Russia will not protect public data on clinical trials of pharmaceutical companies
On 01 January 2016, the so-called rule on data exclusivity of pre-clinical and clinical studies came into effect. Paragraph 18 of Article 18 of Law FZ-61, "On Circulation of Medicines" says that during six years after the registration of a reference drug, the abovementioned data cannot be used without permission of the copyright holder. Less than a year later, they have decided to remove this rule. Posted on regulation.gov.ru is a draft bill, which introduces the corresponding amendments.
