Article 1

¡@¡@This Act is enacted for the prevention and treatment of rare diseases; for the early diagnosis of these diseases; for the intensive care of rare disease patients; for assisting patients gaining access to specific pharmaceuticals for the treatment of these diseases and to special nutrient foods essential to the maintenance of life; and for promoting and ensuring the supply, manufacturing, and research and development of such pharmaceuticals and foods.

For matters not regulated in this Act, regulations of other relevant Acts will apply.

Article 2

¡@¡@The competent authorities stipulated in this Act shall be the Department of Health of the Executive Yuan at the central government level; the municipal governments at the municipality level; and the county and city governments at the county and city level.

Article 3

¡@¡@The rare diseases specified in this Act refer to diseases with prevalence lower than that formulated and publicly announced by the central competent authority, and recognized by the Committee specified in Article 4 of this Act; or diseases designated and publicly announced by the central competent authority under special circumstances.
¡@¡@Orphan drugs specified in this Act refer to pharmaceuticals with major indications for the prevention, diagnosis and treatment of rare diseases that have been duly submitted in accordance with this Act for application and have been publicly announced by the central competent authority.

Article 4

¡@¡@To review and evaluate matters related to rare diseases, the central competent authority shall set up a Committee for the Review and Examination of Rare Diseases and Orphan Drugs (hereafter referred to as the Committee). The organization and meetings of the Committee shall be regulated by the central competent authority.
¡@¡@Members of the Committee shall consist of representatives of government organizations, scholars and specialists in medical affairs, and impartial citizens. At least two-thirds of the members of the Committee shall be scholars and specialists in medical affairs.

Article 5

¡@Missions of the Committee are:
¡@¡@1. Identification and control of rare diseases;
¡@¡@2. Review and approval of orphan drug application;
¡@¡@3. Testing, marketing & registration of orphan drugs;
¡@¡@4. Review and examination of funding, research and development of orphan drugs;
¡@¡@5. Review and examination of the diagnosis, treatment, or international cooperation plans for rare diseases, and issues concerning assistance and counseling;
¡@¡@6. Review and examination of the use of non-orphan drugs for the treatment of some specific diseases; and
¡@¡@7. Other relevant issues.
¡@¡@In the execution of the aforementioned missions, the Committee shall consult other relevant scholars, specialists and representatives of industry or patients of rare diseases for their opinions.

Article 6

The central competent authority may entrust institutions with projects concerning the control and research of rare diseases.

Article 7

Medical personnel, upon identifying patients of such rare diseases specified in Article 3, or human remains died of such diseases, shall report to the central competent authority.

Article 8

The central and the municipal competent authorities, upon receiving reports or on identification of persons with genetic anomalies of rare diseases, may, if need be, dispatch specialists from genetic health counseling centers for interviewing. They shall tell patients the relevant effects of the disease.

Article 9

¡@¡@ Organizations, institutions, and personnel authorized by this Act for the execution of functions specified in Article 8 and Article 9 shall be attentive to their attitude and methods of execution. They shall respect the will and dignity of the patients. They shall also protect the privacy and normal social functioning of the patients.

Article 10

¡@¡@The central and the municipal competent authorities shall encourage medical care institutions and research institutions at all levels to conduct the prevention and control of rare diseases; and provide them funding for manpower development, research, and facilities.
        Funds required for the aforementioned subsidies shall come from budgets of the central and the municipal competent authorities. Donations from organizations and groups.   Under either one of the following conditions, the central competent authority may, irrespective of the regulations of Paragraph 1 of Article 17, accept applications for registration and market approval of other pharmaceuticals of the same kind and issue them permit licenses.
¡@¡@1. The new applicants have in their possession authorized consent from right-holders of the orphan drugs duly issued through registration and market approval.
¡@¡@2. New applications for orphan drugs of same indications and similar quality and their safety and efficacy have been proved to be superior to those of the orphan drugs already issued licenses.
¡@¡@3. Permit license owners for orphan drugs fail to meet demands on the orphan drugs.
¡@¡@4. Prices of the orphan drugs are considered unreasonable by the central competent authority.
¡@¡@Regulations of the preceding Article will apply to permit licenses issued by the central competent authority through registration and market approval under subparagraph 2 through subparagraph 4 of the preceding Paragraph.

Article 19

¡@¡@Government organizations, medical care institutions, patients of rare diseases and their families, and relevant foundations, societies, and associations, may apply on ad hoc basis to the central competent authority for permission for orphan drugs not yet processed through registration and market approval, or meeting one of the conditions specified in subparagraph 3 and subparagraph 4 of Paragraph 1 of the preceding Article. These orphan drugs shall not be for profit making.
¡@¡@The central competent authority may, if necessary, entrust or designate relevant institutions or groups to process the aforementioned ad hoc applications.
¡@¡@ Documents required for ad hoc applications specified in Paragraphs 1 and 2, their review procedures, and other relevant issues shall be regulated by the central competent authority.

Article 20

¡@¡@When orphan drugs are proved to be unsafe or hazardous to health, the central competent authority may order pharmaceutical firms or ad hoc applicants to recall the orphan drugs in due time. If necessary, permits issued to the orphan drugs may be revoked.

Article 21

¡@¡@The central competent authority shall compile annual report of orphan drugs approved by this Act for marketing or on ad hoc basis. The report shall contain information on the amount taken, number of patients, any adverse reactions, and other relevant matters.
¡@¡@Pharmaceutical firms and ad hoc applicants shall submit relevant information for the aforementioned report.

Article 22

¡@¡@Regulations concerning registration and market approval and ad hoc application of this this Act shall apply to pharmaceuticals that are difficult to manufacture or import by regulations of the Pharmaceutical Affairs Act, but are reviewed and confirmed by the Committee to be beneficial to the medical care of certain specific diseases.

Article 23

¡@¡@The central competent authority shall announce periodically the recognition, permission, revoking, and annulment of rare diseases and orphan drugs.

Article 24

¡@¡@Fees for review, registration, or licenses shall be paid for applying for registration and market approval, conducting clinical trials, issuance and extension of permit licenses, and ad hoc applications, The fee schedule shall be determined by the central competent authority.

Article 25

¡@¡@The central competent authority may promote the supply, manufacturing, and research and development of orphan drugs. Regulations governing the recipients of incentives, ways of promotion, and matters to be followed by the recipients shall be decided by the central competent authority.

Article 26

¡@¡@Manufacturing and importation of orphan drugs without permission, or the sales, supply, dispensing, transportation, deposit, trading of stolen goods, transfer, or display for sale of orphan drugs known for not being permitted shall be punished according to the regulations of Article 82 and Article 83 of the Pharmaceutical Affairs Act.

Article 27

¡@¡@Any violations of the regulations of Article 16 shall be fined NT$ 30,000 to NT$ 150,000. For serious violations, pharmaceutical firms shall be suspended from making application for registration and market approval for the said pharmaceutical for two years. Medical care institutions may be suspended for one month to one year.

Article 28

¡@¡@ In the case of submitting false documents for the application for registration and market approval of orphan drugs or extension of licenses for such orphan drugs, the applicants shall be fined NT$ 20,000 to NT$ 100,000, and shall be suspended from making application for registration and market approval of the said pharmaceutical for two years. Permit licenses already in the possession of the applicants shall be revoked. For their criminal responsibilities, they shall be sent to judicial organizations for further investigation.

Article 29

¡@¡@Any violations of the regulations of Paragraph 1 of Article 19 to allow orphan drugs approved on ad hoc basis for profit-making, the applicants shall be fined NT$ 30,000 to NT$ 150,000; the profits thus made shall be confiscated; and the applicants shall be suspended from making any ad hoc application for orphan drugs for two years.

Article 30

If orphan drugs ordered to be recalled in due time by the central competent authority under regulations specified in Article 20 are not recalled, the pharmaceutical firms or ad hoc applicants shall be fined NT$ 30,000 to NT$ 150,000, consecutively until the orphan drugs are recalled.

Article 31

Pharmaceutical firms in violation of the regulations of Paragraph 2 of Article 21 shall be fined NT$ 10,000 to NT$ 50,000. Ad hoc applicants in violation of such regulations, their future applications for orphan drugs shall not be permitted by the central competent authority.

Article 32

Fines regulated in this Act shall be administered by the central and the municipal competent authorities.
¡@¡@The aforementioned fines should be paid in due time. If not, the cases shall be transferred to the judicial court for enforcement by law.

Article 33

The central competent authority shall allocate budget to subsidize costs for the diagnosis, treatment, pharmaceuticals, and special nutrient foods essential to the maintenance of life not reimbursable according to the regulations of the National Health Insurance Act. Ways of subsidies, their contents, and other relevant issues shall be determined by the central competent authority.
¡@¡@ Funds for the aforementioned subsidies may also be solicited from relevant organizations and groups.

Article 34

Special nutrient foods essential to the maintenance of life of patients of rare diseases may be managed with reference to relevant regulations of this Act.

Article 35

The Enfercement Rules of this Act shall be formulated by the central competent authority.

Article 36

This Act shall become effective as of six months after the promulgation.

Article 37

The Executive Yuan shall review and amend this Act within six months after this Act is implemented for one year.