35 PA Cons Stat § 5402 (2021)
2021 Pennsylvania Consolidated & Unconsolidated Statutes|Title 35 - HEALTH AND SAFETY|Chapter 54 - Cancer Trial Access for Pennsylvania Patients|Section 5402 - Legislative findings and intent

§ 5402. Legislative findings and intent. (a) Findings and declarations.--The General Assembly finds and declares as follows:  (1) A Pennsylvanian will be diagnosed with cancer approximately every four minutes, and a Pennsylvanian will die of cancer every 10 minutes. African-American Pennsylvanians in particular face higher rates of cancer incidence and mortality compared to other races and ethnicities.  (2) The ability to translate medical findings from research to practice relies largely on having robust and diverse patient participation in cancer clinical trials.  (3) A low participation rate or a homogenous participant group prevents segments of the population from benefiting from advances achieved through clinical research, creates uncertainties over the applicability of research findings and has proven to develop lifesaving drugs that work for some ethnic populations but not others.  (4) Conversely, some drug trials are canceled because they do not show promise for the current homogenous study population of patients but could be beneficial to other ethnicities who are not receiving the trial drug because of poor participation rates.  (5) Diverse patient participation in cancer clinical trials depends, in part, on whether a participant can afford ancillary medical and other costs, including transportation for clinical visits required by trial participation, which are not covered by standard of care, or lodging during the course of his or her participation. A national study in 2015 found that patient households making less than $50,000 annually were almost 30% less likely to participate in clinical trials.  (6) Another barrier to cancer clinical trial participation is the cost of travel, lodging and other expenses for a patient's travel companion, including a family member, friend, health care provider or chaperone that attends cancer clinical trial treatments to provide emotional, physical and mental support to the trial participant. Some trial participants are too old, too young or too ill to simply travel on their own.  (7) Cancer clinical trials often only cover the actual cost of the drug being tested and very rarely the direct costs of participation by a patient-subject. There are often significant expenses associated with enrollment in a clinical trial that are not covered by the clinical trial site or sponsor. These include travel expenses to and from the clinical sites whether by air, car, bus, train, taxi or public transportation along with the travel costs of parking, car rental, gas, tolls and lodging.  (8) This disparity threatens one of the most basic ethical underpinnings of clinical research, the requirement that the benefits of research be made available equitably among all eligible individuals.  (9) According to the National Cancer Institute, Cancer Clinical Trials Resource Guide, some of the barriers preventing individuals, with cancer or at high risk of developing cancer, from participating in clinical trials are direct and indirect financial and personal costs, including travel.  (10) Some corporations, individuals, public and private foundations, health care providers and other stakeholders are hesitant to contribute to or accept funds from programs that are organized to alleviate financial burdens faced by patients who wish to participate in clinical trials and their caregivers due to concerns that the United States Food and Drug Administration or other Federal regulators would view the payments made from those funds as prohibited inducements for patients to receive the health care services provided during clinical trials.  (11) While the United States Food and Drug Administration recently confirmed to Congress and provided guidance that, in fact, reimbursement of direct patient-incurred expenses is not inducement, many organizations, pharmaceutical companies, philanthropic individuals, charitable organizations, government entities and others still operate under the understanding that such reimbursement could be, in fact, considered inducement.  (b) Intent.--It is the intent of the General Assembly to enact legislation to define and establish a clear difference between what is considered inducement for a patient to participate in a clinical trial and direct reimbursement of patient-incurred expenses for participating in a cancer clinical trial.