Established, promulgated and enacted on August 9, 2000 under Order No. Wei-Sho-Bao-Tzu 0890009922

Amended on April 7, 2011 under Order No. Shu-Sho-Guo-Tzu 1000400309

Amended on December 29, 2011 under Order No. Shu-Sho-Guo-Tzu 1000402881

Amended on October 13, 2014 under Order No. Bu-Sho-Guo-Tzu1000402881

Amended on March 6, 2015 under Order No. Bu-Sho-Guo-Tzu 1040400442

Article 1  This regulation is established in accordance with the provisions of Paragraph 1, Article 33 of the Rare Diseases and Orphan Drugs Act.

Article 2  Patients with rare diseases may apply for subsidies for the following disease-related medical expenses paid by themselves in accordance with this Regulation, except for expenses that have been covered by other grants:

1.   Diagnostic expenses with significant impact on the treatment methods or genetic counseling recommendations for rare diseases.

2.   Expenses for treatments, pharmaceuticals, and special nutrient foods essential to the maintenance of life, which have been proofed by domestic or foreign research studies and reviewed by the Rare Diseases and Orphan Drugs Review Committee for considerable efficacy and safety.

3.   Laboratory fees for diagnosing suspected rare diseases.

4.   Nutritional counseling fees for  metabolic rare diseases

5.   Expenses of home health care equipment required for maintaining life.

6.   Laboratory fees for diagnosing relatives of patients with rare diseases within four degrees of consanguinity who are suspected of suffering from rare diseases or of being genetic carriers.

7.   Expenses of the drug incurred during the period of review of an application for adding such drug onto the list of covered drugs under the National Health Insurance Pharmaceutical Benefits and Reimbursement Schedule if such drug has been designated by the Rare Disease and Orphan Drugs Review Committee and proclaimed by the central competent authority as an orphan drug. However, such expenses shall be subject to the approval by the Review Committee for Rare Diseases and Orphan Drugs.

The provisions of subparagraph 3 and 5 of the preceding paragraph 1 have been implemented since January 1, 2011; the provisions of Subparagraph 6 of Paragraph 1 have been enacted since October 13, 2014.

Article 3  Patients suspected of having a rare disease that has not been designated by the Review Committee for Rare Diseases and Orphan Drugs and proclaimed by the central competent authority as a rare disease may apply for subsidies for laboratory fees for disease diagnosis.

The preceding regulation has been enacted since October 13, 2014.

Article 4  Applications for subsidies specified in subparagraphs 1 and 2 of paragraph 1of Article 2 shall be submitted by regional hospitals or higher-level medical institutions to the central competent authority and must be accompanied with relevant supporting documents; the maximum subsidized amount is eighty percent of the expenses. However, expenses of special nutrient required for maintain life will be fully subsidized.

The preceding regulation has been enacted since on April 7, 2011.

Article 5  Applications for subsidies specified in subparagraphs 3 and 6 of paragraph 1of Article 2 and Article 3 shall be submitted by the treating medical institutions to the central competent authority and must be accompanied with relevant supporting documents; the maximum subsidized amount is eighty percent of the expenses.

Applications for subsidies specified in subparagraphs 4 of paragraph 1of Article 2 shall be submitted by the treating medical institutions to the central competent authority and must be accompanied with relevant supporting documents; the attached table sets forth the amount and frequency of subsidies.

Treating medical institutions applying for subsidies specified in subparagraph 7 of Paragraph 1 of Article 2 shall obtain prior approval from the Review Committee for Rare Diseases and Orphan Drugs.

Treating medical institutions applying for subsidies specified in the preceding paragraph shall submit applications accompanied with relevant supporting documents to the central competent authority within 3 years after such drugs have been designated by the Review Committee for Rare Diseases and Orphan Drugs and proclaimed by the central competent authority as orphan drugs; the maximum subsidized amount payable to each individual is eighty percent of the drug expenses and subject to an upper limit of NT500,000 dollar per month.

Article 6  Applications for subsidies specified in subparagraphs 5 of paragraph 1of Article 2 shall be submitted by rare disease patients or their legal representatives to the central competent authority and must be accompanied with relevant supporting documents; the maximum subsidized amount is eighty percent of the expenses.

Article 7  Restrictions prescribed in the preceding three articles are not applicable to the following expenses:

1.  Medical expenses of a patient from low-income or middle-low-income households.

2.  Expenses of emergency medicine needed for maintaining life of a rare genetic disease patient.

Article 8  Medical institutions applying for subsidies of medical and related expenses shall not charge patients in advance, and shall apply to the central competent authority within three months after expenses occurred or account settled.

The central competent authority may cut down any abnormal or excess medical expenses applied for by medical institutions; the medical institutions shall not charge patients for the above-stated expenses.

Article 9  Expenses from human trials of medical projects shall be charged in accordance with the relevant provisions of the Medical Care Act and shall not, except regular medical services implemented in diagnosis determination, be charged to participants.

Hospitals may apply to the central competent authority for partial subsidies for expenses of human trials specified in the preceding paragraph, and the amount shall be subject to the review and approval of the Rare Diseases and Orphan Drugs Review Committee before the trial; likewise for clinical trials entering multi-center stage.

Article 10 The use of subsidized drug and special nutrient foods essential to the maintenance of life shall not be transferred to others; however, temporary transfer by clinic physicians based on urgent needs of the patients shall not be subject to this restriction.

Article 11 Unless otherwise specified, this Regulation shall take effect upon promulgation.

Attached table  Provisions governing the subsidies for Nutritional counseling fees for metabolic rare diseases