| 초록 |
Although the marine bio-industry is a promising field to lead the bioeconomic future, it has failed to respond to government regulations that realistically emphasize the safety and effectiveness of products. This article analyzes the regulatory status and problems of the domestic marine bio- industry, reviews EU which is one of the major advanced countries, and suggests ways to improve the legal policies of the marine bio-industry in Korea in the future.Regulations in the health·medical and food sector of the marine bio -industry include the Pharmaceutical Act, the Medical Devices Act, the Food Sanitation Act, and the Health Functional Food Act, whitch have a conservative point of view by each stage of process. These regulations have problems that they are not properly prepared for manufacturing permits or registration requirements of venture companies·SMEs, and standards that reflect the characteristics of marine and fisheries life resources. In addition they have limitations that there are shortages of support for establishing governance structures and providing regulatory information, and separation from regulatory and industrial support policies. On the other hand, the EU, whitch is a major advanced country, establishes Marine Biotechnology Strategic Rearch and Innovation Roadmap about marine bio in general, European Medicines Agencies Network Strategy to 2025 and EMA Regulatory Science to 2025 in health care sector, EFSA Strategy 2020 and Food Safety Regulatory Research Need 2030 in the food sector. In other words, EU is promoting industrial support policies along with the improvement of regulations in the marine bio-industry by perepareing a policy roadmap systemetically for each area that considers the process stage of the marine bio-industry, creating an environment for companies to conduct innovative research based on regulatory science, and activating the participation of stakeholders and the support of venture companies.Consequently, regulations on the domestic marine bio-industry should be improved in terms of legal policy as follows: First, the current regulations shall be adjusted to reflect the characteristics of the marine bio industry. It is necessary to improve the facility standards, permits, or registration standards for the manufacturing industry fiting on the role of SMEs·venture companies and to set relevant standards and specifications by reflecting the special habitat environment of the sea or to improve the criteria for setting heavy metals and index components of edible food resources. Second, an innovative research environment based on regulatory science should be created. The paradigm of marine bio-industry regulations should be changed to regulations that encourages innovative research and development, rather than evaluating the regulatory compliance of itself as in the existing method. Third, it is necessary to strengthen the prior review system and legalize the pre-consultation system. In other words, marine bio companies and regulatory agencies should communicate from the initial stage of product R&D to enhance their understanding of marine and fisheries bio resources so that the products can proceed the final approval smoothly. Fourth, we need the governance of establishing and supporting the regulatory information. The National Marine Biodiversity Institute, which currently hosts the Marine Bio Forum, should form governance participating the government, industry, academia and research institutes and link experts who can deliver regulatory, facility, and resource information needed by marine bio companies. Fifth, it shall be implemented in conjunction with regulatory policies and industrial support policies. As the relationship with these are like two sides of the coin, we should understand regulations at each stage of the process and establish necessary support policies according to the intensity of the regulations. |
