12 LC
33 4647
Senate
Bill 488
By:
Senators Bethel of the 54th, Loudermilk of the 52nd and Mullis of the 53rd
A
BILL TO BE ENTITLED
AN ACT
To
amend Article 5 of Chapter 4 of Title 26 of the Official Code of Georgia
Annotated, relating to prescription drugs, so as to provide that a reference
product license holder shall have immunity from liability from claims for loss
arising from the use of a biosimilar biological product; to provide for
definitions; to provide for applicability; to provide for related matters; to
repeal conflicting laws; and for other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Article
5 of Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating
to prescription drugs, is amended by adding new a Code section to read as
follows:
"26-4-81.1.
(a)
As used in this Code section, the terms 'biological product,' 'biosimilar,'
'interchangeable,' 'license,' and 'reference product' shall have the meanings
that apply to such terms under section 351 of the Public Health Service Act (42
U.S.C. 262).
(b)
A reference product license holder and each entity marketing, selling, or
distributing the reference product shall be immune from liability under the laws
of this state with respect to all claims for loss caused by, arising out of,
relating to, or resulting from the administration to or the use by an individual
of any biosimilar biological product, including any such product that is
interchangeable with the reference product. Such claims shall include, but not
be limited to, any claim for product liability including failure to warn, design
defect, or manufacturing defect and any type of breach of warranty including any
warranty for merchantability, fitness, or any implied or express warranty. This
Code section shall apply to claims for any type of loss, including:
(A)
Death;
(B)
Physical, mental, or emotional injury, illness, disability, or
condition;
(C)
Fear of physical, mental, or emotional injury, illness, disability, or
condition, including any need for medical monitoring; and
(D)
Loss of or damage to property, including business interruption
loss.
(c)
This Code section shall not apply to a reference product license holder with
respect to a biosimilar biological product that is manufactured by such
holder."
SECTION
2.
All
laws and parts of laws in conflict with this Act are repealed.