HB 370 - Controlled Substances Therapeutic Research Act; repeal

First Reader Summary

A BILL to amend Chapter 34 of Title 43 of the Official Code of Georgia Annotated, relating to physicians, physician's assistants, and respiratory care, so as to repeal Article 5, known as the "Controlled Substances Therapeutic Research Act"; and for other purposes.

O'Neal, Earl L (75th)
Status Summary HC: H&E SC: LA: 02/03/97 H - Read 2nd Time
Page Numbers - 1/ 2/ 3/ 4/ 5/ 6
Code Sections - 43-34-120/ 43-34-121/ 43-34-122/ 43-34-123/ 43-34-124/ 43-34-125/ 43-34-126
House Action Senate
1/31/97 Read 1st Time
2/3/97 Read 2nd Time

HB 370                                              LC 9 9017 
                        A BILL TO BE ENTITLED 
                               AN ACT 
  1- 1  To amend Chapter 34 of Title 43 of the Official Code of 
  1- 2  Georgia Annotated, relating to physicians, physician's 
  1- 3  assistants, and respiratory care, so as to repeal Article 5, 
  1- 4  known as the "Controlled Substances Therapeutic Research 
  1- 5  Act"; to provide an effective date; to repeal conflicting 
  1- 6  laws; and for other purposes. 
  1- 8                           SECTION 1. 
  1- 9  Chapter 34 of Title 43 of the Official Code of Georgia 
  1-10  Annotated, relating to physicians, physician's assistants, 
  1-11  and respiratory care, is amended by striking Article 5, 
  1-12  known as the "Controlled Substances Therapeutic Research 
  1-13  Act," which reads as follows: 
  1-14    43-34-120. 
  1-15    This article shall be known and may be cited as the 
  1-16    'Controlled Substances Therapeutic Research Act.' 
  1-17    43-34-121. 
  1-18    (a) The General Assembly finds and declares that the 
  1-19    potential medicinal value of marijuana has received 
  1-20    insufficient study due to a lack of financial incentives 
  1-21    for the undertaking of appropriate research by private 
  1-22    drug manufacturing concerns. Individual physicians cannot 
  1-23    feasibly utilize marijuana in clinical trials because of 
  1-24    federal governmental controls which involve expensive, 
  1-25    time-consuming approval and monitoring procedures. 
  1-26    (b) The General Assembly further finds and declares that 
  1-27    limited studies throughout the nation indicate that 
  1-28    marijuana and certain of its derivatives possess valuable 
  1-29    and, in some cases, unique therapeutic properties, 
  1-30    including the ability to relieve nausea and vomiting which 
  1-31    routinely accompany chemotherapy and irradiation used to 
  2- 1    treat cancer patients. Marijuana also may be effective in 
  2- 2    reducing intraocular pressure in glaucoma patients who do 
  2- 3    not respond well to conventional medications. 
  2- 4    (c) The General Assembly further finds and declares that, 
  2- 5    in enabling individual physicians and their patients to 
  2- 6    participate in a state-sponsored program for the 
  2- 7    investigational use of marijuana and its derivatives, 
  2- 8    qualified physicians and surgeons throughout the state 
  2- 9    will be able to study the benefits of the drug in a 
  2-10    controlled clinical setting, and additional knowledge will 
  2-11    be gained with respect to dosage and effects. 
  2-12    (d) It is the intent of the General Assembly in enacting 
  2-13    this article to permit research into the therapeutic 
  2-14    applications of marijuana and its derivatives in cancer 
  2-15    and glaucoma patients. This would allow qualified 
  2-16    physicians approved by the Patient Qualification Review 
  2-17    Board created by Code Section 43-34-124 to provide the 
  2-18    drug on a compassionate basis to seriously ill persons 
  2-19    suffering from the severe side effects of chemotherapy or 
  2-20    radiation treatment and to persons suffering from glaucoma 
  2-21    who are not responding to conventional treatment, which 
  2-22    persons would otherwise have no lawful access to it. It is 
  2-23    the further intent of the General Assembly to facilitate 
  2-24    clinical trials of marijuana and its derivatives, 
  2-25    particularly with respect to persons suffering from cancer 
  2-26    and glaucoma who would be benefited by use of the drug. 
  2-27    (e) This article is limited to clinical trials and 
  2-28    research into therapeutic applications of marijuana only 
  2-29    for use in treating glaucoma and in treating the side 
  2-30    effects of chemotherapeutic agents and radiation and 
  2-31    should not be construed as either encouraging or 
  2-32    sanctioning the social use of marijuana. Nothing in this 
  2-33    article shall be construed to encourage the use of 
  2-34    marijuana in lieu of or in conjunction with other accepted 
  2-35    medical treatment, but only as an adjunct to such accepted 
  2-36    medical treatment. 
  2-37    43-34-122. 
  2-38    As used in this article, the term: 
  2-39      (1) 'Composite board' means the Composite State Board of 
  2-40      Medical Examiners established pursuant to Article 2 of 
  2-41      this chapter. 
  3- 1      (2) 'Marijuana' means marijuana or tetrahydrocannabinol, 
  3- 2      as defined or listed in Article 2 of Chapter 13 of Title 
  3- 3      16. 
  3- 4      (3) 'Physician' means a person licensed to practice 
  3- 5      medicine pursuant to Article 2 of this chapter. 
  3- 6      (4) 'Program' means the Controlled Substances 
  3- 7      Therapeutic Research Program established pursuant to 
  3- 8      Code Section 43-34-123. 
  3- 9      (5) 'Review board' means the Patient Qualification 
  3-10      Review Board established pursuant to Code Section 
  3-11      43-34-124. 
  3-12    43-34-123. 
  3-13    (a) There is established under the Composite State Board 
  3-14    of Medical Examiners the Controlled Substances Therapeutic 
  3-15    Research Program, which shall be administered by the 
  3-16    composite board. Under the program, the composite board 
  3-17    shall act as a sponsor of state-wide investigational 
  3-18    studies, utilizing as drug investigators individual 
  3-19    physicians who elect to participate in accordance with the 
  3-20    guidelines and protocols developed by the composite board. 
  3-21    Such guidelines and protocols shall be designed to ensure 
  3-22    that stringent security and record-keeping requirements 
  3-23    for research drugs are met and that participants in the 
  3-24    program meet those research standards necessary to 
  3-25    establish empirical bases for the evaluation of marijuana 
  3-26    as a medically recognized therapeutic substance. The 
  3-27    composite board shall promulgate such rules and 
  3-28    regulations as it deems necessary or advisable to 
  3-29    administer the program. In promulgating such guidelines, 
  3-30    protocols, rules, and regulations, the composite board 
  3-31    shall take into consideration those pertinent rules and 
  3-32    regulations promulgated by the Federal Drug Enforcement 
  3-33    Agency, the Food and Drug Administration, and the National 
  3-34    Institute on Drug Abuse. 
  3-35    (b) The program shall be limited to patients who are 
  3-36    certified to the composite board by a physician as being: 
  3-37      (1) Cancer patients involved in a life-threatening 
  3-38      situation in which treatment by chemotherapy or 
  3-39      radiology has produced severe side effects; or 
  3-40      (2) Glaucoma patients who are not responding to 
  3-41      conventional controlled substances. 
  4- 1    (c) No patient may be admitted to the program without full 
  4- 2    disclosure by the physician of the experimental nature of 
  4- 3    the program and of the possible risks and side effects of 
  4- 4    the proposed treatment. 
  4- 5    (d) The cost of any blood test required by the federal 
  4- 6    Food and Drug Administration prior to entrance into the 
  4- 7    program shall be paid by the patient seeking entrance into 
  4- 8    the program. 
  4- 9    (e) Only the following persons shall have access to the 
  4-10    names and other identifying characteristics of patients in 
  4-11    the program for whom marijuana has been prescribed under 
  4-12    this article: 
  4-13      (1) The composite board; 
  4-14      (2) The review board created by Code Section 43-34-124; 
  4-15      (3) The Attorney General or his designee; 
  4-16      (4) Any person directly connected with the program who 
  4-17      has a legitimate need for the information; and 
  4-18      (5) Any federal agency having responsibility for the 
  4-19      program. 
  4-20    43-34-124. 
  4-21    (a) The composite board shall appoint the Patient 
  4-22    Qualification Review Board. Each member of the review 
  4-23    board shall be approved for such membership by a majority 
  4-24    vote of the composite board and shall serve at the 
  4-25    pleasure of the composite board. The review board shall be 
  4-26    composed of: 
  4-27      (1) A board certified physician in ophthalmology; 
  4-28      (2) A board certified physician in surgery; 
  4-29      (3) A board certified physician in internal medicine and 
  4-30      medical oncology; 
  4-31      (4) A board certified physician in psychiatry; 
  4-32      (5) A board certified physician in radiology; and 
  4-33      (6) A pharmacist licensed under Title 26, relating to 
  4-34      pharmacists, pharmacy, and drugs. 
  4-35    (b) The review board shall elect from its members a 
  4-36    chairman and a vice-chairman. The review board shall hold 
  4-37    regular meetings at least once every 60 days and shall 
  4-38    meet at such additional times as shall be called by the 
  5- 1    chairman of the review board or the president of the 
  5- 2    composite board. Each member of the review board shall 
  5- 3    receive for services for each day's attendance upon 
  5- 4    meetings of such board the same amount authorized by law 
  5- 5    for members of the General Assembly for attendance upon 
  5- 6    meetings of the General Assembly. 
  5- 7    (c) The composite board shall adopt such rules and 
  5- 8    regulations as it deems necessary for the performance of 
  5- 9    the duties of the review board. 
  5-10    (d) The review board shall review all patient applicants 
  5-11    for the program and their physicians and shall certify 
  5-12    those qualified for participation in the program. The 
  5-13    review board shall additionally certify pharmacies which 
  5-14    are licensed by the state and which are otherwise 
  5-15    qualified and certify physicians regarding the 
  5-16    distribution of marijuana pursuant to Code Section 
  5-17    43-34-125. Meetings of the review board to certify 
  5-18    patients, physicians, or pharmacies shall not be open to 
  5-19    the public, as otherwise required by Chapter 14 of Title 
  5-20    50. 
  5-21    43-34-125. 
  5-22    (a) The composite board shall apply to contract with the 
  5-23    National Institute on Drug Abuse for receipt of marijuana 
  5-24    pursuant to this article and pursuant to regulations 
  5-25    promulgated by the National Institute on Drug Abuse, the 
  5-26    Food and Drug Administration, and the Federal Drug 
  5-27    Enforcement Agency. 
  5-28    (b) The composite board shall cause marijuana approved for 
  5-29    use in the program to be transferred to a certified 
  5-30    pharmacy, licensed by the state, for distribution to the 
  5-31    certified patient by a licensed pharmacist upon a written 
  5-32    order for research medication of the certified physician, 
  5-33    pursuant to this article. Any reasonable costs incurred by 
  5-34    the composite board in obtaining or testing marijuana 
  5-35    shall be charged to participating physicians who may seek 
  5-36    reimbursement from their research subjects utilizing the 
  5-37    marijuana. 
  5-38    43-34-126. 
  5-39    Patient participants in the program are immune from state 
  5-40    prosecution for possession of marijuana as authorized by 
  5-41    this article and under the program established in this 
  5-42    article.  A person authorized under this program shall not 
  6- 1    possess an amount of marijuana in excess of the amount 
  6- 2    prescribed under the authority of this article.  The 
  6- 3    amount prescribed shall be maintained in the container in 
  6- 4    which it was placed at the time the prescription was 
  6- 5    filled. Physician, pharmacy, and pharmacist participants 
  6- 6    in the program are immune from state prosecution for 
  6- 7    possession, distribution, and any other use of marijuana, 
  6- 8    which use is authorized such persons by this article.  Any 
  6- 9    such possession, distribution, or other use not authorized 
  6-10    by this article shall be enforced and punished as provided 
  6-11    in Chapter 13 of Title 16, relating to controlled 
  6-12    substances and dangerous drugs, and Chapter 4 of Title 26, 
  6-13    relating to pharmacists and pharmacies.", 
  6-14  and inserting in its place the following: 
  6-15                           SECTION 2. 
  6-16  Notwithstanding the provisions of Code Section 1-3-4.1, this 
  6-17  Act shall become effective on the first day of July 
  6-18  following the approval of this Act by the Governor or its 
  6-19  becoming law without such approval. 
  6-20                           SECTION 3. 
  6-21  All laws and parts of laws in conflict with this Act are 
  6-22  repealed. 

Clerk of the House
Robert E. Rivers, Jr., Clerk
Last Updated on 04/20/98