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Where to place the screening power in the chain from biodiversity explorer to end-user is also challenging: On one hand industry is often reluctant to take on novel molecules without adequate evidence of likely efficacy and safety, on the other hand it is unlikely that researchers discovering novel molecules have the capacity or resources to carry out such high-content broad-target screening. The main challenges related to pharmaceutical discovery from marine bioresources are linked to: legal aspects (secure access to marine resources and intellectual property rights); quality of marine resources (identification and variability); technology (screening of active compounds and replication, preventing repeated rediscovery and increasing the amount of novel structures); and structural costs of drug discovery from natural products. The access to capital is an important issue as well, as the development of new drugs is an 8-12 year process demanding some billion USD with the very high risk of failure even in late stages of the development. Table 0.11 Drivers of marine biotechnology in the health sector Drivers Existing Drivers Current extent evolving in absence of measures Established value chain with strong End User group Strong demand of innovations, i.e. new active and functional ingredients Financial incentives: Expanding population and lucrative health business Market opportunities: Multiresistant bacterial threats incl. re-emerging pandemies, growth in resistant strains of bacteria to existing antibiotics. Knowledge about marine living resources Research facilities Strong academia and SME interconnection Knowledge and technology base Success stories +++ strong, ++ medium, + small, ↑ supporting drivers Table 0.12 Barriers of marine biotechnology in the health sector barriers Existing Barriers Current extent evolving in absence of measures Supply issue: Limitation of sustainable sources of natural products Regulations knowledge and effort needed for follow all regulation, lack of harmonisation Financing, access to venture capital, high costs of innovative techniques and products Non-existent synergistic concept of sustainability and marine biotechnology and its clear communication Non-existent embedding of MB into technology transfer policy and other administrative concepts (e.g. Integrated Coastal Zone Management, fishery policy) + ++ +++ ++ +++ +++ +++ +++ ++ ++ barriers evolving with successful measures + ↓ ++ ↓ ++ ↓ + ↓ + ↓ ++ +++ ++ ++ ++ +++ ++ ++ Drivers evolving with successful measures +++ ↑ +++ ++ ++ + + + ++ ++ ++ + ++ ++ + +++ ↑ ++ ↑ +++ ↑ +++ ↑ +++ ↑ Study in support of Impact Assessment work on Blue Biotechnology 125

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