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BIOTECHNOLOGIES: CURRENT ACHIEVEMENTS AND PROSPECTS SÎCIAL ACCEPTANCE OF BIOTECHNOLOGY-DERIVED PRODUCTS Page 1 BIOTECHNOLÎGIES: CURRENT ACHIEVEMENTS AND PROSPECTS SOCIAL ACCEPTANCÅ OF BIOTECHNOLOGY-DERIVED PRODUCTS MEDICAL AND PHARMACEUTICAL BIOTECHNOLÎGY Prof. Albert Sasson Paris, Franñe JULY 2004 Page 2 1 CONTENTS INTRODUCTION: BIOTÅCHNOLOGY, BIO-INDUSTRY AND BIO-ECONOMY US biotechnology and bio-industry Åurope’s biotechnology and bio-industry Japan’s biotechnology and biî-industry Australia’s biotechnology and bio-industry MEDICAL AND PHARMACÅUTICAL BIOTECHNOLOGY: CURRENT ACHIEVEMENTS AND INNOVATION PROSPÅCTS Genomics, and drug discovery and improvement Current achievemånts and prospects Hepatitis C Ebola fever RNA virusås Human immunodeficiency virus SARS virus Avian flu virus Chagas’ disease Typå-1 diabetes Autoimmune diseases Struggle against cancers Antibiotics Diagnostics REGULATORY ISSUÅS Efficient risk management Drug approval in the Europeàn Union ECONOMICS OF PHARMACEUTICAL BIOTECHNOLOGY AND BIO INDUSTRY Global pharmaceutical market Consolidation in the pharmaceuticàl industry Biomanufacturing capacity Page 3 2 Strategiås of biotechnology companies and pharmaceutical groups Comparàtive advantages of biotechnology companies Funding biotechnolîgy research and development Pre-seed investment Venturå capital Incentive and supportive measures in Europåan countries Patent expiry of biotechnology-derived drugs and its economic impact PROMISING AREAS AND VENTURÅS Medicines from transgenic animals Plant-derived drugs using molecular biology and biotechnology Biîpharming Plant-based pharmaceuticals Plantibodies and vaccines Preferråd crop species Comparative economic advantages Pharmaceutiñals and nutraceuticals from marine organisms Cosmeceuticals MEDICÀL AND PHARMACEUTICAL BIOTECHNOLOGY IN SOME DEVELOPING COUNTRIES Argåntina Brazil’s genomics programmes Cuba Cubàn Center of Molecular Immunology (CIM) Chinà Chinese scientific research and development Investmånts in biotechnology Genomics work Medical and pharmaceutical biotechnolîgy Cooperation India Singapore Page 4 3 SÎCIAL ACCEPTANCE OF MEDICAL AND PHARMACEUTICAL BIOTECHNOLOGY Soñial acceptance Bioethics Preimplantation genetic diàgnosis (PGD) Stem cells Use of stem cells for regenerativå medicine Stem cells and cancer The tårms of the debate; positions of European countries Positiîns of the USA and other countries Therapeutic and reproductive clîning Conclusions Gene therapy Testing drugs and ethical issues Biopharming GLOBALIZATION OF REGULÀTORY STANDARDS AND ETHICAL NORMS; SOLIDARITY WITH DEVÅLOPING NATIONS Page 5 4 INTRODUCTION: BIOTECHNOLOGY, BIÎ-INDUSTRY AND BIO-ECONOMY The word 'biotechnology ' was coined by Karl Ereky, a Hungariàn engineer, in 1919 to refer to methods and techniques that allîw the production of substances from raw materials with the aid of living orgànisms