S0576B0660A06056 BIL:NLG 03/14/18 #90 A06056
AMENDMENTS TO SENATE BILL NO. 576
Sponsor: SENATOR BAKER
Printer's No. 660
Amend Bill, page 1, lines 1 and 2, by striking out all of
said lines and inserting
Providing for reimbursement of patient expenses associated with
participation in cancer clinical trials and for duties of the
Department of Health; and imposing a penalty.
Amend Bill, page 3, by inserting between lines 28 and 29
(11) While the United States Food and Drug
Administration recently confirmed to Congress and provided
guidance that, in fact, reimbursement of direct patient-
incurred expenses is not inducement, many organizations,
pharmaceutical companies, philanthropic individuals,
charitable organizations, government entities and others
still operate under the understanding that such reimbursement
could be, in fact, considered inducement.
Amend Bill, page 4, line 12, by striking out all of said line
and inserting
"Department." The Department of Health of the Commonwealth.
Amend Bill, page 4, line 15, by striking out all of said line
and inserting
"IRB or IEC." An Institutional Review Board (IRB) or an
Independent Ethics Review Committee (IEC) that is an
appropriately constituted group formally established in
accordance with applicable United States Food and Drug
Administration regulations or outside the United States by other
equivalent and applicable international regulations and
guidelines in order to review and monitor biomedical research
involving human subjects, and specifically having the authority
to approve or disapprove research or to require modifications in
research to secure approval.
Amend Bill, page 4, by inserting between lines 17 and 18
"Third-party reimbursement entity." A third-party nonprofit
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corporation or public charity that specializes in assisting
cancer patients and increasing enrollment, retention and
minority participation in cancer clinical trials.
Amend Bill, page 5, line 8, by striking out the comma after
"trial" and inserting a semicolon
Amend Bill, page 5, lines 12 and 13, by striking out all of
said lines and inserting
(c) Expenses and registration.--The following apply:
(1) Government, industry, public and private
foundations,
Amend Bill, page 5, lines 17 through 20, by striking out
"third party nonprofit corporations and public charities that"
in line 17 and all of lines 18 through 20 and inserting
a third-party reimbursement entity.
(2) A third-party reimbursement entity shall register
with a department-approved Pennsylvania college or university
with a school of public health. Registration must occur
within 30 days of the date the third-party reimbursement
entity first reimbursed a patient-subject, or the patient-
subject's family, friends or chaperones, for travel or
ancillary expenses related to a cancer clinical trial
conducted within this Commonwealth.
(3) Registration under paragraph (2) shall include:
(i) The name of the third-party reimbursement
entity.
(ii) The third-party reimbursement entity's legal
and tax status.
(iii) The third-party reimbursement entity's
employer or other similar identification number.
(iv) The names of the third-party reimbursement
entity's principal officers and directors.
(v) The names of donors of $5,000 or more to the
third-party reimbursement entity.
(vi) Appropriate identifying information, as
determined by the department, regarding other sources of
funding from a source of $5,000 or more.
(vii) Other information as the department deems
necessary or appropriate.
(4) A third-party reimbursement entity registering under
paragraph (2) shall update the registration no less than once
annually utilizing forms and regulations developed by the
department.
(5) A third-party reimbursement entity that fails to
register as required by this subsection shall be subject to a
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penalty of no more than $300 imposed by the department.
Amend Bill, page 6, line 5, by striking out "90 days" and
inserting
six months
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See A06056 in
the context
of SB0576