By Warner Brown III
Throughout the country, millions of adults and children rely on federal programs like Medicaid to access healthcare. In California alone, more than 14 million people are enrolled in Medi-Cal, the state’s Medicaid program, making it one of the largest Medicaid populations in the nation.
Even with that coverage, many patients still struggle to afford the medicines they need. That’s why many life sciences companies have long operated voluntary patient assistance programs that provide free or deeply discounted medications to uninsured and underinsured individuals. These programs serve as an essential safety net, helping ensure that financial hardship doesn’t prevent patients from receiving lifesaving or life-changing treatments.
For many Californians, these programs are the difference between getting the care they need and going without it. But a bill moving through Sacramento threatens not only these vital patient assistance programs but also the innovation delivering the next generation of lifesaving therapies.
Assembly Bill 1776, introduced to strengthen California’s antitrust laws, could have far-reaching unintended consequences for patients. Its broad language creates significant legal uncertainty regarding many of the partnerships and pricing arrangements that enable patient assistance programs, clinical trials, and public health initiatives. Rather than expanding access to care, the bill could make it harder for underserved Californians to receive the medicines and treatments they need. If enacted, AB 1776 could treat voluntary patient assistance programs that provide medicines at little or no cost as unlawful “price-setting” arrangements, when in reality they are designed to ensure that financial hardship does not prevent patients from accessing lifesaving care.
By treating these voluntary programs as “antitrust violations,” the bill could invite competitors to challenge these programs in court, exposing innovators to baseless litigation. Since lawsuits are incredibly time-consuming and costly, the uncertainty alone could force companies to eliminate or scale back these vital patient assistance programs simply to avoid years of defending against frivolous claims. Resources that would otherwise be invested in expanding patient access could instead be diverted to legal fees and litigation, leaving California patients with fewer options and ultimately fewer treatments.
Additionally, AB 1776 could have far-reaching consequences for medical innovation. Our healthcare ecosystem depends on clinical trials, which often require exclusive partnerships between life sciences companies, researchers, and healthcare providers to ensure patient safety and meet the Food and Drug Administration’s rigorous approval standards.
AB 1776 could expose these standard research arrangements to antitrust challenges simply because they involve exclusive partnerships. In turn, the result could be delays or even the cancellation of scientifically rigorous clinical trials that deliver safe and effective new treatments to patients every day. Beyond research, AB 1776 could jeopardize arrangements that help make diagnostics and treatments for life-altering diseases such as HIV/AIDS, tuberculosis, and hepatitis B and C, affordable for patients. The current partnership between community health centers and local clinics, particularly those serving underserved and rural communities, is vital to ensuring they can stretch their limited resources and provide care to patients who might otherwise go without treatment.
Even more alarming, AB 1776 could undermine California’s ability to respond to future public health emergencies, as was essential during the COVID-19 pandemic. If innovators are threatened with legal liability, their hesitancy to take the steps needed to respond quickly in a public health crisis will skyrocket. During the pandemic, collaborations among a variety of individuals and organizations helped accelerate the development and delivery of vaccines, treatments, and diagnostics, and California should not adopt policies that would make such collaborations legally risky the next time an emergency arises.
If California wants to remain a leader in medical innovation, lawmakers must foster policies that encourage investment, research, and collaboration. Innovation and patient access go hand in hand, and protecting both is essential to ensuring Californians continue to benefit from the next generation of lifesaving treatments.
Warner Brown III PmHNP-BC is a Board-certified psychiatric nurse practitioner and community activist.
