S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   3932
 
                        2017-2018 Regular Sessions
 
                           I N  A S S E M B L Y
 
                             January 30, 2017
                                ___________
 
 Introduced  by M. of A. ROSENTHAL, GUNTHER, GALEF, ZEBROWSKI, BENEDETTO,
   ARROYO, COLTON, M. G. MILLER, COOK -- Multi-Sponsored by -- M.  of  A.
   BLAKE, SIMON -- read once and referred to the Committee on Health
 
 AN  ACT  to amend the public health law, in relation to establishing the
   "right to try act"

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section  1.  This act shall be known and may be cited as the "right to
 try act".
   § 2. The public health law is amended by adding a new article 29-CCCCC
 to read as follows:
                             ARTICLE 29-CCCCC
                             RIGHT TO TRY ACT
 SECTION 2994-AAA. DEFINITIONS.
         2994-BBB. MANUFACTURERS' OBLIGATIONS.
         2994-CCC. COVERAGE.
         2994-DDD. LIABILITY FOR PATIENT DEBT.
         2994-EEE. ACTIONS AGAINST LICENSE OR CERTIFICATION.
         2994-FFF. IMMUNITY.
         2994-GGG. ACCESS TO TREATMENT.
         2994-HHH. CAUSE OF ACTION.
   § 2994-AAA. DEFINITIONS. THE FOLLOWING WORDS  AND  TERMS  WITHIN  THIS
 ARTICLE  SHALL  HAVE  THE FOLLOWING MEANINGS, UNLESS THE CONTEXT CLEARLY
 INDICATES OTHERWISE.
   1. "TERMINAL ILLNESS", FOR PURPOSES OF  THIS  ARTICLE  ONLY,  MEANS  A
 PROGRESSIVE  DISEASE  OR  MEDICAL  OR  SURGICAL  CONDITION  THAT ENTAILS
 SIGNIFICANT FUNCTIONAL IMPAIRMENT, THAT IS NOT CONSIDERED BY A  TREATING
 HEALTH  CARE  PROVIDER  TO  BE  REVERSIBLE  EVEN  WITH ADMINISTRATION OF
 CURRENT UNITED STATES FOOD AND DRUG ADMINISTRATION APPROVED  AND  AVAIL-
 ABLE  TREATMENTS AND THAT, WITHOUT LIFE-SUSTAINING PROCEDURES, WILL SOON
 RESULT IN DEATH.
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD05460-01-7

 A. 3932                             2
 
   2. "ELIGIBLE PATIENT" MEANS AN INDIVIDUAL WHO MEETS ALL OF THE FOLLOW-
 ING CONDITIONS:
   (A)  HAS  A  TERMINAL  ILLNESS,  ATTESTED TO BY THE PATIENT'S TREATING
 HEALTH CARE PROVIDER.
   (B) HAS CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY  APPROVED  BY
 THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
   (C) HAS RECEIVED A RECOMMENDATION FROM HIS OR HER TREATING HEALTH CARE
 PROVIDER FOR AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
   (D)  HAS GIVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE INVESTIGA-
 TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
   (E) HAS DOCUMENTATION FROM HIS OR HER TREATING  HEALTH  CARE  PROVIDER
 THAT HE OR SHE MEETS THE REQUIREMENTS OF THIS SUBDIVISION.
   3.  "INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE" MEANS A DRUG,
 BIOLOGICAL PRODUCT OR DEVICE THAT HAS SUCCESSFULLY COMPLETED  PHASE  ONE
 OF A CLINICAL TRIAL BUT HAS NOT YET BEEN APPROVED FOR GENERAL USE BY THE
 UNITED  STATES  FOOD  AND DRUG ADMINISTRATION AND REMAINS UNDER INVESTI-
 GATION IN A UNITED STATES FOOD AND DRUG ADMINISTRATION-APPROVED CLINICAL
 TRIAL.
   4. "WRITTEN, INFORMED CONSENT" MEANS A WRITTEN DOCUMENT THAT IS SIGNED
 BY THE PATIENT; PARENT, IF THE PATIENT IS A MINOR;  LEGAL  GUARDIAN;  OR
 HEALTH  CARE AGENT DESIGNATED BY THE PATIENT UNDER ARTICLE TWENTY-NINE-C
 OF THIS CHAPTER AND ATTESTED TO BY THE PATIENT'S  TREATING  HEALTH  CARE
 PROVIDER  AND  A  WITNESS  AND  THAT,  AT A MINIMUM, INCLUDES ALL OF THE
 FOLLOWING:
   (A) AN EXPLANATION OF THE CURRENTLY APPROVED PRODUCTS  AND  TREATMENTS
 FOR THE DISEASE OR CONDITION FROM WHICH THE PATIENT SUFFERS.
   (B)  AN  ATTESTATION THAT THE PATIENT CONCURS WITH HIS OR HER TREATING
 HEALTH CARE PROVIDER  IN  BELIEVING  THAT  ALL  CURRENTLY  APPROVED  AND
 CONVENTIONALLY   RECOGNIZED  TREATMENTS  ARE  UNLIKELY  TO  PROLONG  THE
 PATIENT'S LIFE.
   (C) CLEAR IDENTIFICATION  OF  THE  SPECIFIC  PROPOSED  INVESTIGATIONAL
 DRUG, BIOLOGICAL PRODUCT OR DEVICE THAT THE PATIENT IS SEEKING TO USE.
   (D)  A DESCRIPTION OF THE POTENTIALLY BEST AND WORST OUTCOMES OF USING
 THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE AND  A  REALISTIC
 DESCRIPTION  OF  THE  MOST LIKELY OUTCOME. THE DESCRIPTION SHALL INCLUDE
 THE POSSIBILITY THAT NEW, UNANTICIPATED,  DIFFERENT  OR  WORSE  SYMPTOMS
 MIGHT RESULT AND THAT DEATH COULD BE HASTENED BY THE PROPOSED TREATMENT.
 THE  DESCRIPTION  SHALL BE BASED ON THE HEALTH CARE PROVIDER'S KNOWLEDGE
 OF THE PROPOSED TREATMENT  IN  CONJUNCTION  WITH  AN  AWARENESS  OF  THE
 PATIENT'S CONDITION.
   (E) A STATEMENT THAT THE PATIENT'S HEALTH PLAN OR THIRD PARTY ADMINIS-
 TRATOR  AND PROVIDER ARE NOT OBLIGATED TO PAY FOR ANY CARE OR TREATMENTS
 CONSEQUENT TO THE USE OF THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR
 DEVICE, UNLESS THEY ARE  SPECIFICALLY  REQUIRED  TO  DO  SO  BY  LAW  OR
 CONTRACT.
   (F) A STATEMENT THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE CARE MAY BE
 WITHDRAWN  IF  THE PATIENT BEGINS CURATIVE TREATMENT WITH THE INVESTIGA-
 TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE AND THAT  CARE  MAY  BE  REIN-
 STATED  IF THIS TREATMENT ENDS AND THE PATIENT MEETS HOSPICE ELIGIBILITY
 REQUIREMENTS.
   (G) A STATEMENT THAT THE PATIENT UNDERSTANDS THAT HE OR SHE IS  LIABLE
 FOR  ALL  EXPENSES  CONSEQUENT  TO  THE USE OF THE INVESTIGATIONAL DRUG,
 BIOLOGICAL PRODUCT OR DEVICE AND THAT  THIS  LIABILITY  EXTENDS  TO  THE
 PATIENT'S ESTATE, UNLESS A CONTRACT BETWEEN THE PATIENT AND THE MANUFAC-
 TURER OF THE DRUG, BIOLOGICAL PRODUCT OR DEVICE STATES OTHERWISE.

 A. 3932                             3
 
   § 2994-BBB. MANUFACTURERS' OBLIGATIONS. 1. A MANUFACTURER OF AN INVES-
 TIGATIONAL  DRUG, BIOLOGICAL PRODUCT OR DEVICE MAY MAKE AVAILABLE AND AN
 ELIGIBLE PATIENT MAY REQUEST THE  MANUFACTURER'S  INVESTIGATIONAL  DRUG,
 BIOLOGICAL  PRODUCT  OR DEVICE UNDER THIS SECTION. THIS SECTION DOES NOT
 REQUIRE  THAT  A  MANUFACTURER  MAKE  AVAILABLE AN INVESTIGATIONAL DRUG,
 BIOLOGICAL PRODUCT OR DEVICE TO AN ELIGIBLE PATIENT.
   2. A MANUFACTURER MAY:
   (A) PROVIDE AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR  DEVICE  TO
 AN ELIGIBLE PATIENT WITHOUT RECEIVING COMPENSATION; OR
   (B)  REQUIRE  AN  ELIGIBLE  PATIENT  TO PAY THE COSTS OF, OR THE COSTS
 ASSOCIATED WITH, THE MANUFACTURE OF THE INVESTIGATIONAL DRUG, BIOLOGICAL
 PRODUCT OR DEVICE.
   § 2994-CCC. COVERAGE. 1. THIS ARTICLE DOES  NOT  EXPAND  THE  COVERAGE
 REQUIRED  OF  AN INSURER UNDER THE INSURANCE LAW OR ANY OTHER APPLICABLE
 LAWS.
   2. A HEALTH PLAN, THIRD PARTY ADMINISTRATOR,  OR  GOVERNMENTAL  AGENCY
 MAY,  BUT IS NOT REQUIRED TO, PROVIDE COVERAGE FOR THE COST OF AN INVES-
 TIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE OR THE  COST  OF  SERVICES
 RELATED  TO  THE  USE  OF AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR
 DEVICE UNDER THIS ARTICLE.
   3. THIS ARTICLE DOES NOT REQUIRE ANY GOVERNMENTAL AGENCY TO PAY  COSTS
 ASSOCIATED WITH THE USE, CARE OR TREATMENT OF A PATIENT WITH AN INVESTI-
 GATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
   4.  THIS  ARTICLE  DOES NOT REQUIRE A HOSPITAL OR FACILITY ESTABLISHED
 UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER TO PROVIDE NEW OR  ADDITIONAL
 SERVICES, UNLESS APPROVED BY THE HOSPITAL OR FACILITY.
   5. THIS ARTICLE DOES NOT AFFECT ANY MANDATORY HEALTH CARE COVERAGE FOR
 PARTICIPATION IN CLINICAL TRIALS UNDER THE INSURANCE LAW OR OTHER APPLI-
 CABLE LAWS.
   §  2994-DDD. LIABILITY FOR PATIENT DEBT. IF A PATIENT DIES WHILE BEING
 TREATED BY AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT  OR  DEVICE,  THE
 PATIENT'S  HEIRS  ARE NOT LIABLE FOR ANY OUTSTANDING DEBT RELATED TO THE
 TREATMENT OR LACK OF INSURANCE DUE TO THE TREATMENT.
   § 2994-EEE. ACTIONS AGAINST  LICENSE  OR  CERTIFICATION.  A  LICENSING
 BOARD  OR  DISCIPLINARY  SUBCOMMITTEE  SHALL  NOT REVOKE, FAIL TO RENEW,
 SUSPEND OR TAKE ANY ACTION AGAINST  A  HEALTH  CARE  PROVIDER'S  LICENSE
 BASED  SOLELY  ON  THE PROVIDER'S RECOMMENDATIONS TO AN ELIGIBLE PATIENT
 REGARDING ACCESS TO OR TREATMENT WITH AN INVESTIGATIONAL  DRUG,  BIOLOG-
 ICAL PRODUCT OR DEVICE. AN ENTITY RESPONSIBLE FOR MEDICARE CERTIFICATION
 SHALL  NOT TAKE ACTION AGAINST A HEALTH CARE PROVIDER'S MEDICARE CERTIF-
 ICATION BASED SOLELY ON THE HEALTH CARE PROVIDER'S  RECOMMENDATION  THAT
 AN  ELIGIBLE  PATIENT HAVE ACCESS TO AN INVESTIGATIONAL DRUG, BIOLOGICAL
 PRODUCT OR DEVICE.
   § 2994-FFF. IMMUNITY. IF AS A  RESULT  OF  THE  INVESTIGATIONAL  DRUG,
 BIOLOGICAL PRODUCT OR DEVICE, A PATIENT'S SYMPTOMS WORSEN OR CHANGE OR A
 PATIENT  DIES, NO HEALTH CARE PROVIDER SHALL BE SUBJECT TO CIVIL LIABIL-
 ITY PROVIDED THAT SUCH HEALTH CARE PROVIDER PARTICIPATED IN  GOOD  FAITH
 COMPLIANCE  WITH  THE  PROVISIONS  OF THIS ARTICLE AND OBTAINED WRITTEN,
 INFORMED CONSENT FROM THE PATIENT.
   § 2994-GGG. ACCESS TO TREATMENT. AN OFFICIAL,  EMPLOYEE  OR  AGENT  OF
 THIS  STATE  SHALL  NOT  BLOCK OR ATTEMPT TO BLOCK AN ELIGIBLE PATIENT'S
 ACCESS TO AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR  DEVICE.  COUN-
 SELING,  ADVICE OR A RECOMMENDATION CONSISTENT WITH MEDICAL STANDARDS OF
 CARE FROM A LICENSED HEALTH CARE PROVIDER IS NOT  A  VIOLATION  OF  THIS
 SECTION.

 A. 3932                             4
 
   §  2994-HHH.  CAUSE  OF ACTION. THIS SECTION DOES NOT CREATE A PRIVATE
 CAUSE OF ACTION AGAINST  A  MANUFACTURER  OF  AN  INVESTIGATIONAL  DRUG,
 BIOLOGICAL  PRODUCT  OR  DEVICE  OR  AGAINST  ANY OTHER PERSON OR ENTITY
 INVOLVED IN THE CARE OF AN ELIGIBLE PATIENT  USING  THE  INVESTIGATIONAL
 DRUG,  BIOLOGICAL  PRODUCT  OR  DEVICE FOR ANY HARM DONE TO THE ELIGIBLE
 PATIENT RESULTING FROM THE INVESTIGATIONAL DRUG, BIOLOGICAL  PRODUCT  OR
 DEVICE,  IF  THE  MANUFACTURER OR OTHER PERSON OR ENTITY IS COMPLYING IN
 GOOD FAITH WITH THE TERMS OF THIS ARTICLE AND HAS  EXERCISED  REASONABLE
 CARE.
   §  3.  This  act shall take effect on the ninetieth day after it shall
 have become a law.