Medical Care Act

When the Minister of Health, Labour and Welfare finds that the supply of a specified pharmaceutical (meaning a specified pharmaceutical prescribed in Article 2, paragraph (17) of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices; the same applies hereinafter) is in shortage, or is likely to be in shortage as reasonably judged from the state of supply and demand of the specified pharmaceutical and other circumstances, and that, as a result, the provision of appropriate medical care will become difficult, which may affect the lives and health of the people, the Minister may request marketing authorization holders (meaning persons who have obtained a license for the business of marketing pharmaceuticals under Article 12, paragraph (1) of that Act; the same applies hereinafter), manufacturers (meaning persons who have obtained a license for the business of manufacturing pharmaceuticals under Article 13, paragraph (1) of that Act; the same applies hereinafter), wholesale distributors (meaning persons who have obtained a license for the wholesale distribution business under Article 34, paragraph (1) of that Act; the same applies in Article 38-4) and other related parties to provide the cooperation necessary to ensure the provision of that specified pharmaceutical or an alternative pharmaceutical (meaning an alternative pharmaceutical prescribed in Article 18-5 of that Act; the same applies hereinafter in this Article) to medical institutions that need it, such as increasing the production of, and adjusting the sale of, that specified pharmaceutical or alternative pharmaceutical.

In the case prescribed in the preceding paragraph, the Minister of Health, Labour and Welfare may request pharmacy establishers (meaning pharmacy establishers prescribed in Article 1-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices), the establishers of hospitals or clinics, and other related parties to provide the cooperation necessary to ensure the provision of medical care to persons who need that specified pharmaceutical or alternative pharmaceutical, such as consideration in dispensing or prescription.

The Minister of Health, Labour and Welfare is to establish guidelines for securing the stable supply of supply security pharmaceuticals and the raw materials or materials recognized as indispensable for their manufacture (hereinafter referred to as "supply security pharmaceuticals, etc.") (hereinafter referred to as the "guidelines for securing stable supply").

The guidelines for securing stable supply are to prescribe the following particulars:

the basic direction concerning securing the stable supply of supply security pharmaceuticals, etc.;

particulars concerning measures to prevent the occurrence of supply shortages of supply security pharmaceuticals, etc.;

particulars concerning manufacture or importation in the case where a supply shortage of supply security pharmaceuticals, etc. occurs; and

other important particulars concerning securing the stable supply of supply security pharmaceuticals, etc.

When the Minister of Health, Labour and Welfare has established or amended the guidelines for securing stable supply, the Minister is to publish them without delay.

"Supply security pharmaceutical" in paragraph (1) means a specified pharmaceutical that the Minister of Health, Labour and Welfare, after hearing the Health Sciences Council, designates as having a high necessity of securing its stable supply, in consideration of the following particulars:

the degree of severity of the symptoms in the case of contracting the disease for which it is used;

the existence or non-existence of a specified pharmaceutical or treatment method that can substitute for the specified pharmaceutical;

the existence or non-existence of special technology required for its manufacture, the supply situation of raw materials or materials, and other particulars to be noted regarding its manufacture or supply; and

other particulars specified by an Order of the Ministry of Health, Labour and Welfare.

When the Minister of Health, Labour and Welfare finds, as reasonably judged from the state of manufacture and other circumstances, that there is a likelihood that the supply of important supply security pharmaceuticals (meaning, among the supply security pharmaceuticals prescribed in paragraph (4) of the preceding Article, those that the Minister of Health, Labour and Welfare, after hearing the Health Sciences Council, designates as being particularly important to secure the stable supply of, in consideration of the particulars listed in the items of that paragraph) and the raw materials or materials recognized as indispensable for their manufacture (hereinafter referred to as "important supply security pharmaceuticals, etc.") will be in shortage, and that, if the supply were to be in shortage, the provision of appropriate medical care would become difficult, which may seriously affect the lives and health of the people, the Minister may instruct the marketing authorization holders or manufacturers of the important supply security pharmaceuticals, etc. to prepare, in line with the guidelines for securing stable supply and as provided by Order of the Ministry of Health, Labour and Welfare, a plan concerning the measures necessary to prevent the occurrence of a supply shortage of the important supply security pharmaceuticals, etc. (hereinafter referred to as a "plan for measures to prevent supply shortages" in this Article) and to notify the Minister of Health, Labour and Welfare of it.

When the Minister of Health, Labour and Welfare finds it particularly necessary to deal with the situation prescribed in the preceding paragraph, the Minister may instruct a marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under that paragraph, in line with the guidelines for securing stable supply, to change the plan for measures to prevent supply shortages relating to the notification (where a notification of change has been made pursuant to the provisions of the following paragraph, the plan after the change; the same applies hereinafter in this Article) and to notify the Minister of Health, Labour and Welfare of it.

A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under the preceding two paragraphs must, when it has changed the plan for measures to prevent supply shortages relating to the notification, notify the Minister of Health, Labour and Welfare of the changed particulars, as provided by Order of the Ministry of Health, Labour and Welfare.

A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under paragraph (1) or (2) must take the measures necessary to prevent the occurrence of a supply shortage of the important supply security pharmaceuticals, etc. relating to the plan for measures to prevent supply shortages, in line with the plan relating to the notification.

When the Minister of Health, Labour and Welfare finds that a marketing authorization holder or manufacturer that received an instruction under paragraph (2) has not complied with the instruction without justifiable grounds, or that a marketing authorization holder or manufacturer prescribed in the preceding paragraph has not, without justifiable grounds, taken the measures necessary to prevent the occurrence of a supply shortage of the important supply security pharmaceuticals, etc. relating to the plan for measures to prevent supply shortages, in line with the plan relating to the notification, the Minister may make public that fact.

When the Minister of Health, Labour and Welfare finds that, due to an increase in demand, a decrease in the quantity manufactured or other circumstances, the supply of important supply security pharmaceuticals, etc. is actually in shortage, or the likelihood of its being in shortage is particularly high as reasonably judged from the state of supply and demand of the important supply security pharmaceuticals, etc. and other circumstances, and that, due to the shortage of supply, the provision of appropriate medical care would become difficult, which may seriously affect the lives and health of the people, the Minister may instruct the marketing authorization holders or manufacturers of the important supply security pharmaceuticals, etc., in line with the guidelines for securing stable supply and as provided by Order of the Ministry of Health, Labour and Welfare, to prepare a plan concerning the manufacture or importation of the important supply security pharmaceuticals, etc. (hereinafter referred to as a "plan for manufacturing, etc." in this Article) and to notify the Minister of Health, Labour and Welfare of it.

When the Minister of Health, Labour and Welfare finds it particularly necessary to deal with the situation prescribed in the preceding paragraph, the Minister may instruct a marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under that paragraph, in line with the guidelines for securing stable supply, to change the plan for manufacturing, etc. relating to the notification (where a notification of change has been made pursuant to the provisions of the following paragraph, the plan after the change; the same applies hereinafter in this Article) and to notify the Minister of Health, Labour and Welfare of it.

A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under the preceding two paragraphs must, when it has changed the plan for manufacturing, etc. relating to the notification, notify the Minister of Health, Labour and Welfare of the changed particulars, as provided by Order of the Ministry of Health, Labour and Welfare.

A marketing authorization holder or manufacturer that has made a notification in compliance with an instruction under paragraph (1) or (2) must manufacture or import the important supply security pharmaceuticals, etc. relating to the plan for manufacturing, etc., in line with the plan relating to the notification.

When the Minister of Health, Labour and Welfare finds that a marketing authorization holder or manufacturer that received an instruction under paragraph (2) has not complied with the instruction without justifiable grounds, or that a marketing authorization holder or manufacturer prescribed in the preceding paragraph has not, without justifiable grounds, manufactured or imported the important supply security pharmaceuticals, etc. relating to the plan for manufacturing, etc., in line with the plan relating to the notification, the Minister may make public that fact.

The national government may take financial and other necessary measures for marketing authorization holders or manufacturers that, in compliance with an instruction under Article 38, paragraph (1) or (2), take the measures necessary to prevent the occurrence of a supply shortage of important supply security pharmaceuticals, etc., and for marketing authorization holders or manufacturers that, in compliance with an instruction under paragraph (1) or (2) of the preceding Article, manufacture or import important supply security pharmaceuticals, etc.

A marketing authorization holder, manufacturer or wholesale distributor of supply security pharmaceuticals, etc., or another person specified by Order of the Ministry of Health, Labour and Welfare, must, in line with the guidelines for securing stable supply and as provided by Order of the Ministry of Health, Labour and Welfare, report to the Minister of Health, Labour and Welfare the status of manufacture, importation, sale or provision of supply security pharmaceuticals, etc. and other necessary particulars.

With regard to supply security pharmaceuticals, etc., the Minister of Health, Labour and Welfare may, in line with the guidelines for securing stable supply, request marketing authorization holders or manufacturers and other persons specified by Order of the Ministry of Health, Labour and Welfare to provide the cooperation necessary to prevent the occurrence of a supply shortage of the supply security pharmaceuticals, etc.

The Minister of Health, Labour and Welfare may, to the extent necessary for the enforcement of the provisions of Article 38 and Article 38-2, have marketing authorization holders or manufacturers report on the state of their business or accounting, or have the relevant officials enter the business offices, offices and other places of business of these persons and inspect books, documents and other articles.

The provisions of Article 6-24, paragraphs (2) and (3) apply mutatis mutandis to the entry and inspection under the provisions of the preceding paragraph.

In order to ascertain the state of supply and demand for specified pharmaceuticals, the Minister of Health, Labour and Welfare may conduct surveys and analysis of the information under Article 12-2, paragraph (3) of the Act on Promotion of Comprehensive Securing of Medical and Long-Term Care in Communities and other information specified by Order of the Ministry of Health, Labour and Welfare (referred to as "information on dispensing of pharmaceuticals, etc." in the following paragraph).

The Medical Information Infrastructure and Medical Fee Examination and Payment Organization or a Federation of National Health Insurance Associations prescribed in Article 45, paragraph (5) of the National Health Insurance Act must, for use in the surveys and analysis under the preceding paragraph, provide the Minister of Health, Labour and Welfare with the information on dispensing of pharmaceuticals, etc. that each of them holds, by the method specified by Order of the Ministry of Health, Labour and Welfare.