Georgia 2023 2023-2024 Regular Session

Georgia House Bill HB196 Comm Sub / Bill

Filed 02/28/2023

                    23 LC 28 0592S
H. B. 196 (SUB)
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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)
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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)
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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)
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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
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(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
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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)
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(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
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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
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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
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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
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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
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(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
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(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