Sec. 9. Prize payments for medical innovation
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For fiscal year 2015, and each subsequent fiscal year, the Board shall award to persons described in subsection
(b)prize payments for medical innovation relating to a drug, a biological product, or a new manufacturing process for a drug or biological product. To be eligible to receive a prize payment under subsection
(a)for medical innovation relating to a drug, a biological product, or a manufacturing process, a person shall be— in the case of a drug or biological product, the first person to receive market clearance with respect to the drug or biological product; in the case of a manufacturing process, the holder of the patent with respect to such process; or in the case of open source contributions, the persons or communities that openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis. The Board shall, by regulation, establish criteria for the selection of recipients, and for determining the amount, of prize payments under this section. Such criteria shall include consideration of the following: The number of patients who would benefit from the drug, biological product, or manufacturing process involved, including (in cases of global neglected diseases, global infectious diseases, and other global public health priorities) the number of non-United States patients. The incremental therapeutic benefit of the drug, biological product, or manufacturing process involved as compared to existing drugs, biological products, and manufacturing processes available to treat the same disease or condition, except that the Board shall provide for cases where drugs, biological products, or manufacturing processes are developed at roughly the same time, so that the comparison is to products that were not recently developed. The degree to which the drug, biological product, or manufacturing process involved addresses priority health care needs, including— current and emerging global infectious diseases; severe illnesses with small client populations (such as indications for which orphan designation has been granted under section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb )); and neglected diseases that primarily afflict the poor in developing countries. Improved efficiency of manufacturing processes for drugs or biological processes. The extent to which knowledge, data, materials and technology that are openly shared have contributed to the successful development of new products or improved processes for manufacturing products. In the case of antibiotics or other products for which drug resistance is a significant public health problem, the expected life cycle benefits of the antibiotic or other product, with appropriate adjustments that reward the conservation of the resources, taking into account drug resistance that is related to use of the product. In the case of products used in stockpiles for potential threats to the public health, the risk adjusted benefits of stockpiling the products. In awarding prize payments under this section, the Board shall comply with the following: In cases where a new drug, biological product, or manufacturing process offers an improvement over an existing drug, biological product, or manufacturing process and the new drug, biological product, or manufacturing process competes with or replaces the existing drug, biological product, or manufacturing process, the Board shall continue to make prize payments for the existing drug, biological product, or manufacturing process to the degree that the new drug, biological product, or manufacturing process was based on or benefitted from the development of the existing drug, biological product, or manufacturing process. The Board may not make prize payments based on the identity of the person who manufactures, distributes, sells, or uses the drug, biological product, or manufacturing process involved. The Board may award prize payments for a drug, a biological product, or a manufacturing process for not more than 10 fiscal years, regardless of the term of any related patents. For any fiscal year, the Board may not award a prize payment for any single drug, biological product, or manufacturing process in an amount that exceeds 5 percent of the total amount appropriated to the Fund for that year. For every drug or biological product that receives market clearance, the Board shall determine whether and in what amount to award a prize payment for the drug or biological product not later than the end of the fourth full calendar-year quarter following the calendar-year quarter in which the drug or biological product receives market clearance.
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Sec. 9
Prize payments for medical innovation
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