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Health The health sector in marine biotechnology is mainly dominated by the search for new pharmaceuticals including biopharmaceuticals (i.e. medicinal products), however the development of medical devices144 gained more importance over the last years. In terms of value, the market for pharmaceutical drugs is still one of the sectors generating highest revenues. However, risk of failure during development is high and increasing due to very strong regulatory demands. In the case of medical devices, the total value per product is lower but products are much faster developed and less risky in terms of legal and regulatory aspects. In 2006, the global medical device market reached approximately USD 209 billion. The differentiation between health and personal care products is not sharp; hence an overlap between both stakeholders and product lines with the sub sector cosmetics is given. Value chains specific to the health sector The pharmaceutical sector is looking for new drug developments based on active molecules derived from marine organisms, and is already using marine compounds in its production processes. There is an increasing demand for bioactive compounds by the pharmaceutical industry. However finding a bioactive molecule is just the beginning from a pharmaceutical perspective, as there are several important steps to validate before being able to register a new drug, i.e. proof of the stability, the safety and the quality of the molecule and testing it through various clinical trials. This process is long (between 15 and 20 years) and expensive (various estimates place the cost between USD 500 million and USD 1 billion)145. The value chain in the area of pharmaceuticals (Figure 0.18) begins with the search for new active agents. This includes, among other things, the collection of samples from the sea, the cultivation of microorganisms, the genetic identification of the organisms, analysis of the chemical profile, as well as the use of marine extracts or pure substances in initial assays to prove biological activities. Manufacturing procedures are also developed at the same time. Biodiscovery is here understood as the systematic search in the marine environment, for new biological activities and biochemical pathways that can be used for the production of goods, knowledge and services. It is to be understood that when we use this term we do not mean the systematic and continuing harvesting of natural living bioresources from the sea, following the discovery of some new use for marine molecules or biomaterials, but rather the use of new knowledge in controlled and sustainable systems. Themes of active interest differ somewhat among countries, but this theme stands out as the one where all countries have one or more on-going activities and follow up strategies. Both research institutes and pharmaceutical companies themselves can be active in this first stage of the value chain. 144 A medicinal product is defined in the European Union (Dir 2001/83/EC) as (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’ A medicinal product has to be distinguished from medical devices, cosmetics and food products. In contrast, medical devices comprise many diverse products: Directive 2007/47/EC defines a medical device as „Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: Diagnosis, prevention, monitoring, treatment, or alleviation of disease; Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap, Investigation, replacement, or modification of the anatomy or of a physiological process; Control of conception. This includes devices that do not achieve their principal intended action in or on the human body by pharmacological, immunological, or metabolic means—but may be assisted in their function by such means. 145 de la Calle F., 2007, “Marine Genetic Resources: A Source of New Drugs - The Experience of the Biotechnology Sector” Presentation at the conference “Biodiversity and Genetic Resources of the Deep Sea” - ITLOS, Hamburg. Sep, 29th 2007. 118 Study in support of Impact Assessment work on Blue Biotechnology

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