SB 5035 — Concerning patients' access to investigational medical products.

S-1206.1SUBSTITUTES-0255.2SENATE SENATE BILL 5035State of Washington65th Legislature2017 Regular SessionBy Senate Health Care (originally sponsored by Senators Pedersen, Rivers, Cleveland, Becker, Keiser, Walsh, Conway, Bailey, O'Ban, Mullet, Kuderer, Darneille, and Wellman)READWellmanRead FIRSTfirst TIMEtime 02/03/17.AN01/11/17. ACT Relating to patients' access to investigational medical products;

Referred to Committee on Health Care.AN ACT Relating to patients' access to investigational medical products;

The use of available investigational drugs, biological products, and devices is a decision that should be made by the patient with a terminal illness in consultation with the patient's health care provider so that the decision to use an investigational drug, biological product, or device is made with full awareness of the potential risks, benefits, and consequences to the patient and the patient's family.The legislature, therefore, intends to allow terminally ill patients to use potentially lifesaving investigational drugs, biological products, and devices.NEW SECTION.  Sec. 2.  The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.(1) "Eligible patient" means an individual who meets the requirements of section 4 of this act.(2) "Health care facility" means a clinic, nursing home, laboratory, office, or similar place where a health care provider provides health care to patients.(3) "Hospital" means a health care institution licensed under chapter 70.41, 71.12, or 72.23 RCW.(4) "Investigational product" means a drug, biological product, or device that has successfully completed phase one and is currently in a subsequent phase of a clinical trial approved by the United States food and drug administration assessing the safety of the drug, biological product, or device under section 505 of the federal food, drug, and cosmetic act, 21 U.S.C.

355.(5)355.(3) "Issuer" means any state purchased health care programs under chapter 41.05 or 74.09 RCW, a disability insurer regulated under chapter 48.20 or 48.21 RCW, a health care service contractor as defined in RCW 48.44.010, or a health maintenance organization as defined in RCW 48.46.020.(6)48.46.020.(4) "Manufacturer" means a person or other entity engaged in the manufacture or distribution of drugs, biological products, or devices.(7)devices.(5) "Physician" means a physician licensed under chapter 18.71 RCW or an osteopathic physician and surgeon licensed under chapter 18.57 RCW.(8)RCW.(6) "Serious or immediately life-threatening disease or condition" means a stage of disease in which there is reasonable likelihood that death will occur within six months or in which premature death is likely without early treatment.NEW SECTION.  Sec. 3.  (1) An eligible patient and his or her treating physician may request that a manufacturer make an investigational product available for treatment of the patient.

Prior to making the investigational product available, the manufacturer shall enter into an agreement with the treating physician and the eligible patient providing that the manufacturer will transfer the investigational product to the physician and the physician will use the investigational product to treat the eligible patient.NEW SECTION.  Sec. 4.  A patient is eligible to request access to and be treated with an investigational product if:(1) The patient is eighteen years of age or older;(2) The patient is a resident of this state;(3) The patient's treating physician attests to the fact that the patient has a serious or immediately life-threatening disease or condition;(4) The patient acknowledges having been informed by the treating physician of all other treatment options currently approved by the United States food and drug administration;(5) The patient's treating physician recommends that the patient be treated with an investigational product;(6)product; The patient is unable to participate in a clinical trial for the investigational product because the patient's physician has contacted one or more clinical trials or researchers in the physician's practice area and has determined, using the physician's professional judgment, that there are no clinical trials reasonably available for the patient to participate in, that the patient would not qualify for a clinical trial, or that delay in waiting to join a clinical trial would risk further harm to the patient;

and(7)and(6) In accordance with section 5 of this act, the patient has provided written informed consent for the use of the investigational product, or, if the patient lacks the capacity to consent, the patient's legally authorized representative has provided written informed consent on behalf of the patient.NEW SECTION.  Sec. 5.  (1) Prior to treatment of the eligible patient with an investigational product, the treating physician shall obtain written informed consent, consistent with the requirements of RCW 7.70.060(1), and signed by the eligible patient or, if the patient lacks the capacity to consent, his or her legally authorized representative.(2) Information provided in order to obtain the informed consent must, to the extent possible, include the following:(a) That the patient has been diagnosed with a serious or immediately life-threatening disease or condition and explains the currently approved products and treatments for the disease or condition from which the eligible patient suffers;(b) That all currently approved and conventionally recognized treatments are unlikely to prolong the eligible patient's life;(c) Clear identification of the investigational product that the eligible patient seeks to use;(d) The potentially best and worst outcomes of using the investigational product and a realistic description of the most likely outcome.

or (iii) palliative or hospice care for an eligible patient who was previously treated with an investigational product but who is no longer being treated with an investigational product.NEW SECTION.  Sec. 7.  ASECTION.  Sec. 7.  (1) hospitalThis oract healthdoes carenot facility:(1)create May,a butprivate isright notof requiredaction.(2) to,A allow a health care practitioner whodoes isnot privilegedcommit tounprofessional practiceconduct orunder whoRCW is18.130.180 employedand atdoes not violate the hospitalapplicable orstandard healthof care facilityby:(a) toObtaining treat, administer, or provide an investigational product pursuant to an eligible patient under this chapter;(2)chapter;(b) MayAdministering establishan ainvestigational policyproduct regardingto treating,an administering,eligible orpatient providingpursuant investigationalto products under this chapter;

and(3)or(c) IsTreating notan obligatedeligible topatient paywith foran the investigational product orpursuant any harm caused to thethis eligiblechapter.(3) patientThe byfollowing thepersons product,and orentities anyare careimmune thatfrom iscivil necessaryliability asarising aout result of thetreatment use of thean investigationaleligible product,patient includingwith underan chapterinvestigational 70.170product, RCW.NEWother SECTION.  Sec. 8.  (1)than Thisacts actor doesomissions notconstituting creategross anegligence privateor rightwillful ofor action.(2)wanton misconduct:(a) A health care practitioner doeswho notrecommends commitor unprofessionalrequests conduct under RCW 18.130.180 and does not violate the applicable standard of care by:(a) Obtaining an investigational product pursuantfor to this chapter;(b) Administering an investigational product to an eligible patient pursuantin tocompliance with this chapter;

or(c)and(b) TreatingA anmanufacturer eligiblethat patientprovides with an investigational product pursuant to a health care practitioner in compliance with this chapter.(3)chapter.(4) The followingprotections persons and entitiesimmunities areset immuneforth fromin civilthis orsection criminalalso liabilityapply andin administrativesituations actionsin arisingwhich outa ofhealth treatmentcare ofpractitioner andenies eligiblea patientpatient's request for a treatment with an investigational product, othereither thanbecause actsthe orhealth omissionscare constitutingpractitioner grossbelieves negligencethere orare willfulmore effective treatments available or wantonbecause misconduct:(a)the Arequested healthtreatment careis practitionernot wholikely recommendsto orbe requestsbeneficial.NEW anSECTION.  Sec. 8.  The investigationalpharmacy productquality forassurance ancommission eligiblemay patientadopt inrules compliancenecessary withto implement this chapter;(b)chapter.Sec. 9.  RCW A69.04.570 manufacturerand that2012 providesc an117 investigationals product338 are each amended to aread healthas carefollows:Except practitioneras permitted by chapter 69.--- RCW (the new chapter created in compliancesection with11 of this chapter;act), no person shall introduce or deliver for introduction into intrastate commerce any new drug which is subject to section 505 of the federal act unless an application with respect to such drug has become effective thereunder.

and(c) A hospital or health care facility where an investigational product is either administered or provided to an eligible patient in compliance with this chapter.(4) The protections and immunities set forth in this section also apply in situations in which:(a) A health care practitioner denies a patient's request for a treatment with an investigational product, either because the health care practitioner believes there are more effective treatments available or because the requested treatment is not likely to be beneficial;

and(b) A hospital or health care facility does not allow a health care practitioner to provide treatment with an investigational product or enforces a policy it has adopted regarding treating, administering, or providing care with an investigational product.NEW SECTION.  Sec. 9.  The pharmacy quality assurance commission may adopt rules necessary to implement this chapter.Sec. 10.  RCW 69.04.570 and 2012 c 117 s 338 are each amended to read as follows:Except as permitted by chapter 69.--- RCW (the new chapter created in section 12 of this act), no person shall introduce or deliver for introduction into intrastate commerce any new drug which is subject to section 505 of the federal act unless an application with respect to such drug has become effective thereunder.

PROVIDED FURTHER, That if the director finds that the requirement of subsection (2) of this section as applied to any drug or class of drugs, is not necessary for the protection of the public health, he or she shall promulgate regulations of exemption accordingly.Sec. 11.  RCWaccordingly.Sec. 10.  RCW 69.50.101 and 2015 2nd sp.s.

355, or chapter 69.--- RCW (the new chapter created in section 1211 of this act) to the extent conduct with respect to the substance is pursuant to the exemption;

The term "useable marijuana" does not include either marijuana-infused products or marijuana concentrates.NEW SECTION.  Sec. 12.  SectionsSECTION.  Sec. 11.  Sections 1 through 98 of this act constitute a new chapter in Title 69 RCW.NEW SECTION.  Sec. 13.  IfSECTION.  Sec. 12.  If any provision of this act or its application to any person or circumstance is held invalid, the remainder of the act or the application of the provision to other persons or circumstances is not affected.--- END ---