23 LC 28 0592S H. B. 196 (SUB) - 1 - The House Committee on Judiciary Non-Civil offers the following substitute to HB 196: A BILL TO BE ENTITLED AN ACT To amend Article 9 of Chapter 12 of Title 16 of the Official Code of Georgia Annotated,1 relating to access to medical cannabis, so as to provide that the Georgia Access to Medical2 Cannabis Commission shall be subject to the Administrative Procedure Act, laws governing3 open meetings and open records, and state purchasing laws; to provide for information to be4 provided to the Medical Cannabis Commission Oversight Committee unless exempt from5 public disclosure under open records laws; to authorize the location of retail outlets for the6 dispensing of low THC oil and products to registered patients at Class 1 and Class 27 production facilities; to authorize the dispensing of low THC oil and products from any8 Class 1 or Class 2 production licensee by any dispensing licensee; to provide for additional9 Class 1 and Class 2 production licenses; to provide for criteria; to provide for appeals to the10 Georgia State-wide Business Court; to require each commissioner to file an annual financial11 disclosure statement; to amend Code Section 31-2A-18 of the Official Code of Georgia12 Annotated, relating to the Low THC Oil Patient Registry, so as to add conditions for which13 low THC oil may be used for treatment; to provide for related matters; to provide for an14 effective date; to repeal conflicting laws; and for other purposes.15 23 LC 28 0592S H. B. 196 (SUB) - 2 - BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:16 SECTION 1.17 Article 9 of Chapter 12 of Title 16 of the Official Code of Georgia Annotated, relating to18 access to medical cannabis, is amended by revising Code Section 16-12-202, relating to the19 creation of Georgia Access to Medical Cannabis Commission, terms, designation, meetings,20 vacancy, and compensation, by adding a new subsection to read as follows:21 "(f) The commission shall be subject to the provisions of Article 3 of Chapter 5,22 Chapter 13, Chapter 14, and Article 4 of Chapter 18 of Title 50."23 SECTION 2.24 Said article is further amended by revising paragraphs (2) and (17) of Code25 Section 16-12-203, relating to powers, duties, and responsibilities of the Georgia Access to26 Medical Cannabis Commission, as follows:27 "(2) To execute a contract or contracts to purchase or obtain low THC oil, cannabis,28 cannabinoids, or any other derivative, compound, or substantially similar products from29 any available legal source and to provide logistics related thereto in accordance with this30 article. Such contract or contracts may be executed with one or more qualified31 corporations or with one or more governmental entities. Purchases made and contracts32 entered into pursuant to this paragraph shall not be subject to state purchasing laws33 contained in Article 3 of Chapter 5 of Title 50 or in other provisions of the Official Code34 of Georgia Annotated;"35 "(17) To levy fines for failure by a Class 1 production licensee, Class 2 production36 licensee, or dispensing licensee to operate in accordance with rules and regulations37 established by the commission within 14 days of written notice by the commission of38 specific violations. Such fines shall not exceed $25,000.00 for a first offense, $50,000.0039 for a failure to remedy the offense within 60 days after written notice of a first offense,40 23 LC 28 0592S H. B. 196 (SUB) - 3 - and $75,000.00 for subsequent failures to remedy noncompliance within 90 days after41 written notice of a first offense. Following a third written notice of a recurring violation,42 the commission may also order a licensee to cease operations for a period of up to 3043 days to correct the violation. Any such fines or orders to cease operations shall be subject44 to Chapter 13 of Title 50, the 'Georgia Administrative Procedure Act.';' provided,45 however, that any appeal from a final decision shall be made to the Georgia State-wide46 Business Court in accordance with Code Section 16-12-221.1."47 SECTION 3.48 Said article is further amended by revising Code Section 16-12-206, relating to annual,49 nontransferable dispensing license, adoption of rules, and fees, as follows:50 "16-12-206.51 (a)(1) Upon request by a licensed pharmacy in this state, the State Board of Pharmacy52 shall be authorized to develop an annual, nontransferable specialty dispensing license for53 an independent pharmacy with a registered office located within this state to dispense low54 THC oil and products to registered patients. The State Board of Pharmacy shall develop55 rules and regulations regarding dispensing pharmacies in this state in accordance with the56 requirements contained in subsection (b) of this Code section.57 (2) The commission shall be authorized to issue five dispensing licenses to each Class58 1 production licensee and each Class 2 production licensee for retail outlets to dispense59 low THC oil and products to registered patients. In addition, the commission shall be60 authorized to issue a dispensing license for a retail outlet to each Class 1 production61 licensee and each Class 2 production licensee for the purpose of establishing a retail62 outlet for the dispensing of low THC oil and products to registered patients at the location63 of the Class 1 production licensee's production facility or at the location of the Class 264 production licensee's production facility. The commission shall ensure that dispensing65 licenses shall be issued so that retail outlets are dispersed throughout the state. The66 23 LC 28 0592S H. B. 196 (SUB) - 4 - commission shall develop rules and regulations regarding retail dispensing licensees in67 this state in accordance with the requirements contained in subsection (b) of this Code68 section. The commission shall be authorized to issue one additional dispensing license69 to each Class 1 and Class 2 production licensee when the Low THC Oil Patient Registry70 established and maintained pursuant to Code Section 31-2A-18 reaches 25,000 patients71 and for every increase of 10,000 patients thereafter.72 (b) The State Board of Pharmacy and the commission shall separately adopt rules relating73 to the dispensing of low THC oil and products, with the State Board of Pharmacy74 promulgating rules and regulations for pharmacies that dispense low THC oil and products75 and the commission promulgating rules and regulations for other retail outlets that dispense76 low THC oil and products. Such rules shall include but not be limited to:77 (1) Standards, procedures, and protocols for the effective use of low THC oil and78 products as authorized by state law and related rules and regulations;79 (2) Standards, procedures, and protocols for the dispensing of low THC oil and products80 by a pharmacy with a dispensing license and by retail dispensing licensees and for the81 utilization of a tracking system;82 (3) Procedures and protocols to provide that no low THC oil or products may be sold to83 or transferred to a location outside of this state;84 (4) The establishment of standards, procedures, and protocols for determining the85 amount of usable low THC oil and products that is necessary to constitute an adequate86 supply for registered patients in this state to ensure uninterrupted availability for a period87 of one month, including amounts for topical treatments;88 (5) The establishment of standards, procedures, and protocols to ensure that all low THC89 oil and products dispensed are consistently pharmaceutical grade;90 (6) The establishment of standards and procedures for the revocation, suspension, and91 nonrenewal of dispensing licenses;92 23 LC 28 0592S H. B. 196 (SUB) - 5 - (7) The establishment of other licensing, renewal, and operational standards which are93 deemed necessary by the State Board of Pharmacy and the commission;94 (8) The establishment of standards and procedures for testing low THC oil and products95 for levels of tetrahydrocannabinol or other testing parameters deemed appropriate by the96 State Board of Pharmacy and the commission;97 (9) The establishment of health, safety, and security requirements for pharmacies and98 retail dispensing licensees dispensing low THC oil and products; and99 (10) Requirements for the issuance of dispensing licenses to pharmacies and Class 1 and100 Class 2 production licensees.101 (c) The commission shall be authorized, by rules and regulations, to establish fees for102 dispensing licenses to Class 1 and Class 2 production licensees commensurate with the103 location of the retail outlet and demand for low THC oil and products at such location.104 (d) Each dispensing location shall be authorized to sell low THC oil and products from any105 Class 1 or Class 2 production licensee in this state."106 SECTION 4.107 Said article is further amended by revising Code Section 16-12-207, relating to establishment108 of Medical Cannabis Commission Oversight Committee, membership, inspections, provision109 of information, plan for accredited lab testing, and patient and physician input, as follows:110 "16-12-207.111 (a) The General Assembly shall establish a Medical Cannabis Commission Oversight112 Committee with two members appointed by the Lieutenant Governor and two members113 appointed by the Speaker of the House of Representatives. Any member of the Medical114 Cannabis Commission Oversight Committee shall be permitted to inspect any production115 facility upon request and after reasonable notice is provided to the production facility.116 (b) The commission shall promptly provide any document or information requested by the117 oversight committee that is in its possession, provided that the commission shall not be118 23 LC 28 0592S H. B. 196 (SUB) - 6 - required to share documents containing data identifying individual patients or physicians,119 information marked as trade secrets by applicants or licensees, information that in the view120 of the commission would interfere with an ongoing licensing applicant selection process,121 or information that in the judgment of the commission would create law enforcement or122 security risks to the citizens of Georgia any information that would be exempt from public123 disclosure pursuant to Code Section 50-18-72 or pursuant to state or federal privacy laws.124 (c) No later than August 1, 2021, the oversight committee shall recommend to the125 commission a process and plan for providing accredited lab testing of products produced126 by licensees and for labeling such products. The commission shall consider the127 recommendations of the oversight committee in adopting policies, procedures, and128 regulations regarding such testing and labeling Reserved.129 (d) The oversight committee may regularly seek input from patients and physicians as to130 the availability and quality of products produced pursuant to this chapter, and recommend131 to the commission changes to policies, procedures, and regulations to improve availability132 and quality. The commission shall consider such recommendations in adopting policies,133 procedures, and regulations."134 SECTION 5.135 Said article is further amended by revising subsection (a) of Code Section 16-12-211, relating136 to Class 1 production licenses, application fees, revocation, and limitation of ownership, as137 follows:138 "(a) The commission may issue up to two initial Class 1 production licenses. The139 commission may issue up to four additional Class 1 production licenses pursuant to140 subsection (a) of Code Section 16-12-221, provided that the total number of Class 1 and141 Class 2 production licenses shall not exceed 15 production licenses. A Class 1 production142 licensee shall be authorized to:143 23 LC 28 0592S H. B. 196 (SUB) - 7 - (1) Grow cannabis only in indoor facilities for use in producing low THC oil, limited to144 100,000 square feet of cultivation space; and145 (2) Manufacture low THC oil and products."146 SECTION 6.147 Said article is further amended by revising subsection (a) of Code Section 16-12-212, relating148 to Class 2 production licenses, application fees, revocation, and limitation of ownership, as149 follows:150 "(a) The commission may issue up to four initial Class 2 production licenses. The151 commission may issue up to seven additional Class 2 production licenses pursuant to152 subsection (a) of Code Section 16-12-221, provided that the total number of Class 1 and153 Class 2 production licenses shall not exceed 15 production licenses. A Class 2 production154 licensee shall be authorized to:155 (1) Grow cannabis only in indoor facilities for use in producing low THC oil, limited156 to 50,000 square feet of cultivation space; and157 (2) Manufacture low THC oil and products."158 SECTION 7.159 Said article is further amended by revising Code Section 16-12-220, relating to confidential160 nature of data, exclusion, and patient privacy, as follows:161 "16-12-220.162 (a) All working papers, recorded information, documents, and copies produced by,163 obtained by, or disclosed to the commission pursuant to the activities conducted pursuant164 to this part, other than information published in an official commission report regarding the165 activities conducted pursuant to this article, shall be confidential data and shall not be166 subject to Article 4 of Chapter 18 of Title 50; provided, however, that any contract,167 memorandum of understanding, or cooperative endeavor agreement entered into by the168 23 LC 28 0592S H. B. 196 (SUB) - 8 - commission pursuant to this article shall be subject to Article 4 of Chapter 18 of Title 50,169 relating to open records.170 (b) In no event shall the commission disclose any information that would reveal the171 identity or health information of any registered patient or violate the federal Health172 Insurance Portability and Accountability Act of 1996, Public Law 104-191."173 SECTION 8.174 Said article is further amended by revising subsection (a) of Code Section 16-12-221, relating175 to contracts awarded through bids or proposals, minimum contract terms and renewals,176 subcontracting, and giving or receiving things of value limited, as follows:177 "(a)(1) The commission shall grant initial licenses under this part pursuant to contracts178 awarded through competitive sealed bids or competitive sealed proposals as provided for179 in Article 3 of Chapter 5 of Title 50. After issuance of two initial Class 1 production180 licenses pursuant to Code Section 16-12-211 and four initial Class 2 production licenses181 pursuant to Code Section 16-12-212, and in the commission shall be authorized to issue182 one additional Class 2 production license for every increase of 5,000 patients in the Low183 THC Oil Patient Registry established and maintained pursuant to Code Section 31-2A-18184 and one additional Class 1 production license for every increase of 10,000 patients in the185 Low THC Oil Patient Registry, subject to the overall limit of total number of Class 1 and186 Class 2 production licenses contained in Code Sections 16-12-211 and 16-12-212. The187 initial increase in the number of patients in the Low THC Oil Patient Registry shall be188 based on the number of patients in the registry as of January 1, 2023. The initial189 additional licenses to be awarded under this paragraph shall be awarded to the apparent190 successful applicants identified in the commission's notices of intent to award, dated191 July 24, 2021, pursuant to its competitive application request for proposals for Class 1192 and Class 2 production licenses, that filed post-award protests of such notices of intent193 to award and appealed the administrative decisions denying such protests to the194 23 LC 28 0592S H. B. 196 (SUB) - 9 - respective superior court and, where appropriate, state appellate court. A person that filed195 a post-award protest which is on appeal that had applied for both a Class 1 and a Class 2196 production license pursuant to such notices of intent to award shall choose which class197 of license such person wants to receive. A person designated under this paragraph shall198 be awarded or issued either a Class 1 or a Class 2 production license, but not both. The199 aggregate number of Class 1 and Class 2 production licenses awarded or issued under this200 paragraph shall not exceed nine licenses.201 (2) In the event that the commission revokes a Class 1 or Class 2 production license, a202 Class 1 or Class 2 production license is surrendered for any reason, or the commission203 issues an additional Class 1 production license pursuant to Code Section 16-12-214, the204 commission shall be authorized to issue any replacement Class 1 or Class 2 production205 licenses in accordance with rules and regulations established by the commission for such206 purpose. Such rules and regulations shall not otherwise conflict with this article, and to207 the extent practicable, such rules and regulations shall incorporate provisions and208 processes similar to Article 3 of Chapter 5 of Title 50."209 SECTION 9.210 Said article is further amended by adding a new Code section to read as follows:211 "16-12-221.1.212 (a) The Georgia State-wide Business Court shall exercise exclusive jurisdiction over any213 appeal by a party aggrieved by a final decision of the commission pursuant to this article.214 The Georgia State-wide Business Court shall conduct expedited hearings on any such215 appeals, and review by the court shall be confined to the record.216 (b) The court shall not substitute its judgment for that of the commission as to the weight217 of the evidence on questions of fact committed to the discretion of the commission. The218 court may affirm any decision of the commission in whole or in part. The court shall219 reverse or remand any case for further proceedings if substantial rights of the appellant220 23 LC 28 0592S H. B. 196 (SUB) - 10 - have been prejudiced because the commission's findings, inferences, conclusions, or221 decisions are:222 (1) In violation of constitutional or statutory provisions or applicable procurement rules;223 (2) Made upon unlawful procedures;224 (3) Affected by other error of law;225 (4) Not reasonably supported by material evidence in view of the reliable and probative226 evidence in the record as a whole; or227 (5) Arbitrary or capricious or characterized by abuse of discretion or clearly unwarranted228 exercise of discretion.229 (c) The court shall require a litigation bond or other form of surety payable to the state230 from any protesting party in an amount determined by the court, which shall be forfeited231 if the court affirms, in whole, the decision of the commission."232 SECTION 10.233 Said article is further amended by revising subsection (c) of Code Section 16-12-222, relating234 to transfer of ownership, appeals, meaning of license, and transfer fees, as follows:235 "(c) A licensee who has been denied transfer approval by the commission may file an236 appeal with the Georgia State-wide Business Court in accordance with Code Section237 16-12-221.1. in the Superior Court of Fulton County in accordance with Chapter 13 of238 Title 50, the 'Georgia Administrative Procedure Act.'"239 SECTION 11.240 Said article is further amended by revising subsection (b) of Code Section 16-12-223,241 relating to revocation of license and appeal, as follows:242 "(b) A licensee whose license has been revoked by the commission may file an appeal with243 the Georgia State-wide Business Court in accordance with Code Section 16-12-221.1. in244 23 LC 28 0592S H. B. 196 (SUB) - 11 - the Superior Court of Fulton County in accordance with Chapter 13 of Title 50, the245 'Georgia Administrative Procedure Act.'"246 SECTION 12.247 Said article is further amended by revising Code Section 16-12-224, relating to limitation on248 ownership by member or former member of commission, limitation on physician's249 involvement, and identification when contributing to political campaigns, as follows:250 "16-12-224.251 (a) No current member of the commission, or former member of the commission for a252 period of five years from the date such individual ceased to be a member, shall own,253 operate, have a financial interest in, or be employed by a low THC oil or product254 manufacturer or distributor, including any licensee under this part.255 (b) No physician who, presently or during the period of such business relationship,256 certifies individuals to the commission pursuant to Code Section 31-2A-18 for the use of257 low THC oil and products to treat certain conditions shall own, operate, have a financial258 interest in, or be employed by a low THC oil or product manufacturer or distributor,259 including any licensee under this part. This subsection shall not prohibit a physician from260 furnishing a registered patient or his or her caregiver, upon request, with the names of low261 THC oil and product manufacturers or distributors. Any physician violating this Code262 section shall be guilty of a misdemeanor.263 (c) Each member of the commission shall file an annual financial disclosure statement for264 the preceding calendar year with the Office of Inspector General no later than July 1 of265 each year. Such financial disclosure shall include ownership interests in businesses,266 income, and source or sources of income for the previous calendar year. For any267 commissioner serving as of May 1, 2023, such disclosure for the 2022 calendar year shall268 be filed with the Office of Inspector General no later than May 31, 2023.269 23 LC 28 0592S H. B. 196 (SUB) - 12 - (c)(d) A licensee that makes a campaign contribution pursuant to Article 2 of Chapter 5270 of Title 21 shall identify itself as a licensee under this part to the recipient of such271 campaign contribution."272 SECTION 13.273 Code Section 31-2A-18 of the Official Code of Georgia Annotated, relating to the Low THC274 Oil Patient Registry, is amended by revising paragraph (3) of subsection (a) as follows:275 "(3) 'Condition' means:276 (A) Cancer, when such disease is diagnosed as end stage or the treatment produces277 related wasting illness or recalcitrant nausea and vomiting;278 (B) Amyotrophic lateral sclerosis, when such disease is diagnosed as severe or end279 stage;280 (C) Seizure disorders related to a diagnosis of epilepsy or trauma related head injuries;281 (D) Multiple sclerosis, when such disease is diagnosed as severe or end stage;282 (E) Crohn's disease;283 (F) Mitochondrial disease;284 (G) Parkinson's disease, when such disease is diagnosed as severe or end stage;285 (H) Sickle cell disease, when such disease is diagnosed as severe or end stage;286 (I) Tourette's syndrome, when such syndrome is diagnosed as severe;287 (J) Autism spectrum disorder, when such disorder is diagnosed for a patient who is at288 least 18 years of age, or severe autism, when diagnosed for a patient who is less than289 18 years of age;290 (K) Epidermolysis bullosa;291 (L) Alzheimer's disease, when such disease is diagnosed as severe or end stage;292 (M) Acquired immune deficiency syndrome, when such syndrome is diagnosed as293 severe or end stage;294 (N) Peripheral neuropathy, when such symptoms are diagnosed as severe or end stage;295 23 LC 28 0592S H. B. 196 (SUB) - 13 - (O) Post-traumatic stress disorder resulting from direct exposure to or the witnessing296 of a trauma for a patient who is at least 18 years of age; or297 (P) Intractable pain;298 (Q) Ulcerative colitis; and299 (R) Myasthenia gravis."300 SECTION 14.301 This Act shall become effective upon its approval by the Governor or upon its becoming law302 without such approval.303 SECTION 15.304 All laws and parts of laws in conflict with this Act are repealed.305