藥物廣告管理之法制【本期企劃】 試閱
Legal Mechanism of Medicaments Advertising Managmenet
藥物與一般食物商品不同，必須有安全與正確使用的管理機制，故直接訴求於消費者之藥物廣告，即應兼具資訊傳遞及履行真實義務的社會責任。由於藥物廣告涉及專業與商業的衝突，為免造成不當的醫療使用，立法者乃於藥事法設定藥物廣告管理專章，採事前審查制度，規範持有該藥物許可證之藥商，應於刊播廣告前，將所有文字、圖畫或言詞向所在地主管機關申請許可，有效期限1年，並應向傳播業者送驗核准文件，違者並課以相當重之行政責任。主管機關審查藥物廣告，以核定之仿單所載之資料為準，所使用之文圖影音，不得誤導消費者，且不得造成消費者之誤認，以免危害民眾健康或有重大危害之虞。實務上對於藥物廣告亦採嚴格之審查，未來是否改為事後檢查制度，建議應著眼於行政效率與經濟效益的評估，探討其法理，明確界定事前審查之內容及流程，以審慎為之。
Different from general food products, there must be management mechanisms of safety and instructions for medicaments. Medicaments advertising that appeal to consumers directly should be transmitted with both information transmission and fulfillment for the real obligations of social responsibilities. Medicaments advertising involve conflicts between professional and commercial prospects, legislators included the pre-examination registrations into the pharmaceutical laws in order to avoid improper medical use. It is regulated that pharmaceutical sellers should file applications of the text, drawings or words of the medicaments advertisements to the local authorities for the license valid for one year. And, the approved documents should be passed to the mass media enterprise. The reviewing of medicaments advertising should be based on the information from the instructions. In order to avoid the hazards to public heath, medicaments advertising must not mislead the consumers. Practically the review for the medicaments advertising should be strict with penalties. The consideration to modify the review system into the post-inspection should be discussed thoroughly with clearly reviewing of the contents and process.
007-020
