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The Rare Disease and Orphan Drug Act
The Rare Disease and Orphan Drug Act 
How it got started 
  In March of 1998, former executive director of TFRD Min-Chieh Tseng and board member Serena Wu, both as
parents of rare disease patients, silently worked to promote the systematization and legalization of rare disease
issues in Taiwan.  On June 16, 1998, the United Daily Evening News reported the issues of rare diseases and
orphan drugs, presenting in-depth stories and testimonials of families that suffered from rare diseases. The report
highlighted how the medical and social systems overlooked and unfairly treated patients with rare diseases, thus
formally unveiling the opportunity for change. With tremendous support from the society and persistence, TFRD
was formally established in June 1999.  Believing in the fundamental right and benefits of patients as the starting
point for the adoption of the " Rare Disease Control and Orphan Drug Act" through media coverage, donations
from all sectors of society, and the active help of patients, families, medical professionals and relevant professionals. 
In January of 2000, after more than forty days and three readings in the Legislative Yuan, the Rare Disease and
Orphan Drug Act was enacted the following month with the announcement from the President.  From that point
forward, patients were protected while they sought medical care.

Article Content
   Enforcement Rules Content

 Legislative History

1.Promulgated by Presidential Order Hua Tsung (1) Yi Tzu No. 8900031600 on February 9, 2000.
2.Deleted Article 12 and Article 37; and amended Article 1, Article 3, Article 5, Article 7 through Article 11, Article 13, 
Article 15, Article 19, Article 25, Article 32, Article 34 and Article 36, and promulgated by Presidential Order Hua 
Tsung (1) Yi Tzu No. 09400004921 on January 19, 2005.
3.Amended Article 6 and Article 33, and promulgated by Presidential Order Hua Tsung (1) Yi Tzu No. 09900331421 
on December 8, 2010.
4.Deleted Article 5; and amended Article 2, Article 3, Article 4, Article 8, Article 10, Article 11, Article 13, Article 15-1, Article 17, Article 22, Article 26, Article 27-1, Article 33 and Article 34-1, and promulgated by Presidential Order Hua Tsung (1) Yi Tzu No. 10400002311 on January 14, 2015.