罕見疾病防治及藥物法

This provision states the law’s purpose: to prevent rare diseases, support early diagnosis and patient care, and promote the supply, manufacture, and research of drugs and special nutrition foods for rare disease patients.

中央主管機關要獎勵醫療機構、研究機構和罕見疾病相關團體從事罕見疾病防治，並補助相關人力、研究和設備經費。

主管機關應辦理罕見疾病的教育與宣導，並在病人就學、就業或就養時協調相關機關（構）提供協助。

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罕見疾病病人或其法定代理人可向中央主管機關申請補助；符合條件時，中央主管機關也可提供國外國際醫療合作補助。

Rare disease drugs may not be manufactured or imported unless they have been registered and a drug permit has been issued by the central competent authority, subject to any other rules in the Act.

符合條件者得申請將藥物查驗登記為罕見疾病藥物；申請所需書證、審查程序及其他事項由中央主管機關訂定。

For rare disease drugs, when the central competent authority has completed registration review or approved a special application and the listing procedure under the national health insurance drug reimbursement/payment standards is being followed, the review committee’s opinion must be sought.

申請罕見疾病藥物查驗登記時，中央主管機關在必要時可以要求進行國內臨床試驗，並應適當公開說明臨床試驗的申請內容與結果。

A rare disease drug permit lasts 10 years. During that period, the central competent authority must not accept registration applications for the same kind of drug. If the drug still needs to be made or imported after 10 years, the permit holder must apply in advance for an extension, and each extension may not exceed 5 years.

在列明的情形下，中央主管機關可以受理其他同類藥物的查驗登記申請，並核發許可證。

Certain government bodies, medical institutions, rare disease patients and families, and related foundations, societies, and associations may apply for special permission from the central competent authority, but the application cannot be for profit.

This provision defines which authority counts as the competent authority: the Ministry of Health and Welfare at the central level, municipal governments in special municipalities, and county/city governments in counties and cities.

如果罕見疾病藥物被認定有害人體健康或有危害疑慮，中央主管機關可以命藥商或專案申請者在期限內回收；必要時，還可以廢止該藥物許可。

中央主管機關要就核准上市或專案申請的罕見疾病藥物編列年報；藥商及專案申請者要提供相關資料配合辦理。

If a rare disease drug is hard to manufacture or import in Taiwan and the review committee finds it helps treat a specific disease, the Act’s rules on inspection/registration and special applications apply mutatis mutandis.

中央主管機關應定期公告罕見疾病及藥物的認定、許可、撤銷與廢止事項。

申請查驗登記、臨床試驗、許可證核發或展延、專案申請的人，應繳納審查費、登記費或證照費。

主管機關可以獎勵罕見疾病藥物或維持生命所需之特殊營養食品的供應、製造與研究發展，並可訂定相關辦法。

People who make or import unlicensed rare disease drugs, or who knowingly sell, supply, dispense, transport, store, broker, transfer, or display them for sale, are punished under Articles 82 and 83 of the Pharmaceutical Affairs Act.

違反第十六條規定者，會被處新台幣3萬元以上15萬元以下罰鍰；情節重大者，藥商2年內不得再申請該藥物查驗登記，且醫療機構可被處1個月以上1年以下停業處分。

停止供應罕見疾病藥物，或未在停止日前六個月以書面通知中央主管機關者，會被處罰鍰；必要時還可以廢止該藥物許可證。

申請罕見疾病藥物查驗登記或展延登記時，若提供不實書證資料，會被罰鍰，並可能在二年內不得再申請、已領證者遭撤銷，涉及刑責者移送司法機關。

If a person uses a project-applied rare disease drug for commercial purposes in violation of Article 19(1), they can be fined, their gains confiscated, and they cannot submit another project application for rare disease drugs for two years.

This article defines three terms: rare disease, rare disease drug, and special nutritional food needed to sustain life.

If someone violates a competent authority’s order under Article 20 to recall items within a set time, they can be fined NT$30,000 to NT$150,000 and fined repeatedly until the recall is completed.

藥商違反第21條第2項時，會被處新台幣1萬至5萬元罰鍰；專案申請者再申請罕見疾病藥物時，中央主管機關可以不予許可。

主管機關可以處罰本法所定的罰鍰；經限期繳納而逾期未繳的，依法移送強制執行。

中央主管機關應編列預算，補助罕見疾病預防、篩檢、研究及部分未由健保給付的罕見疾病相關費用。

醫療機構可以專案申請輸入罕見疾病病人維持生命所需的特殊營養食品；相關書證資料、審查程序及其他應遵行事項，由中央主管機關訂定辦法。

中央主管機關應協助診療醫院及罕見疾病病人，緊急取得維持生命所需的特殊營養食品與罕見疾病適用藥物。

本法施行細則由中央主管機關訂定。

This provision says the Act starts six months after promulgation, while the amended provisions take effect on promulgation.

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罕見疾病及藥物審議會負責處理本條列出的罕見疾病相關審議、諮詢、協助與補助研發事項，並須徵詢相關專家、產業及病人代表意見。

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中央主管機關必須辦理罕見疾病的防治與研究。

醫事人員發現病人罹患罕見疾病或因此死亡時，應向中央主管機關報告。

中央主管機關在接獲報告或發現罕見遺傳疾病缺陷者，經病人或其法定代理人同意後，應派專業人員訪視並提供說明與支持服務。

Certain agencies, institutions, organizations, and their staff must act carefully, respect patients, and protect patient privacy and social life; staff must also keep rare disease information confidential and not disclose or hand it over without cause.