Report on the

Executive course on genomics and public health policy

Muscat, Ornari 28-23 Septerriber 20@3

World Health Organization Regional Office for the Eastern Mediterranea~

Cairo 2004

O World Health Organization 2004

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Document Wl 10-EMIRPCiOI I/E/O5.04/192

CONTENTS

TECfJNlCAT. SESSIONS ................................................................................................. 2 ....................................................................... . 2 1 Genornics: scientific developments 2

................................................................. 2.2 Report on genoniics and world health 3 2.3 Top ten biotechnologics for irnproviry I!cath in dcvclcping countries ................... 5

...................... 2.4 Islamic perspectives on stem cells, cloning, genetic engineering etc 6 ................................................................................................. 2.5 Innovation systems 7

2.6 . Business models .................................................................................... ...... 9 .................................................................................... 2.7 Intellectual property rights 10

............................................................... 2.8. Regulatory systems and related issues 1 1 .......................................................................................... 2.9 Public cngngernents 13

.................................................................................. SUMMARY OF GROUP WORK 14

.............................................................................................. RECOMMENDATIONS 15

Annexes AGENDA ........................................................................................................................ l ' /

............................................................................................................ PROGRAMMt': 18 .............................................. I , IST OF PARTICIPANTS .- ..... .- .................................... 20

................................................................ . ADDRESS BY DK HIJSSEIN A (>EZAlKY 26

Over the past century. innovations in medicine. science and technology have resulted in improved health. quality of lifc and a rise in life expectancy for tnarly people ivorldwidc. I lowever, thc benefits of modern medicine continue to elude mil I inns of people in the poorer parts of the world. In thc Eastern Mcditcrranran Region there is a serious lack uf scientific capacity to absorb thc bencfits of biotechnology and apply it towards the health needs of the population.

'I'he Eastern Mediterranean Regiorl corisists of 2 1 countries. 'I'here is a wide range of scientific capacity arid health system development in the Region. For example, Egypt and Pakistan have made some advances in biotechtiology while some other countries lag behind. In order to assess the potential of genomics to address hcalth necds in the Region, the Eastern Mediterranean Regional Vfficc of the World Hcalrh Orgnnizarion and rhe University o i

'Toronto Joint Centre for Rioethics jointIy organi~ed an Exccutivc Course on Gcnornics and P~tblic Health Pol icy, on 20-23 September 2003 in Muscat, 01nan.

'I'hc overall objective of the Genomics Policy Exccutivc Course was to familiarize participants with the potential of genomics and related biotechnolugies to address health needs and to collcctivcly address thc qucstioil "How to h ~ s t I - t n r n ~ q ~ gpnnrnirs tn in ip rnv~

health i n the Eastern Mediterranean Region'!" Part~cipants from I 3 countries of the Kegion reprcscnteri a wide rar~gc of stakeholders i n the crncrging arca of genotnics a11d included scientists from acadcni ic institutions and i ~dus t~y . industry executives, legal and rcgulatorv oilicials, W 110 representatives and the media. Spcc~fic objcctivcs of thc coursc were to:

familiarize participants wi t I l the curretit status and in~plications of health genoti~ ics/bic>tcchnology, and to provicic in fortnation relevant to pub! ic pol icy on health gcnonl ics/biotechnolngy; provide frarncworks for arialysing and debating ttlc policy issues and related ethical questios~s in health get~omics/hiott.ct~~lology, and to help urider-star~d, anticipate and possibly influc~~co the legal nrld regt11:itvry fi-amcwotks llndcr which hcalth biotec hnology industries will opel-ate, both nationall} and i titernat ionally;

w hcgir~ developing a11 opinion-Icadcrs network ;!cross diffcrcnt scctors {itlclusrty~ acaciern ic, governnient. NGOs) by sharing pcrspcctives and bui Iding relationship.

I-lis Escellency Dr Ali Bin hloharnrncd Hill Moc>sn. Minister of I lealth, Oman, presided over tlic opcning ccrctllorly of thc Esecutivc Coursc in tie~lornics 3rd t'ubliz I Iealth Policy. tIe hailed tile el'forts of the W1 I 0 Regional Office and the IJnivctsity of 'Ibronto Joitit C:ct~trc for Bioethics in urganizing tlic Course i v i t t ~ a view tc! L I S I I I ~ biotecl~nology 2nd genorrlics to improve health in the Region. Hc csprcsscd liopu that the n.orksliop wo~tld bc successfi~l in drafting the necessary rccoriimeridations to s~~ppor-t hIembrr States in tt-tcir efforts to harness genom its for pub1 ic henltli. I-le obscrvcd that i r i s very irri pot-tarlt to acknowlcdgo tflu

eno~-mot~s potclitial of gerlorrlics I+ ithiri ;i ivide f ran~c ivu tk of hcalth. Stressing t he complesity of biotec hnologjv and yenornics. hc 11oted the need for intc~isive I ~ L I ltidiscil,l irln1-y and n~uItiscctorn1 action to b r ~ n g the t r ~ ~ ~ t s of gcrlomlcs to the K e g ~ o n .

Dr Hussein ,4. Gezairq. WHO Kugiurliii Dir r ~ t u ~ f u ~ the Cnstcx-n h1criitcrranea1-l.

expressed h o p e that the workshop would provide the impetus needed in the Region to promote biutechnulogy and genomics for hcalth, tie pointed out that the sequencing of the h ~ i m o n gcnotnc would likcly cnhunce understanding of how genes function. This ~ v o u l d

enable the development of new and improved techniques for the diagnosis, prevention and treatn~erlt of not only genetic disorders, but also many con-lmunicable and noncommunicable diseases. Dr Gc7ait-y obscrvcd that it was llnfnrt~inste that many countries of the fiegion have not given enough attention t o genornics, but was confident that the workshop would help to highlight the tt*emcndous pote~ltiaf of this science. Of paramount importance was the need to develop relevant human capacity and institutional infrastructure to support gcnornics and biotechnology in thc Region. These efforts, he said, must be coupled with measures to creafc enabling cr~vironments in which scientists and policy-makers could perfonn. Dr Gczairj pointed out that thc course was in many ways a landmark event that allowed the oppnrtunity for sen io r policy-makers, scientists, membcrs of the private scctur and other sectors such as the media to discuss and debate the issue of genon~ics and its relevatice for thc Kegion.

Dr Peter A . Singer, Director of the U~~iversiiy uf ' l ' t ~ ~ u n ~ o Joint Centt-c fnr I3iocthicu.

introduced thc coursc and described the rncthodalogy and programme. The course agenda, programme and list of participants are attached as Annexes 1, 2 and 3 respectivcly. The fill[ text of Ur Gczrtiry's address is included ns Annex 4 . Dr Ali Jaffcr Suleimar~ (Oman) served

Chairman.

2. TECHNICAL SESSIONS

2.1 Genurnics: scientific developments Dr RiurJ D c y n ~ i ~ ? r i

Dr Riad Raynumi described the current state of genrlnlics and reecnt advances that havc emerged ftotn the genomics r~vn l~ l t inn , tnuching ~lporl topics such as bioinfonnatics and proteomics . I-le began with basic cor~ccpts in modern genetics and nlolecular biology? describing t l~e structure of DNA and thc central dogma of DNA lo IiNA to protein. I le went

u n to detail the historical t in~e l i~ le o f important discvverics in ge!ictics, starting frorrl Mendel's cspcrit~lcnts to the con!ple:ion of t l ie seq~lence of the l~iirrlarl genome. I le described the sequencing strategy of the Human Gctiomc Prnjcct, as we!! as the shotgun S C ~ I I L ' I ~ C I I ~ ~

aplsroach by C ctcra. The Human Gcnome Project Ied to thc e s t a h l i s h ~ ~ ~ c n t of public databasus that serve as respositories of genetic scili~ur~ce data, as wcll as functiatial arltl protein databases, such as C;cnl3ank, OMLbl and Swiss-PROT.

Ncw sc icn t i fk dcvclupn~ents that have resulted fro111 the gc!iotliics rt .vulurior~, such as

proteomics, were a '-IIUW llur~ia~l biuIogy". Iri tllis, tllc structure and fil~lctiotl of all proteins tvould be ~ I ~ O I V I I . and their con~ples interactions. both n i t 1 1 each othcl- as wcll as w i ~ h thc envtr-onmerit. under.stood. Orlier ndvn~ lces l l~r-i l I1;iic r cs~~ l t cc l f t u r ~ l tllc gcr~nrnics rcs,olutio~r

itlclude l r~appi l~g of single nucleotide poIyrnorphis11is (SNPs) to fi~rrhcr ~~ncfcrstat~d human genetic variation and its rclatiot~sllip with disease: gene e..;prr_.ssior\ chips ttn tnonitor tlii'ii-I-crltial ~LI - l r : T K ~ I C S S ~ V I I iirld idcr~tify dnlg tnlgets; n ~ i d h i o i ~ l f ( > ~ . ~ ~ i : ~ t i c s AS :i I I ~ \ V fielci tl?:it

cotn bines biology mathematics. sratistics and computer programrnlng to rn ]nu largc-scalc biological data. He ci>ncluded by saying that the human genome sequerlce is tllc beginning of a new era and that tIic ability to descl-ibe all human physiology at the rnolec~ilar level would revolutionize biology and medicine.

' I he discussion began with a qucstiotl on access to infomati011 for scientists from the Region and Dr Bayoumi assured the participants that all genomic data are freely available in tht: piihlir rlnmain Most, if not a1 I nf the d n t a h a ~ e s he described are public. 1 Iowevcr. the key

to using these data eft'ectively to scnJe health in thc Kcgion is scientific capacity. Sonle infrastructure and capacity exists, but Member States will need a regional strategy to build upon existing capacity to effectively capture the benefits of thc gcno~nic rcvnlution. 'Thc participants ngrced that scientific capacity must be built in the Region. but pointed out that

there is also need to raise awareness of genornics among decision-makers and political lenders, and ;I need to create r i l l ef fect ive palicy network between them. This network, for which WHO-EMKO might takc responsibility, could help to improve capacity i n the Kegion by paving the way for regiotlal collaborfition. Countries of the Region will benefit most frorn genomics if they conduct research themselves and choose their own strategic points o f entry without relying on the rndustrialrzed world. For this i t is critical to cngagc and mobilize younger generations and providc then1 with the training, skills and resollrces tllcy noed.

- - - - - . . - -- . - - - - - - - -. - - - - - -

KEY MESSf\GE Over the past two decildes there have been uo~)recerlenterl advances in Chu life scicnccs that have tremendous potcntial to irnprove hurnan hcalth. Existing 1 scientific i d professional capacity in the Eastern Mediterranean Region is insuftlcient to ci~pturc the potcntial of the genornics revolution. and the Region must tluild capacity in order to best harness these advanccs to imprnvc hcalth in the Kcgion. 1 - - --. - . -- --- - . - . . -.

2.2 Report on genomics and world health Dr i i lcxlmdcr Cnpron

The Wf I0 report (ienorrtiu.v c r r d ~rrnrlti hcnltil was prcparcd at ttic rcqwst o f W H O L)ircctor-Cicncrnl i r i 2001. Follo~sing a coi~sul t ; i t ion proccss that lcd to ~Iie dt-ali ~ c r s i o n in

Septerr~ber 2001, the rcport was revised by the Advisory Committee on Hcnltll Rescai-cl~ for final rclease in 2002.

The report covers an ethical fran~c\vork of Justicc. rcspect for autonon~q: non- tt~aleficcncc and be~icticcricc. Justice relates to appropriate dcvciop~ner~t of capacity ill basic reseasc h and relevance of this research to tlic I~caltli tlceris oc tl-ie pop~il;~tior\. Respect for

ailtonomy involves cotnri~itrnent to consent in the use of geuonl i cs tect~rlologics along wit11

social schemes for "opting out''. -l'lic potenrial risks of Siotccllriology ciernnnd adhcrcnct. to the PI-inciplcs of riotl-maleficcncc nlid /~t . i tnlrtu ?lor1 ~zou~r .c . Hcneticcncc puirlts tr? thc potential for benefits of gc11on1 ics to the populatiorl.

Dr Caproll called attcntio~l to the lack of i t~cc~it ivc to invest for diagnosis or trcatmcnt or diseuses rhar pritlcipal ly a Wect resource-poor countries. 'I 111s rcsl~l ts 111 thc I ll!L1O gal, Irl

WFIO-Eh!/RPCIOi 1 '1: Page 4

global biomedical research, where 90% of the attention in health-related rescarzh gcies towards relieving just 10% of the burden of disease globally. He cautioned that the benefits that result from gcnomics research are most likely to be relevant to those countries that have

a functioning health care system and represent the market to absorb new applications.

The genomlcs revolution gives rise to several new technologies. s:~ch as gcr~elic

screening, DNA databases and pharmacogenetics, that raise ethical concerns. For instance, genetic screening seeks out defects in individuals and raises the risk of unfair discriminlt' ( ion. This is especially sensitive with respect to disability rights. Similarly. genetic databanks. such as Decode in Iceland, could lead to individual discrimination as well as group stigmatization and need to ensure strong confidentially protections.

Recommendations from the WHO report include increasing technical cooperation between WHO and Member Statcs (c.g. assessing the health impacts of genomics research to

support informed priority setting; capacity building for genoniics research and hiotechnology in deveioping countries; development of ethical review stnictures atid bioethics capacity) and enhancing WHO'S normat~ve functions (e.g. developing regulatory principles to safe-guard

against the risks and hazards; advocating a balance between well-tried research me tho do log^? and genomics research; ensuring that advances from genomics are accessible to developing countries; advocating increased investment in genomics research directed :it the health problems of developing countries; promoting educational atid public engagc~rlent programme< for genom ics).

The discussion began with some questions on the science of pharmacogct~ornics to cIarify the definition of SNPs and to understand the relationship between genetic variation and dlsease prediction. The participants raised the ques l i o r~ vT 11vw tilt. ~ecu~nn~endatiuns o f

Genomics ~ n d world h e ~ ~ l t h relate to Mernber States, and how the Member States should coordinate regulations and regulatory systems. Dr Caplaon responded that the report provides guidelines and recommendations, but not "regulations". 'The report offers models from experience so that Member States can use them to develop capacity to dcal \ k i t h developments in genomics. The principle of confidentiality, a well-established rncdical principle, was seen as very important. In addition to ethical issues arising fro111 the misuse of gene databanks, the participants pointed out the importance of intellectual property rights (IPR) issues related to knowledge derived from populations I t was felt t h ~ t there i q an urgent need to develop gu~delines fur research going forward.

KEY MESSAGE The 2002 WHO report Grnomics r ~ t z i l world hrtiltlr pr-ow-ides an in- depth examination of , genomics and its relevance to gloh:~l health. The recommendations outlined fo r both the N'orld Health Organization as \\ell as its member states are a useful framework with which to sddrcss Lhe pote~rtii~l benefits as well as risks of genomics fur health. Countries of the Region must act fast to de\relop appropriate etliical guidelines for ger~et ic I-esearch, screening and testing with particular reference to health nceds of the Region.

2.3 Top ten hiotechnologics fur improving heath in developing cotlntries Dr A bdulluh DL~LII'

The Top 10 Biotechnologies for Improving Health in-Developing Countries were identified through a study conducted by the linivcrsity of 'lbrcnto Joint Centre tbr Bioethics and supported by the Canadian Program on Genornics and Global 1Iealth. As the 10190 gap indicates, most basic research is concerned with the priorities of industrialized nations. The lack o f gennrnics applications in developing countries may contribute to the creation of a genomics divide. Given the current state of affairs, it is difficult to see how genomics will have a positive impact on five sixths of the world's population.

Genon~ics and wurlri heultlz recommended that WHO "should develop the capacity to evaluate advances in gennmics, to anticipate their potential for research and clinical application . . . and to assess thelr effect~veness and cost in comparison to current practice". To encourage the successful applicatiorl of biotechnology to global health, the University of 'Toronto Joint Centrc for Bioethics carried out a technology foresigllt exercise to identify priority technologies for developing countries. The study, completed in November 2002, identifies the tell rnost promising biotechnologies for improving health in developing countries in the next five to ten years.

Dr Daar went on to describe the rr~ethodology of the study. An intcrnatiunal group of cmincnt scicntists with expcrtisc in global health issues was asked to identify the top ten

biotechnologies for improving health in developillg ccuntries. The scientists were askcd an open-ended question: "What do you think are the major biotechnologies that can help improve health in developing c o ~ ~ t ~ t r i e s in the next five to ten years?" The panel was then askcd to idenlify the criteria driving their choices: impact, appropriateness, burclen, feasibility. knowledge gap, and indirect benefits.

Using ll~t: Delphi method, three rounds of personal interviews, e-mail messages, faxes and phone calls helped to achieve consensus. Analysis of the input generated the final list, which Dr Daar described, using specific exatnples of each technology that are applicable (cr in some cases even in use) in dcveloping countries. The technologies arc shown below.

Modified nlolecular technologies for affordable, simple diagnosis of infectious diseases Recombinant tecl~nologies to develop vaccines against infecticus diseases Technologies for more efficient drug and vaccine delivcry systenls Technologies for environmental improvement (sanitation. clean water, bioremediation) Sequerlcing pathogen genomcs to understand their biology and to identify new antirnicrobials

Female-controlltrd protection against sexually transnl ittcd dise:iscs, both ~t ' i t l l and ~vi thot~ t contracepti\.e effect Bioir~ror-ri~a~ics LU ideri~ilj/ drug Largels a11d iu t..xa~rli~~e pu r t~~gc~ l - l l u~ t i~~ tc r i r c t i c~~rs

Genetically rncidified crops v/ith increased nutrients to counter specific deficiencies Recombinant technology to make tlierapeutic products (for cxanlplc, ins~llitl, interferons) morc affordable Co t~~h i~ ia to r~a l chernist~v for dnlg discovery

l'11c: rc:;ults offcr c r u i J n ~ ~ c c to t b v ~ c 1% hv c u l l i ~ i I? L I L ' I ~ U C i l . : ~ d i ~ - ~ t i i ( > t ~ t:!' ~ C ~ U : I I . L ! : ;li:i!

dcvelopmcnt. 'I'hcy also ci-tallenge ctnn7niurl I i t t i i.cIt.~ancc c i F

biotechnology for developing oou~~tr icc . as shou,n by rii;lpy?ii:i.r rlltl top 10 hioti.cl?r~o!o~ics onto t h e 1 lh' hl i l l~nn iun l Llcvelopment Gnsls.

1.0 fosrer biotechnulogy in developing c u ~ ~ n t r i c s it is csccntial tl> h ~ i ~ l c i sapilcity

(among researchers, politicians, tegisiators. entrcpreneilrs ptc) i n t11c:rc zor~n tries. !-Ie

described various initiatives that do this. such as the Fogrlrrq. [ntcr-:~atio~~al t'cnter programlnc to train mid-career professionals in bioethics at the Joint C'CII tre frlr rlioetll iss.

The discussion focused on t he affordability ot' biotccllni~lopy a1)1~lic;1tio11s f i ) ~ . developing countrjes, 1 o I l luslrnte the ntt01,dability of t ~ i u t e ~ h ! ~ o l ~ ~ : : v ,.. tools. otle of the pal-ticipants presented the exnnlplc of hcpatitis B vaccilie. Ide inrlr ~ ; l t c d t11;it the V I I C C ~ ~ I U IS

priced at IjS$ 20 pet- dose, but that an Indiati biotcchnolvgy company hz~s dcvelopuct tI!c tcchtlology to pruduce t l ~ c : v i l c ~ i r ~ c i111cl is selling i r ar 1!S.$ 0.2'1 PUI. C ~ O S C . -l Ills, i l l O l ~ g wlt11

recent certification by the W i lo, has rtiadc i t possibtc for LWIC I lt; lo p~~ncut,e millions of doses of Shanthn Biotechn tcs' hepatitis 13 vaccitlc for distri butior~ iri tlcvulopirlg col~ntries.

It was also pointed o u t that capacity r1ct.d~ to bc l7i11It it1 suvcral scctors. and that

perhaps the study dcscribcd by Dr Daar c o i l f t i bc crll~:tt~cucI tly tlle incl~lsiori of l)oIii> -tn:lhcrs in the Delphi process I~ '~~rt l icnnort~. t lip fu i :~~s t' t l ~ c t r j p 1 il t c c i ~ n c , l c ~ ~ ; ~ : ; seeni:; to I,c

comtnunicablc disoascs, with low represontatinn of H ~ I ~ ~ O I ~ I ~ I ~ ~ I I I I C ' ~ t~lc rliscnsc.;. Althr,uSI~ i t

was recognized that techriology is not the solution to all PI-clblcri~s 111 thc rlcvclopi~lg WOI-Id, the possibility of "lcap-fro4iq$ngM to new tcr:l~~i~,lor,:~cs w;ls ~ ~ ~ l 1 - r ~ r : c i v c ~ i .

..... - .... - . . .... .... . . - .... - .- - - - - -. -.

KEY hZESSAGE Gcnornics and reI;itc~I t ) I~ ) tc~I~~~o log ics E:III hc r ~ I ~ v ; l ~ t t to dcve!opinji countries, i is iflustri~tt.d by the 1Jnivcrsity of Toronto's l'orcsigl~l study. I n onler tl~r harness the potential of theso tc.chr~ologiub, i t i s usscnti:rl to b ~ ~ i l c l c;ipacify in thu - 1

! developing world. . . . . . . .... . - . . - -- . -. .- -- - -. .- - - j

2.4 lsirrmio pcrspuctives on stcrn crlls, cloning, genetic crrgincct.ing vtc. 1.1~ i\ l o /w t~ i tn~ ! l / L,j I f l t / ~ -

Applicd aspccrb o f rcl;casc.l~ in biotcuI~nt-)lng~~ I ~ a \ . c gi\ c*!) ! ~ s c t i ) ;i ~ ~ ~ ~ r ! ~ i l c t - nf issric;; i l l

bioett~ics. Thc huri~an FCIIOIIIC S C ~ ~ ~ C I ~ C C ; I I I ( I ~ [ I I c I . I - C ~ C I I I ; ~C I \ ;~ I~LJ~ 'S in I>i(.-ltcchvoloy>- iniplications f o r t11c I s l r ~ ~ n i : : \~~orlcI . 1:or hl115li1ns t l~cr -c ; ~ t - i . t ~ ~ o 1!1;1jo1. Soltl.crb r ~ f ~ L I ~ ~ ; I I I C C : t l l ~ Q ~ i l a n , w h ~ c h pl.ovidcs n code c-)f c o ~ ~ t i ~ i c t , n ~ l ~ i 1112 bod!. of hntiitl~. \-{I~i:h Arc ~ n ! ~ i ~ i y \ or

a c t i o ~ ~ s xct- ibcd to t l ~ i : I't.ol111ct b l ( > h ; i ~ ~ ~ ~ n ~ d (PI31 11-1 ). I ,'~i115 I I ~ C S U ; I I I ~ otllcr S011I.CL'S. [ IS :I I ~ ~ o v i d c d evicle~jcc rn illiistratc Isl ; i~t~ ic pctspccti\ c5 orl gctlctic tCsl ill!:. if i i i 'rti l i ' t~.

abofiitrn, cloriing. rccombiriat;~ Dh':2 tc'chtlolo;! n t ~ t l ntlicr gcnorrl~ic.;;-t~c.!;~~~rI t ~ r : l ~ ~ i ~ l o ~ i c s . Llqing these cs;rml)lcs, l lc sh~>\t.crl r l l ; i t Islarli arld si. iC!\cc 1 1 : i \ . t ; I ! \ \ ; I \ '% l?ccn ;il i ? ~ ~ c d th1-ul1y11 history and t l ~ ; ~ t Isla111 crlcou~.;tsc< S C ~ C I I C ' C . :\I I \ ~ L ' i a l l l c t ~ I I I C . I . i l ; \ r ~ ~ ic [?CI s ; ~ c i t i \ - ~ - ; OII ~ S S L I C ~

rniscd hjr thc gcrlotnics ~ . c \ c l l ~ ~ t i t ~ r ~ ;~r-c L I I I I L I I I C to the l:nstct-n ,Llcdrft.!.r.a~~c;t~~ Kcyic)~~ n11cI t i l t

Region's religious leaders and scholars must take the initiative to funhel- develop these

concepts and formulate recommendations.

Discussion

Keligious leaders play a critical role in the acceptance of tlew technologies, so early cngagcmrnt of rcligiuus Icadcl-ship is csscntiill fur thc Rcgiuii tu pluglesb. Lack uf

inforn~ation car1 lead to mishaps that may be of detriment to the Region. Furthemorc, it is important to be careful about portraying L'lslarnic" perspectives internationally. The term "Islamic" should only be used when referring to a primary source, such as the Quran, hadith and sunna. An important observation from this session's discussion was that the consultative process of decision-making that i s typical of IsIan1 is likely to cffcct change in the Muslim world over the next ten years.

. ..- -

KEY MESSAGE It is crucial to involve, inform and engage religious leaders in the Region in order to promote genomics and biotechnology for improving public health. In doing so, i t is worthwhile to note that lslarn and science have always been aligned through history and it is well-established that Islam encourages science. Furthermore, the Holy Quran can hclp to guide hioethics in the Region. --

2.5 Innovation systems

Dr I'eicr Singer

?'here are many reasons for a co~rntry to innovate, among them meeting the needs of its population, developing its technology sector and creating new econorn ic opportunities. Nntionnl systcms of innovation (NSI) llavc hccn idcntitied as tltc " ~ ~ c l w v r k ui' irislitutior~s iri

the public and private sector whosc activities initiate, import, tnodify and diffuse new technologies". At the core of NSI i s the concept of interdepetidencc and non-linearity.

Institutions that are clustered together geographically tend to be linked by cornmonalitics and complernentarities. Clusters generally have n conlpetitive edge by, for instance, taking advantage o f increased access to knowledge and other resources. i)r Singer illustrated the innovation power of clusters with clusters in the IJrliled States, such as the pharmaceutical cluster i n New Jerscy and Pennsylvania. There arc a numbcr of critical factors for cluster omergencc, for example a research centre such as a university or govcmment institution that represents knowledge itlfiastn~cture.

Despite the identification of factors that foster innovation systems, there is nn nrlc model that guarantees succcss; each country follows its own urliql~e path. The application of NSI to developing co~intries is a fnirlg. recent concept. The Canadian Programtne on Crenomics and Globat Ilealth is currently in the process of cond~~c t ing studies of tlie NSI of 7 d ~ v ~ l ~ j p i r ~ g C U U I I I ~ I ~ S : Brazil, China, Cuba, Egypt, India, South Africa and Soul11 Korea. Ur Singer presented sotrle pretirninnry results from Cubal Egypt arid SoritI1 ..Zfr~ca. I n Cuba, f~or

instance: thcrc i s emphasis on health, education and sciences and their s>ncrgic cffects. I'herc has baen cons i s ten t and Iont;-tcmm support by thc political icildcrsl~ip i - i ~ ~ d il C r ~ u s url a l u ~ a l

problcm (~nrningit is B). This problem has sewed as a source of innovation Iciiding to the

'VV~IO-F;\!~RP(" '0 I 1 1-

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dt.velupincnt of thc m e ~ ~ i n ~ i t i s 13 vaccinc . which propcllcd C u b a to t t ~ c fnrcfront of

biotcchnology. In Egypt, the government has played a prominent role but the private :;ector contribution to the NSl has been weak. Govcrn~nent efTo1-t~ to builrf hefilth bintcchnolo_gy appear to bc s>,sten~atic and are promotiny the devclopnlcnt of centres of rcsearch esccllcrlcc.

Sotne challenges include weak pharmaccut ical research ai1:3 deb-clnprncnt and I in1 itod linkages behvecn the main institutinr~s in the country. Currently, there is stror!ger en~phasis nn ter.hnnlngy transfer from abroad instead of developing loc:iI innovatiotls although this appears to be changing, with the cmergerlce of firms such as VACSERA. 'I'he main irnpedimerlts for innovation appear to be lack of funding, inadequate tcchtlical cxpcrt ise and bureaucratic complexities. Dr Singer concluded with questions for the pnrticipant.s, ~ v i t h a focus on countries of thc Eastern Mediterranean Region.

How successful dn you t h i n k the Eastern Mediterrancarl Rcirifin ha< hect~ iri gctlntliicq Ibiotechnology? What are the reasons for its success or lack of success? What are the most helpful steps to foster genome innovation in the Kegtoti'!

In respurwe to Dr Singcr's questions, participants fronr Egypt, Islalnic Kepi~blic of Irarl: Lebmon, I1akistnn and -1'unisia described their col~ntrics' biotechnology i 11 tiovation systems. In Egypt, it i s recognizcd that advances i n intellectual propcrty rights may be in1port;lllt to

cncouragc inriovatiori. Thc Minister of I Icalth arid Population has taken a kcen interest in improvirlg linkages bctwccn sectors to er~hnr~ce intersectoriil cutnmunication. I'rjvate scctvr dcvelop~~ler~t is of high priority, as itldicated by goverrlnler~t support of cotnpnnies such as VACSERA. In the Islamic Kcptlbl~c of Iran, thc trade embargo has Icd to ;l shortage oi' lirnds, but has in sotile ways helped to strengthen thc ~rlr~nvatiuti systetll t l ~ m ~ ~ g l ~ the liccd for self- reliance. ? h e Islamic Republic of I r ; ~ r l and Cuba have reachcd an agt-eeltlent lor coopc~.atiuri and transfer o f technology to produce hepatitis-R vaccit~e, interferon-cx, streptokinaso anti erythropoietin. 'I'he Islan~ic Kcpublic of Ir a11 t ~ d b dcvclvped scvcrnl pruducts bascrf nn

rccomhinant DNA tcchnulugy, and thc ~~~~~~~~y is also active1 y hirilding tcscarch coltaboratiuti networks. Pakistan has had some succcssus i n agricultural biotcch~~cllogy a l~d mndc so~nc odvunces in biocthic:;. Although thcre are pc>u!erful i n s t i t~ r t ions i t ] place, tlrc,

country rleeds to cotititn~e to strengtlien facilities, reso:lrccs arld human capitnl. cT'l~urc i s n

need to bring products to thc public. I_eb:~r~on has a well-devclopcii healti1 industty, a t ~ d llns dcvrIuped rup r r t ir;? in genetic tesling. biocthics and ir~tullectunl property rights. It kvas f It that surveys uf national innovation systenls in the Region W O ~ C csscntinl tor t i i r ~ l ~ c t .

devcloprnent of the coutitry's i~inoviition sys t c t~~ . Tunisia has strong researc!i infrastnicii~t-t.

and has made advances it1 ~ e n c t i c counselling, cytngcnctics and diagrrosis ot' g c ~ ~ c t i c

diseases. along witI1 regulation and legislation. 110~vcvc.r the j)hnrnlncc~~t-ical indost~y is not ablc tu optimize the potential of public sector research. for which regional c o o p e r a l i o ~ ~ ~vuu lc l be valuable.

- ---A .- -- --

KEY MESSAGE Several developing countries such as China, Cuba and India are investing in biotechnolog and have developed strong biutechnology sectors. A study of these advances nil1ri11 the co~ l tex tua l framcwork of nutionul systems of innovatioil can

help tn identify factors for successful growth of biutechnology sectors. Other developing countries may benefit from this knowledge.

2.6. Husiness models 12.ir Khcrlil Ahrned Ur t'eler Singer

Shanthn Biotechnics, bascd in Hydcrabnd, India, was stai-rcd I 1097 by urltrepreliculs. Will1 c~~ t lo~se~ i i cn t by the Omilni Minister for Foreign Affairs, seed tnoncy lvas

heavily supplemented by the Government of Oman, which now urvns half thc company. Writhin four ycrirs, the conlpany was able to cornmuroiall7c SllanvacrM B, a hepatitis R vaccine based on recombinant DNA technology Shnntha i s the tint Intlian company to get i ts

hepatitis t3 vaccitie certified by WI 10, paving the way for IJNlCCF to buy 8.5 million doscs for distribution globaily. The company recently received a iong-term order from Islamic Repitblic of Iran for the supply of 10 million doscs of hepatitis vaccine annually, and a similar thrce-year order from Egypt.

Another recombinant product, interferon alpha 2b. has also hcen launched, under the

brand natrlc SllanferonrM, in partnership with Ptizcr. Shanthn okrctcnme hurdles such as disruption of eflicacy trials of ShrtnferonrM on monkeys by animal activists i n 1999, which dclayed the process o f introducing the drug interferon alpha 2b in tIic Indian market by two years.

Mr Alirncd pojntcd out that Sl-iantha has worked hard to launch ~vorld-class products at affordable prices for developing counrrics, bur srresscd that rhe legal artd regulatury cnvirunnrent i n developing countries should help to fbster privatc et~tetpl- isc, An ctlnbling environment can help private iirrns grow and acl~icvc much more. Ciovernment s ~ ~ p p o r t for privatc scctor dcvciopmcnt is csscn tin1 to build indigcnuus cxpel.tisc.

Shnntha is developing therapeutic hunran monoclonal antiboti~es alorlg with its U.S. subsidiary, S l~ :~n t . l~a CV(:st Inc i n Snn n i ~ g n 111 r~rnpnition of t h e co1-npany's achicvcments, Shantha was awarded the 2003 National Technology Award (for the second time) for 'svccessfi~l comn~crcialization of ilicl~genous technologqb'

Thc prescrltatiotl was ruccivcd with t~-ertlendo~~s cntli~~si;isn~. The successes of ;I

hiotechnoiogy firm in a dcvclopir~g count1-y were seen as a source of ir~spirarion by fhc

participants. The discussiun began with spucific qliestiotis otl ttlc demand and sale u f hepatitis B vaccine in India. to which h,lr Ahrned responded that Sllar~\,at: H cotrl~nands ahout 50% of tlic l~rdiiin mcr~-lict.

The issue of-cl~laltty control was raised. specificaliy h o ~ v (d i t i i c~~l t is i t fhr compnnies in

developing cuunrries to mect international quality standards. Mr Ahrned nckr~owlcdged that developing countqr biotechnolopy products are faced with credibi l i t~. issues and arc subject to close moniwring for quslliry. However, ils Sllarrllla Biu iec l i~~ics l ~ a s sllu~vll t111-nus11 the

recent WHO certification of the hepatitis-B vaccine. these hrlrdlcs can be overcome and can lend credibility to research and development and priviitc firms in the dcvelopin_r, \vorld.

-. P - . - - - - - . - - -

(KEYMESSAGE Private sector success can be achieved with determinetion and support and commitment from develsping country governments. Indigenous capacity in hirbterhnnlnm can bc built and can lead to economic success as well as self-sufficiency

health. - - - --.-- -.--

2.7 Intellectualpropertyrights Dr Richard Gold

111 his presentation on propet-ty in biological material, i)r Goid described the !xisics of' ~ntelIectual property rights, pacenrs and copyrigh~ issues, as well ilu tllu pulicq- u p t i r ~ n s f 7 t -

dcvcloping countries i n the international context. Intellectual prupcrty (LP) can bc an effective policy tool by regulating activity rclated to ktiowledge creation, innovation, dcvclup~ilc~tt, cu~nrncrciali;ration and urrc of new technologies. In ;b sense, 1P confers private

rights in order to achicve tht: p ~ ~ b l i c good. Ilr Gold used the nlicroscope as an exn~nple to dcmonstmtc different ty pcs OF propcrty rights: the physical microscope is the purcllfiscr's; the right to ninkc and sell microscopes i s t h y patcnt holder'%: the ri&t tt) il:lta r r ~ l l e c t e d throt1gt.l the use of the microscope i s the researcher's, etc. 'I'radc secrets anti patents arc the two rnain w i y s of protecting biotechnology innovation. Although there is n o siriglc ir~ternationnl pntcnr syc;tem, co~rntrier can SII bscribc tu irttornationai treaties whose pi~rpose is tn SL'I rnjnirnurr~ standards, filcilitatc patent application in inany courltries 3rd recogni;re thc right r>t'peuple to apply f i ~ r patents in other cour~tries. 'l'he primary purpose of a patent is it~ccntivc fbr- disclos~irc of kl~owledgc that i s beneficial to society. An irnpot-tant point abuut a patentable invcr~tion is that in patent law. soinuttling i s an invention if it ~ v o u l d not exist in t l~c form described w i t l ~ o ~ ~ t hl~man inlerver~tinn. 'I'hcrcforc. it DNA scqi~er~ce by itself catinot bc p;~tentcd, but a gcneticnlly niocliticd U N A sequence, or a clnr~cd LINA sequcnce may be potut~ted.

DNA sequences arc special becat~se they blur the line bctrveen an nhjcct (the scqucnce itselt) ;u>d know ledge - (rhr basic scic~lrific infunrlatiun~ 111i1i 11-11: suc l t ic~icc I epi-cscnts).

InternationaI agreen~ents csff'cr considerable flexibility to c o ~ ~ n t r ~ c s on how to nppty patcnt l a ~ v s to genornics anti bio~echnology. 2nd dcvolupirlg countries havc a nutnbcr of options.

such a5 c u ~ ~ i p u l s o r y I iccnsins ~ u t ~ c l rcsci~rct~ csct~lpt innn. r o dca1 wit11 prr~pcrt). r~gh t s .

I hc discussion drew out firl-thct details of pntcnts 011 biological nlaierial and their consequencas for dcvcloping countries. Dr Gold was of thc opinion that compulsory licensiry c<\ul(I bc the Ililpt: fbr developing cnuntric.; and that natio~lal l;\\vc; ~ h o u I d penni{ cor~~pulsor>, licensing. I le clatificd r l i a ~ scqticnct. discrn.cr-~. i tsclf is nut p c r c c ~ ~ ' c t l ns nrl

irrventiun but tllat flllicti011 m ~ ~ s t bc dcscritxd to I I I C C ~ utility. I'hc forczs of g1cbalizatiun must balance forces of protectionism. especially by the industrialized ivorld. and both national and regiorlnl regirncs should rcspcct international patcnt law to takc ad\*anrngt: of ~lobalization. If developing countries are involved ~ I I inte~~lational rescarch collaboratio~ls. they' should ensure that ttlcy obtain pntcnls, 111 view or this, i r i s esse~ltiril fijr d1:vcloping countries to build capacity and training in patent law and learn how to forn~ulnte ef'fectlve pntz:lts. Curre~lt ly the T R I P S ogrccnient is for-r~lulatcd in tcrnls that allow for tlcxibility in intcrprctntic~n. If

developing countries take advan~age of this, the TRIPS agreement can bc used to their advantage, but failing this it would rriove towards Ihe industrializcd world rnodel of intellectual property rights.

KEY MESSACiF, Tllcre are several ways to protect property. l'i~tents, ibs upposed to trade secrets, encoungc disclosure of information ancl spread of knowledge. Patents lead to ethical conccms, such as how they affect access to healthcare, but application of patents to biotcchnology is still evolving and flexible. Developing countries must build capaciiy and knowledge in order to choose the best policy options to reitp the benefits of the internatinns1 patent regime.

2.8. Kegulibtory systems and related issues Dr D. r:. . JU~CI .S t i r i y ~ ~ I>r ,4 n, rlcw 1 f i ~ z . s i t r z

I I l ~ r i l ~ g thc tlrst part of this session, L)r Jaynsuriya gavc 21 presentation on how law can facilitate best use of biotcchnolopy. ' I ljc Ic,qal status oi'h'calth irlterventions and tcc!lrlcJogi(:s call take seve~-aI forms: they can be expt-cssly pcrrii itteci. speci tical ly prohihi tud , tacitly tolcrlltcci u r f i l l within "grey areas''. Hcaltli law hiis 21 t ~ l ~ n ~ b c r of functions, such as regulating procedures and i~ltervctltions. I iccrisir~g health service providers, rcgistcr-ing insritutions an J cstablislling ir~stitiltional n ~ c c h a n i s ~ ~ i s . arid scttir~g standards. 'The IegrtI framework i s madc u p of laws. regulntions. orders, dccrccs, guidelines. hilntcral and intcrn;~tiona! trcatics and convcntinns. utc.

The I J n i v c ~ - ~ i ~ l L)cclar;irion on thc f Iumnn Cicnorne a1-1(1 If 11 t r i i ~ t l R~ghts M-3s adq>te(i hy IINESCO in 1997 and by the I!N Ciencrnl Asscritblj in 1998. The dcc1nl.atio11 states that thc hr~tnatl gcnnrnc i:i, i t 1 n s~.rr~hr>l iz scnsc, t l ~ c I I C I ~tiigc or l~urri;irii~>. i t 1 1 ~ 1 that everyone has n

right tn respcct for thcir J i g ~ ~ i t y and for tl~cir- riglits reg:lrd!ess uf their gcl~ctic chatactcristics. In order to reform Iarv in t i l t C O I I ~ C S ~ of genol~iics. it is i ~ ~ l p ~ ~ t i i r ~ t ;is ;1 first step to identify Ifiw~, r t . g i ~ l a ~ ihns and ~ u i c l c l i ~ ~ e s r e l ~ t i n ~ to tucnoi-rlics and health. 7'11oir nppliciitiut~ n c ~ d s to

bc rc\,ie~vt.tl and aciaprcd ;is r cq~~~rec i . eitller tlisc~ugh ~i~odilicatior) or ttlrough t ' s t t t ~ d i r l ~ tllc scope of ekisting legal niechanism<. I s g a l tcfornl i s ccscntial is hccnlisr. the scicjlcc is r ap i t l l~ evolving, and thcrc a]-t. et-ncrging cn~-tcct-tl< r r , l : l t in~~ to p:lticr~ts' t-ights, er i~plc~~ .ce rights. rncdical l i ab i l i t~ etc. F~~~rlicnriat-c. intcr~lational nol-111~ ['or Ilaturlt protcctiorl and prupcrt>, riglits are evc>lvin2. I3r .lit> asuri>.a cc~~ic l~ idcd \>I- p t ~ c s u r ~ t i t ~ ~ tOu Jr;l\-s in l ~ h i c l l J~c;~lth

Inu can l'niilitatc best ~ i s c u f biotecl~t ic l l~>g~,: h>' proiridin: ftv f i~qt- t rack nppt.uv:~l of

biotechnologv products; reducing import duties on health ititerventions: and allowing multiple channels of procurement and distribution to improve access and optirnize prices.

In the second part of the session, Dr Nasiln talked about regulatory svstenls a r ~ d related issues. Biotechnology holds great potevtial to irnprnve health and the environment, but also potential risks. It could have adverse effects on biological diverslq, hunlan health and the envlronn~ent. Modern biotechnology includes many technologies that could raise regulatory concerns, such as transgenic organiqms. genetic screening. clonlng, stem-cells. and DNA patenting. Regulations are req~~i red to qafeguard the environment and people from negative consequences of the practice and application5 of biotechnology products. Rcgulatic~~is call also ensurt: the safe devc lvp~ne~i t o f b i u t e c l ~ r ~ u l u g ~ j ~ ~ u d u c l s a11d ll~eir safe appl~cation. A national-lcvel b~osafety s!/stcnl s l~o~ i ld provide gu~~ l t ' l I I IZS for use and I-clease of biotechnology products conduct b~osafety reviews rind risk asscssrnents anci formulate mechanisms for feedback to irnprovc the syctem through cxpcrience. Reginnal cooperation behveen these national biosafety systems is essential. There arc a nurnher of documents on biosafety guidelines, such as the Cartagena Protocol on Riosafety, the IrN Food Hiowfety Pact, and the Kio Declaration on Environment and Development.

In Pnkiqtan, thc National Commi<sion of Biotechnology, established in Novembcr

204) 1, focuses on biotechnology regulatory issues in agriculti~rc, elivironment, industtx llealth, and animals. Dr Nasim illustrated the pros and cons of biatechnology with the example of genetically modified c ~ u p s . FOI example, genetically ~nudificd rvuds orfer a way

to quickly improve crop characteristics such as yield, pest resistance, or herbic~dc tolerance. often to a degree not possible with traditional methods. FIowever, they also entail risks, such as unanticipated allergic responses to novel substances in foods, thc spread of insect resistance or herbicide tolerance to wild plants, inadvertent toxicity t o benign wildlife, and increasing cvi~tsol of agsic~~lturc by bintechnology corporations. Some of these risks could be mitigated through elimination of antibiotic resistance and othct- marker genes engineering plant chloroplast DNA that 1s not spread through pollination Dr Nasim concluded that bint~chnnlngy h a s a n~rn lhc r nf hencfits 2nd risks and that the purpose of biotccl~nolog~i regulation is to optimize the balance between them.

The participants agreed that each courltry in the Region should try to set lip n National Biotcchnoiogp. Commission whose purposc would be to hclp devise regulations to facilitate

biotechnology. It should have broad cross-sectoral representation in oriicr to rninin~izc tile negative effects of inter-inst~tutional rivaIry. Although regl~lations do exist In tnost countries, ~mplementatlon and enforcement o t lcglslatlon IS poor. I+u~-tIiermor-c. most countrres In the Region worlld benefit from long-tenn capacity bullding in ethics.

- - - - -

/KEYMESYA(;E Science sllould be permitted to rnijrrh fanvnrd, but reg~l i t tors and [law-tnakcrs must keep up with the science and should not lag behind. -- -A

'IVHO-EhI,'RPC/O WE Page 13

2.9 Public engagements hfr Ehsan Masood

Mr Ehsan Masood began by defining public awareness versus public information versus engagement. Whereas awareness and information lead to public icnowledge, what matters most is the active public engagement based upon informed knowledge that stimulates the momentum towards improved public health. Eie pointed out that public engagement is far

greater in today's world than it has ever been in the past. This is because of several factors including: a) the implications of research on public health are enonnous and fast growing; b) increased awareness in civil sucieties to invest in health care and research; c ) increasing

awareness for empirical evidence for policy change and action; d) improved health leading to overalI national deveIopment; e) significant economic paybacks in health care industry and fi development and access of ~nformatlon technolog~es developing In the public dornaln.

When people are given a choice, the pace of research could change. Approaches to health care become more sensitive to addressing directly the public needs. He exemplified the increasing role of public engagement in health in Europe and In the United States, underscoring the need for media to be culture sensitive and specific. He cautioned against campaigning journalism and unprofessional practices where wrong story (message) may get highlighted with harmful repercussions. He stated that media can sornetirnes be a force f ~ r goad, and it is necessary to understand what media can d o well and what it cannot do.

The discussion focussed on use of media to influence change in health with specific references to rhe cultural and religious sensitivities of the Eastern Mediterranean Region. It is important to protect the public from potential possible harm resulting from situations with conflicting interests. There is therefore need for caution, guidelines and regulations for information transmission and protection.

In countries under development, l i ~ e many in the Eastern Mediterranean Region, the public health information systems are less developed. In such situations the media plays an

important role in raising awareness and alarm against emergencies and disease outbreaks. Media is increasingly used in many countries of the Region and i t is important that public health specialists and ltealth xientists sliould bt: c~cuu~agec l tu ellgage dctively dibst-~riiriate

e~ridence-based and correct ~nfonnatiot~ in disease prevention and control through m c d ~ a

I KEY MESSAGE Public engagement can change the pace of research, leading tq / increased opportunities for greater societal involvement for improved health care. 1

I I Media can be used as a catalyst to raise community awareness for social beneficence, 1 equity and justice in health care. 2

On the last day of the moeting the participants Lvere divided into jive groups. Each croup was assigned the task to on tllc dcliberatc t h e key y i ~ e s t i o n " I low best to harness L

genomics and biotechnology to improve the health of the pcnpic in the Eastern Mediterranean Region?" Following a two-hour discussion each group presented an overview of the discussion. A summary of the group discussions i s given below as bullet points.

Harness political support from the hishest authorities i n i tldivic1u;il countries. Establish a national focal point (coordinator) with executive trlatldate and power to support and coordinate activities at national and regional levels. Provide n one-year time-frntne to initiate specific activities airncd at developing genetics and biotechnology withiti Member States.

At national level, out focus on political commitment, resource mobilization, raising a~,~areness, insti tuting regulations, legislations, guidelines for safeguarding ethical and

equity principles, undertaking research and implernet~tation o f programmes. At regional level, focus on coorditlation and networking, rcgiotlal bodies a11d pnrtnerqh ipq nnrl bin-wfety g ~ ~ i d e l i n c ~

Kcy i~~tervetltion areas shol~ld include developtnet~t of vaccines. diagz.~oslics and

therapeutics.

?'he areas nf focus should include: a) raisit~g awarcncss and advocacy; b) cducatioti anci capacity building: c) bin-safety; d) conducive environment for scientists; e) resource mobilization anci nat~onal, regior~al a t~d intet.natiotla1 collaboration; and f) ir~volvcrr~o~lt of youth at all lcvcls. Si tunriorl analysis of currenr htarus with rcspccr to gcncrics and biorcchnology

putcntia t in the countries should bc carried out \+ ith a view to a) identify strengths and weaknesses and b) develop a database. Countries nccd to dcvclop strntcpic and opcrntionnl p l a t~s to dcvclop gcnc t i cs n t ~ c l

biotechnology. EMKO s l ~ o ~ ~ l d support national sitriatio!~ analysis uffr~rts, proviiie tecl~nical arid f innncinl support. facilitate natiL\nal atid slnhnl t i r h ~ ~ n r k ~ t ~ c rlnrl <haring nf hcqr

practices and succcss stories, provide advice to Mctnber Statcs on TKIPS and bio- safeq, and develop r~~onitoring a11d cbraluat iotl s~~s t cms .

Focus 011 raising awnreness throuyl~ h 'G0s . c i ~ i l soc~otics . ac:lrlutuic ins t i t~ i t io i~s and

U I ~ ~ ; ~ I ~ ~ L ; ~ L ~ U I I > L I I I L I I cl I ~ ~ C J L I S l ~ n d i c s .

Dcvclop networks on genomics and biotechno1ogy and bio-informatics. EMRO to support national efforts throirgh establishlllellt of Re3ional Advisory C'ummittcc for Cienomics and Biotechnology, iinernational publications and dissemination o f infonnation, development of rlational programmes on disease

diagnosis, vaccines and drug development and environmental biotechnology.

Member States should establish a national task force to undertake a situation analysis, define ctrnttagir vi<ic\n 2nd ilirtlr;tion, fhrmulate national policy and raise awareness.

Member States should focus on priority issues (e.g, ir-ifrastructure developrnent), networking, rcsource mobilization, monitor~ng and cvalualion m ~ c ~ ~ a n i s m s and enabling legislation. EMKO should advocate for increasing political con?mitmcnt from Member States to support genetics and biotechnology and i ts applications in health care and support

national htlrnan resource development programmes in this area.

1 . Each Mcmbur State should create an effective national body on genomics, biotechnology and hcrtlah, if this function has not othenv~se bccn estnblishcd, it~clirding a coordinator who will serve as the focal po111t for this activity The membership should be multisectoml and include youth, womcn and civil society. 'l hc focus s h o ~ ~ l d itlclude ethical issues.

2 . ?'he national body on gcnotnics, biotechnology and hcalttl s l l o ~ ~ l d ~ C V C I O P progra~rilt~es of pub1 ic; ~ W ~ I C I I C M drid t'rlgigernct~t. Important Target groups ~nc lude r t led~a and religious leaders as wcll as the public at large. The discussio~l should include etliical issues.

3. The national body on genomics, biotcchnology n r ~ J health should encourage ncadon~ ic itistrtutions, including schools and l~rliversities. to ~ n c l u d e 1iealtl-i biutechnology topics \\ i thin their curr ic~i ln arid creatc ~ p e ( - i a I i 7 ~ d prclgrn111111t's and degrees r\ hc1-e appropi.inte. 'I'hcre should be particlllar ernpliasis un ICT and b~oir~forrnatics.

3 The nntinnnl bocly on gcnnnlrcs. hiott.chnuIogv and health. in collaboratiori with the r-cle~ant minisrr~ts, should cfevelop a plan to irltegmtc gunet~c and genorriics p~ocilicts (includitlg diapnustics. vacclrics. thurnp~es. and n t l~e r ~cl~ot l i ic : priorities), within the Ilcalth system and pub1 ~c health progrn1ntne.s. Thc url~phrlsis c h n u Id be on ncccssibili tv and equity to improce the health uf the poor.

5 Based otl evidcrice from a nntio~lal survey, Mcm ber- S t n t e ~ s l ~ o ~ l Id devclop and adopt. at

rhc Iligl~esr level. a nnt~unitl b~c>lcchnology stratcg~'.

'A 1 ~~>-T3bl/TII'(:;\~l 1 , F

Page 16

6. I'he \\orkshup recommends that thc Kegional Director advocatr ivs\..ith Member States at the highest level for actively cons~der ing t h ~ pmpnvilq of this workstsap and tor giving

priorlty attention lo genomics for health and health biotec hnoloev. Effective advocacy rnaterial should be disseminated, emphasizing the link w-rth povcrry alleviation, public lle2lth nhjrrrives. and nccd for transfer rand ir~ternalizatinn) of technology.

7. EMRO, in collaboration with the Organization of the Islnm~c Conference Standing

Committee for Scierlce and 'Technology (COMS'I'ECH) and otl~er relevant groups. should provide coordination and networking arrlong nattonal biotechnology bodics and coordinators to exchange information, expertise. tra~ning and regional experience in production and utilization o f health biotechnulogv.

8. EMRO, in collaboratiatl with Member States and their nationlil biotechnology bodies. should coordinate a national survey of health biotechnnlogy innovation systems. including scient~f I C and managcmenr capacity, goverrlrrlerll pulicica, l~gisldtion and

regujations, ititellectrial property policies, private sector activity, and stre~~gths, weaknesses, opportur~ities and threats.

9. EMRC), i n collaboratior~ with C0MSI't;;CH and Member States, should develop a proposal for a Regional Genom ics anci t lealth Kescarcll Fun, cmpl~asizing both peer I-c-vic~vcd rcscnrch and cnpnciv strengthening.

WHO-EVli KPC, 0 I 1 ; Page I '

Annex 1

AGENDA

1. Opening address

2 . Genomics: scientific dcvcIopnicnts

3. WHO report on genornics and world health

4. Top 1 0 biotechnologies for improving tlcalth in developing cour~tries

5. National innovation systems

6. Business models in genomics

7. Intelluctual property rights

8 . Regulatory systems

9. Ethical issues, Islamic perspectives on sten1 cells, clorling and gcneti:: engineering

1 0 . Pu t~ l i c crlgagement and nenvorkil~g of opiniots le:itii;rs

Saturday, 20 September 2U03

OX:30-1 l :OO Opcnir~g address H. F. Dr ,411 R i n Lbi~~osn, Mnistor qf Heallh, Oman DP H ~ ~ s s c i ~ .4. Gozairy: Rogiontrl D i ~ c c t a r . EMRO

Introduction and course overvicw Tt.u~~,fi.orn Iiniversiry oJ Totwnto

Introductory remarks: gcnoinics and thc public hcalth perspective

Dr rlli ,J~!fcr Sl~leiw~un, Minisrrj~ u/'Herr/ih, Omun

11:OO-13:OO Genorn ics: scientific developments Dr R i d Buyotini, , Y Z ~ ~ C I M @ ~ W I W . C f r ~ i l ~ ~ r . s i ~ ~

14:OO-15:45 W H O report on Cienomics and world hcalth Ur Alcx~lnder Cnpnln. Direcror, Dcpcrrtmcnt of Ethics, Trodc onrl Humun Riglrts, WHO/'HQ

15:45- 16:30 'fop I0 biotechnoiogics for improving health in developing countries l)r Ahduil(rh IS: DCICII; I j j ~ i ~ v r ~ i t y (~f . ir i )rot t f~

Sundity, 2 1 September 2003

08:30--09:OO Summary 1-jr P L J I P Y ,J. , S ~ ? I , ~ P ) ; L r ~ 7 j ~ ~ ~ ~ ~ . s j f v of R w ~ ) ~ ! o

09:OO-1 I :00 Isiamic perspective on stem cclls. cloning. genetic engineering. ..ctc Dr !2~?ohanz~ncci i l l Ilirr: King filhd X1edicc~I Rc.rcaroh C'c?rtri), Sril,~li Arcrhicr

b\,'HO-EhIi'RPC:O I 1 ;:L Page 13

Monday, 22 September 2003

0830- O9:OO Summary Dr Porr~r. A. Singt'~ Chliversiry uj'Turunlo

09:OO-i l :OO Intellectual property rights Dr Rirqharrl G ~ l t i , ibf(:Gi/l rJniver.vity, Cenlrc jilt- lntel/eclual Properly Policy

11:OO -12:30 Regulatoty systems arid reIated issues Llr U. C. Joyus uriyu, Uireclo~ !JIVA IDS; P~rkistun Dr iinlvur ~V(z.cirn. Chairman, ~Zrcrtionrti Council nj' Biotechnolo,): P L ~ kis f cm

12:30-14:OO TRIPS and pharmaceutical issues in public health. Dr Abdef Aziz Suleh Speoiul Adviser to Ihc Regional Director ,for blediuine, WHO/EMRO

i 4:30-16:OO Public engagement hir Ehsan hf~rsood, Sciilcv.nor, linircd Kingdom

16:OO- 1730 Ciroup work

Tucsdsy, 23 September 2003

08:30-09:OO Golden Nuggets (prev ions day's sum tn.ary) DI- Pctci- A. L5'itzpcr; r/ltivo-sitj/ ~ f - T o r o t r ~ ~

09:OO-,-OC):30 Opinion leaders network l j r I'e~cr A. Singer, I;r~iversi/v u/~Turonfo Dr Taru Achtrryr. Universi/y ofToronto

09:30 - 1 1 :00 Ciroup work

I 1 :OO - l 6 : O O Group presentations and discussion

16:OO - 17130 Rccorn menciations Dr Ptlfer S'ir~grc Ijr~j\'ersi!y qf'lhronio

17:30 Conc Iuding I-etnnrks and ciosurc of the workshop

WHO-EktiKPCiO I 11 E

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Annex 3

LIST OF PARTICIPANTS

BAHRAIN Dr Shaikha A1 Arrayed Director

Genetic Unit Bahrain Medical Centre Manama

EGYPT Dr Marwa Nagib VACSERA Cairo

Dr Ezz El Din Llcnsllary Faculty o f PIlarmacy Cairo University Cairo

111- Wagida A. Anwar

Professor of Community, Environmental and Occupational Medicine Director of the Genetic Engineering and Biotech Centre .4in Shams Ur~ivcrsibr

Cairo

[It- Ali Haggag

Faculty of I'hal-n~acy Tan ta \ Jn iversity Tan ta

ISLAMIC REPUBI,IC OF IRAN Dr biosscin Mnlek Afiali Dep~ity Minister for Kesearch and Technology Ministry of Health and Medical Education 'leheran

Dr Sayod I-Iossein Davoodi Exccul ivt: Allv i s v ~ tu Ucputy of 1 lealth

Ministry of I-Icalth and Medical Education Batidar A bbas University Hundur Abbas

WHO-EM/RPC/O I I !E Page 2 1

Dr Mohammed Kahirn Kadivar Associate Professor of Paediatric Infectious Disease Vicc-C~ha~~ccllor of Public Health Sbiraz IJn~vet-sity of Medical Sciences Membcr of Committee of Health Promoti011 Ministry of Health and Medical Education Tehcran

JORDAN Mr Salih Artitneh Mcdia Development Director Television and LZnJio Institutirri~

Amman

Dr Adel Bitbisi

Director Communicable Disease Control Directorate Ministry of CIealtll Amman

KUWAIT Dr Lulwa Abdelrahrnan A1 3eryan Senior Molecular Biofogist Molecular Genetic Centre Ministry of Public t-Iealth Kuwait

LEBANON T)r Fouad Houstani I'resiclent

National Con~~ni l tec fur I Iealth Ethics Beirut

Dr N imat Assaad Kanaan Director General blinistrq. of Social Affairs Heirut

Dr rlsaad Rizk Fornier Mir~ister of 1 leatth Beirut

WHO-EM:KPC/II I I /PA

Page 22

his Chalica Sassine Media Representative Beirut

NlOROCCO Mr hdot~atned rimouu i Ilead of Laboratorj of Genetics Pastcur Institute Uohot

OMAN Dr Sarnir Ismail Al-Azawi Senior Consultant Haemotology Department Mirlistry of Health Muscat

Llr Salarn Bin Salem Al Kindy Deputy Director and Consultant I Iaemotology Department S u l ~ a r ~ Qabuus IJrkiver sitg

Muscat

Dr Rind B n y o ~ ~ m i

Professor nnci Head Depart~ncrlt of Biochcmistq Fsci~lty o f Medicine Sultan Qaboos University Muscat

T)r I leenn Kamez Mahfouz Study Specialist Mitiistly of l~lforrnation Muscat

Dr An3 liagab C'OII.;~ ltant and !-lead Dcpa~tment of Cienctic I3 lood Disorders Ministp of Hcalt l~ ;VIuscar

Dr A l i Gaafar Mohamed Suleiman Director General of Health Affairs Ministry o f Health Muscat

FAKl STAN

Dr Iasleem Akhtar Executive Director Pakistan Medical Rcscarch Council

Islamabad

Mr Ejaz Rahinl Secretary Health Federal Ministry of Health Islamabad

Dr Riazuddin Sheikh Head National Centre of Excellence in Molecular Biology Lahore

SAUIII ARABIA I)r Khalid Mohnrnmed J . Merghalnni General : < U I J G ~ v i ~ u r

tlealth Information and I'ublication Department Ministry of Health Riyadh

SUDAN Dr Sawsnn Mustafa Abdulla Kesuarch Directorate Fcdernl Ministry of Health Khartoum

Dr Nngucb Suleiman I11t.cctor National Hcalth Laboratories I-edcl-al b1irlistr-y o f I-lealth Khartoum

WHO-Ehl!'RPCiO 1 l i E

Page 24

SYRIAN ARAB EruaLIc Dr Fadi Sakkal blinistr~ of Health Damascus

n r Mahrnoud Zarour Ministry nf Ht::ilth

Da~nascus

TlJNISTA Dr t-labiba El Cl~aabouni Bouharned Mem bet- of the Technical Commission o f Arab League Genetic Diseascs Prevention and Genetic Counselling Professor of Mcdical Genetics Chief of Congenital and Hereditary Diseases Department Tunis

FACILITA'TORS

Dr Tara Achnrya IJniversity o!'Tol-onto

Toronto CANADA

Ur Khalil Ahrned Executive Llirector Shantha Biotech Bombay INDIA

n r Mohamed Ali AI-Bar Consultatit in IsIani ic Medicine King Eahd Mcdical Kesearch Center Faculty of Medicine King A b d ~ l ,4ziz IJniversity Jeddah SAIJDI ARABIA

I l r Abdul lah S. Daar IJ~~i\ersi t j uf 'h i -onto

Toronto UAN:IDA

WHO- E MIRPCIO 1 1 /E Page 25

Dr Kicl~ard <;old IJnivursity of McCiill Toronto CANADA

Dr Dayanath Chandraj ith Jayasuriya Dit-cctor UNAILIS Islamabad PAKISTAN

Mr Ehsan Masood Surrcy UNITED KINGDOM

Ur Anwar Nasim Science Advisor and Chief of Biotcchnology

Islamabad PAKISTAN

Dr CIamaI I . Serour International Islamic Center for Populatio~l Studies and Research Cairo ETiY P'T

Dr Pcter Singer University o f Toronto 'T'oranto

CANADA

WHO Secretariat

Dr I Ir~sscin A . (.iczai~y, Rrgiur~al Direclur, WHO/EMRO

T)r M . Hnqtham Khayat, Senior Policy Advisor to the Regional Director: WHOIEMRO Dr Abdel Aziz Saleh, Special Advisor i o the Regional Director for Medicine, W HO/EMRO T)r Ihrnhirtl Abdt.1 Rahim, W HCS Kepresentativc, Oman

Dr Ef Fatih El Snmani, W H O Representative, Iran Dr Hnbib Moharnnlead Latiri. WHO Kcpresentativc, Lebanon L3r Khalif Bile Mohamud, WHO Represent~tive, Pakiqtnn

Dr M. Ahdur Kab, Regional Advisor, Research Policy & Coordination, WHOIGMRO Dr Alexander Capron, Director, Department of Ethics, Trade, l luman Rights, and T,aw. WI (O!t IIJ Mr. Amr El Sheikh, Computer Suppport, WHC>/EMKO Ms May F.1 Sasiakouss>~, Seuior Adtninistrative Assistant, WI-IOIEMRO hls l r~ lan Zaki, Adr-ninistrativc Assistant, ?irHO/Ornan Ms Amani Kanlal, Secretary, W HOiEbf RO

ADDRESS Rk' IIK HI!SSEZNA. GEZAIRY W HU Kk,C;IUBAL L)lKk.C,' I'OK F'UH I ' l iE EASTERN hIEDITEKHANEAN

EXECUTIVE COURSE ON GI'NOMICS AND PUBLIC HEALTH POLICY Muscat, Oman, 20-23 Septeniber 2003

Ir gives me great pleasure to ~ve lcome you all to this beautifill country of Omati on this important occasion. I would likc to first of all thank I Iis Cscellcncy Dr Ali Dill bluusa, Minister of Health, for graciorisly ncceptrng to host this Executive Course on Genotnics and PubIic IieaIth Policy here in Oman. We are all honoiired to be here and grateful for the ~ ~ ~ I H - O U S Iincpitality that His Fxcellency and nlenlbers of hi< team have extended to us.

We gather here today to deliberate on the vital issue of getromics and biotechnotogy. Advances in this tcchnolopy her rcvcdutinnnry insights not only to global health care but

also equally, and perhaps even tnore importanlly, to related sectors such as agriculture and economics. Unfortunately, Inany countries in the Region, likc other developing countries, have thus far not given cnough nttentiori tu this subject.

The unrabelling of the human gerlorilc stn~cture and the understanding of genes and their functions have erlabled the development of new and improved techniques for the diagnosis, conlrol and prcvcrition of not c111y gonctic disorders, but also many cotnmunicablc

nnd noncumn~unicitble diseases. 'I'hc understanding of microbial genomes has pioneered inventions and in~provernents in diagnostics. and has also stiruulatcd drug and vaccine r~evelopincnt. Similar stivanr:cq in f igr ic~~l t t 1r3I hioi~[:hllnlogy and the resli l f i t ~ ~ increase food

and crop production bring rerlewed hope to the 111 illions of starving atld impoverished people across tllc i t n r l d .

'Thc study nncj dcvcloprncnt of gcnot~lics and biotcchnology providcs us wit11 unique opportuniries to cur11 bat i l l health. Ncrv avenues for minimizing and even eliminating diseases have been opcned. Disease prevent ion tcchtliql!es such as carrier de tcc t io~~ , prenatal dingr~osis, p r r - i r~~plgn ia t iun diagnc.rsis and I:ew c-tfkctivc vaccines are developing fast. Highly

s c ~ ~ s i t i v e and accurate ciiagnostrc techniq ucs arid more predictive testing technologics are now available for prevention of diseases. A11 array of new and effective drugs and interventions arc available to cure but11 corr~~i~utlicable and not~communicnble diseases. With cach passing da). crrres for diseases such as malaria, tuberculosis. AIDS, d~abctes and even various cancers once considered ir-lzur;~blc. draw closer to bt.c.onling a reality. Research in thc human erlorrle has revolutioni7cd organ rl-ansplr~nt tecllnology, and the role u f biotcchnology irl r-ever-sir-rg t.nvirurlr~rcrltd dcgradaticlt~ is now being recogtljzcd. Clearly, the technology has an enortnous potential, for r~o t only the developcci world but more so for the developing \vorld.

bloivevct.. as thc ~ c n o ~ i l i c revolutioti ushers us int-o the era of a "new health world 011Jcr", ~ V C must reuogllize that along 5vjtJ1 irs p ron~ ise, the social jn~plications will also be vct-y broad. Biolcchnolc.rgq' perhaps c a n ~ m t solve the deep-rootcd pr-oblems such as povcrtjV for those who live u n d e r IJS$ 1-2 per riny. i ~ l \ o s c !)lain needs are o l c a ~ ~ dri~lkirig-water. food,

shelter and iivelihood. Genomics i s inherently controversial because of its central role in jssues such as reproduction. race. prlvacy and finance. Aiarnls have all-early been raised about eugenics. cloning, discrimination and genetic determination. Even without genomics we are witnessing technical abuses s11cl-1 as prenatal sex selcctiorl in some societ~es. The

development of genetically modified foods, so called "Frankenfoods", and creation of "biological Frankensteins" are real public health concerns and worries. Critical social qucstiui~s, S U C I I as whet11e1- the new tech~lulug~cs fi71- ~rcading u u ~ gc~~clic, ~ u ~ ~ h t i t u t i r ~ ~ i w i l l

challenge our identities, our fundamental rights to privacy or our freedom from discrimination, loom largely unanswered. Cloning of animal species is now an established technology. Serious corlscqucnccs of these experiments are coming to light as well. I t

remains to be seen whether these are technological flaws or nature's way of responding to those who tamper with i t !

1 1 1 i f ~ : recerll pas1 t t ~ e Regional O1'fice has been actively engngea in raising this issue. In

2002, the Kcgional Consultntivc Comrriittec recommended afI?rmative action for dcvclopmenr of biotechnology and bioethics in the Kegion. 'l'hc same ycar, the Kcgior~al Advisory Conlrnittce for Health Rescnrch, in its 20th sussion, cctcnsivcly dcbntcd biocthics

atid biotcchnology development in the Region and made strong recommendations to policy- makers in Member courltries to take necessary actiotl to develop capacities for prornotilig the use of genetics and hintechnnlngy Cp~r:itirnlly ~rnphnq i7~d was the need for providing

support to developing rcsourccs, raising awareness regarding ethical, social and legat issues arnurlg comnlumi tics and stakeholders ar~d identifying specific areas of health cvhich rnay benef i t from hiotechnology developmci;ts.

Of paramount importance i s t!lc need to develop relevant human and institutional infrastn~cture to support biotechllology. This must be coupled with nlcasures to create ~ u a h l i n g t~rivirc~nnients i n which h igh ly qualified scientists can perfvrm. Countries w ~ t h the

most intellectual resources achicvc the highest rates of econonlic growth and developmer~t o f

science at id t~chnology. A recently pub1 ished report from onc Mcmhcr State illustrates these issucs. The country spent alr~iost IOU t ~ ~ n e s its per capita incorne on each of the I h candidates for doctoral lcvel training abroad in the area of hcatth sciences over n 7 to 8 year period. Just over half could be traced in thc col~l~try , and many were not working in the nrcn they had trained in. 'I'his is a cIassic picture in most developing countrie5, and one that must be reversed. 'l'hc orlly way to do so is through strong puliticai action to put into place praciicus and pot icics that respect and reward trained scientists. Without political will and concci-ted action, the iildustrializcd couritries wilt co!~tinue to grab the [ion's share of' human resources lrom the develop~ng world. I'hc need f'or developing human resou t-ces i n gcrletics and biotechnolugy is, by l'rlr, t t ~ c rrlost acute. The diversity nf i ts scicncc, the associated social, legal and ethical ran~ificatiorls, issues of intellectual property rights, trade, bio- infni-rnatics, la tgc-s~ulv uppur~ur~i i i t .~ fur research and dcvelopn~cnl of products are complex but inter-related components and products of biotechnology. iVe nccd to Icarn from dcvclnpitlg coiirltries such as Brazil, China. C:uba a11d 11lciia. tvhicli 11ac.e understood the value o t' ;he emerging science o f biotcchno!ogy and arc t ~ o w c o ~ n p c t i ~ ~ g wit11 1111. i11cluslr~ia1izt.d world. Building a11d retaining indigenous capacity for genetics and biotechnology nlust

bccorrie a priority, as this i s l~itnl for sustainable dccelopnient. Fnill~rc to do so \ \ ' i l l have cata~trophic tmplicatint~r; Clr2t-Iy. r.n~lntrics in the R c ~ i c 3 1 1 need to 3ct fast to rncct tllest'

clli~llengcs, othenvisc bridging the 10i90 Snp in hcaltll will rcrnain an elusive drean~.

\\ ti(>-1.M t<I'C;Ol Ilk

Page 38

l'he c~rlguir~g clebalt: i l l thc World ?'radc Orgnnizntion'v C'oun~ i l nil ?rade Kelnted

Aspects of' Intcllcctunl Property Right, or TRIPS, on the implementation of various articlcs o f Doha Declaration on TRIPS and Public Health has raised serious corlcerns on the availabiltty of ncw drugs, including those that may result from gcnnrnic and proteomir r e ~ e a r c h , tn

developing countries. The controversy ovcr thc actual cost uf research and development of new drug entities has added to the concerns over lack of transparency. Although compulsnry licensing can contributr tn better fivailahility of new drugs to countries k i n g public health emergencies, i ts effectiveness may be hindered by several factors, including lack of production capabilities and necessary technological proficiency.

One possible wily tu ensure mcdicinc for all is the establishment o f global fund

managed by WHO that couId negotiate and buy patent rights of new drugs for developing countries. Tllc fiind would take into considcrntion the reasonablc cost of new innovations and thc share of developirlg countries in the gloh~l market, which i s usually !ess than 10%. T i ~ c fund could also cover the cost of contracting research studies or1 new drugs for diseases of developing countries that may not attract the interest of niultinational drug companjcs, and prnvide funds for capacity-building in developing courltrics it1 areas of new technology including genomics and proteornics research.

Thc agerldn for this meeting is comprehensive, yet specific. Equity, justice and fairness appear to bc thc ovct-arching principles of this debatc. Ethirnl : ~ n d legnl matters, issues nf' intellectual property rights and trade, and policy developtncnt and networking will take centrc stage alongside discussions on science. This gattlcritlg will provide the basis of a road map for c o u ~ ~ t r i c s of t h e Region to Lake the steps necessary to hanless hiotechnojogy towards better ar?d Inore equitable health care. All countries nccd to consider and identify areas of human and pathogcn genomics that have dcvcloped to a stage where they have direct clinicai or public health impact. They need tn ascertain how such technologies can be effectively developed and utilized w~thout major increases it1 health expenditure. 'The technology should not be forced at the expense of effective and prover) convetitional approaches to disease control.

This meeting is in many ways a landmark event. It provides an opportunity fbr scniur policv-makcrs, scientists, geneticists, hcaltti managers and members frum related sectors and civil society firom the Region to discuss and debate this issue. The outcome of this meeting will Iargcly clctcnnine the policies, strategic directions and actloris of Member States and the Rcgional Office for biuteclinology research and developnlent. I am confidctlt that the distinguished pat-ticipants gathered here will be able to rccomnienc! the actions necessary and appropriate to advat-tce biotechnalogy within our social and cultural contexts.

Finally, It is my hope that this meeting will galvanize stakeholrlet~s at both country and regional 1cvt.l tn r:ike f i l l1 advantage of the power of biotuch~~ology to improve the health a11d

social well-being of our peoples. The ?.!st century will witness drarnatic developments i t ]

biological sciences. N o countt-y can afford n o t to invest ill th is technology. Frlilure to do sc will widen the global I~ealth gap at a rate never seen bcfore, i would like to thank the esteemed facilitators fi-om the University o f Toronto ar~d fro111 other i ns t i tli tions. fronl bcth within and outside thc Kegion, for suppor t i~~g out. efforts. I lvish all of 4,011 succcss and assure you of m y full support and coope~-atinn. Thank you.