TITLE 16

Health and Safety

Food and Drugs

CHAPTER 48B. Prescription Opioid Funds; Litigation Authority

§ 4801B. Findings and purpose.

(a) It is the intent of the General Assembly that the Prescription Opioid Impact Fund be established under this chapter to fund prevention and treatment of opioid addiction. In establishing the Prescription Opioid Impact Fund, the General Assembly finds as follows:

(1) The Prescription Opioid Impact Fund is needed to prevent and respond to the dramatic increase in opioid addiction in this State.

(2) The Prescription Opioid Impact Fund is needed to protect the public health, safety, and general welfare of the citizens of this State.

(3) In the 4 years prior to the creation of the Prescription Opioid Impact Fund, prescription opioids were dispensed to Delaware residents as follows:

a. In 2015, 870,017 prescriptions for 59,138,601 individual doses totaling 1,104,171,268 MMEs.

b. In 2016, 831,005 prescriptions for 56,440,474 individual doses totaling 1,050,147,346 MMEs.

c. In 2017, 750,944 prescriptions for 49,875,000 individual doses totaling 921,842,143 MMEs.

d. In 2018, 750,691 prescriptions for 46,125,690 individual doses totaling 826,770,680 MMEs.

(4) There is a direct connection in this State between the quantity and strength of opioids prescribed to citizens and the rates of opioid addiction and overdose deaths.

(5) There is a substantial nexus between the opioid manufacturers subject to the impact fee and the State, in part because only those manufacturers whose prescription opioids are dispensed in the State in amounts sufficient to meet the quarterly threshold in § 4804B(a) of this title are subject to the impact fee.

(6) Opioid manufacturers receive revenues in connection with prescription opioids dispensed in in this State.

(7) The Prescription Opioid Impact Fund will pay for a share of the cost incurred by the State of opioid substance abuse treatment and prevention.

(8) The impact fee does not discriminate against interstate commerce, because both in-state and out-of-state opioid manufacturers are equally subject to its provisions.

(9) The impact fee is fairly apportioned because it is based upon the volume of an opioid manufacturer’s product dispensed within Delaware, with recognition that some manufacturers’ products have different underlying costs and are sold at substantially different prices.

(10) By paying a share of the cost of opioid addiction treatment and prevention, the opioid manufacturers receive assistance in promoting responsible product use and offset negative effect that these products have on Delaware residents.

(b) It is the intent of this chapter to ensure that adequate public funds are available to do all of the following:

(1) Prevent more individuals from becoming addicted to opioids.

(2) Provide funding to defray expenses incurred by the Prescription Monitoring Program under this chapter.

(3) Provide opioid addiction treatment to all Delawareans who have opioid addiction.

(4) Fund emergency medical assistance to treat opioid overdoses.

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, § 6

§ 4802B. Definitions.

For purposes of this chapter:

(1) “Generic substitution” means a drug that is the same active ingredient, equivalent in strength to the strength written on the prescription, and is classified as being therapeutically equivalent to another drug in the latest edition or supplement of the Federal Food and Drug Administration Approved Drug Products with Therapeutic Equivalence Evaluations, sometimes referred to as the “Orange Book”.

(2) a. “Government entity” means all of the following:

1. A governmental subdivision within this State, including a county, municipality, district, town, or village.

2. A subdivision, special district, department, agency, division, board, commission, officer, or instrumentality of an entity under paragraph (2)a.1 of this section.

3. A sheriff, school district or public school.

b. “Government entity” does not mean the Department of Justice or a statewide department, agency, division, board, or commission.

(3) “Impact fee” means a payment of money imposed upon an opioid manufacturer, as a result of the provisions of this chapter, to pay for a share of the cost of preventing and treating opioid addiction.

(4) “Manufacturer of prescription opioids” or “opioid manufacturer” means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription opioid drug, but does not include a person who is engaged in the preparation and dispensing of a drug pursuant to a prescription.

(5) “Morphine milligram equivalent” or “MME” means the conversion factor used to calculate the strength of an opioid using morphine dosage as the comparative unit of measure.

(6) “Prescription Monitoring Program” or “PMP” means the program established under § 4798 of this title.

(7) “Prescription opioid” means a drug that is a controlled substance under Chapter 47 of this title and is either an opiate, derived from the opium poppy, or an opiate-like synthetic drug. “Prescription opioid” does not include buprenorphine.

(8) “Released claims” means released claims as that term is defined in the statewide opioid settlement agreements, or, if not therein defined, the claims sought to be released in such statewide opioid settlement agreement.

(9) “School district” means any of the following:

a. A school district as defined in § 1002 of Title 14.

b. A county vocational-technical high school district or county vocational-technical center district under Chapter 26 of Title 14.

(10) “Statewide opioid settlement agreement” means an agreement, including consent judgments, consent decrees filed or unfiled, and related agreements or documents, between this State, represented by the Department of Justice, and certain opioid manufacturers, distributors, dispensers, consultants, chain pharmacies, related entities, or the subdivisions of this State, to provide or allocate remuneration for conduct related to the manufacture, promotion, dispensing, sale, or distribution of opioid products.

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, §§  2, 6

§ 4803B. Prescription Opioid Impact Fund.

(a) A special fund known as the Prescription Opioid Impact Fund (“Impact Fund”) is established and the State Treasurer shall invest the Impact Fund consistent with the investment policies established by the Cash Management Policy Board. The State Treasurer shall credit interest to the Impact Fund on a monthly basis consistent with the rate established by the Cash Management Policy Board. The Impact Fund shall be administered collectively with the Prescription Opioid Settlement Fund under § 5196B of this title.

(b) The following moneys must be deposited in the Impact Fund:

(1) All impact fees collected by the State under § 4804B of this title.

(2) [Repealed.]

(3) Any other money appropriated or transferred to the Impact Fund by the General Assembly.

(c) Money in the Impact Fund must be used for activities in 1 or more of the following categories:

(1) Opioid addiction prevention.

(2) The following opioid addiction services:

a. Inpatient and outpatient treatment programs and facilities, including short-term and long-term residential treatment programs and recovery residences.

b. Services relating to treating substance use disorder for the under-insured and uninsured.

c. Emergency assistance relating to prescription opioids, including purchasing pharmaceuticals used to reverse the effect of an opioid overdose.

d. Peer support programs.

e. Services to address adverse social determinants of health which act as a barrier to recovery, including family support services.

(3) The cost of administering this chapter, as follows:

a. No more than 15% of the money annually deposited into the Impact Fund may be used for administering this chapter including expenses incurred by the Prescription Monitoring Program under this chapter.

b. Entering into contracts to implement this chapter, including contracts entered into by the Secretary of the Department of Health and Social Services or the Secretary of State for administration of this chapter.

c. Costs incurred by the Attorney General to bring an action to enforce this chapter must be covered by the Impact Fund and are not subject to or included in the 15% cap on administrative expenses.

(d) Money in the Impact Fund may not be used to supplant existing state or local government funding.

(e) The Behavioral Health Consortium shall distribute the money in the Impact Fund based upon the recommendations of the Prescription Opioid Settlement Distribution Commission.

(f) Money appropriated by the General Assembly to implement this chapter must be reimbursed from money received under this section.

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, §§  3, 6

§ 4804B. Prescription opioid impact fee.

(a) A manufacturer of a prescription opioid must pay a prescription opioid impact fee to the State if more than 100,000 MME of the manufacturer’s prescription opioid products are dispensed in this State in a quarter.

(b) The prescription opioid impact fee is calculated as follows:

(1) The impact fee is $0.01 per MME for a prescription opioid dispensed and reported in the PMP.

(2) The impact fee is $0.0025 per MME for a prescription opioid that is a generic substitution.

(c) The Secretary of State shall calculate the total amount of the impact fee on a quarterly basis using the information in the PMP.

(d) The Secretary of State shall send an invoice to manufacturers of prescription opioids dispensed in this State for the impact fee due under this section quarterly, beginning after the close of the first full quarter after June 12, 2019.

(e) Manufacturers of prescription opioids shall pay the impact fee 1 month after the date of an invoice.

(f) When a manufacturer of prescription opioids fails to pay the impact fee within 1 month after the date of an invoice, the penalty is $100 a day or 10% of the impact fee due, whichever is greater. In addition, any unpaid impact fee bears interest at the rate of 1% a month.

(g) A manufacturer who disputes the amount of an invoice sent under this chapter may request a hearing under § 4736 of this title.

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, § 6

§ 4805B. Enforcement.

The Attorney General may bring an action on behalf of the State to enforce this chapter. The Attorney General may recover interest and reasonable attorney fees and expenses as a result of a successful action to enforce this chapter. Any attorney fees recovered in an action to enforce this chapter must be remitted to the Fund.

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, § 6

§ 4806B. Policies and procedures.

(a) The Secretary of the Department of Health and Social Services shall develop necessary policies and procedures and promulgate necessary regulations to implement § 4803B of this title.

(b) The Secretary of State shall develop necessary policies and procedures and promulgate necessary regulations to implement § 4804B of this title.

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, § 6

§ 4807B. Annual report [Repealed].
82 Del. Laws, c. 37, § 1repealed by 83 Del. Laws, c. 243, § 4, effective Oct. 14, 2021.

§ 4808B. Prescription Opioid Settlement Fund.

(a) A special fund known as the Prescription Opioid Settlement Fund (Settlement Fund) is established and the State Treasurer shall invest moneys in the Settlement Fund consistent with the investment policies established by the Cash Management Policy Board. The State Treasurer shall credit interest to the Settlement Fund on a monthly basis consistent with the rate established by the Cash Management Policy Board. The Settlement Fund shall be administered collectively with the Prescription Opioid Impact Fund under § 5196B of this title.

(b) The Settlement Fund shall hold all moneys collected by the State and its subdivisions as a result of the terms of statewide opioid settlement agreements, judgments, or other recoveries in connection with a defendant’s actual or alleged liability for contributing to the opioid crisis in Delaware that must be used for purposes of remediating or abating the opioid crisis in Delaware.

(c) All money in the Settlement Fund is continuously available for expenditure under § 5196B of this title and spending limits imposed by the General Assembly, including for salaries and other routine operating expenses of the Settlement Fund or the Prescription Opioid Settlement Distribution Commission.

(1) Annually, $300,000 or 5% of the total annually deposited into the Settlement Fund, whichever is greater, may be used for administering this chapter and §§ 5196 through 5196B of Title 16.

(2) Money appropriated by the General Assembly to implement this chapter and §§ 5196 through § 5196B of Title 16 must be reimbursed from the Funds.

(d) Money in the Settlement Fund must be used for activities in 1 or more of the following categories:

(1) For services that remediate the harm caused by opioids.

(2) To reduce harm caused by opioids.

(3) Consistent with the terms of the settlement, judgment, or other source of the moneys.

(e) Money in the Settlement Fund may not be used to supplant existing state or local government funding.

(f) Money in the Settlement Fund does not lapse at any time and must not be transferred to or commingled with any other fund.

(g) The Behavioral Health Consortium shall distribute the money in the Settlement Fund based upon the recommendations of the Prescription Opioid Settlement Distribution Commission.

83 Del. Laws, c. 243, § 3

§ 4809B. Limitation on authority of government entities to bring lawsuits.

No government entity has the authority to assert released claims after February 28, 2021 against entities released by the Department of Justice in a statewide opioid settlement agreement executed by the Attorney General and the released party.

83 Del. Laws, c. 243, § 3

82 Del. Laws, c. 37, § 183 Del. Laws, c. 243, §§  1, 6