11/02/2010 Barwon Health, The Geelong Hospital, Geelong Victoria 3220

Transcription

1 Barwon Halth, Th Glong Hospital, Glong Victoria 3220 Excutiv Summary... 1 Introduction... 2 Gnral s... 5 Spcific s... 6 Contact Dtails Rfrncs Excutiv Summary Th Barwon Halth Bon Bank is a small human tissu bank locatd at th Glong Hospital in Victoria. W xclusivly bank fmoral hads from liv donors having total hip rplacmnt surgry. W provid ths as non-irradiatd bon for us in orthopadic procdurs, primarily in th Glong rgion and occasionally to Bndigo and othr aras. W support th nd to provid a saf and rliabl tissu srvic for th Australian public, but w sk to challng th Thraputic Goods Committ to rviw ths nw rgulatory documnts with a viw to dvloping a mor blood, tissu and cllular thrapy spcific rgulatory vision, rathr than a st of manufacturing principls. W argu, in this submission, that th currnt modl is concptually and practically flawd and propos a paradigm shift to rgulation of blood and tissu banking as a srvic and not a manufacturing industry. Quality and safty standards should b maintaind through Good Tissu Practic rathr than Good Manufacturing Practic. At minimum, w bliv a trminology shift to mor appropriat languag would b bnficial to th rgulation and licnsing assssmnt of th sctor. For th bnfit of th Australian public, blood, blood componnts, human tissu and cllular thrapy srvics must b ncouragd to xpand and dvlop with mrging tchnology, in a saf and controlld mannr, with a rasonabl balanc of justifid ovrsight, but without xcssiv or undu rgulatory burdn. Barwon Halth Bon Bank 1 of 13

2 Introduction Th (formrly th Douglas Hocking Rsarch Institut Bon Bank) is a rpository for Human Tissu, donatd by public and privat patints undrgoing Total Hip Rplacmnt (THR) surgry in th Glong rgion. Although th Bon Bank is opratd by Barwon Halth Th Glong Hospital, w rly on th coopration and support of th local Orthopadic Surgons and th thatr staff of th two local privat hospitals. Th Orthopadic surgons and thatr staff ar involvd in th scrning and consnt of donors and collction of donations during Total Hip Rplacmnt surgry. Thy rciv no financial rmunration for thir contributions to th bon bank, and thr is no cost rcovry for th institutions that thy work for. Th collcts, stors and supplis frsh frozn (non-irradiatd) fmoral hads for bon graft in orthopadic surgry. W aim to provid sufficint stock to mt th nds of our local surgons and, whn sufficint stock is availabl, w oftn supply bon to surgons in Bndigo and othr aras upon rqust. Th bank is licnsd to manufactur this product by th Thraputic Good s Administration (TGA) undr th currnt rgulatory rgim. Our small bank is maintaind by thr cor staff mmbrs who ar mployd in a part-tim capacity for thir bon bank dutis. Quality control and mdical dirctor rols ar fulfilld in a prdominantly advisory capacity, which is fundd dirctly by Barwon Halth, as th approvd cost rcovry rbat currntly allowd through sction B of th Prosthsis List is not sufficint to mt ths costs. W ar on of only 2 or 3 small banks in th country who struggl to routinly supply this nonirradiatd product, which our local orthopadic surgons prfr ovr th irradiatd altrnativs producd by othr, mostly largr, bon banks. Th Banks Rviw 1 discusss th nd to rduc th rgulatory crp that rsults in unintndd and unncssary, prvasiv ffcts on small businss. Rgulatory crp in th human tissu sctor gravly jopardiss th futur of small, localisd banks such as ours. W far that rgulatory crp will undoubtdly rmov our valud, non irradiatd tissu rsourc from th halthcar systm. This is not bcaus of any failur of our bank or th prcious tissu w supply, which has bn in common mdical us for many dcads, but bcaus th banks that supply ths tissu itms will bcom non-viabl undr th rgulatory and cost rcovry rbat systms. Obviously, this would b an unintndd and unncssary consqunc of th Thraputic Goods Act. 2 Unfortunatly, th currnt post rlas cost rcovry systm dos not ffctivly compnsat or nsur th long trm survival of any tissu bank and rgulatory crp incrass th burdn on th tissu sctor. Our own rcnt xprinc with th rquirmnts for microbiological contamination tsting stands as an xampl of th rstrictiv consqunc of a rgulatory burdn that potntially thratns th survival of th ntir sctor. Our contractd srvic laboratory casd providing a TGA licnsd microbiological contamination srvic to us in Th Australian Cod of Good Manufacturing Practic for Human Blood and Tissus 3 mandats that this tsting b prformd in a TGA licnsd facility, Barwon Halth Bon Bank 2 of 13

3 howvr, thr is no othr licnsd facility in Victoria that is prpard to mt th rgulatory rquirmnts for introducing and validating th cultur mthods rquird for our sampl typs. It simply is not cost ffctiv, particularly considring th rlativly small numbr of sampls to b culturd for us annually. Our microbiological sampls could b rliably culturd using similar cultur mthods, within a coupl of hours of collction, at a local pathology srvic, but th mandat for TGA licnsd facilitis has rquird us, at significant additional cost, to transport microbiological spcimns from Glong to Sydny, ovrnight, to a TGA licnsd microbiology laboratory. Th sampls ar ultimatly culturd up to 24 hours aftr collction. Evn undr validatd transport conditions, th prolongd, intrstat transport tim clarly cannot nhanc our sampl or tissu quality in any way, yt has srvd to doubl our upfront costs. This is an invitabl consqunc of th high rgulatory burdn that has bn applid to th sctor. Thr ar currntly vry fw microbiology tsting laboratoris prpard to undrtak th onrous procss of TGA licnsur and it has bn our rcnt xprinc that many of thos that ar not dirctly linkd to a blood or tissu srvic ar qustioning th cost implications and rational for continuing to provid licnsd srvics. Th additional impacts of this singl rgulatory rquirmnt illustrat som xampls of th vry ral financial consquncs that thratn th xistnc of our tissu bank srvic: Although th significant additional cost of transport and th highr srvic fs for th tsting wr incurrd in mid 2008, w wr unabl to rcovr ths additional costs until our application for a rbat incras on Part B of th Prosthsis List was approvd in Fbruary 2009 (Plas not that that our approvd rbat is at a lowr rat than was justifid in our application). Consquntly, our budgt was strtchd for mor than 6 months, with additional costs incurrd for transport and no guarant that our rbat incras would b approvd. This lft our public hospital to absorb th additional costs whil w waitd for th Fbruary 2009 List. Th altrnativ would b to clos th bank for collctions until th additional cost rcovry could b guarantd. Fortunatly for orthopadic patints in Glong, our hospital s Chif Excutiv Officr lctd to support th bank financially rathr than los 6 months worth of potntial donations. If not for th 180 day donor rtsting rquirmnt for liv donors, which dlays th rlas of tissu until follow-up srology scrning is compltd, w would nvr b abl to rcoup th additional cost of any tissu rlasd bfor th Fbruary 2009 Prosthsis List was publishd. Although rgulatory and cost rcovry issus ar sparat, on cannot b considrd without considration to th implications of th othr. Th impact of rgulatory rquirmnts on th financial viability of tissu banking in this country must b considrd by th Thraputic Goods Committ in th rviw of ths draft documnts. Thr is no opportunity to rcovr th cost of discardd or non-conforming product, yt significant cost is still incurrd. Barwon Halth Bon Bank 3 of 13

4 Th chang control for this issu alon took mor than 6 months for our part-tim staff to complt to a standard that will satisfy th rgulatory rquirmnts of th TGA. Th biggst issus wr firstly, finding an appropriatly licnsd facility that was willing to tak our work, thn ngotiating and validating a transport mthod to safly dlivr th spcimns intrstat within dfind tim and tmpratur limits. In th transition priod btwn srvic contracts, 10% of our donations (and consquntly our incom) for 2008 was lost, du to an inability to hav th spcimns culturd. This incom loss and 6 months of staff tim, divrtd from rgular dutis, will nvr b rcovrd or compnsatd undr th currnt rbat schm. Thus laving our local public hospital to absorb th cost. To mt transport srvic rquirmnts for ovrnight dlivry, our spcimns must b dispatchd by 15:00 hours ach day. This prvnts collction from surgical cass schduld in th aftrnoon. As a rsult, our collction rat in 2009 has bn dcimatd by 40%as compard to Thrfor, on top of th staff tim loss for 2008, our ability to gnrat incom to support th srvic has also bn rducd by 40%. This is just on of th rgulatory factors that hav contributd a doubling in our Prosthsis List approvd rbat from $1,080 to $2,113 on th Fbruary 2009 list. Th cost of our srvic, to both public and privat halthcar, has incrasd 5 fold sinc th introduction of rgulation in Yt w still tst, packag, stor and supply our bon donations in much th sam way and thr hav bn no advrs clinical outcoms rportd from cass involving tissu from our bank in that tim. In fact, our Audit of th Douglas Hocking Rsarch Institut bon bank: tn yars of non-irradiatd bon graft 4 publishd in 2009, documnts that th incidnc of dp infction in procdurs using our non-irradiatd bon, was no gratr than th incidnc of dp infction for all local joint rplacmnt surgry. Orthopadic surgons, thatr staff, and th halthcar srvics thy work for, rciv no compnsation for th costs that thy incur through thir support of th bon bank. Our quality control and mdical advisors ar likwis unfundd. Th tru cost of providing human tissu for transplant is not narly mt by th cost rcovry modl, but by th goodwill of halthcar providrs who can ill afford th additional xpns and individuals who choos to contribut thir skills for th gratr good of th community. In this introduction, w hav attmptd to giv th Thraputic Good Committ an insight into th ral implications of th rgulatory burdn on this, mostly publicly fundd, sctor. Giving particular focus to th struggl of banks to provid quality tissu itms for th community, within th constraints of a not-for-profit, cost rcovry financial systm. W apprciat that th rol of th Thraputic Goods Committ and th Blood and Tissu rfrnc group dos not involv th financial considrations of th blood and tissu sctor, howvr, on cannot b considrd without th implications to th othr. W implor th committ to carfully judg th implications of th additional rgulatory rquirmnts that ar proposd in ths draft documnts and to wigh th conundrum of maintaining quality with th rality of continuing to provid a human tissu srvic. Barwon Halth Bon Bank 4 of 13

5 If th impact of mor stringnt rgulatory standards ultimatly rducs our ability to provid tissu srvics, thn it is not th bst outcom for th halthcar of Australian citizns? Gnral s Th introduction of this nw draft of th cod rprsnts an opportunity to rconsidr som of th manufacturing concpts usd in rlation to th provision of Blood and Blood componnts, Human tissus and cllular thrapis. W bliv thr is a fundamntal lgislativ flaw in dfining human tissu itms as products. Th us of trms such as product and manufactur consquntly lock th human tissu banking sctor into a rgulatory paradigm dvlopd for manufacturrs of inanimat objcts and pharmacuticals. Ths rgulations wr nvr stablishd with th complxitis and uniqu proprtis of human tissu itms or th potntial of mrging cllular thrapis in mind. Human tissu and cllular thrapis do not fit wll within th manufacturing framwork. W hav xprssd this viw in th currnt round of govrnmnt rviws into aras that affct tissu banking and Halth Tchnology Assssmnt 5. W s this as a timly opportunity to rassss th dfinitions and rgulation of human tissu itms. Th gratst obstacl facing human tissu products in th currnt rgulatory modl is that thy ar not considrd in thir own contxt. Thy ar consolidatd within an xisting systm, dsignd for manufactur of pharmacuticals and dvics, a rgulatory systm in which thy simply do not fit, nor blong. Human tissu itms, by thir vry natur, ar as uniqu and variabl as th donor from which thy com. Human tissu products ar rgulatd as manufacturd mdical dvics, which thy clarly ar not. Many of th manufacturing principls simply don t apply to somthing that is procurd from a living bing, rathr than manufacturd from dfind and controllabl raw matrials. Th simpl fact is that human tissu itms ar nithr manufacturd, nor ar thy products. Our far is that th spctr of this manufacturing styl of rgulation and rgulatory crp will hav ngativ implications in th futur for organ transplant activitis and will also stifl th dvlopmnt of cllular thrapis from th rsarch lab to clinical application in our not-forprofit, cost rcovry lgislatd srvic industry. If tissu and cllular thrapis ar to dvlop and prolifrat in this country, thn w fl thr nds to b a rconsidration of th currnt rgulatory modl. Th Amrican Association of Tissu Banks in th Unitd Stats has dvlopd a Cod of Good Tissu Practic to apply to human tissu banking and prsumably cllular thrapis. If th principls ar basd on th provision of a tissu srvic, thn this would sms to b a mor nlightnd approach to th rgulation of human tissu and cllular thrapis. W rcommnd a brav lap to th us of mor appropriat trminology and a rfrshd cod and standards that rflct th ralitis and uniqu natur of th provision of human blood and blood componnts, human tissus and cllular thrapis. Firstly, it is our viw that th provision of human blood and blood componnts, human tissus and cllular thrapis is a srvic industry and not a manufacturing industry. W collct Barwon Halth Bon Bank 5 of 13

6 altruistic donations and procss, not manufactur, ths as a not-for-profit srvic to provid a thraputic bnfit. W would lik to rcommnd that th Thraputic Goods Committ considr a chang in th trminology of th cod from products to human blood and tissu itms and from manufactur to mor appropriat trm such as procssing or prparation, whr rlvant. As any additional rquirmnts in ths nw draft documnts will hav significant implications for smallr banks such as us, w urg th Thraputic Goods Committ to idntify th additional rquirmnts and to considr th ral addd quality valu vrsus th potntial additional cost of implmntation. W hop th committ undrstands th fragility of th altruistic tissu srvics and apprciats that additional rgulatory rquirmnts dirctly incras th cost of providing human blood and tissu itms, which will ultimatly incras th cost of halthcar. Spcific s W ar concrnd with th TGA s rcnt communications, intrprting a mandat for NAAT tsting of liv tissu donors, in addition to 180 day rpat srology. Succssful implmntation of such an intrprtation would hav imposd significant additional cost to th sctor dspit th scintific position that thr is no additional safty bnfit of NAAT whn 180 day rpat srology rprsnts th safst and most appropriat scrning rgim for liv donors. Th TGA has snsibly rscindd this intrprtation, but w caution th Thraputic Goods Committ to rviw ths nw rgulatory instrumnts to spcifically avoid th risk of unjustifid, xtranous or inappropriat intrprtation. Schdul 2 POLICY (1) 9 Th intnt of this claus can b achivd without th nd to rquir a spcific policy documnt in rlation to mitigation of disas risk, spcially as th contnt of this TGO is particularly dtaild and spcific. It should not b ncssary for individual banks to documnt a policy that rgurgitats th rquirmnts of this TGO. (1) (b) 9 This structur of this claus could b statd in a clarr mannr. Again, it should not b ncssary for individual banks to documnt a policy that rgurgitats th rquirmnts of this TGO. (i) W do not agr with mandating th xclusion of tissu donors basd on an arbitrary 6 month priod of possibl xposur btwn th arbitrary dats that wr st for vcjd risk for blood and blood componnts? Barwon Halth Bon Bank 6 of 13

7 (1) (b) (i) 9 W disagr with mandating th xclusion of tissu donors basd on th arbitrary 6 month priod of prcivd xposur to vcjd in th Unitd Kingdom btwn 1980 and 1996 as st for blood and blood componnts. Asid from th subjctiv dats and xposur priod (i.. 6 months) dscribd, thr rmains no convincing clinical vidnc of disas transfr through tissu. W rcommnd a thorough rviw of th mdical vidnc bfor approving this claus. (3) Again, th intnt of this claus can b achivd in procdural documnts, without th nd to rquir a spcific policy documnt. Schdul 3 MEDICAL & SOCIAL HISTORY (2) 10 W, as do othr tissu bankrs, qustion th spcific rquirmnt for fac-to-fac Mdical and Social History donor intrviws. (2) (a) 10 Th ral practicalitis of surgry schduls, spcially in th public sctor with surgical waiting lists and rschduling of cass dpndnt on mrgncy dmands, mans that a rquirmnt to intrviw donors no mor than 7 days prior to donation will b difficult to achiv. In our xprinc, it is not uncommon for surgical donors to attnd a prioprativ pradmission clinic 2-4 wks prior to surgry. W activly protst th concpt of obtaining mdical history on th day of donation for surgical donors on th grounds that th donor may fl undr durss immdiatly prior to surgry, thus impairing thir ability to accuratly rcall spcific information to complt a qustionnair or intrviw. Early surgical cass rquir vry arly admission tims and donors may b prscribd a sdativ or rciv asthtic prmdications vry arly on th day of donation. W support th cas for a 90day allowanc for liv donors, givn th rquirmnt for 180 day rtsting. Barwon Halth Bon Bank 7 of 13

8 (2) (b) 10 W qustion th inconsistncy of allowabl timframs btwn compltion of Mdical and Social History and donation for donors of diffrnt tissu typs. In particular th 30 day window for HPC-A and HPC-M donors and allowanc of 14 days post donation for confirmation of th history for umbilical cord donors. W qustion th justification for this discrpancy. (2) (c) 10 Again, w qustion th inconsistncy of allowabl timframs btwn compltion of Mdical and Social History and donation for donors of diffrnt tissu typs. In particular th 30 day window for HPC-A and HPC-M donors and allowanc of 14 days post donation for confirmation of th history for umbilical cord donors. With rgard to writtn confirmation of currnt history on th day of donation, w qustion th ability and lgal capacity of a woman during labour. (2) (d) 10 W objct to th impracticality of this nw rquirmnt for confirmation of mdical history currncy, no mor than 7 days prior to donation for surgical donors. Rfr to commnts for (2)(a). 10 W would ncourag th Thraputic Goods Committ to sk 2 mdical guidanc on th contnt of 2, with th viw to crating consistncy in 6 month or 12 month dfrral for slction critria that rprsnt a risk of rcnt xposur to infctious disass. Espcially in liv donors who ar rpat 2 (b) 2 (c) 2 (d) tstd. 10 This dfrral critrion raiss a fw qustions. Will this nd to b followd-up and documntd, or is th donor s assuranc accptabl? Will invstigation of currncy of th practitionr licnc or vidnc of th us of stril, non-rusd ndls b xpctd? 11 Should this dfrral critrion b intrprtd to man that no dfrral is rquird if injury or contact is not hight risk for HpC, HpB or HIV? 11 W ar concrnd about th us of arbitrary hours for this critrion. Barwon Halth Bon Bank 8 of 13

9 2 (k) 2 (o) 2 (p) 2 (t) 11 Should this dfrral priod b intrprtd as rquiring stablishmnt of disas fr status prior to donation, or can post donation (and 180 day rtst for liv donors) b considrd vidnc of disas fr status? 11 Must th disas fr status for tubrculosis b stablishd by tsting or mdical consultation or is th donor s assuranc sufficint? 12 Dos this imply a lvl of activ invstigation or is th donor s assuranc sufficint? 12 Should this b intrprtd to man thr is no rquirmnt to dfr for rcipints of allognic blood, blood componnts or blood products that mt th rquirmnts of this ordr? Schdul 4 SAMPLING, TEST KITS, TEST PROTOCOLS AND TEST MANAGEMENT (2) (b) 14 Wording is unclar rgarding 7 day rquirmnt. Bfor or aftr donation? (2) (c) 14 What is th justification for diffrnt blood sampling standards for diffrnt blood/tissu typs? Sampling 7 days bfor or aftr donation is allowd for umbilical cord blood. (2) (d) 14 What is th justification for diffrnt blood sampling standards for diffrnt blood/tissu typs? Up to 30 days prior donation is allowd for HPC-A and HPC-M. (4) (b) 14 Again, why th diffrnt standard for HPC-A & HPC-M. Up to 30 days prior. (6) (a) 14 W ar wary of th potntial intrprtation of th wording of this claus with rgard to nw or updatd tchnologis, spcially givn th rcntly rscindd notification that NAAT tsting should b rquird for liv donors, vn though 180 day srology is rquird and rducing th window priod at collction provids no nt bnfit. (10) 15 W qustion th justification for maintaining both a donation sampl and a 180 day rtst sampl for archiv? Surly th rtst sampl is sufficint to assss th donor s infctiv status. Furthr to this, th claus should allow for discard of any archiv srum sampls if th donation is not rlasd for transplant. Barwon Halth Bon Bank 9 of 13

10 (11) 15 If a nw, mor snsitiv, scrning tchnology vr bcoms availabl, this claus will ffctivly nforc a complt frz on th rlas of all blood, tissu and clls in Australian banks until rtrospctiv tsting of stock is compltd. Also, givn Australia s cost rcovry systm and th 6 month (minimum) dlay in approval for rbat incrass on th Prosthsis List, rcovry of th cost of this rtrospctiv tsting cannot b claimd for any tissu rlasd prior to th publication of th nxt Prosthsis List. Schdul 5 DONOR TESTING AND EXAMINATION (1) 16 This claus spcifically introducs a nw rquirmnt for mandatory physical xaminations for liv donors. W protst th logistics and additional cost to implmnt this rquirmnt and qustion th rational for inclusion. Th purpos of th physical xamination, as dfind at th bginning of this TGO, is to sk vidnc of injuris, tratmnts or bhaviour that would othrwis b capturd in a Mdical and Social History qustionnair and intrviw. If th TGA is concrnd that donors may not b truthful in complting a mdical qustionnair, thn w caution th rviwrs that th introduction of this rquirmnt will likly rduc donation rats bcaus of difficultis with complianc and donor s rluctanc to consnt to unncssary prsonal invasion. W suspct th consqunt rduction in tissu donations would unncssarily xcd th prcivd risk of donor dishonsty in a voluntary and altruistic stting. W urg th rviwrs to carfully considr th potntial implications of this proposd rquirmnt. Barwon Halth Bon Bank 10 of 13

11 (1)(c) 16 An inconsistncy xists hr. (1) Spcifis donors of human blood and blood componnts, human tissus or human cllular thrapis must b tstd and xamind for vidnc of infctious disas, yt (c) spcifically xcluds rfrnc to blood and blood componnts but (c) (i) again spcifis blood. Is this an ovrsight in point (c) of this claus or is this rcognition of th logistical burdn and rduction in donations that would rsult from imposing a rquirmnt for physical xamination on whol blood and plasma donation? If th lattr is tru, thn w strnuously protst th inconsistnt application of a rquirmnt for physical xamination and advocat th rmoval of th rquirmnt for tissu and clls. (1)(c) 16 (ii) Why is a rstriction of 5 days and no mor than 7 days so loosly rcommndd hr? If this nw rquirmnt for physical xamination is to b nforcd, thn th grac priod should b consistnt with th rquirmnts for obtaining Mdical and Social History, as statd in Sction 3. (2) 16 Although th intnt of this claus sms to rflct our position that NAAT should not b rquird whn 180 day rpat srology can b prformd, w ar concrnd that th currnt wording of th claus is opn to altrnat intrprtation. W rcommnd that th intnt of th claus b statd mor clarly and spcifically with rgard to tsting rquirmnts for liv donors. Barwon Halth Bon Bank 11 of 13

12 (5) 17 Undr th currnt cod, it has bn intrprtd that thr is no rquirmnt for bioburdn dtrmination of tissu which is not tratd for bioburdn rduction. Mor spcifically, w hav not bn rquird to stablish th bioburdn of our non-irradiatd bon as donations ar discardd if any microb is dtctd by microbiological contamination sampling. W qustion th intnt of this claus as statd and highlight th uncrtainty, dscribd in our gnral commnts, associatd with th us of manufacturing trms in th rgulation of human blood and tissu. In th cas of our bon stock, w rlas th fmoral hads as rcivd from collction in th oprating thatr. Th packaging in not opnd and no procssing or manipulation of th tissu occurs. Our tissu is not manufacturd, yt w hold a Thraputic Goods Licnc to Manufactur. Hnc th uncrtainty with rgard to this claus. Dos this claus now rquir us to dtrmin th bioburdn of our non-irradiatd bon, or dos th us of th trm manufactur rlat only to tissu that is procssd, modifid or manipulatd, thus introducing a risk of furthr contamination? W rsist any rquirmnt to dtrmin th bioburdn of our tissu as w discard for any microbiological growth and thr is no nt bnfit of imposing th additional cost, which cannot b rcovrd. W rqust an appropriat amndmnt to th wording of this claus. Barwon Halth Bon Bank 12 of 13

13 Thank-you for th opportunity to xprss our viws in this submission. Furthr information or confidntial xampls can b obtaind by contacting us dirctly. Gavin Van Dr Mr BSc. Production Scintist, Barwon Halth - Bon Bank Laboratory Mangr, Barwon Biomdical Rsarch Barwon Halth Th Glong Hospital PO Box 281 Glong, Victoria 3220 gavinv@barwonhalth.org.au Ph: (03) Fax: (03) Assoc. Prof. Mark Kirkland MBBS, PhD, FRCPA Mdical Dirctor, Barwon Halth - Bon Bank Laboratory Dirctor, Barwon Biomdical Rsarch Barwon Halth Th Glong Hospital PO Box 281 Glong, Victoria 3220 markkl@barwonhalth.org.au Ph: (03) Fax: (03) Rthinking Rgulation Rport of th Taskforc on Rducing Rgulatory Burdns on Businss, January 2006 (th Banks Rviw) 2. Thraputic Goods Act, Australian Cod of Good Manufacturing Practic - Human Blood and Tissus, August Audit of th Douglas Hocking Rsarch Institut bon bank: tn yars of non-irradiatd bon graft.lov D, Pritchard M, Burgss T, Van Dr Mr G, R, Williams S,. ANZ J Surg Jan-Fb;79(1-2): Rviw of Halth Tchnology Assssmnt in Australia (th HTA Rviw) Barwon Halth Bon Bank 13 of 13