S0003B0889A06007 BIL:NLH 03/11/16 #90 A06007
AMENDMENTS TO SENATE BILL NO. 3 (As amended by A05835)
Sponsor: REPRESENTATIVE WATSON
Printer's No. 889
Amend Bill, page 1, line 13 (A05835), by inserting after
"for"
academic clinical research centers and for
Amend Bill, page 2, by inserting between lines 48 and 49
(A05835)
Chapter 20. Academic Clinical Research Centers
Section 2001. Definitions.
Section 2002. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Section 2003. Research study.
Amend Bill, page 16, line 34 (A05835), by inserting after
"organization"
, including a clinical registrant under Chapter 20,
Amend Bill, page 18, line 38 (A05835), by inserting after
"organization"
, including a clinical registrant under Chapter 20,
Amend Bill, page 25, line 42 (A05835), by inserting after
"organization"
, including registration under Chapter 20,
Amend Bill, page 26, line 2 (A05835), by inserting after
"organization"
, including registration under Chapter 20,
Amend Bill, page 27, line 25 (A05835), by inserting after
"value."
However, money in the fund may not be expended on activity
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under Chapter 20.
Amend Bill, page 27, line 46 (A05835), by inserting after "7"
and Chapter 20
Amend Bill, page 33, by inserting between lines 30 and 31
(A05835)
(31) Regulations necessary to implement Chapter 20.
Amend Bill, page 33, line 31 (A05835), by striking out "(31)"
and inserting
(32)
Amend Bill, page 34, line 49 (A05835), by inserting after
"organization"
, including an employee or principal of a clinical registrant
under Chapter 20,
Amend Bill, page 35, line 51 (A05835), by inserting after
"organization"
, including an employee or principal of a clinical registrant
under Chapter 20,
Amend Bill, page 36, line 10 (A05835), by inserting after
"organization"
, including an employee or principal of a clinical registrant
under Chapter 20,
Amend Bill, page 38, line 39 (A05835), by inserting after
"conditions."
The program shall not include a clinical registrant or
academic clinical research center under Chapter 20.
Amend Bill, page 42, by inserting between lines 12 and 13
(A05835)
CHAPTER 20
ACADEMIC CLINICAL RESEARCH CENTERS
Section 2001. Definitions.
The following words and phrases when used in this chapter
shall have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Academic clinical research center." An accredited medical
school within this Commonwealth that operates or partners with
an acute care hospital licensed within this Commonwealth.
"Clinical registrant." An entity registered as both a
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grower/processor and a dispensary which has a contractual
relationship with an academic clinical research center as set
forth under section 2002.
Section 2002. Registration as both grower/processor and
dispensary collaborating with an academic clinical
research center.
Notwithstanding the limitations in sections 706 and 707, the
department may register up to eight entities which are
registered as both a grower/processor and a dispensary that have
a contractual relationship with an academic clinical research
center under which the academic clinical research center or its
affiliate provides advice to the entities registered as both a
grower/processor and a dispensary regarding, among other areas,
patient health and safety, medical applications and dispensing
and management of controlled substances. Each entity may provide
medical marijuana at not more than six separate locations. The
total number of locations authorized to dispense medical
marijuana under this section shall not exceed 48. The following
apply with respect to this category of clinical registrant:
(1) A clinical registrant must be registered as both a
grower/processor and a dispensary.
(2) A clinical registrant must pay the fees and meet all
other requirements under this act for registration, except as
provided in section 708(g)(1)(iv) and (2)(v), as a
grower/processor and a dispensary.
(3) The clinical registrant must have a minimum of
$15,000,000 in capital. The department shall verify the
capital requirement.
(4) The clinical registrant must comply with all other
requirements of this act regarding growing, processing and
dispensing medical marijuana.
Section 2003. Research study.
Notwithstanding any provision of this act to the contrary,
the department may, upon application, approve the dispensing of
medical marijuana by a clinical registrant to the academic
clinical research center for the purpose of conducting a
research study. The department shall develop the application and
standards for approval of such dispensing by the clinical
registrant. The following apply to the research study:
(1) The clinical registrant shall disclose the following
information to the department in its application:
(i) The reason for the research project, including
the reason for the trial.
(ii) The strain of medical marijuana to be used and
the strength of the medical marijuana to be used in the
research study.
(iii) The anticipated duration of the study.
(iv) Evidence of approval of the trial by accredited
institutional review board, including any other required
regulatory approvals.
(v) Other information required by the department,
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except that the department may not require disclosure of
any information that would infringe upon the academic
clinical research center's exclusive right to
intellectual property or legal obligations for patient
confidentiality.
(2) The academic clinical research center shall provide
its findings to the department within 365 days of the
conclusion of the research study or within 365 days of
publication of the results of the research study in a peer-
reviewed medical journal, whichever is later.
(3) The department shall allow the exchange of medical
marijuana seed between clinical registrants for the conduct
of research.
Amend Bill, page 42, lines 30 through 42 (A05835), by
striking out all of said lines and inserting
(a) Licensure.--None of the following shall be subject to
arrest, prosecution or penalty in any manner, or denied any
right or privilege, including civil penalty or disciplinary
action by a Commonwealth licensing board or commission, solely
for lawful use of medical marijuana or manufacture or sale or
dispensing of medical marijuana, or for any other action taken
in accordance with this act:
(1) A patient.
(2) A caregiver.
(3) A practitioner.
(4) A medical marijuana organization.
(5) A health care medical marijuana organization or
university participating in a research study under Chapter
19.
(6) A clinical registrant or academic clinical research
center under Chapter 20.
(7) An employee, principal or financial backer of a
medical marijuana organization.
(8) An employee of a health care medical marijuana
organization or an employee of a university participating in
a research study under Chapter 19.
(9) An employee of a clinical registrant or an employee
of an academic clinical research center under Chapter 20.
(10) A pharmacist or certified registered nurse
practitioner under section 707(9).
Amend Bill, page 44, lines 46 through 51; page 45, lines 1
and 2 (A05835), by striking out all of said lines on said pages
and inserting
(xvi) Chapter 20.
(xvii) Section 2101.
(xviii) Section 2102.
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(xix) Section 2103.
(xx) Section 2104.
(xxi) Section 2105.
(xxii) Section 2106.
(xxiii) Section 2108.
(xxiv) Section 2109.
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