Test data exclusivityとは 意味・読み方・使い方

Test data exclusivity refers to protection of clinical test data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug, and prevention of generic drug manufacturers from relying on this data in their own applications. Pharmaceutical companies argue that since test data is so expensive to produce, it is an unfair advantage to let other companies rely on that data without cost. Critics charge that it can act as a restriction to producing a generic copy; that although it would not raise prices of drugs, it would prevent prices from falling due to generic competition; and make it more costly for the poor to gain access to life-saving drugs (e.g. anti-HIV & anti-malarial medications.) Developed countries with innovative pharmaceutical industries (including the United States) have sought data exclusivity provisions in Free Trade Agreements with their trading partners, e.g. DR-CAFTA which includes such a provision.