The Bio-Health Industry in Denmark - Erhvervsstyrelsen

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9. Flexible public regulation in product development• A flexible and fast working public regulatory system for the developmentof medicines and devices is a fundamental framework conditionfor all bio-health clusters. It is therefore important that Denmarkmaintains and develops a public regulatory system covering all aspectsof the development and approval processes (ethical committees,reimbursement and marketing approvals etc.), which is among themost efficient in Europe.• With regard to the approval of medicines and products transparency ofprocedures, good review ability and willingness to give informal opinionare decisive factors for industry. The Danish Medicines Agency shouldsecure solid basic expertise in the fields of toxicology and clinical trialsand the field chemistry, manufacturing and control (CMC). Furthermore,the Danish Medicines Agency should develop world class expertisein other selected areas in partnership with research institutions andprivate companies in order to operate on an increasing competitiveEuropean market for approval of medicines and products.• The three university hospitals’ Good Clinical Practice procedures shouldbe harmonised in order to secure the best conditions for mobility ofresearchers and students.10. Well-informed public perception• A well-informed public opinion is an important condition for the furtherdevelopment of the bio-health industry. The responsibility for thedissemination of information rests with the public sector as well asthe private sector. The ongoing government initiative to promote opennessand debate on bioethics is important and should be continued.Furthermore, the government should inform, stimulate and qualify thedebate in new areas of ethical interest. Companies should contribute byenhancing transparency and by informing the public on ethical issues.Finally, the ethical discussion should not be confined to biotechnology. Itis the application of biotechnology – and other technologies – and notmerely the technology in itself that may give rise to ethical questions.The Bio-Health Industry in Denmark 12
August 2002National Agency forEnterprise and HousingDahlerups PakhusLangelinie Allé 17DK-2100 København ØTel. (+45) 35 46 60 00www.ebst.dkErhvervslivets HotlineTel. (+45) 35 46 66 66The Bio-Health Industry in Denmark 13
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The Bio-Health Industry in Denmark - Erhvervsstyrelsen

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