The Bio-Health Industry in Denmark - Erhvervsstyrelsen
The Bio-Health Industry in Denmark - Erhvervsstyrelsen
The Bio-Health Industry in Denmark - Erhvervsstyrelsen
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9. Flexible public regulation <strong>in</strong> product development• A flexible and fast work<strong>in</strong>g public regulatory system for the developmentof medic<strong>in</strong>es and devices is a fundamental framework conditionfor all bio-health clusters. It is therefore important that <strong>Denmark</strong>ma<strong>in</strong>ta<strong>in</strong>s and develops a public regulatory system cover<strong>in</strong>g all aspectsof the development and approval processes (ethical committees,reimbursement and market<strong>in</strong>g approvals etc.), which is among themost efficient <strong>in</strong> Europe.• With regard to the approval of medic<strong>in</strong>es and products transparency ofprocedures, good review ability and will<strong>in</strong>gness to give <strong>in</strong>formal op<strong>in</strong>ionare decisive factors for <strong>in</strong>dustry. <strong>The</strong> Danish Medic<strong>in</strong>es Agency shouldsecure solid basic expertise <strong>in</strong> the fields of toxicology and cl<strong>in</strong>ical trialsand the field chemistry, manufactur<strong>in</strong>g and control (CMC). Furthermore,the Danish Medic<strong>in</strong>es Agency should develop world class expertise<strong>in</strong> other selected areas <strong>in</strong> partnership with research <strong>in</strong>stitutions andprivate companies <strong>in</strong> order to operate on an <strong>in</strong>creas<strong>in</strong>g competitiveEuropean market for approval of medic<strong>in</strong>es and products.• <strong>The</strong> three university hospitals’ Good Cl<strong>in</strong>ical Practice procedures shouldbe harmonised <strong>in</strong> order to secure the best conditions for mobility ofresearchers and students.10. Well-<strong>in</strong>formed public perception• A well-<strong>in</strong>formed public op<strong>in</strong>ion is an important condition for the furtherdevelopment of the bio-health <strong>in</strong>dustry. <strong>The</strong> responsibility for thedissem<strong>in</strong>ation of <strong>in</strong>formation rests with the public sector as well asthe private sector. <strong>The</strong> ongo<strong>in</strong>g government <strong>in</strong>itiative to promote opennessand debate on bioethics is important and should be cont<strong>in</strong>ued.Furthermore, the government should <strong>in</strong>form, stimulate and qualify thedebate <strong>in</strong> new areas of ethical <strong>in</strong>terest. Companies should contribute byenhanc<strong>in</strong>g transparency and by <strong>in</strong>form<strong>in</strong>g the public on ethical issues.F<strong>in</strong>ally, the ethical discussion should not be conf<strong>in</strong>ed to biotechnology. Itis the application of biotechnology – and other technologies – and notmerely the technology <strong>in</strong> itself that may give rise to ethical questions.<strong>The</strong> <strong>Bio</strong>-<strong>Health</strong> <strong>Industry</strong> <strong>in</strong> <strong>Denmark</strong> 12