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REGULATIONS ON RELIEF OF INJURY FROM ADVERSE DRUG REACTION

Presidential Decree No. 25862, Dec. 16, 2014

Amended by Presidential Decree No. 26844, Dec. 31, 2015

 Article 1 (Purpose)
The purpose of this Decree is to provide for matters delegated under Articles 68-11, 86 (5), 86-2, and 86-4 of the Pharmaceutical Affairs Act, and necessary matters for the enforcement thereof.
 Article 2 (Constitution of the Council for Deliberation on Adverse Drug Reaction)
(1) The council for deliberation on adverse drug reaction (hereinafter referred to as the “Council for Deliberation”) under Article 68-11 of the Pharmaceutical Affairs Act (hereinafter referred to as the “Act”), shall be comprised of persons classified as follows, duly considering gender:
1. Persons falling under Article 68-11 (3) 1 of the Act: six to eight persons;
2. Persons falling under Article 68-11 (3) 2 of the Act: two persons;
3. Persons falling under Article 68-11 (3) 3 of the Act: one to three persons;
4. Persons falling under Article 68-11 (3) 4 of the Act: two persons.
(2) “Public official of a relevant central administration agency prescribed by Presidential Decree” set out in Article 68-11 (3) 4 of the Act, refers to the public official belonging to the senior civil service of the Ministry of Health and Welfare or the Ministry of Food and Drug Safety, who is in charge of the safety of drugs.
(3) The term of members falling under subparagraphs 1 through 3 of Article 1, shall be two years: Provided, That the term of each member newly commissioned as a result of a vacancy, including the resignation of a member, shall be the remaining period of the term of the preceding member.
(4) The Council for Deliberation may have one administrative secretary for dealing with its affairs. In such cases, the administrative secretary shall be designated by the Minister of Food and Drug Safety, from among public officials in charge of duties related to adverse drug reaction, in the Ministry of Food and Drug Safety.
 Article 3 (Exclusion, Recusal, and Evasion of Members of the Council for Deliberation)
(1) Each member of the Council for Deliberation in any of the following cases, shall be excluded from the deliberation and decision-making in the relevant Council for Deliberation:
1. Where the member or his/her spouse or former spouse becomes a party to the case, or is a joint rights holder or a person having joint obligations with the party of such case (where the party is a corporation, organization, etc., the party includes the executive thereof; hereinafter the same shall apply);
2. Where the member is a relative or former relative of a party to the case;
3. Where the member conducted or is conducting consulting, research, services (including subcontracts), appraisals, or investigation relevant to the case;
4. Where the member, or a corporation, organization, etc., to which the member belongs, is a representative or former representative of a party to the case;
5. Where an enterprise, etc., in which the member engages as an executive or employee or engaged as a former executive or employee in the last three years, conducts consulting, research, services (including subcontracts), appraisals, or investigation.
(2) Where there are circumstances making it difficult to expect fair deliberation or decision-making by the member, a party to the case may file for exclusion with the Council for Deliberation; and the Council for Deliberation shall determine by its resolution, whether to exclude him/her. In such cases, no member who is a subject of filing for exclusion shall participate in determining the resolution.
(3) Where the member falls under the grounds for exclusion pursuant to any subparagraph of paragraph (1), he/she shall exclude himself/herself from deliberation or decision-making on the relevant case.
 Article 4 (Operation of the Council for Deliberation)
(1) The chairperson of the Council for Deliberation shall call a meeting of the Council for Deliberation and chair such meeting.
(2) If the Minister of Food and Drug Safety or a majority of the incumbent members requests a meeting to be called, the chairperson of the Council for Deliberation shall promptly call the meeting.
(3) A meeting of the Council for Deliberation shall be held upon attendance of a majority of the incumbent members; and its resolution shall be passed by a two-thirds majority vote of the members present.
 Article 5 (Constitution and Operation of the Specialized Committee)
(1) The Council for Deliberation may establish a specialized committee for each field of drugs pursuant to Article 68-11 (5) of the Act.
(2) The members of the specialized committee shall be commissioned by the Minister of Food and Drug Safety, from among persons recommended by the head of association or organizations relevant to drugs or the Korea Institute of Drug Safety and Risk Management pursuant to Article 68-3 of the Act (hereinafter referred to as the “Institute of Drug Safety and Risk Management”) pursuant to Article 68-3 of the Act; and the chairperson shall be designated by the chairperson of the Council for Deliberation, from among the members of the specialized committee.
(3) The head of the Institute of Drug Safety and Risk Management may allow the specialized committee to provide technical consulting, etc., before requesting deliberation by the Council for Deliberation pursuant to Article 86-4 (3) of the Act.
 Article 5-2 (Dismissal of Members)
(1) Where each member of the Council for Deliberation referred to in Article 68-11 (3) 1 through 3 falls under any of the following cases, the Minister of Food and Drug Safety may dismiss the relevant member:
1. Where he/she becomes unable to perform his/her duties due to a mental or physical disability;
2. Where he/she has engaged in illegality in his/her duties;
3. Where he/she is deemed inappropriate as a member of the Council for Deliberation due to neglect of duty, injury to dignity or other grounds;
4. Where he/she fails to exclude himself/herself, although he/she falls under any of subparagraphs of Article 3 (1);
5. Where the member himself/herself indicates it is difficult for him/her to perform his/her duties.
(2) Where each member of the specialized committee referred to in Article 5 (2) falls under any of subparagraphs 1 through 3 or under subparagraph 5 of Article 1, the Minister of Food and Drug Safety may dismiss the relevant member.
[This Article Newly Inserted by Act No. 26844, Dec. 31, 2015]
 Article 6 (Benefits, etc.)
(1) The Minister of Food and Drug Safety may pay benefits, and reimburse travel expenses and other expenses, within budgetary limits, to the members who attend a meeting of the Council for Deliberation or the specialized committee: Provided, That where the head of the Institute of Drug Safety and Risk Management provides technical consulting, etc., to the specialized committee pursuant to Article 5 (3), within budgetary limits of the Institute of Drug Safety and Risk Management, he/she shall pay such benefits, and reimburse such travel expenses and other expenses of the members who attend a meeting of such specialized committee.
(2) Notwithstanding paragraph (1), no benefits, travel expenses and other expenses shall be paid or reimbursed where the member who is a public official attends a meeting directly related to his/her duties.
 Article 7 (Detailed Regulation of Operation)
Except as expressly provided for in Articles 2 through 6, necessary matters for the constitution and operation of the Council for Deliberation and the specialized committee, shall be determined by the chairperson of the Council for Deliberation following a resolution by the Council for Deliberation.
 Article 8 (Entrustment of Duties)
The Minister of Food and Drug Safety shall entrust the Institute of Drug Safety and Risk Management with duties regarding projects for relief of injury from adverse drug reaction pursuant to Article 86 (5) of the Act (hereinafter referred to as “projects for relief of injury”) and regarding the imposition and collection of charges for relief of injury from adverse drug reaction pursuant to the latter part of Article 86-2 (1) of the Act (hereinafter referred to as “charges”).
 Article 9 (Calculation of Charges)
“Amount prescribed by Presidential Decree” in the main body of Article 86-2 (2) of the Act, refers to the amount calculated in accordance with attached Table.
 Article 10 (Imposition, Collection, etc., of Charges)
(1) Charges shall be imposed and collected semi-annually, in accordance with the following:
1. Imposing and collecting charges in January, based on the amount of production or the amount of importation (hereinafter referred to as “amount of production, etc.”) and the amount of payment for relief of injury for each item in the first half of the preceding year, for each drug manufacturer or each person who has obtained an item license for a drug and each importer of drugs (hereinafter referred to as “drug manufacturer, etc.”);
2. Imposing and collecting charges in July, based on the amount of production, etc., and the amount of payment for relief of injury for each item in the second half of the preceding year, for each drug manufacturer, etc.
(2) When the Minister of Food and Drug Safety (referring to the head of the Institute of Drug Safety and Risk Management, where the duties of imposing and collecting charges are entrusted pursuant to the latter part of Article 86-2 (1) of the Act; hereinafter in this Article and until Article 13 the same shall apply) imposes charges pursuant to Article 86-2 of the Act, he/she shall issue a notice of payment of charges (hereinafter referred to as “notice of payment”) to a drug manufacturer, etc.
(3) The deadline for paying charges shall be 30 days from the day the notice of payment is issued.
(4) The Minister of Food and Drug Safety shall set up a separate account in a financial institution to manage the charges.
(5) The Minister of Food and Drug Safety shall record and manage matters regarding the imposition and collection, etc., of charges, as prescribed by Ordinance of the Prime Minister.
 Article 11 (Installment Payment etc., of Charges)
(1) When the Minister of Food and Drug Safety deems it difficult for a drug manufacturer, etc., to pay charges due to extenuating grounds, he/she may allow payment of the charges in installments or delay the deadline for paying the charges classified as follows:
1. Payment of the charges in installments: paying the charges in two installments;
2. Delaying the deadline for payment: delaying only once by up to 90 days.
(2) When the Minister of Food and Drug Safety allows payment of the charges in installments or delays the deadline for paying the charges, he/she shall collect the charges by adding the amount corresponding to interest accruing on a term deposit of one year to the amount of the charges paid in installments or for which the deadline for payment is delayed.
(3) Each person who intends to pay charges in installments or delay the deadline for paying the charges pursuant to paragraph (1) (hereinafter in this Article referred to as “applicant”), shall file notice of intent to pay the charges in installments or the delay of the deadline for paying the charges with the Minister of Food and Drug Safety, as prescribed by Ordinance of the Prime Minister.
(4) The Minister of Food and Drug Safety shall notify the applicant as to whether the payment in installments is allowed or the deadline for payment is delayed, in writing within 30 days from the day of the notice filed under paragraph (3).
(5) Where the Minister of Food and Drug Safety deems that the notice filed under paragraph (3) is appropriate, he/she shall re-issue the notice of payment, including the following matters, to the applicant by not later than 30 days before the deadline for payment:
1. Amount of payment to which the interest accruing pursuant to paragraph (2) is added;
2. Deadline for payment.
(6) Where each person who intends to pay charges in installments, falls under any of the following cases, the Minister of Food and Drug Safety may collect the full amount of charges in lump sum before the deadline for payment of the final installment. In such cases, the Minister of Food and Drug Safety shall determine the deadline for payment for such collection and re-issue the notice of payment to the applicant not later than 30 days before the deadline for payment in such final installment:
1. Where he/she fails to pay charges by the deadline for payment in the first installment;
2. Where it is deemed that a person who intends to pay charges in installments is unable to pay the full amount of the charges by the deadline for payment of the final installment by falling under any of subparagraphs of Article 14 (1) of the National Tax Collection Act.
(7) Except as expressly provided for in paragraphs (1) through (6), necessary matters for the procedure and method, etc., of payment in installments and delay of the deadline for paying the charges, shall be prescribed by Ordinance of the Prime Minister.
 Article 12 (Filing Objection Against Charges)
(1) Where a drug manufacturer, etc., has an objection against the charges imposed pursuant to Article 10, he/she may file an objection with the Minister of Food and Drug Safety by not later than the deadline for payment as prescribed by Ordinance of the Prime Minister.
(2) Upon receipt of an objection filed under paragraph (1), the Minister of Food and Drug Safety shall notify the applicant of the result thereof in writing within 30 days from the day of receipt of an objection filed.
(3) If the Minister of Food and Drug Safety deems that the details of an objection filed pursuant to paragraph (1) are well grounded, he/she shall issue the written notice of payment of the amount and deadline for payment by not later than 30 days before the deadline for payment. In such cases, the deadline for payment shall be determined by considering the period from the day of the objection filed to the date of the result notified pursuant to paragraph (2).
(4) If there is an amount to be refunded out of the amounts paid as charges by a drug manufacturer, etc., as a result of the filing of an objection, the Minister of Food and Drug Safety shall promptly refund it to the person who paid the charges.
 Article 13 (Measures, ect., for Overdue Charges)
(1) If a drug manufacturer, etc., fails to pay charges by the deadline for payment, the Minister of Food and Drug Safety shall issue a written reminder of the following matters within 30 days after the deadline for payment pursuant to Article 86-2 (5) of the Act. In such cases, the deadline for payment shall be 30 days from the day the reminder is issued:
1. Amount of charges;
2. Surcharges referred to in the latter part of Article 86-2 (5) of the Act (hereinafter referred to as “surcharges”);
3. Deadline for payment.
(2) The rate of surcharges shall be 20 percent a year, but the surcharges shall be calculated on a daily basis from the day following the deadline for payment to the day preceding the deadline for payment written in the reminder. In such cases, no total amount of surcharges shall exceed three percent of the overdue charges.
 Article 14 (Constitution of Finance Steering Committee)
(1) The Finance Steering Committee pursuant to Article 86-2 (4) of the Act (hereinafter referred to as the “Finance Steering Committee”), shall be comprised of 10 members including the chairperson, duly considering gender.
(2) The chairperson of the Finance Steering Committee shall be the head of the Institute of Drug Safety and Risk Management; and other members shall be commissioned or appointed by the head of the Institute of Drug Safety and Risk Management classified as follows:
1. Persons recommended by the pharmaceutical organizations established pursuant to Article 67 of the Act: four persons;
2. Persons recommended by non-profit, non-governmental organizations pursuant to Article 2 of the Assistance for Non-profit, Non-Governmental, Organizations Act: two persons;
3. Persons engaged in practicing as a lawyer or accountant for at least five years: one person;
4. Public officials belonging to the Ministry of Food and Drug Safety: one person.
(3) The term of members falling under subparagraphs 1 through 3 of Article 2, shall be two years: Provided, That the term of each member newly commissioned as a result of a vacancy, including the resignation of a member, shall be the remaining period of the term of the preceding member.
(4) The Finance Steering Committee shall have one administrative secretary. In such cases, the administrative secretary shall be designated by the chairperson, from among employees belonging to the Institute of Drug Safety and Risk Management.
 Article 15 (Operation of the Finance Steering Committee)
(1) The Finance Steering Committee shall deliberate on the following:
1. Rates for imposition of charges;
2. Matters regarding imposition and collection of charges;
3. Matters regarding payment and recovery, etc., of allowances for recovering from injuries;
4. Other matters regarding imposition, collection, and management of charges, for deliberation referred to by the chairperson of the Finance Steering Committee or by its members.
(2) The chairperson of the Finance Steering Committee shall call a meeting of the Finance Steering Committee and chair the meeting.
(3) Where a majority of the incumbent members request a meeting to be called, the chairperson of the Finance Steering Committee shall promptly call the meeting.
(4) A meeting of the Finance Steering Committee shall be held upon attendance of a majority of the incumbent members; and its resolution shall be passed by a two-thirds majority vote of the members present.
 Article 16 (Benefits, etc.)
The head of the Institute of Drug Safety and Risk Management may pay benefits, reimburse travel expenses and other expenses to the members of the Finance Steering Committee, within budgetary limits: Provided, That this shall not apply regarding any member who is a public official attends a meeting directly related to his/her duties.
 Article 17 (Financial Resources, etc., for Allowances for Recovering from Injuries)
(1) Each allowance for relief of injury from adverse drug reaction that shall be provided pursuant to Article 86-3 of the Act (hereinafter referred to as “allowance for relief of injury”), shall be appropriated from the following financial resources:
1. Charges and surcharges;
2. Amounts collected pursuant to Article 86-5 (2) of the Act;
3. Donations;
4. Interest and other gains;
5. Balance carried forward from the preceding year.
(2) The head of the Institute of Drug Safety and Risk Management shall be undergo an accounting audit by an external accounting firm every year regarding the financial resources of and details of expenditure on each allowance for relief of injury, and shall submit the result of such audit to the Minister of Food and Drug Safety.
 Article 18 (Preparation and Submission of Evaluation Report)
(1) Each year, the head of the Institute of Drug Safety and Risk Management shall prepare an evaluation report containing the following details, to advance with projects for relief of injury effectively:
1. Results from imposing and collecting charges;
2. Results from payment of each allowance for relief of injury and the payment thereof;
3. A plan for collecting charges necessary for projects for relief of injury;
4. Other matters the Minister of Food and Drug Safety deems necessary.
(2) The head of the Institute of Drug Safety and Risk Management shall submit each evaluation report prepared pursuant to paragraph (1), to the Minister of Food and Drug Safety by the last day of February in the following year, following deliberation by the Finance Steering Committee.
 Article 19 (Management of Sensitive Information and Personally Identifiable Information)
The Minister of Food and Drug Safety and the head of the Institute of Drug Safety and Risk Management may process data, including information regarding health pursuant to Article 23 of the Personal Information Protection Act or resident registration numbers, passport numbers, or alien registration numbers pursuant to subparagraphs 1, 2, or 4 of Article 19 of the Enforcement Decree of the same Act, where essential to conduct affairs regarding:
1. The imposition and collection of charges referred to in Article 86-2 of the Act;
2. The payment of each allowance for relief of injury referred to in Article 86-3 of the Act;
3. The procedures, etc., for relief of injury referred to in Article 86-4 of the Act;
4. Decisions on suspending the payment of each allowance for relief of injury and regarding the collection, etc., of unfair gains referred to in Article 86-5 of the Act;
5. Investigations, etc., of injury from adverse reaction referred to in Article 86-6 of the Act.
ADDENDA
Article 1 (Enforcement Date)
This Decree shall enter into force on December 19, 2014.
Article 2 (Preparation Regarding Imposition, etc., of Charges)
(1) In order to advance with projects for relief of injury smoothly, the head of the Institute of Drug Safety and Risk Management to whom the duties of imposition and collection of charges are entrusted pursuant to the latter part of Article 86-2 (1) of the Act, may determine the rate for imposing charges for basic charges to be imposed in 2015, after approval by the Minister of Food and Drug Safety, before this Decree enters into force pursuant to subparagraph 1 (d) of the attached Table: Provided, That deliberation by the Finance Steering Committee may be omitted.
(2) Before this Decree enters into force, the head of the Institute of Drug Safety and Risk Management to whom the duties of imposition and collection of charges are entrusted pursuant to the latter part of Article 86-2 (1) of the Act, may pre-notify a drug manufacturer, etc., of the details of the amount and calculation of basic charges calculated in accordance with subparagraph 1 of the attached Table, for which the rate for imposing charges referred to in paragraph (1) is applied, and allow them to peruse such details.
(3) Where the head of the Institute of Drug Safety and Risk Management deems that the operation of the Finance Steering Committee is necessary, he/she may constitute the Finance Steering Committee pursuant to Article 14 before this Decree enters into force.
Article 3 (Scope of Incremental Payment of Allowances for Recovering from Injuries)
Each allowance for relief of injury shall be paid incrementally, in accordance with the following, pursuant to Article 4 of the Addenda to the Partial Amendment of the Pharmaceutical Affairs Act (Act No. 12450):
1. By December 31, 2015: payment of lump-sum compensation for death;
2. From January 1, 2016 to December 31, 2016: payment of lump-sum compensation for death, funeral expenses, and lump-sum compensation for disability;
3. After January 1, 2017: payment of each allowance for relief of injury under any of subparagraphs of Article 86-3 (1) of the Act.
Article 4 Omitted.
ADDENDUM <Presidential Decree No. 26844, Dec. 31, 2015>
This Decree shall enter into force on the date of its promulgation.