NY State Senate Bill 2019-S5682

Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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Actions

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 08, 2020	referred to health
May 10, 2019	referred to health

co-Sponsors

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2019-S5682 (ACTIVE) - Details

See Assembly Version of this Bill:: A7588
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §280-d, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2021-2022: S1737, A133
2023-2024: S604, A7954

2019-S5682 (ACTIVE) - Summary

Creates a wholesale prescription drug importation program which complies with federal standards and regulations for the purpose of generating substantial savings for consumers.

2019-S5682 (ACTIVE) - Sponsor Memo

                                
 
BILL NUMBER: S5682

SPONSOR: SKOUFIS
 
TITLE OF BILL:  An act to amend the public health law, in relation to
creating a wholesale prescription drug importation program

 
PURPOSE:

To create a state program to import prescription drugs from other coun-
tries at lower cost.

 
SUMMARY OF PROVISIONS:

The Commissioner, of Health will seek federal certification for a
program under which an approved wholesaler may import drugs that meet
U.S. Food and Drug Administration standards from only suppliers who are
regulated and authorized under the laws of their country for distrib-
ution and sale only in New York.

The operation of the program will be funded by annual fees paid by the
authorized wholesaler. The Commissioner will make regulations to require

and authorized wholesaler application process, reporting and audits;
collaborate with the Attorney General to combat fraud; seek all required
federal approvals for participation including those required for the
340-B program; and report annually to the legislature.

 
JUSTIFICATION:

Concern about drug pricing is at an all-time high. Studies show how U.S.
consumers pay the highest prices in the world for life-saving and
enhancing drug treatments. The prices we pay may fund the research and
development that benefits the entire world but those same prices make
treatment options unavailable here at home if patients cannot afford
their medicines or public programs cannot finance expensive treatments
for everyone in need. Drug importation is high on the list of solutions
the public wants to pursue.

Federal law allows the Secretary of Health and Human Services (HHS) to
certify programs for personal and wholesale importation from countries
such as Canada if consumer safety is on par with the U.S.  drug supply
chain system and significant consumer cost savings are realized.

Under the federal law, shipments from Canada, for example, will be test-
ed on a sample basis for purity and potency and products would be
labeled properly for the U.S. market and distributed to retail pharma-
cies and other settings included in the program. Just as in the regular
commercial market, retail pharmacies and other dispensing settings order
and pay for products, and administrative costs set by the Commissioner.
The product acquisition cost will be the Canadian price. Pharmacies and
other dispensers will charge the Canadian price without mark-up, except
for cost-based dispensing fee, for uninsured people or people in their
deductible period. Health plans and other payers will pay dispensers for
the product at the Canadian price without mark-up except for cost-based
dispensing fee.

Medical care is a fundamental fact of life at some point or another, but
the burden of paying for that care should not, on its own, be the death
of us.

 
LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

None.

 
EFFECTIVE DATE:
Immediately

2019-S5682 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   5682
 
                        2019-2020 Regular Sessions
 
                             I N  S E N A T E
 
                               May 10, 2019
                                ___________
 
 Introduced  by  Sen. SKOUFIS -- read twice and ordered printed, and when
   printed to be committed to the Committee on Health
 
 AN ACT to amend the public health law, in relation to creating a  whole-
   sale prescription drug importation program
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Title 2 of article 2-A of the public health law is  amended
 by adding a new section 280-d to read as follows:
   §  280-D.  WHOLESALE  PRESCRIPTION  DRUG IMPORTATION PROGRAM.   1. (A)
 THERE IS HEREBY CREATED IN THE DEPARTMENT A WHOLESALE PRESCRIPTION  DRUG
 IMPORTATION PROGRAM.
   (B)  AS  USED  IN  THIS  SECTION,  UNLESS THE CONTEXT CLEARLY REQUIRES
 OTHERWISE, THE FOLLOWING TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   (I) "WHOLESALE PRESCRIPTION DRUG  IMPORTATION  PROGRAM"  OR  "PROGRAM"
 MEANS  THE WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM CREATED UNDER
 THIS SECTION.
   (II) "PRESCRIPTION DRUG WHOLESALER"  MEANS  AN  ENTITY  AUTHORIZED  TO
 ACQUIRE  PRESCRIPTION DRUGS AND SELL OR DISTRIBUTE THEM WHOLESALE IN THE
 STATE.
   (III) "APPROVED  WHOLESALER"  MEANS  A  PRESCRIPTION  DRUG  WHOLESALER
 APPROVED UNDER THIS SECTION TO PARTICIPATE IN THE PROGRAM.
   (C)  THE  COMMISSIONER  SHALL  DEVELOP  AND  IMPLEMENT  THE PROGRAM IN
 CONSULTATION WITH INTERESTED STAKEHOLDERS AND APPROPRIATE FEDERAL  OFFI-
 CIALS.  THE  PROGRAM  SHALL COMPLY WITH APPLICABLE FEDERAL REQUIREMENTS,
 INCLUDING 21 U.S.C. § 384, AND REQUIREMENTS REGARDING  SAFETY  AND  COST
 SAVINGS. UNDER THE PROGRAM:
   (I)  THE  COMMISSIONER  SHALL  APPROVE  ONE  OR MORE PRESCRIPTION DRUG
 WHOLESALERS  TO  SEEK  FEDERAL  CERTIFICATION  AND  APPROVAL  TO  IMPORT
 PRESCRIPTION  DRUGS  FROM  ONE  OR  MORE  OTHER COUNTRIES, TO BE SOLD OR
 DISTRIBUTED WHOLESALE IN THE STATE;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD11421-01-9

 S. 5682                             2
 
   (II) PRESCRIPTION DRUGS SHALL ONLY BE ACQUIRED  FROM  SUPPLIERS  REGU-
 LATED  AND AUTHORIZED UNDER THE LAWS OF THE OTHER COUNTRY OR A JURISDIC-
 TION THEREOF;
   (III)  ONLY PRESCRIPTION DRUGS MEETING THE U.S. FOOD AND DRUG ADMINIS-
 TRATION'S SAFETY, EFFECTIVENESS, AND OTHER STANDARDS SHALL  BE  IMPORTED
 UNDER THE PROGRAM;
   (IV)  ONLY PRESCRIPTION DRUGS EXPECTED TO GENERATE SUBSTANTIAL SAVINGS
 FOR CONSUMERS SHALL BE IMPORTED;
   (V) THE APPROVED WHOLESALER SHALL AT ALL TIMES COMPLY WITH THE  TRACK-
 ING  AND TRACING REQUIREMENTS OF 21 U.S.C. §§ 360EEE AND 360EEE-1 TO THE
 EXTENT FEASIBLE AND PRACTICAL, INCLUDING PRIOR TO IMPORTED  PRESCRIPTION
 DRUGS COMING INTO ITS POSSESSION;
   (VI)  AN APPROVED WHOLESALER SHALL NOT SELL OR DISTRIBUTE PRESCRIPTION
 DRUGS IMPORTED UNDER THE PROGRAM OUTSIDE THE STATE;
   (VII) THE COMMISSIONER MAY IMPOSE AN ANNUAL  FEE  ON  APPROVED  WHOLE-
 SALERS,  WHICH  MAY  BE  BASED  IN  WHOLE  OR  IN  PART  ON THE VALUE OF
 PRESCRIPTION  DRUGS  IMPORTED  BY  THE  APPROVED  WHOLESALER  UNDER  THE
 PROGRAM, TO SUPPORT THE OPERATION OF THE PROGRAM;
   (VIII)  EVERY  APPROVED WHOLESALER SHALL PROVIDE THE COMMISSIONER WITH
 INFORMATION ON ITS PARTICIPATION IN THE PROGRAM AS  REASONABLY  REQUIRED
 BY  THE  COMMISSIONER;  THE COMMISSIONER MAY PROVIDE FOR KEEPING CERTAIN
 INFORMATION CONFIDENTIAL WITHIN THE DEPARTMENT WHERE  REASONABLY  NECES-
 SARY FOR SUCCESSFUL OPERATION OF THE PROGRAM; AND
   (IX)  THE  COMMISSIONER  SHALL  PROVIDE  FOR  AUDITING OF THE PROGRAM,
 INCLUDING MAKING SURE THAT PRESCRIPTION  DRUGS  ARE  MADE  AVAILABLE  AT
 SUBSTANTIAL SAVINGS TO CONSUMERS AS A RESULT OF THE PROGRAM.
   (D)  THE  COMMISSIONER  SHALL  MAKE REGULATIONS AND TAKE OTHER ACTIONS
 REASONABLY NECESSARY TO IMPLEMENT THE PROGRAM.
   2. THE COMMISSIONER SHALL CONSULT WITH THE ATTORNEY GENERAL TO IDENTI-
 FY THE POTENTIAL FOR, AND TO MONITOR, ANTICOMPETITIVE BEHAVIOR UNDER  OR
 IN RELATION TO THE PROGRAM.
   3. (A) THE COMMISSIONER SHALL SEEK ALL NECESSARY APPROVALS AND CERTIF-
 ICATION  BY  THE  SECRETARY  OF  THE U.S. DEPARTMENT OF HEALTH AND HUMAN
 SERVICES OR OTHER APPROPRIATE FEDERAL  OFFICIALS  OR  AGENCIES  FOR  THE
 WHOLESALE PRESCRIPTION DRUG IMPORTATION PROGRAM.
   (B)  THE  COMMISSIONER  SHALL  SEEK THE APPROPRIATE FEDERAL APPROVALS,
 WAIVERS, EXEMPTIONS, OR AGREEMENTS, OR A COMBINATION THEREOF, AS  NEEDED
 TO  ENABLE  ALL COVERED ENTITIES ENROLLED IN OR ELIGIBLE FOR THE FEDERAL
 340B DRUG PRICING PROGRAM TO PARTICIPATE IN THE  WHOLESALE  PRESCRIPTION
 DRUG IMPORTATION PROGRAM TO THE FULLEST EXTENT POSSIBLE WITHOUT JEOPARD-
 IZING THEIR ELIGIBILITY FOR THE 340B PROGRAM.
   4.  THE  COMMISSIONER SHALL ESTABLISH PROCEDURES FOR PRESCRIPTION DRUG
 WHOLESALERS TO APPLY AND BE  APPROVED  TO  BE  AN  APPROVED  WHOLESALER,
 INCLUDING  REQUIREMENTS  FOR  PERIODIC  RENEWAL  OF  THAT  APPROVAL. THE
 COMMISSIONER SHALL PROVIDE REASONABLE GROUNDS FOR SUSPENDING OR REVOKING
 APPROVAL OF AN APPROVED WHOLESALER UNDER THIS SECTION, INCLUDING REASON-
 ABLE PROVISION FOR NOTICE, OPPORTUNITY TO BE HEARD, AND APPEAL.
   5. THE COMMISSIONER SHALL ANNUALLY REPORT TO THE  ASSEMBLY  COMMITTEES
 ON  HEALTH AND ON WAYS AND MEANS AND THE SENATE COMMITTEES ON HEALTH AND
 ON FINANCE REGARDING THE OPERATION OF THE  WHOLESALE  PRESCRIPTION  DRUG
 IMPORTATION PROGRAM.
   § 2. This act shall take effect immediately.

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Senate Bill S5682

Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

co-Sponsors

2019-S5682 (ACTIVE) - Details

2019-S5682 (ACTIVE) - Summary

2019-S5682 (ACTIVE) - Sponsor Memo

2019-S5682 (ACTIVE) - Bill Text download pdf

Comments

Senate Bill S5682

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Sponsored By

Archive: Last Bill Status - In Senate Committee Health Committee

co-Sponsors

2019-S5682 (ACTIVE) - Details

2019-S5682 (ACTIVE) - Summary

2019-S5682 (ACTIVE) - Sponsor Memo

2019-S5682 (ACTIVE) - Bill Text download pdf

Comments