Volume 31 Number 5 May 2014 Pages 607-696 Natural P r od u c t Reports www.rsc.org/npr Ctnenojyfiora » L aéC a. 2 0 1 4 ISSN 0 2 6 5 - 0 5 6 8 ROYAL SOCIETY CHEMISTRY VIEWPOINT Laura E. Lalller e t al. Access to and use o f m arine g e n e tic resources: understanding th e legal fra m e w o rk W 1^ NPR ROYAL ROYA SOCIETY OF CHEMISTRY CI VIEW POINT Access to and use of marine genetic resources: understanding the legal fram ew orkf Cite this: Nat Prod. Rep., 2014, 31, 612 Laura E. Lallier,*3 O o n a g h M cM eel,3 T h o m a s G reiber,b T h o m a s V a n ag t,3 Alan D. W. D o b s o n c a n d Marcel J a s p a r s d W ith t h e a d o p t i o n o f t h e N a g o y a P r o t o c o l in 2 0 1 0 , a n a d d i t i o n a l le g a l i n s t r u m e n t u n d e r t h e C o n v e n t i o n o n B i o l o g i c a l D iv e rs it y (199 2), t h e le g a l l a n d s c a p e s u r r o u n d i n g t h e a c c e s s t o a n d u til i z a t i o n o f g e n e t i c r e s o u r c e s will c h a n g e . T h i s is likely t o i m p a c t w o r k i n g p r o c e d u r e s f o r s c i e n t i s t s , t u r n i n g p r e - e x i s t i n g Received 18th November 2013 e t h i c s i n t o le g a l o b l i g a t i o n s . T h e a i m o f th is a r t i c l e is t o i n f o r m s c i e n t i s t s o n t h e g l o b a l a c c e s s a n d b e n e f i t - s h a r i n g f r a m e w o r k w h i c h h a s b e e n s e t b y t h e C o n v e n t i o n o n B io l o g i c a l D iv e rs it y a n d its N a g o y a DOI: 10.1039/c3np70123a www.rsc.org/npr 1 P ro to c o l , fo c u s in g specifically o n th e ir a p p lic atio n t o m a rin e g e n e t ic r e s o u r c e s fo r w h ic h t h e U nited N a t i o n s C o n v e n t i o n o n t h e L a w o f t h e S e a (1982) a l s o h a s r e l e v a n c e . Introduction M arine biodiscovery d e p e n d s u p o n access to m a rin e o rg an ism s, collectively te rm e d m a rin e g en etic re so u rc e s (MGR). S cientists, fa m ilia r w ith th e p o te n tia l ch allen g es o f c o llectin g MGR sam p les in th e m a rin e en v iro n m e n t, are o fte n less aw are o f th e legal a n d policy fram ew orks go v ern in g access to MGR. T he C o n v en tio n o n B iological D iversity (CBD)1 a n d its N agoya P rotocol o n Access to G enetic R esources a n d th e F air a n d E q u itab le S h arin g o f B ene­ fits A rising fro m th e ir U tilizatio n (Nagoya P rotocol),2 as w ell as th e U n ited N atio n s C o n v en tio n o n th e Law o f th e Sea (UNCLOS)3 are o f p a rtic u la r relevance in th is reg ard . T h is article w ill c o n sid e r th e CBD a n d its N agoya P ro to co l, as w ell as th e UNCLOS a n d ex am in e h o w th e se legal fram ew o rk s im p a c t m a rin e scientific re se a rc h , d e p e n d in g o n th e a re a s in w h ic h th e MGR are co llected a n d o n th e p u rp o se o f th e re search . F u rth e r it w ill pro v id e a clea r overview o f th e m e c h a ­ n is m s in place a n d th e step s w h ic h n e e d to b e ta k e n in o rd e r to com ply w ith th e s e rules. 1.1 The C onvention on Biological Diversity and th e Nagoya Protocol T he CBD, w h ic h e n te re d in to force in 1993, a d d re s se s b io d i­ versity irrespective o f w h e th e r it is te rre stria l o r a q u a tic in aeCOAST Marine Research, Esplanadestraat 1, 8400 Ostend, Belgium. E-mail: info@ ecoast.be bIUCN Environmental Law Centre, Godesberger Allee 108-112, D-53175 Bonn, Germany cEnvironmental Research Institute, University College Cork, Cork, Ireland. E-mail: a. dobson@ucc. ie dMarine Biodiscovery Centre, Dept, o f Chemistry, University o f Aberdeen, Old Aberdeen, AB24 3UE, UK f Electronic supplementary inform ation (ESI) available: Authors’ biographies. See DOI: 10.1039/c3np70123a 612 I Nat. Prod. Rep., 2014, 31, 612-616 o rig in . It h a s th re e m a in objectives: th e c o n se rv a tio n o f b io d i­ versity, th e s u s ta in a b le u se o f its c o m p o n e n ts a n d , w hile d e c la rin g th e sovereignty o f sta te s over th e ir n a tu ra l reso u rces (article 3), it e n c o u ra g e s th e c re a tio n o f access a n d benefits h a rin g (ABS) m e c h a n ism s w h e n it co m e s to th e ex p lo itatio n o r u tiliz a tio n o f g e n e tic reso u rce s (art. 1 & 15). T h is la s t objective w as d ev ised to sh a re th e co sts a s w ell as th e b e n e fits o f b io d i­ versity c o n se rv atio n b e tw e en dev elo p ed a n d d ev elo p in g c o u n ­ trie s. W h ilst ABS d isc u ssio n s are o fte n lim ite d to q u e stio n s a ro u n d th e s h a rin g o f m o n e ta ry b e n e fits fro m re s e a rc h a n d d ev elo p m e n t, it sh o u ld be rec o g n ized th a t b iodiscovery rarely re su lts in lucrative p a te n ts a n d p ro d u c ts. T h u s, n o n -m o n e ta ry b e n e fits m u s t also b e co n sid e re d . F u rth e rm o re , th e objective o f ABS is b ro a d e r th a n p ro m o tin g th e s h a rin g o f th e b en efits g a in e d fro m th e u se o f g e n e tic m a te ria l. ABS is also a b o u t fa c ilita tin g access to g e n e tic re so u rc es (ref. 14 p. 28). T h is is p artly w hy th e C o n feren ce o f th e P artie s to th e CBD a d o p te d th e N agoya P ro to co l in 2010, w h ic h is a n a d d itio n a l a g re e m e n t to th e C o n v e n tio n th a t is ex p ected to e n te r in to force in 2014. It fu rth e r e la b o ra te s th e CBD's ABS m e c h a n is m a n d p ro m o te s th e d e v e lo p m e n t o f w o rldw ide ABS fram ew o rk s w h ich w ill e n a b le sta k e h o ld e rs to b e tte r u n d e rs ta n d a n d com ply w ith n a tio n a l ABS p ro c e d u re s. In a d d itio n , th e P ro to col clarifies so m e a sp e cts o f th e CBD, expressly in c lu d in g b io ch em ical c o m p o u n d s w ith in th e scope o f th e fram ew o rk a n d p ro v id in g ex am p les o f b o th m o n e ta ry a n d n o n -m o n e ta ry b e n e fits in its ann ex . 1.2 The U nited N ation s C onvention o n th e Law o f the Sea B ecause it h a s evolved th r o u g h c e n tu rie s o f tra d itio n s a n d c u sto m a ry ru le s im p licitly a c c e p te d a n d m o re o r less effectively im p le m e n te d by th e v ario u s m a ritim e acto rs, th e law o f th e sea is a stro n g ly ro o te d a n d p a rtic u la r field o f law. T he UNCLOS w as a d o p te d in 1982 (e n te re d in to force in 1994), a n d c a n be This journal is © T h e Royal Society of C hem istty 2014 Viewpoint NPR d e sc rib e d as a co d ifica tio n o f th e se c u sto m a ry ru les, w ith som e novel a d d itio n s . In its sim p le st te rm s, th e UNCLOS is a g lo b al a n d g e n e ra l fram ew o rk se ttin g th e b o u n d a rie s o f sta te s' ju r is ­ d ic tio n a n d re g u la tin g th e activ ities ta k in g place th e re, in c lu d in g m a rin e scien tific re se a rc h (MSR). A lth o u g h it do es n o t refer explicitly to g e n e tic re so u rce s, it d o es a d d re s s ‘liv in g ’, ‘n a tu r a l’ o r ‘b io lo g ical’ reso u rc e s in te rm s o f co n serv atio n , ex p lo itatio n a n d re s e a rc h (ref. 4 p. 150). T h erefo re a sta te th a t re g u lates MSR in its w ate rs m ay im p o se c e rta in access re s tric ­ tio n s to th e MGR w ith in its ju risd ic tio n . □QDGDOO^ CZJ cu <y It is im p o rta n t th a t sc ie n tists are aw are o f th e d is tin c t reg im es g o v ern in g access to MGR u n d e r b o th th e CBD a n d its N agoya P rotocol o n th e o n e h a n d , a n d u n d e r th e UNCLOS o n th e o th e r h a n d . C o m p lian ce w ith th e p ro v isio n s a state m ay have in place u n d e r th e UNCLOS d o es n o t e n su re co m p lian c e w ith n a tio n a l ABS reg im e u n d e r th e CBD a n d its N agoya Proto col, a n d vice versa. OSES 2 Global co m m o n m echanism of ABS: a harmonized international framework Fig. 1 As m e n tio n e d previously, w h e n th e N agoya P ro to co l e n te rs in to force all state p a rtie s w ill b e ex p ected to have a n a tio n a l reg im e w h ic h m e e ts g lo b al s ta n d a rd s , th ere b y e n a b lin g u se rs to k n o w w h a t to expect w h en ev e r th e y w ish to access a n d u tilize MGR. T he P ro to co l's m e c h a n is m (Fig. 1) w ill im p a c t b io p ro sp e c tin g activities in d e p e n d e n tly o f th e w ay sa m p le s a re initially ac q u ire d . W h e n th e g e n e tic m a te ria l is ac c e sse d fro m a n 'ex situ ’ co llection, i.e. a b io rep o sito ry , th e n th e access p ro v isio n s o f th e CBD a n d th e N agoya P ro to co l apply. If, how ever, th e g en etic m a te ria l is accessed 'in situ ’ via a sa m p lin g e x p e d itio n th e n th e UNCLOS p ro v isio n s re g a rd in g MSR w ill also apply. P rio r to c o n sid e rin g th e m a ritim e specificities, it is first im p o rta n t to u n d e rs ta n d th e ABS m e c h a n ism . As th e N agoya P ro to co l fu rth e r e la b o ra te s th e CBD's ABS p ro v isio n s, th e follow ing ex p la n a tio n s w ill m ain ly fo cu s o n th e P ro to co l a n d n o t o n th e C o n v en tio n . 2.1 Prior inform ed co n sen t and m utually agreed term s T he ABS reg im e o f th e N agoya P ro to co l is b a se d o n th e n e g o ­ tia tio n o f m u tu a lly a g re ed te rm s (MAT) in o rd e r to be g ra n te d access by th e p rio r in fo rm e d c o n s e n t (PIC) o f th e p ro v id in g state (art. 5 & 6). In d e e d , th e a p p lic a n t fo r PIC - th e fu tu re u se r - m u s t first com p ly w ith th e d o m estic ABS re q u ire m e n ts by n e g o tia tin g MAT, w h ic h in c lu d e s issu e s su c h a s access c o n d itio n s, m a te ria l tra n s fe r rig h ts a n d b e n e fit-sh a rin g a g re e m e n ts w ith th e p ro v id er (Fig. 1). O ften th e first p o in t o f c o n ta c t in a p ro v id in g c o u n try is a p a rtn e r in s titu tio n to th e u se r o r to th e re se a rc h p ro ject. B oth th e CBD a n d th e P ro to co l e n co u ra g e th e p a rtic i­ p a tio n o f n a tio n a ls fro m th e p ro v id e r c o u n try o n a fo reig n re s e a rc h p ro ject. T he c o n te n t o f MAT h a s to be g u id e d by d o m e stic m e a s u re s, w h ic h m ay re q u ire so m e specific asp ects. T he m o s t p ro b a b le a n d c o m m o n re q u ire m e n ts th a t c a n be expected are p ro v id ed a s ex am p les by th e P ro to co l (art. 6) a n d in clu d e: te rm s o n b e n e fit-sh a rin g , te rm s o n th ird p a rty use, a n d te rm s o n th e c h an g e o f in te n t. This journal is © T h e Royal Society of C h em istty 2014 ABS F r a m e w o r k in t h e N a g o y a P r o t o c o l . S o u r c e : F a c t s h e e t o n A c c e s s a n d B ene fit-S ha ring, S e c re ta ria t o f t h e C o n v e n t io n o n Bio­ l o g ic a l D ivers ity , 2 0 1 1 . 15 2.1.1 Subsequent third-party transfer. S u b se q u e n t th ird p a rty tra n s fe r is a key ch a lle n g e o f th e n e g o tia tio n p ro cess, th a t is th e fu tu re tra n sfe r o f th e co llected m a te ria l a n d /o r asso c ia te d k n ow ledge to a th ird p arty in te re ste d in th e u tiliz a tio n o f su c h m aterial/k n o w led g e, b u t n o t involved in th e o rig in al n e g o tia ­ tio n o f MAT. G iven th e n a tu re o f th e bio d isco v ery p ip elin e, w h ic h m ay in c lu d e m u ltip le sta k e h o ld e rs,5 it is c ru cial to set clear te rm s o n s u b s e q u e n t tra n sfe rs fro m th e o n set. In th is resp ect, th e co a stal sta te c a n e ith e r ch o o se n o t to legislate, leav in g th e n e g o tia tio n s free, o r it c a n reg u la te it, e.g. by im p o sin g a c o m e b a c k clau se th a t w o u ld o blige th e u se r to seek th e c o n se n t o f th e so u rce c o u n try a u th o ritie s fo r e ach n ew tra n sfe r. M o n ito rin g th e u tiliz a tio n o f th e g en e tic reso u rces is in d e e d im p o rta n t fo r ABS im p le m e n ta tio n . 2.1.2 B enefit-sharing. T h e b e n e fit-s h a rin g a s p e c ts o f MAT a re c e n tra l to th e n e g o tia tin g p ro c e s s. As m e n tio n e d b e fo re, b e n e fit-s h a rin g d o e s n o t o n ly im p ly m o n e ta ry b e n e fits (su c h a s p a y m e n ts o f ro y a lties), a n d in d e e d in m o s t c a se s th e m a in b e n e fits w ill b e n o n -m o n e ta ry . A nnex I o f th e P ro to c o l p ro v id e s e x a m p le s o f v a rio u s ty p es o f b e n e fits, a n d it is e m p h a s iz e d th a t b e n e fits s h o u ld a s m u c h a s p o ss ib le be d ire c te d to w a rd s th e c o n s e rv a tio n a n d s u s ta in a b le u se o f b io d iv e rsity (a rt. 9). T h e s h a r in g o f re s u lts , p a rtic ip a tio n o f n a tio n a ls in p ro d u c t d e v e lo p m e n t, c o n tr ib u tio n s to e d u c a tio n a n d tr a in in g in th e p ro v id in g c o u n try , te c h n o lo g y a n d c a p a c ity tr a n s fe r a re so m e o f th e m o s t c o m m o n b e n e fits c u rre n tly fo u n d in MAT. P a rtn e rs h ip s a n d c o n tra c ts hav e lo n g b e e n c u s to m a ry p ra c tic e in th is re s p e c t, a n d c a n g e n e ra lly b e c o n s id e re d a s b e s t p ra c tic e fo r fu tu re b e n e fit-s h a rin g a g re e m e n ts .6’7 Nat. Prod. Rep., 2014, 31, 612-616 | 613 NPR Viewpoint 2.1.3 Change o f in ten t. T h e b iodiscovery p ro ce ss is a c o n tin u u m w h ich o fte n b e g in s w ith acce ssin g MGR fo r b asic re se a rc h p u rp o s e s b u t m ay evolve in to a co m m ercially driven p ro cess via a n ap p lie d re se a rc h p h a se . D e lin e a tin g e ac h o f th ese p h a se s c a n be difficult, how ever, id en tify in g th e c h a n g e o f in te n t is also a n im p o rta n t a sp e c t o f MAT a n d m u s t b e c o n sid e re d . In th is reg ard , a tw o p h a se a p p ro a c h m ay be re c o m m e n d e d , as ap p licab le: firstly n e g o tia tin g MAT a s a ‘b asic re se a rc h ag ree­ m e n t’ w ith th e p o ssib ility to seco n d ly re n e g o tia te a ‘co m m e rc ia l d ev elo p m en t a g re e m e n t’ w h e n th ere is a c h a n g e o f in te n t d u e to a n ew co m m ercial in te re st a ris in g fro m th e re se a rc h , a n d n o t only b ecau se a p a te n t w as o b ta in e d o n a p ro d u c t.6 In d e ed , b ecau se c e rta in p a te n ts d o n o t n e cessarily e n ta il co m m e rc ia l co n seq u en ces, th e g ra n tin g o f su c h p a te n ts m ay n o t have any effect o n th e o rig in al b io p ro sp e c tin g p e rm it if th e o rig in a l MAT w ere n e g o tia te d to p rovide fo r su c h a situ a tio n . 2.2 C om pliance requirem ents d e p e n d s o n th e p ro v id er c o u n try 's legal a n d in s titu tio n a l set-up. C o n sid e rin g MGR th e s itu a tio n w ith re g ard to th e CNA m ay a g a in differ. F or exam p le, in S o u th Africa, th e CNA fo r te rre stria l b io p ro sp e c tin g is th e D e p a rtm e n t o f E n v iro n m e n ta l Affairs, b u t for MGR th e O cean s a n d C o asts b ra n c h is c o m p e te n t,9 w hile in N orw ay it is th e M in istry o f F ish e rie s.10 R e tu rn in g to th e p o te n tia l o verlap b etw e e n th e UNCLOS a n d th e CBD fram ew o rk s, w h ere a sta te h a s im p le m e n te d m e a s u re s w ith re sp e c t to b o th , it is im p o rta n t to n o te th a t d is tin c t n a tio n a l a u th o ritie s m ig h t b e c o m p e te n t for d iffe re n t asp e c ts o f th e sam e activity. T h e o n u s is o n th e re se a rc h e rs to e n su re th a t th ey have c o n ta c te d all rele v a n t a u th o ritie s a n d e sta b lish e d th e p ro c e d u re s w h ic h th ey m ay b e re q u ire d to follow in o rd e r to access MGR. 3 The UNCLOS and the Nagoya Protocol: overlapping frameworks for the collection of sam ples on site T he n e g o tia tio n o f cle a r a n d legally c e rta in MAT stro n g ly T he p ro v isio n s o f th e CBD a n d its N agoya P ro to col apply to in flu en ce th e d e c isio n s o f c o m p e te n t n a tio n a l a u th o ritie s o n b io d iv ersity a c c essed w ith in th e n a tio n a l ju ris d ic tio n o f co astal w h e th e r to g ra n t PIC to a c ce ssin g MGR. T he c o m p e te n t a u th o rity is th e a d m in is tra tio n a p p o in te d by th e state to offi­ sta te s. Since th e UNCLOS g ra n ts ju ris d ic tio n to co a stal sta te s u p to 350 n a u tic a l m ile s (nm ) fro m th e b a se lin e s, th e N agoya cially approve th e p a rtn e rs h ip 's MAT. T he PIC sh a ll be g ra n te d in a w ritte n fo rm th a t w ill ev en tu a lly a cq u ire th e legal value o f P ro toco l (w hich h a s to be im p le m e n te d in re sp e c t o f th e UNCLOS a c c o rd in g to art. 4) also a p p lie s in th e se m a ritim e a n in te rn a tio n a lly reco g n ized p e rm it (art. 17). T h is p e rm it (or its area s. A nd b e c a u se b o th legal fram ew o rk s se t th e ir ow n ru le s to eq u iv alen t) is th e key d o c u m e n t o f th e ABS m e c h a n ism , a s it is reg u la te e ith e r ‘MSR’ (UNCLOS p a rt XIII) o r ‘U tilizatio n o f m e a n t to e n su re legal c erta in ty fo r b o th th e u se r a n d th e g e n e tic re s o u rc e s’ (NP a rt. 1), th e situ a tio n is likely to re s u lt in p rovider. It affo rd s secu rity to th e p ro v id er, a n d e n a b le s th e u se r th e a p p lic a tio n o f tw o d is tin c t p ro c e d u re s fo r th e sam e activity. to prove it h a s a c q u ire d th e m a te ria l legally a n d c a n th u s p ro g re ss safely a n d law fully fu rth e r a lo n g th e b iodiscovery 3.1 M arine scientific research u n der the UNCLOS p ip elin e. T h is is o f p a rtic u la r relevance for th e u se r sin ce th e N agoya T he UNCLOS g ra n ts v ario u s rig h ts to th e co a sta l states P rotocol re q u ire s th a t th e p a rtie s p rovide fo r m e a s u re s e n su rin g d e p e n d in g o n th e specific m a ritim e a re a s (Fig. 2 for d e lim ­ th a t g e n e tic reso u rces b e in g u tiliz e d w ith in th e ir ju ris d ic tio n ita tio n s). T h e te rrito ria l sea c an b e c o m p a re d to th e p ro lo n g a ­ w ere a c q u ire d in c o m p lian c e w ith th e p ro v id e r's ABS le g isla tio n tio n o f th e sta te 's territo ry : m e a n in g th e sta te h a s full (art. 15). T h erefo re b e n e fit-sh a rin g a g re e m e n ts a re n o t sim ply sovereignty over th e se w ate rs w ith all th e d is c re tio n th a t it a n eth ic a l p ractice, b u t are a legal o b lig a tio n w ith all th e rele ­ im p lies, in c lu d in g th e re g u la tio n o f MSR (art. 2). B ut th e ju r is ­ v a n t c o n se q u e n c e s in case o f n o n -c o m p lia n c e . P o te n tia l d ic tio n o f c o a sta l sta te s over th e ir n a tu r a l reso u rce s e x ten d s far c o n se q u e n c e s are: s u s p e n sio n o r even c e ssa tio n o f th e b io ­ b ey o n d th e 12 n m o f th e te rrito ria l sea. In d e e d , w ith in th e discovery p ro cess, fines, in a b ility to a p p ly for a p a te n t o r to 200 n m o f th e exclusive eco n o m ic zone (EEZ) as w ell as o n th e co m m ercialize, etc. It is n o tew o rth y th a t th e E u ro p e a n U n io n is cu rre n tly e la b o ra tin g a re g u la tio n to e n su re th a t all u se rs o f g en etic reso u rces have c o m p lie d w ith th e d o m e stic law s o f C o n tig u o u s p ro v id in g c o u n trie s, befo re c o n d u c tin g an y re s e a rc h a n d d ev e lo p m e n t w ith in th e U n io n . T h e High S e a s 2.2.1 C om petent national authorities (CNA). O ne o f th e c o n se q u e n c e s o f th e above d e sc rib e d b ila te ra l ABS a p p ro a c h is th e inv o lv em en t o f sta te 's c o m p e te n t a u th o ritie s in th e a p p li­ c a tio n p ro cess. T he CNA m ig h t for in s ta n c e b e a d e p a rtm e n t o f th e source co u n try 's M in istry o f E n v iro n m e n t th a t is re s p o n ­ Scale o f R ights sible fo r g ra n tin g PIC. T h is is in fact th e case in C o sta Rica, S o v e re ig n r ig h ts to th e w a t e r c olum n S o v e re ig n rig h ts to S o v e re ig n T erritory No n a tio n a l rig h ts w h ere th e N a tio n al C o m m issio n o f B iodiversity M a n a g e m e n t g ra n ts th e b io p ro sp e c tin g p e rm its (w w w .conagebio.go.cr/). Fig. 2 M a r i t i m e B o u n d a r i e s in t h e U N C L O S . S o u r c e : A r c t i c C o u n c i l , H ow ever, it m ig h t also be th e case th a t m u ltip le p e rm its n e e d to A rc tic M a rin e S h ip p in g A sse ssm e n t 2 0 0 9 R e p o rt ( T r o m s o , N o r w a y : b e o b ta in e d fro m d iffe re n t g o v e rn m e n t in s titu tio n s in o rd e r to 2 0 0 9 ) , p. 52, a v a i l a b l e at: w w w . p a m e . i s / i m a g e s / s t o r i e s / P D F _ F i l e s / g et p ro p e r PIC, as is fo r ex am p le th e case in K enya.8 It all A M S A _ 2 0 0 9 _ R e p o r t _ 2 n d _ p r i n t . p d f . 614 I N a t Prod. Rep., 2014, 31, 61 2 -6 1 6 This journal is © T h e Royal Society of C h e m is ty 2014 Viewpoint c o n tin e n ta l s h e lf (CS) w h ic h c a n be u p to 350 n m , th e co a stal state is g ra n te d exclusive rig h ts, w h ic h m u s t b e d iffe re n tia te d fro m sovereignty in th e se n se th a t su c h rig h ts o n ly ap p ly to specific activities {i.e. p ro te c tio n o f th e en v iro n m e n t, o r th e ex p lo ratio n a n d ex p lo ita tio n o f n a tu ra l reso u rces). O ne o f th e rig h ts g ra n te d to th e co a stal sta te re la tes d irectly to MSR. In d e e d , th e co a stal state h a s to be n o tifie d six m o n th s in advance o f any MSR p ro je c t re q u irin g access to its EEZ o r CS. It also h a s th e rig h t to re q u ire th e p a rtic ip a tio n o f n a tio n a l observ ers in th e p ro je ct (art. 248). B ecause th is p ro c e d u re is m o re re la te d to th e su p erv isio n o f th e traffic a n d o n g o in g activities w ith in n a tio n a l ju ris d ic tio n th a n to th e re g u la tio n o f access to reso u rces fo r an y a p p lie d p u rp o se a n d ex p lo itatio n , th e c o m p e te n t au th o rity re sp o n sib le fo r g ra n tin g th e a u th o ri­ z a tio n is o fte n th e navy. For in sta n c e , in C hile th e Office o f th e C o m m an d er-in -C h ief o f th e Navy g ra n ts th e a u th o riz a tio n follow ing c o n su lta tio n w ith th e Navy H y d ro g rap h ic a n d O cean o g rap h ic Service.11 C o n se n t fro m th e c o a sta l state is easily a c q u ire d since o n e o f th e UNCLOS o bjectives is to p ro m o te MSR, a n d th e sta te 's c o n s e n t sh o u ld alw ays be g ra n te d ‘u n d e r n o rm a l c irc u m sta n c e s’ (art. 246).4 Even th o u g h it is b e y o n d th e scope o f th is article to d isc u ss w h a t c a n be c o n sid e re d as a b n o rm a l c irc u m sta n c e s, it is n o te w o rth y th a t th e d isc re tio n a ry pow er o f th e c o astal sta te to refu se th e access o f a cru ise c a m p a ig n to its w aters in cases w h ere th e re m ig h t be a ‘sig n if­ ic a n t effect’ o n th e ex p lo itatio n o f n a tu ra l re so u rc e s (art. 246). 3.2 In situ m arine gen etic resources under the Nagoya Protocol Since s ta te s have sovereig n ty over th e n a tu ra l re so u rc e s fo u n d w ith in th e ir ju r is d ic tio n u n d e r th e CBD, it is very im p o rta n t to refer to th e C o n v en tio n a n d its N agoya P ro to co l to g e th e r w ith th e UNCLOS to u n d e rs ta n d w h ere th is ju r is d ic tio n e x ten d s. W ith in th e 200 n m lim its o f th e EEZ a n d CS it is clearly sta te d th a t th e c o astal sta te h a s ju r is d ic tio n over all ‘n a tu ra l re s o u rc e s’ (art. 56 & 77). H ow ever it is w o rth m e n tio n in g th a t th e ju r is d ic tio n o f sta te s c a n so m e tim e s e x te n d u p to 350 n m (art. 77), a fte r th e ex te n sio n o f th e CS w as s u b m itte d to th e C o m m issio n o n th e L im its o f th e CS (Annex II). At p re s e n t, only 18 sta te s have a c q u ire d su c h e x te n d e d rig h ts (w w w .u n .o rg / d e p ts/lo s/clcs_ n ew /clc s_ h o m e .h tm ). T h e se rig h ts g ra n t sta te s ju r is d ic tio n over th e ‘se d e n ta ry sp e c ie s’ (b e n th o s) o f th e se a b e d th e re in . H ow ever, fo r th e w a te r c o lu m n above th e e x te n d e d CS th e fre e d o m o f th e H ig h Seas a p p lie s. T h erefo re, if b e n th ic o rg a n ism s are sa m p le d fro m th e se a b e d w ith in su c h e x te n d e d ju ris d ic tio n , th e a p p ro p ria te c o n s e n t o f th e c o a sta l sta te m u s t b e so u g h t. C o n seq u en tly , w h a t sh o u ld b e b o rn e in m in d is th a t PIC a n d MAT are re q u ire d for an y activity re la te d to MGR u p to 200 n m (w ater co lu m n ) o r 350 n m (ex ten d ed CS), a n d th a t th e sole a u th o riz a tio n o f c o n d u c tin g re s e a rc h w ill n o t be su fficien t. Two p e rm its, p ro b ab ly g ra n te d by d iffe re n t a u th o ritie s, m a y th e re ­ fore be re q u ire d : a n a u th o riz a tio n to c o n d u c t m a rin e re se a rc h w ith in th e co a sta l sta te 's ju ris d ic tio n a n d a p e rm it to access a n d u tilize MGR. H ow ever, it is n o t cle a r w h e n MSR b ec o m e s b io ­ p ro sp e c tin g , a n d w h e n or, to w h a t ex ten t, th e c o m m e rc ia l in te n t This journal is © T h e Royal Society of C h em istty 2014 NPR b e c o m e s decisive for th e d e fin itio n o f th e activity. To fu rth e r c o m p licate m a tte rs n a tio n a l le g islatio n s im p le m e n tin g th e P ro toco l c o u ld w ell prov id e d iffe re n t an sw e rs to th is q u e stio n fro m o n e c o u n try to a n o th e r, a s several ‘d e fin itio n s’ o f b io ­ p ro s p e c tin g exist globally. It is th u s p ro b a b ly sa fe st to sy stem ­ atically e n te r in to a re la tio n sh ip w ith a p a rtn e r fro m th e source c o u n try a n d in c lu d e a c h a n g e o f in te n t clau se, i.e. to foresee any s u b s e q u e n t a n d u n p la n n e d fu tu re c o m m ercia l ex p lo itatio n . Concluding remarks A lth o u g h th e N agoya P ro toco l is a n e w legally b in d in g in s tru ­ m e n t w h ic h w ill c ertain ly a d d a d m in istra tiv e layers to th e c o n d u c t o f MSR a n d re la te d b io p ro sp e c tin g activities, it w ill also b rin g m o re legal c e rta in ty to th e b iodiscovery p ip e lin e a n d , th ro u g h th e n e g o tia tio n o f a g re e m e n ts, avoid th e m isa p p ro ­ p ria tio n a n d m isu se o f g e n e tic re so u rc e s.12 In th is reg ard , all p a rtie s involved in th e value c h a in o f th e u tiliz a tio n o f legally a c q u ire d g e n e tic reso u rce s sh o u ld b e n e fit fro m th e security th u s p ro v id ed a n d p u rs u e th e ir w o rk safely. To fu rth e r en co u rag e g o o d p ractice, we w o u ld re c o m m e n d th a t relev an t scien tific jo u r n a ls m ay w ish to a d o p t a policy w h ereb y accep ­ ta n c e o f a re s e a rc h p a p e r w h ic h re la te s to th e access o r u tili­ z a tio n o f a g e n e tic reso u rc e w o u ld b e c o n tin g e n t o n a s ta te m e n t e n s u rin g co m p lia n c e w ith ex istin g re g u la tio n s. It is w o rth m e n tio n in g th a t, w h ile w a itin g for th e e n try in to force o f th e P ro to co l a n d th e ra tific a tio n o f th e p a rtie s, som e u n c e rta in tie s re m a in . T h ese are, a m o n g s t o th e rs, th e re p a rti­ tio n o f MGR in a re as involving several p ro v id in g sta te s o r in situ a tio n s w h ere th e sam e MGR ca n be fo u n d w ith in a n d b ey o n d n a tio n a l ju ris d ic tio n s . It is also n o te w o rth y to e m p h a ­ size th e reg im e o f th e in te rn a tio n a l h ig h seas a n d d eep seab ed area s. A lth o u g h sta te s are o b lig e d to d is se m in a te in fo rm a tio n a n d k n ow ledge fro m MSR in th e se a re a s - w h ic h c o u ld be c o m p a re d to a fo rm o f n o n -m o n e ta ry b e n e fits sim ila r to th o se u n d e r th e CBD a n d its N agoya P ro to co l - th e access to g en etic re so u rce s b ey o n d n a tio n a l ju ris d ic tio n re m a in s free a t th e m o m e n t. T h is is likely to c h a n g e in th e n ex t decad e as c u rre n t d isc u ssio n s w ith in th e U n ite d N a tio n s G en eral A ssem bly a p p e a r to be h e a d in g to w a rd s th e p o ssib le e la b o ra tio n o f a n a d d itio n a l a g re e m e n t to th e UNCLOS w ith re sp e c t to ABS o f MGR in in te rn a tio n a l w a te rs.4’13 Abbreviations ABS Art. CBD CNA CS EEZ MAT MGR MSR PIC UNCLOS Access a n d B enefit-S haring Article (of a C o n v en tio n ) C o n v e n tio n o n B iological D iversity C o m p e te n t N a tio n a l A uth o rity C o n tin e n ta l S h elf Exclusive E co n o m ic Zone M utu ally A greed T erm s M arine G en etic R eso u rces M arine S cientific R esearch P rio r In fo rm e d C o n se n t U n ite d C o n v e n tio n o n th e Law o f th e Sea N a t Prod. Rep., 2014, 31, 612-616 | 615 NPR A cknow ledgem ents T h is w o rk w as su p p o rte d by th e P h a rm aS ea p ro jec t fu n d e d by th e EU S ev enth F ram ew o rk P ro g ra m m e , a n d reflects o n ly th e a u th o rs ' view s. C o n tra c t n u m b e r 312184. w w w .p h arm a -se a.eu . N otes and References 1 Convention on Biological Diversity, Rio de Ja n e iro , 2 2 n d m ay 1992. E n te re d in to force 2 9 th Dec. 1993, 193 p a rtie s o n 3.10.13. w w w .cb d .in t/c o n v e n tio n /te x t/. 2 Nagoya Protocol on Access to Genetic Resources an d the Fair and E quitable Sharing o f Benefits A rising o f their Utilization, N agoya, 2 9 th O ct. 2010. Yet to e n te r in to force, ex p ected 2014: w w w .cb d .in t/ab s/te x t/. 3 United N ations Convention on the Law o f the Sea, M o nteg o Bay, 1 0 th Dec. 1982. In to force 1 6 th Nov. 1994, 166 p a rtie s o n 20.09.13. w w w .u n .o rg /D e p ts/lo s/in d e x .h tm . 4 C. S alpin, T he Law o f th e Sea: A befo re a n d a n a fte r Nagoya?. In The 2010 Nagoya Protocol on Access a n d Benefit-sharing in Perspective, Im plications fo r In ternational Law and Im plem entation Challenges, by E. M orgera, M. B uck a n d E. T sio u m a m i, M a rtin u s N ijh o ff P u b lish e rs 2013, p. 149-183. 5 S. L aird a n d R. W ynberg, B iosciences a t a C ro ssro ad s: Im p le m e n tin g th e N agoya P ro to co l o n Access a n d BenefitS h a rin g in a T im e o f Scientific, T ech n o lo g ical a n d In d u s tria l C h an g e, Secretariat o f the CBD Policy Brief, 2012. 6 G. M. C ragg, F. Katz, D. J. N ew m an a n d J. R o sen th al, T he im p a c t o f th e U n ited N a tio n s C o n v e n tio n o n B iological D iversity o n n a tu ra l p ro d u c ts re sea rc h , Nat. Prod. Rep., 2012, 29, 1407-1423. 616 I Nat. Prod. Rep., 2014, 31, 612-616 Viewpoint 7 G. M. C ragg, F. Katz, D. J. N ew m an a n d J. R o se n th al, Legal a n d E th ical Issu e s Involving M arin e B iodiscovery a n d D ev elo p m e n t, in H andbook o f M arine N a tu ra l Products by E. F a tto ru sso , W .H . G erw ick a n d O. T aglialatela-Scafati, S p rin g er N e th e rla n d s P u b ., 2012, 1314-1342. 8 E. C. K am au a n d G. W in te r, S tre a m lin in g Access P ro ced u res a n d S ta n d a rd s. In Genetic resources, traditional knowledge, and the law: solutions fo r access a n d benefit sharing, by E.C. K am au a n d G. W in ter. E a rth s c a n 2009, p . 365-379. 9 Bioprospecting Guidelines, S o u th Africa: w w w .cb d .in t/ab s/ m e a s u re s/g ro u p /? c o d e = z a . 10 M arin e R eso u rces Act n o 37, 2009, Norway: w w w .cb d .in t/ab s/ m e a s u re s/g ro u p /? c o d e = n o . 11 S u p rem e D ecree n o 711, A ugust 2 2 n d 1975, C hile: h ttp :// w w w .sh o a .c l/tra m ite s/d e c re to 7 1 1 _ in g .p d f. 12 C. C h ia re lla , B iopiracy a n d th e Role o f Private In te rn a tio n a l Law U n d e r th e N agoya P ro to co l 2012, W orking Paper no. 02/ 12, IDDRI, P aris, F ran ce, 20p. 13 D. Leary, M oving th e M arin e G en etic R eso u rces D ebate F orw ard: Som e R eflections, The International Journal o f M arine a n d C oastal Law, 2012, 27(2), 435-448. 14 T. G reiber, S. P. M oreno, M. A hrén, J. N. C arrasco, E. C. K am au , J. C. M edaglia, M. J. Oliva, F. P erro n-W elch in c o o p e ra tio n w ith N. Ali a n d C. W illiam s, 2012. An E xplanatory Guide to the Nagoya Protocol on Access and Benefit-Sharing. IUCN, G lan d , S w itzerland, xviii + 372 pp. A vailable at: h ttp ://d ata.iu cn .o rg /d b tw -w p d /ed o cs/E P L P 083.pdf. 15 ABS In fo rm a tio n Kit p ro d u c e d a n d p u b lis h e d by th e CBD se c re ta ria t (2011). A vailable at: w w w .cb d .in t/ab s/aw aren essraisin g /. This journal is © T h e Royal Society of C hem isfty 2014