(a)In this subtitle the following words have the meanings indicated.
(b)(1) “Essential off–patent or generic drug” means any prescription drug:
(i)For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired;
(ii)1. That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or
2. That has been designated by the Secretary as an essential medicine due to its efficacy in treating a life–threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living;
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(a) In this subtitle the following words have the meanings indicated.
(b) (1) “Essential off–patent or generic drug” means any prescription drug:
(i) For which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired;
(ii) 1. That appears on the Model List of Essential Medicines most recently adopted by the World Health Organization; or
2. That has been designated by the Secretary as an essential medicine due to its efficacy in treating a life–threatening health condition or a chronic health condition that substantially impairs an individual’s ability to engage in activities of daily living;
(iii) That is actively manufactured and marketed for sale in the United States by three or fewer manufacturers; and
(iv) That is made available for sale in the State.
(2) “Essential off–patent or generic drug” includes any drug–device combination product used for the delivery of a drug for which all exclusive marketing rights, if any, granted under the Federal Food, Drug, and Cosmetic Act, § 351 of the federal Public Health Service Act, and federal patent law have expired.
(c) “Price gouging” means an unconscionable increase in the price of a prescription drug.
(d) “State health plan” has the meaning stated in § 2–601 of this title.
(e) “State health program” has the meaning stated in § 2–601 of this title.
(f) “Unconscionable increase” means an increase in the price of a prescription drug that:
(1) Is excessive and not justified by the cost of producing the drug or the cost of appropriate expansion of access to the drug to promote public health; and
(2) Results in consumers for whom the drug has been prescribed having no meaningful choice about whether to purchase the drug at an excessive price because of:
(i) The importance of the drug to their health; and
(ii) Insufficient competition in the market for the drug.
(g) “Wholesale acquisition cost” has the meaning stated in 42 U.S.C. § 1395w–3a.