Senate Bill S3156

                            
                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  3156

                       2009-2010 Regular Sessions

                            I N  S E N A T E

                             March 12, 2009
                               ___________

Introduced  by  Sen.  MONSERRATE  -- read twice and ordered printed, and
  when printed to be committed to the Committee on Consumer Protection

AN ACT to amend the general business law, in relation to  disclosure  of
  certain  gifts  provided  by  pharmaceutical  manufacturers or medical
  device manufacturers to health care providers

  THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. The general business law is amended by adding a new article
38-B to read as follows:
                              ARTICLE 38-B
                PHARMACEUTICAL MANUFACTURERS AND MEDICAL
                    DEVICE MANUFACTURERS; DISCLOSURE
SECTION 825. DEFINITIONS.
        826. DISCLOSURE REQUIREMENTS.
        827. PENALTIES.
        828. RULES AND REGULATIONS.
  S 825. DEFINITIONS. AS USED IN THIS ARTICLE, THE FOLLOWING TERMS SHALL
HAVE THE FOLLOWING MEANINGS:
  1.  "PHARMACEUTICAL  MANUFACTURER"  SHALL MEAN A PERSON WHO COMPOUNDS,
MIXES, PREPARES, PRODUCES AND BOTTLES OR PACKS DRUGS FOR THE PURPOSE  OF
DISTRIBUTING  OR  SELLING TO PHARMACIES OR TO OTHER CHANNELS OF DISTRIB-
UTION.
  2. "MEDICAL DEVICE MANUFACTURER" SHALL MEAN A PERSON WHO MANUFACTURERS
AND PACKS, FOR THE PURPOSE OF DISTRIBUTING OR  SELLING  TO  HEALTH  CARE
PROVIDERS OR TO OTHER CHANNELS OF DISTRIBUTION:
  (A)   ANY  INSTRUMENT,  APPARATUS,  IMPLEMENT,  MACHINE,  CONTRIVANCE,
IMPLANT, IN VITRO REAGENT, OR OTHER SIMILAR OR RELATED ARTICLE,  INCLUD-
ING  A  COMPONENT  PART,  OR  ACCESSORY WHICH IS INTENDED FOR USE IN THE
DIAGNOSIS OF DISEASE OR OTHER CONDITIONS, OR IN  THE  CURE,  MITIGATION,
TREATMENT, OR PREVENTION OF DISEASE; OR

 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD10135-02-9

              

S. 3156                             2

  (B)  INTENDED TO AFFECT THE STRUCTURE OR ANY FUNCTION OF THE BODY, AND
WHICH DOES NOT ACHIEVE ANY OF  ITS  PRIMARY  INTENDED  PURPOSES  THROUGH
CHEMICAL  ACTION  WITHIN  OR  ON  THE  BODY OF A PERSON AND WHICH IS NOT
DEPENDENT UPON BEING METABOLIZED FOR  THE  ACHIEVEMENT  OF  ANY  OF  ITS
PRIMARY INTENDED PURPOSES.
  S  826. DISCLOSURE REQUIREMENTS. 1. ANY PHARMACEUTICAL MANUFACTURER OR
MEDICAL DEVICE MANUFACTURER, INCLUDING ANY EMPLOYEE  OR  AGENT  OF  SUCH
MANUFACTURER,  THAT  MAKES  ANY  GIFT,  WHETHER  IN  THE  FORM OF MONEY,
SERVICE, LOAN, TRAVEL, ENTERTAINMENT, HOSPITALITY, THING OR PROMISE,  OR
IN  ANY  OTHER  FORM, TO A HEALTH CARE PROVIDER SHALL REPORT THE GIFT TO
THE COMMISSIONER OF HEALTH IN THE MANNER SET FORTH IN SUBDIVISION TWO OF
THIS SECTION.
  2. ANY PHARMACEUTICAL MANUFACTURER OR MEDICAL DEVICE MANUFACTURER  WHO
MAKES  AT LEAST ONE GIFT UNDER SUBDIVISION ONE OF THIS SECTION SHALL, ON
OR BEFORE JUNE FIRST, FILE WITH THE COMMISSIONER  OF  HEALTH  AN  ANNUAL
REPORT,  OF  ALL  GIFTS  MADE  BY  SUCH MANUFACTURER TO SUCH HEALTH CARE
PROVIDER.
  3. SUCH ANNUAL REPORT SHALL CONTAIN:
  (A) THE NAME, ADDRESS  AND  TELEPHONE  NUMBER  OF  THE  PHARMACEUTICAL
MANUFACTURER OR MEDICAL DEVICE MANUFACTURER;
  (B)  AN ITEMIZED LIST CONTAINING A DESCRIPTION OF EACH GIFT SUBJECT TO
THE PROVISIONS OF SUBDIVISION ONE OF THIS SECTION;
  (C) THE NAME, ADDRESS AND TELEPHONE NUMBER OF THE HEALTH CARE PROVIDER
WHO RECEIVED EACH GIFT;
  (D) THE MONETARY VALUE OF EACH GIFT; AND
  (E) SUCH OTHER INFORMATION AS IS DEEMED NECESSARY BY THE  COMMISSIONER
OF HEALTH FOR COMPLIANCE WITH THIS ARTICLE.
  4. THE FOLLOWING SHALL BE EXEMPT FROM DISCLOSURE:
  (A)  THE  PAYMENT  OF  REASONABLE  COMPENSATION  AND  REIMBURSEMENT OF
EXPENSES IN CONNECTION WITH BONA FIDE CLINICAL TRIALS;
  (B) ANY GIFT THE VALUE OF WHICH IS LESS THAN SEVENTY-FIVE DOLLARS;
  (C) SCHOLARSHIP OR OTHER SUPPORT FOR MEDICAL STUDENTS,  RESIDENTS  AND
FELLOWS  TO ATTEND A SIGNIFICANT EDUCATIONAL, SCIENTIFIC, OR POLICY-MAK-
ING CONFERENCE OF A NATIONAL, REGIONAL, OR SPECIALITY MEDICAL  OR  OTHER
PROFESSIONAL  ASSOCIATION  IF  THE RECIPIENT OF THE SCHOLARSHIP OR OTHER
SUPPORT IS SELECTED BY THE ASSOCIATION;
  (D) UNRESTRICTED GRANTS FOR CONTINUING MEDICAL EDUCATION PROGRAM;S
  (E) PRESCRIPTION DRUG REBATES AND DISCOUNTS; AND
  (F) FREE SAMPLES OF DRUGS.
  S 827. PENALTIES. 1. THE COMMISSIONER OF HEALTH  MAY  IMPOSE  A  CIVIL
PENALTY  FOR FAILURE TO FILE A TIMELY REPORT AS REQUIRED BY THIS ARTICLE
IN AN AMOUNT UP TO FIFTY DOLLARS A DAY UNTIL SUCH  REPORT  IS  FILED  OR
THREE THOUSAND DOLLARS, WHICHEVER IS LESS.
  2.  ANY  PERSON WHO VIOLATES ANY OTHER PROVISION OF THIS ARTICLE SHALL
BE SUBJECT TO A CIVIL PENALTY IN AN AMOUNT NOT TO EXCEED THREE  THOUSAND
DOLLARS FOR EACH VIOLATION.
  S 828. RULES AND REGULATIONS. THE COMMISSIONER OF HEALTH IS AUTHORIZED
TO PROMULGATE RULES AND REGULATIONS AS DEEMED NECESSARY TO CARRY OUT AND
ENFORCE THE PROVISIONS OF THIS ARTICLE.
  S  2. This act shall take effect on the first of January next succeed-
ing the date on which it shall have become a law.