2022 -- H 7024 | |
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LC003747 | |
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STATE OF RHODE ISLAND | |
IN GENERAL ASSEMBLY | |
JANUARY SESSION, A.D. 2022 | |
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A N A C T | |
RELATING TO COMMERCIAL LAW-- GENERAL REGULATORY PROVISIONS | |
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Introduced By: Representatives J Lombardi, Hull, Cassar, Potter, Felix, Morales, and | |
Date Introduced: January 10, 2022 | |
Referred To: House Judiciary | |
It is enacted by the General Assembly as follows: | |
1 | SECTION 1. Title 6 of the General Laws entitled "COMMERCIAL LAW – GENERAL |
2 | REGULATORY PROVISIONS" is hereby amended by adding the following chapter: |
3 | CHAPTER 13.4 |
4 | PRICE-GOUGING OF PRESCRIPTION DRUGS PROHIBITED |
5 | 6-13.4-1. Purpose. |
6 | The purpose of this act is to prohibit prescription drug price-gouging or excessive pricing |
7 | during market shortages. |
8 | 6-13.4-2. Findings. |
9 | The general assembly finds as follows: |
10 | (1) Many pharmaceutical drugs are necessary to maintain the health and welfare of the |
11 | American people; |
12 | (2) Currently the nation is facing a chronic shortage of vital drugs necessary in surgery, in |
13 | treating cancer, and in fighting other life-threatening illnesses; and |
14 | (3) In order to prevent any party within the chain of distribution of any vital drugs from |
15 | taking unfair advantage of consumers during market shortages, the public interest requires that such |
16 | conduct be prohibited and made subject to criminal penalties. |
17 | 6-13.4-3. Definitions. |
18 | As used in this chapter the following words and terms shall have the following meanings: |
19 | (1) "Biologic" means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood |
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1 | component or derivative, allergenic product, or analogous product, or arsphenamine or derivative |
2 | of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, |
3 | treatment, or cure of a disease or condition of human beings; |
4 | (2) "Drug" means a drug intended for use by human beings that: |
5 | (i) Because of its toxicity or other potential for harmful effect, or the method of its use, or |
6 | the collateral measures necessary to its use, is not safe for use except under the supervision of a |
7 | practitioner licensed by law to administer such drug; or |
8 | (ii) Is limited by an approved application under §505 of the Federal Food, Drug, and |
9 | Cosmetic Act (21 U.S.C. 355) to use under the professional supervision of a practitioner licensed |
10 | by law to administer such drug; |
11 | (3) "Market emergency" means any declaration of a state of emergency by the governor or |
12 | by declaration by the President; |
13 | (4) "Market shortage" means a situation in which the total supply of all clinically |
14 | interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected |
15 | demand at the user level; |
16 | (5) "Price gouging" means charging a consumer an unreasonably high price for any drug |
17 | during a declared market emergency. This section shall not prohibit the fluctuation in the price of |
18 | drugs that occurs during the normal course of business; |
19 | (6) "Unreasonably excessive drug pricing" means the amount charged represents a gross |
20 | disparity between the average prices at which the same or similar commodity was readily available |
21 | and sold or offered for sale within the local area in the usual course of business during the thirty |
22 | (30) days immediately before the declaration of the market emergency and the additional charges |
23 | are not substantially attributable to increased cost to retailers, imposed by their suppliers, including |
24 | replacement costs imposed by the vendors' source. Additionally, the average price calculation |
25 | during said thirty (30) day period shall not include discounted prices set and offered as a result of |
26 | bona fide manufacturer's or supplier's limited discounts or rebates; and |
27 | (7) "Vital drug" means any drug or biologic used to prevent or treat a serious or life- |
28 | threatening disease or medical condition, for which there is no other available source with sufficient |
29 | supply of that drug or biologic or alternative drug or biologic available. |
30 | 6-13.4-4. Unreasonably excessive drug pricing. |
31 | (a) The governor may issue an executive order or rely on an executive order of the |
32 | President, declaring a market shortage or market emergency for a period of six (6) months with |
33 | regard to one or more vital drugs due to a market shortage under this chapter. |
34 | (b) If the governor or the President issues an executive order under subsection (a) of this |
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1 | section, it shall be unlawful for any person to sell vital drugs at a price that is unreasonably |
2 | excessive and such action indicates that the seller is taking unfair advantage of the circumstances |
3 | related to a market shortage to unreasonably increase prices during such period. |
4 | (c) Enforcement. -- The attorney general is authorized to enforce penalties under this |
5 | chapter. |
6 | 6-13.4-5. Penalties. |
7 | (a) Any person who sells or offers to sell any vital drug during a declared market shortage |
8 | with the knowledge and intent to charge a price that is unreasonably excessive under the |
9 | circumstances shall be guilty of a felony and shall be imprisoned for up to five (5) years and by a |
10 | fine of up to ten thousand dollars ($10,000) or both. |
11 | (b) Multiple Offenses. In assessing the penalty provided by subsection (a) of this section |
12 | each day of a continuing violation shall be considered a separate violation. |
13 | (c) Whenever it shall appear to the attorney general that any person or entity is engaged in |
14 | practices constituting a violation of any provision of this chapter and until such complaint is |
15 | dismissed by the attorney general or set aside by a court upon review, the attorney general may in |
16 | their discretion bring an action in the superior court for the county in which the violation has |
17 | occurred, to enjoin such acts or practices, and upon a proper showing a permanent or temporary |
18 | injunction or restraining order shall be granted in the interest of the general public. |
19 | 6-13.4-6. Determination of unreasonably excessive. |
20 | (a) The attorney general, in determining whether an alleged violator's price was |
21 | unreasonably excessive, shall consider whether: |
22 | (1) The price reasonably reflected additional costs, not within the control of that person or |
23 | company, that were paid, incurred, or reasonably anticipated by that person or company; |
24 | (2) The price reasonably reflected additional risks taken by that person or company to |
25 | produce, distribute, obtain, or sell such product under the circumstances; |
26 | (3) There is a gross disparity between the challenged price and the price at which the same |
27 | or similar goods were readily available in the state and prior to the same declared market shortage; |
28 | (4) The marginal benefit received by the wholesaler or distributor is significantly changed |
29 | in comparison with marginal earnings in the year before a market shortage was declared; |
30 | (5) The price charged was comparable to the price at which the goods were generally |
31 | available in the New England area if the wholesaler or distributor did not sell or offer to sell the |
32 | prescription drug in question prior to the time a market shortage was declared; and |
33 | (6) The price was substantially attributable to local, regional, national, or international |
34 | market conditions. |
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1 | (b) Consultation. Not later than one year after the date of enactment of this chapter and |
2 | annually thereafter, the attorney general or designee, shall consult with representatives of the |
3 | National Association of Wholesalers, group purchasing organizations, pharmaceutical distributors, |
4 | hospitals, manufacturers, patients, and other interested community organizations to reassess the |
5 | criteria set forth in subsection (a) of this section in determining unreasonably excessive and prepare |
6 | and submit to the general assembly a report on the results of the reassessment. |
7 | 6-13.4-7. Duration. |
8 | (a) Any market shortage declared by the governor or President in accordance with this |
9 | chapter shall be in effect for a period not to exceed six (6) months from the date on which the |
10 | governor or President issues the executive order. |
11 | (b) Termination. Any market shortage declared by the governor or President in accordance |
12 | with this chapter shall terminate if: |
13 | (1) There is enacted a law terminating the market shortage which shall be passed by the |
14 | general assembly after a national market shortage is declared; or |
15 | (2) The governor or President issues a proclamation terminating the market shortage; |
16 | whichever comes first. |
17 | (c) Declaration Renewal. The governor or President may renew the state of market shortage |
18 | declared under subsection (a) of this section, if the governor or President declares that the severe |
19 | shortage continues to affect the health and well-being of citizens beyond the initial six (6) month |
20 | period. |
21 | SECTION 2. This act shall take effect upon passage. |
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EXPLANATION | |
BY THE LEGISLATIVE COUNCIL | |
OF | |
A N A C T | |
RELATING TO COMMERCIAL LAW-- GENERAL REGULATORY PROVISIONS | |
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1 | This act would prohibit price-gouging of prescribed drugs or pharmaceuticals in times of |
2 | market emergency or market shortages, and would make violators guilty of a felony. The act would |
3 | further make them subject to injunctive relief upon suit brought by the attorney general of the state |
4 | of Rhode Island. |
5 | This act would take effect upon passage. |
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