United Nations University Press is the publishing arm of the United Nations University. UNU Press publishes scholarly and policy-oriented books and periodicals on the issues facing the United Nations and its people and member states, with particular emphasis upon international, regional and trans-boundary policies. TheUnitedNationsUniversityisanorganoftheUnitedNationsestab- lishedbytheGeneralAssemblyin1972tobeaninternationalcommunity ofscholarsengagedinresearch,advancedtraining,andthedissemination of knowledge related to the pressing global problems of human survi- val, development, and welfare. Its activities focus mainly on the areas of peace and governance, environment and sustainable development, and science and technology in relation to human welfare. The University op- erates through a worldwide network of research and postgraduate train- ing centres, with its planning and coordinating headquarters in Tokyo. Medical biotechnology This book wasproduced as an outcome of the United NationsUniversity Institute of Advanced Studies (UNU-IAS) programme on Science Policy for Sustainable Development. The UNU-IAS was inaugurated in April 1996. Its mission statement is ‘‘Advancing knowledge and promoting learning for policymaking to meet the challenges of sustainable development’’. UNU-IAS conducts research, postgraduate education, and capacity de- velopment,both in-houseandincooperationwithaninteractivenetwork of academic institutions and international organizations. The Institute’s research concentrates on exploring the key catalysts and drivers of sus- tainabledevelopment,which oftendependon ourcapacitytoharmonize, ifnotoptimize,theinteractionbetweensocietalandnaturalsystems.This includes the development and use of new technologies and approaches; the study of major trends and pressures such as urbanization, regional- ization, and globalization; as well as the exploration of integrated approaches to policy-making, decision-making, and sustainable develop- ment governance. UNU-IAS website: http://www.ias.unu.edu Medical biotechnology: Achievements, prospects and perceptions Albert Sasson a United Nations University Press TOKYOuNEWYORKuPARIS 6UnitedNationsUniversity,2005 Theviewsexpressedinthispublicationarethoseoftheauthoranddonotneces- sarilyreflecttheviewsoftheUnitedNationsUniversity. UnitedNationsUniversityPress UnitedNationsUniversity,53-70,Jingumae5-chome, Shibuya-ku,Tokyo,150-8925,Japan Tel:þ81-3-3499-281 Fax:þ81-3-3406-7345 E-mail:[email protected] Generalenquiries:[email protected] http://www.unu.edu UnitedNationsUniversityOfficeattheUnitedNations,NewYork 2UnitedNationsPlaza,RoomDC2-2062,NewYork,NY10017,USA Tel:+1-212-963-6387 Fax:+1-212-371-9454 E-mail:[email protected] United Nations University Press is the publishing division of the United Nations University. CoverdesignbyRebeccaS.Neimark,Twenty-SixLetters PrintedinHongKong ISBN92-808-1114-2 LibraryofCongressCataloging-in-PublicationData Sasson,Albert. Medicalbiotechnology:achievements,prospectsandperceptions/Albert Sasson. p.;cm. Includesbibliographicalreferencesandindex. ISBN9280811142(pbk.) 1.Biotechnology. 2.Biotechnologyindustries. 3.Pharmaceutical biotechnology.[DNLM:1.Biotechnology.2.Technology,Pharmaceutical. QV778S252m2005] I.Title. TP248.2.S273 2005 660.6—dc22 2005018003 Contents Foreword .............................................................. vi 1 Introduction: Biotechnology, bio-industry and bio-economy .... 1 2 Medical and pharmaceutical biotechnology: Current achievements and innovation prospects ........................... 17 3 Regulatory issues ................................................... 45 4 The economics of pharmaceutical biotechnology and bio- industry.............................................................. 49 5 Promising areas and ventures ...................................... 76 6 Medical and pharmaceutical biotechnology in some developing countries ............................................................ 95 7 Social acceptance of medical and pharmaceutical biotechnology 114 8 The globalization of regulatory standards and ethical norms: Solidarity with developing nations................................. 140 References............................................................. 143 Index................................................................... 149 v Foreword Since the advent of civilization, biotechnology has gradually become commonplace around the world and it has developed into a global multi-billion dollar industry. But, as with many new technologies, soci- ety’s ability to manage, share and regulate the development and use of modern biotechnology poses many challenges, opportunities and even risks. The implications of modern biotechnology connote a broad cover- age of sectors and issues such as human health, industrial applications, foodsafety,andthelifeandhealthofplantsandanimals.Theriskscould includeeverythingfromgeneticallymodifiedorganisms,alienspeciesand introduced plant and animal pests, to the erosion of biodiversity, toxic weapons of war, utilization of genetic resources and ‘‘mad cow’’ disease. The UNU-IASProgrammeonSciencePolicyforSustainableDevelop- mentiselaboratingthechallengesthatarefacingmodernsocietythrough theadvancesinmodernbiotechnology.Itisdoingsobyexploringtheim- plications,impacts,perceptionsandprospectsforensuringthesecureand wise use in the future of products derived from modern biotechnology. This book by Professor Albert Sasson, Medical Biotechnology: Achievements,ProspectsandPerceptions,isthefirstinaseriesofpublica- tions that UNU-IAS is undertaking to present these broad implications of modern biotechnology and takes stock of the advances that have been made in recent years. The book first looks at the drivers of modern biotechnology develop- ment in the United States, the European Union and Japan and at what progress has been made in the development of biotechnology to fight vi FOREWORD vii major global health concerns such as Ebola fever, the human immuno- deficiency virus, the SARS virus and the Avian flu virus, before turning to some of the regulatory and public perception concerns. The book also provides a state of the art analysis of the progress of selected developing countries in the development of their own biotech industries. Finally, Professor Sasson examines some of the most controversial areas of mod- ern biotechnology, including issues such as stem cell research and gene therapy and some of the ethical issues they raise. Thefindingsofthisbookareavaluablecontributiontothestateofour knowledgeaboutmodernbiotechnology,totheUNU-IASeffortstoraise awareness among policy makers and stakeholders, and to educating the public at large about the greater implications and prospects concerning the advances of this rapidly growing new technology. A. H. Zakri Director, UNU-IAS This page intentionally left blank