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This week, PhRMA submitted comments to the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) regarding the Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization draft. In our comments, we expressed our strong opposition to policy proposals that would inhibit the biopharmaceutical industry partnering with the government to address pressing public health needs. With many PAHPA programs set to expire on September 30th and only a few legislative days left before the start of August work period, it is critical that lawmakers of both parties work together to ensure timely reauthorization of core programs authorized under PAHPA.
It is vital that members of Congress avoid harming the highly successful U.S. biopharmaceutical research ecosystem and the patients who need innovative treatments. In reauthorizing PAHPA, policymakers should focus on advancing a program vital to protecting the health of Americans, without undermining the development of tomorrow’s life-saving medicines.
As members of Congress evaluate this legislation that helps prepare for future public health emergencies, here are three key considerations to keep in mind:
- Continued partnerships and intellectual property protections are needed to address current and future public health crises.
America’s biopharmaceutical companies collaborated with hundreds of key health stakeholders at state, national and international levels to address the COVID-19 pandemic. These partnerships – paired with strong intellectual property (IP) protections – enabled the efficient research, development, manufacturing and delivery of vaccines and treatments to combat the virus. Between December 2020 and March 2022, U.S. vaccine efforts prevented 2.3 million deaths, 66 million infections, and saved $899 billion in health care costs. Timely reauthorization of PAHPA is key to fostering a policy environment that will support ongoing public-private partnerships and ensure pandemic preparedness long after our fight with COVID-19.
- Government price setting provisions would undermine America’s R&D ecosystem.
Unfortunately, so-called “reasonable pricing” clauses included in the draft legislation by Sen. Sanders, pose serious threats to medical innovation. We’ve been down that road before, and the result was disastrous for patients and taxpayers. In 1989, the National Institutes of Health (NIH) imposed similar “reasonable pricing” conditions on collaborative agreements between federal labs and outside parties to conduct research and development. The policy was subsequently revoked in 1995 after NIH concluded that it significantly chilled collaboration between the public and private sectors. Policymakers should reject this proposal that would upend our R&D ecosystem and jeopardize our ability to respond to future pandemics and public health emergencies.
- Addressing antimicrobial resistance should be a key priority.
Antimicrobial resistance (AMR) is a growing health crisis resulting in nearly 50,000 U.S. deaths and 1.27 million deaths globally each year – higher than HIV/AIDS and malaria. If we fail to address this urgent threat, many modern medical advances that depend on antibiotics – such as routine surgery, cancer therapy and treatment of chronic diseases – could be jeopardized. Having a robust pipeline of medicines to address AMR is a key part of pandemic preparedness, and we urge policymakers to incorporate the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2023 into PAHPA. This bipartisan legislation would support the development of new treatments that can fight off antibiotic-resistant pathogens.
While we can collectively take great pride in the efforts that ended the COVID-19 pandemic, it is critical that we build upon lessons learned to prepare for future public health emergencies. PhRMA and our members remain committed to bolstering pandemic preparedness and health care resiliency, and we will continue advocating for policy solutions to advance these important goals. We shouldn’t do anything to stand in the way of that continued progress.
Jocelyn Ulrich
Jocelyn Ulrich, MPH, is Vice President of Policy and Research at the Pharmaceutical Research and Manufacturers of America (PhRMA). At PhRMA, she is responsible for developing legislative and policy analysis and research studies on a range of issues impacting innovative biopharmaceutical companies including intellectual property issues, FDA policy issues, the R&D process, the value of innovation, and other issue areas impacting the environment for innovation. In addition to her experience at PhRMA she has over 15 years of experience in the pharmaceutical industry at Pfizer, Human Genome Sciences, and EMD Serono in roles in clinical research management, investigator-initiated and collaborative research, and global policy and corporate affairs. Jocelyn holds an MPH in global health policy and management from New York University.
Jocelyn Ulrich
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