Enforcement Rules of the Rare Diseases and Orphan Drugs Act Article 7

The central competent authorities shall formulate the plans relating to the organizing and holding of educational activities for the prevention and control of rare diseases annually, in accordance with the regulations of Paragraph 1, Article 11 of the Act.In event of mediation stipulated in accordance to the regulations of Paragraph 2, Article 11 of the Act, the central competent authority may provide necessary information to relevant institutions and/or agencies for reference, under informed consent of the patient, or the legal representative, and the legal guardian. For patients lacking disposing capacity, the central competent authority shall obtain informed consent from the respective assistant.