin/K. Nix­dorff (eds.), BWPP Bio­lo­gi­cal Wea­pons Rea­der, 2009, 13. Avail­ab­le at http://www.bwpp.org/documents/ BWPP%20BW%20Reader_final+.pdf (29.8.2014).

17 D. But­ler, Bio­wea­pons trea­ty in dis­ar­ray as US blocks plans for veri­fi­ca­ti­on, 414 Natu­re (2001), 675.

18 P.D. Mil­lett, The Bio­lo­gi­cal Wea­pons Con­ven­ti­on: Con­tent, Review Pro­cess and Efforts to Streng­t­hen the Con­ven­ti­on, in: K. McLaughlin/K. Nix­dorff (eds.), BWPP Bio­lo­gi­cal Wea­pons Rea- der, 2009, 19, 30. Avail­ab­le at http://www.bwpp.org/documents/ BWPP%20BW%20Reader_final+.pdf (29.8.2014).

62 ORDNUNG DER WISSENSCHAFT 2 (2015), 59–64

on of the con­ven­ti­on, coope­ra­ti­on and assi­s­tance wit­hin the con­ven­ti­on, sur­veil­lan­ce of dise­a­se out­breaks, secu­ri- ty and over­sight of bio­lo­gi­cal agents, codes of con­duct and awa­reness-rai­sing edu­ca­ti­on of life sci­en­tists about dual-use bio­se­cu­ri­ty issu­es. Under the “effec­ti­ve action” part of the pro­cess, sta­tes par­ties are cal­led upon to re- com­mend spe­ci­fic actions that can, howe­ver, only be ag- reed on at the next sche­du­led Review Con­fe­rence. The BWC is pre­sent­ly in the midd­le of its third ISP (2012- 2015), which was estab­lis­hed at the Seventh Review Con- ference (Fn 15). So far most obser­vers agree that the Sta- tes Par­ties have reached many com­mon under­stan­dings, but have pro­mo­ted litt­le to no effec­ti­ve action.19

For examp­le, the topic of the review of deve­lo­p­ments in sci­ence and tech­no­lo­gy of rele­van­ce to the con­ven­ti­on has been inten­si­ve­ly dealt with as one of three stan­ding agen­da items in this pre­sent ISP. Wit­hin this pro­cess the man­da­te is to (1) review the most rele­vant deve­lo­p­ments, (2) con­si­der the impli­ca­ti­ons of the­se deve­lo­p­ments and (3) recom­mend risk manage­ment mea­su­res that can mi- tiga­te (mini­mi­ze) the risks that the­se deve­lo­p­ments car- ry. The­re has up to now been much acti­vi­ty in the way of dealing with the first two ele­ments, but very litt­le con­si- dera­ti­on of the gover­nan­ce issue (Fn 19). Nevertheless, the mem­ber sta­tes have been cal­led upon to com­mu­ni­ca- te their efforts and expe­ri­en­ces in imple­men­ting mea­su- res for streng­t­he­ning bio­lo­gi­cal risk manage­ment, volun- tary codes of con­duct and edu­ca­ti­on and awa­reness-rai- sing about dual-use bio­se­cu­ri­ty issu­es in the life sci­en­ces. Only a few sta­tes have respon­ded to this call with the draf­ting of bio­se­cu­ri­ty-ori­en­ted risk manage­ment poli- cies giving detail­ed descrip­ti­ons of pro­ce­du­re; the­se po- lici­es inclu­de the over­sight sys­tem of the USA20, which has been imple­men­ted, and the pro­po­sed over­sight and awa­reness-rai­sing sys­tem of The Nether­lands, which is in the imple­men­ta­ti­on process.21

  1. 19  K. Nix­dorff, The 2013 Mee­ting of Experts to the BWC, with a Focus on the Stan­ding Agen­da Item Review of Sci­ence and Tech­no­lo­gy Deve­lo­p­ments, Poli­cy Paper 2, Bio­che­mi­cal Secu­ri­ty 20130 Pro­ject (2013); M. Dan­do, To What Extent Was the Review of Sci­ence and Tech­no­lo­gy Made More Effec­ti­ve and Effi­ci­ent at the 2013 Mee­ting of BTWC Sta­tes Par­ties? Poli­cy Paper 5, Bio­che- mical Secu­ri­ty 20130 Pro­ject (2014). Both papers are avail­ab­le at http://biochemsec2030.org/policy-outputs/ (20.2.2015).
  2. 20  United Sta­tes, United Sta­tes Government Poli­cy for Over­sight of Life Sci­en­ces Dual Use Rese­arch of Con­cern (2012). Avail­ab­le at http://www.phe.gov/s3/dualuse/Documents/oversight-durc.pdf (29.8.2014).
  3. 21  Roy­al Nether­lands Aca­de­my of Arts and Sci­en­ces, Improving

III. Germany’s Response

Now Ger­ma­ny has acted in this con­text. In 2012 the Federal Government of Ger­ma­ny com­mis­sio­ned the Ger­man Ethics Coun­cil to draft an opi­ni­on as to whe­ther the exis­ting regu­la­ti­ons and other mea­su­res such as codes of con­duct were suf­fi­ci­ent to mini­mi­ze the risk of or even pre­vent the misu­se of deve­lo­p­ments in life sci­en- ces work. The Ger­man Ethics Coun­cil took this oppor­tu- nity to ana­ly­ze the issue of free­dom ver­sus respon­si­bi­li­ty in life sci­ence work in the con­text of bio­se­cu­ri­ty. It came to the con­clu­si­on that addi­tio­nal bio­se­cu­ri­ty regu­la­to­ry mea­su­res were nee­ded, and made recom­men­da­ti­ons to the Ger­man government in 2014 toward a cohe­rent regu- lato­ry sys­tem for minimizing/preventing the misu­se of advan­ces in life sci­en­ces work.22

The recom­men­da­ti­ons con­tain a balan­ced set of mea- sures that allow sci­en­tists working in the field to de- mons­tra­te that they act respon­si­b­ly in car­ry­ing out their rese­arch pro­gram­mes, with suf­fi­ci­ent regu­la­ti­ons to gui- de them in taking the steps nee­ded in this pro­cess in or- der to mini­mi­ze misu­se of their work. Edu­ca­ti­on of life sci­en­tists about dual-use-bio­se­cu­ri­ty issu­es is pla­ced first in the recom­men­da­ti­ons, reflec­ting the reco­gni­ti­on that this is con­si­de­red to be an essen­ti­al bio­se­cu­ri­ty gover- nan­ce mea­su­re; that only when life sci­en­tists under­stand the issu­es will they be able to reco­gni­ze the poten­ti­al risks and be con­vin­ced of the neces­si­ty for mini­mi­zing tho­se risks. Inde­ed, Peter Hale, foun­der of the Foun­da­ti- on for Vac­ci­ne Rese­arch sta­ted in an inter­view in Sci- enceInsi­der that the Opi­ni­on “for the first time, con­tains a set of sub­stan­ti­ve recom­men­da­ti­ons that will hope­ful­ly inform/inspire deba­te and action in other coun­tries” and that “The report should be requi­red rea­ding for govern- ments around the world”.23

Bio­se­cu­ri­ty, Assess­ment of Dual-Use Rese­arch (2013). Avail­ab­le at https://www.knaw.nl/shared/resources/actueel/publicaties/pdf/ advies-bio­se­cu­ri­ty-engels-web (29.8.2014).

22 Deut­scher Ethik­rat, Stel­lung­nah­me, Bio­si­cher­heit- Frei­heit und Ver­ant­wor­tung in der Wis­sen­schaft (2014). Avail­ab­le at http:// www.ethikrat.org/dateien/pdf/stellungnahme-biosicherheit.pdf (29.8.2014). Eng­lish Ver­si­on avail­ab­le at http://www.ethikrat.org/ files/opinion-bihttp://www.ethikrat.org/files/opinion-biosecurity. pdfosecurity.pdf (21.1.2015).

23 M. Enser­ink, Sci­en­ce­In­si­der, Ger­man Ethics Coun­cil: Govern- ment Should Regu­la­te Dan­ge­rous Rese­arch, Sci­en­ce­In­si­der (2014). Avail­ab­le at http://news.sciencemag.org/europe/2014/05/ (29.8.2014).

Nix­dorff · Bio­safe­ty and Bio­se­cu­ri­ty Rele­vant Life Sci­en­ces Work 6 3

Until other sta­tes fol­low the­se examp­les, a way for- ward at the inter­na­tio­nal level would be for the Sta­tes Par­ties to the BWC to start ana­ly­zing the­se three detail­ed risk manage­ment sys­tems in a working group set­ting, with con­clu­si­ons and recom­men­da­ti­ons about best prac­ti­ces repor­ted to the next Mee­ting of Sta­tes Par­ties as gui­de­li­nes for tho­se sta­tes that as yet have no risk ma- nage­ment pro­gram­me in place.

Prof. Kathryn Nix­dorff ist eme­ri­tier­te Pro­fes­so­rin am Insti­tut für Mikro­bio­lo­gie und Gene­tik an der TU Darmstadt.

64 ORDNUNG DER WISSENSCHAFT 2 (2015), 59–64