Conclusion. Comparing Access and Benefit-Sharing in Europe
Pre-print of the conclusion of the edited book ‘Implementing the Nagoya Protocol. Comparing
Access and Benefit-sharing Regimes in Europe.’
Full citation: Coolsaet, Brendan (2015) Comparing Access and Benefit-Sharing in Europe. In
Coolsaet B, F Batur, A Broggiato, J Pitseys, and T Dedeurwaerdere (eds.) Implementing the Nagoya
Protocol. Comparing Access and Benefit-sharing Regimes in Europe. Martinus Nijhoff Publishers
For more information see http://www.brill.com/products/book/implementing-nagoya-protocol
Conclusion. Comparing Access and
Benefit-Sharing in Europe
The concept of access and beneit-sharng (ABS) grew out of the emergence of
the global governance of genetc resources durng the second half of the twen-
teth century. The evoluton of envronmental ethcs, of nternatonal envron-
mental law, of North–South relatons, and of nternatonal cooperaton for
scentic research all nourshed an nternatonal regme, whch eventually led
to the Nagoya Protocol. The Protocol thus s the product of a seres of nterna-
tonal legal doctrnes, as exposed n the ntroducton of ths book. Lkewse,
the mplementaton of the Protocol wll need to buld on a seres of exstng
legal prncples and rules, whch are currently governng ssues related to
access and beneit-sharng. As llustrated throughout the chapters n the irst
part of the book, these ssues are numerous and dfer from country to country,
ncludng inter alia property regmes, market regulaton and access, ndustral
polcy, health, nternatonal development, legslaton related to envronmental
matters and nature conservaton, agrculture, research & development trad-
tonal knowledge, admnstratve laws, and prvate nternatonal law. In add-
ton, the mple mentaton wll have to complement and/or further a plethora of
quas-legal nstruments, best practces and prvate standards, all of whch may
or may nothave been desgned wth ABS or the Nagoya Protocol n mnd.
Fnally, European ABS nstruments wll also converge at the European level,
where an EU-harmonsed approach on complance measures for users from
the Nagoya Protocol was adopted n Aprl 2014. The story of the Nagoya
Protocol thus can be sad to be one of legal conuence: born out of a unon of
legal doctrnes, tgathers a large range of legal ields extendng far beyond
envronmental lawonly, and combnes (or wll need to combne) exstng legal
regmes, numerous actors, both publc and prvate, and a multtude of polcy
and prvate ntatves.
The conuence of these dferent streams nto a functonal ABS regme s of
paramount mportance for the EU, n partcular for ts botechnology sector
and ts non-commercal bodversty research sectors. Although beng only
1 Regulaton (EU) No 511/2014 of the European Parlament and of the Councl on complance
measures for users from the Nagoya Protocol on Access to Genetc Resources and the Far
and Equtable Sharng of Beneits Arsng from ther Utlzaton n the Unon.
© j , , | .6/78_7
0002480457.INDD 363 3/25/2015 7:22:09 PM
second to North Amerca n terms of pharmaceutcal sales, Europe domnates
the world pharmaceutcal manufacturng sector. For nstance, 11 EU countres
and Swtzerland together account for over 0% of the world exports of medc-
nal and pharmaceutcal products, and medcaments. About half of the world
largest cosmetcs companes are located n Western-Europe, the largest by
sales beng France-based l’Oreal wth 22.5 bllon euros of sales n 2012.
Moreover, through ts extensve ex situ network of botancal gardens, culture
collectons and gene banks, Europe hosts a consderable amount of the world
genetc materal, be t endemc or non-endemc. Together wth Swtzerland
and Norway, the EU member states approxmately host a quarter of all botan-
cal gardens worldwde, whch keep over 50% of the world lvng plant acces-
sons. In more than 500 culture collectons and gene banks, these countres
also possess 30% of all cultures of mcroorgansms and between 10 and 15% of
the total accessons of germplasm for food and agrculture n the world.More specically, whle not necessarly mentoned n ths book, numerous
examples of European research and development actvtes nvolvng genetc
resources and tradtonal knowledge can be found n the lterature. Among
many others, examples nclude:
Vernonia Galamnensis, the ol of whch s used n plas-
tc formaton and coatng, by the Brtsh company Vernque Botech;proect, by the Dutch breedng companes Enza Zaden B.V. (hgher-yeldng
2 EFPIA, The Pharmaceutical Industry in Figures (European Federaton of Pharmaceutcal
Industres and Assocatons, 2013).
3 Fgures from UN Commodty Trade Statstcs Database, Medicinal and Pharmaceutical
Products, Other than Medicament (SITC 541) and Medicaments (including veterinary medica-
ments) (SITC 542) (New York, 2011), Avalable at http://comtrade.un.org/.
4 Chang Hoon Oh, Alan M. Rugman, “Regonal Sales of Multnatonals n the World Cosmetcs
Industry,” European Management Journal, Volume 24 (200): 13–13.
5 BGCI, Global Dstrbuton of Botanc Gardens: http://www.bgc.org/map.php, accessed on 20
European Commsson, Impact Assessment Accompanying the Document Proposal for a Regulation
of the European Parliament and of the Council on Access to Genetic Resources and the Fair and
Equitable Sharing of Benets Arising from their Utilization in the Union, SWD(2012) 292 inal.
WFCC, World Data Center for Mcroorgansms: http://www.wfcc.nfo/ccnfo/statstcs/,
accessed on 20 January 2014.
Approxmate igure based on FAO, The Second Report on the State of the World’s Plant Genetic
Resources for Food and Agriculture and Accompanying Country Studies (Rome: FAO, 2010).
9 R. Feyssa, “Farmers’ Rghts n Ethopa. A Case Study,” FNI Report 7 (200).
0002480457.INDD 364 3/25/2015 7:22:09 PM
tomato plants) and Western Seeds Internatonal (seedless tomatoes), wth
tomato wld relatves from Ecuador and Peru;Prunus Africana bark n Cameroon by Plantecam, a sub-
sdary of the French company Groupe Fourner, to be sold n Europe as a
treatment for bengn prostatc hyperplasa;-
sdase nhbtor,” a drug regulatng absorpton of glucose for type dabetes
patents, by Bayer (Germany);Artemisia Judaica, a Lyban medcnal plant, and ts assocated
Argania spinosa) products n the cosmet-
cs, skn and har care ndustry, n partcular by BASF (Germany) and l’Oreal
(France);derved from a natve Brtsh ower Colchicum Autumnale.Ths chapter takes stock of the regulatory contexts n whch the above exam-
ples take place. It does so by comparng the provsons detaled n the country
case studes of ths book (chapters 1 to 10). Alongsde the selected EU coun-
tres, Norway and Turkey have been ncluded n the comparatve analyss.
Readers are nvted to consult the separate case studes for more n-depth
analyss, as ths chapter only provdes a comparatve summary of the
As a concluson to ths book, ths chapter then bulds on the comparatve
analyss to dscuss some of the future challenges and opportuntes to mple-
mentng the Nagoya Protocol n the EU. It does so by dscussng the provsons
of the EU Regulaton on ABS, n lght of the nput provded by the chapters of
the second part of ths book (chapters 11 to 14).
10 Edward Hammond, Biopiracy Watch. A Compilation of Some Recent Cases (Penang,
Malaysa: Thrd World Network, 2013).
11 Charles Zerner, People, Plants, and Justice: The Politics of Nature Conservation (New York/
West Sussex: Columba Unversty Press, 2013).
12 Jay McGown, Out of Africa: Mysteries of Access and Benet Sharing (Washngton, USA:
Edmonds Insttute/ Afrcan Centre for Bosafety, 200).
14 Danel F. Robnson, Biodiversity, Access and Benet-sharing. Global Case Studies (London/
New York: Routledge, 2015).
15 Battson, L., “Brtsh Flowers are the Source of a New Cancer Drug,” BBC News, Scence &
Envronment, 12 September 2011; [See contrbuton by Smth to ths volume (Chapter )].
0002480457.INDD 365 3/25/2015 7:22:09 PM
I Comparing ABS Regimes in Selected European Countries
Whle all EU member states and the Unon tself are Party to the Conventon
on Bologcal Dversty, t must be acknowledged that, snce the entry nto
force of the CBD, lttle was done to mplement ABS oblgatons embedded n
Artcles 15 and () of the Conventon. Specic regulaton for the utlzaton of
genetc resources and assocated tradtonal knowledge s rather scarce, wth
mportant dferences exstng among countres.
Ths secton compares the dferent regulatons n place n selected
Europeancountres, accordng to the thematc dvson of the research ques-
tons descrbed n the ntroducton of ths book. Consecutvely, ths secton
summarzes and dscusses provsons related to:
() the legal status of genetc resources and tradtonal knowledge;
() access to domestc genetc resources and tradtonal knowledge;
() beneit-sharng mechansms;
() complance mechansms; and
() the dstrbuton of ABS-related competences.
1 The Legal Status of Genetic Resources and Traditional Knowledge
To determne the applcable rules for access and utlzaton of genetc resources
and tradtonal knowledge, one needs to consder the current legal status of
these resources and/or knowledge irst. The legal status of genetc resources
refers to the way these resources are covered by natonal and sub-natonal law,
ncludng property regmes, admnstratve law and legslaton for the protec-
ton of natural areas and/or plant and anmal speces.
Although rarely explctly specied, and although a dstncton s beng
made by the CBD, the ownershp of genetc resources n our selected
European countres s generally derved from the ownershp of bologcal
resources and/or land, whch s deined ether by the Consttuton or the cvl
code. Ths means that when genetc resources occur n in situ condtons and
are not (ndrectly) covered by specic legal rules (see below), landowners can
manage ther bologcal resources as they see it, and reap the potental bene-
its arsng from ther use. In our subset of countres, only Norway (and poten-
tally France n the near future) specically ndcates that genetc resources are
1 Conventon on Bologcal Dversty Artcle 2.
1 CBD, “Report on the Legal Status of Genetc Resources n Natonal Law. Includng Property
Law, where applcable, n a Selecton of Countres,” (200) UN Doc UNEP/CBD/
0002480457.INDD 366 3/25/2015 7:22:10 PM
consdered a common resource belongng to socety as a whole, even f that
does not preclude the applcaton of (ntellectual) property law and other rel-
evant legslaton. It should also be noted that ctzens n most of our studed
countres enoy a consttutonal rght to a healthy and sustanable envron-
ment, n some form or the other. In Greece, for nstance, the consttutonal
rght to “the protecton of the envronment,” to “the development of the human
personalty,” and to “the protecton of the value of the human beng” extends to
the protecton and use of envronmental goods such as wld ora and fauna,
and bodversty.In most countres, the ownershp of land or of an organsm extends to the
fruts and the products generated by t. Once the frut or the product s col-
lected or extracted, thus becomng movable property, a dferent property
regme may apply. As such, n our studed countres, mmovable property
extends to the essental components of a thng as long as they are unted,
attached and/or ncorporated to t. Once collected, these products become
movable property for whch the buyer or recpent automatcally obtans own-
ershp over the exchanged good and ts genetc resources. Lkewse, plants kept
n ex situ condtons for temporary purposes (e.g. nurseres for publc sellng)
may be consdered as movable property.
Some countres provde exceptons to these ownershp rules for specic
cases. As such, n Greece, for trees located at boundares of mmovable
propertes a separate ownershp s establshed. In Norway, prvate owner-
shp over bologcal materal may end when ths materal stops beng exclud-
able. Tvedt uses the example of an escaped farmed salmon, whch, f not
re-captured by ts legtmate owner and not protected by IPR, can be used
by anyone who inds t. These examples of specal stuatons mght serve as
nspraton for the further regulaton of the utlzaton of genetc resources
accessed n “transboundary stuatons or for whch t s not possble to grant
or obtan pror nformed consent.” Independently of potental exceptons,
all European countres dspose of a seres of cvl and/or crmnal lablty
and redress optons whch may be sutable to address msappropraton of
genetc resources (e.g. theft, concealment, breach of trust…).
Whle genetc resources can be consdered bophyscal enttes, they also
comprse an nformatonal component (i.e. the genetc code, tradtonal knowl-
edge, publshed data etc.). However, the above descrbed property rules usually
apply to genetc resources as bophyscal goods, and the rules governng the
1 [See contrbuton by Mara and Lmnou to ths volume (Chapter 5)].
19 [See contrbuton by Tvedt to ths volume (Chapter )].
20 Nagoya Protocol Artcle 10.
0002480457.INDD 367 3/25/2015 7:22:10 PM
ownershp of assocated nformaton are rarely as clear and homogeneous. In
some cases, authors have ndcated that unless they are protected by exclusve
rghts (such as IPR), these nformatonal components mght consttute a res
communis: “thngs owned by no one and subect to use by all.” In such cases,
the nformatonal components may not be subect to exstng lablty and
redress optons for the enforcement of property rghts, snce they cannot be
approprated. However, some authors have argued that, under certan crcum-
stances, property rghts on a thng may encompass the assocated nforma-
tonal components.Use rghts over genetc resources and assocated tradtonal knowledge
may also be regulated through ntellectual property rghts. Dferent case
studes n our book address ths ssue, wth an unusual homogenety. Broadly
speakng, potental ntellectual property rghts applcable to genetc resources
and tradtonal knowledge nclude patents, plant varety rghts and geograph-
In all studed European countres, ownershp and use of bologcal resources
s lmted n some way by nature conservaton laws or by legslaton on pro-
tected speces, protected areas, forests and/or marne envronments, some of
whch have a European orgn. The level of protecton can be contngent upon
the type of resources, wth several countres rankng ther protected fauna and
lora accordng to ther protecton level. In Greece and Turkey, addtonal ds-
tnctons are made between natve and non-natve speces. Ths creates a lot of
potental constrants whch wll need to be taken nto account when establsh-
ng future ABS rules (see next sectons). These lmtatons are not only reserved
for protected areas n the strct sense of the word: n some regons, the use of
natural resources found n “unprotected areas” s equally lmted. In Flanders,
Belgum, for nstance, all acts that are not understood to nclude the normal
mantenance of vegetaton requre a permt, ncludng n commonly access-
ble green spaces such as parks and gardens.
As for the legal status of tradtonal knowledge, few of the studed coun-
treshave explctly addressed the ssue. There s currently no nternatonally-
agreed deinton of “tradtonal knowledge assocated wth genetc resources.”
Moreover, some countres consder that tradtonal communtes do not exst
(anymore) or cannot be traced back, even though some (manly agrcultural)
practces could be consdered tradtonal knowledge. Ths has not kept some
countres, lke Span, to deine the concept of tradtonal knowledge, thereby
attendng to the deintonal gap left by the CBD. France s the only country
21 [See for example contrbuton by Ptseys et al., to ths volume (Chapter 1)].
0002480457.INDD 368 3/25/2015 7:22:10 PM
currently envsagng to specically deine both tradtonal knowledge assoc-
ated wth genetc resources and tradtonal communtes. The latter, deined n
the new draft Bodversty Law n the broadest possble manner, are under-
stood as beng communtes of nhabtants dervng ther means of subsstence
from the natural envronment.
2 Access to Domestic Genetic Resources and Traditional Knowledge
The above descrbed legal status of genetc resources and tradtonal knowl-
edge n European countres has drect nuence on the way these resources
and knowledge can (or wll) be accessed. When the legal status of genetc
resources s derved from the ownershp rules of the land or of an organsm,
the permsson for collectng such resources needs to be agreed upon wth the
legal owner. However, access to and use of bologcal resources are generally
the subect of a large body of exstng rules, as deined by envronmental, urban
plannng, nature conservaton, forest, marne, water, agrculture and/or admn-
stratve laws. Access may also be regulated for certan types of (genetc)
resources but not for others. Ths secton therefore compares the dferent
access provsons descrbed n the country case-studes. Whle “access” and
“use” here do not necessarly correspond to “access for utlzaton” as under-
stood n the Nagoya Protocol, they do cover acts whch are lkely to occur n
the case of “access for utlzaton.” These nclude inter alia capturng, collect-
ng, pckng, cuttng, uprootng, transferrng, transplantng, transportng, pur-
chasng, sellng, exchangng and/or exportng the resources. Unless otherwse
specied, the terms “access” and “use” n ths secton should thus be under-
stood as referrng to these acts and not to “access for utlzaton.”
Although most European countres have relatvely low levels of bodversty
potental and could therefore be more exble on access to ther domestc
resources than bodversty-rch countres, only the Netherlands and Denmark
have mplctly or explctly adopted a poston of unrestraned access to ther
genetc resources. For access to unprotected bologcal and/or genetc
resources, other countres and regons can be dvded nto three groups:
regulated access, wth most acts requrng a permt/noticaton): e.g.
Flanders (Belgum), France (draft Bodversty Law), Greece, Turkey;
23 Nagoya Protocol Artcle 2.
24 See GEF, “Beneits ndex for bodversty,” accessed March 2014, http://data.worldbank.
org/ndcator/ER.BDV.TOTL.XQ. [See also contrbuton by Maggon et al., to ths volume
0002480457.INDD 369 3/25/2015 7:22:10 PM
freeaccess s allowed n non-protected areas and for non-protected speces):
e.g. Brussels (Belgum), France (current rules), Germany, Norway, the
law or other nature-related or admnstratve rules: e.g. Span.
Through the “everyman’s rght,” a rght for the publc to access prvately owned
land, Nordc countres provde a set of generalzed exceptons to access bo-
logcal resources found on prvate property. In Denmark, the “Danske Lov”
ncludes a provson allowng for the collecton of “nuts” by all, whether these
are located on prvate ground or not. Nuts nclude bophyscal enttes contan-
ng unts of heredty such as owers, leaves, berres, fruts, fung etc. In Norway,
lke n most other Nordc countres, the “allemansretten” s a rght of publc
access to prvately owned land. Whle orgnally conceved for roamng, t
alsoallows vstors to pck and collect bologcal materal under certan
Access regulaton n natural areas, whether protected or not, comes n all
possble forms and avors n Europe. Ths heterogenety can lead to a complex
maze of access and use rules across countres but also potentally wthn the
same country. These may also be addtonal to the future requrements for
“access for utlzaton.” The stuaton n Belgum s premontory n ths regard.
As envronmental management s a hghly decentralzed competence n the
country, at least three dferent knds of access rules for each category of bo-
logcal resources (protected, cultvated, forest…) co-exst on ts small terrtory.
Each power level, moreover, provdes ts own set of specic exceptons to these
access rules. Access rules can also be coupled wth condtons of use, especally
when related to genetc resources for food and agrculture. In Turkey, for
nstance, a techncal commttee regulates the amount of endemc seeds, bulbs
or other parts of natural bulbous owers that can be collected and mposes
quotas for ther producton. Access restrcton mposed by nature protecton
laws may also be lmted n tme, to prevent dsturbance of breedng perods or
n relaton to huntng seasons. Whereas countres lmt access to protect natu-
ral resources from a bologcal pont of vew, some also nvoke cultural reasons
for regulatng access and thus see genetc resources as part of ther natonal
Access for research, whch s partcularly relevant for ABS under the Protocol,
s generally made possble through a multtude of exceptons n all studed
countres. However, the way n whch ths s done vares consderably. Whle
certan countres requre a specic permt to be acqured for research-related
0002480457.INDD 370 3/25/2015 7:22:10 PM
access, others smply mpose a noticaton requrement. Some countres
havetred dferentatng access rules dependng on the purpose of the
research.Span, for nstance, specied dferent rules for commercal and non-
commercal access, although authors n our case-study seem to be rather scep-
tcal about the efectveness of ths dstncton. In Greece, dferent rules
apply when the collected materal s destned for export, as well as when the
accessed materal s a natve landrace and/or a tradtonal varety.
In lght of the above analyss, at the moment of ths wrtng, none of the
European countres, wth the excepton of Denmark, have currently regulated
access to ther genetc resources for utlzaton, as deined by the Nagoya Protocol.
Nor have any of them ntroduced a formal PIC requrement for ther domestc
resources. Denmark has decded not to requre PIC for ts genetc resources, but
s envsagng noticaton requrements for access to genetc resources of wld
speces. Norway and France are both on track to mplement full-edged Nagoya-
complant access legslaton. The French Bodversty Law contans dferent
access-relevant aspects whch are worth mentonng here, as they mght nspre
other countres. The French Bodversty Law dferentates access rules by ts
stated purpose: non-commercal research and emergency stuatons only requre
noticaton to the competent authorty, whle other types of access requre gong
through a specic access procedure. The Law also ncludes specic rules for
access to tradtonal knowledge, whereby denticaton and consultaton of the
concerned communtes, and the establshment of a beneit-sharng agreement
wth them, are mandatory steps n the access procedure. Fnally, the Law envs-
ages a broader temporal scope than the Nagoya Protocol, wth the current pro-
posal coverng all new uses. In such a case, ABS provsons would be trggered for
all new R&D actvtes not prevously pursued by the same user, ndependently
of how and when the orgnal materal was accessed.
3 Benefit-Sharing Mechanisms
Whle the role of Europe as a provder of genetc resources and/or tradtonal
knowledge s a debatable matter, ts poston as a maor user of global genetc
resources s a settled fact. 20 years after the ntroducton of the CBD, the ques-
ton arses as to whether European users share or have shared beneits for
genetc resources and/or tradtonal knowledge they utlze. And f so, whether
the beneit-sharng arrangements are regulated by applcable law n European
countres, or by prvate mechansms? Ths secton takes stock of beneit-
sharng arrangements whch mght have been concluded by users of our
s tuded countres, as well as the regulatory contexts, f any.
25 [See contrbuton by Slvestr and Lago Candera to ths volume (Chapter 9)].
0002480457.INDD 371 3/25/2015 7:22:10 PM
A irst example s the beneit-sharng arrangement concluded n 2005
between the Dutch company Healthand Performance Food Internatonal
(HPFI) and the Ethopan Insttute of Bodversty Conservaton (IBC), men-
toned by Vsser et al., The agreement gave HPFI access to tef varetes n
Ethopa, and allowed the company to utlze them for the development and
commercalzaton of food and beverages. Access to and use of assocated tra-
dtonal knowledge was prohbted. In exchange, both monetary and non-
monetary beneits were agreed upon, ncludng a lump sum of proits arsng
from use of tef genetc resources, royaltes on the net proit of the sale of tef
seeds, lcense fees, contrbutons to a local fund to mprove lvng condtons of
farmers and research related provsons such as cooperaton and the sharng of
results. However, whle consdered an example of an deal ABS agreement at
the tme, varous problems ncludng an over-estmaton of potental beneits,
a controversal patent clam, dstrust between HPFI and IBC, rregulartes n
the management and the eventual bankruptcy of HFPI, and the lack of user-
measures n the Netherlands led to the falure of the agreement.Another, more successful, example of beneit-sharng by a European user
sthe cooperaton agreement concluded between the German Research
Foundaton and several Ecuadoran unverstes. Ths proect s a clear example
of non-monetary beneit-sharng, coupled wth envronmental obectves. The
proect ncluded the establshment of ont graduate programs, funded post-
graduate and PhD students, research facltes and equpment as well as broader
structural beneits such as the mprovement transport and energy systems.
However, examples of beneit-sharng arrangements are rare n our case
studes. It s unclear whether the avalablty of such a small amount of
agreements s due to potental conidentalty ssues or to ther non-exstence.
Whle the reasons behnd the absence of such agreements are potentally
numerous, the responsblty of the user countres manly resdes n ther
nablty to ill the current legal vacuum surroundng the utlzaton of genetc-
resources and the absence of bndng beneit-sharng rules. As the European
Commsson tself acknowledges, the lack of measures adoptng ABS rules by
user countres has led to the establshment of restrctve condtons for access
2 [See contrbuton by Vsser et al., to ths volume (Chapter )].
2 Sarah Lard and Rachel Wynberg, “Access and Beneit-sharng n Practce: Trends n
Partnershps across Sectors,” Techncal Seres No. 3 (Montreal: Secretarat of the
Conventon on Bologcal Dversty, 200), 140 pages.
2 Regne Andersen and Tone Wnge, “The Access and Beneit-sharng Agreement on tef
Genetc Resources, Facts and Lessons,” FNI Report 6 (2012). Oslo, Norway.
29 European Commsson, “Impact Assessment.”
0002480457.INDD 372 3/25/2015 7:22:10 PM
to genetc resources and/or tradtonal knowledge n provder countres. Falng
to access global genetc resources would strongly afect the actvtes of a wde
range of European economc and envronmental stakeholders n the future,
ncludng botanc gardens, culture collectons, gene banks, academc research
nsttutons, botechnology companes and the food and beverages ndustry.
Even when European countres have ABS-related nstruments n place,
these rarely nclude provsons that go beyond statng that beneit-sharng s a
desrable obectve to be acheved. Denmark, for nstance, adopted an ABS Act
ttled “Act on Sharng of Beneits arsng from the Utlzaton of Genetc
Resources,” but t contans no provsons ensurng that beneits are truly shared
wth provders. Moreover, the Act excludes beneit-sharng for the utlzaton
of tradtonal knowledge, as ts deinton for utlzaton does not encompass
Countres whch regulate access to ther own domestc genetc resources
have not always establshed clear beneit-sharng rules ether. In Greece, for
nstance, access to genetc resources s subect to a permt delvered by the
competent natonal authortes, but these permts contan no beneit-sharng
provsons, be t for utlzaton or trade of the resources. Lkewse, the Norwegan
Nature Dversty Act only ncludes the possblty to requre beneit-sharng for
the utlzaton of Norwegan genetc resources, wthout makng t mandatory.
Ths absence explans why the sharng of beneits for the exchange or the utl-
zaton of genetc resources currently tends to be self-regulated by the sector, for
better or for worse.
4 Compliance Mechanisms
Currently avalable complance mechansms appear as the weak spot of the
ABS regmes throughout the studed European countres. The adopton of a
common EU Regulaton focusng manly on user-measures s therefore a wel-
comed (and overdue) step n the rght drecton.
Some exceptons nonetheless exst. Denmark and Norway have both devel-
oped extensve user-measures, albet wth dferng approaches. The mport of
genetc resources for utlsaton n Norway from countres requrng access
consent s only allowed n accordance wth ths consent. The country also has
taken a strong poston n favour of the enforcement of the condtons set out
n such consents, by empowerng the State to brng legal acton on behalf of
the provder. The Norwegan Nature Dversty Act further mposes a seres of
nformaton requrements for users of genetc materal, whch bear some
resemblance to the due dlgence approach of the EU Regulaton on ABS. Users
have to keep nformaton regardng the provder, the country of orgn, and the
access consent, f relevant. Unlke n Norway, whch prohbts the import of
0002480457.INDD 373 3/25/2015 7:22:10 PM
llegal materal, Denmark prohbts the use of llegally acqured genetc
resources and/or tradtonal knowledge. Illegal materal, n ths case, s materal
acqured “n contraventon of the legslaton on access to genetc resourcesof
the country from whch they orgnate.” Interestngly enough, the choce
ofwords n ths ctaton may pont to an expansve nterpretaton of Artcle 15
of the Nagoya Protocol. Indeed, unlke Artcle 15 whch refers to the “regulatory
requrements of the other Party” (i.e. the provder country), the Dansh ABS
Act refers to the alleged country of orgn. Fnally, both countres regulate the
use of genetc resources orgnatng from countres whch have establshed
ABS-relevant legslaton or whch are Partes to the Protocol. What poston
they adopt vs-à-vs non-Partes to the Protocol remans unclear at ths stage.
As ndcated earler, the man ABS-related mplementaton measure taken
by European countres s the transposton of EU Drectve 9/44/EC, the
European Botechnology Drectve. In ts rectal 2, the Drectve calls for the
ncluson of nformaton on the country of orgn n patent applcaton
usngbologcal resources. As a drect consequence of the adopton of ths
Drectve, Belgum, Denmark, Germany and Norway have ntroduced a dsclo-
sure requrement n ther respectve patent systems, requrng the patent
applcaton usng bologcal materal to ndcate the country of orgn, f
known. Norway also requres the applcaton to menton whether Pror
Informed Consent was requred by the country of orgn, and has extended
both requrements to apply to applcatons for Plant Varety Protecton.
However, non-complance wth ths dsclosure requrement s unlkely to be
sanctoned, as the opportunty s generally provded to crcumvent the requre-
ment by declarng the country of orgn to be unknown. It should also be noted
that, although extensvely dscussed and then inally dropped n the negota-
tons, the nformaton dsclosure s not ncluded n the Protocol. Nonetheless,
for countres that do have the requrement n place, t may be used as an easly
mplementable and low-cost element of a broader Nagoya-complant montor-
The absence of user-complance measures has not kept some users of
genetc resources and tradtonal knowledge to take the lead n establshng
self-regulated complance measures. In Belgum, the Belgan Coordnated
Collecton of Mcro-organsms (BCCM) uses a voluntary code of conduct and
a standardzed Materal Transfer Agreement (MTA). Both these nstruments
are kept n lne wth the CBD, the TRIPS Agreement and other applcable
natonal and nternatonal laws. To access resources held by the BCCM, users
30 Dansh ABS Act, Sectons3 and 4. [For an n-depth overvew of the Dansh ABS Act see
0002480457.INDD 374 3/25/2015 7:22:10 PM
pror to startng usng the resources.In numerous European countres, botancal gardens have oned the Inter-
natonal Plant Exchange Network (IPEN), a network of botanc gardens that
organzes the exchange of lvng plant specmens. IPEN’s members have
adopted a code of conduct regardng access to genetc resources and beneit-
sharng. In lne wth the code, the gardens only accept plant materal that has
been acqured n accordance wth the provsons of the CBD. Materal can only
be suppled on the same terms under whch t was acqured, unless an “agree-
ment on the supply of lvng plant materal for non-commercal purposes leav-
ng the Internatonal Plant Exchange Network” s sgned by authorzed staf.
Some prvate botechnology companes also provde boprospectng gude-
lnes, such as BIO, the world’s largest botechnology assocaton, and the
Internatonal Federaton of Pharmaceutcal Manufacturers and Assocatons
(IFPMA).5 The Distribution of ABS-Related Competences in European Countries
It can be argued that recent evolutons n nternatonal envronmental law
have renforced the natonal enclosure of natural commons governed by
state soveregnty. However, the mplementaton of access and beneit-
sharng n Europe has largely taken the shape of a strongly decentralzed
approach. Power and competences are dstrbuted on a terrtoral scale,
allowng for natonal, sub-natonal and local power-levels to co-govern
genetc resources and tradtonal knowledge. Ths power s also shared
between publc and prvate actors, wth the transnatonal exchange of genetc
resources beng generally self-regulated by prvate actors, and wth the amb-
ton of strengthenng the rghts of ndgenous and local communtes to
determne the terms of access to ther tradtonal knowledge. Moreover,
alongsde ths vertcal dvson of powers, there s also a horzontal dvson:
ABS encompasses a large range of ssues extendng far beyond sole envron-
mental matters, ncludng market regulaton and access, nternatonal trade,
ndustral polcy, agrculture, health, development cooperaton, research &
31 [See contrbuton by Ptseys et al., to ths volume (Chapter 1)].
32 [For more examples see contrbuton by Olva to ths volume (Chapter 12)].
33 Peter H. Sand, “Soveregnty Bounded: Publc Trusteeshp for Common Pool Resources?”
Global Environmental Politics 4(2004): 4–1.
34 Coolsaet, Brendan; Dedeurwaerdere, Tom; Ptseys, John. 2013. “The Challenges for
Implementng the Nagoya Protocol n a Mult-Level Governance Context: Lessons from
the Belgan Case.” Resources 2, no. 4: 555–50.
0002480457.INDD 375 3/25/2015 7:22:10 PM
development and nnovaton. Ths secton compares the dferent nsttu-
tonal contexts of European Member States, n whch the Nagoya Protocol
wll be mplemented.
Two of our case studes are de jure federal states: Belgum and Germany. In
both these countres, the mplementaton of the Nagoya Protocol wll fall
under the competences of both the federal and federated enttes (n Belgum:
Regons and/or Communtes; n Germany: Länder). Nonetheless, the dv-
sonof ABS-related competences s dferent. In Germany, both the federal
Government and the Länder possess concurrent nature conservaton acts,
whch regulate access to and use of natural resources. In Belgum, the Regons
have full competences on overall envronmental polcy, wth the excepton of
some matters that have been reserved for the federal government and resdual
matters. Flowng from ths, the postons both countres take wth regard to the
competent natonal authorty (CNA) under the Nagoya Protocol also dfers.
Rodríguez and Holm-Mueller assume that Germany wll establsh a sngle
CNA, whle the Belgan authortes rather envsage four dferent authortes,
albet possbly wth a common access pont for users. Moreover, Belgum,
unlke Germany, has an addtonal layer of competences held by the language
Communtes: the Flemsh Communty, the German speakng Communty and
the Wallona-Brussels Federaton. These Communtes possess competences
on fundamental research and hgher educaton n Belgum, as well as the regu-
laton of researchers’ fundng and the management of research nsttutons, all
key aspects of ABS. Ths s further complexied by the fact that the Regons
and the federal government stay competent for research matters related to the
exercse of ther own competences.
Most of the others studed countres are untary states, wth more or less
devoluton to some sub-natonal enttes. Span forms a specal case, and could
be seen as a de facto federal state when t comes to envronmental protecton.
Whle the Spansh Consttuton grants exclusve competence on envronmen-
tal protecton to the natonal Government, ths s ncreasngly beng chal-
lenged by the Autonomous Communtes of the country. As such, n 2004,
these Communtes were devolved full competence over the management of
Natonal Parks found on ther terrtores. The specic mplementaton of ABS
and the choce of ntroducng PIC and MAT n Span, however, have to be taken
through a Royal Decree, whch can only be enacted by the natonal Government.
35 [See contrbuton by Rodríguez, Dross, and Holm-Mueller to ths volume (Chapter 4).]
3 Coolsaet Brendan, Dedeurwaerdere Tom, Ptseys John, and Batur Fulya (2013), Study for
the mplementaton n Belgum of the Nagoya Protocol on Access and Beneit-sharng to
the Conventon on Bologcal Dversty. Fnal Report, 21st of March 2013.
0002480457.INDD 376 3/25/2015 7:22:10 PM
In all our studed countres, a strong horzontal dvson of competences can
be observed. ABS-relevant competences are dstrbuted among many dferent
relevant admnstratve sectors, whch do not necessarly concde across
countres. In Greece, the management of access to bologcal materal for
research purposes, for nstance, s dferent dependng on the subect of the
research. Hence, the competent authorty n charge of grantng permts mght
be dferent from one access to the other, even when concernng the same
resources. France also envsages havng dferent competent authortes, but
dferentates the procedures by the type of resources beng accessed.
Accordng to the new Bodversty Law, the Mnstry of Agrculture, Agrfood,
and Forestry, the Mnstry of Ecology, Sustanable Development and Energy,
and the Mnstry of Socal Servces and Health wll all be responsble n the
near future for access to genetc resources under the Nagoya Protocol. In the
Netherlands, t s the Mnstry of Economc Afars whch co-ordnates
the mplementaton of the Conventon on Bologcal Dversty and the Nagoya
Protocol. The Mnstry also assumes the role of Competent Natonal Authorty
on ABS. Turkey has recently splt ts potental competent natonal authortes
on ABS, wth the Mnstry of Envronment managng the country’s protected
areas and the Mnstry ofForestry and Water Afars hostng the natonal focal
pont to the CBD. Asmlar stuaton can be found n Norway, where the
Mnstry of the Envronment ensures the functon of natonal focal pont on
ABS, but shares responsblty of the management of a new ABS permt system
wth the Fsheres Mnstry (hosted by the Mnstry of Commerce).
Some of the EU Member States n our subset of countres encompass over-
seas terrtores, (some of whch are not part of the EU) and have varyng legal
status, autonomy and potental ABS rules. The Dansh Realm, for nstance, con-
ssts of Denmark, the Faroe Islands and Greenland (the two latter are not part
of the Dansh membershp to the European Unon). The Consttuton apples
to all three parts of the Realm, but they have dferent approaches tomple-
mentng ABS. As ndcated earler, Denmark has chosen not torequre PIC but
adopted user legslaton. Greenland has done the exact opposte (PIC, but no
user legslaton), whle the Faroe Islands have no legslaton whatsoever regard-
ng ABS. France also has a consderable amount of overseas terrtores wth
dvergng rules. These terrtores are dvded nto overseas departments and
regons (DROM), on the one hand, and overseas collectvtes and terrtores
(COM), ncludng Clpperton Island, the French Southern and Antarctc Lands
and New Caledona, on the other. The former are subect to French law and are
part of the EU. They wll thus be subect to the same legslatve framework on
ABS as metropoltan France (i.e. the EU Regulaton on ABS and the French
Bodversty Law). The latter, wth a whole set of possble exceptons, wll not.
0002480457.INDD 377 3/25/2015 7:22:10 PM
It should be noted that some (parts) of these overseas terrtores, both DROM
and COM, already have local ABS regulaton n place.II The Future of ABS in Europe
1 The EU Regulation on ABS
On Aprl 1, 2014, followng an extensve tralogue wth the European Com-
msson and the European Parlament, the Councl adopted “Regulaton
N° 511/2014 of the European Parlament and of the Councl on complance
measures for users from the Nagoya Protocol on Access to Genetc Resources
and the Far and Equtable Sharng of Beneits Arsng from ther Utlzaton n
the Unon” (hereafter, the “EU Regulaton on ABS”).
As the ttle ndcates, the EU Regulaton focuses prmarly on user-
complance measures. In the explanatory memorandum of ts 2012 proposal for
a regulaton, the European Commsson usties ths approach by statng that
[harmonzng user complance] avods negatve efects on the nternal
market n nature-based products and servces that would result from a
fragmentaton of user-complance systems n the Member States and also
has the best performance as regards the creaton of an enablng context
for research and development on genetc resources wth beneits for the
conservaton and sustanable use of bologcal dversty worldwde.In dong so, the European Commsson seems to consder the regulaton as an
nstrument for the strengthenng of the nternal market and for the facltaton
of R&D, thereby appearng at odds wth ts own clam of legslatve compe-
tence on the bass of Artcle 192(1) of the Treaty on the Functonng of the
European Unon (the Unon’s envronment polcy competence). Ths approach
s further renforced by the EU Regulaton whch, wth the excepton of ts
Artcle 13(2), contans no provsons for conservaton and sustanable use of
3 [For an example of ABS regulatons n place n a French overseas terrtory, see contrbu-
et al., to ths volume (Chapter 11)].
3 European Commsson, proposal for a regulaton of the European Parlament and of
theCouncl on Access to Genetc Resources and the Far and Equtable Sharng of
BeneitsArsng from ther Utlzaton n the Unon, explanatory memorandum, p.
39 “The Commsson and Member States shall, as approprate, encourage users and provd-
ers to drect beneits from the utlsaton of genetc resources towards the conservaton of
0002480457.INDD 378 3/25/2015 7:22:10 PM
bodversty. However, ths irst step does not pre-empt the Commsson to take
addtonal legal measures for harmonzaton n later stages of mplementaton
of the Protocol f ths would be deemed approprate and necessary.
The Regulaton apples to genetc resources over whch States exercse sov-
eregn rghts and to assocated tradtonal knowledge that are accessed after
the entry nto force of the Nagoya Protocol. It thus only consders clams
wthn ths narrow temporal scope, whle the Protocol more generally, through
ts Artcle 3, apples to genetc resources wthn the scope of Artcle 15 of
theConventon and to assocated tradtonal knowledge wthn the scope
ofthe CBD. In other words, the Regulaton does not ill the legal vacuum
surroundng the utlzaton of resources and knowledge acqured before the
entry nto force of the Protocol.
In ths context, the man provson of the Regulaton s ts “oblgatons for
users.” It requres users to exercse “due-dlgence,” wth the am of ensurng
that genetc resources and assocated tradtonal knowledge have been
accessed and are beng utlzed n accordance wth regulatory requrements
and mutually agreed terms. Exercsng due dlgence has to be understood as
seekng, keepng and transferrng the “nternatonally recognzed certicate of
complance” to subsequent users. The nternatonal certicate s an access
permt delvered by the provder country, provdng evdence that genetc
resources have been accessed through pror nformed consent and that mutu-
ally agreed terms have been establshed for ther utlzaton. In case such a
certicate does not exst, the Regulaton lsts a seres of nformaton and rele-
vant documents to be sought, kept and transferred by users, ncludng the date
and place of ntal access, the descrpton of the resources, the source of access
and the prevous users, the relevant ABS-related rules, the access permt and
the mutually agreed terms.
Wth regard to montorng of user complance, the EU Regulaton estab-
lshes two checkponts: the recepton of research fundng and the “stage of
inal development” of a product before commercalsaton. The Regulaton
requres users to declare that they have fulilled the user oblgatons and con-
tacted the competent authortes to collect these declaratons. It s mportant
to note that the competent authortes referred to here are not the research
bologcal dversty and the sustanable use of ts components n accordance wth the
provsons of the Conventon.”
40 EU Regulaton on ABS, Artcle 2.
41 EU Regulaton on ABS, Artcle 4.
42 EU Regulaton on ABS, Artcle 3(11).
43 EU Regulaton on ABS, Artcle . The stage of inal development s descrbed n Rectal 25.
0002480457.INDD 379 3/25/2015 7:22:10 PM
fundng authortes or the market approval authortes, for nstance, but the
natonal competent ABS authortes under the Protocol, as descrbed above. As
these measures come on top of other admnstratve measures along the devel-
opment chan, users may face a double admnstratve burden. In ths book,
Godt argues ths s a mssed opportunty to adopt an ntegratve approach to
ABS, whereby ABS measures are ncluded wthn exstng procedures along the
development chan. Not only would ths lower the admnstratve burden of
both users and the state, t would also strongly mprove transparency of the
ow of genetc resources and/or tradtonal knowledge n the development of
a product. Moreover, such an ntegratve approach would also help to avod a
scenaro where due dlgence s only montored at a very advanced stage of the
development chan (e.g. before commercalsaton). Puttng the burden of
proof at the end of the development chan does not encourage early users
(whose products never make t to the commercalzaton stage) to acqure
genetc resources legally, ncreasng the legal uncertanty of end users.
Although only superically addressng ABS measures, a lmted example of
such an ntegratve approach can be found n Belgum. Alongsde the develop-
ment of a self-standng bodversty strategy, a plan of sectoral ntegraton of
bodversty was adopted n 2010. The plan lsts a number of actons to nte-
grate bodversty measures n exstng polcy sectors such as the economy, the
development cooperaton, the scence polcy and the transport sector.Followng the wordng of the Nagoya Protocol, the term “montorng” s
somewhat msleadng here. The accuracy of these declaratons s not checked
by the competent authorty. Montorng has to be understood as keepng
record of nformaton related to the utlzaton of genetc resources and/or
assocated tradtonal knowledge. Checks are however regulated by Artcle 9
of the Regulaton. Competent authortes wll verfy user complance when
possessng nformaton regardng user’s non-complance, followng a perod-
cally revewed plan, and/or through on on-the-spot checks. However, wth the
excepton of the irst scenaro, competent authortes “wll not know who ut-
lzes genetc resources n the irst place,” gven that no nformaton transfer
are establshed between relevant ABS and non-ABS authortes. Ths s a sg-
nicant dference from exstng due dlgence processes n the EU, whch
44 [See contrbuton by Godt to ths volume (Chapter 13)].
45Study to Analyze Legal and Economic Aspects of Implementing the
Nagoya Protocol on ABS in the European Union (Brussels/London, 2012).
4 [See contrbuton by Ptseys et al., to ths volume (Chapter 1)].
4 EU Regulaton on ABS, Artcle .
4 [See contrbuton by Godt to ths volume (Chapter 13)].
0002480457.INDD 380 3/25/2015 7:22:10 PM
nclude genune montorng and/or certicaton schemes. In the regulaton
of tmber, for nstance, thrd-party montorng organzaton are created to
verfy proper use of the due dlgence system and to dentfy cases of non-
complance. These organzatons can trace the use of tmber product along the
supply chan and keep llegally harvested tmber from enterng t. Wth ts
focus on downstream use, the EU Regulaton on ABS does not allow dong ths
for the utlzaton of genetc resources, nor does t envsage the creaton of
ndependent thrd-party vericaton.
The patentng stage of development as a possble checkpont s notably
absent n the Regulaton, as t could have been an opportunty to extend the
scope of EU Drectve 9/44/EC on botechnologcal nventons and make the
dsclosure requrement bndng and complant wth the Nagoya Protocol. EU
Drectve 9/44/EC calls upon Member States to nclude nformaton on the
geographcal orgn of bologcal materal used n patent applcaton. It would
also have been consstent wth the EU poston at WIPO, where t ntally sup-
ported bndng dsclosure requrements of the country of orgn of genetc
resources and assocated tradtonal knowledge n patent applcatons. The
absence of the patent stage as a potental checkpont s also problematc n
lght of recent research showng a steadly ncreasng trend of patent actvty
nvolvng genetc resources and assocated tradtonal knowledge.The ssue of tradtonal knowledge assocated wth genetc resources s
barely addressed n the Regulaton. The Regulaton does not attend to the dei-
ntonal gap on tradtonal knowledge, but crcumvents the ssues by statng
that tradtonal knowledge assocated wth genetc resources s to be deined n
the mutually agreed terms. Ths approach s problematc for dferent reasons.
49 [See contrbutons by Olva to ths volume (Chapter 12)].
51 Drectve 9/44/EC of the European Parlament and of the Councl of July 199 on the
legal protecton of botechnologcal nventons.
52 See the letter dated 11 May 2005 by the Permanent Delegaton of the European Commsson
to the Internatonal Organzatons n Geneva addressed to WIPO’s Intergovernmental
Swtzerland, 2005. Avalable onlne: http://www.wpo.nt/edocs/mdocs/tk/en/wpo
_grtkf_c_/wpo_grtkf_c__11.pdf (accessed on 15 June 2013).
53 Paul Oldham, Stephen Hall and Oscar Forero, “Bologcal Dversty n the Patent System,”
PLoS ONEOne World
0002480457.INDD 381 3/25/2015 7:22:10 PM
beneit-sharng agreement and wll thus be dferent from one agreement to
the other. Accessng the same tradtonal knowledge at dferent ponts n tme,
or through dferent provders, may thus possbly produce a changng dein-
ton, a soluton whch wll hardly mprove legal certanty. Yet, n ts rectals, the
Regulaton nonetheless ndcates that relyng on such a dynamc approach
allows ensurng exblty and legal certanty for provders and users. Second,
ths approach de facto excludes tradtonal knowledge whch has been accessed
wthout a beneit-sharng agreement. Ths can be the case, for example, for
“publcly avalable tradtonal knowledge,” whch was acqured before the
entry nto force of the CBD and the Nagoya Protocol. In other words,
“[w]here there s no contract for access to tradtonal knowledge, […] European
law would therefore provde no protecton aganst bopracy.”Ths problem s further amplied by the fact that, at varous occasons, the
Regulaton seems to envsage stuatons where the mutually agreed terms (or
ts provsons) related to genetc resources may be unnecessary or even
“rrelevant.” Examples are Artcle 4.2 and Artcle 5.3(c). The former ndcates
that genetc resources and tradtonal knowledge may only be utlzed n accor-
dance wth MAT “if they are required by applcable legslaton.” The latter
states that regstered collectons must provde genetc resources for ther utl-
zaton only wth evdence of lawful acquston and, “where relevant, wth
mutually agreed terms.” However, havng regard to Artcle 5.1 of the Nagoya
Protocol, for Partes to the Protocol, t s unclear under whch crcumstances
mutually agreed terms would not be requred or prove to be rrelevant. Unlke
other provsons of the Protocol, Artcle 5.1 does not contan the usual deblta-
tve qualiers (e.g. “where applcable”) and thus consttutes a clear “oblgaton
of means.” Such a provson requres “the adopton of a partcular course of
conduct” (i.e. beneit-sharng upon MAT) whch s “not characterzed by ts
54Optons for ex-stu Collectons n Academc Research,” n Global Governance of Genetic
Resources. Access and benet sharing after the Nagoya Protocol, edted by Sebastan
55 Brendan Tobn, “Bopracy by Law: European Unon Draft Law Threatens Indgenous
Intellectual Property Review 3 (2) (2014): 12.
5 EU Regulaton on ABS Artcles 4.2 and 5.3(c).
5 EU Regulaton on ABS Artcle 4.2, emphass added.
5 EU Regulaton on ABS Artcle 5.3(c), emphass added.
59 Perre-Mare Dupuy, “Revewng the Dicultes of Codicaton: On Ago’s Classicaton of
Oblgatons of Means and Oblgatons of Result n Relaton to State Responsblty,”
European Journal of International Law 10 (1999): 31–35.
0002480457.INDD 382 3/25/2015 7:22:10 PM
exblty but, on the contrary, by the strct legal determnaton of ts content.”
In other words, for the utlzaton of genetc resources accessed after the entry
nto force of the Protocol, beneit-sharng upon mutually agreed terms wll
always be relevant. Ths oblgaton s further renforced by Artcle 5.3 of the
Protocol, whch stresses that “each Party shall take legslatve, admnstratve
or polcy measures” to mplement beneit-sharng upon MAT. Hence the obl-
gaton “extends not only to countres provdng access to genetc resources but
also to [Partes to the Protocol] where bodversty-based research, develop-
ment, and commercalzaton usually take place” (i.e. user countres).Fnally, t s mportant to note that the Regulaton does not encompass spe-
cic sanctons or penaltes related to non-complance wth the oblgatons
ofusers and the montorng requrements. Both the ntal proposal by the
European Commsson and the amended verson by the Envronmental
Commttee of the European Parlament ncluded examples of penaltes such
as ines, suspenson of utlzaton and coniscaton of llegally acqured genetc
resources, but these were not sustaned n the inal verson. The EU thus
leaves the responsblty of sanctonng non-complance to the Member-States.
As n the Nagoya Protocol, t only calls upon Member States to establsh “efec-
tve, proportonate and dssuasve” penaltes applcable to nfrngements.2 The Role of Non-State Actors
Important responsblty s left by the EU Regulaton on ABS to non-state
actors, through self-regulaton and voluntary provsons, especally on the pro-
vder sde. As such, the Regulaton ams to establsh a lst of regstered ex situ
collectons whch restrct “the supply of samples of genetc resources to thrd
persons wth documentaton provdng evdence of legal access.” The obec-
tve of ths measure s to reduce the rsk of the utlzaton of llegally acqured
genetc resources n the Unon. Users accessng genetc resources from a regs-
tered collecton wll be consdered to have exercsed due dlgence, a measure
whch s lkely to lower the admnstratve burden. However, t s unlkely that
all the collectons wll have the capactes (and/or funds) to onng the lst.
1 Thomas Greber et al., An Explanatory Guide to the Nagoya Protocol on Access and Benet-
sharing (Gland, Swtzerland: IUCN, 2012): .
2 See Artcle 11 of the ntal proposal COM(2012) 5 and Amendments 2 and 3 n the
Draft Report by the Commttee on the Envronment, Publc Health and Food Safety on
the proposal for a regulaton, publshed on May , 2013.
3 EU Regulaton on ABS Artcle 11. The Regulaton does not deine the terms “efectve, pro-
portonate and dssuasve.”
4 EU Regulaton on ABS, rectal (2).
0002480457.INDD 383 3/25/2015 7:22:10 PM
Moreover, as stressed prevously, the Regulaton does not provde a soluton for
the utlzaton of the numerous resources acqured by European collectons
(whch wll potentally become regstered collectons) before the entry nto
force of the Protocol. Wll a user be allowed to utlze pre-Nagoya resources
provded by a collecton? Wll the acquston of such resources from a regs-
tered collecton be consdered as exercsng due dlgence? What are the rules
surroundng the utlzaton of genetc resources for whch a regstered collec-
ton has no nformaton and relevant documents on PIC and MAT? And what
happens wth resources whch have been accessed long before the entry nto
force of the CBD? All these questons reman unanswered wth the Regulaton,
thereby creatng legal uncertanty for users and collectons alke.
Non-state actors are also solcted for the development of codes of conduct
and best practces, as called for n Artcle 20 of the Nagoya Protocol. To ths
efect, the Regulaton ntroduces the concept of “assocatons of users.” They
represent the nterests of users and are responsble for developng and over-
seeng best practces. These practces are deined as a combnaton of proce-
dures, tools and/or mechansms enablng users to comply wth the EU
Regulaton, whch are to be recognzed by the European Commsson. It s an
opportunty to buld upon practces whch are already beng used by European
actors, especally by ex situ collectons. Throughout the chapters of the book,
authors have stressed the mportance of exstng nstruments. In most of the
studed countres, sem-publc or prvate ex situ collectons rely upon some
form of standardzaton of contractual clauses and procedures for collectng,
accessng and exchangng genetc resources, whch are complant wth the
provsons of the Protocol. Examples n ths book nclude the InternatonalPlant
Exchange Network (IPEN), the nternatonal Mcro-organsms Sustanable
Useand Access Regulaton Internatonal Code of Conduct (MOSAICC), the
European Culture Collecton Organsaton (ECCO).
Oically recognzng these nstruments as best practces wll hopefully
allow addressng the strong heterogenety of uses and nterests wth the Nagoya
Protocol among non-state actors. And voluntary norms have proved useful to
mprove, strengthen and complement exstng procedures and publc polcy n
other sustanablty sectors such as polluton control, food qualty montorng,
natural resources management and the reducton of carbon emssons.
However, questons reman as to how successful and efectve voluntarly mea-
sures wll be n the ABS context. Wthout an overarchng nsttutonalsaton of
5 [For a more n-depth overvew of prvate norms n envronmental governance see contr-
buton by Olva to ths volume (Chapter 12)].
0002480457.INDD 384 3/25/2015 7:22:10 PM
the obectves to be met through the mplementaton of the Nagoya Protocol,
wthout at least agreeng on the underlyng prncples governng the respons-
bltes of the prvate actors, and wthout an efectve follow-up and montor-
ng system, voluntary measures may not be suicent to generate convergence
of the nterests of the dferent actors nvolved n the transacton. Moreover, as
noted by Maggon et al., due to the scope of the EU Regulaton on ABS,
potental recognton of best practces under Regulaton would only apply to
the utlzaton actvtes of ex situ collectons. Collectng msson and access
procedures wll be left to the dscreton of member states, and are thus unlkely
to be smplied and/or standardzed any tme soon, despte what the above
mentoned ntatves have been tryng to acheve.
In 2010, 1 years after the entry nto force of the CBD, the Nagoya Protocol was
adopted by the 10th Conference of the Partes to the CBD. The Protocol provdes
a long overdue legal framework to protect the soveregn rghts of countres on
ther genetc resources and the rghts of ndgenous and local communtes over
ther tradtonal knowledge, as nsttuted by the CBD. Between 1993 and 2010,
some Partes to the CBD have establshed ABS-related rules n ther legal sys-
tems. The EU, however, although beng one of the maor users of genetc
resources and tradtonal knowledge n the world, was laggng behnd.
Wth the adopton of the EU Regulaton on ABS n 2014, and the decson to
ratfy the Nagoya Protocol, the EU has set a decsve step n the rght drecton
towards takng ts responsblty on ABS. Ths Regulaton closes a chapter of the
ABS saga, and starts a new one. As we have seen n ths book, much remans to
be done for Europe to have a functonng, efectve and stable ABS regme.
Tellngly, wth the excepton of Denmark, the most advanced ABS framework n
Western-Europe addressed n ths book, s found n a country whch s not a EU
member state (Norway). On user measures, as f they had been watng for n-
tatves comng from the European Unon, member states’ acton on ABS has
been broadly lmted to the transposton of the European Botechnology
Brendan Coolsaet, Tom Dedeurwaerdere and John Ptseys, “The Challenges for Imple-
mentng the Nagoya Protocol n a Mult-Level Governance Context: Lessons from the
Belgan Case,” Resources 2 (2013): 555–50.
et al., “Governance Optons for ex-stu Collectons n Academc
[See contrbuton by Maggon et al., to ths volume (Chapter 14)].
0002480457.INDD 385 3/25/2015 7:22:10 PM
Drectve. On the access sde, Denmark and the Netherlands are the only EU
countres havng specied the condtons for access to ther genetc resources.
Whle the EU has lad the groundwork for an EU-harmonzed approach on (user-
measures for) ABS, whch s to be complemented wth exstng measures, ths
book llustrates that currently exstng rules, both publc and prvate, strongly
dfer n terms of depth, scope and efectveness as well as across dferent types
of users. Furthermore, we have seen that access and utlzaton of genetc mate-
ral s already (drectly or ndrectly) regulated by prvate and publc law prov-
sons–f not by specic ABS laws. Ths s not to say that these exstng rules are
complant wth access and utlzaton under the Nagoya Protocol, nor that they
wll be suicent for an efectve mplementaton of the Protocol. These exstng
nstruments wll, however, mpact or be mpacted by a harmonzaton at EU
level. Ths stuaton s further complcated by the pluralty of poltcal structures
and the very broad dvson of competences wthn member states, as well as by
ther dferent nterests wth the Nagoya Protocol (user, provder or both).
Dferent legal processes are currently under way n Europe, and wll gve
rse to natonal Nagoya-complant ABS regmes. However, the mnmal
approach adopted by the EU Regulaton already generates very dferent
nterpretatons and mplementaton approaches n Europe. Moreover, as t
stands today, the due dlgence approach of the EU s lackng some basc
features to guarantee ts efectveness. Examples dscussed n ths book nclude
the ambgutes concernng the temporal scope, the lack of ndependent mon-
torng provsons, the postonng of the man burden of proof at the end of
the development chan, the heavy relance on prvate standards and voluntary
measures, the absence of nformaton exchange between exstng product
development processes and future ABS authortes, the weak language wth
regard to the applcablty of the mutually agreed terms and the nablty to
efectvely protect the tradtonal knowledge of ndgenous peoples.
An efectve ABS regme s one that prevents llegal use of genetc resources
and tradtonal knowledge and ensures genune beneit-sharng arrangements.
Falng to mplement such a regme n Europe wll generate restrctve cond-
tons for access to genetc resources and/or assocated tradtonal knowledge
n provder countres. Ths would not only have mportant consequences for
the European botechnology sector, but would also threaten the nternatonal
envronmental ustce obectves nsttuted by the Nagoya Protocol. It would
also undermne the global eforts to conserve and sustanably use bodversty,
the irst two obectves of the CBD, thereby eopardzng the legtmacy of the
European Unon as a global envronmental leader.
9 European Drectve on the Legal Protecton of Botechnologcal Inventons (Drectve
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