House File 2384 - Introduced HOUSE FILE 2384 BY COMMITTEE ON COMMERCE (SUCCESSOR TO HSB 607) A BILL FOR An Act relating to the medical cannabidiol Act, making 1 related modifications, and providing for civil and criminal 2 penalties and fees. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 6011HV (4) 86 rh/rj
H.F. 2384 Section 1. Section 124D.2, Code 2016, is amended by striking 1 the section and inserting in lieu thereof the following: 2 124D.2 Definitions. 3 As used in this chapter: 4 1. “Cannabidiol” means a nonpsychoactive cannabinoid found 5 in the plant Cannabis sativa L. or Cannabis indica or any 6 other preparation thereof that is essentially free from plant 7 material, and has a tetrahydrocannabinol level of no more than 8 three percent. 9 2. “Debilitating medical condition” means any of the 10 following: 11 a. Intractable epilepsy. 12 b. Multiple sclerosis. 13 c. Cancer, if a health care practitioner has determined a 14 prognosis for a patient of less than twelve months of life. 15 3. “Department” means the department of public health. 16 4. “Health care practitioner” means an individual licensed 17 under chapter 148 to practice medicine and surgery or 18 osteopathic medicine and surgery who provides specialty care 19 for a resident of this state for one or more debilitating 20 medical conditions. 21 5. “Intractable epilepsy” means an epileptic seizure 22 disorder for which standard medical treatment does not prevent 23 or significantly ameliorate recurring, uncontrolled seizures or 24 for which standard medical treatment results in harmful side 25 effects. 26 6. “Medical cannabidiol manufacturer” means an entity 27 located in this state and licensed by the department to 28 manufacture and to possess, cultivate, harvest, package, 29 process, transport, supply, and dispense cannabidiol pursuant 30 to the provisions of this chapter. 31 7. “Primary caregiver” means a person, at least eighteen 32 years of age, who has been designated by a patient’s health 33 care practitioner or by a person having custody of a patient, 34 as being necessary to take responsibility for managing the 35 -1- LSB 6011HV (4) 86 rh/rj 1/ 12
H.F. 2384 well-being of the patient with respect to the medical use of 1 cannabidiol pursuant to the provisions of this chapter. 2 Sec. 2. Section 124D.3, Code 2016, is amended to read as 3 follows: 4 124D.3 Neurologist Health care practitioner recommendation 5 —— medical use of cannabidiol. 6 A neurologist health care practitioner who has examined 7 and treated a patient suffering from intractable epilepsy a 8 debilitating medical condition may provide but has no duty to 9 provide a written recommendation for the patient’s medical use 10 of cannabidiol to treat or alleviate symptoms of intractable 11 epilepsy the debilitating medical condition 12 if no other satisfactory alternative treatment options exist 13 for the patient and all of the following conditions apply: 14 1. The patient is a permanent resident of this state. 15 2. A neurologist health care practitioner has treated 16 the patient for intractable epilepsy a debilitating medical 17 condition for at least six months. For purposes of this 18 treatment period, and notwithstanding section 124D.2, 19 subsection 4 , treatment provided by a neurologist health care 20 practitioner may include treatment by an out-of-state licensed 21 neurologist health care practitioner in good standing. 22 3. The neurologist health care practitioner has tried 23 alternative treatment options that have not alleviated the 24 patient’s symptoms. 25 4. The neurologist health care practitioner determines 26 the risks of recommending the medical use of cannabidiol are 27 reasonable in light of the potential benefit for the patient. 28 5. The neurologist health care practitioner maintains a 29 patient treatment plan. 30 Sec. 3. Section 124D.4, subsection 1, paragraph c, Code 31 2016, is amended to read as follows: 32 c. Requests the patient’s neurologist health care 33 practitioner to submit a written recommendation to the 34 department signed by the neurologist health care practitioner 35 -2- LSB 6011HV (4) 86 rh/rj 2/ 12
H.F. 2384 that the patient may benefit from the medical use of 1 cannabidiol pursuant to section 124D.3 . 2 Sec. 4. Section 124D.4, subsection 1, paragraph d, 3 subparagraph (3), Code 2016, is amended to read as follows: 4 (3) Full name, address, and telephone number of the 5 patient’s neurologist health care practitioner . 6 Sec. 5. Section 124D.4, subsection 1, Code 2016, is amended 7 by adding the following new paragraph: 8 NEW PARAGRAPH . e. Submits a cannabidiol registration card 9 fee of one hundred dollars to the department. If the patient 10 attests to receiving social security disability benefits, 11 supplemental security insurance benefits, or being enrolled in 12 the medical assistance program, the fee shall be twenty-five 13 dollars. 14 Sec. 6. Section 124D.4, subsection 3, paragraph b, Code 15 2016, is amended to read as follows: 16 b. Requests a patient’s neurologist health care practitioner 17 to submit a written recommendation to the department signed by 18 the neurologist health care practitioner that a patient in the 19 primary caregiver’s care may benefit from the medical use of 20 cannabidiol pursuant to section 124D.3 . 21 Sec. 7. Section 124D.4, subsection 3, paragraph c, 22 subparagraph (4), Code 2016, is amended to read as follows: 23 (4) Full name, address, and telephone number of the 24 patient’s neurologist health care practitioner . 25 Sec. 8. Section 124D.5, subsection 1, paragraph b, 26 subparagraph (1), Code 2016, is amended by adding the following 27 new subparagraph division: 28 NEW SUBPARAGRAPH DIVISION . (c) To authorized employees of 29 a medical cannabidiol manufacturer, but only for the purpose 30 of verifying that a person is lawfully in possession of a 31 cannabidiol registration card issued pursuant to this chapter. 32 Sec. 9. Section 124D.5, subsection 2, Code 2016, is amended 33 by striking the subsection and inserting in lieu thereof the 34 following: 35 -3- LSB 6011HV (4) 86 rh/rj 3/ 12
H.F. 2384 2. The department shall adopt rules pursuant to chapter 1 17A to administer this chapter which shall include but not be 2 limited to rules to do all of the following: 3 a. Govern the manner in which the department shall consider 4 applications for new and renewal cannabidiol registration 5 cards. 6 b. Establish requirements for the suspension and revocation 7 of a cannabidiol registration card and a medical cannabidiol 8 manufacturer license. 9 c. Establish requirements for the licensure of medical 10 cannabidiol manufacturers and set forth procedures for medical 11 cannabidiol manufacturers to obtain licenses. 12 d. Develop a dispensing system for medical cannabidiol 13 manufacturers to dispense cannabidiol within this state that 14 provides for all of the following: 15 (1) Medical cannabidiol manufacturers within this state 16 housed on secured grounds. 17 (2) The dispensing of cannabidiol to patients and their 18 primary caregivers in person to occur at medical cannabidiol 19 manufacturer locations designated by the department. 20 e. Establish and collect annual fees from medical 21 cannabidiol manufacturers to cover the costs associated with 22 regulating and inspecting medical cannabidiol manufacturers. 23 f. Specify and implement procedures that address public 24 safety including security procedures and product quality 25 including measures to ensure contaminant-free cultivation of 26 cannabidiol, safety, and appropriate labeling. 27 g. Establish and implement a real-time, statewide 28 cannabidiol registry management sale tracking system that 29 is available to medical cannabidiol manufacturers on a 30 twenty-four-hour-day, seven-day-a-week basis for the purpose 31 of verifying that a person is lawfully in possession of 32 a cannabidiol registration card issued pursuant to this 33 chapter and for tracking the date of the sale and quantity of 34 cannabidiol purchased by a patient or a primary caregiver. 35 -4- LSB 6011HV (4) 86 rh/rj 4/ 12
H.F. 2384 h. Establish and implement a cannabidiol inventory and 1 delivery tracking system to track cannabidiol from production 2 by a medical cannabidiol manufacturer through dispensing by a 3 medical cannabidiol manufacturer. 4 Sec. 10. Section 124D.6, subsections 1 and 2, Code 2016, are 5 amended to read as follows: 6 1. a. A recommendation for the possession or use of 7 cannabidiol as authorized by this chapter shall be provided 8 exclusively by a neurologist health care practitioner for a 9 patient who has been diagnosed with intractable epilepsy a 10 debilitating medical condition . 11 b. Cannabidiol provided exclusively pursuant to the 12 recommendation of a neurologist shall be obtained from an 13 out-of-state source and health care practitioner shall only be 14 recommended for oral or transdermal administration. 15 c. A neurologist health care practitioner shall be the sole 16 authorized recommender as part of the treatment plan by the 17 neurologist health care practitioner of a patient diagnosed 18 with intractable epilepsy a debilitating medical condition . 19 A neurologist health care practitioner shall have the sole 20 authority to recommend the use or amount of cannabidiol, 21 if any, in the treatment plan of a patient diagnosed with 22 intractable epilepsy a debilitating medical condition . 23 2. A neurologist health care practitioner , including 24 any authorized agent thereof, shall not be subject to 25 prosecution for the unlawful recommendation, possession, or 26 administration of marijuana under the laws of this state for 27 activities arising directly out of or directly related to 28 the recommendation or use of cannabidiol in the treatment of 29 a patient diagnosed with intractable epilepsy a debilitating 30 medical condition . 31 Sec. 11. Section 124D.6, Code 2016, is amended by adding the 32 following new subsection: 33 NEW SUBSECTION . 2A. A medical cannabidiol manufacturer, 34 including any authorized agent or employee thereof, shall 35 -5- LSB 6011HV (4) 86 rh/rj 5/ 12
H.F. 2384 not be subject to prosecution for manufacturing, possessing, 1 cultivating, harvesting, packaging, processing, transporting, 2 supplying, or dispensing cannabidiol pursuant to this chapter. 3 Sec. 12. Section 124D.6, subsection 3, paragraphs a and b, 4 Code 2016, are amended to read as follows: 5 a. In a prosecution for the unlawful possession of marijuana 6 under the laws of this state, including but not limited to 7 chapters 124 and 453B , it is an affirmative and complete 8 defense to the prosecution that the patient has been diagnosed 9 with intractable epilepsy a debilitating medical condition , 10 used or possessed cannabidiol pursuant to a recommendation by a 11 neurologist health care practitioner as authorized under this 12 chapter , and, for a patient eighteen years of age or older, is 13 in possession of a valid cannabidiol registration card. 14 b. In a prosecution for the unlawful possession of 15 marijuana under the laws of this state, including but not 16 limited to chapters 124 and 453B , it is an affirmative and 17 complete defense to the prosecution that the person possessed 18 cannabidiol because the person is a primary caregiver of a 19 patient who has been diagnosed with intractable epilepsy a 20 debilitating medical condition and is in possession of a 21 valid cannabidiol registration card, and where the primary 22 caregiver’s possession of the cannabidiol is on behalf of the 23 patient and for the patient’s use only as authorized under this 24 chapter . 25 Sec. 13. NEW SECTION . 124D.9 Medical cannabidiol 26 manufacturer licensure. 27 1. The department shall license two medical cannabidiol 28 manufacturers by December 1, 2016, to manufacture and dispense 29 cannabidiol within this state consistent with the provisions 30 of this chapter. The department shall relicense the existing 31 medical cannabidiol manufacturers by December 1 of each year. 32 2. As a condition for licensure, a medical cannabidiol 33 manufacturer must agree to begin supplying and dispensing 34 cannabidiol to patients in this state by July 1, 2017. 35 -6- LSB 6011HV (4) 86 rh/rj 6/ 12
H.F. 2384 3. The department shall consider the following factors 1 in determining whether to license a medical cannabidiol 2 manufacturer: 3 a. The technical expertise of the medical cannabidiol 4 manufacturer in cannabidiol. 5 b. The qualifications of the medical cannabidiol 6 manufacturer’s employees. 7 c. The long-term financial stability of the medical 8 cannabidiol manufacturer. 9 d. The ability to provide appropriate security measures on 10 the premises of the medical cannabidiol manufacturer. 11 e. The medical cannabidiol manufacturer’s projection of 12 and ongoing assessment of fees on patients with debilitating 13 medical conditions. 14 4. The department shall require each medical cannabidiol 15 manufacturer to contract with the state hygienic laboratory at 16 the university of Iowa in Iowa City to test the cannabidiol 17 produced by the medical cannabidiol manufacturer as to 18 content, contamination, and consistency. The department shall 19 require that the laboratory report testing results to the 20 medical cannabidiol manufacturer in a manner determined by the 21 department pursuant to rule. 22 5. Each entity submitting an application for licensure as 23 a medical cannabidiol manufacturer shall pay a nonrefundable 24 application fee of ten thousand dollars to the department. 25 Sec. 14. NEW SECTION . 124D.10 Medical cannabidiol 26 manufacturers. 27 1. A medical cannabidiol manufacturer shall pay the cost of 28 all laboratory testing. 29 2. The operating documents of a medical cannabidiol 30 manufacturer shall include all of the following: 31 a. Procedures for the oversight of the medical cannabidiol 32 manufacturer and procedures to ensure accurate recordkeeping. 33 b. Procedures for the implementation of appropriate security 34 measures to deter and prevent the theft of cannabidiol and 35 -7- LSB 6011HV (4) 86 rh/rj 7/ 12
H.F. 2384 unauthorized entrance into areas containing cannabidiol. 1 3. A medical cannabidiol manufacturer shall implement 2 security requirements, including requirements for protection 3 of each location by a fully operational security alarm system, 4 facility access controls, perimeter intrusion detection 5 systems, and a personnel identification system. 6 4. A medical cannabidiol manufacturer shall not share 7 office space with, refer patients to, or have any financial 8 relationship with a health care practitioner. 9 5. A medical cannabidiol manufacturer shall not permit any 10 person to consume cannabidiol on the property of the medical 11 cannabidiol manufacturer. 12 6. A medical cannabidiol manufacturer is subject to 13 reasonable inspection by the department. 14 7. A medical cannabidiol manufacturer shall not employ a 15 person who is under twenty-one years of age or who has been 16 convicted of a disqualifying felony offense. An employee 17 of a medical cannabidiol manufacturer shall be subject to a 18 background investigation conducted by the division of criminal 19 investigation of the department of public safety and a national 20 criminal history background check. 21 8. A medical cannabidiol manufacturer shall comply with 22 reasonable restrictions set by the department relating to 23 signage, marketing, display, and advertising of cannabidiol. 24 9. a. All manufacturing, cultivating, harvesting, 25 packaging, and processing of cannabidiol shall take place in an 26 enclosed, locked facility at a physical address provided to the 27 department during the licensure process. 28 b. A medical cannabidiol manufacturer shall manufacture 29 a reliable and ongoing supply of cannabidiol to treat every 30 debilitating medical condition listed in this chapter. 31 c. A medical cannabidiol manufacturer shall not, within 32 a thirty-day period, dispense more than thirty-two ounces of 33 cannabidiol to a patient or a primary caregiver. 34 10. A medical cannabidiol manufacturer shall pay an 35 -8- LSB 6011HV (4) 86 rh/rj 8/ 12
H.F. 2384 annual fee determined by the department equal to the cost of 1 regulating and inspecting the medical cannabidiol manufacturer 2 during that year. 3 Sec. 15. NEW SECTION . 124D.11 Fees. 4 Cannabidiol registration card fees and medical cannabidiol 5 manufacturer application and annual fees collected by the 6 department pursuant to this chapter shall be retained by 7 the department, shall be considered repayment receipts as 8 defined in section 8.2, and shall be used for the purpose of 9 regulating medical cannabidiol manufacturers and for other 10 expenses necessary for the administration of this chapter. 11 Notwithstanding section 8.33, moneys that remain unencumbered 12 or unobligated at the end of the fiscal year shall not revert 13 to the general fund of the state. 14 Sec. 16. NEW SECTION . 124D.12 Use of cannabidiol —— smoking 15 and vaping prohibited. 16 A patient shall not consume cannabidiol possessed or used as 17 authorized by this chapter by smoking or vaping cannabidiol. 18 Sec. 17. NEW SECTION . 124D.13 Penalties. 19 1. A person who knowingly or intentionally possesses or uses 20 cannabidiol in violation of the requirements of this chapter is 21 subject to the penalties provided under chapters 124 and 453B. 22 2. A medical cannabidiol manufacturer shall be assessed 23 a civil penalty of up to one thousand dollars per violation 24 for any violation of this chapter in addition to any other 25 applicable penalties. 26 Sec. 18. REPEAL. Sections 124D.7 and 124D.8, Code 2016, 27 are repealed. 28 EXPLANATION 29 The inclusion of this explanation does not constitute agreement with 30 the explanation’s substance by the members of the general assembly. 31 This bill relates to the medical cannabidiol Act, makes 32 related modifications, and provides for civil and criminal 33 penalties and fees. 34 MEDICAL CANNABIDIOL ACT —— OVERVIEW. Iowa Code chapter 35 -9- LSB 6011HV (4) 86 rh/rj 9/ 12
H.F. 2384 124D, the medical cannabidiol Act, currently allows an Iowa 1 licensed neurologist who has examined and treated a patient 2 suffering from intractable epilepsy to provide a written 3 recommendation for the patient’s medical use of cannabidiol 4 to treat or alleviate symptoms of intractable epilepsy if 5 no other satisfactory alternative treatment options exist 6 and if certain conditions apply. A patient who receives a 7 written recommendation from the patient’s neurologist or 8 the patient’s primary caregiver is required to have a valid 9 cannabidiol registration card to use or possess cannabidiol 10 for medical purposes. The cannabidiol must be obtained from 11 an out-of-state source. The department of public health 12 is required to maintain a confidential file of the names 13 of each patient and primary caregiver to or for whom the 14 department issues a cannabidiol registration card and to keep 15 such information confidential except as otherwise allowed. 16 The medical cannabidiol Act provides affirmative defenses 17 to a neurologist, a patient, and a primary caregiver from 18 prosecution. A person who knowingly or intentionally possesses 19 or uses cannabidiol in violation of the medical cannabidiol 20 Act is subject to the penalties provided under Code chapters 21 124 (controlled substances) and 453B (excise taxes on unlawful 22 dealing in certain substances). 23 DEBILITATING MEDICAL CONDITIONS —— HEALTH CARE PRACTITIONER. 24 The bill amends the medical cannabidiol Act to include multiple 25 sclerosis and terminal cancer, in addition to intractable 26 epilepsy, as additional debilitating medical conditions for 27 which a patient may receive a written recommendation from a 28 health care practitioner for the patient’s medical use of 29 cannabidiol. “Health care practitioner” is defined to mean any 30 Iowa licensed physician who provides specialty care for one or 31 more debilitating medical conditions. 32 CANNABIDIOL REGISTRATION CARD FEE. The bill requires a 33 patient to submit a cannabidiol registration card fee of $100 34 or $25 to the department, depending on whether a patient is the 35 -10- LSB 6011HV (4) 86 rh/rj 10/ 12
H.F. 2384 recipient of certain public assistance. 1 CONFIDENTIALITY. The bill provides that confidential 2 patient and primary caregiver cannabidiol registration card 3 information maintained by the department may be disclosed to 4 authorized employees of a medical cannabidiol manufacturer 5 under certain circumstances. 6 MEDICAL CANNABIDIOL MANUFACTURER —— LICENSURE. The bill 7 requires the department to license by December 1, 2016, 8 two medical cannabidiol manufacturers to manufacture and 9 dispense cannabidiol within this state. As a condition for 10 licensure, a medical cannabidiol manufacturer must agree to 11 begin supplying and dispensing cannabidiol to patients in 12 this state by July 1, 2017. The department is directed to 13 consider several factors in determining whether to license a 14 medical cannabidiol manufacturer. Each medical cannabidiol 15 manufacturer is required to contract with the state hygienic 16 laboratory at the university of Iowa to test the cannabidiol 17 produced by the manufacturer and to report testing results to 18 the medical cannabidiol manufacturer, and is required to pay a 19 nonrefundable application fee of $10,000. 20 MEDICAL CANNABIDIOL MANUFACTURER —— ADDITIONAL REQUIREMENTS. 21 The bill provides that certain requirements must be included in 22 the operating documents of a medical cannabidiol manufacturer. 23 A medical cannabidiol manufacturer is prohibited from engaging 24 in certain activities and is subject to reasonable inspection 25 and reasonable restrictions by the department. 26 A medical cannabidiol manufacturer is required to provide 27 a reliable and ongoing supply of cannabidiol to treat every 28 debilitating medical condition pursuant to the provisions of 29 the bill and shall manufacture, cultivate, harvest, package, 30 and process cannabidiol in an enclosed, locked facility at 31 a physical address provided to the department during the 32 licensure process. 33 FEES. Cannabidiol registration card fees and medical 34 cannabidiol manufacturer application and annual fees collected 35 -11- LSB 6011HV (4) 86 rh/rj 11/ 12
H.F. 2384 by the department shall be retained by the department, and 1 shall be used for the purpose of regulating medical cannabidiol 2 manufacturers and for other expenses necessary for the 3 administration of the bill. 4 ADDITIONAL DEPARTMENT DUTIES —— RULES. The bill requires 5 the department to adopt rules relating to cannabidiol 6 registration cards and medical cannabidiol manufacturer 7 licenses, requirements for the licensure of medical cannabidiol 8 manufacturers, a dispensing system for medical cannabidiol 9 manufacturers to dispense cannabidiol within this state 10 that follows certain requirements, annual fees from medical 11 cannabidiol manufacturers, public safety procedures, and the 12 establishment and implementation of a statewide cannabidiol 13 registry management sale tracking system. 14 USE OF CANNABIDIOL —— SMOKING AND VAPING PROHIBITED. The 15 bill provides that a patient, including an out-of-state patient 16 who is in Iowa, shall not consume the cannabidiol by smoking or 17 vaping the cannabidiol. 18 USE OF MEDICAL CANNABIDIOL —— AFFIRMATIVE DEFENSES. 19 The bill provides prosecution immunity for a health care 20 practitioner and a medical cannabidiol manufacturer 21 including any authorized agents or employees of the health 22 care practitioner or medical cannabidiol manufacturer, for 23 activities undertaken by the health care practitioner or 24 medical cannabidiol manufacturer, pursuant to the provisions 25 of the bill. 26 PENALTIES. The bill provides that a medical cannabidiol 27 manufacturer shall be assessed a civil penalty of up to $1,000 28 per violation for any violation of the bill in addition to any 29 other applicable penalties. 30 REPEAL. The bill repeals Code sections 124D.7 (penalties) 31 and 124D.8 (repealing Code chapter 124D on July 1, 2017). 32 -12- LSB 6011HV (4) 86 rh/rj 12/ 12