TRIPS协定下药品试验数据保护的政府义务

TRIPS协定第39.3条为成员方政府设置了保护药品试验数据义务的最低标准,成员方在遵循基本义务的前提下,在药品数据保护制度的制定和实施中仍有一定的灵活度和自由空间,不同成员方可以采取不同的立法模式。无论从履行国际义务的层面,还是从促进我国制药产业的创新与发展的角度来说,药品试验数据保护都是政府需要承担的义务和职责。应在现有的法律规定下,结合我国行业发展情况的实际,研究制定进一步的实施细则。

On the Governmental Obligation in Pharmaceutical Test Data Protection under TRIPS Agreement

Through the interpretation of key terms of Article 39.3 of TRIPS,the minimum standard of Members＂ obligation to protect pharmaceutical test data under TRIPS can be illustrated.Members have flexibility and discretion when they take measures to protect test data.They can choose the different legislation models to fulfill the obligation,In the perspective of fulfilling the international obligation and promoting the innovation and development of pharmaceutical industry,pharmaceutical test data protection is the obligation and responsibility of government.Considering National situation and industrial development of China,Chinese government should study how to carry out the relative provisions in our law and regulation.