Taiwan drafts the "Regulation for Notification of Drug Patent Linkage Agreements”

With a view to avoiding delays of registration of other generic drugs and negative impacts on patient's access to medicines resulted from unfair or restrictive competition agreements, the Food and Drug Administration of the Ministry of Health and Welfare drafted the "Regulation for Notification of Drug Patent Linkage Agreements” in accordance with Paragraph 2 of Article 42-19 of the Pharmaceutical Affairs Act to ensure public health and fair market transactions. The content of the draft Regulations includes: 1. The method, content and starting date of reporting reverse payment interest agreements. 2. Obligations of the parties that report the agreements. 3. Notification to the Fair Trade Commission by the central health competent authority of agreements that it considers is likely to violate the Fair Trade Act.

Draft Text 1 is available for download in the following languages: Chinese