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.
Some academics allege that pharmaceutical data exclusivity protection unfairly restricts the rapid public dispersal of knowledge that is supposed to be the trade-off for a grant of a patent or intellectual monopoly privilege.
Specifically, it is considered unethical under the Declaration of Helsinki to undertake duplicative clinical trials on human subjects.
Similar concerns have been raised in the context of test data protection for certain agricultural or cosmetic products, leading in some countries to proposals for cost sharing rather than exclusive rights as the form of test data protection.