Biotechnology Support Act of the Republic of Korea

Enforcement: Feb. 29, 2008

Act No. 8852, Feb. 29, 2008, Amendment of Other Laws and Regulations

Ministry of Education, Science and Technology (Future Fundamental Technology Division)

02-2100-6833

Article 1 (Purpose)

The purpose of this Act is to develop and support biotechnology more efficiently by laying the foundation of biotechnology research, and to contribute to the sound progress of the national economy by facilitating the industrialization of the technology. <Amended Jan. 5, 1995>

Article 2 (Definitions)

The term “biotechnology” in this Act means the science and technology falling under each of the following subparagraphs:

1. The science and technology which are aimed at researching and utilizing the biotechnological system, biomass, dielectrics or other materials derived therefrom in order to industrially manufacture useful products and to improve the production process; and
2. The science, including physiology, pathology and pharmacology (hereinafter referred to as the “basic medical science”), which are aimed at providing the basic knowledge of biotechnology by researching the origin of vital phenomena, the cause of diseases and the process of the outbreak of illness. [Wholly Amended Dec. 30, 2003]

Article 3 (Scope of Application)

Except as otherwise prescribed by other Acts, matters concerning biotechnology shall be governed by this Act. <Amended Jan. 5, 1995>

Article 4 (Formulation of Basic Plan for Biotechnology Support <Amended Jan. 5, 1995>)

(1) The heads of the ministries and agencies concerned, as referred to in Article 13, shall submit plans on biotechnology support to the Minister of Education, Science and Technology related to the matters within the jurisdiction of each ministry or agency. <Amended Jan. 5, 1995, Dec. 30, 2003, Feb. 29, 2008>

(2) The Minister of Education, Science and Technology shall formulate the basic plan for biotechnology support (hereinafter referred to as the “basic plan”) by integrating and coordinating the plans on biotechnology support related to matters within the jurisdiction of such ministries and agencies which are submitted by the heads of the ministries and agencies concerned under paragraph (1). <Amended Jan. 5, 1995. Dec. 30, 2003, Feb. 29, 2008>

(3) The basic plan under paragraph (2) shall include the following: <Amended Jan. 5, 1995, Aug. 28, 1997>

1. Comprehensive plan and guidelines on basic studies of biotechnology and promotion of research for industrial application thereof;
2. Guidelines related to a comprehensive fostering plan and efficient utilization of human resources required for the research in biotechnology; and
3. Plans and guidelines on the researches in biotechnology and international exchange of industrial technology manpower related thereto, and on the utilization of overseas scientists and engineers.

(4) The Minister of Education, Science and Technology shall, when intending to formulate the basic plan, undergo the deliberation by the Council for Comprehensive Biotechnology Policy as referred to in Article 6. <Amended Jan. 5, 1995, Dec. 30, 2003, Feb. 29, 2008>

Article 5 (Formulation, Etc. of Annual Implementation Plan for Biotechnology Support <Amended Jan. 5, 1995>)

(1) Each head of the ministries and agencies concerned shall formulate an annual implementation plan for biotechnology support (hereinafter referred to as the “implementation plan”) in accordance with the basic plan, and execute it. <Amended Jan. 5, 1995>

(2) Each head of the ministries and agencies concerned shall, when intending to formulate the implementation plan, consult with the Minister of Education, Science and Technology in advance. <Amended Dec. 30, 2003, Feb. 29, 2008>

(3) The Minister of Education, Science and Technology may, when he/she deems it necessary, establish basic guidelines required for the formulation of implementation plans and notify the heads of the ministries and agencies concerned thereof. <Amended Dec. 30, 2003, Feb. 29, 2008 >

(4) Necessary matters concerning the formulation and execution of the implementation plans shall be prescribed by Presidential Decree.

Article 6 (Council for Comprehensive Biotechnology Policy <Amended Jan. 5, 1995>)

(1) The Council for Comprehensive Biotechnology Policy (hereinafter referred to as the “Council”) shall be established under the jurisdiction of the Minister of Education, Science and Technology to undertake the affairs related to the formulation of the basic plan and execution and coordination thereof. <Amended Jan. 5, 1995, Dec. 30, 2003, Feb. 29, 2008>

(2) The Council shall deliberate and make decisions on the following matters: <Amended Jan. 5, 1995, Aug. 28, 1997, Dec. 30, 2003, Feb. 29, 2008>

1. Formulation of plans on basic studies of biotechnology and promoting researches for industrial application thereof, and the coordination of application of such plans;
2. Formulation of the basic plan for research and technology development in biotechnology, and establishment of major policies pursuant to the basic plan and coordination of their implementation;
3. Formulation of the comprehensive plan for the development and utilization of human resources in the biotechnology field, and establishment of major policies and guidelines for the utilization of human resources, and coordination of their implementation;
4. Formulation of plans on development exchange of researches in biotechnology and industrial technology manpower related thereto, and on the utilization of overseas scientists and engineers, and the coordination of their implementation;
5. Formulation of an R&D plan for the utilization and preservation of genetic resources, and coordination of its implementation; and
6. Other matters that the Minister of Education, Science and Technology deems necessary for the biotechnology support.

(3) The Council shall consist of not more than 17 members including a chairman. <Newly Inserted Dec. 30, 2003>

(4) The Minister of Education, Science and Technology shall be the chairman of the Council, and members of the Council shall be the persons falling under each of the following subparagraphs: <Newly Inserted Dec. 30, 2003, Feb. 29, 2008>

1. Vice-Ministerial level public officials of the central administrative agencies concerned who are prescribed by Presidential Decree; and
2. Persons specializing in biotechnology in academia, research institutes and the industrial sector, and experts on life ethics.

(5) Necessary matters concerning the organization and operation, etc. of the Council, except for the matters stipulated in this Act, shall be as prescribed by Presidential Decree. <Newly Inserted Dec. 30, 2003>

Articles 7 and 8 Deleted. <Dec. 30, 2003>

Article 9 (Research and Technical Cooperation)

The Minister of Education, Science and Technology shall make efforts to promote international cooperation in biotechnology researches and technologies, and devise efficient measures for the inducement of advanced technologies. <Amended Jan. 5, 1995, Dec. 30, 2003, Feb. 29, 2008>

Article 10 (Promotion of Joint Research)

The Government shall promote joint researches among academia, research institutes and industries for the efficient research and technological development in biotechnology. <Amended Jan. 5, 1995>

Article 11 (Assistance to Facilitate Industrial Application of Biotechnology)

The Government shall take policy measures to support the matters falling under each of the following subparagraphs, in order to vitalize R&D of biotechnology and to facilitate the industrial application of the results thereof:

1. Matters concerning support for the manufacture of new technological products related to biotechnology;
2. Matters concerning R&D aimed at facilitating the industrial application of biotechnology research results, and building of regional R&D bases; and
3. Matters concerning assistance in the start-up of small and medium venture enterprises involved in biotechnology. [Wholly Amended Dec. 30, 2003]

Article 12 (Collection and Dissemination of Technology Information)

The Government shall make efforts to promote R&D by collecting information on biotechnological research and disseminating such information to related organizations. <Amended Jan. 5, 1995>

Article 13 (Working out Policies to Support Biotechnology, Etc.)

(1) The Government shall take policy measures falling under each of the following subparagraphs with respect to the basic research in biotechnology and the research on its industrial application in order to efficiently nurture the biotechnology: Provided, that the task of facilitating R&D of the basic medical science and nurturing the basic medical science shall be put under jurisdiction of the Minister of Education, Science and Technology and the Minister for Health, Welfare and Family Affairs: <Amended Aug. 28, 1997, Jan. 29, 2001, Dec. 30, 2003, Dec. 31, 2004, Feb. 29, 2008>

1. Deleted. <Feb. 29, 2008>
2. The Minister of Education, Science and Technology shall engage in formulating the basic plan under Article 4 (2), assist and conduct general coordination for establishing policies by each ministry, foster specialized manpower to promote biotechnology research, support basic studies in biotechnology, support advancement of basic technology and cutting-edge technology related to biotechnology, support research aimed at securing, analyzing, utilizing and preserving useful genes in the science and technology field, and nurturing and development of supporting organizations involved in biotechnology;
3. The Minister for Food, Agriculture, Forestry and Fisheries shall engage in supporting application research such as breeding and improving animals, plants, germs, and developing new food stuff, and to support basic studies for securing, analyzing, utilizing and preserving genes useful in agricultural and forestry field, and to nurture and develop research institutes, and also to support application research in the maritime sector such as production of useful material utilizing aquatic life, breeding and improving them and developing food stuff, as well as to support basic studies for securing, analyzing, using and preserving useful genes, etc.;
4. The Minister of Knowledge Economy shall engage in supporting the advancement and improvement of the biotechnology-related industrial process, exploitation of new and renewable energy and efficient utilization of mineral resources, and to facilitate the industrialization of developed technologies, as well as to support the development of information communication technology for nurturing and building up biotechnology;

4-2. Deleted. <Feb. 29, 2008>
5. The Minister for Health, Welfare and Family Affairs shall engage in facilitating R&D of technologies related to biotechnology involving health, medical care and food hygiene, and to foster specialized manpower related thereto, as well as to nurture businesses related to clinical trials and to support researches related thereto; and
6. The Minister of Environment shall engage in supporting technological advancement, basic studies and applied research for the conservation of biodiversity, sustainable use of its components, treatment of sewage and wastes using biotechnology, and prevention of environmental pollution, as well as to support technological development for the prevention of sea pollution, etc. and to foster research institutions related thereto.
7. Deleted. <Feb. 29, 2008>

(2) The Minister of Education, Science and Technology and the Minister for Health, Welfare and Family Affairs shall, when intending to take a policy measure for supporting the basic medical science, consult with each other thereabout. <Newly Inserted Dec. 30, 2003, Feb. 29, 2008> [Wholly Amended Jan. 5, 1995]

Article 14 (Certification and Clinical Test)

(1) The Government shall establish a system for certification and clinical tests of biotechnology-related products. <Amended Jan. 5, 1995>

(2) Necessary matters concerning the establishment of the system for certification and clinical tests under paragraph (1) shall be prescribed by Presidential Decree.

Article 15 (Preparation and Implementation of Experimental Guidelines)

(1) The Government shall prepare and implement experimental guidelines for the promotion of biotechnological research and industrialization thereof. <Amended Jan. 5, 1995>

(2) The experimental guidelines under paragraph (1) shall include measures required for preventing biological hazard, negative influence upon the environment and any ethical problems that may arise in the course of research on biotechnology and its industrialization, and shall also include safety standards for the transfer, handling and use of a genetically converted organism. <Amended Jan. 5, 1995>

Article 16 (Korea Research Institute of Bioscience and Biotechnology <Amended Jan. 5, 1995, Dec. 30, 2003>)

(1) The Korea Research Institute for Bioscience and Biotechnology (hereinafter referred to as the “Research Institute”) may be established as a foundation to play a pivotal role in supporting researches on biotechnology (excluding basic medical science; hereinafter in this Article the same shall apply) and on the utilization and preservation of genetic resources, as well as to maintain, develop and support a mutually cooperative system among academia, research institutions and industries. <Amended Jan. 5, 1995, Dec. 30, 2003>

(2) The Research Institute referred to in paragraph (1) shall be a specific research institute to which the Support of Specific Research Institutions Act applies. <Amended Dec. 30, 2003>

(3) Deleted. <Dec. 6, 1995>

Article 17 (Organization in Charge of Nurturing Basic Medical Science)

(1) The Government may designate and operate an organization in charge of nurturing the basic medical science (hereinafter referred to as the “nurturing organization of basic medical science”).

(2) The Government may financially support the costs for operating the nurturing organization of basic medical science within the limit of budget.

(3) Necessary matters concerning the designation and operation of the nurturing organization of basic medical science shall be prescribed by Presidential Decree. [This Article Newly Inserted Dec. 30, 2003]

Article 18 Deleted. <Dec. 6, 1995>

Article 19 (Customs Clearance by Ex Post Facto Approval <Amended Dec. 30, 2003>)

(1) Deleted. <Dec. 30, 2003>

(2) In order to secure the safety of items that are not domestically produced among materials, machinery or reagents required for biotechnology research activities, which may be spoiled in the course of lengthy customs formalities, the ex post facto approval may substitute for the existing customs clearance procedure under the conditions prescribed by Presidential Decree, notwithstanding the provisions in the Customs Act. <Amended Dec. 30, 2003>

Article 20 Deleted. <Dec. 30, 2003>

ADDENDA (Government Organization Act) <No. 8852, Feb. 29, 2008>

Article 1 (Enforcement Date)

This Act shall enter into force on the date of its promulgation: Provided, that …… <Omitted> Among the laws amended in accordance with Article 6 of Addenda, the amended parts of the law which was announced before the enforcement of this Act but has not been enforced yet shall become effective from the enforcement date of the concerned law.

Articles 2 through 10 Omitted.

Article 6 (Amendment of Other Law)

<1> through <132> Omitted
<133> The Biotechnology Act shall be partially amended as follows:
The term “Minister of Science and Technology” in Article 4 (1), (2), (4), Article 5 (2), (3), Article 6 (1), subparagraphs 6 of Article 6 (2), Article 6 (4) (part other than subparagraphs) and Article 9 shall each be amended to “Minister of Education, Science and Technology.”
Of the proviso to the part other than subparagraphs in Article 13 (1), “the Minister of Science and Technology and the Minister of Health and Welfare” shall be amended to “the Minister of Education, Science and Technology and the Minister for Health, Welfare and Family Affairs,” and subparagraph 1 of the same Article shall be deleted, and of subparagraph 2 of the same Article, “the Minister of Science and Technology shall engage in formulating the basic plan under Article 4 (2) and assist and coordinate of establishing policies by each ministry” shall be amended to “the Minister of Education, Science and Technology shall engage in formulating the basic plan under Article 4 (2), assist and coordinate establishing policies by each ministry, foster specialized manpower to facilitate researches in the biotechnology field and support basic research in biotechnology,” and of subparagraph 3 of same Article “Minister of Agriculture and Forestry” shall be amended to “Minister for Food, Agriculture, Forestry and Fisheries,” and “nurturing and development” shall be amended to “nurturing, development, and support for application research in maritime field such as production of useful material utilizing aquatic life, breeding and improving them and developing food stuff, as well as support for basic research to secure, analyze, use and preserve useful genes, etc.,” and of the subparagraph 4 of the same paragraph, “Minister of Industry and Resources” shall be amended to “Minister of Knowledge Economy,” and “facilitation” to “facilitation and support for development of information communication technology for nurturing and building up biotechnology,” and subparagraph 4-2 of the same paragraph shall be deleted, and of subparagraph 6 of the same paragraph, “support for applied research” shall be amended to “support for applied research as well as technology development and nurturing research institutes for prevention of sea pollution, etc.” and subparagraph 7 of the same paragraph shall be deleted, and among paragraph (2) of the same Article “the Minister of Science and Technology and the Minister of Health and Welfare” shall be amended to “the Minister of Education, Science and Technology and the Minister for Health, Welfare and Family Affairs.”
<134> through <760> omitted

Article 7 omitted

Sources

• Ministry of Government Legislation