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  • Health authorities require, as part of a submission for a marketing authorization, that proprietary information be disclosed in order to ensure public health and patient safety.
  • The innovator assumes the entire risk for the generation of the data, what requires expensive and lengthy clinical trials.
  • Data Exclusivity is necessary to provide a measure of certainty to the innovator that they will be provided with a period of protection for their efforts of testing a drug.
  • Patents and data exclusivity are different concepts, protect different subject matter, arise from different efforts, and have different legal effects over different time periods.

Background

The information collected by an innovative company to prove the safety and efficacy of a new medicine encompasses proprietary pre-clinical and clinical trial results. This proprietary information is collectively the “data” protected by data exclusivity. Health authorities require, as part of a submission for a marketing authorization, that this proprietary information be disclosed to that authority in order to ensure public health and patient safety. 

The generation of these data takes considerable time, effort and expense, and begins when a compound is identified as a potential medicinal product. Scientists and researchers may think that a compound has certain properties and will act in a certain manner, but to ascertain the underlying proof of principle, extensive testing is required. Authorities use these data to assess the product’s quality, efficacy and safety before a medical product is approved for use in patients. Even after marketing, clinical studies and pharmacovigilance continue.

The innovator assumes the entire risk for the generation of the data. The innovator will not know in advance whether the data will demonstrate a safe and effective product and/or whether the regulatory authorities will consider the data sufficient to support the marketing of that product. If, at any stage of the development process, a test or clinical trial is unsuccessful, or if the authorities require further testing, the development process may be substantially delayed or stopped.

Data Exclusivity is necessary to provide a measure of certainty to the innovator that they will be provided with a period of protection for their efforts of testing a drug and ensuring its safety and effectiveness for patients no matter when, where or how long it takes to bring a drug to market. Patents are an important form of intellectual property, but are not themselves necessarily sufficient to create the favorable environment needed to support the development of medical advances. Data exclusivity is not an extension of patent rights , and it does not prevent the introduction of generic versions of the innovative drug during the data exclusivity period, as long as the marketing approval of the generic version does not use or rely upon the innovator’s test data.

Data exclusivity refers to a set period of time after the marketing approval, during which no one else may rely on or use the innovator’s data to obtain a marketing authorization for a particular product. It constitutes an important incentive to the research and development of new medicines.

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