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New Law: Rights of the Terminally Ill to

Try Experimental Treatment

By Amy A. Edwards

The Legislature has created North Carolina Session Law 2015-137, a new article to be added to Chapter 90 of the General Statutes, which becomes effective October 1, 2015. It is known as “The Right to Try Act.” The purpose of the law is to authorize access to, and the use of, experimental treatments for patients with terminal illnesses. The government certainly has a strong interest in protecting patients from unsafe medical treatment (medications, biologicals, procedures, devices, etc.). However, when a patient has exhausted the traditional FDA approved treatment, this law allows him or her to take a risk that the experimental treatment is better than the inevitable result of terminal illness. A key feature of the law addresses the hesitation on the part of medical professionals and treatment manufacturers.  They might otherwise be afraid to try these treatments for fear of being sued by patients or their next of kin if the treatment is unsuccessful or causes harm to the patient. With the close interaction with, and guidance of, the treating physician, this law facilitates the decision of patients to explore all options.

Who is Eligible to Use Experimental Treatment?

In order to meet the eligibility requirements, someone must have an illness that is terminal. The new law defines terminal illness as a progressive disease or medical or surgical condition that:

(i) entails significant functional impairment, and

(ii) is not considered by a treating physician to be reversible even with available FDA approved treatments, and

(iii) will soon result in death without life-sustaining procedures.

The treating physician plays a pivotal role, and must certify that the terminally ill person meets the other eligibility requirements. The treating physician and patient must confirm they have considered the options approved by the U.S. Food and Drug Administration (FDA); The treating physician has recommended experimental treatment (the investigational drug, biological product, or device); and the patient has given a detailed informed consent in writing. The informed consent is extensive and includes the potentially best and worst outcomes resulting from use of the treatment.

Third Parties

No manufacturer can be required to provide experimental treatment, and manufacturers may choose to provide that treatment either for free or for a price.  If a patient dies after receiving experimental treatment, his or her heirs are not responsible for any outstanding debt related to the treatment, including any out-of-pocket costs when the deceased person did not have health insurance. When a manufacturer has made a good-faith effort to comply with this law, and has exercised reasonable care in doing so, there is no legal right for individuals to sue the manufacturer for any harm to the patient that results from the experimental treatment.

Licensing boards cannot revoke, fail to renew, suspend, or take other disciplinary action against healthcare providers when the only basis for doing so is that the provider recommends experimental treatment.  Although State employees, officials or agents may counsel a patient as needed based on reasonable medical standards, they are prohibited from attempting to block an eligible patient’s access to experimental treatment.

Amy A. Edwards is a family law attorney in Greenville, NC, certified by the NC State Bar Board of Legal Specialization as a Family Law Specialist, and is licensed only in NC. Laws change.  This article is current as of August of 2015.

www.AmyEdwardsFamilyLaw.com   © 2015.

 

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