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ENFORCEMENT DECREE OF THE BRAIN RESEARCH PROMOTION ACT

Ministry of Education, Science and Technology (Future Fundamental Technology Division) 02-2100-6833

Article 1 (Purpose)

The purpose of this Decree is to prescribe the matters delegated by the Brain Research Promotion Act and matters required for the enforcement thereof. Article 2 (Report of Performance Results)

(1) Pursuant to Article 5 (1) of the Brain Research Promotion Act (hereinafter referred to as the "Act"), the Minister of Education, Science and Technology, the Minister of Knowledge Economy and the Minister for Health, Welfare and Family Affairs (hereinafter referred to as the "heads of the central administrative agencies concerned") shall submit the performance results of the previous year of brain research promotion under their respective jurisdiction by the end of February of every year to the Minister of Education, Science and Technology. (2) The Minister of Education, Science and Technology shall, upon receiving the performance results under paragraph (1), combine them with the performance result of the Ministry of Education, Science and Technology in previous year, etc. and submit them to the Brain Research Promotion Council (hereinafter referred to as the "Council").

Article 3 (Formulation of Basic Plan to Promote Brain Research) (1) Pursuant to Article 5 (1) of the Act, the heads of the central administrative agencies concerned shall submit plans to promote brain research under their respective jurisdiction to the Minister of Education, Science and Technology by the end of February of the year before the commencement year of the basic plan to promote brain research provided in Article 5 (2) of the Act (hereinafter referred to as the "basic plan").

(2) The Minister of Education, Science and Technology shall formulate the basic plan for a five year term.

Article 4 (Formulation of Implementation Plan to Promote Brain Research) Each head of the central administrative agencies concerned shall, when intending to consult with the Minister of Education, Science and Technology on the formulation of implementation plans to promote brain research (hereinafter referred to as the "implementation plan") under Article 6 (2) of the Act, submit the draft implementation plan of the respective agencies to the said Minister by the end of February of every year.

Article 5 (Request for Provision of Data)

The Minister of Education, Science and Technology may, when preparing basic guidelines required for the formulation of implementation plans under Article 6 (3) of the Act, request the heads of the central administrative agencies concerned to provide necessary data.

Article 6 (Term of Office for Council Members)

The term of office for the Council members shall be two years: Provided, that term of office for members appointed or commissioned to fill a vacancy shall be the remaining period of the predecessor's term, and that term of office for members who are public officials shall be during the tenure of the respective posts. Article 7 (Duties of Chairman)

(1) The chairman of the Council shall exercise overall control and supervision of the Council affairs.

(2) In the event that the chairman is unable to perform his/her duties due to inevitable causes, a council member designated by the chairman in advance shall act on behalf of the chairman.

Article 8 (Meetings)

(1) The chairman of the Council shall convene meetings of the Council and preside over them.

(2) Meetings of the Council shall be divided into regular meetings and special meetings. (3) Regular meeting shall be convened once a year and special meeting shall be convened when the chairman deems necessary.

(4) The meetings shall open with the attendance of a majority of its members and be resolved with the consenting votes of a majority of its members present. Article 9 (Secretary)

The Council shall have a secretary to perform the affairs of the Council, who shall be appointed by the Minister of Education, Science and Technology among public officials belonging to the Ministry of Education, Science and Technology.

Articles 10 (Organization and Operation of Working Committee for Brain Research) (1) The working committee for brain research provided in Article 8 of the Act (hereinafter referred to as the "Working Committee") shall consist of not more than 20 members including a chairman.

(2) The Assistant Minister in charge of the Office of Academic Research Policy, of the Ministry of Education, Science and Technology shall be the chairman of the Working Committee, and members of the Committee shall be the persons falling under each of the following subparagraphs:

1. One person each from the Ministry of Strategy and Finance, the Ministry of Education, Science and Technology, the Ministry of Knowledge Economy, and the Ministry for Health, Welfare and Family Affairs, appointed by the head of the competent agency from Grade III public officials (including special-category public officials of equivalent rank), general or special-category public officials in Senior Civil Service Group; and

2. Brain research experts engaged in academia, research institutes and industries, who have professional learning and abundant experience in brain research and who are commissioned by the Minister of Education, Science and Technology. (3) The provisions of Articles 6 through 8 shall apply mutatis mutandis to the organization and operation of the Working Committee. In such cases, the "Council" shall be deemed as the "Working Committee."

(4) The Working Committee may organize and operate a subcommittee for each field under the jurisdiction of the Committee, in order to conduct specialized examination of the agenda for such fields as brain science, brain medicine and pharmacy, brain engineering, etc.

(5) Necessary matters concerning the organization and operation of the subcommittees under paragraph (4) shall be determined by the chairman of the Execution Committee, subject to the resolution of the Committee.

Article 11 (Hearing of Opinions)

The Council and Working Committee may, if deemed necessary in relation to the matters to be deliberated, etc., have related public officials or experts with professional knowledge and experience in brain research attend meetings of the Council or Working Committee and state their opinions.

Article 12 (Allowances)

Allowances or expenses may be paid to the members, public officials and experts who attend the meeting of the Council and Working Committee, within the limit of budget: Provided, that the same shall not apply to the case where public officials attend such meetings as members in direct relation with their duties. Article 13 (Operating Rules for Council, Etc.)

Necessary matters concerning the operation of the Council and Working Committee, other than those provided in this Decree, shall be determined by the chairpersons of the Council and Working Committee respectively, subject to the resolution of the Council and Working Committee respectively.

Article 14 (Support for Joint Research)

In order to promote joint research for the study of the brain and the development of technologies among academia, research institutes and industries under Article 11 of the Act, the Minister of Education, Science and Technology may recommend joint procurement of research equipment, materials and reagents as well as joint utilization of research facilities, and may provide support required for such activities.

Article 15 (Support for Manufacture of New Technology Products) (1) In order to support the manufacture of new technology products and to promote the industrialization of brain research results under Article 12 of the Act, the Minister of Education, Science and Technology and the heads of central administrative agencies concerned (for the field under their respective jurisdiction) may, after undergoing deliberation by the Council, request the heads of the relevant ministries and agencies to take necessary measures such as financial assistance and purchase of the products on a priority basis, etc.

(2) The heads of the relevant ministries and agencies who have received requests as referred to in paragraph (1) shall take necessary measures accordingly, unless there exists special reason to the contrary.

Article 16 (Preparation of Guidelines for Clinical Test and Certification) (1) In order to build a system for clinical tests and certification of products related to brain research under Article 15 of the Act, the Minister of Education, Science and Technology and the heads of the central administrative agencies concerned shall prepare and implement the guidelines for the clinical tests and certification after undergoing deliberation by the Council: Provided, that the same shall not apply to the cases where other laws and regulations prescribe otherwise. (2) The guidelines for clinical tests and certification as referred to in paragraph (1) shall include the matters falling under each of the following subparagraphs: Provided, that if there are matters which cannot be covered by the guidelines due to special characteristics of the products related to brain research, such matters may not be included in the guidelines:

1. Animal test and clinical test of commodities produced or manufactured by brain research;

2. Analysis of components and degree of purity, etc. of commodities produced or manufactured by brain research; and

3. Other necessary matters concerning clinical tests and certification of products related to brain research.

Article 17 (Preparation of Guidelines for Experiments) Pursuant to Article 16 of the Act, the Minister of Education, Science and Technology and the heads of the central administrative agencies concerned shall prepare and implement the guidelines for experiments for the portion under their respective jurisdiction, after undergoing deliberation by the Council. ADDENDA (Office Organization of the Ministry of Public Administration and Security, and the agencies belonging to the Ministry) Article 1 (Enforcement Date)

This Act shall enter into force on the date of its promulgation. Articles 2 through 4 Omitted.

Article 3 (Amendment of Other Laws and Regulations) through <16> Omitted.

<17> The Enforcement Decree of the Brain Research Promotion Act shall be partially amended as follows:

The term "Minister of Science and Technology" in subparagraph 2 of Article 10 (2) shall become "Minister of Education, Science and Technology." <18> through <175> Omitted.