HB 311

1	A bill to be entitled
2	An act relating to vaccine production facilities;
3	providing incentives for vaccine production facilities to
4	produce certain vaccines; exempting certain business
5	entities from liability under certain circumstances;
6	establishing a loan and loan guarantee program; requiring
7	the Department of Health to purchase a portion of vaccines
8	produced in the state for a specified period of time;
9	providing an effective date.
10
11	WHEREAS, the adequacy of our country's supply of vaccines
12	has been called into question because of the growing demand for
13	the influenza vaccine and other vaccines in response to the
14	exhortations of public health officials, and
15	WHEREAS, this growing demand for vaccines has increased the
16	pressure on the nation's domestic suppliers and created the
17	potential for a major public health crisis, and
18	WHEREAS, the issue of the inadequacy of vaccine supplies to
19	meet the needs of our citizens, and particularly to protect the
20	public against influenza, which kills some 36,000 Americans each
21	year, has now advanced to the forefront of the public health
22	agenda, and
23	WHEREAS, urgent action is needed to augment the limited
24	domestic vaccine supply, especially the supply of influenza
25	vaccine, in order to protect the health of the American public,
26	not only those individuals who are most at risk from vaccine-
27	preventable diseases but also the rest of the population as
28	well, and
29	WHEREAS, given the impediment to the increased production
30	of vaccines created by the regulatory requirements imposed by
31	the United States Food and Drug Administration, the state should
32	offer financial incentives to pharmaceutical manufacturers to
33	increase the production of vaccines and thereby ensure their
34	availability in quantities that are adequate to protect the most
35	vulnerable individuals in the state and to permit the rest of
36	the citizens of the state who wish to be vaccinated to receive
37	this protection as well, NOW, THEREFORE,
38
39	Be It Enacted by the Legislature of the State of Florida:
40
41	Section 1.  Vaccine production facilities; incentives for
42	vaccine production; liability; loan program.--
43	(1)  The Department of Health shall conduct an outreach
44	campaign to encourage pharmaceutical companies located in this
45	state to produce vaccines for the prevention of communicable
46	diseases and to encourage pharmaceutical companies located
47	outside of this state to establish facilities in this state to
48	produce vaccines for the prevention of communicable diseases.
49	(2)  A business, corporation, sole proprietorship,
50	partnership, subchapter S corporation, limited liability
51	corporation, nonprofit corporation, consortium, or other
52	business entity located in this state that in good faith
53	develops or produces vaccines for the prevention of communicable
54	diseases shall not be held liable for civil damages for any act
55	or omission, except for knowing and willful acts or omissions,
56	in the development or production of vaccines for the prevention
57	of communicable diseases that are approved for market
58	distribution by the United States Food and Drug Administration.
59	(3)  The Department of Health shall establish a loan and
60	loan guarantee program to increase the financing available to
61	fund the costs incurred by new or expanded production facilities
62	in the state that produce vaccines for the prevention of
63	communicable diseases, including, but not be limited to, the
64	influenza virus. Loans or loan guarantees shall be made
65	available to pharmaceutical companies, partnerships of such
66	companies, and consortia of such companies, provided that the
67	production facility meets the requirements of the United States
68	Food and Drug Administration to ensure the safety, efficacy,
69	purity, and potency of the vaccines produced at the facility.
70	(4)  The Department of Health shall enter into an agreement
71	with each production facility that commences production of
72	vaccines for the prevention of communicable diseases to purchase
73	a portion of all vaccines produced at the facility that are
74	approved by the United States Food and Drug Administration to
75	ensure the safety, efficacy, purity, and potency of the vaccine.
76	Such an agreement may be for no more than 1 year. The department
77	shall take all actions that are necessary to encourage
78	physicians, nurses, health care facilities, pharmacies, and
79	other entities that dispense vaccines in the state to obtain a
80	portion of their vaccine supply from vaccine production
81	facilities currently located in the state or facilities that
82	commence production of vaccines in the state after July 1, 2006.
83	Section 2.  This act shall take effect July 1, 2006.

CODING: Words stricken are deletions; words underlined are additions.