Pharma squeezed across the Western world

The ideas and innovators shaping health care

Aug 11, 2023 View in browser   By Evan Peng, Daniel Payne and Erin Schumaker WEEKEND READ Drug companies say new price controls in the U.S. and Europe will mean fewer new medicines. | Rick Bowmer/AP Photo The pharmaceutical industry is trying to fend off regulators on both sides of the Atlantic. By Sept. 1, the Biden administration is expected to announce the first 10 drugs for which it will seek price reductions for Medicare under a provision in last year’s Inflation Reduction Act. That’s prompted lawsuits from drugmakers — Johnson & Johnson, Merck, Bristol Myers Squibb and Astellas Pharma — plus the U.S. Chamber of Commerce and the industry’s Washington lobby, the Pharmaceutical Research and Manufacturers of America. Across the pond: In Europe, the industry faces major regulatory changes aimed at driving down prices as well, POLITICO’s Helen Collis reports. The EU’s proposed overhaul of its rules around medicines will fundamentally change the European pharma market’s competitiveness, drugmakers say. Planned changes announced in April will squeeze pharma’s market protections for new drugs unless they’re breakthrough treatments quickly made available to all EU citizens. Measures include cutting from eight to six years the period that data underpinning new drugs will be protected from competitors, affecting about a third of innovative drugs where their data-protection period outlasts their intellectual property protections. An extra six months’ market protection will be awarded to drugs that meet a high unmet medical need, with another six months if the company carries out comparative clinical trials, and an extra two years if companies make their products available in all EU countries within two years. China bound? Pharma executives say it’s impossible to meet those conditions as they stand and have threatened to move their European research abroad. “Science is fluid, and it moves away from Europe,” said Lars Fruergaard Jørgensen, CEO of Novo Nordisk and president of the European Federation of Pharmaceutical Industries and Associations. “Innovation then moves to the U.S., China,” he said at a June event held by the federation.   A NEW PODCAST FROM POLITICO: Our new POLITICO Tech podcast is your daily download on the disruption that technology is bringing to politics and policy around the world. From AI and the metaverse to disinformation and cybersecurity, POLITICO Tech explores how today’s technology is shaping our world — and driving the policy decisions, innovations and industries that will matter tomorrow. SUBSCRIBE AND START LISTENING TODAY.     WELCOME TO FUTURE PULSE Fenway Park, Boston | Shawn Zeller This is where we explore the ideas and innovators shaping health care. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Evan Peng at epeng@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, host Alice Miranda Ollstein talks with POLITICO’s White House correspondent, Adam Cancryn, about the millions of people states are removing from the Medicaid program as they reassess eligibility for the first time since the Covid pandemic — and how it's coming at the worst time for President Joe Biden. Listen to today’s Pulse Check podcast THE NEXT CURES The collaboration between Caltech and an artificial intelligence company is aiming for an HIV breakthrough. | Getty Images A potentially useful HIV treatment is getting an AI boost, courtesy of a grant from the Bill & Melinda Gates Foundation. Researchers at the California Institute of Technology are using a $1.1 million Gates Foundation grant to partner with Absci, a company using artificial intelligence to create new drugs. They hope to collaborate on affordable HIV therapeutic vaccinations. The vaccines are meant to be given to people who already have HIV to improve their bodies’ immune response to the virus. Why it matters: HIV still has no vaccine or cure, and while antiretroviral therapies have vastly improved outcomes for patients — or at least those who can access and afford them — the drugs don’t eliminate the virus and must be taken for life. The Caltech researchers, led by Drs. Pamela Bjorkman and Stephen Mayo, hope to develop a novel HIV therapy exploiting antibody binding sites that stay constant across virus strains. Absci offers generative AI that it says can speed up the synthetic antibody designing process. The goal is to create a vaccine that can potentially both treat and prevent infection while ensuring its affordability, scalability and accessibility.   YOUR TICKET INSIDE THE GOLDEN STATE POLITICAL ARENA: California Playbook delivers the latest intel, buzzy scoops and exclusive coverage from Sacramento and Los Angeles to Silicon Valley and across the state. Don't miss out on the daily must-read for political aficionados and professionals with an outsized interest in California politics, policy and power. Subscribe today.     DATA DIVE HHS wants to know when medical personnel respond to heat-related emergencies. | Jae C. Hong/AP Photo Heat-related illness will be tracked in a new way in the U.S., HHS said Wednesday, releasing a dashboard to track responses related to high temperatures from local emergency medical services. The tracker comes from the agency’s Office of Climate Change and Health Equity, in conjunction with the National Highway Traffic Safety Administration. Updated weekly, it shows that Arkansas, Nevada and Kansas have the highest rate of heat-related EMS responses. The data also shows that the national rate of heat-related responses has risen significantly — more than 40 percent — since 2018. Why it matters: The enhanced tracker’s introduction comes at a time when hospitals are reporting more heat-related illnesses, including burns from pavement or other hot surfaces. What’s next? The data will help direct resources to where they’re most needed and inform strategies to build resilience to rising temperatures — from planting more trees near pavement to opening cooling centers.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker Evan Peng @thepngfile   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.